On February 13, 2023 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, reported that the Company will host a conference call and live audio webcast on Tuesday, February 28, 2023 at 5:00 PM ET to report its fourth quarter and full year 2022 financial results and provide a corporate update (Press release, Fate Therapeutics, FEB 13, 2023, https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-webcast-conference-call-reporting-fourth-8 [SID1234627099]).

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In order to participate in the conference call, please register using the conference link here. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

On February 13, 2023 Exelixis, Inc. (Nasdaq: EXEL) and Sairopa B.V. (Sairopa) reported that the U.S. Food and Drug Administration (FDA) has cleared Sairopa’s Investigational New Drug (IND) Application to evaluate the safety and pharmacokinetics of ADU-1805 in adults with advanced solid tumors (Press release, Exelixis, FEB 13, 2023, View Source [SID1234627098]). As a monoclonal antibody active against all human alleles of SIRPα, ADU-1805 has the potential to address a broader patient population than other SIRPα-directed therapies.

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"The clearance of this Investigational New Drug Application for ADU-1805 is an exciting milestone for our expanding biologics pipeline, marking the first of many anticipated advancements we expect this year," said Vicki L. Goodman, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. "Based on its best-in-class potential and broad applicability, we look forward to learning more about ADU-1805 from the upcoming phase 1 trial across multiple tumor types, as we continue toward our goal of finding innovative solutions for patients with advanced cancers."

By blocking SIRPα, a significant immune-suppressive component of the tumor microenvironment, ADU-1805 has the potential to improve the immune system’s ability to attack tumors. ADU-1805 has been optimized to bind preferentially to SIRPα compared with other SIRP family members, which may enhance its ability to stimulate immune cells.

Under the terms of the clinical development and option agreement announced in November 2022, Exelixis has the option to obtain an exclusive, worldwide license to develop and commercialize ADU-1805 and other anti-SIRPα antibodies upon review of data from prespecified phase 1 clinical studies of ADU-1805 to be completed by Sairopa during the option period. This IND clearance triggers a $35 million milestone payment to Sairopa which will be paid in the first quarter of 2023.

"Given the robust preclinical data generated, we are thrilled that ADU-1805 is now able to advance to the clinic," said Laura Lassouw-Polman, Chief Operating Officer, Sairopa. "This is an important step forward in our partnership with Exelixis to explore the potential of ADU-1805, advancing our mission to develop therapies that modulate immune system activity to improve outcomes for cancer patients."

On February 13, 2023 Astex Pharmaceuticals (UK) ("Astex"), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system and The Medicines Discovery Institute, Cardiff University ("MDI") reported that they have entered into a multi-year, multimillion pound drug discovery research collaboration, aimed to identify new drugs to treat neurodegenerative diseases (Press release, Astex Pharmaceuticals, FEB 13, 2023, View Source [SID1234627097]).

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The collaboration brings together the world-leading research expertise of Dr Emyr Lloyd-Evans & Dr Helen Waller-Evans in lysosomal biology, the drug discovery capabilities of the MDI and the fragment-based drug discovery platform at Astex. The combined teams will focus on identifying compounds which modulate lysosomal activity as a way to develop potential new treatments for neurodegenerative diseases with high unmet medical need. Lysosomes are a subset of organelles that are crucial for cellular function and mutations in the genes encoding lysosomal and associated proteins are linked to a number of neurodegenerative and lysosomal storage diseases for which there are currently no effective treatments.

Under the terms of the agreement, scientists at the MDI and Astex will collaborate to carry out drug discovery research against a chosen lysosomal target with the aim to identify and optimise compounds that modulate its activity. Cardiff University will receive committed R&D funding and is eligible to receive development and regulatory payments if drug compounds progress and a royalty payment on the sales of any approved products. Further financial details are not disclosed.

Prof Simon Ward, Director, Medicines Discovery Institute commented "We are excited to be working with Astex in a way that allows each partner to play to its individual strengths and build a combined team which is greater than the sum of its parts. This is a validation of the scientific and translational capabilities we have been building at Cardiff University over the last few years and we look forward to delivering outputs that may ultimately benefit patients for whom current treatment options are so limited. This is an excellent demonstration of the power of academic and industrial teams working together to try to solve currently intractable medical problems."

Dr David Rees, FMedSci, FRSC, Chief Scientific Officer of Astex commented, "We are very excited about this opportunity to work with Cardiff University, Medicines Discovery Institute. Astex has a long tradition of effective collaborations between academia and industry which we believe is critical for the successful translation of basic science. This partnership aims to support and advance ground-breaking research with the potential to transform the lives of patients with neurodegenerative diseases."

On February 13, 2023 Alligator Bioscience AB ("Alligator") (Nasdaq Stockholm: ATORX) and Aptevo Therapeutics ("Aptevo") (Nasdaq: APVO) reported the dosing of the first patient in the companies’ Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors expressing the tumor-associated antigen 5T4 (Press release, Alligator Bioscience, FEB 13, 2023, View Source [SID1234627096]). ALG.APV-527 is a bispecific antibody with a tumor-directed 4-1BB agonistic effect and the ability to specifically stimulate antitumor-specific T cells and NK cells involved in tumor control.

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"We are very pleased to announce the initiation of a clinical trial to evaluate ALG.APV-527 in patients with solid tumors with high prevalence of 5T4. For Aptevo, the initiation of a second clinical program means we are now developing therapeutics to treat both solid tumors and hematological malignancies – a strategic win for our company," said Marvin White, President, and CEO of Aptevo. "ALG.APV-527 is a compelling candidate, as preclinical studies showed it has the potential to activate key immune cell populations within the tumor microenvironment while demonstrating a favorable safety profile. We look forward to sharing preliminary results, which we anticipate will be available in 2023."

"The start of this Phase 1 first in human study is an important milestone in the development of ALG.APV-527 and demonstrates the growing strength and effectiveness of our partnership with Aptevo," said Søren Bregenholt, PhD, CEO of Alligator Bioscience. "It also marks Alligator’s third asset currently in clinical development and we are particularly excited to evaluate its tumor-directed 4-1BB function with its promise of a broad therapeutic window and, alike ATOR-1017, highly differentiated safety and efficacy profile compared to the first generation 4-1BB agonists."

The ALG.APV-527 Phase 1 trial is a multi-center, multi-cohort, open-label trial that will include six cohorts in a 3+3 design. The trial will be conducted at up to 10 sites in the U.S. among adult patients with multiple solid tumor types/histologies likely to express the 5T4 antigen, including (but not limited to) non-small cell lung cancer (NSCLC), gastric/gastro-esophageal cancer and head and neck cancer. ALG.APV-527 will be given intravenously once every two weeks. The trial will assess the safety and tolerability, pharmacokinetic, pharmacodynamic and preliminary anti-tumor activity of ALG.APV-527.

About ALG.APV-527

ALG.APV-527 is a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4. This has the potential to be clinically important because 4-1BB has the ability to stimulate the immune cells (antitumor-specific T cells and NK cells) involved in tumor control, making 4-1BB a particularly compelling target for cancer immunotherapy. 5T4 is an oncofetal tumor associated antigen overexpressed on numerous solid tumors including non-small-cell lung carcinoma (NSCLC), breast, head and neck, cervical, renal, gastric, and colorectal cancer.

Preclinical studies, highlighting the differentiated design of the molecule that minimizes systemic immune activation, allowing for highly efficacious tumor-specific responses as demonstrated by potent activity in preclinical models, were recently published in the peer-reviewed publication, Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The full article is available via this link.

The information was submitted for publication, through the agency of the contact persons set out below at 2:05 p.m. CET on February 13, 2023.

On February 12, 2023 IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, reported that the U.S. Food and Drug Administration (FDA) has granted both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track (FT) designation to its investigational new drug BCMA CAR-T CT103A (Equecabtagene Autoleucel) for relapsed/refractory multiple myeloma (RRMM) (Press release, IASO Biotherapeutics, FEB 12, 2023, View Source [SID1234627086]).

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About CT103A

Equecabtagene autoleucel (CT103A) is a BCMA chimeric antigen receptor autologous T cell injection, a lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3ζ activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform, and integrated in-house manufacturing process improvement, the construct of CT103A is potent and shows prolonged persistency in patients. The NMPA accepted the New Drug Application for equecabtagene autoleucel for the treatment of relapsed/refractory multiple myeloma (RRMM). Equecabtagene autoleucel also received Breakthrough Therapy Designation by the NMPA in February 2021 and Orphan Drug Designation (ODD) in February 2022 and IND approval in December 2022 by the U.S. FDA. In addition to multiple myeloma, the NMPA has approved IND application of equecabtagene autoleucel for the new expanded indication of Neuromyelitis Optica Spectrum Disorder (NMOSD). IASO Bio and Innovent Biologics, Inc. (1801.HK) are jointly developing equecabtagene autoleucel for the treatment of RRMM in mainland China.

About RMAT Designation

Established under the 21st Century Cures Act, RMAT designation is intended to help the FDA facilitate an efficient development program of any drug that (1) qualifies as RMAT, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products; (2) is intended to treat, modify, reverse or cure a serious or life threatening disease or condition; and (3) has preliminary clinical evidence to indicated the drug has the potential to address unmet medical needs for such a disease or condition.

About FT Designation

Fast Track designation is designed to accelerate the development and review of treatments for serious and life-threatening diseases where no treatment exists or where the treatment in discovery may be better than what is currently available, thus enabling drugs to potentially reach patients earlier. Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.