On July 15, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest"), a clinical-stage biotechnology company developing a pipeline of advanced chimeric antigen receptor T-cell ("CAR-T") product candidates, reported details of its next-generation in vivo CAR-T platform. The company plans to advance TPST-4003, its lead in vivo CAR-T product candidate, into a first investigator-initiated clinical trial in patients with nervous system autoimmune diseases, initially focusing on myasthenia gravis ("MG") and multiple sclerosis ("MS"). The study is expected to enroll approximately 10 patients, with first patient dosing anticipated in the fourth quarter of 2026.

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TPST-4003 combines Tempest’s next-generation CD7-targeted mRNA lipid nanoparticle ("CD7-tLNP") delivery platform with the same dual-targeting CD19 B-cell maturation antigen ("CD19/BCMA") chimeric antigen receptor ("CAR") architecture used in TPST-2003, the company’s clinical-stage CAR-T program. Interim Phase 1/2a clinical data generated with TPST-2003 demonstrating the achievement of a 100% complete response rate, together with its successful U.S. manufacturing, provide important support of the underlying CAR construct, establishing a foundation for TPST-4003.

"We are excited to announce the strategic prioritization of our next-generation in vivo CAR-T pipeline and our plan to advance TPST-4003 toward an anticipated first patient dosing later this year," said Matt Angel, Ph.D., President and Chief Executive Officer of Tempest. "We believe our differentiated in vivo CAR-T platform may enable broader addressable T-cell coverage and support scalable repeat dosing once developed and commercialized, supporting future commercial attractiveness of in vivo CAR-T therapy. The lead product candidate in our pipeline, TPST-4003, is being designed to enable broad B-cell lineage depletion and reset with its dual CD19/BCMA targeting architecture, with the goal of potentially delivering improved efficacy and durability compared with single-target CAR approaches. We look forward to advancing TPST-4003 into clinical development later this year."

Planned Investigator-Initiated Trial of TPST-4003

The first planned investigator-initiated trial is expected to evaluate TPST-4003 in approximately 10 patients with nervous system autoimmune diseases, initially focusing on MG and MS. Initial study planning has involved discussions with six prospective clinical centers and principal investigators experienced in neurological autoimmune diseases. The company expects first patient enrollment and dosing to occur in the fourth quarter of 2026.

The study is expected to assess safety, cellular kinetics and pharmacodynamic activity following initial dosing. Key assessments are expected to include treatment-emergent adverse events and serious adverse events; the generation and expansion of peripheral blood CD4+ and CD8+ CAR-T cells and CD56+ CAR-NK cells; CAR transgene copy number; and the depth and kinetics of CD19+ B-cell depletion and B-cell subset reconstitution. Where clinically appropriate, exploratory assessments may also include the detection of CAR-positive immune cells in cerebrospinal fluid and the evaluation of B-cell depletion in lymphoid tissue.

Disease-specific clinical activity will be evaluated using established measures. Initial safety and pharmacodynamic data from the first patients are expected in the first half of 2027, followed by an interim clinical update including preliminary safety, pharmacodynamic and efficacy data in the second half of 2027.

Additional preclinical programs leverage advanced payloads and create a modular in vivo CAR-T portfolio. These include TPST-001 for non-B-cell hematologic malignancies and TPST-002 for solid tumors.

Tempest’s in vivo CAR-T platform, CD7-tLNP, is being designed to expand the potential of next-generation in vivo CAR-T therapy through three core differentiators:

Broader T-Cell Reach: The platform is being engineered to efficiently target both CD4+ and CD8+ T-cell populations, targeting broad CAR expression across the key cellular drivers of durable immunity. This comprehensive T-cell engagement is intended to support a more balanced and effective therapeutic response.
Better Delivery Logic: A differentiated targeting ligand, combined with rapid cellular internalization and a chemically optimized mRNA payload, is being designed to maximize intracellular delivery and CAR protein expression. Nucleoside-modified mRNA and optimized construct architecture together target a reduced innate immune sensing, extended functional mRNA activity, and robust yet transient CAR expression – enhancing delivery efficiency while preserving the advantages of an in vivo approach.
Scalable In Vivo CAR-T: By increasing CAR expression on a per-particle basis, the platform is being designed to achieve meaningful biological activity at lower doses, supporting improved manufacturing efficiency, reduced cost of goods, and the potential for scalable, repeatable treatment.

Together, we believe these capabilities may position the CD7-tLNP platform as a differentiated solution for the next generation of in vivo CAR-T therapies.

About TPST-4003

TPST-4003 is a preclinical, in vivo dual-targeting CD19/BCMA CAR-T product candidate that combines proprietary CD7-targeted mRNA/LNP delivery with a clinically validated dual-target CAR architecture utilized in the company’s TPST-2003 CAR-T program. Targeting broad B-cell lineage depletion and reset, TPST-4003 is being designed to address a range of autoimmune and oncology indications, initially including MG and MS.

(Press release, Tempest Therapeutics, JUL 15, 2026, View Source [SID1234669236])

On July 15, 2026 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 significant progress in the protection of its proprietary innovations across key international markets. The company has received multiple favorable patent actions encompassing three notices of allowance and one grant decision to further strengthen Phio’s global intellectual property portfolio in the United States, Canada, and Japan, respectively. This reinforces the Company’s commitment to developing and safeguarding breakthrough technologies for the INTASYL compounds.

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"Strong patent protection is an important component of our strategy to advance innovative immuno-oncology therapies and maximize the long-term value of our INTASYL siRNA platform," said Robert Bitterman, President and Chief Executive Officer of Phio Pharmaceuticals. "These additional patent advancements across therapeutic areas and geographic regions will facilitate strategic partnerships, support R&D initiatives, and eventual commercialization."

The patent portfolio consists of 54 issued patents. The portfolio encompasses the INTASYL chemistry, specific gene targets, immuno-oncology compounds and therapeutic indications in key countries.

(Press release, Phio Pharmaceuticals, JUL 15, 2026, View Source [SID1234669235])

On July 15, 2026 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported the dosing of first patients in an investigator-initiated Phase 2 proof-of-concept (POC) study of MP0317 in combination with chemoimmunotherapy in first line treatment for patients with advanced biliary tract carcinoma (TACTIC), also known as cholangiocarcinoma.

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The randomized, multicenter TACTIC study (NCT07036380) in France aims to recruit 75 patients, with a 2-to-1 design, with 50 patients in the experimental arm and 25 in the control arm. The objective of the study is to assess the clinical benefit of MP0317 combined with standard-of-care (SoC) comprising the immunotherapy durvalumab, an anti-PD-L1 checkpoint inhibitor, plus gemcitabine-cisplatin-based chemotherapy, compared to SoC alone in frontline setting.

Nine expert trial sites are now activated and patient treatment is ongoing. A data update from the trial is expected in 2027, and completion of the study in 2028. A trial-in-progress poster on the MP0317 Phase 2 study has been accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, taking place October 23-27 in Madrid, Spain.

"Adding an immune modulating compound with the profile of MP0317 to front-line therapy could offer deeper and longer responses for cholangiocarcinoma patients who are receiving SoC. To date we have treated a number of patients through several cycles, and the study is advancing according to plan. We are highly encouraged by the progress so far and look forward to seeing what improvement in response is possible in these patients. MP0317 holds considerable potential to improve treatment options for patients, and we look forward to updating on trial progress in 2027," said Prof. Christophe Borg, Head of the Medical Oncology Department at the University Hospital of Besançon and Principal Investigator of the TACTIC study.

"We are proud to support the TACTIC consortium in pursuing this novel treatment for patients with such a dire need for improved therapies. MP0317 has shown proof-of-mechanism in the completed Phase 1 study, with immune-mediated remodeling of the tumor microenvironment. We believe MP0317 could potentiate the effect of SoC for greater patient benefit across several cancer indications, and that combination with immunotherapy and SoC in first line cholangiocarcinoma is an optimal setting to evaluate its activity," said Philippe Legenne, M.D., CMO of Molecular Partners.

MP0317, a FAP-localized CD40 agonist designed to drive immune-mediated remodeling of the tumor microenvironment (TME), is hypothesized to improve 12-month progression-free survival rate of patients with advanced cholangiocarcinoma compared to SoC alone. The TME is known to play a crucial role in the development of cholangiocarcinoma and other solid tumors, as well as in their treatment resistance.

Molecular Partners completed a Phase 1 dose-escalation study of MP0317 in patients with advanced solid tumors with 46 patients treated across 9 dose levels. Comprehensive biomarker analyses from the trial showed tumor-localized CD40 activation and TME remodeling as intended by design. The results of this Phase 1 study were recently published in Nature Cancer (Steeghs et al. 2026; DOI: 10.1038/s43018-026-01150-1).

(Press release, Molecular Partners, JUL 15, 2026, View Source [SID1234669234])

On July 15, 2026 MimiVax Inc., a clinical-stage biotechnology company dedicated to the development of innovative cancer immunotherapies, reported that data cutoff has been reached for the SURVIVE trial (NCT05163080), the Company’s Phase 2b randomized, double-blind, placebo-controlled clinical trial evaluating SurVaxM in patients with newly diagnosed glioblastoma (nGBM). The dataset has been transferred to the trial’s independent statistical team, who have initiated the pre-specified analysis.

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The SURVIVE trial, which completed enrollment in 2024 across 11 major cancer centers in the United States, is designed to evaluate whether adding SurVaxM to standard-of-care adjuvant temozolomide chemotherapy improves survival outcomes compared to temozolomide alone in patients with newly diagnosed glioblastoma. The study enrolled 249 patients with newly diagnosed, resected glioblastoma across institutions including Roswell Park Comprehensive Cancer Center, Dana-Farber Cancer Institute, Cleveland Clinic, Fred Hutchinson Cancer Center, UCSF, NYU, Miami Baptist Cancer Center, Northwell Health, Norton Cancer Institute, Overlook Medical Center and Texas Oncology.

"Five years ago, we began the SURVIVE trial with the conviction that SurVaxM will meaningfully extend survival for patients diagnosed with glioblastoma. Completing the data cutoff brings us one step closer to achieving that goal," said Michael Ciesielski, PhD, chief executive officer and co-founder of MimiVax. "None of this would have been possible without the patients and families who trusted us with their care, and the clinical teams who made this trial work."

"Reaching the data cutoff is a milestone our team, our investigators, and most importantly our patients have been working toward for years," said Robert Fenstermaker, MD, chief medical officer and co-founder. "With the independent analysis now underway, we look forward to sharing topline results soon."

Glioblastoma is the most common and aggressive malignant primary brain tumor in adults, with a median overall survival of approximately 16 – 18 months with standard therapy alone. The SURVIVE trial was built upon encouraging results from the preceding Phase 2a study of SurVaxM in 63 newly diagnosed glioblastoma patients, which demonstrated a median overall survival of 25.1 months. Fifty percent of patients receiving SurVaxM survived at least two years, and 19 percent survived at least five years. Individuals with the strongest immune responses had a much longer median overall survival (mOS) of 43.1 months.

About the SURVIVE Trial

SURVIVE (NCT05163080) is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating SurVaxM in combination with standard-of-care adjuvant temozolomide versus temozolomide alone in patients with newly diagnosed, resected glioblastoma. The SURVIVE trial is being conducted at 11 major cancer centers across the United States.

About SurVaxM

SurVaxM is a first-in-class, patented peptide mimic immunotherapeutic vaccine that targets survivin, a cell-survival protein present in approximately 95 percent of glioblastomas. Delivered via subcutaneous injection, SurVaxM is engineered to stimulate patients’ own immune response to recognize and attack survivin-expressing cancer cells, with the goal of controlling tumor growth and preventing recurrence. SurVaxM holds FDA Fast Track Designation for newly diagnosed glioblastoma and is being evaluated across multiple cancer indications, including glioblastoma, neuroendocrine tumors, multiple myeloma, and pediatric brain cancer.

(Press release, MimiVax, JUL 15, 2026, View Source;utm_medium=rss&utm_campaign=mimivax-announces-data-cutoff-for-phase-2b-survive-trial-of-survaxm-in-newly-diagnosed-glioblastoma [SID1234669233])

On July 15, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported the Phase 3 KEYNOTE‑C93 trial evaluating KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, met its primary endpoint of progression-free survival (PFS) for the treatment of patients with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer who had not previously received systemic chemotherapy or who experienced recurrence more than six months after completing prior adjuvant therapy. KEYTRUDA is the first and only PD-1 inhibitor to show a statistically significant and clinically meaningful improvement in PFS as monotherapy compared to platinum doublet chemotherapy for these patients in a Phase 3 trial.

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At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, a trend toward improvement in overall survival (OS), the trial’s other primary endpoint, was observed for KEYTRUDA; however, these OS data were not mature at the time of this analysis. The trial is ongoing, and OS for the full study population will be evaluated at a future analysis. This analysis also showed a clinically meaningful overall response rate (ORR), as well as complete response rate (CRR) and duration of response (DOR) for KEYTRUDA. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified. Results will be presented at an upcoming medical meeting and shared with regulatory authorities.

"This is the first Phase 3 trial of a PD-1 inhibitor to show improved PFS compared to platinum doublet chemotherapy when given as monotherapy in the frontline setting for these patients, potentially providing a chemo-free option," said Dr. Brian Slomovitz, director of Gynecologic Oncology and deputy director of the Braman Comprehensive Cancer Center at Mount Sinai Medical Center in Miami Beach, Florida, and the study’s overall principal investigator.

"These findings build upon the well-established role of KEYTRUDA in endometrial cancer, one of the few cancers with rising incidence rates," said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. "We are committed to helping women facing this disease by advancing potential treatment options. We thank the patients and investigators for their important contributions to this study and look forward to sharing these results with the medical community."

In the U.S., KEYTRUDA is the only anti-PD-1 therapy with three approved indications for patients with certain types of endometrial cancer. KEYTRUDA is indicated: in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma; in combination with LENVIMA (lenvatinib), in collaboration with Eisai, for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR), as determined by an FDA-authorized test, or not microsatellite instability-high (MSI-H), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation; and as a single agent, for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Merck has a comprehensive clinical development program evaluating KEYTRUDA (both as monotherapy and in combination with chemotherapy) and sacituzumab tirumotecan (sac-TMT), an investigational TROP2-directed antibody-drug conjugate (ADC) being developed in collaboration with Kelun-Biotech, in endometrial cancer. As previously announced, TroFuse-005 (NCT06132958) met its primary endpoints of PFS and OS, as well as its key secondary endpoint of ORR in patients with endometrial cancer who have previously received platinum-based chemotherapy and immunotherapy. In addition, TroFuse-033 (NCT06952504) is enrolling patients with pMMR endometrial cancer to evaluate sac-TMT in an earlier treatment setting of first-line maintenance. The KEYNOTE-B21 trial (NCT04634877) remains ongoing for analysis in the dMMR subgroup.

About KEYNOTE-C93

KEYNOTE-C93 is a randomized, open-label Phase 3 trial (NCT05173987) evaluating KEYTRUDA monotherapy versus carboplatin plus paclitaxel in patients with dMMR advanced or recurrent endometrial cancer who have not previously been treated with prior systemic chemotherapy. The trial enrolled 299 patients who were randomized to receive either:

KEYTRUDA (400 mg) intravenously every six weeks for up to 18 cycles, or;
Combination of paclitaxel (175 mg/m2) and carboplatin (AUC 5 or 6) every three weeks for six cycles.
The trial’s dual primary endpoints are PFS, as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), and OS. A key secondary endpoint of the study is ORR.

About endometrial cancer

Endometrial cancer (also referred to as endometrial carcinoma) begins in the inner lining of the uterus, which is known as the endometrium, and is the most common type of cancer in the uterus. More than 90% of uterine body cancers occur in the endometrium. Endometrial cancer is one of the few cancers with increasing mortality. In the U.S., it is estimated there will be approximately 68,270 patients diagnosed with endometrial cancer and approximately 14,450 patient deaths from the disease in 2026. Globally, endometrial cancer is the sixth most common cancer in women and the 15th most common cancer overall.

(Press release, Merck & Co, JUL 15, 2026, View Source [SID1234669232])