On June 25, 2025 Hamlet BioPharma, the pharmaceutical company, specializing in the development of drugs for cancer and infections, reported the successful first in-person meeting with the U.S. Food and Drug Administration (FDA) (Press release, HAMLET Pharma, JUN 25, 2025, View Source [SID1234654118]). The meeting was held on June 24, 2025. The ‘take home message’ from the discussion was a clear pathway to the Phase III trial leading to market approval.

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The Hamlet team summarized the scientific and clinical background and presented data from Hamlet’s successful and recently completed Phase II study (Dec 2024). The impressive data to date in the Alpha1H program was well received by the FDA and the fruitful discussion included the clinical team in Prague and Target Health’s regulatory expertise and leadership.

The discussion proceeded to cover FDA’s helpful feedback on a new Phase III trial design for NMIBC patients, which will support the registration of Alpha1H. Hamlet BioPharma will now incorporate FDA’s input into its Phase III protocol. The company remains on track to initiate the Phase III trial, subject to final protocol agreement and regulatory clearance. The meeting marked a key milestone in the regulatory pathway and provided an opportunity to align with the FDA on key aspects of the trial design.

`’Congratulations to the Hamlet team,” says Adam Harris, MM, RAC, from Target Health, who was regulatory lead for the meeting with the FDA.

"We appreciate the FDA’s engagement and valuable feedback as we continue the late-stage development of Alpha 1H and the treatment of Bladder Cancer," comments Catharina Svanborg, CEO, Hamlet Biopharma. "This meeting brings us one step closer to delivering a new treatment option for patients facing bladder cancer."

On June 25, 2025 Crinetics reported the management team for a R&D Day to discuss Company’s proprietary in-house discovery engine and proven development approach for differentiated endocrine therapies (Press release, Crinetics Pharmaceuticals, JUN 25, 2025, View Source [SID1234654117]).

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The event will highlight Crinetics’ early-stage pipeline strategy and data to deliver sustainable long-term growth, with a focus on:

NETs and beyond – NDC platform with CRN09682
TSH antagonist for Graves’ disease and thyroid eye disease (TED)
SST3 agonist for autosomal dominant polycystic kidney disease (ADPKD)
Date:
June 26, 2025
Time:
9:00 AM EDT
Virtual Meeting:
Note: You must register to be eligible to
participate in the meeting.

On June 25, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported that the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for satricabtagene autoleucel ("satri-cel", CT041) (an autologous CAR T-cell product candidate against protein Claudin18.2) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy (Press release, Carsgen Therapeutics, JUN 25, 2025, View Source [SID1234654116]). The NDA submission is mainly based on the results of an open-label, multicenter, randomized controlled confirmatory Phase II clinical trial (CT041-ST-01, NCT04581473) conducted in China. The data have been presented in The Lancet and at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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In addition, the company is actively expanding satri-cel application in early-line treatment and perioperative treatment of cancer, including an ongoing Phase Ib registrational trial for pancreatic cancer adjuvant treatment and an ongoing investigator-initiated trial for consolidation treatment following adjuvant therapy in patients with resected G/GEJA.

Professor Lin Shen from Beijing Cancer Hospital, the principal investigator of the CT041-ST-01 clinical trial, said, "Gastric cancer is a malignancy with a substantial global disease burden and significant treatment challenges. For patients with advanced gastric cancer, in particular, existing therapeutic options and their efficacy remain severely limited, resulting in extremely poor survival outcomes. Within the current treatment landscape for gastric cancer, a growing number of patients have experienced failure with immunotherapy and anti-angiogenic therapies. Treatment choices and potential benefits become even more constrained in the third-line setting and beyond. Consequently, there exists a significant unmet clinical need for advanced gastric cancer patients after second-line treatment failure. The confirmatory randomized controlled clinical trial of satri-cel has clearly demonstrated that, compared with existing standard therapies, satri-cel offers significant advantages and clinical value in extending both progression-free survival (PFS) and overall survival (OS). The trial results have garnered widespread international attention and recognition, providing a solid evidentiary foundation for satri-cel’s New Drug Application (NDA) submission. We look forward to the approval and market launch of satri-cel, which will offer a new treatment option for the broader population of gastric cancer patients."

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "We are delighted to announce that the NDA for our self-developed Claudin18.2-targeted CAR T-cell product satri-cel has been accepted for review by China’s NMPA. This marks the world’s first CAR T-cell therapy product for solid tumors to reach the NDA stage—a major milestone for the CAR-T field. I extend my sincere gratitude to all clinical investigators, trial coordinators, and patients involved in this program. We are hopeful for its timely approval to provide gastric cancer patients with a new treatment option."

About Satri-cel

Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets the treatment of Claudin18.2-positive solid tumors with a primary focus on G/GEJA and pancreatic cancer (PC). Initiated trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced G/GEJA in China (CT041-ST-01, NCT04581473), a Phase Ib registrational trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), an investigator-initiated trial for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010, NCT06857786), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595).

Satri-cel has been granted Priority Review by the Center for Drug Evaluation (CDE) of China’s NMPA for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in May 2025. Satri-cel has been granted Breakthrough Therapy Designation by the CDE of China’s NMPA for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in March 2025. Satri-cel was granted Regenerative Medicine Advanced Therapy designation by U.S. FDA for the treatment of advanced G/GEJA with Claudin18.2-positive tumors in January 2022. Satri-cel received Orphan Drug designation from the U.S. FDA for the treatment of G/GEJA in September 2020.

On June 25, 2025 Photocure reported the publication of the study "Use of photodynamic diagnosis (PDD) at primary TURB*: Potential influence on recurrence and progression rates in NMIBC in a registry-based study using a country cohort" in the Scandinavian Journal of Urology this week (Press release, PhotoCure, JUN 25, 2025, View Source;utm_medium=email_campaign&utm_campaign=newsletter [SID1234654115]). An abstract of this study was first presented at the NUF 2022 congress in Helsinki.

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This Danish population study assesses recurrence and progression impact of BLC using national registries in Denmark. It shows beneficial impact on recurrence and progression in patients treated at clinics who have a higher level of use of BLC in primary patients, further strengthening the importance of BLC in bladder cancer care.

On June 25, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported that the Safety Monitoring Committee (SMC) recommended dose escalation in its Phase 1b clinical trial designed to evaluate the safety and tolerability of intratumoral (IT) PH-762 in the treatment of Stages 1, 2, and 4 cutaneous squamous cell carcinoma (cSCC), Stage 4 melanoma, and Stage 4 Merkel cell carcinoma (Press release, Phio Pharmaceuticals, JUN 25, 2025, View Source [SID1234654114]).

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Five patients were enrolled in the fourth cohort of the Phase 1b clinical trial (NCT 06014086). Four of the enrolled patients were diagnosed with cSCC and one patient with Merkel cell carcinoma. As with the previous three cohorts, injections were well-tolerated and there were no dose-limiting toxicities, serious adverse events, or clinically relevant treatment-emergent adverse reactions reported.

Pathology results related to the efficacy of PH-762 in the fourth cohort will be forthcoming.

"We are encouraged by the continuing safety profile of PH-762 having now progressed through four escalating dose concentrations, and we anticipate that IT administration of the highest dose concentration of PH-762 in cohort 5 will result in a similar safety profile," said Mary Spellman, MD, Phio’s acting Chief Medical Officer.

To date, a total of 15 patients with cutaneous carcinomas have been treated with PH-762 in Cohorts 1 through 4. These cohorts included 13 patients with cSCC, one patient with metastatic melanoma, and one patient with Merkel cell carcinoma.

Pathological response at Day 36 (planned tumor excision) in the previous three cohorts demonstrated complete response (100% tumor clearance) in 4 of 9 patients with cSCC. One cSCC patient had a near complete response (>90% clearance) and one cSCC patient had a partial response (>50% clearance). The other three patients with cSCC and one patient with metastatic melanoma had a pathologic non-response (< 50% clearance). No patients exhibited clinical progression of disease. Patients with a pathologic complete response (100% tumor clearance) may have visual signs of residual scar or subdermal inflammation prior to resection.

Phio expects to complete enrollment in the expected final cohort in this trial in the third quarter of 2025.

"The continuing favorable safety profile of PH-762 through the fourth cohort provides promise of a well-tolerated treatment for skin cancer," said Robert Bitterman, CEO and Chairman of Phio Pharmaceuticals.