Valence Discovery to Support Repare Therapeutics on AI-Enabled Drug Discovery in Precision Oncology

On March 17, 2021 Valence Discovery ("Valence"), an emerging leader in AI-enabled drug design, reported it has entered into a drug discovery agreement with Repare Therapeutics ("Repare", Nasdaq: RPTX), a precision oncology company pioneering synthetic lethality to develop novel therapeutics for genetically-defined patient populations (Press release, Repare Therapeutics, MAR 17, 2021, View Source [SID1234576788]). This agreement will combine Valence’s unique expertise in few-shot learning, generative chemistry, and multiparameter optimization with Repare’s expertise in target identification and medicinal chemistry to rapidly optimize drug candidates against multiple potency, selectivity, safety, and pharmacology criteria.

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"We broadly sought out a machine learning partner for our proprietary drug discovery and ultimately found the ideal fit in our own backyard," says Cameron Black, Ph.D., Executive Vice President of Discovery at Repare Therapeutics. "The depth and breadth of the machine learning talent here in Montreal is exceptional, and we are pleased to be initiating this project with the drug design experts at Valence Discovery."

"As a world-leader in precision oncology, Repare’s team and technologies have the potential to unlock the next generation of precision oncology medicines for patients," says Daniel Cohen, CEO at Valence. "We look forward to bringing our expertise in AI-enabled drug design to bear on such important challenges in drug discovery."

About Valence’s AI-Enabled Drug Design Platform

The Valence platform expands upon academia-leading research done by the company’s founding team at Mila, the world’s largest deep learning research institute. In particular, Valence has pioneered the application of few-shot learning in drug design, allowing the company to unlock prediction tasks for which only small amounts of training data are available, including novel targets and complex ADME criteria, while also ensuring that AI-generated molecules are of high medicinal chemistry quality and readily synthesizable. In addition, Valence uses active learning and iterative optimization strategies to ensure that only the most information-rich compounds are selected for synthesis, enabling the design of compounds meeting the target potency, selectivity, and ADME criteria in fewer iterations, and with far less data, than otherwise possible.

Avid Bioservices to Participate in KeyBanc Capital Markets Life Sciences & MedTech Investor Forum

On March 17, 2021 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported that the company will participate in the KeyBanc Capital Markets Life Sciences & MedTech Investor Forum (Press release, Avid Bioservices, MAR 17, 2021, View Source [SID1234576787]). Nick Green, president and chief executive officer of Avid Bioservices, will be the featured speaker in a fireside chat at the conference, which will take place March 23-24, 2021 in a virtual format.

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Details of the company’s participation are as follows:

KeyBanc Capital Markets Life Sciences & MedTech Investor Forum
Conference Date: March 23-24, 2021
Fireside Chat Time/Date: 4:15 p.m. Eastern on Wednesday, March 24, 2021
Format: Virtual Conference

Armata Pharmaceuticals Announces Closing of Second and Final Tranche of $20 Million Private Placement with Innoviva

On March 17, 2021 Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, reported that, following a vote in favor of the transaction by the Armata shareholders, the Company has completed the closing of the second and final tranche of the Company’s $20 million private placement of its common stock with Innoviva Strategic Opportunities LLC, a wholly-owned subsidiary of Innoviva, Inc. (NASDAQ: INVA) (together, "Innoviva") (Press release, AmpliPhi Biosciences, MAR 17, 2021, View Source [SID1234576786]). In connection with the second closing, Armata issued 4,285,935 common shares and 4,285,935 warrants with an exercise price of $3.25 per share, at a per unit price of $3.25 per unit, in exchange for gross proceeds of approximately $13.9 million. Approximately 99% of the Armata shares represented and voting at the special meeting of shareholders voted in favor of the transaction.

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The Company and Innoviva closed an initial tranche of the investment on January 26, 2021, which raised gross proceeds of approximately $6.1 million through the issuance of 1,867,912 common shares and warrants to purchase an additional 1,867,912 common shares at a strike price of $3.25 per share.

As of March 17, 2021, and following the second closing, Armata has 24,940,442 shares outstanding and warrants exercisable for 16,649,465 shares of common stock.

Armata was represented in the transaction by Thompson Hine LLP, and Ladenburg Thalmann & Co. Inc. acted as Armata’s financial advisor.

Willkie Farr & Gallagher LLP represented Innoviva in the transaction.

This release does not constitute an offer to sell or the solicitation of an offer to buy any security. The shares offered have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws and may not be offered or sold in the United States or any state thereof absent registration under the securities act and applicable state securities laws or an applicable exemption from registration requirements.

Ambrx Granted Orphan Drug Designation for ARX788 for the Treatment of Gastric Cancer

On March 17, 2021 Ambrx, a clinical stage biopharmaceutical company using an expanded genetic code to create Engineered Precision Biologics, reported that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for ARX788 for the treatment of patients with HER2-positive gastric cancer, including cancer at the gastroesophageal junction (Press release, Ambrx, MAR 17, 2021, View Source [SID1234576785]).

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The FDA’s Office of Orphan Drug Products grants orphan status to support the development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S. Orphan drug designation for ARX788 for gastric cancer provides Ambrx with certain benefits, including an exemption to FDA prescription drug user fees and tax credits for qualified clinical trials. Orphan drug designation also confers eligibility for seven years of market exclusivity to an orphan drug post-approval, subject to receiving marketing approval from the FDA.

"The ongoing Phase 1 ACE-Gastric-01 trial has shown promising anti-tumor activity in HER2-positive advanced gastric patients who have been previously treated with trastuzumab and chemotherapy in the metastatic setting," said Feng Tian, Ph.D., President and CEO of Ambrx. "Receiving orphan drug designation from the FDA is an important milestone in our ongoing efforts to develop ARX788 for a wide range of HER2-positive cancers. We are proud to be targeting a rare disease that is currently severely underserved by advancing ARX788 into additional clinical trials."

The company anticipates the release of additional Phase 1 data from the ACE-Gastric-01 trial by the end of 2021 and initiation of ACE-Gastric-02, a global Phase 3 trial for HER2-positive gastric cancer, in the second half of 2021. ACE-Gastric-02 is currently planned to be a randomized trial of ARX788 versus physician’s choice of treatment in second line HER2-positive gastric cancer and HER2-positive cancer at the gastroesophageal junction.

About ARX788
ARX788 is a homogeneous and highly stable antibody drug conjugate (ADC) targeting the HER2 receptor. ARX788 is an Engineered Precision Biologic ADC that consists of two cytotoxic payloads site-specifically conjugated to a Herceptin (trastuzumab)-based antibody. ARX788 was designed to maximize potential anti-tumor activity by optimizing the number and position of the payloads and the chemical bonds that conjugate the cytotoxic AS269 payloads to the antibody. AS269 is a proprietary tubulin inhibitor specifically designed to form a highly stable covalent bond with our synthetic amino acids, a fundamental step in the creation of an Engineered Precision Biologic ADC. Ambrx licensed the China rights to ARX788 to its partner NovoCodex.

About HER2-positive Gastric Cancer
Human epidermal growth factor receptor 2 (HER2) is a tyrosine kinase receptor growth-promoting protein found on the surface of some cancer cells. Gastric cancer with HER2 overexpression has shown aggressive biological behavior, with higher frequencies of disease recurrence in HER2-positive tumors. The frequency of HER2 overexpression in gastric cancer, and cancer at the gastroesophageal junction, range widely with an average of 20% expression. The heterogeneity within gastric tumors and poor treatment options shows an unmet medical need for patients with HER2-positive advanced gastric cancer.

West Announces Participation in Upcoming Investor Conference

On March 17, 2021 West Pharmaceutical Services, Inc. (NYSE: WST) reported that management will present virtually at the KeyBanc Capital Markets Life Sciences & MedTech Investor Forum at 10:00 AM ET on Wednesday, March 24, 2021 (Press release, West Pharmaceutical Services, MAR 17, 2021, View Source [SID1234576779]).

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A live audio webcast of the presentation and a copy of the presentation will be accessible from the Company’s website at www.westpharma.com/en/investors.