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Biodexa Initiates Support Activities for FAP Patients and Treatment Centers in France

On July 29, 2026 Biodexa Pharmaceuticals PLC (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers reported that it has held its first round table meeting in Paris, France as part of expanding its support for Familial Adenomatous Polyposis (FAP) patients and prescribers. The sharing of experience and expertise amongst patients, patient advocacy groups and clinicians is informing Biodexa’s goal of improving outcomes and quality of life for FAP patients. These activities will augment Biodexa previous step of making eRapa available for FAP patients via an Early Access Program and Named Patient prescribing. A global initiative which gives clinicians who treat FAP patients the opportunity to prescribe this investigational medicine outside of a clinical trial for the first time.

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Commenting, Stephen Stamp, Chief Executive Officer of Biodexa said "We are delighted to be expanding our support for the FAP community and are committed to improving the lives of patients. We are proud to be support clinicians and patients in this way in addition to making eRapa available to clinicians for whom there are no currently approved therapeutic options."

About Familial Adenomatous Polyposis

FAP is characterized as a proliferation of polyps in the colon and/or rectum, usually occurring in mid-teens. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. If untreated, FAP typically leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with a reported incidence of one in 5,000 to 10,000 in the US and one in 11,300 to 37,600 in Europe. eRapa has received Orphan Designation in the US with plans to seek such designation in Europe. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP.

About eRapa
eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorigenesis. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP. Data from an open label Phase 2 trial were presented at Digestive Disease Week and InSIGHT 2024 in May and June 2024, respectively. Based on those data, Biodexa initiated a double-blind, placebo-controlled Phase 3 registrational trial which is planned to initiate 30 clinical sites across the US and Europe and to enrol 168 patients randomized 2:1, drug: placebo. The Phase 3 program is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas.

(Press release, Biodexa Pharmaceuticals, JUL 29, 2026, View Source [SID1234669513])

Silexion Therapeutics Successfully Initiates Phase 2/3 Clinical Trial of SIL204 in Locally Advanced Pancreatic Cancer at Tel Aviv Sourasky Medical Center

On July 29, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported the successful initiation of its Phase 2/3 clinical trial of SIL204, the Company’s lead small interfering RNA (siRNA) product candidate, at Tel Aviv Sourasky Medical Center ("TASMC" or "Ichilov"), formally activating the first clinical site for the study in patients with locally advanced pancreatic cancer ("LAPC"). With the trial now initiated at TASMC, the site is cleared to commence patient screening.

The initiation on July 29, 2026 follows the receipt of all regulatory and institutional approvals required to open the site — including the Israeli Ministry of Health authorization received on March 24, 2026, and the institutional ethics approval previously granted by TASMC – and confirms that Silexion’s investigational medicinal product ("IMP") for SIL204 is available in Israel and positioned for the site upon initial patient screening. TASMC, commonly known as Ichilov, is one of Israel’s largest teaching hospitals and a leading center for oncology clinical research, and serves as the anchor site for the Israeli arm of Silexion’s Phase 2/3 program.

Within approximately four months, Silexion completed a rapid sequence of clinical readiness milestones for SIL204: the Israeli Ministry of Health approval received in March 2026; the initiation of GMP clinical supply manufacturing with Catalent announced in May 2026; TASMC’s own institutional ethics approval for the Phase 2/3 trial announced in May 2026; and the BfArM authorization in Germany received in June 2026, all of which culminated in the activation of TASMC as the first clinical site for the SIL204 program on July 29, 2026. With the first clinical site now formally active, Silexion’s SIL204 program is moving beyond the regulatory preparation phase and into active clinical execution, with additional Israeli and German sites progressing through activation in parallel and first patient dosing anticipated as the next milestone.

"Successfully initiating our first clinical site at Tel Aviv Sourasky Medical Center is a defining operational milestone for Silexion and for the SIL204 program," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "This is the moment where years of preclinical development, GMP manufacturing scale-up, and multi-jurisdictional regulatory work have translated into an active clinical program. TASMC is one of Israel’s premier oncology research centers and having it as our first active site provides an exceptional foundation as we bring additional Israeli and German centers online in the weeks and months ahead. We look forward to advancing rapidly toward first patient dosing."

The Phase 2/3 trial is designed to evaluate SIL204 in combination with standard-of-care chemotherapy in patients with locally advanced pancreatic cancer, using Silexion’s innovative dual-route administration strategy— combining intratumoral delivery designed to overcome the stromal barrier that can limit systemic drug penetration into the primary tumor, alongside systemic administration to address metastatic disease. The study is structured as an initial safety run-in cohort of approximately 18 patients, followed by expansion into sites worldwide to obtain a randomized cohort of approximately 166 patients. Additional Israeli sites, alongside leading German oncology centers approved under the EU Clinical Trials Regulation framework, are advancing through site activation and are expected to join the program in the coming months.

SIL204, which is designed to silence a broad range of KRAS mutations rather than a single variant, supports Silexion’s potential applicability across multiple high-value cancer indications beyond pancreatic cancer. KRAS mutations are present in approximately 90% of pancreatic cancers, 45% of colorectal cancers, and 30–35% of lung adenocarcinomas, representing one of the largest and most persistent unmet needs in oncology. Pancreatic cancer—which is the subject of the current, initial clinical trial— remains one of the most lethal malignancies, with a five-year survival rate below 13%, and more than 80% of pancreatic cancer mortality driven by metastatic disease.

(Press release, Silexion Therapeutics, JUL 29, 2026, View Source [SID1234669512])

Allogene Therapeutics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Cemacabtagene Ansegedleucel (Cema-Cel) as First-Line Consolidation Therapy for Large B-Cell Lymphoma

On July 29, 2026 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations to cemacabtagene ansegedleucel (cema-cel) for the treatment of adult patients with large B-cell lymphoma (LBCL) who, at the completion of first-line (1L) therapy, are in complete or partial response suitable for observation but test positive for minimal residual disease (MRD). Together, the designations enable more frequent FDA engagement and support an efficient development and review process.

Cema-cel is an investigational allogeneic CAR T product being studied in the pivotal ALPHA3 trial as part of 1L treatment for patients with LBCL who are at high risk of relapse. The ALPHA3 trial uses Natera’s CLARITY MRD assay, which is powered by its phased variant MRD technology, to identify patients in remission but who are likely to experience disease recurrence following completion of 1L chemoimmunotherapy. Patients who test positive for MRD are enrolled and assigned to receive either a single dose of cema-cel or close observation, the current standard of care, with outcomes compared between the two groups.

"The FDA’s decision to grant both RMAT and Fast Track designations provides additional validation for the strategy we defined with the ALPHA3 trial and strengthens our ability to work closely with the agency on an efficient path to advance cema-cel as a first-line consolidation therapy for large B-cell lymphoma," said Zachary Roberts, M.D., Ph.D., President and Chief Executive Officer of Allogene Therapeutics. "There is a shared goal across the treatment community to reach patients earlier in their disease course and reduce the barriers that limit access to CAR T therapy. The interim ALPHA3 findings, which showed rapid and substantial MRD reduction, with most patients treated in the outpatient setting, support cema-cel’s potential as an off-the-shelf therapy that can be delivered at scale in community settings where approximately 80% of first-line patients receive their care."

The FDA granted RMAT designation for cema-cel as 1L consolidation therapy for patients with high-risk LBCL following full review of the interim futility analysis from the ongoing ALPHA3 trial, underscoring the continued need for new treatment options. At the protocol-defined data cutoff, triggered when the 24th patient enrolled in the ongoing study arms completed the Day 45 MRD assessment, 58.3% (7/12) of patients in the cema-cel arm achieved MRD negativity compared to 16.7% (2/12) in the observation arm. This represents a 41.6% absolute difference in MRD clearance between the two arms. Published literature and cross-study benchmarks suggest that MRD clearance differences of 25-30% may lead to clinically meaningful improvement at study completion.

Cema-cel was well-tolerated as of the data cutoff with no treatment-related serious adverse events. There were no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease (GvHD) or high-grade infections. No tocilizumab or steroids were administered for toxicity prophylaxis or treatment, and no patients were hospitalized for treatment-related adverse events. This profile compares favorably with the broader CAR T experience, where hospitalization for toxicity management remains common.

Regenerative Medicine Advanced Therapy (RMAT) designation is intended to expedite the development and review of regenerative medicine therapies intended to treat, modify, or cure a serious or life-threatening disease or conditions when preliminary clinical evidence indicates the therapy has the potential to address an unmet medical need for that disease or condition. Fast Track designation further supports expedited development and review, including potential eligibility for rolling review and priority review, if relevant criteria are met.

(Press release, Allogene, JUL 29, 2026, View Source [SID1234669511])

Xencor to Receive $105 Million From Alexion to Resolve Ultomiris® U.S. Royalty Matter

On July 29, 2026 Xencor, Inc. (NASDAQ:XNCR) ("Xencor"), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported its agreement with Alexion Pharma International Operations Limited, an Irish limited company ("Alexion"), to resolve a commercial dispute related to U.S. royalties on Ultomiris (ravulizumab-cwvz) (the "Settlement Agreement").

Under the Settlement Agreement, Xencor will receive $105 million in two equal payments, the first $52.5 million payment is anticipated in August 2026 and the second $52.5 million payment on the one-year anniversary of the executed Settlement Agreement, and Alexion will have no further obligation to pay royalties on U.S. sales of Ultomiris. Xencor expects to continue receiving royalties on ex-U.S. sales of Ultomiris under the existing terms of their license agreement.

"We are pleased to have reached a resolution that provides immediate capital and reflects the value of the U.S. royalty stream that we had previously expected through 2028," said Bassil Dahiyat, Ph.D., president and chief executive officer of Xencor. "We have returned our operating runway estimate to extend through 2028."

As previously disclosed, in March 2026, Alexion informed Xencor of its position that no additional royalties were owed on U.S. sales of Ultomiris and that it did not intend to make future payments related to U.S. sales. The Settlement Agreement fully resolves the dispute.

Ultomiris is a drug being developed and commercialized by Alexion Pharmaceuticals, Inc., and is its registered trademark.

Financial Guidance: Based on current operating plans, Xencor expects to have sufficient cash resources to fund research and development programs and operations through 2028. Guidance for year-end 2026 cash, cash equivalents and marketable debt securities will be updated with financial results for the second quarter of 2026.

(Press release, Xencor, JUL 29, 2026, View Source [SID1234669510])

Estrella Immunopharma Activates Baylor Scott & White Research Institute as Second Clinical Site for Phase I/II STARLIGHT-1 Trial in B-cell Non-Hodgkin’s Lymphoma

On July 29, 2026 Estrella Immunopharma, Inc. (NASDAQ: ESLA) ("Estrella" or the "Company"), a clinical-stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS T-cell therapies to treat cancer and autoimmune diseases, reported the activation of a second clinical site for its ongoing STARLIGHT-1 Phase I/II clinical trial evaluating EB103, a CD19-Redirected ARTEMIS T-cell therapy, in patients with relapsed or refractory ("R/R") B-cell non-Hodgkin’s lymphoma ("NHL"). The new site, Baylor Research Institute d/b/a Baylor Scott & White Research Institute in Dallas, Texas, has begun screening and enrolling patients.

"Partnering with Baylor Scott & White Research Institute, a nationally recognized medical institution, represents a key step forward in broadening the reach of our STARLIGHT-1 trial," said Cheng Liu, CEO of Estrella Immunopharma. "The expansion of our clinical footprint will help accelerate development and increase patient access to EB103, while we remain focused on our mission to deliver safer, more effective treatments for patients with advanced NHL."

The ongoing expansion phase of the Phase I/II clinical trial for EB103 is designed as a multi-center, open-label study intended to further evaluate the safety and efficacy of EB103 at the recommended Phase II dose ("RP2D") in subjects (≥ 18 years of age) who have R/R B-cell NHL. Data from this expansion cohort will be used to determine the pivotal trial strategy for EB103. As of the date of this press release, active clinical sites for the trial are UC Davis Comprehensive Cancer Center and Baylor Scott & White Research Institute. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier NCT06343311.

About EB103

EB103, a T-cell therapy, also referred to as Estrella’s "CD19-Redirected ARTEMIS T-Cell Therapy," utilizes ARTEMIS technology licensed from Eureka Therapeutics, Inc. (Eureka), Estrella’s parent company. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS T-Cell, such as EB103, allows it to be activated and regulated upon engagement with cancer targets through a cellular mechanism that more closely resembles that of an endogenous T-cell receptor. Once infused, EB103 T cells bind to and destroy CD19-positive cancer cells.

(Press release, Estrella Immunopharma, JUL 29, 2026, View Source [SID1234669509])