Biomea Fusion to Attend H.C. Wainwright Global Investment Conference

On May 20, 2022 Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported that Biomea will attend the H.C. Wainwright Global Investment Conference virtually and will participate in 1×1 meetings held by the conference organizers (Press release, Biomea Fusion, MAY 20, 2022, https://investors.biomeafusion.com/news-releases/news-release-details/biomea-fusion-attend-hc-wainwright-global-investment-conference [SID1234614914]).

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Entry into a Material Definitive Agreement

On May 20, 2022, Aeglea BioTherapeutics, Inc. (the "Company") reported that entered into a Capital on DemandTM Sales Agreement (the "Offering Agreement") with JonesTrading Institutional Services LLC, as agent ("JonesTrading"), pursuant to which the Company may offer and sell, from time to time through JonesTrading shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), having an aggregate offering price of up to $60.0 million (the "Shares") (Filing, 8-K, Aeglea BioTherapeutics, MAY 20, 2022, View Source [SID1234614913]). In connection with the Offering Agreement, the Company’s existing Capital on DemandTM Sales Agreement, dated April 16, 2020, by and between the Company and JonesTrading, was terminated pursuant to the terms of the Offering Agreement.

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The offer and sale of the Shares will be made pursuant to a shelf registration statement on Form S-3 (File No. 333-239706) and the related base prospectus filed by the Company with the Securities and Exchange Commission (the "SEC") on July 6, 2020, and declared effective by the SEC on July 14, 2020, as supplemented by a prospectus supplement (the "Prospectus Supplement") dated May 20, 2022 and filed with the SEC pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the "Securities Act").

Pursuant to the Offering Agreement, JonesTrading may sell the Shares by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415 of the Securities Act (the "Offering"). JonesTrading will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the Shares from time to time, based upon instructions from the Company, including any price or size limits or other customary parameters or conditions the Company may impose.

The Company is not obligated to make any sales of the Shares under the Offering Agreement. The offering of Shares pursuant to the Offering Agreement will terminate upon the earliest of (a) the sale of all the Shares subject to the Offering Agreement or (b) the termination of the Offering Agreement by JonesTrading or the Company, as permitted therein.

The Company will pay JonesTrading a commission rate up to 3.0% of the aggregate gross proceeds from each sale of Shares and has agreed to provide JonesTrading with customary indemnification and contribution rights. The Company will also reimburse JonesTrading for certain specified expenses in connection with entering into the Offering Agreement. The Offering Agreement contains customary representations and warranties and conditions to the placements of the Shares pursuant thereto.

The foregoing description of the Offering Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. The opinion of the Company’s counsel regarding the validity of the Shares that will be issued pursuant to the Offering Agreement is also filed herewith as Exhibit 5.1.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Common Stock discussed herein, nor shall there be any offer, solicitation, or sale of common stock in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

VerImmune and Fosun Pharma enter into an Exclusive License and Option Agreement for VerImmune’s Virus-inspired Particle (ViP) platform as Novel Immunotherapies in China

On May 20, 2022 VerImmune Inc. ("VerImmune"), a privately-held biotechnology company developing a novel therapeutic virus-inspired particle (ViP) modality that redirects the body’s pre-existing immunity against viral pathogens to attack cancer, and Fosun Pharma USA, the US based subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"), a leading global pharmaceutical and healthcare provider headquartered in China, reported that the companies have entered into an Exclusive License and Option agreement effective May 18th,2022 (Press release, VerImmune, MAY 20, 2022, View Source [SID1234614909]).

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Under the terms of the agreement, VerImmune has granted Fosun Pharma an exclusive license to VerImmune’s lead AIR-ViP product candidate, VERI-101, with an option to license certain potential future AIR-ViP products arising from the development of VerImmune’s pipeline for the territory of Chinese Mainland , Hong Kong and Macau Special Administration Regions and Taiwan Region. Fosun Pharma will be responsible for all clinical development and commercialization in these territories. VerImmune is eligible to receive up to $125M in total milestone payments plus tiered royalties up to the low double digits on net sales of VERI-101 in specified territories. Subject to Fosun Pharma’s exercise of its option to select future AIR-ViP product candidates, VerImmune is eligible to receive additional milestone payments and royalties on net sales for each additional product candidate.

"Cancer is a global unmet medical need and thus we are very excited to be working with the Fosun Pharma companies to bring our novel lead AIR-ViP immunotherapeutic products to China. Fosun Pharma has both the expertise and access to reach these fast-growing markets We hope to benefit more Chinese patients and the region through our cooperation " said Joshua Wang, Ph.D., VerImmune Founder and CEO.

VerImmune’s core technology is an innovative Virus-inspired Particle (ViP) platform technology that can be used as a delivery system to attack cancer. Building upon this highly adaptable ViP platform, VerImmune has developed a First-in-Class novel therapeutic strategy called "Anti-tumor Immune Redirection" (AIR). This approach uses the ViP platform (now termed AIR-ViP) to redirect natural pre-existing immunity from past viral infections or childhood vaccinations to target cancer.

"The field of tumor immunotherapy is the frontier of current biomedical research, and it is also one of the key directions of Fosun Pharma’s strategic layout. We are pleased to partner with VerImmune to bring such a promising immunotherapy to China, and hope the cutting-edge biotherapeutic technologies and products can benefit more patients in China " commented Wu Yifang, Chairman and CEO of Fosun Pharma. "

Almac Discovery and HitGen Announce Strategic Research Collaboration

On May 20, 2022 Almac Discovery, the research driven drug discovery company and a member of the Almac Group, reported a new research collaboration with HitGen Inc. (SSE: 688222.SH), a world leader in the development and application of DNA-encoded library (DEL) technology for novel chemical equity (NCE) generation (Press release, Almac, MAY 20, 2022, View Source [SID1234614904]). The collaboration is focused on the identification of novel compounds against selected Deubiquitinating enzyme (DUB) targets of strategic interest to Almac.

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Almac Discovery has built an industry-leading platform to prosecute novel targets emerging from the DUB class of enzymes, an increasingly important target class for drug development, which is underpinned by high quality biological validation linking these targets to disease indications. Almac has utilised this platform to generate its own portfolio of drug discovery programmes, as well as to advance a number of DUB programmes of interest to pharmaceutical partners through a collaborative model.

In this collaboration, the companies will work together to identify novel chemical compounds against selected DUB targets. Almac will provide the targets, and HitGen will then screen their expansive library of over 1.2 trillion small molecules against these targets. Initial hits resulting from the screens will be further validated, and those that meet Almac Discovery’s selection criteria will be taken forward into discrete research and development programmes. The ultimate objective will be to generate highly potent and selective lead compounds that will allow the pharmacological validation of selected DUB targets in a number of different therapeutic modalities.

Professor Tim Harrison, Vice President of Drug Discovery at Almac Discovery, said: "We are delighted to have signed our latest research collaboration agreement with such an experienced and renowned leader in drug discovery chemistry research. The technology that HitGen has developed perfectly complements our expertise in DUB target chemistry and biology.

"We are excited at the possibility of utilizing DUBs to enable new approaches to disease modulation and look forward to working with HitGen to develop innovative treatments for diseases with high unmet medical need."

Dr. Jin Li, Chairman of the Board and Chief Executive Officer of HitGen, said: "As one of HitGen’s four core technology platforms, DEL is an efficient ‘engine’ to drive drug discovery with proven success. Over the past few years, we have worked with our partners to utilize this platform to generate nearly 500 licensed novel chemical structures for their research projects. We look forward to working with Almac Discovery to identify novel small molecule starting points from DNA-encoded libraries. We will work closely with Almac Discovery’s scientists to generate new lead compounds for their research programs to address unmet medical needs."

HitGen has built four core technology platforms including DNA-encoded library (DEL), molecular fragment and structure design (FBDD/SBDD), synthetic therapeutic oligonucleotide (STO) and targeted protein degradation (TPD). The DEL technology platform, centered around the design, synthesis and interrogation of over one trillion component libraries of DNA-encoded small molecules, is capable of providing services and products including DEL screening, customized DEL library, OpenDEL etc.

Allogene Therapeutics Announces Oral Presentation of Pre-Clinical Data Highlighting Improved Anti-Tumor Activity of Donor-Derived Allogeneic CAR T Cells at American Society of Gene and Cell Therapy (ASGCT) Annual Meeting

On May 19, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that it will present preclinical findings evaluating the characteristics and function of donor-derived allogeneic CAR T cells (Press release, Allogene, MAY 19, 2022, View Source [SID1234616277]). Data showed that cells from a diverse set of younger donors had improved characteristics and better in vitro anti-tumor activity compared to cells from older donors. The study also showed that cells from patients with certain cancers generally performed suboptimally based on functional assays and often could not be used to generate viable CAR T therapies. The findings will be presented during an oral session at the 2022 American Society of Gene and Cell Therapy Annual Meeting (ASGCT) (Free ASGCT Whitepaper) at 10:45am ET.

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"These results further support the benefits and characteristics of allogeneic CAR T cells produced from healthy donors and the potential for AlloCAR Ts to improve patient outcomes," said Rafael G. Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer at Allogene. "Cells derived from healthy, younger donors were more abundant, with greater fitness and cancer killing potential and have the potential to eliminate the risk of manufacturing failures seen with autologous CAR T therapies."

The study evaluated the characteristics and performance of CAR T cells derived from healthy donors aged 19 to 62, comparing the healthy donor cells to those derived from patients with cancer. Based on the analysis, CAR T cells produced from younger donors had stronger T cell phenotypes and better in vitro anti-tumor activity cytotoxicity compared to older donors. The expression of specific exhaustion and activation markers was also correlated with increased donor age and in vitro anti-tumor activity decreased with donor age. Regardless of age, the CAR T cells derived from healthy donors performed better and had a lower manufacturing failure rate compared to those derived from patients with cancer.

Creating allogeneic CAR T cells from healthy donors reduces product variability; reduces the risk of manufacturing failures; and enables treatment within days, eliminating the need for bridging chemotherapy. This study provides additional evidence that younger, healthy donors may improve product characteristics and potency compared to older donors.
Allogene currently has four clinical programs underway investigating the potential of AlloCAR T product candidates for the treatment of relapsed/refractory (R/R) large B cell lymphoma, RR multiple myeloma and advanced renal cell carcinoma.