1stOncology™: Cancer Intelligence Service – Page 6519 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Artiva Biotherapeutics Announces FDA Allowance of IND for AB-201, a HER2-Targeted CAR-NK for the Treatment of Solid Tumors

On September 20, 2022 Artiva Biotherapeutics, Inc., a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies that are safe and accessible to cancer patients, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug (IND) application for AB-201 (Press release, Artiva Biotherapeutics, SEP 20, 2022, View Source [SID1234619685]). AB-201 is an allogeneic HER2-targeted chimeric antigen receptor NK (CAR-NK) cell therapy for the treatment of solid tumors in the outpatient setting with the option for repeat dosing. Starting in the first half of 2023, Artiva plans to conduct a clinical study of AB-201 in HER2-expressing cancer patients at multiple clinical sites in the U.S.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"AB-201 is the first systemically administered, CAR-NK cell therapy candidate targeting the most prevalent HER2-positive cancer indications, including breast and gastric carcinomas," stated Fred Aslan, MD, CEO at Artiva. "Our Manufacturing-First strategy and highly scaled AlloNKTM platform has now demonstrated the ability to produce both non-engineered and CAR-NK product candidates for off-the-shelf use in the outpatient setting, with the potential to treat thousands of patients from single umbilical cord blood donors."

"There is a significant unmet need for effective therapies in the treatment of HER2-positive tumors, and AB-201 has demonstrated compelling preclinical anti-tumor activity," said Dr. Edith Perez, a member of Artiva’s Board of Directors.

HER2, also known as ErbB-2, is a member of the epidermal growth factor receptor (EGFR) family of receptors and an oncogene that is highly expressed on the surface of several types of cancers. HER2 status is a predictive factor in several cancer types, and multiple HER2-directed agents, including monoclonal antibodies, antibody-drug conjugates, and small molecule tyrosine kinase inhibitors have been developed for use in the treatment of HER2-positive cancer. However, most patients will eventually experience a relapse or progression of their disease, and once HER2-directed therapies have been exhausted, patients may be offered cytotoxic chemotherapy that provides only a modest benefit. The absence of safe and effective treatments for patients who have exhausted HER2-directed options represents an important unmet medical need.

AB-201 utilizes Artiva’s AlloNKTM manufacturing platform and proprietary CAR design. A novel, high affinity anti-HER2 antibody converted to scFv structure confers highly specific tumor targeting and is coupled with Artiva’s unique costimulatory structure and IL-15 expression for enhanced activity and persistence. AB-201 has demonstrated potent anti-tumor activity in multiple preclinical HER2-positive tumor model systems. The underlying NK cell is derived from umbilical cord blood donors preselected for advantageous attributes including the high affinity variant of the CD16 receptor and a KIR-B haplotype. AB-201 cell products maintain high expression of CD16, as well as other activating innate cell tumor engaging receptors, enabling the potential for dual targeting therapeutic approaches via monoclonal antibody combinations. The resulting CAR-NK is manufactured at very large scale and cryopreserved in infusion-ready media to enable repeat clinical administrations in the outpatient setting.

Alpine Immune Sciences Announces Proposed Public Offering

On September 20, 2022 Alpine Immune Sciences, Inc. (Nasdaq: ALPN), a clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, reported that it has commenced an underwritten public offering of $100.0 million of shares of its common stock and, in lieu of shares of common stock to certain investors that so choose, pre-funded warrants to purchase shares of its common stock, pursuant to its existing shelf registration statement (Press release, Alpine Immune Sciences, SEP 20, 2022, View Source [SID1234619684]). It is expected that the underwriters of the offering will be granted an option for a period of 30 days to purchase up to an additional $15.0 million of shares of common stock at the public offering price, less the underwriting discounts and commissions. All shares of common stock to be sold in the proposed offering will be sold by Alpine. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Morgan Stanley, SVB Securities and Cowen are acting as joint book-running managers for the proposed offering. Wedbush PacGrow is acting as lead manager for the proposed offering.

A shelf registration statement relating to the securities offered in the proposed public offering described above was filed with the Securities and Exchange Commission (SEC) on May 14, 2021 and declared effective by the SEC on May 20, 2021. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by telephone: 1-866-718-1649, or by email at [email protected]; SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered 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.

CytoReason Announces Expanded Collaboration Deal with Pfizer to Deliver AI for Drug Discovery and Development

On September 20, 2022 CytoReason reported an extension of its multi-year partnership with Pfizer to use CytoReason’s artificial intelligence technology for Pfizer’s drug development programs (Press release, Pfizer, SEP 20, 2022, View Source [SID1234619681]).

Under the terms of the agreement, Pfizer will make a $20M equity investment, have options to license CytoReason’s platform and disease models, and fund supplementary project support, in a deal potentially worth up to $110M over the next five years.

Since launching the collaboration in 2019, Pfizer has used CytoReason’s biological models in its research to enhance the understanding of the immune system, as it develops innovative drugs for immune-mediated and immuno-oncology diseases. CytoReason’s platform has provided Pfizer with multiple insights in research and development programs across over 20 diseases.

The new research agreement and investment will support the development of additional disease models and the creation of high-resolution models, spanning across a number of therapeutic areas.

"We’re pleased to expand our strategic collaboration with CytoReason," said Mikael Dolsten, Chief Scientific Officer and President, Pfizer. "We look forward to continuing our work with the company’s leading scientists, and to leveraging its cutting-edge platform. CytoReason’s biological data allows us to gain deeper insight into the best drug development pathways for patients, resulting in more informed decisions that are timely and cost-effective."

CytoReason has established itself as a global leader in computational modeling of human diseases thanks to its unique ability to combine computational models, proprietary human data, and the AI tools needed to provide actionable insights for accelerating drug development. The company’s multidisciplinary team of 70 leading biologists, bioinformaticians and data engineers has developed a platform that enables pharmaceutical and biotech companies to prioritize new targets, find biomarkers, and predict which patients may best respond to novel treatments.

"Pfizer has been a strategic partner of CytoReason since 2019, and we are thrilled to scale our collaboration as one of Pfizer’s trusted AI partners for accelerating drug development," said David Harel, CEO and Co-founder of CytoReason. "This partnership is advancing a significant shift in the biotech industry, and helping drive future R&D for pharmaceutical companies as they continue to use machine learning to develop treatments more efficiently. Transforming complex data into useful actionable insights will potentially provide leading researchers and scientists a roadmap to further develop their drug portfolios."

NETRIS Pharma, Orano and Centre Léon Bérard Announce Scientific Collaboration to Develop Novel Antibody Radio-Conjugate Therapies

On September 20, 2022 NETRIS Pharma SAS, a private clinical-stage biopharmaceutical company, reported that it has entered into a scientific collaboration agreement with Orano and the Centre Léon Bérard (CLB) to develop novel Antibody Radio-Conjugates for the treatment of cancer (Press release, Netris Pharma, SEP 20, 2022, View Source [SID1234619678]). Initially, the parties intend to conduct a preclinical proof-of-concept efficacy study with new radio-conjugate targeting Netrin-1, combining Netris’ monoclonal antibody (mAb) NP137 with undisclosed radioelement from Orano.

"Based on strong preclinical evidence showing the potential of linking NP137, our proprietary mAb, with approved radioelements for both imaging and therapy purposes, this collaboration with Orano and CLB has the potential to develop novel radio-conjugate that provide significant clinical benefits to patients," said Patrick Mehlen, Founder and Chief Executive Officer of NETRIS Pharma.

Both NETRIS Pharma and Orano have entered into this collaboration with Centre Léon Bérard based on the potential opportunities brought by novel radioisotope conjugates in oncology. Under the terms of the agreement, planned to be completed within one year, NETRIS Pharma, Orano and CLB will contribute their unique respective expertise in anti- netrin-1 biology and mode-of-action, radioisotope and nuclear based products, and preclinical and clinical oncology expertise to develop new compounds for clinical use.

"For Orano, it is a real opportunity to couple a new radioisotope with NP137developed by NETRIS Pharma thanks to the know-how of the Léon Bérard Comprehensive Cancer Center, in order to create a highly effective compound," declared Guillaume Dureau, Orano’s Director of Research & Development and Innovation. "With this collaboration, we hope to lay the foundation of a long-term partnership driven by the significant complementary expertise of the three partners."

"The vectorized radiotherapy practice of the Léon Bérard Comprehensive Cancer Center is among the most innovative ones in Europe," said Jean-Yves Blay, General Director of CLB. "New technologies using original cargoes to deliver radioelement are key to provide more effective treatments to patients. With the collaboration leveraging our strong clinical practice, we look forward to the future developments of this project".

About NP137

NP137, a humanized monoclonal antibody of isotype IgG1 directed against netrin-1, is the first drug candidate developed by NETRIS Pharma. Most types of tumors produce an abnormal amount of dependence receptor ligands, which prevents cells from dying. Netrin-1 is overexpressed in a large percentage of human cancers. Expression of netrin-1 often correlates with disease severity and no therapy has ever been tested against this new pathway. Preclinical studies show NP137 to have an anti-cancer effect as a monotherapy as well as synergistic effects in combination with chemotherapy or immune checkpoint inhibitors. NP137 has been so far administered to more than 140 patients and confirmed its excellent safety profile both in monotherapy and combination with chemotherapy and immunotherapy. The company is currently actively recruiting up to 240 patients in its Phase 2 trial in uterine cancer indications.

Just – Evotec Biologics awarded contract from U.S. Department of Defense under accelerated antibodies program

On September 20, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that the U.S. Department of Defense ("DOD") has awarded Evotec’s Seattle-based subsidiary, Just – Evotec Biologics, Inc. a contract valued up to $ 49.9 m for the rapid development of monoclonal antibody ("mAb")-based drug product prototypes targeting plague (Press release, Evotec, SEP 20, 2022, View Source;evotec-biologics-awarded-contract-from-us-department-of-defense-under-accelerated-antibodies-program-6213 [SID1234619677]). Plague, an infectious disease caused by the bacterium Yersinia pestis ("Y. pestis"), is one of the designated targets of interest under the DOD’s Accelerated Antibodies Program .

Under the contract, Just – Evotec Biologics will develop mAb-based drug product prototype(s) from sequence discovery or evaluation of existing mAbs to completion of Phase I first-in-human ("FIH") clinical trials. To enable rapid development, Just – Evotec Biologics will leverage its data-driven, highly automated end-to-end biologics technology platform, J.DESIGN, that includes; antibody discovery (J.HAL), molecular optimisation, cell line and process development, and continuous manufacturing at its J.POD Redmond, Washington (US) facility. In addition, Evotec will provide pre-clinical and clinical capabilities for mAb prophylactic approvals.

The rapid, cost-efficient development of mAb product protypes will yield an accelerated supply of safe and efficacious mAb medical counter measures ("MCMs") for use against plague.

J.DESIGN employs a series of innovative technologies relying on the use of artificial intelligence, machine learning, intensified and continuous bioprocesses specifically designed for flexible and efficient biologics development, from discovery through to clinical and commercial manufacturing. The advanced Just – Evotec Biologics platform is specifically well suited for monoclonal antibodies as well as other protein modalities such as Fc fusion proteins.

Dr Linda Zuckerman, Executive Vice President Global Head Biotherapeutics at Just – Evotec Biologics commented: "It is an honor to continue our partnership with the JPEO-CBRND team in this new effort to support the DOD’s Accelerated Antibodies program. We are pleased to provide a single integrated discovery, development and manufacturing solution for the DOD."

Dr Craig Johnstone, Chief Operating Officer of Evotec, added: "We are delighted to support the DOD with this work of strategic national importance, and which we feel represents a clear validation of both the efficiency and speed our leading science, technology and expertise offers our partners."

Mr. Bruce Goodwin, Joint Project Lead for CBRND Enabling Biotechnologies, added: "JPEO-CBRND-EB is pleased to work with Just/Evotec on this innovative and significant program to protect the Warfighter. Just/Evotec brings a unique approach, a robust toolset and deep expertise to address a challenging threat in a highly accelerated time frame."

The contract was awarded by the Joint Project Lead for CBRND Enabling Biotechnologies (JPL CBRND-EB) within the DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA). Contract number MCDC2203-001.

Just – Evotec Biologics’ J.POD Redmond, Washington biologics development and cGMP manufacturing facility will develop mAb-based drug products for the US Department of Defense. The state-of-the-art facility is joining the DOD’s Advanced Development and Manufacturing network of facilities, providing DOD with the space and tools necessary to rapidly produce quality medical countermeasures at the lowest possible cost of goods.