Researchers aim AI at rising oral cancers with $3.3M grant from National Cancer Institute

On January 5, 2021 Researchers at Case Western Reserve University and partners in the United States and India reported that are applying the investigative and predictive capabilities of artificial intelligence (AI) to help physicians customize treatments for patients with oral squamous cell carcinomas (Press release, Case Western Reserve University, JAN 5, 2021, View Source [SID1234573758]).

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Research shows that oral squamous cell carcinomas is already the 8th most common cancer type worldwide and numbers are steadily increasing in the United States, India and other parts of Asia.

The National Cancer Institute awarded a five-year, $3.3 million grant to a group led by Anant Madabhushi, the Donnell Institute Professor of Biomedical Engineering at Case Western Reserve and head of the Center for Computational Imaging and Personalized Diagnostics (CCIPD), and James Lewis Jr., a Professor of Pathology, Microbiology and Immunology at Vanderbilt University Medical Center.

The CCIPD has become a global leader in AI-driven precision medicine research. Madabhushi and his research team at the CCIPD hold more than 60 patents, many tied to their work in various cancers.

In this work, researchers will use advanced computer vision and machine learning techniques to identify cancer and immune cells on digitized images of oral squamous cell carcinoma tissue slides and then recognize spatial patterns among those cells.

This technology allows computerized vision to recognize patterns and quantify features that simply are beyond the human visual system but are powerful indicators of tumor biology. These algorithms will help oncologists and pathologists to then better determine which cancers are more versus less aggressive.

This, in turn, will then enable them to identify which patients with early stage disease could safely receive surgery alone, versus who might need postoperative radiation. In addition, it could help identify which patients with advanced stage disease might need chemotherapy with radiation after initial treatment versus who may be adequately treated with radiation alone.

Madabhushi and Lewis will work with a number of partners–Cleveland Clinic and University Hospitals in Cleveland, the San Francisco VA Health System, and Tata Memorial Centre in Mumbai, India–in a national and global endeavor to improve oral cavity squamous cell carcinoma patient care with advanced technology and data sharing.

The clinical partners will provide glass slides to be digitized or will directly provide digitally scanned whole slide images which will be used to train the AI algorithms for predicting outcomes as well as treatment benefit.

The team will also have access unique datasets from completed prospective, randomized, clinical trials of oral squamous cell carcinoma patients at the Tata Memorial Center as well as from the cancer clinical cooperative group NRG Oncology. The datasets that will allow for validation of the AI tools.

Seeking precise, personal predictions

Currently, physicians place oral carcinoma patients into one of three categories: those who require just surgery; those who should have surgery plus radiation therapy; or those who will need surgery, followed by radiation and chemotherapy.

"That’s the gold standard right now: a system that puts patients in those very broad categories," Madabhushi said. "For clinicians and pathologists, this is limiting because it relies on a limited number of parameters. But our machines are looking at the appearance of cells, their spatial architecture and interplay between different cell types, to parse out those patients who should actually be in another category."

For example, Madabhushi said, their AI research has already shown that there is a subset of early stage patients now placed in the first category–surgery alone–who are actually at a much higher risk and would do poorly with surgery alone.

"Instead, they should be offered radiation therapy as well, but under the current parameters, that is not called for," Madabhushi said.

The group will also look at anticipated differences in the appearance of oral cancer among patients of different races, a fast-developing aspect of Madabhushi’s AI-based investigations.

Previous research by the lab used AI to reveal apparent tissue level cellular distinctions between Black and white men with prostate cancer, enabling the development of population-specific risk prediction models.

Oral cancers rising

Oral carcinomas include cancers of the mouth, tongue, gums, and lips. According to the National Institutes of Health (NIH), these cancers can develop on the mobile tongue, the tissue lining the gums and hard palate, and on the underside of the tongue and floor of the mouth,

Oral carcinoma accounts for roughly 3% of all cancers diagnosed annually in the United States, with nearly 400,000 new cases being diagnosed annually worldwide.

Oral carcinoma most often occurs in people over age 40 and affects more than twice as many men as women. Most oral cancers are related to tobacco use, alcohol use, or both. Infection by the human papillomavirus (HPV), which is very common in oropharyngeal carcinomas, is a less common cause of oral carcinomas.

Other members of the research team include: Drs. Shlomo Koyfman, David Adelstein, and Deborah Chute at the Taussig Cancer Center, Cleveland Clinic; Dr. Ted Teknos, president of Seidman Cancer Center, University Hospitals; Dr. Stephen Connelly, San Francisco VA Health System; and Drs Sarbani Ghosh-Laskar and Swapnil Rane, Tata Cancer Center.

Case Western Reserve University is one of the country’s leading private research institutions. Located in Cleveland, we offer a unique combination of forward-thinking educational opportunities in an inspiring cultural setting. Our leading-edge faculty engage in teaching and research in a collaborative, hands-on environment. Our nationally recognized programs include arts and sciences, dental medicine, engineering, law, management, medicine, nursing and social work. About 5,100 undergraduate and 6,200 graduate students comprise our student body. Visit case.edu to see how Case Western Reserve thinks beyond the possible.

Pharma Two B Appoints Sheila Oren, M.D., M.B.A., as Chief Executive Officer

On January 5, 2021 Pharma Two B Ltd., a privately held company developing innovative therapeutics based on previously approved drugs for Parkinson disease, reported that Sheila Oren, M.D., M.B.A., was appointed Chief Executive Officer of Pharma Two B, effective January 1, 2021 (Press release, Pharma Two B, JAN 5, 2021, View Source [SID1234573533]). Dr. Oren brings more than 25 years of demonstrated success as a biomedical industry executive with experience in global strategy, clinical and regulatory development, and medical affairs. She has specific expertise in Parkinson’s disease, having led all global clinical research and development of rasagiline (AZILECT) from Phase 1 to market. Dr. Oren will replace David Tierney M.D. who has agreed to act as a strategic consultant to the Company for a transition period.

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"This is an exciting time for Pharma Two B, with the Company’s main product candidate P2B001 having the potential to become a much needed and important therapeutic option for early-stage Parkinson’s Disease," stated Dr. Oren. "My immediate priority will be to leverage the necessary resources to complete the ongoing Phase 3 trial and advance P2B001 towards NDA submission. In tandem, I look forward to exploring new opportunities to expand Pharma Two B’s pipeline—delivering on the Company’s mission to develop innovative therapeutics for patients."

Dr. Oren was previously a biopharma consultant at Soren Medical Consulting. Prior to that she was Chief Medical Officer at NeuroDerm Ltd. She joined NeuroDerm when it was a small startup company and was instrumental in building it into a successful company that went through a successful IPO on NASDAQ. NeuroDerm was later acquired by Mitsubishi Tanabe Pharma Corporation for $1.1 billion.

Prior to NeuroDerm, Dr. Oren held leadership roles at Teva Pharmaceutical Industries. As a Clinical and Medical Director, she led global clinical development and marketing plans for new CNS drugs. She had a major role in the development, approval, and launch of Azilect, a worldwide-approved drug used to treat Parkinson’s disease. She played a critical role in designing the Azilect delayed-start "neuroprotection" study and is one of the co-inventors recognized in the patent application. The report of this study was published in the New England Journal of Medicine in 2009. Dr. Oren received an MD degree from the Sackler School of Medicine, Tel Aviv University, Israel and an MBA from the Interdisciplinary Center, Herzliya, Israel.

Fate Therapeutics Announces Pricing of Public Offering of Common Stock and Pre-Funded Warrants

On January 5, 2021 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported the pricing of an underwritten public offering of 4,421,053 shares of its common stock at a public offering price of $85.50 per share. In addition, in lieu of common stock to certain investors, the Company announced the pricing of an underwritten public offering of pre-funded warrants to purchase 257,310 shares of its common stock at a purchase price of $85.499 per pre-funded warrant, which equals the public offering price per share of the common stock less the $0.001 exercise price per share of each pre-funded warrant. This represents an aggregate offering of approximately $400 million. Fate Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 701,754 shares of its common stock. The proceeds to Fate Therapeutics from this offering are expected to be approximately $376 million after deducting underwriting discounts and commissions and other estimated offering expenses but excluding any exercise of the underwriters’ option. Fate Therapeutics intends to use the net proceeds from the offering to fund clinical trials and nonclinical studies of its product candidates, the manufacture of its clinical product candidates, the expansion of its cGMP compliant manufacturing operations, including the construction, commissioning and qualification of its new facility, the conduct of preclinical research and development, and for general corporate purposes. All shares of common stock and pre-funded warrants to be sold in the offering are being offered by Fate Therapeutics. The offering is expected to close on or about January 8, 2021, subject to customary closing conditions.

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Jefferies, BofA Securities, SVB Leerink and Barclays are acting as joint book-running managers for the offering. Wells Fargo Securities is acting as lead manager for the offering, and Cantor Fitzgerald & Co. and Oppenheimer & Co. Inc. are acting as co-managers for the offering.

The securities described above are being offered by Fate Therapeutics pursuant to an automatic shelf registration statement on Form S-3 (File No. 333-228513) that was previously filed by Fate Therapeutics with the Securities and Exchange Commission (the "SEC") and automatically became effective upon filing on November 21, 2018. The securities may be offered only by means of a prospectus.

A preliminary prospectus supplement and a free writing prospectus related to the offering were filed with the SEC on January 4, 2021 and January 5, 2021, respectively, and are available on the SEC’s website at View Source and a final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website at View Source. Copies of the final prospectus supplement and the accompanying prospectus for the securities being offered may also be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 547-6340; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525 ext. 6132 or by email at [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

IconOVir Bio Raises $77 Million in Series A Financing to Develop Next-Generation Oncolytic Viruses to Treat Solid Tumors

On January 5, 2021 IconOVir Bio, Inc., a preclinical-stage biotechnology company pioneering the next generation of oncolytic virus therapy to improve the treatment of patients with cancer, reported it has raised $77 million in a Series A financing (Press release, IconOVir Bio, JAN 5, 2021, View Source [SID1234573525]). The financing was co-led by Nextech and Vida Ventures, with participation from Two River Group, Bellco Capital, Polaris Partners, GV, Wellington Partners Venture Capital and Logos Capital. IconOVir was founded by Two River Group, chaired by Arie Belldegrun, M.D., FACS, the team who founded Kite Pharma, Inc., Allogene Therapeutics, Inc., and Kronos Bio, Inc. IconOVir also announced the appointment of Mark McCamish, M.D., Ph.D., as Chief Executive Officer.

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IconOVir has developed a proprietary platform to create next-generation oncolytic viruses based on more than a decade of oncolytic virus research by IconOVir’s Scientific Founder Clodagh O’Shea, Ph.D., of the Salk Institute for Biological Sciences. IconOVir’s discovery pipeline of multiple differentiated oncolytic virus candidates have the potential to be potent, tumor-selective, administered intravenously and broadly infect tumor cells.

"Conquering cancer requires therapeutic agents that are as genetically sophisticated and deadly as the tumor itself," said Dr. O’Shea. "With a team of visionary leaders, IconOVir has the requisite experience to translate transformative science into game changing cancer therapies. As Chair of the Scientific Advisory Board, I look forward to providing my insights and expertise towards advancing the IconOVir pipeline into the clinic."

IconOVir’s lead candidate, IOV-1042 is derived from the common cold virus. Preclinical research has shown that IOV-1042 infects and kills a broad range of tumor cells, including head and neck, bladder, lung and breast, suggesting that it could have potential utility in a wide range of solid tumor indications. IconOVir expects to submit an Investigational New Drug Application (IND) for IOV-1042 in the first half of 2022.

"IconOVir has a proven management team, led by Dr. Mark McCamish, and its oncolytic viral platform has the ability to transform the clinical landscape for how we treat patients with solid tumors," said David Chang, M.D., Ph.D., Chairman of IconOVir’s Board of Directors. "Given my personal experience in developing oncolytic viruses, I look forward to working with Mark, the management team and other Board members to grow this company and advance innovative oncolytic virotherapy, which has the potential to be disruptive to the current cancer treatment paradigm."

Dr. McCamish has extensive experience in drug development in the biopharmaceutical industry. Before joining IconOVir, he served as President and Chief Executive Officer at Forty Seven, Inc., an immuno-oncology company acquired by Gilead. Dr. McCamish earned an M.D. from the University of California, Los Angeles, and a Ph.D. in human nutrition from Penn State University.

"We are committed to designing and developing the next generation of high-potency, tumor-selective oncolytic viruses that can be used in a wide variety of solid tumors, including metastatic disease. This can address the major limitations of the only currently marketed oncolytic virus therapy," said Dr. McCamish. "In pursuit of that goal, and in collaboration with Dr. O’Shea, we have created a robust discovery pipeline. With our Series A financing, raised from the support of premier healthcare investors, we believe we have the financial resources to advance our product candidates into clinical development over the next 18 to 24 months."

"IconOVir has everything we look for when investing in an oncology company. It has a founding team of academic thought leaders and seasoned company builders, a Board and scientific advisors with deep expertise in oncology, and a differentiated discovery pipeline with next-generational oncolytic viruses based on groundbreaking research," said Jakob Loven, Ph.D., Partner at Nextech.

"We invested in IconOVir based on the stellar combination of team experience and the company’s high throughput synthetic and systems biology platform. We believe IconOVir’s approach to cancer by engineering, developing, manufacturing and commercializing curative virus-based oncology therapies will be a game changer," said Helen Kim, Managing Director, Vida Ventures.

IconOVir Board of Directors

The company’s Board of Directors has deep oncology expertise and decades of experience in oncology innovation. In addition to Dr. McCamish, the Board includes:

Arie Belldegrun, M.D., FACS, Executive Chairman, Co-Founder of Allogene Therapeutics and Co-Founder, Sr. Managing Director of Vida Ventures
David Chang, M.D., Ph.D., Co-Founder, President and Chief Executive Officer of Allogene Therapeutics
Joshua Kazam, Partner, Two River Group
Helen Kim, Managing Director, Vida Ventures
Jakob Loven, Ph.D., Partner, Nextech

IDEAYA Biosciences Doses First Patient in a Phase 1 Combination Study of IDE196 and Crizotinib, a cMET Inhibitor

On January 5, 2021 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, reported First-Patient-In (FPI) in the Phase 1 combination study of IDE196 and crizotinib, a cMET inhibitor, in metastatic uveal melanoma (MUM) (Press release, Ideaya Biosciences, JAN 5, 2021, View Source [SID1234573524]). The clinical combination of IDE196 and crizotinib is being evaluated by IDEAYA in collaboration with Pfizer pursuant to a clinical trial collaboration and supply agreement.

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"IDEAYA is executing on its clinical trial strategy to evaluate IDE196 combination therapies in Metastatic Uveal Melanoma (MUM). We identified cMET as a potential combination agent through our translational research, including evaluation of cMET expression in MUM patient clinical samples from an IDE196 Phase 1 clinical trial and preclinical demonstration of synergy between IDE196 and crizotinib, going from bench to bedside in approximately one year," said Mick O’Quigley, Vice President, Head of Development Operations. IDEAYA plans to present preclinical translational data supporting the IDE196/crizotinib combination therapy in H1 2021.

"IDEAYA’s clinical trials evaluating IDE196 plus either crizotinib or binimetinib as combination therapies are each based on compelling biological rationale for treating patients with metastatic uveal melanoma – a solid tumor for which there is a high unmet medical need and currently no approved therapies," said Meredith McKean, MD, MPH, Associate Director, Melanoma and Skin Cancer Research Program, Sarah Cannon Research Institute at Tennessee Oncology.