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.

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"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 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.

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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 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, reported that it will have multiple oral and poster presentations at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 17-22, 2026, in San Diego, California. New preclinical data for Selective SMARCA2 inhibitor FHD-909 will be featured as part of an oral presentation and preclinical data for Selective CBP, Selective EP300, and Selective ARID1B degrader programs will be featured as poster presentations.

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"FHD-909 is advancing in the clinic in collaboration with Lilly as the first potential selective SMARCA2 inhibitor for the treatment of SMARCA4-mutant cancers. We are excited to present new, compelling preclinical data further supporting potential expansion opportunities in combination with an anti-PD-1 antibody, as part of Dr. Bellon’s oral presentation at this year’s AACR (Free AACR Whitepaper)," said Adrian Gottschalk, President, and Chief Executive Officer of Foghorn. "Poster presentations will also highlight additional preclinical data characterizing our wholly owned Selective CBP, Selective EP300, and Selective ARID1B degrader programs. Collectively, these data underscore the differentiated profiles of our pipeline programs which may translate to improved therapeutic outcomes for difficult to treat cancers with significant unmet need."

Oral Presentation Details

Title: Targeting chromatin regulatory proteins in hematologic malignancies
Town Meeting: Chemistry, Hematologic Malignancies – From Molecules to Medicine – Driving Breakthroughs in Blood Cancer Treatment: A CICR-HMWG Town Hall
Session Date/Time: Monday, April 20, 6:30 p.m. – 8:30 p.m. PDT
Presenter: Gromek Smolen, VP, Biology, Foghorn Therapeutics

Title: Leveraging paralog relationships for targeting chromatin modulators in cancer: ARID1B and SMARCA2 (FHD-909)
Session: Molecular/Cellular Biology and Genetics, Chemistry, Drug Development – Synthetic Lethality in Oncology: Progress Made, Pitfalls Encountered, and the Path Forward
Session Date/Time: Tuesday, April 21, 10:15 a.m. – 11:45 a.m. PDT
Presenter: Steven Bellon, Chief Scientific Officer, Foghorn Therapeutics

Title: Towards new cancer medicines with degraders of chromatin regulatory proteins
Session: Chemistry, Drug Development, Experimental and Molecular Therapeutics – Induced Proximity Pharmacology: Degraders and Beyond
Session Date/Time: Wednesday, April 22, 10:15 a.m. – 11:45 a.m. PDT
Presenter: Danette Daniels, VP, Degrader Platform, Foghorn Therapeutics

Poster Presentation Details

Title: Preclinical evaluation of selective and potent EP300 degraders demonstrates robust antitumor activity and favorable tolerability in hematologic malignancies
Session: Experimental and Molecular Therapeutics – Quantitative Pharmacology and Translational Modeling
Poster Number: 1828 / 16
Session Date/Time: Monday, April 20, 9:00 a.m. – 12:00 p.m. PDT
Presenter: Meiyun Lin, Senior Scientist, Pharmacology, Foghorn Therapeutics
Abstract: Click here

Title: Leveraging selective degradation of CBP and EP300 for potent anti-cancer activity
Session: Chemistry – Targeted Protein Degradation and Induced Proximity
Poster Number: 5163 / 13
Session Date/Time: Tuesday, April 21, 9:00 a.m. – 12:00 p.m. PDT
Presenter: Karolina Mizeracka, Principal Scientist, Cell Biology, Foghorn Therapeutics
Abstract: Click here

Title: Identification of first-in-class selective ARID1B degraders
Session: Experimental and Molecular Therapeutics – Proximity-Induced Drug Discovery 2
Poster Number: 5792 / 19
Session Date/Time: Tuesday, April 21, 2:00 p.m. – 5:00 p.m. PDT
Presenter: Madeleine Henley, Senior Scientist, Foghorn Therapeutics
Abstract: Click here

Title: Preclinical characterization of FHT-171, a first-in-class degrader targeting CREB-binding protein (CBP) in CBP-dependent solid tumors
Session: Experimental and Molecular Therapeutics – Epigenetic Modulators 2
Poster Number: 7075 / 22
Session Date/Time: Wednesday, April 22 9:00 a.m. – 12:00 p.m. PDT
Presenter: Darshan Sappal, Director, Biology, Foghorn Therapeutics
Abstract: Click here

Dr. Bellon’s presentation and the posters will be accessible under the Science section of the Company’s website.

(Press release, Foghorn Therapeutics, APR 9, 2026, View Source [SID1234664291])

On April 9, 2026 Boehringer Ingelheim and Click Therapeutics reported a strategic agreement to support the commercialization of CT-155, an investigational prescription digital therapeutic that is being studied for the treatment of the experiential negative symptoms of schizophrenia in adults aged 18 years and older.3 Under the agreement, Boehringer will transfer full product responsibility, including all commercial and marketing authorization rights, to Click Therapeutics. To support this transition, Boehringer has made a $50M Series D strategic investment and provided dedicated commercial funding to help bring CT-155 to patients, if cleared by the FDA. CT-155 was co-developed by Boehringer and Click.

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"Boehringer Ingelheim’s selection of Click to deliver CT-155 to patients is powerful validation of our vision and the capabilities we have spent over a decade building," said David Benshoof Klein, CEO and founder of Click Therapeutics. "We are eager to take the lead with CT-155 and are focused on getting this FDA-designated Breakthrough Device to patients after clearance by the FDA."

At the core of Click’s commercialization strategy will be the clinical data from the Phase III CONVOKE study (CONVOKE; NCT05838625).2,3 The randomized, double-blind, controlled study investigated the effectiveness and safety of CT-155 versus a digital control app as an adjunct to standard of care antipsychotic therapy in people diagnosed and living with schizophrenia experiencing negative symptoms.3,4

The study met its primary endpoint, as presented at the 38th Annual European College of Neuropsychopharmacology (ECNP) Congress2, which was change in experiential negative symptoms from baseline to 16 weeks as measured by the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP).2,3 Treatment with CT-155 demonstrated a Cohen’s D effect size of -0.36 (p value= 0.0003) reflective of a 6.8-point improvement of negative symptoms severity as measured by CAINS-MAP at 16 weeks (vs. 4.2-point in digital control arm), representing a 62% relative improvement.2

CT-155 was well-tolerated and demonstrated an adverse event (AE) profile consistent with past studies. The AE rates with CT-155 and the digital control arm were 8.3% vs 13.4%, respectively.2 There were no trial discontinuations attributed to CT-155 and two (2) for the digital control arm. There were no serious AEs related to either group.2

Additional clinical and engagement data is being generated in real-world-like settings through the ENSPIRUS study (NCT06791122).5 Boehringer Ingelheim will continue to lead completion of the ENSPIRUS study.

"Fostering science to create new treatments for patients is at the heart of what we do," said Jan Stefan Scheld, Head of Global Therapeutic Areas at Boehringer Ingelheim. "The collaboration with Click Therapeutics has played a vital role in advancing a potentially meaningful innovation for people living with schizophrenia and we believe this agreement enables Click to continue on our successful co-development of CT-155, leveraging their capabilities and expertise to maximize its impact."

About CT-155

CT-155 (BI 3972080) is an investigational prescription digital therapeutic that aims to provide interactive psychosocial intervention techniques as an adjunct to standard antipsychotic therapy to people living with schizophrenia experiencing negative symptoms.1,3,6 CT-155 was co-developed by Click Therapeutics, Inc. and Boehringer Ingelheim.3

In 2024, CT-155 was granted Breakthrough Device designation by regulatory authorities in the U.S.1

CT-155 has not been authorized by any regulatory authorities. Safety and effectiveness have not been established by any regulatory authority.

About the CONVOKE study

CONVOKE (NCT05838625) was a Phase III, multicenter, randomized, double-blind, 16-week study evaluating the efficacy and safety of CT-155 versus a digital control app as an adjunct to standard of care antipsychotic therapy in people diagnosed and living with schizophrenia and experiential negative symptoms.3 The study enrolled adults and late adolescents with schizophrenia who were stable on antipsychotic medication.3

The primary endpoint evaluated improvement in experiential negative symptoms as an adjunct to standard of care as measured by changes from baseline to week 16 in the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP).3

Other endpoints include: change from baseline in CAINS-MAP at week 8; change from baseline in CAINS expressivity scale (CAINS-EXP) at weeks 8 and 16; change from baseline in positive symptoms measured by the Positive and Negative Syndrome Scale (PANSS) at weeks 8 and 16; change from baseline in social functioning measured by the Personal and Social Performance Scale (PSP) at weeks 8 and 16; and patient global impression of improvement measured by Patient Global Impression of Improvement Scale (PGI-I) at weeks 8 and 16.

(Press release, Boehringer Ingelheim, APR 9, 2026, View Source [SID1234664290])

On April 9, 2026 Oxford BioTherapeutics ("OBT"), is a clinical stage oncology company focused on the discovery and development of immuno-oncology (IO) and Antibody Drug Conjugate (ADC)-based therapies enabled by its OGAP-Verify platform reported a multi-year, selective target collaboration with Bristol Myers Squibb (NYSE: BMY, "BMS") focussed on the discovery and development of novel T-cell engager therapies for solid tumours.

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OBT will leverage its proprietary OGAP-Verify target discovery and validation platform, to identify novel, tumour-selective targets for solid cancers and generate next-generation T-cell engager molecules. The collaboration extends beyond discovery, with OBT assuming responsibility for the design and delivery of development candidates, highlighting the company’s expanding evolution into a fully integrated discovery and preclinical development platform. Subsequent research, development and commercialisation activities for these targets will be led by BMS.

Under the terms of the agreement, OBT will receive an upfront inclusive of research funding and the potential for significant downstream milestone payments and royalties on commercialised products from BMS. Financial terms were not disclosed.

The collaboration with BMS marks OBT’s third partnership with a major pharmaceutical company in the past 12 months, following strategic partnerships with GSK and Roche in 2025.

"Collaborating with Bristol Myers Squibb, a global leader in oncology, represents an important milestone for OBT and underscores the momentum behind our partnerships with leading pharmaceutical companies," said Christian Rohlff, PhD, Chief Executive Officer of OBT. "This new partnership builds on the proven strength of our platform to identify and validate highly differentiated, tumour-selective targets and reflects the growing confidence in our ability to translate that science into development-ready therapeutic candidates. By combining OGAP-Verify’s discovery and validation capabilities with Bristol Myers Squibb’s expertise in translating oncology innovation into clinical and commercial outcomes, we are confident that together we can advance a new generation of innovative cancer therapies that have the potential to make a meaningful difference for patients."

OBT’s OGAP-Verify discovery platform enables highly sensitive identification of oncology targets with improved attributes for drug development, supporting the creation of differentiated antibody-based therapies.

(Press release, Oxford BioTherapeutics, APR 9, 2026, View Source [SID1234664289])