On April 24, 2024 Endeavor BioMedicines, Inc. ("Endeavor"), a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, reported the closing of a $132.5 million Series C financing, including the conversion of a $5 million convertible instrument (Press release, Endeavor BioMedicines, APR 24, 2024, View Source [SID1234642326]). The oversubscribed round was led by AyurMaya, an affiliate of Matrix Capital Management, with participation from new investors including Fidelity Management & Research Company, Invus, SymBiosis, Velosity Capital, and Woodline Partners; and strong support from existing investors including funds managed by abrdn Inc. (formerly Tekla Capital Management LLC), Ally Bridge Group, Avidity Partners, Eckuity Capital, Longitude Capital, Omega Funds, Perceptive Advisors, Piper Heartland Healthcare Capital, Silver Arch Bio, and T. Rowe Price Associates.

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Endeavor will use the financing proceeds to advance the clinical development of ENV-101, its lead candidate for the treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF); and to advance ENV-501, a human epidermal growth factor 3 (HER3) antibody-drug conjugate (ADC) for the treatment of HER3-positive solid tumors through clinical proof-of-concept studies.

"We appreciate the support from this group of leading life sciences investors, who recognize the tremendous progress we’ve made since our initial funding rounds as well as the life-changing potential of our therapeutic candidates to reverse the trajectory of relentless diseases," said John Hood, Ph.D., Co-Founder, CEO and Chairman of Endeavor. "Endeavor BioMedicines has the momentum, coupled with the right team and the necessary financing, to advance our mission of delivering transformational medicines to patients who need them."

Advancing potential groundbreaking medicine for fibrotic lung diseases
Endeavor’s lead investigational candidate, ENV-101, has the potential to improve lung function and reverse the fibrotic process in the lungs of individuals with IPF and PPF. ENV-101 blocks a cellular wound-healing pathway known as Hedgehog (Hh) that is abnormally activated in IPF and PPF and causes the buildup of scar tissue in the lungs. Current standard-of-care therapies do not address the underlying cause of IPF or PPF. They minimally slow the decline of lung function, but do not stop or reverse it, and have tolerability issues that limit their long-term use in most patients.

Preliminary results from the recently completed randomized, double-blind, placebo-controlled Phase 2a clinical trial of ENV-101 (NCT04968574) underscore its potential to modify disease and offer treatment outcomes that go beyond slowing disease progression for patients with IPF. Results will be presented at the American Thoracic Society (ATS) International Conference in May. Endeavor plans to initiate a Phase 2b trial in patients with IPF and in parallel a cohort of patients with PPF in 2024.

Pursuing a validated therapeutic target in solid tumors
Endeavor’s second investigational candidate, ENV-501, is a next-generation anti-HER3 ADC that has been engineered to minimize off-target toxicity and has a clear path for differentiation against other HER3 ADCs in development. The HER3 protein is a growth factor receptor related to clinically validated oncology targets. HER3 is overexpressed in many solid tumors and those cancers that are HER3-positive are associated with poor prognosis and resistance to certain types of therapies. ENV-501 incorporates chemical and genetic features designed to improve the delivery of the drug to tumors and thereby increase its potency and reduce the toxicities commonly associated with ADCs. Endeavor intends to initiate a Phase 1/2 trial of ENV-501 in 2024.

"Endeavor BioMedicines’ novel drug candidates have the potential to disrupt the underlying mechanisms that cause serious, life-threatening diseases," said Karan Takhar, Senior Managing Director at Matrix, who will join Endeavor BioMedicines’ Board of Directors as part of the Series C financing. "I look forward to collaborating with Endeavor BioMedicines’ executive team and other members of the board to support the company’s clinical execution as it pursues significant milestones in 2024 and beyond."

On April 24, 2024 Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, reported the launch of a Phase II clinical study in minimal residual disease positive (MRD+) HPV-driven head and neck cancer (Press release, Naveris, APR 24, 2024, View Source [SID1234642325]). The study will be led by Memorial Sloan Kettering Cancer Center (MSKCC), a top cancer treatment and research institution.

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The primary objective of this multicenter randomized study is to evaluate the efficacy of HB-200, a novel intervention, for patients with HPV16+ head and neck squamous cell cancer (HNSCC) with molecular relapse, defined as the presence of circulating Tumor Tissue Modified Viral (TTMV)-HPV DNA without clinical or radiographic evidence of recurrence following definitive treatment. This will be the first MRD-treatment trial for this patient population.

NavDx, Naveris’ proprietary flagship blood test that detects TTMV-HPV DNA to diagnose disease recurrence or relapse in HPV-driven head and neck cancer, will be utilized to enroll patients to the trial, with requirements including detectable TTMV-HPV DNA by the NavDx assay three or more months after a patient received treatment for HPV16+ HNSCC. The NavDx test will be performed prior to, during, and following treatment.

"This study will propose a novel intervention for patients with MRD+ HPV-driven head and neck cancer and will assess the ability of NavDx to identify MRD in these patients," said Alan L. Ho, MD, PhD, Head and Neck Oncologist and Cellular Therapist, Memorial Sloan Kettering, and the primary principal investigator for the study. "The findings from this study will provide critical insights into the utility of treating patients identified at the early stage of molecular relapse."

NavDx is the first and only clinically validated circulating tumor HPV DNA blood test that provides a non-invasive and precise method for detecting disease recurrence or relapse in HPV-driven head and neck cancer before there is clinical or radiographic evidence of cancer recurrence.

"We are excited to announce the beginning of Phase II of our landmark trial, which marks the next step in our mission to bring innovative resources to viral-driven cancer surveillance," said Barry M. Berger, Chief Medical Officer of Naveris. "This trial is the first of its kind for this patient population and provides a promising look into the future of treatment paths, with NavDx being used to identify TTMV-HPV DNA and allowing for action earlier than ever before. We are grateful to the research team at Memorial Sloan Kettering Cancer Center for their collaboration and we look forward to presenting the results of this study when they are complete."

On April 24, 2024 Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, reported two presentations, including an oral presentation on the Phase 1 first-in-human study of OBX-115, a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15), in patients with immune checkpoint inhibitor (ICI)-resistant advanced or metastatic melanoma (NCT05470283), at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago on May 31–June 4 (Press release, Obsidian Therapeutics, APR 24, 2024, View Source [SID1234642324]).

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Oral Poster Presentation

Title: OBX-115, an interleukin 2 (IL2)-sparing engineered tumor-infiltrating lymphocyte (TIL) cell therapy, in patients (pts) with immune checkpoint inhibitor (ICI)-resistant unresectable or metastatic melanoma.
Session Title: Rapid Oral Abstract – Melanoma/Skin Cancers
Date and Time: Monday, June 3, at 9:45 a.m. CT/10:45 a.m. ET
Abstract Number: 9515
Speaker/Lead Author: Rodabe N Amaria, M.D., The University of Texas MD Anderson Cancer Center
Clinical Trial Identifier: NCT05470283 (First-in-human study)
Trials in Progress Poster Presentation

Title: A phase 1/2 study to investigate the safety and efficacy of OBX-115 engineered tumor-infiltrating lymphocyte (TIL) cell therapy in patients (pts) with advanced solid tumors.
Session Title: Poster Session – Melanoma/Skin Cancers
Date and Time: Saturday, June 1, at 1:30 p.m. CT/2:30 p.m. ET
Abstract Number: TPS9599
Speaker/Lead Author: Adam J Schoenfeld, M.D., Memorial Sloan Kettering Cancer Center
Clinical Trial Identifier: NCT06060613 (Multicenter study)
About OBX-115

Obsidian’s lead investigational cytoTIL15 program, OBX-115, is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). OBX-115 has the potential to become a meaningful therapeutic option for patients with advanced or metastatic melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process to enhance persistence, antitumor activity, and clinical safety of TIL cell therapy. OBX-115 is being investigated in two ongoing and enrolling clinical trials in advanced or metastatic melanoma and NSCLC (NCT05470283 and NCT06060613).

On April 24, 2024 SOTIO Biotech, a clinical-stage immuno-oncology company owned by PPF Group, reported it will present a Trial-in-Progress poster on the DUET-01 Phase 1/2 study of BOXR1030 at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 31 – June 4, 2024, in Chicago, IL (Press release, SOTIO, APR 24, 2024, View Source [SID1234642323]).

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BOXR1030 is a next-generation GPC3-targeted CAR T-cell therapy enhanced with a transgene encoding GOT2, a critical enzyme involved in cellular metabolism. Preclinical studies of BOXR1030 have demonstrated its superior activity compared to standard CAR T-cell therapies. It is the most advanced therapeutic candidate from SOTIO’s BOXR platform of enhanced cell therapies for the treatment of solid tumors.

The DUET-01 clinical trial is a first-in-human, open-label, multicenter, dose escalation study to assess and determine the recommended Phase 2 dose of BOXR1030 in patients with GPC3 positive advanced solid tumors. The trial will enroll up to 98 patients with advanced, unresectable hepatocellular carcinoma, squamous cell lung cancer, myxoid/round cell liposarcoma, and Merkel cell carcinoma.

Poster details are as follows:

Title: "DUET-01: A first-in-human, phase 1/2 study of BOXR1030 in patients with advanced glypican-3-positive solid tumors"
Abstract Number: TPS2681
Session: Developmental Therapeutics — Immunotherapy
Date & Time: June 1, 2024, 9:00 a.m. – 12:00 p.m. CDT

Presentation materials will be available after presentations conclude here.

On April 24, 2024 Agenus Inc. ("Agenus") (Nasdaq: AGEN), a leader in developing novel immunological agents to treat various cancers, reported an upcoming presentation from the Phase 1b trial of botensilimab in combination with balstilimab ("BOT/BAL") in patients with relapsed/refractory microsatellite stable colorectal cancer with no active liver metastases (r/r MSS CRC NLM) will be presented at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting, to be held May 31 – June 4, 2024, in Chicago, IL (Press release, Agenus, APR 24, 2024, View Source [SID1234642322]). The poster presentation is for a sub-analysis of the r/r MSS CRC cohort of the Phase 1b study. This sub-analysis was done to determine whether treatment outcomes are correlated with specific sites of metastatic disease in patients with non-active liver mets.

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Presentation Details:

Abstract Title: Botensilimab plus balstilimab in microsatellite stable metastatic colorectal cancer: Assessing efficacy in non-liver metastatic sites.

Abstract Number: 3556

Presenting Author: Marwan Fakih, MD, Division Head, GI Medical Oncology, City of Hope Comprehensive Cancer Center

Session: Poster Session – Gastrointestinal Cancer – Colorectal and Anal

Session Date and Time: June 1, 2024, at 1:30 p.m. – 4:30 p.m. CT

Complete abstracts will be released Thursday, May 23, 2024, at 5:00 p.m. ET. Data presented at the conference will be available to view in the publications section of the Agenus website (View Source) following the ASCO (Free ASCO Whitepaper) Meeting.

About Botensilimab

Botensilimab is an investigational multifunctional anti-CTLA-4 immune activator (antibody) designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.

Approximately 900 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316.