Commercialization of a Novel Approach to Saving Lives
New York, New York-based HiberCell recently launched with the goal of preventing cancer relapse and metastasis. A noble, and important goal—and some could argue—based on paradigm shifting science representing the next chapter in our war against cancer. If proven to be commercially viable, millions could then benefit by keeping their loved ones longer and the investors and founders of this fresh New York City-based venture will have materially progressed the battle against cancer.
Patients typically don’t die from the primary diagnosis. Rather, it is when the cancerous cells break off from a primary tumor, hibernate in other tissues of the body—often for long periods of time—and eventually activate and turn into aggressive new tumors that resist treatment. There are many who have someone close to them who has experienced the pain and suffering from losing a loved-one to metastasis. What if we had a weapon against this killer?
HiberCell was born to develop first-in-class therapeutics that targeted dormant disseminated tumor cells (DTCs) from solid and liquid cancers. The venture’s core intellectual property results from research work originating from a laboratory at the Icahn School of Medicine at Mount Sinai.
With $60 million upon launch, HiberCell investors are funding a science that could save millions of lives, and could strike massive returns based on paradigm changing science. The company plans to combat DTCs by eradicating them or by inducing dormancy. The company will be the first biotech to occupy office space at the Hudson Research Center, a partnership between Taconic Investment Partners and Silverstein Properties. Initial space will accommodate 50 employees according to preliminary reports. New York City will take a new center stage in the biotech industry if HiberCell treatments achieve FDA and EMA approvals. The stakes for this one is that big, and the venture was announced only days ago.
Although the life science industry has made considerable progress treating primary tumors, the reality is that relapsed or metastatic cancer claims the lives of most cancer patients—even when the primary tumor had been successfully treated. Enter the co-founders: Julio Aguirre-Ghiso, a professor of medicine; director of head and neck cancer basic research, solid tumor and metastasis research; and co-leader of the cancer mechanisms program for the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai; and Alan Rigby formally with U.S. pharmaceutical giant Eli Lilly. But before the co-founder background, a brief review of the underlying science.
The Science: Created at Icahn Medical School Lab
HiberCell has been formed to capitalize on the paradigm shifting work of the Aguirre-Ghiso lab at the Icahn School of Medicine, Mount Sinai—focusing on the targeting of relapse and metastasis. Considerable progress has been made in treating primary tumors, however, cancer patients presumed cured after primary tumor removal and associated therapy often carry non-proliferating dormant disseminated tumor cells (DTCs) for years before reactivating to form incurable metastasis. Thus, despite cancer cells carrying genetic alternations, micro-environmental and epigenetic mechanisms appear to induce tumor cell dormancy. The Icahn School of Medicine lab run by Julio Aguirre-Ghiso paid close attention to the biology of dormant DTCs and their reactivation to target them and prevent relapses. Surprisingly, this is contrary to the vast mainstream of cancer research, which has focused on the science of constant cancer growth. What is unquestionably a paradigm shift, the Aguirre-Ghiso lab led research looking at novel cancer biology. By integrating basic stress and mitogenic signaling, adult stem cell and micro-environmental biology, they began to understand that a reciprocal crosstalk between DTCs and the microenvironment regulates the inter-conversion between dormancy and proliferation.
A fundamental achievement by the Icahn lab was the discovery that an imbalance in p38α/β and ERK1/2 signaling regulates lineage commitment transcription factors (NR2F1, DEC2), and an epigenetic network that determines dormancy induction. Moreover, they also identified retinoic acid and TGFβ2 in the microenvironment as inducers of the high p38/ERK-signaling ratio, and that dormancy (quiescent phenotype) is controlled by mechanisms driving adult stem cell biology. Furthermore, they identified that translating retinoic acid biology to medicine identified a “dormancy signature” enriched in dormant DTCs from patients asymptomatic for up to 18 years, which predicts for prolonged metastasis-free periods in different cancers.
The New York research team uncovered that dormant DTCs can possibly originate early during cancer evolution—disseminating during pre-malignant stages of cancer but still contributing to metastasis development. While at the lab, Aguirre-Ghiso and team designed an epigenetic reprogramming therapy to induce dormancy of DTCs. They were planning on developing into a clinical trial program which undoubtedly represents core and critical intellectual property for HiberCell moving forward. The team also uncovered that UPR signaling tends to promote the survival of dormant tumor cells and that macrophages are key agents in the regulation of early dissemination and dormancy.
The team set up a collaboration to run a National Cancer Institute-Tumor Microenvironment Network Center focusing on the microenvironmental stress and dormancy, and develops new technologies to image and target metastasis. The collaborative effort sought to describe dormancy in human breast, prostate, and head and neck cancer DTCs in addition to the study of epigenetic regulation of DTC dormancy. The Aguirre-Ghiso lab at Icahn Medical School, Mount Sinai sought to form a translational program with commercial clinical sponsors in the hopes of identifying potential treatments to target dormant disease.
In a Forbes article, the founding team noted that HiberCell’s licensed molecules can use the biology of dormancy to both induce it in cells and kill them. No human studies have commenced yet, however, a small clinical trial has been set up for the principals to test the approach of inducing dormancy in recurrent prostate cancer patients with repurposed drugs already approved by the FDA. The Principal Investigator for that trial is William Oh of Icahn School of Medicine.
TrialSite News certainly anticipates that any material biopharmaceutical alliances formed with the lab will probably be assigned to Hibercell as part of an elaborate spinoff agreement.
Julio Aguirre-Ghiso, obtained his MSc in 1994 and PhD in 1997 from the University of Buenos Aires, Argentina where he trained at the Institute of Oncology. In 1998 he commenced his postdoctoral training at Mount Sinai School of Medicine where he received a prestigious Charles H. Revson Fellowship that funded his research until he launched his independent laboratory—and ultimately the genesis for the work that contributes to the formation of HiberCell. By 2003, Dr. Aguirre-Ghiso became an independent investigator at the School of Public Health, New York State Department of Health. In 2008 he returned to Mount Sinai as an Associate Professor and received tenure. By 2013 he was promoted to full professor with tenure. An internationally recognized cancer biology expert, he has focused his intensive study on the understanding of disseminated tumor cell (DTC) dormancy and its contribution to cancer relapse and metastasis.
Alan Rigby previously led a prioritized and focused effort to translate ‘Natures Intracellular Biologic” into transformative medicines for oncology and antibiotic resistance while chief scientific officer at recently acquired Warp Drive Bio. Prior, he was chief scientific officer at Synta Pharmaceuticals. Before Synta, Dr. Rigby was vice president global antibody drug conjugate biology and head of external innovation for oncology research at the New York site for Eli Lilly. Dr. Rigby’s experience and pedigree are deep. Before industry activities, he was a National Institutes of Health (NIH) funded assistant professor and principal investigator at Beth Israel Deaconess Medical Center, Harvard Medical School. While at Harvard Medical School, he founded and directed the Drug Discovery and Target Validation Program within the Beth Israel Deaconess Medical Center.
The HiberCell founders have generated considerable backing. With a considerable $60.8 million Series A round, the following investors are participating:
The NYC Life Science Fund investment originates from the New York City Economic Development Corp’s $150 million biotech fund, which was formed in 2013 but, apparently hadn’t made any material investments as of yet—until now. Celgene, an investor, is one of the most focused oncology biotech companies worldwide. That ownership may transfer to Bristol-Myers Squibb (BMS) with the imminent BMS and Celgene merger. Lead investor ARCH Venture Partners, invests primarily in companies co-founded with leading scientists and entrepreneurs, concentrating on market innovations in life sciences, physical sciences and information technology. They have established a leadership position as venture capitalists that lead successful academic research institution commercialization initiatives. They manage seven funds totaling nearly $1.5 billion. Their investors include major corporations, pension funds, endowment funds, financial institutions and private investors. Hillhouse Capital and 6 Dimensions are Chinese-based venture capital groups.
HiberCell was born based on a relentless intellectual pursuit to study cancer biology with a focus on development of first-in-class therapeutics that targeted dormant disseminated tumor cells (DTCs) from solid and liquid cancers. The venture’s core intellectual property originates from research work from a laboratory at the Icahn School of Medicine at Mount Sinai. Considering the size of the A round financing combined with the talent of the founders, scientific board members and the sophistication of the investors, the prognosis for combatting cancer at heretofore more intense levels becomes better.
Mr. O’Connor has spent nearly 20 years providing technology and value-added services to the clinical trials and health technology industry. An entrepreneur, he has been instrumental in building different ventures focusing on FDA 21 Part 11 enterprise document management, technology-enabled patient recruitment services, clinical safety data exchange, as well as population health and community care coordination for at-risk populations with Eccovia Solutions. He is a co-founder of a public benefit corporation launching a global clinical research site accreditation standard–ACRES ReServ. At TrialSite News, www.trialsitenews.com Mr. O’Connor and team have developed a comprehensive clinical research site data base and intelligent clinical news curation engine to contribute to clinical research transparency with a focus on sites and investigators. He earned his combined MA and JD from the University of California (Los Angeles and Hastings College of the Law) and undergraduate from San Francisco State University.