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.

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 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 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.

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!

"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 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.

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!

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 Taiho Pharmaceutical Co., Ltd. (hereinafter "Taiho") reported that the PI3Kα inhibitor, HAIZEXIN tablets 10mg (generic name: risovalisib mesilate hydrate), has been listed on the National Health Insurance (NHI) reimbursement price list. The launch of this new product in Japan is scheduled for July 28, 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!

In March 2026, Haihe Biopharma K. K., a fully owned affiliate of Haihe Biopharma Co., Ltd. (hereinafter "Haihe"), obtained approval to manufacture and market HAIZEXIN in Japan for the treatment of a patient with ovarian clear cell carcinoma (hereinafter "OCCC") harboring PIK3CA gene mutations that has progressed after chemotherapy. Taiho will be responsible for sales and medical information activities for HAIZEXIN in Japan pursuant to an exclusive license agreement with Haihe, entered into in October 2025, for the development, manufacture, and commercialization of HAIZEXIN.

HAIZEXIN is a small-molecule PI3Kα inhibitor developed by Haihe. HAIZEXIN binds to the ATP-binding site of PI3Kα and inhibits its kinase activity, thereby inhibiting the phosphorylation of AKT, a downstream molecule in the PI3K signaling pathway¹, which is believed to result in antitumor effects.

Taiho and Haihe together will work with healthcare professionals to serve patients with OCCC by providing HAIZEXIN as a new treatment option.

Summary of Product Information in Japan
Brand name HAIZEXIN tablets 10mg
Generic name Risovalisib mesilate hydrate
Indications Ovarian clear cell carcinoma (OCCC) harboring PIK3CA gene mutations that has progressed after chemotherapy
Dosage and administration Normally, for adults, oral administration in fasting condition of 40mg of risovalisib once daily. Dosage should be reduced based on the patient’s condition.
Date of manufacturing and marketing approval March 23, 2026
Date listed in NHI reimbursement price listing July 15, 2026
Scheduled launch date in Japan July 28, 2026
NHI reimbursement price JPY 7,313.40 / tablet
Packaging PTP Packaging: 28 tablets (14 tablets x 2)
Manufacturer and distributor Haihe Biopharma K. K.
Distributor Taiho Pharmaceutical Co., Ltd.
About Ovarian Clear Cell Carcinoma with PIK3CA Gene Mutations
Ovarian cancer is one of the leading causes of cancer-related death in women, with approximately 320,000 new cases diagnosed worldwide in 2022, making it the third most common gynecologic cancer.2 In Japan, the number of registered ovarian cancer cases was reported to be 16,590 in 2023.3 OCCC is a histological subtype of epithelial ovarian cancer and accounts for approximately 21.9% of ovarian cancers in Japan.4 OCCC has a high prevalence of PIK3CA gene mutations, which are observed in approximately 30% to 40% of cases5,6; based on this prevalence, the annual number of patients with OCCC harboring PIK3CA gene mutations is estimated to be approximately 650 to 950. OCCC is a rare cancer with limited treatment options, and there remains a need to develop new therapies.

(Press release, Taiho, JUL 15, 2026, View Source [SID1234669206])

On July 15, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application no. 18/784,354 entitled "Treatment of Low-Grade Intermediate-Risk Non-Muscle-Invasive Bladder Cancer With a Thermally Gelling Pharmaceutical Composition Containing Mitomycin." The allowed claims cover methods of treating patients with recurrent, low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) without a transurethral resection of a bladder tumor (TURBT), supported by data from the ENVISION and ATLAS clinical trials. The U.S. patent, once issued, will have an expiration date in July 2044.

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!

"This patent allowance further strengthens the intellectual property foundation supporting ZUSDURI and our UGN-103 investigational medicine, if approved, and underscores the innovation behind our proprietary RTGel technology," said Liz Barrett, President and Chief Executive Officer of UroGen. "Supported by data from the ENVISION and ATLAS trials of ZUSDURI, these patent claims reflect the ability of our RTGel-based technology to deliver mitomycin as a primary, non-surgical treatment option for adults with recurrent LG-IR-NMIBC without a TURBT. We believe this approach helps patients achieve highly durable recurrence-free intervals while reducing the burden of repeat surgical interventions."

Building on the growing body of clinical evidence supporting ZUSDURI and UGN-103, UroGen remains focused on advancing its proprietary RTGel technology and developing innovative therapies that have the potential to expand non-surgical treatment options for patients with urothelial cancers and strengthen the company’s long-term growth opportunities.

About ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.

About UGN-103
In January 2024, UroGen entered into a licensing and supply agreement with medac to develop UGN-103 for recurrent LG-IR-NMIBC. UGN-103 is designed to reinforce and extend the clinical and commercial profile of ZUSDURI, the first and only FDA-approved treatment for adults with recurrent LG-IR-NMIBC. The program maintains UroGen’s innovative and proven RTGel technology, enabling sustained mitomycin exposure in the bladder, while incorporating next-generation enhancements, including a more streamlined manufacturing process and simplified reconstitution to support improved ease of use in clinical practice. UroGen holds U.S. patents covering the combination of its proprietary RTGel technology with medac’s licensed lyophilized mitomycin formulation, as well as the use of UGN-103 in LG-IR-NMIBC, with intellectual property protection expected to extend into December 2041.

(Press release, UroGen Pharma, JUL 15, 2026, View Source [SID1234669237])