4D Path Announces Collaboration with Daiichi Sankyo to Advance AI-Driven Predictive Biomarkers for an Antibody Drug Conjugate Program

On April 14, 2026 4D Path, a company dedicated to personalizing cancer care through a novel, physics-informed approach to predicting tumor response to therapy, reported a collaboration with Daiichi Sankyo (TSE: 4568) to develop next-generation predictive biomarkers in an antibody drug conjugate (ADC) clinical development program.

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ADCs are among the most promising therapeutic classes in oncology, yet there remains a significant unmet need for scalable biomarkers that predict which patients are most likely to benefit from increasingly complex regimens and combination therapies. This collaboration brings together 4D Path’s ability to compute biologically grounded, physics-informed treatment predictive biomarkers from routine pathology specimens with the ADC innovation leadership of Daiichi Sankyo.

Under the collaboration, 4D Path will apply its proprietary Q-Plasia OncoReader (QPOR) platform to standard Hematoxylin and Eosin (H&E)-stained tumor biopsy slides to compute interpretable, quantitative biomarkers associated with cell-cycle deregulation and tumor microenvironment dynamics. These biomarkers will be evaluated for their ability to identify patients most likely to benefit from the select ADC, helping enable more precise, non-invasive, and cost-effective patient selection, potentially improving response rates and accelerating clinical trials.

This approach is designed to be compatible with both retrospective analyses of archived clinical specimens and prospective evaluation in ongoing and future studies.

"While the introduction of ADCs has improved outcomes for patients, more advanced biomarkers that are predictive of response to these agents is needed. 4D Path’s novel approach to utilizing biological and physical characteristics from routine H&E-stained biopsy slides to predict benefit from ADCs has the potential to improve outcomes, helping patients get the right therapy at the optimal time in their disease course," said Lee Schwartzberg, medical oncologist and Scientific Advisory Board member, 4D Path.

The collaboration is expected to also generate functional mechanistic insights into tumor-specific patterns of response and resistance—helping illuminate how biological context may interact with ADC designs. By transforming routine pathology images into actionable, physics-informed collective tumor state variables, the agreement aims to enrich translational understanding while supporting more personalized and effective treatment strategies.

"The deep precision medicine focus of this collaboration in digital pathology brings in 4D Path’s QPOR platform-derived pan-cancer insights identifying patients likely to respond to treatment, by one-shot computation of cell cycle and tumor microenvironment dynamics from routine tissue images. Additionally, this will potentially shed light on tumor specific biological understanding of response and resistance, enriching knowledge of the relative impact of targets, linkers, and payloads on outcomes and accelerating precision ADC treatments," said Satabhisa Mukhopadhyay, Ph.D., co-founder and chief scientific officer at 4D Path.

This collaboration underscores the industry-wide shift toward AI-driven, image-based biomarkers that can be deployed at scale using standard-of-care specimens—supporting faster, more confident treatment decisions and improving the probability of success in clinical development.

(Press release, Daiichi Sankyo, APR 14, 2026, https://www.businesswire.com/news/home/20260408304934/en/4D-Path-Announces-Collaboration-with-Daiichi-Sankyo-to-Advance-AI-Driven-Predictive-Biomarkers-for-an-Antibody-Drug-Conjugate-Program [SID1234664383])

Novigenix AI to Present Clinical Data at AACR 2026 Linking Immuno-Pharmacodynamics to Radioligand Therapy Response

On April 14, 2026 Novigenix AI, a leader in AI-driven healthcare solutions, reported the presentation of new data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026 Annual Meeting demonstrating, for the first time in a human clinical setting, the dynamic role of the immune system in response to radioligand therapy in patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NET).1

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The study, conducted in collaboration with RadioMedix, Inc., a clinical-stage biotechnology company, examined the immune response of GEP-NET patients treated with the targeted alpha-emitter 212Pb-DOTAMTATE (AlphaMedix) or beta-emitter 177Lu-DOTATATE (Lutathera) peptide receptor radionuclide therapies (PRRTs). Researchers used the Novigenix AI LITOSeek platform, an AI-enabled liquid biopsy platform designed for longitudinal whole-blood immuno-transcriptomic profiling, to uncover systemic immune responses connected to the treatment.

The study showed that the alpha- and beta- PRRTs induce strong and distinct immune activation patterns in patients achieving clinical response. Two distinct waves of immuno-transcriptomic modulation were identified, likely reflecting kinetics heterogeneity of immune activation between early and late responders, highlighting heterogeneous yet coordinated immune dynamics across patients.

"Preclinical research has consistently pointed to the immune system as a critical mediator of radiotherapy efficacy, but until now, this has been difficult to demonstrate dynamically in patients," said Dr. Pedro Romero, Chief Medical and Scientific Officer, Novigenix AI. "With LITOSeek, we are able to capture these systemic immune responses along the patient journey, providing the first clinical evidence of Immuno-Pharmacodynamics in radioligand therapy and opening new avenues for biomarker-driven patient management."

"This collaboration highlights the power of combining innovative radiopharmaceuticals with advanced liquid biopsy immune monitoring technologies to interrogate treatment response," said Dr. Ebrahim Delpassand, Chief Executive Officer, RadioMedix, Inc. "The ability to observe how targeted radioligand therapies activate the immune system in patients’ response to treatment represents a major step forward for the field and supports the development of more effective, biology-driven treatment approaches."

These findings represent a significant advance in translation research, bridging preclinical insight into clinical reality and establishing Immuno-Pharmacodynamics (ImmunoPD) profiling as a critical dimension of radioligand therapy evaluation. "This work represents a pivotal milestone in translational oncology," said Dr. Brian Hashemi, CEO and Chairman, Novigenix AI. "By unveiling the Immuno-Pharmacodynamic response of patients to radioligand therapies, Novigenix AI is not only validating decades of preclinical research but also redefining how we assess and optimize these treatments in the clinic."

AACR Abstract and Poster Presentation Details

To learn more, view Abstract 3859 and attend the Poster Presentation given by Dr. Pedro Romero, Chief Medical and Scientific Officer at Novigenix AI, at AACR (Free AACR Whitepaper) 2026 on Monday, April 20, 2PM-5PM PST.

Poster #5953; Poster Section 45; Presentation Number 3859. "Dynamic systemic immune modulation in metastatic neuroendocrine tumor (NET) patients treated with targeted alpha-emitter 212 Pb-DOTAMTATE AlphaMedix."

(Press release, Novigenix, APR 14, 2026, View Source [SID1234664382])

CrossBridge Bio Enters an Agreement to be Acquired by Eli Lilly to Advance Next-Generation Dual-Payload Antibody-Drug Conjugates

On April 14, 2026 CrossBridge Bio, Inc., a pre-clinical biotechnology company pioneering the development of next-generation dual-payload antibody-drug conjugates (ADCs) reported a definitive agreement to be acquired by Eli Lilly and Company ("Lilly").

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CrossBridge Bio, a Houston-based biotechnology firm founded in 2023, is developing a new dual-payload ADC technology originally created by Kyoji Tsuchikama at the University of Texas Health Science Center at Houston (UTHealth Houston). The company is focused on advancing next-generation ADCs with the potential to transform clinical practice. Its lead candidate, CBB-120, is a TROP2-targeting TOP1i/ATRi dual-payload ADC for cancer treatment. It is designed to enhance the therapeutic index and generate more durable responses compared to current TROP2-targeting ADCs, while also addressing key resistance mechanisms. U.S. Food and Drug Administration Investigational New Drug application for CBB-120 is anticipated in 2026.

"We look forward to seeing how Lilly advances our new generation of dual-payload antibody-drug conjugates, including CBB-120, with the potential to meaningfully improve outcomes for patients with limited treatment options. At CrossBridge Bio, we believe our dual-payload ADC platform is uniquely positioned to be transformative in oncology. I’m proud of how well our team has executed and advanced our platform in such a short time since the company’s founding. By becoming a part of Lilly, a leader in patient-focused therapeutic development, we are well-positioned to further accelerate the clinical potential of this approach," said Dr. Michael Torres, Co-Founder and CEO.

Under the terms of the agreement, Lilly will acquire CrossBridge Bio, and CrossBridge Bio shareholders could receive up to $300 million in cash, inclusive of an upfront payment and a subsequent payment upon achieving a specified development milestone.

Cooley LLP is serving as legal counsel to CrossBridge Bio, and Zwick Advisory, LLC acts as a strategic advisor to the Company’s Board of Directors.

(Press release, CrossBridge Bio, APR 14, 2026, View Source [SID1234664381])

BostonGene and ImmunoGenesis Announce Strategic Partnership to Overcome Immunotherapy Resistance

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.

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"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])

Samsung Bioepis Initiates Phase 1 Clinical Trial for SBE303, Nectin-4 Targeting Antibody-Drug Conjugate (ADC) Candidate

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).

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