On April 9, 2026 Boehringer Ingelheim reported a clinical trial collaboration with BioNTech to evaluate a novel immuno‑oncology combination in extensive‑stage small cell lung cancer (ES-SCLC), one of the most aggressive and underserved forms of cancer. Under the agreement, BioNTech will supply pumitamig (BNT327/BMS‑986545), a PD‑L1/VEGF‑A bispecific antibody being jointly developed by BioNTech and Bristol Myers Squibb, and Boehringer Ingelheim will be the regulatory sponsor of the Phase Ib/II study. The aim is to assess safety, tolerability and early clinical activity of obrixtamig (BI 764532), Boehringer Ingelheim’s investigational DLL3/CD3 T‑cell engager, in combination with pumitamig.

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!

SCLC is the most aggressive subtype of lung cancer and represents around 15–20% of all lung cancer cases. It progresses rapidly, metastasizes early and almost always recurs within a year after initial treatment. While the addition of immune checkpoint inhibitors to chemotherapy has led to improved survival outcomes for patients with extensive-stage disease, most patients progress within months after treatment, and the prognosis remains poor. The collaboration combines two complementary immunotherapeutic mechanisms to explore a potential new path to enhance and sustain antitumor immunity. Obrixtamig redirects T-cells to kill DLL3 expressing tumor cells, while pumitamig aims to restore T-cells’ ability to recognize and destroy tumor cells while cutting off the blood and oxygen supply that feeds the tumor with the intention of preventing it from growing and proliferating.

"By uniting T‑cell redirection against DLL3 with PD-L1 and VEGF pathway modulation, we aim to address two central barriers in SCLC – immune evasion and an immunosuppressive, pro‑angiogenic microenvironment," said Itziar Canamasas, Global Head of Oncology at Boehringer Ingelheim. "We are committed to advancing combinations that could deliver more durable benefit for people living with ES‑SCLC."

Obrixtamig is Boehringer Ingelheim’s investigational bispecific DLL3/CD3 T‑cell engager, designed to direct immune cells to attack DLL3‑expressing cancer cells, a hallmark of small cell lung cancer and other neuroendocrine carcinomas. In the global Phase I first‑line ES‑SCLC study DAREON‑8, in combination with chemotherapy and atezolizumab, obrixtamig achieved a 68% confirmed objective response rate, 89% disease control rate, and a 9‑month progression‑free survival rate of 52%, with a favorable safety profile1. Obrixtamig is being evaluated across multiple global studies and is advancing into a global Phase III trial (DAREON‑Lung‑1, NCT07472517). It has received FDA Fast Track and Orphan Drug Designations, as well as Orphan Drug status from the European Commission for neuroendocrine carcinomas.

Pumitamig is an investigational PD‑L1/VEGF‑A bispecific antibody being jointly developed by BioNTech and Bristol Myers Squibb that combines two complementary, validated mechanisms in one single molecule – immune checkpoint inhibition and anti-angiogenesis. In a global Phase II first‑line ES‑SCLC study in combination with chemotherapy, pumitamig demonstrated a 76.3% confirmed objective response rate, 100% disease control rate, and median progression-free survival of 6.8 months, with a manageable safety profile2. The program has advanced into a global Phase III trial (ROSETTA LUNG‑01, NCT06712355) and received FDA Orphan Drug Designation in 2025 for the treatment of SCLC.

Under the terms of the agreement, BioNTech will supply pumitamig and Boehringer Ingelheim will be the regulatory sponsor of the study. Both companies retain full rights to their respective assets, and the agreement is mutually non-exclusive. The trial will begin dosing patients in the second half of 2026.

(Press release, Boehringer Ingelheim, APR 9, 2026, View Source [SID1234664292])

On April 9, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that Dr. Amit Kumar, Anixa’s Chairman and CEO, will participate in the upcoming RedChip Biotech Resurgence: Platforms and Pipelines of Today’s Innovators virtual investor conference on April 16, 2026, at 3:30 pm ET.

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!

The presentation will cover several topics, including an overview of the Company and its business model, the Company’s breast cancer vaccine meeting primary endpoints and generating protocol-defined immune responses in 74% of participants in its Phase 1 clinical trial, and the Company’s ovarian cancer CAR-T therapy, lira-cel, exhibiting positive survival data in its ongoing Phase 1 clinical trial.

RedChip’s virtual investor conference brings investors direct access to publicly traded companies advancing the future of healthcare across biopharma, medtech, diagnostics, and digital health. Throughout this full-day virtual event, company executives will present their business models, pipeline strategies, clinical and commercial milestones, and competitive positioning within an evolving healthcare landscape. Each session will include a live Q&A, giving investors the opportunity to engage directly with leadership teams.

Registration to attend this virtual investor conference may be completed at: Event Registration.

(Press release, Anixa Biosciences, APR 9, 2026, View Source [SID1234664261])

On April 9, 2026 Alpheus Medical, Inc., a private, clinical-stage biotechnology company, reported the initiation of its Phase 2b randomized controlled trial in newly diagnosed glioblastoma (nGBM) with 10 patients enrolled to date and additional clinical sites continuing to come online.

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!

Glioblastoma is a highly infiltrative brain tumor in which cancer cells extend beyond the visible tumor margins and spread throughout the brain hemisphere, limiting the effectiveness of surgery and localized therapies.

To address this challenge, the Alpheus study is evaluating an investigational therapy based on Porphyrin Metabolite Activation (PoMA), an approach previously described in the literature as Sonodynamic Therapy (SDT). This drug-centered approach leverages a molecule that preferentially accumulates in tumor cells, followed by activation using low-intensity ultrasound to enable localized pharmacologic effects. The treatment is designed to act within tumor cells throughout the affected hemisphere.

"Glioblastoma patients have few effective treatment options and poor long-term outcomes, highlighting the urgent need for innovation," said David Reardon, MD, Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, and Principal Investigator of the study. "Alpheus’ approach is designed to address the diffuse nature of the disease by enabling treatment across the affected hemisphere. We look forward to generating data to understand its potential role in patient care."

"The Phase 2b trial marks an important step forward in bringing our new therapeutic approach to patients with glioblastoma," said Vijay Agarwal, MD, FAANS, FCNS, Chief Executive Officer of Alpheus Medical. "We believe our drug-centered approach has the potential to address the diffuse nature of the disease in ways that localized treatment cannot. With strong early enrollment, we are focused on generating the randomized clinical data to advance this therapy."

About the Therapy and Trial
Alpheus Medical is developing a novel therapeutic approach based on Porphyrin Metabolite Activation (PoMA), a drug-centered strategy that leverages a molecule that preferentially accumulates in tumor cells, followed by activation using low-intensity, diffuse ultrasound designed to enable treatment across the affected hemisphere, achieving localized pharmacologic effects. Previously described in clinical literature as SDT, this non-invasive approach is intended to activate the molecule directly within tumor cells while minimizing systemic exposure.

The company’s Phase 2b study (NCT07225621) is a multi-center, randomized trial expected to enroll more than 100 newly diagnosed high-grade glioma patients at up to 15 U.S and European sites. Eligible patients have undergone resection and standard radiochemotherapy. The study compares standard of care alone to standard of care plus investigational therapy. The primary endpoint is progression-free survival (PFS) with key secondary endpoints including overall survival (OS), safety, and tolerability.

For patients and caregivers seeking more information about the study and enrolling sites, visit www.BrainCancerTrial.com.

(Press release, Alpheus Medical, APR 9, 2026, View Source [SID1234664277])

On April 9, 2026 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, reported the selection of 400mg once daily on a 5-days-on, 2-days-off schedule (400mg QD 5:2) as the optimal monotherapy dose of azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC) based on the prespecified interim data analysis from DENALI Part 2a. This dose will be carried forward in the ongoing potentially pivotal DENALI Phase 2 clinical trial as well as the confirmatory ASPENOVA Phase 3 clinical trial.

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!

"Selecting the pivotal monotherapy dose for azenosertib is a key inflection point that supports our registration-intended path. Beyond executing on DENALI and ASPENOVA, we are initiating launch preparedness by adding commercial capabilities to our organization, scaling manufacturing capacity, and advancing companion diagnostic development," said Julie Eastland, Chief Executive Officer of Zentalis. "Importantly, the therapeutic profile of the selected dose from the DENALI Part 2a interim analysis provides us confidence to further pursue expansion of the clinical pipeline for azenosertib into first-line maintenance, or platinum sensitive, ovarian cancer and explore combinations in new tumor types."

"The emerging DENALI Part 2a data from the planned interim analysis provide a favorable benefit-risk profile at the 400mg QD 5:2 dose over 300mg QD 5:2. A meaningful, differentiated response rate with the selected dose and comparable safety profiles across both dose groups were observed in this interim analysis," said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis. "While DENALI is an ongoing trial, we are encouraged by the interim Part 2a data and continued momentum of the clinical study. As an oral monotherapy, azenosertib may offer Cyclin E1-positive PROC patients an efficacious, convenient alternative to current standard-of-care intravenous chemotherapy, if approved."

DENALI Part 2a Interim Analysis

A comprehensive review of the interim data from DENALI Part 2a informed the selection of the 400mg QD 5:2 dose over 300mg QD 5:2. A prespecified interim analysis showed:

A meaningful and clearly differentiated response rate at 400mg QD 5:2 over 300mg QD 5:2 dose
Comparable safety profiles across the two dose groups and observed improvements in several key measures, such as a discontinuation rate due to adverse events at approximately half of the rate reported in DENALI Part 1b and no treatment-related deaths.

Consistent with the seamless design of the registration-intended DENALI Part 2 trial, data from Part 2a will be included in the ongoing, full Part 2 dataset after the trial is completed, rather than reported separately. This approach is intended to preserve the integrity of the overall pivotal dataset and support the potential accelerated approval pathway.

DENALI Part 2 Trial Design Updated to Address Evolving PROC Landscape

The treatment landscape in PROC is evolving. The DENALI Part 2 study has been expanded to maintain alignment between the study population and available approved treatment options.

A new DENALI cohort that broadens inclusion to patients previously treated with a taxane-containing regimen for PROC, called Part 2c, intends to further align the study with the evolving treatment landscape. Enrollment in Part 2c is planned to initiate in Q2 2026.

Together, all three DENALI Part 2 cohorts are designed to support a potential accelerated approval pathway in the Cyclin E1 biomarker selected patient population, subject to regulatory review. Zentalis expects to complete enrollment in all cohorts of DENALI Part 2 and provide a topline readout by year-end 2026.

About Azenosertib
Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.

Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment, based on retrospective analysis of azenosertib studies in PROC. Validation of the Cyclin E1 companion diagnostic assay is ongoing in the DENALI and ASPENOVA trials.

Azenosertib has been granted Fast Track Designation by the U.S. FDA for the treatment of patients with Cyclin E1-positive platinum-resistant ovarian cancer. Fast Track Designation is intended to facilitate the development and expedite the review of therapies that have the potential to treat serious conditions and address unmet medical needs.

About DENALI Clinical Trial
DENALI is a multi-part Phase 2 registration-intended clinical trial (NCT05128825) studying azenosertib in PROC patients.

Part 1b enrolled patients with PROC regardless of Cyclin E1 protein expression, all treated at 400mg QD 5:2. Part 2 is prospectively enrolling PROC patients with Cyclin E1 protein overexpression based on Zentalis’ proprietary immunohistochemistry cutoff.

Part 2, in total, is designed to support accelerated approval, pending study outcome and discussions with the FDA. The study design consists of the following parts:

Part 2a: Dose confirmation evaluated two doses, 300mg QD 5:2 and 400mg QD 5:2, with approximately 30 patients enrolled per dose group. 400mg QD 5:2 was selected as the optimal monotherapy dose. Recruitment at the 300mg QD 5:2 dose level has been discontinued. All patients enrolled in Part 2a will contribute to the overall safety database submitted to the FDA.
Part 2b: Enrollment expansion at the selected dose up to approximately 100 patients, including patients at the 400mg QD 5:2 dose in Part 2a. This cohort is currently enrolling.
Part 2c: Broadening study population to include approximately 40 patients previously treated with a taxane-containing regimen for PROC. Enrollment is expected to initiate in this cohort in Q2 2026.

For physician and patient information about the DENALI trial, please visit www.denalitrial.com.

About ASPENOVA Clinical Trial
ASPENOVA is a Phase 3 randomized, confirmatory clinical trial designed to support full approval of azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC). The trial will enroll approximately 420 patients and compare azenosertib monotherapy at 400mg QD 5:2 to investigator’s choice of standard-of-care single-agent chemotherapy (paclitaxel, pegylated liposomal doxorubicin [PLD], gemcitabine, or topotecan) in this biomarker-selected population. The trial design was aligned with the U.S. FDA to meet requirements for the accelerated approval pathway and potential conversion to full approval. ASPENOVA is expected to initiate in Q2 2026.

(Press release, Zentalis Pharmaceuticals, APR 9, 2026, View Source [SID1234664293])

On April 9, 2026 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science reported that it has entered into a new collaboration agreement with Roche (SIX: RO, ROP; OTCQX: RHHBY) to advance research in the emerging degrader-antibody conjugate (DAC) modality. Working together, C4T and Roche will combine antibody-drug conjugation (ADC) and targeted protein degradation (TPD) to develop a new way to treat cancers that leverages both the specificity and catalytic efficiency of degraders with the delivery capabilities of ADCs.

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!

"For the past decade, C4T and Roche have worked together to drive research in targeted protein degradation and to establish this modality as a new way to treat cancer," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "Our new collaboration leverages C4T’s ability to design highly catalytic and selective degraders, as well as degrader payloads for DACs, alongside Roche’s extensive experience developing ADCs with specific binding. Together, these capabilities build a powerful new modality that can offer transformative medicines for patients."
"Roche has been a believer in targeted protein degradation and its potential for differentiation early on, when partnering with C4T for the first time in 2016," said Boris Zaïtra, head of corporate business development, Roche. "Our relationship with C4 Therapeutics is built on a decade of trust and shared scientific ambition. We are pleased to enter into our third collaboration, expanding our long-standing partnership to pioneer the emerging modality of degrader-antibody conjugates (DACs)."

Under the joint research plan, C4T and Roche will collaborate on two programs to develop DACs against undisclosed oncology targets exclusive to the collaboration. C4T will use its proprietary TORPEDO platform to design degrader payload candidates. Roche will select and design the antibody as well as conjugate the antibody to the degrader payload. Roche will be responsible for advancing DAC candidates through preclinical and clinical development as well as commercialization.

C4T will receive a $20 million upfront payment for the two programs. Should Roche exercise its option for a third target, C4T will receive an additional payment. Across the collaboration, C4T will receive near-term discovery milestone payments. C4T is eligible to receive over $1 billion in discovery, regulatory and commercial milestone payments. In addition, C4T is entitled to tiered royalties on future sales, subject to reductions under certain circumstances as described in the collaboration agreement.

About Degrader-Antibody Conjugates (DACs)

ADCs over the last 15 years have made important contributions to cancer therapy, but their clinical utility has historically been challenged by a limited therapeutic margin. Degrader-based ADCs, or degrader-antibody conjugates (DACs), represent a potential step-change in this modality. By utilizing degrader payloads that target specific cellular dependencies, DACs offer a superior therapeutic index. These small-molecule degraders are characterized by a catalytic mechanism of action—a feature unique to this approach—rendering them exceptionally well suited for targeted antibody delivery.

(Press release, C4 Therapeutics, APR 9, 2026, View Source [SID1234664262])