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aTyr Pharma to Present at the Oppenheimer Fall Healthcare Life Sciences and MedTech Summit

On September 16, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported that Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer, will present a corporate overview at the virtual Oppenheimer Fall Healthcare Life Sciences and MedTech Summit, which is being held from September 20 – 23, 2021 (Press release, aTyr Pharma, SEP 16, 2021, View Source [SID1234587896]).

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The presentation will take place on Wednesday, September 22, 2021, at 3:45 p.m. ET.

In addition to the presentation, management will be available to participate in virtual one-on-one meetings with investors who are registered attendees of the conference.

Following the event, a replay of the live presentations will be available on the Investor’s section of the company’s website at www.atyrpharma.com.

Entry into a Material Definitive Agreement.

On September 16, 2021, Gritstone bio, Inc. (the "Company") reported that it entered into a Securities Purchase Agreement (the "Purchase Agreement") with certain purchasers identified on the signature pages thereto (the "Purchasers"), pursuant to which the Company issued and sold to the Purchasers, in an unregistered offering, an aggregate of 5,000,000 shares of common stock, par value $0.0001 per share (the "Common Stock") at a per share purchase price of $11.00 per share, for aggregate gross proceeds to the Company of $55.0 million (the "Private Placement"). The closing of the Private Placement occurred on September 17, 2021 (the "Closing") (Filing, 8-K, Gritstone Oncology, SEP 16, 2021, View Source [SID1234587887]).

Pursuant to the Purchase Agreement, the Company has agreed to file a resale registration statement with the Securities and Exchange Commission as soon as practicable, and in all events within 30 days after the Closing, to register the resale of the Securities issued at the time of the Closing.

Cowen & Company LLC acted as sole placement agent for the Private Placement.

The foregoing summaries of the Private Placement, the Shares to be issued in connection therewith, and the Purchase Agreement are qualified in their entirety by reference to the definitive transaction documents. A copy of the Purchase Agreement is attached hereto as Exhibit 10.1 and is incorporated herein by reference.

Strategic collaboration between Bioneer A/S & National Biologics Facility

On September 16, 2021 Bioneer A/S, a globally operating Danish specialty-CRO creating and commercializing innovative research service solutions for early stage drug development and in vitro modelling, reported that it has entered a strategic collaboration with the National Biologics Facility (NBF) (Press release, Bioneer, SEP 16, 2021, View Source;utm_medium=rss&utm_campaign=strategic-collaboration-between-bioneer-a-s-national-biologics-facility [SID1234587874]). The entity, previously named CHO CORE, is one of the largest academic groups in the world working on Chinese Hamster Ovary cell (CHO) modelling and mechanisms. Funded by the Novo Nordisk Foundation, NBF was established in 2012 at the Technical University of Denmark (DTU). This collaboration will enable Bioneer to offer end-to-end non-GMP production of recombinant proteins utilizing both microbial and mammalian expression platforms.

Bioneer and NBF complement each other’s capabilities. NBF brings broad experience in CHO cell line engineering and expert understanding of stable protein expression in CHO cells. Bioneer brings nearly 40 years of commercial and scientific experience creating customized service solutions in the field of expression and production of special proteins and antibodies.

Jette Asboe Lassen, CBO at Bioneer, says: "We are excited to join forces with NBF and to be able to expand our offering and capacity to clients seeking mammalian cell line development and production capabilities for recombinant proteins."

Bjørn Voldborg, Director at NBF, says: "I am extremely excited about this collaboration that will allow us to deploy the expertise, know-how, and infrastructure for protein and cell line development in mammalian cells we have generated over the past 8 years at DTU."

With this partnership, the recombinant protein production capacity available to Bioneer will be nearly doubled. State-of-the-art, Copenhagen-based, laboratories for mammalian cell line development and protein expression are established at NBF and similar facilities will be ready at the end of the year at Bioneer, which is currently expanding its laboratories, including the construction of brand-new protein laboratories.

The collaboration between Bioneer and NBF will be of great benefit to the national and international biotech and pharma industries, in a climate where the global need for facilities dedicated to the development of biologically based therapeutics and specialty proteins is more important than ever.

Biomea Fusion Announces FDA Clearance of
Investigational New Drug Application for
Irreversible Menin Inhibitor BMF-219

On September 16, 2021 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug application to begin a Phase I trial of BMF-219, a selective irreversible menin inhibitor, in adult patients with relapsed or refractory acute leukemia including those with an MLL/KM2TA gene rearrangement or NPM1 mutation (Press release, Biomea Fusion, SEP 16, 2021, View Source [SID1234587873]).

"First of all, I would like to take this opportunity to thank the FDA, the Contract Research Organizations, our consultants, our investors, and of course TEAM FUSION for the commitment, guidance, support, and tireless effort in getting BMF-219, an investigational new drug, in the hands of patients in need. It was a true community effort, and we are so blessed here at Biomea to be in position to provide an impactful therapy against aggressive cancers," said Thomas Butler, Biomea’s CEO and Chairman of the Board. "This is just the beginning for BMF-219 as we are planning to pursue multiple indications with our novel molecule. This is also just the beginning for the company, as we continue to make significant progress with our pipeline programs. We are in a strong position to continue to bring novel small molecules into the clinic and help the many patients with life threatening and life altering diseases."

"Over the past 6 months, we have brought together a first-class team of biotech professionals to tackle our next phase of growth, which will include clinical development of BMF-219 in not only liquid but also solid tumors," said Ramses Erdtmann, Biomea’s COO and President. "BMF-219 is a very special compound, with a unique effect on menin which we believe will lead to improved outcomes for patients with specific gene arrangement and mutations."

An irreversible small molecule, such as BMF-219, is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional reversible drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response.

The Phase 1, first-in-human, open-label, dose-escalation and dose-expansion clinical trial of BMF-219 will assess the safety, pharmacokinetic (PK) and pharmacodynamic (PD) profile of BMF-219 in adult patients with relapsed or refractory acute leukemia including those with an MLL/KM2TA gene rearrangement or NPM1 mutation.

About Acute Myeloid Leukemia (AML)

AML is the most common form of acute leukemia in adults and represents the largest number of annual leukemia deaths in the U.S. and Europe. AML originates within the white blood cells in the bone marrow and can rapidly move to the blood and other parts of the body, including the lymph nodes, spleen, and central nervous system. Approximately 30,000 people in the U.S. and Europe are diagnosed with AML each year, and the five-year overall survival rate in adults roughly 29%. Among patients with relapsed/refractory disease, the need is greatest, as the overall survival is approximately 3 to 9 months. It is estimated that upwards of 45% of AML patients have menin dependent genetic drivers (MML-r or NPM1).

About BMF-219

BMF-219 is an irreversibly binding inhibitor of menin, a protein that is known to play an essential role in oncogenic signaling in genetically defined leukemias. Preclinically, BMF-219 has demonstrated robust downregulation of key leukemogenic genes in addition to menin itself (via MEN1) in well-established MLLr AML cell lines. Additionally, BMF-219 has shown efficacy in multiple in vivo and in vitro models of acute leukemias. BMF-219 will be evaluated in a first-in-human trial in patients with relapsed or refractory acute leukemia with MLL/KM2TA gene rearrangement or NPM1 mutation.

TD2 and Deep Lens Partner to Enable Diversity, Access and Faster Clinical Trial Enrollment for Community Oncology Practices

On September 16, 2021 Translational Drug Development (TD2), a leading precision oncology contract research organization (CRO), and Deep Lens reported a strategic partnership that will enhance access to tailored oncology treatments and novel clinical studies for patients receiving care in community oncology practices (Press release, TD2, SEP 16, 2021, View Source [SID1234587862]). The partnership will enable TD2 to offer Deep Lens’ proprietary clinical trial matching solution, VIPER, as well as other research coordination services, to its drug development clients, thereby improving the ability for hospitals, trial coordinators, investigators, and patients to promote, collaborate, participate in and manage oncology clinical trials.

There has been tremendous growth in precision oncology, or the development of treatments that target the molecular profile of a patient’s tumor. The number of approved novel immunotherapy and targeted agents for different cancer indications has increased dramatically over the past five years, as has the number of clinical trials studying their safety and efficacy1. However, identifying and recruiting eligible patients for precision medicine trials can be challenging. Complex eligibility criteria coupled with very narrow timelines for enrollment can be difficult and labor intensive for study sites and sponsors. The blending of TD2 expertise in precision oncology with the Deep Lens’ clinical trial matching solution platform will improve efficiencies in trial recruitment and enrollment, increase patient access to trials, specifically at community oncology sites, where the majority of patients are diagnosed, and facilitate enhanced access to the right care, for the right patient, at the right time.

The Deep Lens VIPER platform automates the study screening process from time of patient diagnosis to qualified enrollment through the ingestion of genomic data, EMR, pathology, radiology and other patient data. VIPER provides rich data and interactive reporting capabilities to aggregate site and study-level patient data, making it easier for sites to achieve study objectives.

"The highest priority for TD2 is to ensure every patient that participates in a TD2 clinical trial has the opportunity of achieving clinical benefit," said Stephen Gately, President and CEO at TD2. "Working with the Deep Lens platform and coordinators, TD2 can match cutting edge science and molecular testing results with clinical protocol inclusion/exclusion criterion to ensure patients get access to clinical trials where there is an increased likelihood of benefit. We are truly excited that this partnership has the potential to change the way early phase oncology trials are run and enrolled, taking the pressure off the sites to find the next patient and putting the focus on the right patient."

"The drug development process has expanded significantly as our knowledge and understanding of cancer has evolved, and this has resulted in an increase in the number of precision medicine trials studying targeted therapies. While this is a positive step in our battle against cancer, unfortunately, the large majority of these trials fail to enroll enough patients to progress," said Dave Billiter, co-founder and chief executive officer of Deep Lens. "Our approach is to reach more patients by working in the community oncology setting, where the majority of these patients are diagnosed and treated. The partnership with TD2 will allow us to support drug developers to identify and enroll patients into trials for which they are eligible – through our AI-based platform, we can do this right at the time of a patient’s diagnosis. This means more patients have access to life-changing therapies sooner, and drug developers can more effectively test the safety and efficacy of new therapies in more diverse populations."