BeiGene Plans to Raise up to $2.5 Billion in Shanghai Star IPO

On November 17, 2020 BeiGene (NSDQ: BGNE; HK: 06160) reported an IPO on the Shanghai Star Exchange that could raise up to $2.5 billion (Press release, BeiGene, NOV 17, 2020, View Source [SID1234571400]). The Beijing company is already listed in Hong Kong and the US, and it raised $2.1 billion in a secondary offering on the Hong Exchange in July of this year. Now ten years old, BeiGene is spending big to conduct clinical trials for drug approvals and additional indications for its products. At the end of Q3, the company has $4.7 billion of cash in hand, but it lost $560 million in the first nine months of 2020 on revenues totaling $371 million.

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Oncternal Therapeutics Announces $20.0 Million Bought Deal Offering

On November 17, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 6,451,613 shares of common stock of the Company, at a price to the public of $3.10 per share, less underwriting discounts and commissions (Press release, Oncternal Therapeutics, NOV 17, 2020, View Source [SID1234571347]). The closing of the offering is expected to occur on or about November 20, 2020, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company also has granted to the underwriter a 30-day option to purchase up to an additional 967,741 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to Oncternal, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter’s option to purchase additional common stock, are expected to be approximately $20.0 million. The Company intends to use the net proceeds from this offering for general corporate purposes, including expenses related to the clinical and preclinical development of cirmtuzumab and TK216, preclinical development of its ROR1 CAR-T program, and for working capital.

The shares of common stock are being offered by Oncternal pursuant to a "shelf" registration statement on Form S-3 (File No. 333-222268) previously filed with the Securities and Exchange Commission (the "SEC") on December 22, 2017 and declared effective by the SEC on January 5, 2018. The offering of the shares of common stock is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

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

OncoSynergy Launches Phase I rial for Patients With Recurrent Glioblastoma

On November 17, 2020 OncoSynergy, a patient-focused biotech startup founded by physicians trained in neurosurgery reported that it has opened enrollment in their phase 1 trial which will study OS2966, a novel therapeutic antibody, for treatment of glioblastoma (Press release, OncoSynergy, NOV 17, 2020, View Source [SID1234571311]). The trial will take place at Moffitt Cancer Center in Tampa, Florida under the leadership of Michael Vogelbaum, MD, PhD.

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OS2966 inhibits Beta1 integrin (CD29), a critical receptor responsible for integrating cancer promoting signals and driving cancer growth and spread. Studies have demonstrated that resistance to anti-angiogenic therapy (i.e., bevacizumab) is associated with increased expression of Beta1 integrin. OncoSynergy studied OS2966 in animal models implanted with patient tumor samples that had become resistant to treatment with bevacizumab. These studies revealed that OS2966 prevented the ability of bevacizumab-resistant tumor cells to invade the surrounding brain and resulted in significant tumor cell death (Carbonell et al, 2013).

Despite advancement of several new promising cancer treatments, successful treatment of glioblastoma has been limited by the presence of the brain’s protective blood brain barrier and the invasive nature of glioblastoma. To combat these obstacles, a technique called convection-enhanced delivery (CED) will be utilized to deliver OS2966 directly to the brain tumor and surrounding tumor-infiltrated brain.

The primary goal of this phase 1 study is to determine the safety and tolerability of OS2966 when delivered directly to the brain. That said, given pre-clinical data demonstrating OS2966’s ability to address therapy resistant tumors and a delivery technique designed to overcome obstacles specific to glioblastoma, the ultimate hope is to improve outcomes for patients suffering from this formidable disease.

Foresee Pharmaceuticals Enters Exclusive License Agreement with GenSci for the Commercialization of Camcevi(TM) in China

On November 17, 2020 Foresee Pharmaceuticals (6576.TWO) ("Foresee")reported that it has entered into an exclusive license agreement with GenScience Pharmaceuticals ("GenSci") – a wholly-owned subsidiary of Changchun High-Tech Industry (Group) Co., Ltd. (000661.SZ) – for the commercialization of Foresee’s novel FP-001 program, Leuprolide Mesylate Injectable Suspension (LMIS) ready-to-use subcutaneous 6-month and 3-month depot formulations ("Camcevi") (Press release, Foresee Pharmaceuticals, NOV 17, 2020, View Source [SID1234571308]). The license agreement will cover the China market.

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Under the terms of this partnership, Foresee, a Taiwan and US-based biopharmaceutical company, will receive 8 million US dollars upfront, and a combination of regulatory milestones, technology transfer milestones, and commercialization milestones payments totalling up to 123.85 million US dollars in addition to a share of the product revenue in the territory. GenSci will cover all costs of development, registration, and commercialisation in the territory.

"GenSci has an impressive record developing and commercializing hormonal therapeutics in the China market and possesses extensive experience, expertise and infrastructure in R&D, regulatory affairs, manufacturing and commercialization," said Dr. Ben Chien, Founder and Chairman of Foresee. "Camcevi 6-month depot is currently under review process by the FDA and EMA, and will soon be followed by Camcevi 3-month depot. This important collaboration with GenSci will allow us to aggressively move forward phase III registration studies, registration, and commercialization of Camcevi in China. We are highly confident in Camcevi’s potential in the China market, and see this as the foundation to a potentially broader partnership with GenSci in the future, related to Foresee’s SIF technology and related programs."

Dr. Lei Jin, CEO of GenSci said, "GenSci is very committed to bringing complex, added value products to the China market, improving the standard of care and ultimately the lives of patients. We are very pleased to have established a partnership with Foresee and look forward to a successful registration and launch of the FP-001 franchise in China. The products will provide meaningful advantages and benefits to patients and all medical practice stakeholders."

D3 Bio Launches with US$200 Million Investment to Develop Precision Medicines Addressing Unmet Patient Needs in Oncology & Immunology

On November 17, 2020 D3 Bio, a global biotechnology company focused on developing and commercializing precision medicines to improve or replace existing standard-of-care treatments that do not fully meet patient needs, reported that launched with US$200 million Series A financing by Boyu Capital, Matrix Partners China, Sequoia Capital China, Temasek, and WuXi AppTec’s Corporate Venture Fund, among others (Press release, D3 Bio, NOV 17, 2020, View Source [SID1234571303]). The funding will support the development of D3 Bio’s portfolio in oncology and immunology.

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"Our strong and agile team of scientific innovators and business executives are experienced in discovery, development and commercialization of important, world-class pharmaceuticals that have achieved blockbuster status on a global basis. We anticipate D3 Bio’s development program in China will be closely followed by ones in other major global markets."

"Our mission at D3 Bio is to build a global biotechnology company that develops innovative and more efficacious medicines for patients worldwide," said George Chen, MD, co-founder, Chairman and CEO of D3 Bio. "The financing and support of our approach by reputable institutional investors give us a great start as we begin our journey to transform drug development to accomplish our mission."

A Powerful Drug Development Approach

D3 Bio brings a unique approach to drug discovery and development. Rather than only following laboratory insights wherever they may lead, the Company surveys the clinical landscape to identify areas of major unmet need in which existing standard-of-care approaches yield unsatisfactory clinical outcomes.

Harnessing insights from clinical development, D3 Bio identifies new disease targets and delivery methods in immunology and oncology to match patients with optimal therapies to treat their diseases. D3 Bio anticipates that having a clear understanding during preclinical development both of relevant cancer biomarkers and the therapeutic improvement or replacement goals will make drug discovery and development as efficient and focused as possible.

"Our R&D programs in oncology and immunology are designed to address current unmet clinical needs and to provide the structure, or ‘backbone,’ upon which future drugs can be developed. D3 Bio intends to create a robust portfolio comprised of internal core assets that can be leveraged for follow-on development as well as in-licensed early-stage clinical assets," explained Dr. Chen. "We expect our entire portfolio to enable discovery and development of additional indications and combination regimens. This cycle of drug development that allows for subsequent discovery and innovation is at the core of D3 Bio. In fact, it underlies our name: Development leading to Discovery that then leads back to more Development, or D3 Bio."

Experienced and Proven Drug Development Industry Leadership

D3 Bio is building a seasoned, agile drug development and business management team. Dr. Chen himself, an oncologist by training, has a successful track record in the multinational pharmaceutical industry. After receiving his medical degree from the Shanghai Medical College of Fudan University and his MBA from the Wharton School of Business at the University of Pennsylvania, he held senior research, management, business development, medical affairs and drug development positions at leading institutions and multi-national companies, including the National Institutes of Health, Eli Lilly, GlaxoSmithKline, Johnson & Johnson and AstraZeneca. Dr. Chen’s experience includes regulatory registrations and market introductions of blockbuster drugs in both the US and Chinese markets, including more than 70 Investigational New Drug (IND) and more than 30 New Drug Application (NDA) approvals.

D3 Bio takes advantage of the diverse, world-class resources of the second largest global pharmaceutical market, including academic research, hospitals and investigators, clinical research organizations, venture capital and broad development talent.

"Leveraging these resources, we expect to accelerate development and delivery of novel, life-transforming therapeutics to serve patients worldwide," Dr. Chen continued. "Our strong and agile team of scientific innovators and business executives are experienced in discovery, development and commercialization of important, world-class pharmaceuticals that have achieved blockbuster status on a global basis. We anticipate D3 Bio’s development program in China will be closely followed by ones in other major global markets."

"We believe that a tremendous amount of medical innovation will be created by D3 Bio coupling China’s talent pool with the global R&D ecosystem," said Yanling Cao, Partner, Boyu Capital. "We share D3 Bio’s vision of developing innovative drugs by integrating deep clinical insights with creative science and technology. D3 Bio’s founders and management team have already demonstrated strong track records and leadership in delivering many first-in-class and blockbuster medications into China from major international pharmaceutical companies."

Dr. Chen adds, "We want to thank the investors in this blue-chip syndicate for their support of our business model. We are now well-positioned to advance the clinical development of our robust pipeline of precision medicines."