On April 1, 2024 Adcentrx Therapeutics ("Adcentrx"), a biotechnology company revolutionizing Antibody-Drug Conjugate (ADC) therapeutics for cancer and other life-threatening diseases, reported that preclinical data for ADRX-0706 will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024, taking place April 5-10, 2024, in San Diego, CA (Press release, Adcentrx Therapeutics, APR 1, 2024, View Source [SID1234641650]).

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The three presentations will include preclinical data for Adcentrx’s lead ADC program, ADRX-0706. The ADC is comprised of a novel fully human IgG1 antibody targeting human Nectin-4 linked to a novel tubulin inhibitor payload, AP052, through Adcentrx’s proprietary i-Conjugation technology using a cleavable linker and stable conjugation chemistry. This novel platform technology generates highly stable ADCs with a drug-antibody ratio of eight (DAR 8), substantially expanding the therapeutic window of auristatin-based ADCs beyond existing vedotin technology. The preclinical data presentations show improved therapeutic window of ADRX-0706, enhanced bystander effect and improved payload delivery to Nectin-4 expressing tumors while minimizing exposure to normal tissues.

Details of the three AACR (Free AACR Whitepaper) poster presentations are below:

Presentation Title: Preclinical characterization of ADRX-0706: A next-generation anti-Nectin-4 antibody-drug conjugate with improved therapeutic window
Abstract Number: 1891
Session Date & Time: Monday, April 8, 9:00 a.m. – 12:30 p.m. PT
Session Title: Antibody-Drug Conjugates and Bispecific Antibodies

Presentation Title: ADRX-0706 Nectin-4 antibody-drug conjugate PK/PD characterization elucidates its widened therapeutic window
Abstract Number: 1902
Session Date & Time: Monday, April 8, 9:00 a.m. – 12:30 p.m. PT
Session Title: Antibody-Drug Conjugates and Bispecific Antibodies

Presentation Title: Advancing a novel tubulin-inhibitor ADC technology: The Adcentrx auristatin platform offers enhanced efficacy and safety profiles compared to vedotin technology
Abstract Number: 1909
Session Date & Time: Monday, April 8, 9:00 a.m. – 12:30 p.m. PT
Session Title: Antibody-Drug Conjugates and Bispecific Antibodies

About ADRX-0706

ADRX-0706 is a fully proprietary ADC product candidate discovered by Adcentrx. The antibody component targets Nectin-4, a cell surface adhesion protein over-expressed in multiple human cancers and associated with poor disease prognosis. ADRX-0706 has a favorable pharmacokinetic and safety profile in preclinical models, and has demonstrated significant efficacy across a variety of tumor indications in vitro and in vivo. ADRX-0706 is currently being evaluated in a Phase 1a/b clinical trial.

For more information about the ADRX-0706 Phase 1a/b clinical trial, please refer to the Study ID NCT06036121 on ClinicalTrials.gov.

On April 1, 2024 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, reported that results from the Phase 3 SIERRA trial of Iomab-B in patients with a TP53 mutation have been accepted for oral presentation at the 50th Annual meeting of the European Bone Marrow Transplant Society (EBMT) being held April 14 – 17, 2024, in Glasgow, Scotland. Iomab-B is a targeted radiotherapy conditioning agent comprised of an anti-CD45 monoclonal antibody and Iodine-131 radioisotope payload. The Phase 3 SIERRA trial enrolled 153 patients with active relapsed or refractory acute myeloid leukemia (r/r AML) and compared outcomes of patients receiving Iomab-B and a bone marrow transplant (BMT) to those of patients receiving physician’s choice of care in the control arm. In total, 24% of patients (37/153) in the SIERRA trial had a TP53 mutation, which is associated with poor outcomes, and 27 of the TP53 positive patients received Iomab-B. Iomab-B met the primary endpoint of durable Complete Remission (dCR) in the SIERRA trial with high-statistical significance (p<0.0001) and 100% of patients receiving a therapeutic dose of Iomab-B achieved BMT access and engagement.

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Dr. Hannah Choe, Assistant Professor of Medicine at Ohio State University and SIERRA trial investigator will present the SIERRA results. Details of the oral presentation are as follows:

Title: I-131-Apamistamab-Led Allogeneic Hematopoietic Cell Transplant Demonstrates Survival Benefit and Overcomes High-Risk TP53 Mutations in Patients with R/R AML

Date and Time: Wednesday, April 17, 2024, 12:39 PM GMT

Session: OS17-02

Location: Scottish Event Campus (SEC Centre)

Dr. Avinash Desai, Actinium’s Chief Medical Officer, said, "In addition to demonstrating unprecedented 100% access to BMT in Iomab-B treated patients with active r/r AML and achieving the primary endpoint of dCR with high statistical significance, we are excited by the compelling outcomes in patients with a TP53 mutation in the SIERRA trial. We look forward to returning to EBMT and once again highlighting the positive results from the Phase 3 SIERRA trial to the European bone marrow transplant community. We are particularly focused on Europe as it represents the largest bone marrow transplant market performing 40% of the BMT transplants globally. We also look forward to continuing to work with our European, Middle East and North African commercial partner, Immedica Pharma Ab, to bring Iomab-B to patients globally."

About the EBMT Annual Meeting

The Annual Meeting of the EBMT is attended by more than 5,500 participants, including physicians, nurses, data managers, statisticians, quality managers, cell therapists, paediatricians, pharmacists, psychologists, psychiatrists and psychoanalysts, transplant coordinators, lab scientists, trainees, patients. This important congress ensures and encourages dialogues and information exchange, education and scientific productivity.

The full annual meeting program is available online at:
View Source

On April 1, 2024 2seventy bio, Inc. (Nasdaq: TSVT), reported the completion of the asset purchase agreement ("APA") by Regeneron Pharmaceuticals, Inc. Under the terms of the APA, Regeneron has acquired all oncology and autoimmune research and development programs and has hired approximately 160 employees from 2seventy bio as part of their newly launched cell medicines business (Press release, 2seventy bio, APR 1, 2024, View Source [SID1234641648]). Going forward, 2seventy bio will focus exclusively on the commercialization and development of Abecma (idecabtagene vicleucel), its BCMA-targeted CAR T cell therapy for multiple myeloma, in collaboration with their partner Bristol Myers Squibb (BMS).

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"With the completion of the Regeneron transaction, 2seventy officially embarks on our new strategic path forward to focus on unlocking the value of Abecma," said Chip Baird, CEO. "We are pleased to have successfully transitioned our innovative cell therapy pipeline to Regeneron and excited for the team members who have joined Regeneron Cell Medicines to continue their important work of developing new treatments for people with cancer. We are also extremely excited about our own future with the potential to bring Abecma to more patients in earlier lines."

Based on the Company’s recent strategic actions, 2seventy bio includes approximately 65 full-time, permanent employees, primarily in quality and supporting functions. With the resulting cost savings from reduced headcount and the sale of the pipeline assets to Regeneron, 2seventy bio has extended cash runway beyond 2027. The Company will continue to support quality control of lentiviral vector (LVV) for Abecma.