On January 2, 2020 BioNTech SE (NASDAQ: BNTX, "BioNTech" or "the Company"), reported a publication in Science on the company’s novel CAR-T therapeutic approach for solid tumors which utilizes a CAR-T Cell Amplifying RNA Vaccine, or CARVac (Press release, BioNTech, JAN 2, 2020, View Source [SID1234552654]). The report entitled "An RNA vaccine drives expansion and efficacy of claudin-CAR-T cells against solid tumors" provides preclinical proof-of-concept data for BioNTech’s first CAR-T product candidate BNT211, an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin 6 (CLDN6), and outlines CARVac as a broadly applicable RNA vaccine approach to improve therapeutic efficacy of CAR-T cell therapies.

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Although CAR-T cell therapy has shown significant clinical efficacy in blood cancers, it still faces major challenges in solid tumors, including a limited number of identified cancer-specific solid tumor targets, inefficient infiltration of CAR-T cells into solid tumors and insufficient CAR-T cell persistence. BioNTech aims to overcome these hurdles by targeting CLDN6, a novel tumor specific antigen expressed in multiple solid tumors, in combination with an RNA vaccine promoting the amplification and persistence and efficacy of CAR-T cells in vivo.

In the published study, a second generation CLDN6-CAR-T therapy with a 4-1BB costimulatory domain (BNT211) was evaluated both in vitro in tumor cell lines and in vivo in mice with human ovarian cancer transplants. In mice, CLDN6-CAR-T cell therapy demonstrated complete tumor regression of transplanted large human tumors within two weeks after treatment initiation. Furthermore, the combination with CARVac achieved improved engraftment, proliferation and expansion of CAR-T cells in vivo, resulting in tumor regression even at sub-therapeutic CAR-T doses. CARVac was also successfully applied for CAR-T cells targeting the pan-cancer antigen CLDN18.2 and CD19, the target of approved CAR-T cell therapies. The combination of CAR-T cell therapy with CARVac underlines the value of cross-platform synergies to address key development challenges in the treatment of cancer.

BioNTech intends to initiate a first-in-human Phase 1/2 clinical trial for BNT211 this year in solid tumors, including ovarian, testicular, uterine and lung cancer. Manufacturing to support clinical trials of BNT211 will be conducted in-house at BioNTech’s state-of-the-art GMP certified cell therapy manufacturing

facility in Idar-Oberstein, Germany, which has been in operation since 1999. BioNTech initiated a multi-year capacity expansion at the facility in 2018 which it expects to complete in 2020.

On January 2, 2020 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2020 (Press release, Eli Lilly, JAN 2, 2020, View Source [SID1234552655]). David A. Ricks, Lilly’s chairman and chief executive officer, will participate in a fireside chat at 5:30 p.m. Eastern time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On January 1, 2020 WuXi Biologics ("WuXi Bio") (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, reported its partner OncoImmune on the U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug (IND) for ONC-392, a novel, next generation anti-CTLA-4 antibody (Press release, WuXi Biologics, JAN 1, 2020, View Source [SID1234552645]).

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As part of the collaboration, WuXi Biologics provided comprehensive and integrated services for the ONC-392 program, including CMC development and GMP manufacturing of the drug substance and drug product, through its world-class development and manufacturing capacities and capabilities.

"It has been our great pleasure working with WuXi Biologics on our ONC-392 program. The clearance of ONC-392 IND by the FDA is an important milestone for OncoImmune," said Yang Liu, PhD, Founder and CEO of OncoImmune. "WuXi Biologics’ state-of-the-art and full-service biologics platform enabled us to complete a solid CMC package in support of our IND submission and clearance. We are excited about the potential of this next generation anti-CTLA-4 antibody with its novel and differentiated mechanism of action to improve therapeutic outcomes while significantly reducing toxicity."

"Congratulations to OncoImmune on reaching this milestone for the ONC-392 program. We are glad to enable OncoImmune to accelerate the development of biologics from DNA to IND," said Dr. Chris Chen, CEO of WuXi Biologics. "We wish the program a great success to benefit more patients suffering from cancers. WuXi Biologics will continue empowering global partners to provide more life-saving treatments to meet health challenges."

On January 1, 2020 Fountain Medical Development Limited ("Fountain Medical" or "Company"), a clinical stage CRO dedicated to offering high-quality one-stop services to pharmaceutical and medical device clients, reported that Mr. Ling Zhen, J.D., M.B.A., is appointed as the Co-Chairman of the Board of Directors and Chief Executive Officer (Press release, Fountain BioPharma, JAN 1, 2020, View Source [SID1234552646]).

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Mr. Zhen has over 25 years of professional experience in the CRO and life science industries, both in China and the US. Most recently, Mr. Zhen served as a Partner at Draper Dragon Venture Group, where he focused on biopharmaceutical and medical technology investments. Prior to that, Mr. Zhen spent over 12 years at IQVIA (previously known as Quintiles) where he served as a global Senior Vice President and the General Manager of Greater China. During this period, he helped to drive expansion and transform IQVIA China into the market leader, through innovative solutions and strategic growth in the region.

Prior to IQVIA and Quintiles, Mr. Zhen also worked in business development, portfolio management, and strategic consulting at world-leading companies such as Eli Lilly, GlaxoSmithKline and Ernst &Young in the US. Mr. Zhen holds a Master of Business Administration (MBA) degree from the Kelley School of Business in Indiana University and a Juris Doctor (JD) degree from the Law School of North Carolina Central University, and is a licensed attorney in the US.

"With the appointment of Mr. Ling Zhen as the Co-Chairman and CEO, Fountain Medical will be able to speed up its global expansion and strategic buildup, allowing us to better serve our existing and future clientele. His hands-on experience and strategic insight related to the CRO sector makes him the ideal leader to transform Fountain Medical into a China-centered, global full-service leading CRO," said Dr. Dan Zhang, Co-Chairman and Co-Founder of the Company.

"I feel very privileged to join Fountain Medical during this exciting time, where drug development and clinical research are undergoing transformational changes across China and rest of the world," said Mr. Zhen himself. "I look forward to working closely with Fountain Medical’s management team and shareholders, and developing a high-caliber team that delivers high-quality services, to help our customers accelerate the development of truly innovative therapies around the world."

On December 31, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova" or the "Company"), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), reported that it has entered into definitive agreements with [two] healthcare-focused institutional investors for the issuance and sale in a registered direct offering of 27,662,518 shares of its common stock at a purchase price of $0.3615 per share, for aggregate gross proceeds of approximately $10 million in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Onconova, DEC 31, 2019, View Source [SID1234552639]).

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The offering is expected to close on or about January 3, 2019, subject to the satisfaction of customary closing conditions.

The Company currently intends to use the net proceeds from the offering for working capital and general corporate purposes, including advancing preparations for a planned New Drug Application (NDA) filing to the FDA for intravenous rigosertib in second-line higher-risk MDS in 2020, and advancing preparations for commercialization if the NDA is approved. The Company surpassed 90% of the required enrollment of the INSPIRE Trial in November 2019 and anticipates reporting topline data in the first half of 2020, following full enrollment and reaching the number of required survival events. With the additional expected proceeds from the offering and the proceeds from recent warrant exercise, the Company believes that it has the sufficient funds to extend operations and ongoing trials late into the first quarter of 2021.

The shares of common stock described above are being offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-221684), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on December 28, 2017. The offering of the shares of common stock will be made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and the accompanying base prospectus may also be obtained 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 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.