ImmunoScape Announces Memorandum of Understanding for Clinical Trial with Premier U.S. Cancer Center

On March 4, 2026 ImmunoScape Pte. Ltd., an A*STAR spin-out backed by Amgen Ventures and EDBI that is developing next-generation TCR-based cancer immunotherapies, reported the execution of a Memorandum of Understanding (MOU) with a premier NCI-designated Comprehensive Cancer Center in the United States, renowned globally for its pioneering history in cellular immunotherapy. This partnership will fast-track ImmunoScape’s "Seed and Boost" platform into the clinic. Concurrently, the company announced a strategic investment from Leonardo DiCaprio.

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!

Accelerating the "Seed and Boost" Clinical Program

Under the terms of the MOU, ImmunoScape will partner with the cancer center to launch an investigator-initiated clinical trial targeting Wilms Tumor 1 (WT1) positive solid tumors. The trial will focus on four difficult-to-treat indications: ovarian, mesothelioma, and other high-unmet need solid tumors such as pancreatic and colorectal cancers. The study is scheduled to dose its first patients by September 2026.

This program leverages ImmunoScape’s differentiated "Seed and Boost" strategy to solve the persistence and exhaustion challenges common in traditional cell therapies:

The Seed: Autologous T-cells engineered with a high-affinity TCR targeting the intracellular antigen WT1.
The Boost: A clinical stage fusion protein (Immuno-STAT technology) that selectively expands and activates the WT-1 targeting T-cells in the patient, mimicking the natural immune synapse while leaving all other T-cells untouched.
"We are honored that a major U.S. Cancer Center has agreed to partner with us to fast-track our Seed and Boost therapeutic approach into a clinical trial," said Michael Fehlings, PhD, CEO of ImmunoScape. "Their experts see the potential that this novel new approach may bring to patients in need."

The Chair of ImmunoScape’s Scientific Advisory Board, Dr. Evan Newell, PhD, also commented, "Cancer patients need new innovative therapies, and this sense of urgency is driving our efforts to test patients before the end of 2026."

Strategic Investment from Leonardo DiCaprio

Highlighting the global urgency for novel cancer interventions, Leonardo DiCaprio has joined ImmunoScape’s roster of investors to support the development of this platform.

"ImmunoScape is pioneering innovative cancer therapies, and its upcoming clinical trials targeting pancreatic, ovarian, and mesothelioma cancers are highly encouraging," said Leonardo DiCaprio. "Through this investment, I hope to play a small role in helping accelerate their development."

Scientific Validation and Leadership

The company also announced that its scientists have been selected to present their groundbreaking work at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2026, underscoring the scientific community’s interest in the "Seed and Boost" mechanism.

"ImmunoScape’s Seed and Boost therapeutic approach has the potential to transform how we treat difficult solid tumor cancers," said Adrian Bot, MD, PhD, ImmunoScape Board Member and former Chief Scientific Officer of both Kite Pharma and Capstan Therapeutics. "It may be able to simultaneously improve treatment efficacy, improve the patient experience, and lower therapeutic costs."

Reflecting on the company’s evolution, Mr. Choon Peng Ng, Chairman and Co-founder of ImmunoScape, added, "From our company’s origins as a spin-out of Singapore’s A*STAR Research Agency to today, we are thrilled that the team’s Singapore-based research has led us to this milestone of a major clinical trial against difficult cancers."

(Press release, immunoSCAPE, MAR 4, 2026, View Source [SID1234663267])

Senhwa Biosciences Signs Major Strategic MOU with Y Combinator-Backed AI Biotech Company CellType to Accelerate the Evolution of CX-4945 into Version 2.0 and Reshape the Global Immunotherapy Landscape

On March 4, 2026 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical stage company focusing on development of first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported the signing of a major strategic Memorandum of Understanding (MOU) with CellType, an AI-driven biotech company backed by Y Combinator (Winter 2026).

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!

Under this partnership, the two companies will integrate CellType’s proprietary AI platform to accelerate the clinical development and global commercialization strategy of Senhwa’s core asset, Silmitasertib (CX-4945).

Prior to formalizing the collaboration, the foundational research underlying CellType’s technology was conducted at Yale University in collaboration with Google DeepMind, where researchers computationally predicted and experimentally validated a novel immune-modulatory mechanism of CX-4945. This strategic alliance marks a transformative milestone for Senhwa: CX-4945 is evolving from a single-target small molecule into a platform-enabling asset—"CX-4945 2.0." Through AI-driven deep data validation, Senhwa aims to expand potential indications, significantly enhance clinical success probability, and strengthen the asset’s attractiveness for partnerships with international pharmaceutical companies for licensing discussion.

In parallel, CellType will feature CX-4945 as the flagship case study of its AI platform, showcasing real-world validation results to global investors—demonstrating how AI can fundamentally transform traditional drug development models, reduce R&D risk, and amplify therapeutic value.

Senhwa Chairman Benny T. Hu stated:

"By integrating CellType’s cutting-edge AI foundation models—capable of reasoning about biology at the cellular level, and rooted in pioneering research from Yale University and Google DeepMind—into Senhwa’s clinical-stage core asset, we are not simply accelerating development—we are redefining the strategic positioning of CX-4945. This collaboration represents Senhwa’s official entry into the next phase of AI-driven drug development. We highly recognize CellType’s scientific excellence and global vision, and we look forward to unlocking new therapeutic possibilities for cancer patients worldwide while delivering sustainable, long-term structural value growth for our shareholders."

AI-Driven Mechanistic Breakthrough

CellType was founded by computational biologist Dr. David van Dijk. The company is backed by Y Combinator (Winter 2026). Its proprietary AI platform applies large language models to single-cell gene expression—the first of its kind—enabling sophisticated decoding of complex tumor microenvironment (TME) signaling.

Through the original research collaboration with Google DeepMind at Yale University, researchers screened over 4,000 compounds and identified CX-4945 as a highly promising candidate. AI-predicted findings were subsequently validated in interdisciplinary laboratories at Yale University. Results indicate that beyond its known mechanism, CX-4945 demonstrates previously unrecognized immune-modulatory potential—including amplification of immune activation, enhancement of tumor antigen presentation, and conversion of "cold tumors" into "hot tumors." These properties may significantly improve immunotherapy efficacy and help overcome resistance challenges.

Six-Month Pilot Program and Strategic Framework

Under the MOU, the parties will initiate a six-month pilot program focused on:

Indication expansion strategies, Biomarker discovery and validation, Combination therapy synergy evaluation in the context of immuno-oncology and new targets for treating different types of cancers and Establishment of an AI-driven translational validation framework.

This collaboration not only position CX-4945 as a core immune-sensitizing molecule in immuno-oncology but also establishes Senhwa as CellType’s founding strategic partner. The agreement preserves flexibility for deeper collaboration structures in the future, including joint ventures, co-development, or licensing arrangements.

Market Opportunity and Strategic Outlook

The global cancer immunotherapy market is entering a high-growth phase, with industry forecasts projecting the market to reach approximately US$305.8 billion by 2033. Despite rapid expansion, overcoming immunotherapy resistance and optimizing the tumor microenvironment remain among the most critical and value-defining challenges in oncology.

This partnership extends beyond a technical pilot—it sends a clear signal to global capital markets: the valuation paradigm of CX-4945 is accelerating, and AI is emerging as a powerful multiplier of clinical success probability.

Looking ahead, Senhwa and CellType will continue to deepen their collaboration, advancing CX-4945 from an innovative therapeutic candidate to a core AI-enabled immunotherapy platform asset—jointly redefining the next key inflection point in cancer immunotherapy and creating enduring value for shareholders, partners, and patients worldwide.

(Press release, Senhwa Biosciences, MAR 4, 2026, View Source [SID1234663266])

Adela Announces Study Published in NPJ Precision Oncology Clinically Validating its Tissue-Free Test to Monitor Immunotherapy Response in Advanced Solid Tumors

On March 4, 2026 Adela, Inc., an innovator in blood testing for molecular residual disease (MRD) monitoring and early cancer detection through a proprietary genome-wide methylome enrichment technology, reported the publication of clinical validation results in npj Precision Oncology for use of its test to monitor response to immunotherapy in patients with advanced solid tumors.

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 study demonstrated that changes in methylated circulating tumor DNA (ctDNA) measured prior to treatment initiation and before cycle 3 of therapy were strongly associated with objective response and clinical benefit. These findings validated the test’s potential to support clinical decision-making regarding continuation or discontinuation of immunotherapy early in a course of treatment.

In patients with advanced cancer receiving immunotherapy, there is a critical unmet need for sensitive, rapid turnaround tools to monitor treatment response during early treatment cycles, as using conventional imaging alone can lead to delayed recognition of non-response and missed opportunities to alter treatment. Most emerging molecular options for response monitoring require tumor tissue, which is often not available in patients with advanced cancer. A tissue-free option offers broader accessibility.

The validation study analyzed banked samples from 64 patients with advanced head & neck, breast, ovarian, melanoma, or other solid tumors who received pembrolizumab at Princess Margaret Cancer Centre, University Health Network as part of the INSPIRE Study (NCT026344369). Blood samples were collected pre-treatment and prior to every three treatment cycles starting at cycle 3 of treatment.

Compared to those with an increase in methylated ctDNA, patients with a decrease in methylated ctDNA between pre-treatment and pre-cycle 3 were more likely to achieve:

Objective response (odds ratio [OR]=31.77, 95% CI: 3.71–4173.19, P=0.0003)
Clinical benefit (OR=15.55, 95% CI: 3.31–151.52, P=0.0002)
A decrease in methylated ctDNA was also associated with significantly better:

Progression-free survival (hazard ratio [HR]=0.27, 95% CI: 0.14–0.50, P<0.0001)
Overall survival (HR=0.49, 95% CI: 0.27–0.86, P=0.01).
"The study supports the use of the test for response monitoring and the early identification of patients who are not responding to immunotherapy and could benefit from a different treatment approach. The test may thus be a useful tool to support clinical decisions regarding therapy continuation or discontinuation to optimize patient outcomes, and perhaps avoid unnecessary toxicity," said Enrique Sanz-Garcia, MD, Medical Oncologist and Clinician Investigator at Princess Margaret Cancer Centre, University Health Network.

Adela’s test has also been clinically validated for surveilling for recurrence in head and neck cancer, with results published in the Annals of Oncology.

"We are pleased to announce the publication of the clinical validation of a second application of our genome-wide methylation-based platform," said Anne-Renee Hartman, MD, Chief Medical Officer at Adela. "Because our approach captures biologically relevant information across the entire methylome, it removes the need for disease-specific panels and supports broad use across solid tumors and diverse clinical settings."

Adela’s test is currently available for use in monitoring immunotherapy response by biopharmaceutical companies and other investigators, including for biomarker discovery and drug development. Adela plans to commercialize the test later this year for use in patients with solid tumors treated with immunotherapy to monitor response and help guide treatment decision-making.

(Press release, Adela, MAR 4, 2026, View Source [SID1234663264])

Creatv Bio’s LifeTracDx® Blood Test Utilized as Exploratory Biomarker in CytoDyn’s Phase 2 Study in Patients with Relapsed/Refractory Metastatic Colorectal Cancer

On March 4, 2026 Creatv Bio, a Division of Creatv MicroTech, Inc. ("Creatv") reported the initiation of a collaboration with CytoDyn Inc. of Vancouver, Washington ("CytoDyn") to provide its’ LifeTracDx liquid biopsy test to support a Phase 2 study evaluating CytoDyn’s leronlimab in combination with TAS-102 and Bevacizumab in previously treated patients with relapsed/refractory metastatic Colorectal Cancer (mCRC).

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!

CytoDyn’s Phase 2 study in mCRC (NCT06699836), now underway, is enrolling 60 participants who will be tested with the LifeTracDx blood test at multiple-time points over the course of the trial. Collected under the study protocol as an exploratory biomarker, Creatv Bio’s LifeTracDx Blood Test will be used to evaluate numeric increases in PD-L1 expression across the patient population. The study’s primary endpoint is objective response rate (ORR), defined as the proportion of patients achieving a confirmed complete or partial response per RECIST v1.1, evaluating the efficacy of leronlimab in combination with trifluridine and tipiracil plus bevacizumab in patients with CCR5-positive, refractory, microsatellite-stable metastatic colorectal cancer (mCRC) over a 12-month treatment period.

LifeTracDx uses both circulating tumor cells (CTCs) and Cancer Associated Macrophage-Like (CAML) cells, which are macrophages that engulf tumor cells, as sensitive and accurate markers for real-time monitoring of tumor response to all forms of treatment and provides pharmacokinetic changes of both CCR5 and PD-L1 from the tumor microenvironment.

In prior studies, leronlimab induced PD-L1 expression on CTCs and CAMLS in 88% of metastatic breast cancer patients treated at doses above 525 mg/week, reinforcing the proposed ability of CCR5 blockade to convert "cold" tumors into "hot," PD-L1–positive tumors. In addition, changes observed in circulating atypical CAMLs further support leronlimab’s role in remodeling the tumor immune microenvironment and enhancing responsiveness to checkpoint blockade.

Creatv Bio has demonstrated that monitoring the expressions of PD-L1 using the LifeTracDx blood test at baseline, followed by sequential sampling after induction of therapy, may identify patients who have upregulated PD-L1 expression in their tumors.

(Press release, CytoDyn, MAR 4, 2026, View Source [SID1234663263])

Fapon Biopharma to Present Next-Generation CD3/TCR VHH TCE Platform at 19th Annual European Life Sciences CEO Forum

On March 4, 2026 Fapon Biopharma reported that Dr. Kaiqing Zhang, Ph.D., Associate Director of Business/Corporate Development, will deliver a company presentation at the 19th Annual European Life Sciences CEO Forum, taking place March 4–5 at the Hilton Zurich Airport Hotel.

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!

In a presentation titled "Unlocking the Next Generation of TCEs: Fapon’s Human/Cyno Cross-Reactive CD3/TCR VHH Platform", Fapon Biopharma will showcase its proprietary CD3/TCR VHH-based T-cell engager (TCE) platform, an innovative approach designed to overcome developability and flexibility challenges associated with traditional multi-specific antibodies.

Built on fully human/cynomolgus cross-reactive single-domain antibodies (VHH), the platform enables a modular "plug-and-play" design with optimized activation kinetics and therapeutic index. This technology is uniquely positioned to power the next wave of therapeutics across two high-growth pillars:

Oncology: Precision T-cell redirection to eradicate solid and hematological tumors, engineered for optimized activation kinetics and a wider therapeutic index to minimize cytokine risk.

Autoimmune Diseases: Potent T-cell engagers designed for deep B-cell depletion, offering a functional "immune reset" for patients with refractory conditions.

The cornerstone of our technology is a series of cross-species CD3/TCR VHHs with different affinity binding to both human and cynomolgus monkeys. This dual reactivity significantly de-risks preclinical safety and accelerates translational timelines. The platform has already successfully completed evaluation demonstrating superior efficacy and safety as well as predictable PK/PD in mouse and NHP studies.

With superior CMC profiles and flexibility for multi-valent formatting, Fapon Biopharma is seeking strategic partners for co-development and licensing. For partnership inquiries, please contact us at [email protected] (USA, Europe and other regions) or [email protected] (Asia-Pacific)

(Press release, Fapon Biopharma, MAR 4, 2026, View Source [SID1234663262])