On April 14, 2026 BostonGene, developer of the leading AI foundation model for tumor and immune biology, and ImmunoGenesis, a clinical-stage biotech company developing innovative, science-driven immunotherapies, reported a strategic partnership to accelerate the clinical development of IMGS-001, the company’s lead program. IMGS-001 is a cytotoxic immune checkpoint inhibitor targeting both PD-L1 and PD-L2, and is being studied in a phase 1a/b dose-escalation and dose-expansion safety and efficacy trial (NCT06014502) in patients with solid tumors that have failed to respond to standard of care therapies. This collaboration will investigate the effect of IMGS-001 on patients based on each patient’s comprehensive immune and genetic profile, which can help identify those patients most likely to respond.

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!

"IMGS-001, through its multifunctional mechanism of both direct cell killing and PD-1 pathway blockade, has been specifically engineered to drive clinical benefit in patients with tumors resistant to current immunotherapies," said James Barlow, President and CEO of ImmunoGenesis. "BostonGene’s cutting edge technology can both elucidate the mechanism of action of the drug and identify those patients with unmet medical need most likely to benefit."

Through this collaboration, BostonGene will apply its AI-driven multiomic platform to perform deep molecular characterization of patients treated with IMGS-001. By integrating high-resolution spatial biology with systemic immune monitoring, the partnership will generate the critical data needed to visualize how IMGS-001 treatment may reshape the tumor microenvironment and identify specific biology to predict patient response. This data-driven approach moves beyond traditional biomarker analysis to deliver a system-level understanding of disease biology and therapeutic impact. It is expected to enable more precise patient selection, improve clinical decision-making, and accelerate the development of IMGS-001.

"We believe this partnership represents a significant leap beyond conventional clinical monitoring," said Charles Schweizer, PhD, Senior Vice President of Clinical Development at ImmunoGenesis. "By embedding BostonGene’s AI-powered insights into our clinical framework, we are decoding the precise cellular and molecular pathways driving clinical outcomes. This clarity will allow us to move with greater speed and precision, ultimately strengthening the potential of IMGS-001 to address unmet medical needs for patients with cold or immune excluded tumors."

The integration of BostonGene’s technology allows for a real-time assessment of how IMGS-001 can unlock anti-tumor immunity. By mapping the complex interactions between the immune system and the tumor, the two companies aim to eliminate the "trial and error" often associated with immunotherapy, ensuring the right patients receive the most effective treatment at the right time.

"Modern oncology demands a shift from broad application to data-driven precision," said Nathan Fowler, MD, Chief Medical Officer of BostonGene. "By combining our spatial and multiomic expertise with the innovative pipeline at ImmunoGenesis, we are defining the mechanism by which IMGS-001 overcomes immunotherapy resistance. This critical collaboration delivers important evidence needed to guide the next generation of precision immunotherapy."

(Press release, BostonGene, APR 14, 2026, View Source [SID1234664380])

On April 14, 2026 Samsung Bioepis Co., Ltd. reported the initiation of Phase 1 clinical trial for SBE303. SBE303 is Samsung Bioepis’s first novel antibody-drug conjugate (ADC) candidate engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including urothelial cancer, lung cancer, and breast cancer.1 The Phase 1 clinical trial for SBE303 is an open‑label, multi-center, first‑in‑human trial to evaluate the safety, tolerability and efficacy of SBE303 in participants with advanced refractory solid tumors. More information on this study is available at clinicaltrials.gov (NCT07524348).

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!

(Press release, Samsung Bioepis, APR 14, 2026, View Source [SID1234664379])

On April 14, 2026 Kivu Bioscience, a clinical-stage biotechnology company developing next-generation antibody-drug conjugates (ADCs) for difficult-to-treat cancers, reported upcoming poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, held April 17–22, in San Diego.

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!

"We are excited to present new data at AACR (Free AACR Whitepaper) that highlight both the strength of our ADC platform and the continued advancement of our pipeline," said Mohit Trikha, Ph.D., Chief Executive Officer, Kivu Bioscience. "KIVU-107 has the potential to be a best-in-class PTK7-targeted ADC, designed to overcome the tolerability challenges seen with earlier programs. Our second program, KIVU-305, expands our reach into CEACAM5, reinforcing our ability to develop differentiated ADCs with improved stability, tolerability and anti-tumor activity."

Poster Presentation Details

Title: KIVU-107: a clinical-stage, best-in-class PTK7 antibody-drug conjugate (ADC) with favorable PK and an improved tolerability profile
Session: Experimental and Molecular Therapeutics
Date/Time: Tuesday, April 21, 2026, 2:00 PM – 5:00 PM PT

Location: Section 10
Poster Number: 5649

KIVU-107 is an ADC targeting protein tyrosine kinase 7 (PTK7), a validated oncology target associated with tumor-initiating cells and overexpressed across multiple solid tumors. A Phase 1 clinical trial in patients with advanced solid tumors is ongoing (NCT07229313).

Title: Preclinical efficacy and safety of KIVU-305, a novel CEACAM5-targeting antibody-drug conjugate (ADC) for colorectal cancer
Session Track: Experimental and Molecular Therapeutics
Date/Time: Tuesday, April 21, 2026, 2:00 PM – 5:00 PM PT

Location: Section 10
Poster Number: 5648

KIVU-305 is a next-generation ADC targeting CEACAM5, a well-validated antigen highly expressed in colorectal, pancreatic, gastric and lung cancers. While earlier CEACAM5-targeted ADCs established clinical feasibility, their impact has been limited by efficacy at tolerable doses, underscoring the need for improved linker-payload design. KIVU-305 is designed to address these challenges, with a Phase 1 clinical trial in patients with advanced solid tumors planned for 2026.

(Press release, Kivu Bioscience, APR 14, 2026, View Source [SID1234664378])

On April 14, 2026 Dyve Biosciences, in collaboration with Moffitt Cancer Center, reported significant study results for a first-of-its-kind investigational therapy applied to the skin and designed to work throughout the body to target the tumor microenvironment, a key driver of treatment resistance and immune evasion.

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 treatment, a novel transdermal therapy designed to modulate tumor pH, helped make tumors substantially less acidic, restore T-cell activity, slow tumor growth and improve survival in preclinical studies.

The findings were recently published in Frontiers in Immunology following studies conducted by researchers at Moffitt Cancer Center using animal models of bladder cancer. Known as DYV800, the treatment also demonstrated systemic effects, with activity beyond the site of application, and may have broader potential across multiple solid tumor types where tumor acidity plays a role.

Instead of attacking the tumor directly, this approach targets the conditions that help tumors survive. Tumor acidity may act as an upstream immune checkpoint and suppress immune response before traditional checkpoint pathways are engaged. Prior research has shown tumor-reactive CD8 T-cell responses can drop significantly in acidic conditions, reinforcing the role of pH in limiting immune activity.

Researchers have increasingly focused on the tumor microenvironment because it influences how tumors grow, evade the immune system and respond to treatment. One important factor is tumor acidity. Solid tumors often develop this acidic environment, typically ranging from pH 6.2 to 6.8 compared to a normal physiological pH of 7.4. This can suppress immune function and contribute to treatment resistance, making it a key focus of ongoing cancer research.

Modulating tumor pH and making tumors less acidic may help restore immune function and improve how some cancer treatments work. In these studies, DYV800 was associated with increased intratumoral pH, 4-1BB, TNF-α, IFN-γ, and antigen-specific CD8 responses, together with reduced tumor burden and prolonged survival. These findings reinforce the view that pH modulation may help improve immune activity within acidic tumor microenvironments.

Designed to Work Systemically

Dyve Biosciences’ transdermal platform delivers medicine through the skin, allowing it to circulate throughout the body. This enables the treatment to reach tumors beyond the site of application and influence the tumor microenvironment systemically.

In follow-on analyses, DYV800 increased tumor pH and helped restore T-cell activity suppressed in acidic environments. These findings were consistent with earlier observations of slower tumor growth, improved survival, and effects beyond the site of application.

In the published work, acidic conditions suppressed tumor-reactive T-cell function at multiple levels, including proliferation, migration, cytokine production, and antigen-specific reactivity, supporting the view that tumor acidity may act as an upstream immune checkpoint.

"Tumor acidity is a major barrier that can prevent the immune system from doing its job," said Shari Pilon-Thomas, PhD, Co-Director, Center for Immunization and Infection Research in Cancer (CIIRC) at Moffitt Cancer Center and Corresponding Author. "By making tumors less acidic, we were able to restore immune activity and improve anti-tumor response in our preclinical models. We believe targeting tumor acidity could represent a potential breakthrough in cancer treatment, particularly when used in combination with immunotherapy, where raising tumor pH may help improve the effectiveness of checkpoint inhibitors."

"We believe this approach represents a game-changing new way to treat cancer by targeting the tumor microenvironment," said Dr. Ryan Beal, CEO of Dyve Biosciences. "Instead of going after the tumor directly, we’re changing the conditions that allow it to survive. That shift has the potential to improve how existing treatments work and expand what’s possible for patients."

DYV800 is an investigational product. Safety and efficacy have not been established.

Long-Standing Cancer Challenge

Tumor acidity has long been recognized as a driver of immune suppression in cancer and may act as an upstream immune checkpoint, but delivering therapies that can safely and effectively change that environment remains a challenge.

Oral buffering approaches showed early promise but have been difficult to translate into clinical use due to dosing limitations, gastrointestinal side effects, and poor tolerability. This has limited the ability to consistently modulate tumor acidity in patients.

Dyve Biosciences’ approach delivers pH-modulating therapy through the skin, bypassing limitations associated with traditional oral delivery and eliminating the need for needles.

New Approach to Drug Delivery

Traditional methods for modulating tumor acidity, including oral buffering strategies, have faced challenges with dosing and tolerability.

DYV800 is designed as a non-invasive transdermal approach intended to address those translational barriers. If the underlying mechanism translates clinically, pH modulation may have broader relevance across solid tumors characterized by acidic tumor microenvironments, where acidity may act as an upstream immune checkpoint.

Preparing for Human Trials

Dyve Biosciences is working with Moffitt Cancer Center through a five-year, multi-trial strategic alliance to advance clinical development. First-in-human studies are expected to begin in 2026.

Early clinical studies are expected to evaluate safety, dosing, and how modulating tumor pH may affect the tumor microenvironment and immune response in patients.

This approach may have relevance across multiple cancers, particularly solid tumors where tumor acidity affects immune response. It may also warrant study alongside existing cancer treatments, including immunotherapy, where reducing tumor acidity may help improve T-cell activity and treatment response.

If supported in clinical trials, pH modulation could represent a new way to make certain cancers more responsive to treatment by changing the tumor environment.

(Press release, Dyve Biosciences, APR 14, 2026, View Source [SID1234664377])

On April 14, 2026 Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standard of care to cure cancer and infectious diseases, reported it will release groundbreaking new data at the 2026 Annual American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting in San Diego, California. A major highlight of this year’s conference participation is the first clinical data disclosure from the MYTHIC Study (NCT04855656), a Phase I trial evaluating the combination of Debiopharm’s WEE1 inhibitor, zedoresertib (Debio 0123), with the PKMYT1 inhibitor lunresertib (Debio 2513) in patients with advanced solid tumors harboring CCNE1, FBXW7, or PPP2R1A genomic alterations. The oral presentation on April 19th 2026 will be given by Dr. Timothy A. Yap, a Medical Oncologist and Physician-Scientist based at the University of Texas MD Anderson Cancer Center and Principal Investigator of the MYTHIC study.

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!

Comprehensive pre-clinical results will also be presented for the MultiLINK ADC Technology Suite, showcasing the potential of novel dual payload antibody drug conjugates (ADCs) to enhance therapeutic efficacy. Two translational research posters will also be featured: the first highlighting the development of a Deep Learning-based "virtual" Cyclin E1 biomarker to predict protein overexpression in gynecological malignancies from H&E slides; the second unveiling how multiplexed spatial profiling and 3D cluster analysis are being used to reconcile RNASeq, mass spectrometry, and IHC data to refine therapeutic strategies for HER3 bispecific antibody and ADC programs.

"The first clinical results of the MYTHIC study mark an important milestone for the program. Early data readouts suggest strong synergistic activity between zedoresertib and lunresertib, with tumor regressions observed in patients," explained Esteban Rodrigo Imedio, Executive Medical Director, Oncology, Debiopharm

"Dual payload ADC technology has the potential to be a game changer for cancer patients. As patients need innovative solutions for hard-to-treat cancers, we hope that our dual payload research using MLINK Duo ADC linker technology will help us reshape how complex cancers are targeted and treated," expressed Antoine Attinger, Director, Translational Pharmacology, Debiopharm.

SESSION DETAILS

Session Type: Clinical Trials Plenary Session
AACR 2026 Oral Presentation

Debiopharm Compound

Title

Presenter

– Sun, April 19
– Time: 2:00 PM

– Hall H

zedoresertib (Debio 0123) & lunresertib (Debio 2513)

First data disclosure of the Phase I trial of the first-in-class combination of WEE1 inhibitor zedoresertib with PKMYT1 inhibitor lunresertib in patients with advanced solid tumors harboring CCNE1, FBXW7, or PPP2R1A genomic alterations

Dr. Timothy A. Yap, Medical Oncologist, University of Texas MD Anderson Cancer Center, Houston, TX

Session Title: Antibody Drug Conjugates and Linker Engineering 1
AACR 2026 Poster Presentation

Debiopharm Technology

Title

Author

– Mon, April 20
– Display: 9:00 AM – 12:00 PM
– Poster #: 1683
– Section: 12

MLINK Duo

Enhancing therapeutic efficacy and overcoming resistance with a novel dual payload antibody drug conjugate technology

Antoine Attinger et al., Translational Medicine,
Debiopharm International SA, Lausanne

Session Title: Digital Pathology 3
AACR 2026 Poster Presentation

Debiopharm Program

Title

Author

– Tue, April 21
– Display: 9:00 AM – 12:00 PM
– Poster #: 4155
– Section: 3

zedoresertib (Debio 0123)

Development of a virtual Cyclin E1 biomarker using Deep Learning from H&E slides for predicting Cyclin E1 overexpression in gynecological malignancy

Jeannette Fuchs et al.,
Translational Medicine, Debiopharm International SA, Lausanne

Session Title: Molecular Targets 2
AACR 2026 Poster Presentation

Debiopharm Program

Title

Author

– Tue, April 21
– Display: 2:00 PM – 5:00 PM
– Poster #: 5738
– Section: 13

HER3 ADCs

Beyond bulk: Resolving RNASeq/mass spectrometry/IHC discrepancies with multiplexed spatial profiling and 3D cluster analysis to refine HER3 (bs)Ab and (bs)ADC therapeutic strategies

Jeannette Fuchs et al.,
Translational Medicine, Debiopharm International SA, Lausanne

ABOUT DNA DAMAGE REPAIR (DDR)

When cells have damaged DNA, they must undergo a repair process known as DDR to survive. Cancer cells rely heavily on DDR as they divide and grow uncontrollably. Inhibition of DDR, particularly in combination with other anticancer agents, prevents cancer cells from repairing their DNA, ultimately activating a programmed cell death process. DDR inhibitors such as zedoresertib (Debio 0123), Debiopharm’s WEE1 inhibitor, are currently being investigated in clinical and preclinical studies.

ABOUT PKMYT1 INHIBITION

Lunresertib (Debio 2513) is a first-in-class, oral PKMYT1 inhibitor designed to exploit specific genetic vulnerabilities in solid tumors, such as CCNE1 amplification. By targeting PKMYT1, the drug induces synthetic lethality, preventing cancer cells from repairing DNA damage and forcing them into programmed cell death. As the most advanced PKMYT1 inhibitor in clinical development, lunresertib has shown encouraging proof-of-concept results both as monotherapy and in combination therapies within the ongoing MYTHIC trial.

(Press release, Debiopharm, APR 14, 2026, View Source [SID1234664376])