On March 2, 2021 GEMoaB, a biopharmaceutical company focused on the development of next-generation immunotherapies for hard-to-treat cancers, reported the publication of clinical data obtained from the ongoing Phase I study of their rapidly switchable UniCAR platform lead asset, UniCAR-T-CD123, in relapsed/refractory acute myeloid leukemia (rrAML), in the journal "Blood" (Press release, GEMoaB, MAR 2, 2021, View Source [SID1234575977]).

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The interim data of UniCAR-T-CD123 in rrAML, published online ahead of print as a letter in "Blood" (Wermke et al. 2021, View Source), demonstrate that UniCAR-T-CD123 in rrAML is well-tolerated with rapid recovery of hematopoiesis and encouraging early efficacy.

"The Blood publication nicely underpins the clinical advantages of our rapidly switchable UniCAR platform, which have also been recently presented at the 3rd EHA (Free EHA Whitepaper)-EBMT CART-Cell Meeting," said Prof. Dr. Gerhard Ehninger, Chief Medical Officer of GEMoaB. "We believe that the benefit-risk profile of UniCAR-T-CD123 obtained in rrAML promises to be highly differentiated, and while we are finishing up our Phase IA clinical study, we are looking forward to enter into the next phase of our clinical development program in this high unmet need indication."

Phase I studies of UniCAR-T-CD123 for the treatment of rrAML and UniCAR-T-PSMA directed against CRPC and other PSMA-expressing late-stage solid tumors are ongoing.

About the UniCAR-T-CD123 Phase IA Study

This first-in-human phase I study is an open-label, non-randomized, dose-finding study designed to evaluate the safety and activity of UniCAR-T-CD123 in up to 16 CD123 positive patients with relapsed/refractory AML. Its purpose is to determine the maximum tolerated dose (MTD) as well as Dose limiting toxicities (DLT) of the combined application of a single dose of UniCAR-T and the continuous infusion of TM123 over 25 days. Application follows post bridging therapy and lymphodepletion. The study also investigates response rates, response duration, persistence of UniCAR-T cells over time as well as the ability to rapidly switch UniCAR-T cells on and off through stopping TM infusion in case of side effects. The study takes place at selected Phase I, Acute Leukemia and CAR-T experienced University centers in Germany. The study is supported by a grant from the German Federal Ministry for Education and Research (project "TurbiCAR"). To learn more about the trial, please visit clinicaltrials.gov.

About UniCAR

GEMoaB is developing a rapidly switchable universal CAR-T platform, UniCAR, to improve the therapeutic window and increase efficacy and safety of CAR-T cell therapies in challenging cancers, including acute leukemias and solid tumors. Conventional CAR-T cells depend on the presence and direct binding of cancer antigens for activation and proliferation. An inherent key feature of the UniCAR platform is a rapidly switchable on/off mechanism (less than 4 hours after interruption of TM supply) enabled by the short pharmacokinetic half-life and fast internalization of soluble adaptors termed TMs. These TMs provide the antigen-specificity to activate UniCAR gene-modified T-cells (UniCAR-T) and consist of a highly flexible antigen-binding moiety, linked to a small peptide motif recognized by UniCAR-T.

On March 2, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 4,375,000 American Depositary Shares (ADSs) of the Company, at a price to the public of $8.00 per ADS, less underwriting discounts and commissions (Press release, RedHill Biopharma, MAR 2, 2021, View Source [SID1234575976]). Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. The closing of the offering is expected to occur on or about March 4, 2021, 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.

In addition, the Company has granted to the underwriter a 30-day option to purchase up to additional 656,250 ADSs at the public offering price, less underwriting discounts and commissions.

The gross proceeds to RedHill, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter’s option to purchase additional ADSs, are expected to be $35 million. The Company intends to use the net proceeds from this offering to fund its clinical development programs, commercialization activities and for acquisitions and general corporate purposes.

The securities described above are being offered by RedHill pursuant to a "shelf" registration statement on Form F-3 (File No. 333-232777) previously filed with the Securities and Exchange Commission (the "SEC") on July 24, 2019 and declared effective by the SEC on August 8, 2019. The offering of the securities is being 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 securities being offered have been filed with the SEC and are available on the SEC’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A final prospectus supplement and the accompanying prospectus relating to the offering will be filed with the SEC and , upon filing, may be obtained 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.

On March 2, 2021 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported their collaboration with Immunitas Therapeutics, Inc. (www.immunitastx.com) for the development of a systems pharmacology model for an oncology pathway with complex receptor-ligand dynamics (Press release, Applied BioMath, MAR 2, 2021, View Source [SID1234575975]). The model will be used to understand the importance of targeting multiple receptors simultaneously and will inform the optimal therapeutic modality. "Efficiently translating early research into a clinical candidate is a top priority at Immunitas," said Tarek Samad, CSO of Immunitas. "We look forward to leveraging Applied BioMath’s mathematical models to better understand the best path forward for this therapeutic program."

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Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis. "Our proprietary software platforms and high-performance computing were designed to model biological systems and enable us to compare various dosing regimens more quickly than traditional approaches," said John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "This ability early on in therapeutic R&D is critical and we are excited to collaborate with Immunitas on this project."

On March 2, 2021 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) reported that it will release fourth quarter and annual 2020 financial results and Company update after the market closes on Tuesday, Mar. 9, 2021 (Press release, Cumberland Pharmaceuticals, MAR 2, 2021, View Source [SID1234575974]). A conference call and live internet webcast will be held on Tuesday, March 9, 2021, at 4:30 p.m. Eastern Time to discuss the results.

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To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 7005878. The live webcast and rebroadcast can be accessed via Cumberland’s website at View Source

On March 2, 2021 Biotheus reported the successful completion of a fourth round of financing, co-led by General Atlantic, a leading global growth equity investor, and IDG Capital, a global leading investment firm (Press release, Biotheus, MAR 2, 2021, View Source [SID1234575973]). Other new investors include Kunlun Capital, CPE, and Cowin Capital, with participation by previous investors Highlight Capital, Shiyu Capital, New Alliance Capital, Huajin Investment, and others.

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Founded in 2018, Biotheus is a clinical development stage company with the mission of treating cancer and autoimmune diseases through next-generation therapeutics. This is supported by the company’s product pipeline, which consists of over 10 novel monoclonal and multispecific antibodies. Biotheus currently has two bispecific antibodies in phase I clinical development for cancer treatment, and a third IND application was submitted at the end of 2020. With this new investment, Biotheus will further increase its investment into its research activities with the aim to have five novel drugs into clinical development by the end of 2021, and drive multiple programs into late-stage clinical development.

Regarding this round of financing, Mr. Xiaolin Liu, President and CEO of Biotheus, remarked: "we are pleased that our efforts have been recognized and supported by leading investors like General Atlantic and IDG Capital. The continued support from our previous investors is also testament to our company’s progress, execution and the strength of our pipeline. This round of financing will fund the development of our existing product pipeline and the construction of our manufacturing facility. With the strong support of all our investors, we will fully drive the development of our product pipeline, strengthen our position in the global market for cancer immunotherapy, and bring much-needed innovative treatments and options to a larger population of cancer patients."

Mr. Lefei Sun, Managing Director and Head of Healthcare for China at General Atlantic, added: "In a short period of time, Biotheus has developed a differentiated and competitive pipeline of next-generation therapies, underpinned by an efficient R&D engine and a premier founding team with a successful track record of antibody development. Taken together, we believe that Biotheus is strongly positioned as an emerging player in the global biopharmaceutical landscape. We look forward to supporting Biotheus and its leadership team to accelerate the development of their deep product pipeline and advance innovative, life-saving cancer treatments to the commercial stage."

"Led by Mr. Xiaolin Liu, the core team of Biotheus has extensive experience in the development of novel antibody drugs," said Mr. Tao Huang, Vice President of IDG Capital. "Biotheus has built multiple platforms critical for drug development and a product pipeline with a strong competitive advantage. The construction of their manufacturing base has also begun. We believe Biotheus has significant growth potential."