Latest NEWS
Apr 16, 2018
Intezyne to Showcase Novel Cancer Resistance Pathway Inhibitor IT-139's Potential in Gastric Cancer at ChinaBio® Partnering Forum 2018 in Suzhou, PRC
TAMPA, Fla., April 16, 2018 /PRNewswire/ -- Intezyne, a clinical-stage biopharmaceutical company focused on developing novel cancer therapies, announced that President and CEO E. Russell McAllister will be attending the ChinaBio® Partnering Forum 2018 in Suzhou, PRC from April 25 - 26 and will be available for investor and partnering meetings in and around Shanghai, PRC from April 23 - May 1.
Intezyne's IT-139 is a novel Cancer Resistance Pathway (CRP) inhibitor for the treatment of pancreatic, gastric and other cancers in combination with existing anti-cancer therapies. IT-139 successfully completed a Phase 1 monotherapy study and was granted an Orphan Drug Designation (ODD) in pancreatic cancer. Additional ODDs are expected in the next 18 months. Intezyne is currently manufacturing IT-139 and expects to initiate one or more combination Phase 1/2 studies by early 2019.
Until the late 1930s, gastric cancer was the leading cause of cancer death in the United States. While gastric cancer is now an orphan disease in the United States, with approximately 26K cases of stomach cancer diagnosed annually, it remains one of the most challenging-to-treat and deadliest forms of cancer, accounting for 11k deaths annually.
Worldwide, however, gastric cancer remains the fifth most common cancer and second leading cause of cancer death, with a 5-year survival rate of patients with advanced gastric cancer of a meager 3%. In China, gastric cancer accounts for approximately 400k deaths annually, surpassed only by lung cancer.
In October 2017, the Food and Drug Administration (FDA) granted accelerated approval to Merck's checkpoint inhibitor Keytruda® (pembrolizumab) for use in patients with PD-L1 positive advanced gastric cancer. In the 259-patient Keynote-059 trial, approximately 12% of patients (16% of PD-L1 positive patients) experienced at least partial tumor shrinkage following treatment, showing the relatively low hurdle for potential approval in gastric cancer and significant unmet medical need. Importantly, IT-139 recently demonstrated synergy in combination with checkpoint inhibitors by reducing checkpoint blockade resistance.
"We are encouraged by significant investment and licensing interest from potential partners worldwide, particularly in China and Japan," stated E. Russell McAllister, CEO of Intezyne. "Supported by compelling preclinical and human safety data, we look forward to initiating IT-139 combination studies by early 2019 which should allow us to quickly demonstrate proof-of-concept of this promising first-in-class adjunctive therapy."
For more information, please visit the Company's website at www.intezyne.com.
Source: Intezyne, Inc.
Contact:
E. Russell McAllister, CEO
193374@email4pr.com, (813) 609-5017
SOURCE Intezyne Technologies, Inc.
Related Links http://intezyne.com
Apr 13, 2018
Data Showing that IT-139 Triggers Immunogenic Cell Death (ICD) to Be Presented at AACR 2018 Annual Meeting
TAMPA, Fla., April 13, 2018 /PRNewswire/ -- Intezyne, a clinical-stage biopharmaceutical company focused on developing novel cancer therapies, announced that the University of Vienna are presenting data showing IT-139's induction of Immunogenic Cell Death (ICD) at the American Association of Cancer Research (AACR) Annual Meeting 2018 in Chicago, Illinois from April 14-18.
Debora Wernitznig, MSc, a Doctoral Candidate in the lab of Michael Jakupec, PhD at the Institute of Inorganic Chemistry and the Translational Cancer Therapy Research Cluster at the University of Vienna, will be presenting a poster entitled, "KP-1339 (IT-139) Induces the Hallmarks of Immunogenic Cell Death in a Colon Cancer 3D Model In Vitro." Recent data show that molecular patterning from dying cells damaged by chemotherapy agents (specifically oxaliplatin) leads to signals that are recognized by the immune system and trigger an immune response, a mechanism called 'Immunogenic Cell Death (ICD)'. Certain proteins are hallmarks of ICD, and the data from Dr. Jakupec's group show that treatment with IT-139 also induces these proteins and triggers ICD.
"With a dedicated focus on translational anti-cancer drug development from bench to bedside, particularly structure-activity relationships of metal complexes in human cancer cell lines, we work closely with the Institute of Cancer Research of the Medical University of Vienna within the joint Translational Cancer Therapy Research Cluster," states Dr. Jakupec. "Our group uses multicellular colorectal cell spheroids as a model because we believe it more closely resembles the tumor microenvironment and better reflects aspects of what happens in vivo than traditional 2-D monolayer culture of cancer cells in vitro."
Prof. Dr. Dr. Bernhard Keppler, Dean of Faculty of Chemistry at the University of Vienna, Head of the Research Cluster for Translational Cancer Therapy Research, and a recognized pioneer of metal-based anti-cancer drugs and co-author of more than 600 scholarly and professional articles, is an important contributor to the abstract. Prof. Keppler originally synthesized IT-139 (KP-1339), selecting IT-139 (KP-1339) from out of more than 200 promising product candidates. Since acquiring IT-139 in 2014, Intezyne has collaborated with Prof. Keppler's team to unravel IT-139's novel and increasingly intriguing mechanism of action.
"It is rare that truly novel mechanisms of action are discovered, but the data increasingly suggest that IT-139 is the first of an entirely new class of anti-cancer agents that selectively target critical cancer cell resistance pathways," added E. Russell McAllister, CEO of Intezyne. "We are encouraged and excited by Prof. Keppler's ongoing contribution to the discovery and development of IT-139 (KP-1339), supported by the pioneering science conducted by Dr. Jakupec's group and other innovators at the joint Translational Cancer Therapy Research Cluster at the University of Vienna. With recent data showing synergy between IT-139 and checkpoint inhibitors adding to existing data showing synergy with directly cytotoxic anti-cancer therapies, we are increasingly excited at the opportunity ahead of us."
For more information about the University of Vienna's Translational Cancer Therapy Research Cluster, please visit their website at https://tctr.univie.ac.at/.
For more information, please visit the Company's website at www.intezyne.com.
Contact:
E. Russell McAllister, CEO
193368@email4pr.com, (813) 609-5017
SOURCE Intezyne Technologies, Inc.
Related Links http://www.intezyne.com
Apr 10, 2018
Combination of Checkpoint Inhibitors and Intezyne's Novel Cancer Resistance Pathway Inhibitor IT-139 Shows Enhanced Immune Efficacy
TAMPA, Fla., April 10, 2018 /PRNewswire/ -- Intezyne, a clinical-stage biopharmaceutical company developing novel anti-cancer therapies, announced exciting results from their ongoing preclinical studies of novel cancer resistance pathway inhibitor IT-139 in combination with immune checkpoint inhibitor molecules such as anti-PD-L1 and anti-CTLA-4, with IT-139's effect on reducing checkpoint blockade resistance showing enhanced immune efficacy in vivo. As a result, Intezyne anticipates exploring therapeutic combinations with existing and development-stage checkpoint inhibitors.
Intezyne's immune blockade combination studies draw on the premise that T cells are profoundly affected by stress, primarily due to increased protein synthesis, as more than 100 newly synthesized proteins are present on T cells under stress. This increased level of protein synthesis and folding required by activated, effector human T cells, which pack most of the punch when it comes to anti-tumor effects, lead to an exhausted and dysfunctional population of cells that have reduced efficacy against tumors. These weak cells often express increasingly high levels of inhibitory receptors including PD-L1 and CTLA-4. Intezyne's research goal is to provide insight into the molecular mechanisms of immune checkpoint inhibitor resistance which is critical to develop combinatorial drug therapy to potentiate therapeutic responsiveness.
GRP78 is the master regulator of the Unfolded Protein Response (UPR), and recent studies have shown that components of the UPR are upregulated after the development of checkpoint therapy resistance compared to before treatment. These findings indicate that UPR signaling may play a novel role in checkpoint inhibitor therapy resistance. Upregulated UPR signaling has also been shown to promote T cell dysfunction, which prevents immune-mediated cancer cell killing as well.
In the 2017 Annual AACR Meeting, the first symposium session for GRP78 and the UPR was held. The key speaker was Dr. Amy Lee from the Norris Cancer Center at USC, who presented her data showing IT-139's effect on GRP78. Dr. Lee's 2013 Oncogene article is recognized as one of their most highly cited papers, reflecting the growing interest in GRP78 and the UPR as important targets for cancer treatment. IT-139 is the only small molecule in clinical trials that targets GRP78. Additional data on IT-139 will be presented at the upcoming 2018 Annual AACR Meeting.
In vitro studies at Intezyne have shown increased anti-tumor effect and down regulation of GRP78, and by extension, the UPR and its pro-tumor effects, thus shifting the immune cell populations from exhausted and senescent towards non-exhausted and increasingly potent effector T cells.
For more information, please visit the Company's website at www.intezyne.com.
Contact:
E. Russell McAllister, CEO
193110@email4pr.com, (813) 609-5017
SOURCE Intezyne Technologies, Inc.
Related Links http://www.intezyne.com
Apr 9, 2018
Intezyne Promotes Adam Carie, PhD to Director, Product Development
TAMPA, Fla., April 9, 2018 /PRNewswire/ -- Intezyne, a clinical-stage biopharmaceutical company developing novel anti-cancer therapies, announced that it has promoted Adam Carie, PhD to Director, Product Development. In his new role, Dr. Carie will help identify compelling product development opportunities, lead internal formulation efforts for potential product candidates, and manage relationships with key external development partners.
"Since joining the company in 2008, Dr. Carie has been an integral part of the development of our current clinical and preclinical assets," said E. Russell McAllister, President and CEO of Intezyne. "Leveraging our extensive laboratory resources and our development expertise, we are able to rapidly formulate and optimize potential product candidates, creating a significant competitive advantage over slower and less nimble biopharmaceutical companies. Within a matter of weeks, we have taken products from concept to in vivo studies, a feat that has astounded both me and potential partners. As Intezyne transitioned from a research and development company to a clinical-stage oncology company, Dr. Carie contributed significantly while concurrently gaining invaluable practical development experience. I look forward enthusiastically to Dr. Carie's continued efforts creating new and exciting collaboration opportunities for Intezyne as Director of Product Development."
Intezyne currently has two clinical-stage programs: IT-139, a novel Cancer Resistance Pathway (CRP) inhibitor for the treatment of pancreatic, gastric and other cancers in combination with existing anti-cancer therapies, and IT-141, a novel topoisomerase I (TOP-I) inhibitor for the treatment of colorectal and breast cancers. IT-139 was granted an Orphan Drug Designation (ODD) in pancreatic cancer in early 2017, and Intezyne expects to initiate one or more Phase 1/2 studies of IT-139 by early 2019.
"I embrace the opportunity to expand my role within Intezyne and continue to build out a product portfolio focused on improving treatment options and quality of life for cancer patients," said Dr. Carie. "I have enjoyed contributing to the development of IT-141 from concept to clinic, and I am excited about working closely with the rest of the Intezyne team to successfully develop other new products in the future. With deep expertise in polymer and noble metal chemistry, drug product formulation and optimization, and manufacturing process development, we are in an excellent position to efficiently advance both new and existing assets while minimizing risk along the development path."
For more information, please visit the Company's website at www.intezyne.com.
Contact: E. Russell McAllister, CEO 192994@email4pr.com, (813) 910-2120
SOURCE Intezyne Technologies, Inc.
Related Links http://www.intezyne.com
Apr 9, 2018
Intezyne Promotes Bradford Sullivan, PhD to Director, CMC
TAMPA, Fla., April 9, 2018 /PRNewswire/ -- Intezyne, a clinical-stage biopharmaceutical company developing novel anti-cancer therapies, announced that it has promoted Bradford Sullivan, PhD to Director, Chemistry, Manufacturing, and Controls (CMC). In his new capacity, Dr. Sullivan will oversee manufacturing for Intezyne's IVECT polymers and active pharmaceuticals ingredients (APIs), providing crucial inputs to Intezyne's rapidly accelerating development efforts.
"Intezyne's core competencies are centered in complex polymer and noble metal chemistry, and as a skilled and accomplished chemist, Dr. Sullivan has contributed significantly to the evolution of Intezyne's technology and resulting products since joining the company in 2013, including developing critical manufacturing innovations that dictate the quality of our IVECT polymers. This is in addition to the successful transfer and scale-up of IT-139 manufacturing from our labs to our GMP manufacturing partner," said E. Russell McAllister, President and CEO of Intezyne. "It is my pleasure to recognize Dr. Sullivan's critical role at Intezyne with this promotion. As the company grows, I'm confident in his ability to successfully lead our CMC efforts, identifying creative and practical solutions to the manufacturing challenges that we will inevitably encounter."
Intezyne currently has two clinical-stage programs: IT-139, a novel Cancer Resistance Pathway (CRP) inhibitor for the treatment of pancreatic, gastric and other cancers in combination with existing anti-cancer therapies, and IT-141, a novel topoisomerase I (TOP-I) inhibitor for the treatment of colorectal and breast cancers. IT-139 was granted an Orphan Drug Designation (ODD) in pancreatic cancer in early 2017, and Intezyne expects to initiate one or more Phase 1/2 studies of IT-139 by early 2019.
"I'm humbled and honored by this decision," said Dr. Sullivan. "I'm fortunate to work with exemplary individuals at Intezyne, and I look forward to continuing to work collaboratively with them in my new role," said Dr. Sullivan. "As IT-139 manufacturing approaches completion, allowing the company to initiate Phase 1/2 studies by early 2019, with a third clinical-stage product potentially on the horizon, it's a tremendously challenging yet exciting time to be at Intezyne."
For more information, please visit the Company's website at www.intezyne.com.
Source: Intezyne, Inc.
Contact: E. Russell McAllister, CEO 192993@email4pr.com, (813) 910-2120
SOURCE Intezyne Technologies, Inc.
Related Links http://www.intezyne.com
Apr 6, 2018
Intezyne CEO E. Russell McAllister Selected as Tampa Bay CFO of the Year Finalist
TAMPA, Fla., April 6, 2018 /PRNewswire/ -- Intezyne, a clinical-stage biopharmaceutical company developing novel anti-cancer therapies, announced that the company's Chief Executive Officer (and former Chief Financial Officer), E. Russell McAllister, has been selected by the Tampa Bay Business Journal as one of twenty 2018 CFO of the Year honorees, one of only three CFO of the Year honorees in the Small Company category (based on 2017 revenues).
"We are delighted that Russell was selected as one of the Tampa Bay Business Journal's nominees in light of his significant and ongoing contribution to both Intezyne and the emerging life sciences industry in the Southeast United States," said David K. Robb, Director and President and Chief Operating Officer of Gaston Capital. "In November 2017, Intezyne's $10M Series A Preferred round, was recognized as 'Deal of the Year: Initial Funding' at the 19th Annual Southeast BIO (SEBIO) Investor & Partnering Forum, an award which recognizes both the companies and the individuals that are driving the growth of the Southeast's life sciences industry – and earlier in 2017, Intezyne was selected by Bioflorida as one of the top four emerging biopharmaceutical companies in Florida. Of those top four companies, Russell was CFO of two of them – hardly a coincidence, in our opinion."
"Drawing on our extensive investment experience, Gaston Capital Partners focuses on finding and investing in small private companies – predominantly those in the Southeast – poised for explosive growth," said Michael K. (Mick) McMahan, founder and Managing Partner of Gaston Capital. "With a compelling and disruptive oncology product candidate portfolio that addresses potentially unmet medical needs in challenging indications such as gastric cancer, which, while an orphan disease in the United States, is nevertheless the third leading cause of cancer mortality in China, Intezyne has the sort of explosive investment potential that we seek. As a result, Intezyne was the lead investment in the Gaston Capital Healthcare Fund."
Intezyne currently has two clinical-stage programs: IT-139, a novel Cancer Resistance Pathway (CRP) inhibitor for the treatment of pancreatic, gastric and other cancers in combination with existing anti-cancer therapies, and IT-141, a novel topoisomerase I (TOP-I) inhibitor for the treatment of colorectal and breast cancers. IT-139 was granted an Orphan Drug Designation (ODD) in pancreatic cancer in early 2017, and Intezyne expects to initiate one or more Phase 1/2 studies of IT-139 by early 2019.
"In light of an honoree group that includes peers from such prestigious entities as Moffitt Cancer Center, I am humbled to have been selected as a finalist," said E. Russell McAllister, CEO. "Momentum continues to build at Intezyne, and I look forward to leveraging our team's capabilities to develop breakthrough products that significantly improve outcomes for patients – which should, in turn, deliver 'explosive growth' for Mick and our other valued investors in a relevant time-frame."
For more information, please visit the Company's website at www.intezyne.com.
Source: Intezyne, Inc.
Contact: E. Russell McAllister, CEO 192929@email4pr.com, (813) 910-2120
SOURCE Intezyne Technologies, Inc.
Related Links http://www.intezyne.com
Mar 22, 2018
Data on Cancer Resistance Pathway Inhibitor IT-139 to be Presented at AACR 2018 Annual Meeting
TAMPA, Fla., March 22, 2018 /PRNewswire/ -- Intezyne, a clinical-stage biopharmaceutical company focused on developing novel cancer therapies, announced that Ayesha Shajahan-Haq, PhD, Assistant Professor of Oncology at the Georgetown Lombardi Comprehensive Cancer Center at Georgetown University, is presenting her most recent data related to IT-139's mitigation of drug resistance in breast cancer at the American Association of Cancer Research (AACR) Annual Meeting 2018 in Chicago, Illinois from April 14-18.
Dr. Shajahan-Haq's poster is titled: 'Inhibition of DNA Repair Pathways in Breast Cancer is a Potential Mechanism of Action of IT-139' and will be presented in the Experimental and Molecular Therapeutics Section under the New Agents and New Targets session.
Leveraging her expertise in mechanisms of drug resistance using a systems approach, Dr. Shajahan-Haq's continues to provide insight into how to both increase effectiveness and mitigate resistance against existing breast cancer therapies, including PARP inhibitors, with which IT-139 has demonstrated synergy. "Long-term treatment usually results in the remaining cancer cells becoming resistant to therapy. Knockdown of GRP78, a key gene in the unfolded protein response (UPR), can re-sensitize resistant cells," says Dr. Shajahan-Haq.
"We know that treating resistant cancer cell lines with IT-139 in combination with other anti-cancer therapies overrides resistance, but Dr. Shajahan-Haq, through her innovative approach, is identifying the precise pathways involved in IT-139's unique mechanism of action, which should provide clues as to the indications and sub-populations where IT-139 will be most clinically effective. IT-139's down-regulation of genes involved in the DNA repair pathway is also an important finding for combinations with targeted therapy – particularly PARP inhibitors – an area which will be explored in the near-future," stated Suzanne Bakewell, PhD, VP of Preclinical Development at Intezyne.
Intezyne's collaboration with Dr. Shajahan-Haq and Georgetown Lombardi originated through her research into cytotoxic stress pathways (including GRP78) in tumor cells that can lead to resistance. At the AACR Annual Meeting 2017, the first symposium session for GRP78 and the UPR was held which featured Intezyne collaborator Dr. Amy Lee, Associate Director for Basic Research at USC's Norris Cancer Center, who presented her data showing IT-139's effect on GRP78. Dr. Lee's 2013 Oncogene article is recognized as one of their most highly cited papers, reflecting the growing interest in GRP78 and the UPR as important targets for cancer treatment.
"On behalf of Intezyne, I enthusiastically congratulate Dr. Shajahan-Haq on this recognition of her important contribution to the rapidly growing field of research on cancer resistance," added E. Russell McAllister, CEO of Intezyne. "As our understanding of the unique mechanism of action of IT-139 continues to grow, so too does our excitement for its powerful therapeutic and commercial potential."
For more information, please visit the Company's website at www.intezyne.com.
Contact: E. Russell McAllister, CEO 192234@email4pr.com, (813) 609-5017
SOURCE Intezyne, Inc.
Related Links http://www.intezyne.com
Mar 19, 2018
5 questions with the new CEO of a Tampa biopharma aiming for an IPO
By: Margie Manning, Finance Editor | Tampa Bay Business Journal
Russell McAllister, newly named president and CEO of Tampa biopharma Intezyne, says he thrives on solving difficult puzzles.
Intezyne's focus on pancreatic and gastric cancers, both with low survival rates, presents just the challenge McAllister wants to tackle.
The company, one of the first pioneers in the University of South Florida Research Center, has raised $10 million in capital and is eyeing a larger funding round, in advance of a potential initial public offering. It has two drugs in development and just partnered with Exosome Diagnostics, a Waltham, Massachusetts-based company with a companion diagnostic for one of the potential Intezyne drugs.
"A 'companion diagnostic' is a diagnostic used alongside a therapy to help physicians determine whether it's working or not. Companion diagnostics are one of the waves of the future since they limit the resources wasted on therapies that aren't effective," McAllister said. "Some of the recent medical breakthroughs in cancer are therapies that are only effective against specific — often quite rare — mutant cancer strains, but they are highly effective against those particular strains. Consequently, quickly identifying if a patient has that particular strain is necessary."
McAllister succeeded Kevin Sill, the former CEO who has left the company. McAllister previously was chief financial officer at Intezyne. He joined the company in late 2016, after a stint as vice president of finance at Qu Biologics in Vancouver, and chief financial officer at Lakewood-Amedex Inc. in Sarasota. Prior to that, he spent much of his career in equity research and health care investment banking. He answered some questions from the Tampa Bay Business Journal after his promotion was announced.
Why did you move from investment banking to taking executive roles at biotech firms?
Equity research and investment banking involved analyzing and/or advising numerous emerging companies either in parallel or serially, respectively. While I found the work intellectually interesting — learning from the many strategic missteps that you observed, always solving new and varied challenges — I also found it ultimately unrewarding because the experiences were transient. The exception was a couple of the turnarounds that I worked on — some of those companies went on to become extremely successful — and that was rewarding. And I believe it was those experiences that ultimately compelled me to move to industry.
What interests/motivates you about developing treatments for cancer?
Everyone wants to feel that their job matters. In biopharmaceuticals — and cancer drug development — that impact is clear. While there is a constant and high risk of failure, if you can successfully advance a product candidate from point A to point Z, you can provide physicians with new treatment options and have a direct and meaningful impact on patients’ lives.
From my perspective, cancer touches everyone — at a high level, we’re good enough at treating infectious diseases and managing chronic cardiovascular and metabolic conditions that cancer is the area of greatest unmet need. I thrive on trying to solve the most difficult puzzles or at least be able to say that I tried. Consequently, I’m drawn to work on products for the most challenging diseases and indications, such as pancreatic and gastric cancers, as these are the patients who are the most desperate for true advances. The five-year survival rate — the proportion of patients still alive five years after diagnosis — for breast and prostate cancers is 90 percent and 99 percent, respectively; by comparison, for pancreatic cancer, it’s 8 percent. Put differently, breast cancer accounts for 15 percent of all new cancer diagnoses, but only 7 percent of deaths; pancreatic cancer accounts for only 3 percent of all new cancer diagnoses, but the same 7 percent of deaths. Trust me when I say you’d much rather be diagnosed with breast or prostate cancer than pancreatic or gastric cancer.
Ironically, I derive more personal satisfaction from some of my failures than my successes. More than a decade ago, I helped raise $70 million for a tiny $10 million company with a breakthrough stroke therapy, another area where the list of failed efforts far exceeds the list of successes. With that money, we ran two clinical studies. It didn’t work. But it was very much worth the effort and investment because that therapy had a real shot at working — and that would have mattered.
Does your promotion signal that Intezyne is moving closer to an IPO or at least additional funding?
I think my promotion signals that Intezyne is evolving and that the board felt that my experience and expertise allow Intezyne to identify and maximize the opportunities immediately in front of it. I have a lot of experience helping emerging biopharmaceutical companies transition from private to public, and that’s a useful strategic option to have. However, prior to going public, Intezyne will need to demonstrate that at least one of its products works — what we call ‘proof-of-concept’ — and getting there will require a solid strategy, additional funding and good execution. Right now, I’m focused on those areas.
Is Tampa a good place to grow a biopharma company? If so, why?
Tampa offers competitive advantages in some areas, such as the cost of lab space and cost of living, and competitive disadvantages in others, such as a fairly shallow talent pool and limited 'network effects' — the symbiotic benefits of growth industry clusters. The challenge for Intezyne is to exploit its competitive advantages while minimizing its competitive disadvantages, which it can do by, among other things, focusing on early development and formulation work and/or partnering with companies located in recognized biotechnology clusters. I’m still trying to figure out how to best leverage ‘days of intense sunshine,’ but I have a hunch that will help me with recruiting.
Who is filling the CFO role at Intezyne?
In the short-term, I am continuing to serve in that capacity, supported by the board and other Intezyne employees. In the intermediate-term, I expect that we will recruit someone to fill the CFO role, preferably someone with relevant industry experience.
Mar 16, 2018
Intezyne Partners With Exosome Diagnostics On IT-139 Companion Diagnostic
TAMPA, Fla., March 16, 2018 /PRNewswire/ -- Intezyne, a clinical-stage biopharmaceutical company developing novel anti-cancer therapies, announced that it has partnered with Exosome Diagnostics, a privately held company focused on developing and commercializing revolutionary biofluid-based diagnostics, to design and validate an assay for use in Intezyne's upcoming Phase 1/2 clinical trials of IT-139, a novel Cancer Resistance Pathway (CRP) inhibitor for the treatment of pancreatic, gastric and other cancers in combination with existing anti-cancer therapies.
"In order to optimize further clinical development of our novel Cancer Resistance Pathway (CRP) inhibitor, IT-139, we need a biomarker to stratify patients into potential responders and non-responders," said E. Russell McAllister, CEO. "After evaluating a number of potential partners and technologies, we selected Exosome to design and validate a GRP78 assay using their proprietary exosomal RNA platform technology."
"We are excited to leverage our patented ExoLution isolation kit, a cGMP-grade exosome RNA isolation platform, that provides increased sensitivity to develop a companion diagnostic for IT-139," stated John Boyce, President and CEO for Exosome Diagnostics. "Exploiting a novel mechanism of action, Intezyne's IT-139 has demonstrated remarkable potential to mitigate pan-cancer drug resistance. We are thrilled to utilize our leading expertise in the liquid biopsy field, potentially enabling such a promising therapeutic breakthrough."
Intezyne's IT-139 is a novel Cancer Resistance Pathway (CRP) inhibitor for the treatment of pancreatic, gastric and other cancers in combination with existing anti-cancer therapies. IT-139 successfully completed a Phase 1 monotherapy study and was granted an Orphan Drug Designation (ODD) in pancreatic cancer. Additional ODDs are expected in the next 18 months. Intezyne is currently manufacturing IT-139 and expects to initiate one or more combination Phase 1/2 studies by early 2019.
About Intezyne, Inc.
Intezyne is a clinical-stage biopharmaceutical company developing novel anti-cancer therapies that is headquartered at the USF Tampa Bay Technology Incubator. Intezyne currently has two clinical-stage programs: IT-139, a novel Cancer Resistance Pathway (CRP) inhibitor for the treatment of pancreatic, gastric and other cancers in combination with existing anti-cancer therapies, and IT-141, a novel topoisomerase I (TOP-I) inhibitor for the treatment of colorectal, gastric and other cancers.
For more information, please visit the Company's website at www.intezyne.com.
About Exosome Diagnostics, Inc.
Exosome Diagnostics is a privately held company focused on developing and commercializing revolutionary biofluid-based diagnostics to deliver personalized precision healthcare that improves lives.
Visit www.exosomedx.com to learn more.
Contact:
E. Russell McAllister, CEO
191944@email4pr.com, (813) 609-5017
SOURCE Intezyne, Inc.
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Mar 15, 2018
Intezyne Taps Veteran Banker E. Russell McAllister As President And CEO
TAMPA, Fla., March 15, 2018 /PRNewswire/ -- Intezyne, a clinical-stage biopharmaceutical company headquartered at the USF Tampa Bay Technology Incubator, announced that the company's Chief Financial Officer, E. Russell McAllister, has been selected as its next President and Chief Executive Officer.
"Since we recruited Russell to join Intezyne as Chief Financial Officer in late 2016, he has had a profoundly positive impact on Intezyne's development and corporate strategy," said Glenn Walthall, Chairman of the Board of Directors and Chief Investment Officer of Gaston Capital. "Russell's 20 years of experience in the biopharmaceutical industry, including senior roles in equity research and healthcare investment banking, and the resulting breadth and depth of his experience, made him the ideal candidate to become Intezyne's next CEO. The Board has great confidence in his ability to successfully lead the company through the next phase of its evolution."
"We enthusiastically hired Russell to help Intezyne optimally leverage its novel technologies, and that strategy is already paying off," added Hooshmand Sheshbaradaran, PhD, Director. "Intezyne's development strategy continues to rapidly evolve as new and compelling mechanism-of-action data emerges, including recent and intriguing data showing immunomodulatory activity of IT-139 in combination with checkpoint inhibitors."
Intezyne currently has two clinical-stage programs: IT-139, a novel Cancer Resistance Pathway (CRP) inhibitor for the treatment of pancreatic, gastric and other cancers in combination with existing anti-cancer therapies, and IT-141, a novel topoisomerase I (TOP-I) inhibitor for the treatment of colorectal, gastric and other cancers. IT-139 successfully completed a Phase 1 monotherapy study and was granted an Orphan Drug Designation (ODD) in pancreatic cancer. Intezyne is currently manufacturing IT-139 and expects to initiate one or more combination Phase 1/2 studies by early 2019. Concurrently, Intezyne continues to enroll patients in a Phase 1 dose-escalation study of IT-141.
"It's an honor to have been selected by the Board to lead Intezyne," said E. Russell McAllister. "After spending much of my career vetting technologies, I view Intezyne's product candidates as among the most compelling, with the potential to significantly improve outcomes for advanced cancer patients in a number of different indications. After building a strong organizational foundation in 2017, I expect 2018 to be a transformative year for Intezyne as we actively evaluate a variety of strategic options, including a pre-IPO Series B round and potential collaborations and licensing transactions with established biopharmaceutical and diagnostics companies worldwide, that would bring these promising product candidates closer to patients and physicians."
For more information, please visit the Company's website at www.intezyne.com.
Contact:
E. Russell McAllister, CEO
191835@email4pr.com, (813) 609-5017
SOURCE Intezyne, Inc.
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Nov 15, 2017
Intezyne's $10M Series A Preferred Round Wins SEBIO's 'Deal Of The Year'
TAMPA, Fla., Nov. 15, 2017 /PRNewswire/ -- Intezyne, a clinical-stage biopharmaceutical company developing novel anti-cancer therapies that is headquartered at the USF Tampa Bay Technology Incubator, announced that its recently closed $10M Series A Preferred round, led by North Carolina-based Gaston Capital, was recognized as the 'Deal of the Year: Initial Funding' at the 19th Annual Southeast BIO (SEBIO) Investor & Partnering Forum, held in Pinehurst, NC from November 14-16, 2017.
"On behalf of Southeast BIO's Awards Committee, I would like to congratulate Intezyne on their continued funding success, which potentially benefits cancer patients worldwide," said David Day, Executive Director, SEBIO. "Southeast BIO's Awards Program recognizes both the companies and the individuals that are driving the growth of the Southeast's life sciences industry."
"We are pleased to see Intezyne's successful fundraising efforts recognized by this award," added Mick McMahan, founder and Managing Partner of Gaston Capital. "As the lead investment in our newly launched Gaston Capital Healthcare Fund (GCHF), we remain excited about Intezyne's prospects as an emerging oncology company that could improve outcomes in some of the deadliest cancer indications."
Intezyne currently has two clinical-stage programs: IT-139, a novel Cancer Resistance Pathway (CRP) inhibitor for the treatment of pancreatic, gastric and BRAF-mutated cancers in combination with existing anti-cancer therapies, and IT-141, a novel topoisomerase I (TOP-I) inhibitor for the treatment of colorectal and breast cancers. IT-139 was granted an Orphan Drug Designation (ODD) in early 2017, and Intezyne expects to initiate parallel Phase 1/2 studies of IT-139 in pancreatic and gastric cancer in mid-2018. Recent pharmacokinetic (PK) data from the company's ongoing Phase 1 clinical study of IT-141 showed successful delivery of SN-38 far in excess of both Pfizer's Camptosar® (irinotecan) and Merrimack's Onivyde® (liposomal irinotecan), the latter of which was acquired by Ipsen in early 2017 for more than $1B.
"Following successful meetings with potential investors related to our just-launched pre-IPO $30M Series B round at the BIO Investor Forum in San Francisco and BIO-Europe in Berlin, we are thrilled to be recognized by SEBIO with this award," said CFO E. Russell McAllister. "In addition to raising additional funding, we're now actively exploring potential licensing transactions with established biopharmaceutical companies worldwide that are looking for disruptive oncology assets with blockbuster potential."
For more information, please visit the Company's website at www.intezyne.com.
For more information about Gaston Capital, please visit their website at www.gastoncapitalpartners.com.
For more information about SEBIO, please visit their website at www.sebio.org.
Contact:
E. Russell McAllister, CFO
185263@email4pr.com, (813) 910-2120
Oct 6, 2017
Intezyne Closes Oversubscribed $10M Series A Financing To Drive Rapid Oncology Portfolio Development
TAMPA, Fla., Oct. 6, 2017 /PRNewswire/ -- Intezyne Technologies, a clinical-stage biopharmaceutical company developing novel anti-cancer therapies, announced that it closed an oversubscribed $10M Series A Preferred round lead by existing investor Gaston Capital Healthcare Fund (GCHF). As part of the financing, David K. Robb, President and Chief Operating Officer (COO) at Gaston Capital, and Glenn Walthall, Chief Investment Officer (CIO) at Gaston Capital, joined Intezyne's Board of Directors.
Intezyne currently has two clinical-stage programs: IT-139, a novel Cancer Resistance Pathway (CRP) inhibitor for the treatment of pancreatic, gastric and BRAF-mutated cancers (including BRAF-mutated melanoma, lung cancer and thyroid cancer) in combination with existing anticancer therapies, and IT-141, a novel topoisomerase I (TOP-I) inhibitor for the treatment of colorectal and breast cancers. IT-139 was previously granted an Orphan Drug Designation (ODD) in the treatment of pancreatic cancer, of the most challenging-to-treat and deadliest forms of cancer, with 1-year and 5-year survival rates of only 20% and 8%, respectively. Gastric (stomach) cancer, while relatively rare in the United States, remains the fifth most common cancer and second most frequent cause of cancer death worldwide, with a 5-year survival rate of patients with advanced gastric cancer of a meager 3%. Preclinical data in both indications, supported by a previously completed Phase 1 safety study, suggest that IT-139 could meaningfully improve patient outcomes.
"This successful financing round puts the company on solid footing as we advance IT-139 and IT-141 through Phase 1/2 trials," said CEO Dr. Kevin Sill. "With compelling data and robust development rationales in a variety of different indications, our ongoing challenge is deciding which indications to prioritize in order to bring these potentially promising therapies to both patients and physicians as expediently as possible."
"In the coming months, we will be seeking additional capital from respected healthcare-focused institutional investors in a soon-to-be-launched $30M Series B Preferred round," said CFO E. Russell McAllister. "The Series B Preferred round is designed to fully fund the company through multiple Phase 2 trials, which should generate the data necessary for one or more lucrative development and commercialization partnerships and, subsequently, a compelling initial public offering (IPO). In the interim, we thank both existing and new investors in the Series A Preferred round for their enthusiastic support of Intezyne."
CEO Dr. Kevin Sill added, "Russell and I will be attending two major industry conferences in order to meet with investors and potential strategic partners: the BIO Investor Forum in San Francisco on October 16-18 and BIO-Europe in Berlin on November 6-8. We welcome any interest that investors, strategic partners, academic collaborators and clinical investigators might have in learning about our development programs."
For more information, please visit the Company's website at www.intezyne.com.
Contact:
Russell McAllister, CFO
Aug 10, 2017
ANOTHER SHOT
By: Business Observer
A foursome of young biotechnology entrepreneurs and Ph.Ds, backed by $3 million in private funds, got together in 2004 to form Intezyne. The goal then remains the same today: Use polymers to protect medication until it can reach cancer cells
The company is still around 13 years later. That itself is a major feat in the biopharmaceutical industry, which is long on promise, short on uber-successful gazelles. After more than $25 million in research and development investment, Intezyne has not generated a dime in profit on any of its products and won’t do so until 2022, at the earliest, say executives.
But Intezyne, after multiple almost-theres, could really be on to something this time.
The Tampa company achieved a significant — and potentially lucrative — regulatory milestone in June when it received an Orphan Drug Designation from the U.S. Food and Drug Administration for IT-139: a therapy designed to enhance the effectiveness of other anti-cancer therapies in treating pancreatic cancer.
The FDA’s ODD designation, intended to encourage development of treatments for “rare” diseases that are poorly addressed by existing therapies, grants Intezyne up to seven years of “post-approval market exclusivity,” assistance in protocol design and an exemption from Prescription Drug User Fee Act (PDUFA) fees — key affirmations in the company’s quest to develop “first-in-class” products designed to improve the effectiveness of cancer-fighting drugs.
“This is a very exciting time for the company,” Intezyne CEO and co-founder Kevin Sill says. “It has taken a lot of dollars and manpower for us to advance to where we are.”
‘A SHARED PASSION’
Sill was part of the four founders of the company in 2004, when they all were fresh out of grad school. They started the business in a 3,000-square-foot laboratory in the Tampa Bay Technology Incubator at the University of South Florida’s Research Park in north Tampa. Intezyne was the TBTI’s first tenant and remains based there.
The company has evolved over the years as it changed from a research-oriented operation to clinical testing, at one time employing 19 people full-time, 12 of them research scientists. Intezyne currently employs nine people. “It was necessary to downsize the company as it transitioned from a research-focused company into a development-focused company in order to reduce overhead,” Sill says.
Intezyne’s CFO, E. Russell McAllister, who joined Intezyne last November after advising public and private biopharmaceutical companies in New York, San Francisco and, most recently, Vancouver, says he was drawn to the company because of its “extreme innovation and the resulting potential of its products.”
Passion for what they do is another key element that has helped Intezyne and its employees persist, McAllister says. “Everyone at Intezyne shares a passion for helping cancer patients,” he says. “Cancer touches everyone. It is encouraging to know that if your company is successful, there are people out there, perhaps even your own family members, who will be living longer and healthier lives as a result. There are not a lot of industries where you can say that.”
Sill agrees, noting, “Technology is really the driver, with remarkable potential to impact and extend patients’ lives. That was the key driver even through the most challenging times.”
The company’s IT-139 could prove particularly useful in treating pancreatic cancer, the fourth most common cancer in the U.S., with approximately 54,000 new diagnoses annually. It is notoriously difficult to treat, with one-year survival rates of only 20% and five-year survival rates of 8%.
Other biopharma companies attempting to develop therapies for pancreatic cancer have failed. But Intezyne thinks it has a viable shot at improving these numbers.
PROFOUND IMPACT
Although IT-139 is Intezyne’s most advanced product, it’s not its only innovation. The company recently initiated a Phase 1 study of its second product, IT-141, at the Mary Crowley Cancer Research Center in Dallas. This trial, which focused primarily on safety and a related expansion trial that will also focus on patient outcomes, are expected to be completed by March 2019.
While IT-139 is a small-molecule drug that uses the rare metal ruthenium to inhibit GRP78, a critical cell survival pathway, IT-141 uses Intezyne’s proprietary nanoparticle delivery platform to deliver an existing drug – in this case, irinotecan – directly to tumors, increasing treatment efficacy while reducing negative side effects.
“Importantly, Intezyne is not inventing new drugs, but instead improving existing drugs with our technology,” McAllister says.
Sill further explains the science: “Intezyne uses a special polymer, or plastic, to form ‘nanocapsules’ invisible to the naked eye that are then wrapped around the medication, shielding it until it gets to where it is needed, at which time the capsules disintegrate.”
Intezyne’s nanoparticle platform delivery technology is “ingenious in its simplicity; profound in its impact,” McAllister says.
“In conventional treatment, relatively little of the cancer drugs that are administered go where they’re supposed to go because they are distributed systemically, or everywhere,” McAllister says.
It’s this incidental dissemination that creates many of the unpleasant or even life-threatening side effects commonly associated with chemotherapy. If Intezyne is successful, McAllister notes, cancer patients will get “more drug where you want it, and less drug where you don’t.”
CHALLENGES AHEAD
According to the Pharmaceutical Research and Manufacturers of America (PhRMA), on average, it takes at least 10 years and costs $2.6 billion for a new medicine to progress from discovery to marketplace. Clinical trials often take seven years. Even then, PhRMA documents, the “overall probability of clinical success — the likelihood that a drug entering clinical testing will eventually be approved — is estimated to be less than 12%.”
This high-risk, high-reward environment is why costs for cutting-edge drugs are so high and why so few biopharma companies survive to see their products commercialized, McAllister explains.
“The resources required to get there are so expansive that only the big multinational biopharma corporations — Pfizer, Merck, AstraZeneca, Roche — can afford to do the necessary research,” he says. “It takes an extremely long time and an investment of hundreds of millions of dollars to successfully develop a cancer drug.”
In essence, Intezyne’s goal is to go out of “business.” “With rare exception, the goal of small biopharma companies like us is to either license our products to one of these companies or be acquired by them – and that’s certainly our plan,” McAllister says. “Instead, our products would be sold by a ‘big pharma’ company like GlaxoSmithKline, Pfizer, or AstraZeneca.”
But before it can license products or be acquired, Intezyne first has to successfully demonstrate its products work. And that’s a daunting challenge. To generate the necessary data, Intezyne will need to invest another “$10 to $15 million over the next two years and then go public to provide adequate funding for the next set of trials, which could cost upwards of $50 million,“ McAllister says. “We’re currently on an IPO trajectory for late 2018 or early 2019.”
Until then, Intezyne must continue to solicit qualified investors at industry events such as June’s 2017 BIO International Convention in San Diego, where, according to articles in trade and medical journals, IT-139 and IT-141 attracted significant attention from both prospective backers and potential strategic partners.
McAllister says Intezyne recently secured a $10 million-plus investment from “an institutional investor, a health care-focused fund,” he declined to identify. The company has otherwise been financed by “accredited, high-net-worth individual investors and family offices,” he adds.
Ultimately, Sill says, “The limiting factor in advancing our products is funding, and raising capital (in the Tampa Bay area) is quite difficult. There are no established institutional life science funds in the area, and, as a result, we will likely have to look outside the Southeast to find suitable investors for our Series B round.”
The irony, Sill adds, is Intezyne could never have gotten to where it is if it had not been for its 12-year tenancy at the USF technology incubator, as well as assistance from Hillsborough County and the city of Tampa. “It is extremely cost-effective lab space compared to similar facilities in Boston or San Francisco,” he says. “It’s been a big asset.”
McAllister agrees: Intezyne’s labs are substantially better equipped and cost a mere fraction of competitors’ space in ‘traditional’ biopharma hubs.
However, as Intezyne grows, its ability to stay in Tampa becomes a growing challenge.
“We would love to stay and become Tampa’s first homegrown biopharma success story, which would encourage other biopharma companies to follow suit, but it’s getting harder and harder to do so,” Sill says. “We would prefer to stay in the area but circumstances may dictate we go elsewhere. We’ll address that when the time comes.”
Jul 28, 2017
BIOTECH NURTURED AT USF RESEARCH IS ON THE BRINK OF BIG BREAKTHROUGHS
By: Margie Manning, Finance Editor | Tampa Bay Business Journal
About 13 years after Intezyne Technologies Inc. became one of the first pioneers in the University of South Florida Research Center, the clinical stage oncology company is on track for regulatory approval of two cancer treatments and is eyeing an initial public offering.
Intezyne hopes to go public in 2019, Russell McAllister, chief financial officer, said during a July 20 presentation for the Tampa Bay chapter of BioFlorida.
If the company can achieve its goal, it would be a major benchmark in the continued growth of the life sciences industry in the state, one of the key focuses for economic developers in part because of the high-skill, high-wage jobs the industry provides. In the biotechnology sector, specifically, nearly 83,000 Floridians work at 5,895 companies, with an average annual wage of $77,622, a fact sheet from BioFlorida says.
Success for a company such as Intezyne would be particularly sweet because it is homegrown. The company was founded by four scientists from the University of Massachusetts, and launched operations in 2004 at USF in Tampa, the hometown of one of the founders, former CEO Habib Skaff.
Skaff stepped down in 2016, and Kevin Sill, a co-founder and chief science officer, was named CEO. McAllister, previously vice president of finance at Qu Biologics in Vancouver and chief financial officer at Lakewood-Amdex in Sarasota, joined Intezyne in November.
About $30 million has been invested in Intezyne to date, McAllister said, and the company is in the midst of an additional $10 million equity raise; all but $3 million of that has been raised so far.
The company has 134 issued patents, with 32 patents pending.
The two products in the pipeline have lots of potential but unassuming names right now.
IT-141 is a formulation of a well-known cancer-fighting compound that previously has been used in Camptosar, a blockbuster product from Pfizer that generates sales of more than $1 billion annually. The compound doesn’t dissolve in water and can’t be injected, making it difficult to use effectively until now, Intezyne said. Intezyne developed an alternative way to administer the compound so it can be administered intravenously. It launched its first in-human trials in March.
“We think we will have a shot at significantly improving outcomes for colorectal cancer patients,” McAllister said.
While IT-141 was developed in-house, the second product, IT-139, was acquired by Intezyne when it bought Niiki Pharma in Hoboken, New Jersey in 2013. It’s a drug used with existing cancer drugs to make them more effective, McAllister said.
In June, IT-139 won “orphan drug designation,” a Food and Drug Administration program that provides benefits to support development of promising drugs for rare diseases. Those benefits include seven-year post-approval market exclusivity, FDA involvement in the development process and clinical trial designs, and exemption from user fees.
Intezyne said in a press release that it would be used to treat pancreatic cancer, the fourth most common cancer in the United States but one that has proven extremely difficult to treat.
The drug has been through a Phase 1 trial and Intezyne is manufacturing the drug now. It expects to launch a Phase 1b/2a study next year.
Intezyne hopes to get new drug approvals from the FDA in 2022 for IT-139 and in early 2023 for IT-141.
IT-139 “probably has greater overall market potential, because it could be used with drugs from lots of different classes” McAllister told Bioworld Today in April.
Jun 20, 2017
Intezyne Technologies Granted Orphan Drug Designation For IT-139 In Pancreatic Cancer
TAMPA, Fla., June 20, 2017 /PRNewswire/ -- Intezyne Technologies, a clinical-stage biopharmaceutical company developing novel anti-cancer therapies, announced that that the Office of Orphan Products Development of the Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to IT-139, the most clinically advanced GRP78 inhibitor in development for solid tumors, for the treatment of pancreatic cancer. The FDA's Orphan Drug program provides numerous benefits to support development of promising drugs for rare diseases, including 7-year post-approval market exclusivity, FDA assistance in protocol design, and an exemption from PDUFA fees.
"Our receipt of an Orphan Drug Designation for IT-139 in pancreatic cancer is an exciting regulatory milestone for Intezyne and a critical step towards clinical advancement of this promising first-in-class therapy addressing an unmet need," stated Dr. Carolyn Paradise, Intezyne's Chief Medical Officer. "Pancreatic cancer is currently the fourth most common cancer in the U.S., with approximately 54,000 new diagnoses annually, the majority of which are diagnosed only after their cancer has spread locally and/or metastasized to distant organs. Sadly, pancreatic cancer has proven extremely difficult to treat, with 1-year and 5-year survival rates of only 20% and 8%, respectively – rates which we hope to improve with IT-139."
The Company's previously completed Phase 1 monotherapy trial of IT-139 showed that it was well-tolerated, with manageable side effects, and successfully demonstrated anti-tumor activity in numerous tumor types. Preclinical studies have shown IT-139's synergy in combination with various other anti-cancer agents including taxanes, platinums, and gemcitabine – the typical first-line therapies for patients with locally advanced or metastatic pancreatic cancer.
Dr. Suzanne Bakewell, Vice President and Program Manager for IT-139 added, "Since completing our Phase 1 monotherapy trial of IT-139, we have been working with academic collaborators to fully characterize IT-139's mechanism of action (MOA) – efforts which have yielded exciting results thus far. IT-139 downregulates the stress-induction of GRP78 in cancer cells, a critical cell survival protein that is associated with both drug resistance and tumor proliferation. GRP78 expression is not elevated in the same way in normal cells, leaving them unaffected."
Dr. Kevin Sill, CEO of Intezyne, commented, "Intezyne is currently completing cGMP manufacturing for IT-139 in anticipation of initiating one or more combination Phase 1b/2a studies in 2018. The synergy with low toxicity observed preclinically in combination with existing anti-cancer agents has already generated considerable attention from both investors and potential strategic partners, a number of whom Russell and I will be meeting this week at the 2017 BIO International meeting in San Diego."
For more information, please visit the Company's website at www.intezyne.com.
Contact:
E. Russell McAllister, CFO
164938@email4pr.com, (813) 910-2120
SOURCE Intezyne Technologies, Inc.
Apr 6, 2017
TIME TO SHINE, INTEZYNE: NANOPARTICLE ENTERS CLINIC, GRP78 WORK MARCHING ON
By: Randy Osborne, Staff Writer | BIOWORLD TODAY
Intezyne Technologies Inc. should find itself “on an IPO trajectory for late 2018 or early 2019,” its chief financial officer (CFO), Russell McAllister, told BioWorld Today, “coinciding with potential licensing deals for both” lead candidates owned by the Tampa, Fla.-based company. He forecast “a lot of interesting things on the financing and licensing fronts,” as the firm raises money privately while gathering data on both candidates that could spark deals.
First-in-human trials have just begun with Intezyne’s topoisomerase-1 inhibitor, IT-141, which encapsulates within a tumor-targeting micelle nanoparticle SN-38, the active metabolite of New York-based Pfizer Inc.’s colorectal cancer drug, Camptosar (irinotecan), and Cambridge, Mass.-based Merrimack Pharmaceuticals Inc.’s Onivyde (liposomal irinotecan) for pancreatic cancer. At the start of the year, Merrimack sold Onivyde along with its generic version of Doxil (liposomal doxorubicin hydrochloride, Janssen Products LP) to Ipsen SA, of Paris, in a potential $1 billion-plus deal – “quite large dollars, given Onivyde’s commercial sales to date,” McAllister said. (See BioWorld Today, Jan. 10, 2017.)
Intezyne CEO Kevin Sill said the company is “currently screening patients [for the IT-141 trial]. We hope to dose within the next two weeks. I imagine next week, but I’ll say two weeks to be safe. The study is active and recruiting.”
Sill noted that irinotecan is “used off label in many gastrointestinal cancers, including gastroesophageal, pancreatic, lung, ovarian, all sorts of different indications. It’s widely known to be effective, but delivering or getting more of the drug to the tumor environment and less to healthy tissues should allow for a much more effective yet safer treatment option.” IT-141, he said, is “well positioned to be a next generation of the irinotecan class of compounds,” and Intezyne is “the only group that’s delivering SN38 directly. That way we’re able to bypass one of the metabolism limitations of irinotecan. We’re hoping to access the patient population that is intolerant of irinotecan or does not respond well.”
CFO McAllister said IT-141, as a new entrant into the class, is “not specifically targeting irinotecan-resistant patients or irinotecan treatment failures” but aiming for a “really broad audience” made of many solid tumor types. “That’s based on approvals for irinotecan, but also there have been a lot of investigator-sponsored studies not specifically on label,” he said.
Despite inefficient delivery (less than 4 percent of irinotecan successfully converts into SN-38, of which only a fraction reaches the tumor), Camptosar became one of Pfizer’s blockbuster products, generating sales of more than $1 billion annually. It remains on the World Health Organization (WHO) List of Essential Medicines. IT-141 was developed in-house, CEO Sill said. “The company was founded around the [nanoparticle] delivery technology. We’ve been working on this for many years.”
At this week’s American Association for Cancer Research meeting, another Intezyne candidate, IT-139 – a glucoseregulated protein 78 (GRP78) inhibitor and the most clinically advanced one in development for solid tumors – was featured in a symposium. The phase I trial with IT-139 showed that it was well-tolerated with manageable side effects, and turned up antitumor activity in numerous types. “We’ve seen synergy both in vitro and in vivo with essentially all classes of compounds that we’ve evaluated,” Sill said. “The challenge for us is to carefully consider all of these data and identify the true lead indications and how we’re going to best utilize this drug.”
EVIDENCE MOUNTS FOR GRP78
CFO McAllister said IT-139 goes after a proliferation and survival pathway that, although known, “was off the radar until relatively recently” but “has gained prominence and fits very well into the current thrust of cancer treatment,” since it combines well with other therapies. “While the data from the phase I showed it has potential as a monotherapy, we’re really focused on adjunctive use,” in order to “defeat resistance to many anticancer agents, including the PD-L1s. That should be very exciting to people, because a lot of these compounds are very effective and then lose that effectiveness within three to six months. We think we could extend that window significantly.”
IT-139 is in the lead “from a clinical perspective,” McAllister said, although the current focus of the company is on IT-141. “We are manufacturing IT- 139 and that’s a somewhat lengthy process, so we won’t have clinical material available until late this year,” he said. The question of which compound might benefit the company most is “a tricky one. I would tend to think IT-139 probably has greater overall market potential, because it could be used with drugs from lots of different classes. We’ll put it back into [the clinic with] a phase Ib in early 2018.”
As long ago as 2004, research published in Cancer Cell established GRP78 as worthy of investigation. Work done by scientists from the University of Texas M.D. Anderson Cancer Center in Houston and the University of Sao Paolo, Brazil, began when the protein GRP78 was discovered on the cell surface of metastatic prostate tumors. Inside the cell, GRP78 is involved in the cellular stress response. Specifically, it was found to be a chaperone protein that interacts with other proteins and helps them fold into shape. (See BioWorld Today, Oct. 1, 2004.)
Last October, scientists at Wake Forest Baptist Center succeeded in enhancing and restoring sensitivity to an estrogen-blocking drug in estrogen-responsive tumors in an animal model. Breast cancer is the most frequently diagnosed cancer among women, with estrogen receptor-positive being the most common type. The research findings were published in Cancer Research. Scientists first tested a GRP78-targeting molecule called a morpholino, which can modify gene expression.
The morpholino compound successfully inhibited GRP78 and restored sensitivity to the estrogen modulator tamoxifen in the resistant tumors. Metabolic analysis of breast cancer cells showed that suppressing GRP78 increased the intracellular concentrations of essential polyunsaturated fats, including linoleic acid, which could mean GRP78 plays a part in mediating cellular lipid metabolism. The same tumor-bearing mice were treated with different doses of linoleic acid and it turned out that this approach had the same effect as targeting GRP78 in restoring tamoxifen sensitivity to the tumors, Wake Forest said.