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Excalipoint Therapeutics and DP Technology Enter into Strategic Partnership to Co-Develop Proprietary AI-Powered TCE Agentic Platform

On July 16, 2026 Excalipoint Therapeutics and DP Technology reported a strategic collaboration to co-develop a proprietary AI agentic platform tailored for T-cell engager (TCE) and multi-specific antibody discovery. The alliance integrates Excalipoint’s deep expertise in TCE engineering with DP Technology’s leading AI Agent technology to address industry bottlenecks in TCE development and streamline delivery of differentiated assets.

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A fundamental challenge in TCE development is how to balance efficacy and toxicity, which demands fine-tuning of highly interdependent parameters: engager-antigen binding affinities, multi-specific valency and molecular spatial geometry. Traditionally, navigating this complex parameter space relies on trial-and-error wet lab screening, resulting in lengthy timelines and high costs.

The new platform leverages Excalipoint’s proprietary TCE molecular libraries and in vitro and in vivo functional datasets as its core foundation, and is fully integrated with DP Technology’s SciMaster and BioMaster life science agent suites to deliver multiple capabilities:

Full-stack AI orchestration: Predictive models for affinity, specificity and developability, together with structural simulation tools, standardized and centrally orchestrated by the core AI agent. All predictions operate on Excalipoint’s proprietary molecular space.
Dynamic parameter balancing: The AI agent dynamically adjusts validation workflows and scoring strategies, breaking rigid pipeline logic to identify optimal parameter combinations and improve the clinical translation efficiency of candidates.
Efficient human-AI co-pilot: The AI agent autonomously conducts molecular prediction, ranking, format enumeration and traceable reporting. Human experts intervene only at critical stages to deliver refined affinity interpretation and definitive evaluation of CRS risks and therapeutic windows.
Wet–dry lab closed-loop Design–Build–Test–Learn (DBTL) cycle: Real-world experimental data is continuously fed back to recalibrate AI models. The platform evolves iteratively alongside project progress, enabling fully autonomous AI molecular design in future R&D.
"Multi-specific antibodies exemplified by TCEs represent the next wave of immunotherapy, yet complex molecular architectures lead to high costs and stagnant translation efficiency. Our full-spectrum TCE molecule portfolio and extensive first-hand experimental datasets serve as the core strengths of our AI-powered discovery platform," said Dr. Lei Fang, Co-Founder, Chairman and CEO, Excalipoint Therapeutics. "This collaboration with DP Technology goes far beyond third-party computational tools. We are building a proprietary AI R&D framework based on internal biological assets to enhance preclinical translational certainty, shorten development timelines and reduce resource wastage. Going forward, we will embed AI throughout full R&D workflow to evolve into a fully digital, intelligent biotech company and accelerate the delivery of globally competitive novel therapeutics."

"DP Technology’s mission is to empower original biomedical innovation through AI for Science. We are delighted to establish deep synergy with Excalipoint. We will deploy our life science agent stack, together with Excalipoint’s rich TCE experimental data and know-how, to build a fully customized AI solution for multi-specific antibody development," said Weijie Sun, Founder and CEO, DP Technology. "We firmly believe deep integration between artificial intelligence and expert scientific judgment will continuously expand the boundaries of biologic drug discovery."

This collaboration marks a key milestone in Excalipoint’s AI transformation. Currently, the agent platform will prioritize accelerating development across Excalipoint’s TCE pipeline. Long-term, it will expand AI deployment across the full workflow, including target identification, pharmacology and toxicology profiling, and clinical trial design, to consistently generate differentiated novel assets for patients with cancer and autoimmune disorders worldwide.

(Press release, Excalipoint Therapeutics, JUL 16, 2026, View Source [SID1234669275])

Valerio Therapeutics Announces Development Collaboration with Abivax and Provides Pipeline Update

On July 16, 2026 Valerio Therapeutics (FR0010095596 – ALVIO), a biotechnology company pioneering next-generation precision-guided RNA therapeutics ("Valerio" or the "Company"), reported that it has entered into a binding term-sheet with Abivax SA ("Abivax"), setting out the principal terms of an exclusive worldwide research and development collaboration. The final terms remain subject to the signing of the definitive co-ownership and license agreement.

In connection with this collaboration, Valerio and Abivax will work together to identify, design and evaluate next-generation therapeutic candidates for immune-mediated inflammatory diseases, leveraging Abivax’s expertise in this area together with Valerio’s targeted technology platforms. The collaboration will include the generation, manufacturing and preclinical evaluation of research candidates. The candidates will be evaluated for their therapeutic potential and may be further developed by Abivax.

Under the terms of the binding term-sheet, Valerio will receive an upfront payment up to approximately €2.4 million and would be eligible to receive development and commercial milestone payments, as well as royalties on net sales and sublicensing revenues, subject to the execution of the definitive co-ownership and license agreement and the achievement of specified milestones and other terms.

"This collaboration brings together two highly complementary scientific capabilities: Abivax’s expertise in immune-mediated inflammatory diseases and Valerio’s advanced technology platforms. We believe this collaboration creates an exciting opportunity to explore innovative therapeutic approaches that leverage complementary expertise. We look forward to working closely with the Abivax team to advance this research and evaluate its potential to address important unmet medical needs for patients," said Gilles Besin, Ph.D., the Company’s Chief Executive Officer.

"We are pleased to collaborate with Valerio Therapeutics and to explore the potential of our complementary scientific capabilities. We look forward to working together as the program progresses," said Marc de Garidel, CEO of Abivax.

For Valerio, the execution of this binding term-sheet represents an important milestone in the evolution of the Company as a precision RNA therapeutics developer with a growing pipeline. The partnership with Abivax will provide non-dilutive funding to support pipeline advancement, will supplement the existing potential for future milestone and royalty revenues and will reinforce the attractiveness of Valerio’s technology platform to biotech and pharmaceutical partners.

This transaction is aligned with Valerio’s strategy of advancing a focused portfolio of wholly owned therapeutic programs while complementing these efforts through partnerships and licensing transactions that leverage its platform capabilities and create additional value creation opportunities.

Valerio will provide further updates in due course, including upon signature of the definitive co-ownership and license agreement, in accordance with its obligations under the binding term-sheet and applicable regulatory obligations.

Pipeline Highlights

Valerio is advancing a pipeline of precision RNA therapeutics focused on diseases where targeted delivery to specific immune cells enables differentiated treatment approaches. The Company’s lead programs have been selected based on a combination of strong disease biology, clear unmet medical need and the ability to leverage Valerio’s proprietary V-Body platform to direct RNA-based payloads to disease-relevant tissue.

The proprietary pipeline currently includes the lead program VTX-001 in ankylosing spondylitis, VTX-002 in IgG4-related disease and VTX-003 in oncology. VTX-001 and VTX-002 are next-generation in vivo CAR-T approaches in the immunity & inflammation field and are designed to selectively deplete pathogenic immune-cell populations, while VTX-003 uses a V-Body–oligonucleotide conjugate approach to deliver siRNA to reactivate exhausted T cells in oncology.

Valerio’s platform is designed to accelerate discovery and development by enabling rapid generation of tailored V-Bodies, which can be combined with RNA payloads and next-generation lipid nanoparticle technologies across multiple therapeutic modalities. The Company’s strategy and pipeline reflect a milestone-driven approach to value inflection, with the ambition to nominate up to two development candidates within 12 to 18 months and to progress at least one program into first-in-human clinical studies within 18 to 24 months.

(Press release, Valerio Therapeutics, JUL 16, 2026, View Source [SID1234669274])

Moderna Announces First Participant Dosed in Phase 1 Clinical Trial Evaluating Investigational Tumor-Targeted Cancer Antigen Therapy in Solid Tumors

On July 16, 2026 Moderna, Inc. (NASDAQ:MRNA) reported the dosing of the first U.S. participant in its Phase 1 study evaluating mRNA-4200, a tumor-targeted cancer antigen therapy candidate, in patients with advanced or metastatic solid tumors. mRNA-4200 encodes for seven antigens commonly shared across patients and tumor types and is designed to help induce and expand T-cell responses against selected tumor targets.

"mRNA-4200 represents our third off-the-shelf cancer antigen therapy candidate and builds on our efforts to explore broad applicability across multiple cancer types," said David Berman, M.D., Ph.D., Chief Development Officer of Moderna. "By encoding multiple shared tumor targets, this investigational therapy reflects our ongoing efforts to expand the potential of cancer immunotherapy beyond single-target approaches as we continue working to transform cancer care for patients."

The first dose was administered by Dr. William McKean, Clinical Investigator at START Mountain Region in Salt Lake City, Utah, part of The START Center for Cancer Research, the world’s largest community-based early-phase oncology site network.

"The first patient dosed in a study represents far more than an operational milestone–it marks the beginning of evaluating a new therapeutic approach that has the potential to impact patients with advanced cancer," said Dr. McKean. "We are proud to continue our collaboration with Moderna and to support the clinical development of mRNA-4200 by providing patients with early access to promising investigational treatments while generating the clinical evidence needed to advance cancer research."

The Phase 1 trial (ClinicalTrials.gov identifier: NCT06880549) is an open-label, multicenter, dose-escalation study that will evaluate the safety and tolerability of mRNA-4200 administered with checkpoint inhibitor therapy in adult participants with advanced solid tumors.

mRNA-4200 was developed in collaboration with Immatics under the Database Program. mRNA-4200 incorporates targets identified using Immatics’ XPRESIDENT target discovery and validation platform and its bioinformatics and AI platform XCUBE.

(Press release, Moderna Therapeutics, JUL 16, 2026, https://feeds.issuerdirect.com/news-release.html?newsid=6014596879866592&symbol=MRNA [SID1234669273])

Greenwich LifeSciences Announces European Approval for Combining Both HLA Populations in FLAMINGO-01

On July 16, 2026 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported the following update on the combination of both HLA-A*02 and non-HLA-A*02 patients in FLAMINGO-01 in Europe.

All European and US Sites to Combine All Patients Independent of HLA Type in the Randomized Arms of FLAMINGO-01

The Company previously announced that US clinical sites started enrolling both HLA-A*02 and non-HLA-A*02 patients in the same randomized arms in FLAMINGO-01, based on the FDA’s review of such protocol changes, effectively more than doubling the enrollment rate of the pivotal arm of the study. Non-HLA-A*02patients who represent about 55% of the population and were on waiting lists for up to a year are now eligible for enrollment.

The European Medicines Agency (EMA) has completed their review and will also allow the combination of both HLA-A*02 and non-HLA-A*02 patients in Europe. Thus, all 170-180 clinical sites in the US and Europe, are now operating under the same protocol and could continue enrolling up to the first interim analysis. Data can be analyzed by individual HLA types as well.

Additional feedback is expected from UK and Canadian regulators. The Company plans to provide updates regarding the resulting improved trial design, including a pathway for the Company to now pursue approval for both HLA-A*02 and non-HLA-A*02 patients using the increased statistical power of a combined analysis of the two patient groups together potentially doubling the market for GP2 by accelerating the clinical development of the non-HLA-A*02 population.

About FLAMINGO-01 Open Label Phase III Data

More than 1,300 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
The AACR (Free AACR Whitepaper) Meeting 2026 delayed-type-hypersensitivity (DTH) poster and the ASCO (Free ASCO Whitepaper) Meeting 2026 injection site reaction (ISR) poster can be seen and downloaded at the bottom of the Phase III clinical trial tab on the Company’s website here.
As shown in both posters the frequency of DTH and ISR reactions increased statistically significantly over time.
As reported in Table 1 of each poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline.
Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A*02 only patients are being vaccinated.

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb posters and results can be summarized as follows and can be seen here:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 170-180 sites globally.

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

(Press release, Greenwich LifeSciences, JUL 16, 2026, View Source [SID1234669271])

BriaCell Opens First Canadian Site – Sunnybrook – for Pivotal Phase 3 Trial in Metastatic Breast Cancer

On July 16, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported that the Odette Cancer Centre at Sunnybrook Health Sciences Centre, a leading cancer center in Toronto, Ontario, Canada, has joined BriaCell’s ongoing pivotal Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor in metastatic breast cancer (ClinicalTrials.gov identifier: NCT06072612).

In the United States, BriaCell’s Phase 3 study now has over 80 active clinical sites across 15 states, including Penn Medicine’s Abramson Cancer Center, Mayo Clinic, Smilow Cancer Hospital at Yale New Haven, DHR Health Oncology Institute, Hematology Oncology Associates of Fredericksburg, Los Angeles Cancer Network, Manhattan Hematology/Oncology Associates, New York Cancer & Blood Specialists, Northwestern University, Sylvester Comprehensive Cancer Center (University of Miami), Texas Oncology-Baylor Charles A. Sammons Cancer Center, and the University of Arizona.

"There are a limited number of effective treatment options for patients with metastatic breast cancer and, unfortunately for most patients, standard treatments eventually stop working," commented Katarzyna Jerzak, MD, MSc, FRCPC, Medical Oncologist and Clinician Investigator at Sunnybrook’s Odette Cancer Centre, and Associate Professor in the Department of Medicine, University of Toronto. "We are excited to evaluate BriaCell’s innovative immunotherapy approach and to offer these patients the opportunity to access a potentially effective new treatment."

"Opening our first Canadian clinical site for BriaCell’s pivotal Phase 3 study is an important milestone," stated Dr. William V. Williams, BriaCell’s President & Chief Executive Officer. "Sunnybrook is a world-class cancer center, and its participation expands access to our Bria-IMT regimen to patients in Canada, as we work to accelerate development of this our novel immunotherapy for patients with metastatic breast cancer."

BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT, in combination with an immune checkpoint inhibitor (CPI), compared with physician’s treatment of physician’s choice in patients with advanced metastatic breast cancer (the Bria-ABC study). The study’s primary endpoint is overall survival (OS). An interim analysis is planned after 144 patient deaths have occurred, comparing mortality in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice.

BriaCell recently received a positive recommendation from the independent Data Safety Monitoring Board (DSMB) to continue the Phase 3 Study in metastatic breast cancer. At ASCO (Free ASCO Whitepaper) 2026, BriaCell reported positive Phase 2 survival data in a similar metastatic breast cancer patient population treated with the same Bria-IMT combination regimen. The Bria-IMT combination regimen has received FDA Fast Track designation.

For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune checkpoint inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612.

(Press release, BriaCell Therapeutics, JUL 16, 2026, View Source [SID1234669270])