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.

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.

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

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.

On January 5, 2021 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, reported management’s participation in the following investor conferences in January (Press release, Immunic, JAN 5, 2021, View Source [SID1234573522]):

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January 11-14: H.C. Wainwright BioConnect 2021 Conference. Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic, will present a company overview at the conference. Beginning January 11, at 6:00 am ET, the presentation will be available on the "Events and Presentations" section of Immunic’s website at: ir.imux.com/events-and-presentations for a period of 90 days after the conference.
January 11-14: 39th Annual J.P Morgan Healthcare Conference. Glenn Whaley, Vice President Finance, Principal Financial and Accounting Officer of Immunic, will attend the conference.
Management will be hosting virtual one-on-one investor meetings during the conferences. To schedule a meeting, please contact: Jessica Breu at [email protected].

Management also provided an update on the phase 2, investigator-sponsored proof-of-concept clinical trial for IMU-838 in primary sclerosing cholangitis (PSC), being conducted at the Mayo Clinic. The single-arm, open label, exploratory study, for which Immunic is providing the study medication, planned to enroll 30 patients with PSC, aged 18 to 75 years, who receive 30 mg of IMU-838 once daily for a period of six months. Together with the investigators, Immunic determined to readout data from the 18 patients who were enrolled prior to the COVID-19 pandemic, as patients with PSC are considered high risk for COVID-19 infections and are advised to avoid the unnecessary social contacts required in a clinical trial. Immunic currently expects the data to be available during the first quarter of 2021, instead of in the fourth quarter of 2020, as previously announced. This delay is due to the COVID-19 pandemic and its impact on those clinical sites conducting the trial.