On March 5, 2024 AvantGen Inc., a leader in antibody discovery and engineering, reported that it has received the first milestone payment from Kite, a Gilead Company, for the achievement of the first patient dosed in the first Phase 1 clinical trial of a novel CAR-T construct targeting human CD19 that is also engineered to express IL18 (Press release, AvantGen, MAR 5, 2024, View Source [SID1234640769]). This construct was developed in a collaboration between Kite and the University of Pennsylvania (Penn).

The Phase 1 open-label, dose-finding clinical study is initially focused on a single disease-specific cohort of subjects with Non-Hodgkin lymphoma (NCT05989204) and is being conducted by Penn as the regulatory sponsor.

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This achievement showcases the application of AvantGen’s innovative approach to antibody discovery for CAR-T research and development. The approach utilized AvantGen’s proprietary Germliner human antibody discovery platform to identify and develop novel CD19 antibodies, one of which is incorporated into the investigational CAR-T therapy. These antibodies, characterized by their high developability, expand the scope of CD19-binders under development as potential CAR-T therapies.

"We are thrilled to reach this milestone resulting from our agreement with Kite. This achievement further demonstrates the power and efficiency of our antibody discovery platform in advancing antibody-based therapeutics," said Xiaomin Fan, Ph.D., President and CEO of AvantGen.

Under the terms of the agreement, AvantGen may be eligible for future milestone and royalty payments if the therapy continues towards commercialization. This achievement highlights AvantGen’s technologies and mission to advance the field of antibody-mediated therapy.

AvantGen conducted this work under an agreement with Tmunity Therapeutics. Kite acquired Tmunity in 2023.

On March 5, 2024 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, reported four poster presentations at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, to take place April 5 to 10, 2024 in San Diego, CA (Press release, Aprea, MAR 5, 2024, View Source [SID1234640768]). The posters will cover ATRN-119, Aprea’s novel macrocyclic ATR inhibitor, and APR-1051, its next generation inhibitor of WEE1 kinase.

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Presentation Details

Title: First-in-human phase 1 study of WEE1 inhibitor APR-1051 in patients with advanced solid tumors harboring cancer-associated gene alterations
Presenter Nadeem Q. Mirza, MD, MPH
Session Title: First-in-Human Phase I Clinical Trials 2
Date and Time: Tuesday Apr 9, 9:00 AM – 12:30 PM PT
Location: Poster Section 48
Poster Board Number: 23
Abstract Presentation Number: CT195

Title: First-in-human phase 1/2a trial of a macrocyclic ATR inhibitor (ATRN-119) in patients with advanced solid tumors
Presenter Nadeem Q. Mirza, MD, MPH
Session Title: First-in-Human Phase I Clinical Trials 2
Date and Time: Tuesday Apr 9, 9:00 AM – 12:30 PM PT
Location: Poster Section 48
Poster Board Number: 24
Abstract Presentation Number: CT196

Title: The novel WEE1i, APR-1051, is a potentially well tolerated and effective treatment for cyclin E-overexpressing cancers
Presenter: Molly Hansbarger
Session Category: Experimental and Molecular Therapeutics
Session Title: DNA Damage and Repair Session
Date and Time: Wednesday Apr 10, 9:00 AM – 12:30 PM PT
Location: Poster Section 22
Poster Board Number: 16
Published Abstract Number: 7121

Title: Convection enhanced delivery of a novel ATR inhibitor synergizes with systemic lomustine for improved treatment of glioblastoma
Presenter: Teresa Lee, Ph.D
Session Category: Experimental and Molecular Therapeutics
Session Title: DNA Damage and Repair
Session Date and Time: Wednesday Apr 10, 9:00 AM – 12:30 PM PT
Location: Poster Section 22
Poster Board Number: 12
Published Abstract Number: 7117

On March 5, 2024 ALX Oncology Holdings Inc., ("ALX Oncology" or "the Company") (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, reported that two clinical abstracts have been accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting, which will be held in San Diego from April 5-10, 2024 (Press release, ALX Oncology, MAR 5, 2024, View Source [SID1234640767]).

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Session titles and information for the two abstracts are listed below and are now available on the AACR (Free AACR Whitepaper) online program planner.

A Phase 1 investigator-initiated trial of evorpacept (ALX148), lenalidomide and rituximab for patients with relapsed or refractory B-cell non-Hodgkin lymphoma
Session Title: Clinical Trials Minisymposium (Oral Presentation) / Novel Agents and Emerging Therapeutic Strategies
Session Date and Time: Tuesday, April 9, 2024 2:30 PM – 4:30 PM PT
Abstract: CT037

Phase 1 study of azacitidine in combination with evorpacept for higher-risk myelodysplastic syndrome (MDS)
Session Title: Phase I Clinical Trials 1
Session Date and Time: Monday April 8, 2024 9:00 AM – 12:30 PM PT
Location: Poster Section 48
Poster Board Number: 10
Abstract: CT060

Copies of the presentations will be available on ALX Oncology’s website at View Source following presentation at the meeting.

On March 5, 2024 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, and Peak Bio Inc. (OTC: PKBO), a clinical-stage biopharmaceutical company focused on developing therapeutics in areas of inflammation and oncology reported a definitive agreement to merge as equals in an all-stock transaction (Press release, Akari Therapeutics, MAR 5, 2024, View Source [SID1234640766]). The combined entity will operate as Akari Therapeutics, Plc, which is expected to continue to be listed and trade on the Nasdaq Capital Market as AKTX.

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Following closing, the company will have an expanded pipeline that contains multiple compelling assets spanning early and late development stages. An assessment of the pipeline is planned, including program prioritization, updated timelines, near-term value creation opportunities, and other considerations. Key highlights of the merger include:

Peak’s innovative ADC toolkit and lead program

The merged pipeline features a robust ADC toolkit with novel payload and linker technologies. By combining chemotherapy with immunotherapy strategies, the merged company aims to develop cutting-edge solutions for cancer patients. In addition, the program includes a novel pre-clinical ADC candidate targeting TROP-2.
Multiple compelling assets spanning early and late stages

Akari’s nomacopan is a bispecific recombinant inhibitor of complement C5 and leukotriene B4 (LTB4) being evaluated in a Phase 3 clinical trial for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). It has potential to be the first approved treatment for HSCT-TMA, a rare complication of stem cell transplantation that has an 80% mortality rate among severe adult and pediatric patients.
Akari’s long-acting version of nomacopan (PASylated-nomacopan) is in the final stages of pre-clinical development for geographic atrophy (GA). It has the potential to address significant unmet patient needs including a longer dose interval between intravitreal injections and reduction of choroidal neovascularization (CNV) risk that is associated with approved complement-only inhibitors currently used in GA treatment.
Peak Bio’s Phase 2-ready PHP-303 program is targeting alpha-1 antitrypsin deficiency (AATD). The program was licensed from Bayer Healthcare and is a 5th generation neutrophil elastase inhibitor (NEI) targeting the inflammatory aspects of AATD, a rare condition.
Strategic focus

The merged company is expected to emphasize business development and licensing with broad potential impact on patients.
Proven leadership

Leadership has extensive strategic and operational experience. Hoyoung Huh, M.D., Ph.D. is expected to serve as incoming Chairman of the Board of the combined entity. Dr. Huh is currently Chairman of the Board of Directors at Pliant Therapeutics and co-founder of BridgeBio Pharma. He is former Chairman of Geron Corporation, CytomX Therapeutics, Epizyme, and is a former partner at McKinsey & Company.
The post-merger Board of Directors will consist of three directors selected by each company and one independent director jointly selected.

Transaction Details

Under the terms of the agreement, Peak stockholders will receive a number of Akari ordinary shares (represented by American Depositary Shares) for each share of Peak stock they own, as determined on the basis of the exchange ratio described in the agreement. The exchange is expected to result in implied equity ownership in the combined company of approximately 50% for Akari shareholders and approximately 50% for Peak stockholders on a fully-diluted basis, subject to adjustment under certain circumstances, including based on each party’s relative level of net cash at the closing of the proposed transaction.

Timing and Approvals

The transaction is expected to close late in the second quarter of this year subject to the satisfaction of customary closing conditions, including approval by the shareholders of both companies.

Legal Advisors

Goodwin Procter LLP is serving as legal advisor to Akari and DLA Piper LLP is serving as legal advisor to Peak Bio.

On March 5, 2024 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, reported that the company is scheduled to present at the Leerink Partners Global Biopharma Conference on Tuesday, March 12, 2024, at 10:00 a.m. ET (Press release, Agios Pharmaceuticals, MAR 5, 2024, View Source [SID1234640765]).

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A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. A replay of the webcast will be archived on the company’s website for at least two weeks following the presentation.