On September 16, 2021 Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported that final results from the Bal/Zal combination study at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Conference 2021 in an abstract titled Balstilimab (anti-PD-1) in combination with zalifrelimab (anti-CTLA-4): final results from a Phase 2 study in patients (pts) with recurrent/metastatic (R/M) cervical cancer (CC) (Press release, Agenus, SEP 16, 2021, View Source [SID1234587897]).

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The data are being presented by lead investigator Dr. David O’Malley, Professor of Obstetrics and Gynecology at The Ohio State University College of Medicine and the Director of the Division of Gynecologic Oncology, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James).

"With a median follow-up of almost 2 years, the Bal/Zal combination showed high response rates, durable clinical activity, and promising overall survival results", said Steven O’Day, MD, Chief Medical Officer of Agenus. "Furthermore, later this year we expect to present new data on our next-generation CTLA-4 inhibitor AGEN1181, which we expect to further define the positive role this combination strategy could have in addressing unmet needs for cancer patients."

The Phase 2 trial was conducted in 155 patients with recurrent/metastatic cervical cancer (R/M CC) which has limited effective treatment options and disproportionately affects younger women. In the 125 evaluable patients, the objective response rate (ORR) in all patients was 26%, with 9% of patients achieving a complete response, and 17% of patients achieving a partial response. The median duration of response (DoR) was not reached after a 19.4-month median follow-up. Notably, responses were also observed in the PD-L1 negative and adenocarcinoma populations, with 9% of both patient groups achieving an ORR. Based on these observations, we predict more than half of the patients to be alive beyond 12 months*.

The Bal/Zal combination continued to show no unexpected toxicities and no new safety signals were identified.

Detailed results from this trial will be presented in a Mini Oral Session on September 19th from 11:35 – 11:40am ET by David O’Malley, MD. In addition, in a Trials in Progress abstract, Agenus presented the RaPiDS trial design for balstilimab alone or in combination with zalifrelimab as second-line treatment for patients with previously treated R/M CC.

"This trial represents the largest study evaluating PD-1 + CTLA-4 inhibition in relapsed cervical cancer to date and shows that the combination could represent a meaningful new option for patients in this setting," said Dr. O’Malley. "Efficacy outcomes continued to improve over time, and the combination likewise continued to show a positive safety profile."

* Updated data to be presented during September 19th Mini Oral session.

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.

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]).

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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.

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.

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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.

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]).

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"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.