On July 28, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the National Medical Products Administration (NMPA) has accepted the supplementary New Drug Application (sNDA) for ivonescimab (PD-1/VEGF bispecific antibody) in combination with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC) (Press release, Akeso Biopharma, JUL 28, 2025, View Source [SID1234654555]).

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This submission represents the third accepted application for ivonescimab in China, following previous filings for its combination therapy in EGFR-TKI resistant locally advanced or metastatic non-squamous NSCLC (nsq-NSCLC), as well as its monotherapy for first-line treatment of PD-L1 positive advanced NSCLC.

PD-1 combined with chemotherapy has become a cornerstone in cancer therapy. The sNDA for ivonescimab’s new indication is based on the strong positive outcomes from its Phase III trial (AK112-306/HARMONi-6 study), which showed that ivonescimab combined with chemotherapy is superior to tislelizumab plus chemotherapy. Building on the success of its head-to-head comparison with pembrolizumab, ivonescimab’s ability to outperform PD-1 combination therapy marks a significant step forward in the evolution of global cancer immunotherapy.

Currently, ivonescimab is involved in over 12 registrational/Phase III clinical trials worldwide, including six head-to-head studies with PD-1/L1 inhibitors. These trials span a diverse range of malignancies, such as various subtypes of lung cancer, first-line colorectal cancer, first-line head and neck squamous cell carcinoma, first-line biliary tract cancer, first-line pancreatic cancer, and first-line triple-negative breast cancer, among others. Ivonescimab has established a broad and strategic footprint across key cancer immunotherapy indications. As part of the company’s "IO+ADC" 2.0 oncology strategy, ivonescimab is positioned as a cornerstone agent in immuno-oncology, being evaluated in combination with innovative therapies targeting novel mechanisms and pathways.

On July 28, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative treatments for urothelial and specialty cancers, reported the publication in Reviews in Urology of results from a Phase 3b study evaluating the feasibility of administering ZUSDURI (mitomycin) for intravesical solution (formerly known as UGN-102) in the home setting (Press release, UroGen Pharma, JUL 28, 2025, View Source [SID1234654575]). The study, titled "Home Instillation of UGN-102 for Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer: A Single-Arm, Open-Label, Phase 3b Trial," demonstrated that trained home health professionals (HHPs) can safely and effectively administer ZUSDURI outside of a traditional clinical setting.

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"The ability to deliver this treatment safely and effectively at home has the potential to ease the burden on patients and reduce reliance on hospital or clinic resources," said David Morris, MD, lead investigator and practicing urologist at Urology Associates, PC, Nashville, TN. "As physicians, we’re always looking for ways to provide effective care with greater comfort and convenience. These findings represent an important step in that direction."

The study assessed the feasibility, safety, and early efficacy of at-home instillations of ZUSDURI in patients with recurrent LG-IR-NMIBC. Six of eight patients (75%) completed all six scheduled treatments, with five of those six patients indicating they would recommend the home-based approach to others. A 75% complete response (CR) rate was observed at three months (95% CI: 34.9, 96.8), and no new safety concerns were identified. Feasibility questionnaires were completed by patients, and HHPs throughout the study. After each home instillation, patients rated their experience based on comfort, safety, communication, preference compared to office instillation, and overall satisfaction. At study end, they were also asked whether they would recommend home instillation of ZUSDURI to other patients and as an alternative to undergoing TURBT. Investigators assessed the clinical comparability of home versus in-office administration. HHPs provided feedback after each visit and at the study’s conclusion, reporting on their comfort with the procedure, perceived difficulty, and adequacy of training and support.

"This patient-centered approach to care reflects our commitment to redefining how urologic cancers are treated, offering patients access to effective and convenient treatment options," said Mark Schoenberg, MD, Chief Medical Officer, UroGen. "The ability to potentially administer ZUSDURI safely in the home represents a meaningful advancement for patients and caregivers alike, especially those who may face challenges traveling to frequent clinic visits."

In this study, ZUSDURI was administered via urinary catheter once weekly for six weeks, with the first dose administered in the clinic, followed by five at-home instillations by HHPs. Investigators found no meaningful differences between home and office instillation for most patients. The safety profile was consistent with previous studies, with most adverse events being mild-to-moderate urinary symptoms.

Study limitations include, among others, the small sample size of eight patients, and the open-label and single-arm design.

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 in an out-patient procedure by a trained healthcare professional using a urinary catheter to enable the treatment of tumors by non-surgical means. Patients can visit ZUSDURI.com for more information.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include TURBT as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.

On July 28, 2025 Zetagen Therapeutics, Inc., a private, clinical stage, biopharmaceutical company focused on developing breakthrough therapies, via intratumorally administration, for primary and metastatic breast cancers, reported they have successfully secured the foundational Composition-of-Matter patents and claims from the USPTO for their proprietary breast cancer platform (Press release, Zetagen Therapeutics, JUL 28, 2025, View Source [SID1234654576]).

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"Securing these allowances and composition-of-matter patents for our intratumorally administered breast cancer therapeutics represents a strategic leap forward in our mission to redefine oncologic care," said Joe C. Loy, CEO of Zetagen Therapeutics. "This latest patent protects the molecular uniqueness of our drug ZetaPrime and affirms the disruptive potential in our pursuit to minimize off target side effects of conventional chemotherapeutics. We are proud to advance precision therapies designed to target tumors directly and deliver meaningful hope to patients with limited options."

Zetagen Therapeutics has built a robust intellectual property portfolio anchored in its groundbreaking discoveries in intratumorally drug administration for both primary and metastatic breast cancer. The company’s IP estate—which now includes multiple composition-of-matter patents—focuses on proprietary and established molecules designed to be delivered directly into tumors, reducing systemic toxicity and off-target side effects. This precision method not only protects healthy tissue but also holds the potential to significantly improve survival outcomes by enhancing therapeutic efficacy at the site of disease. Zetagen’ s growing suite of patents underscores its commitment to redefining standards of care and advancing targeted oncology innovation.

"Receiving multiple composition-of-matter patents for our breast oncology candidates is a transformative milestone for our scientific and clinical mission," said Bryan S. Margulies, Ph.D., CSO of Zetagen Therapeutics. "By securing these patents, we validate the unique molecular design of our compounds and strengthen our pursuit of transformative therapies for underserved patient populations."

Zetagen has enlisted Foley & Lardner LLP as its intellectual property counsel and maintains a collaborative professional relationship with Steve Maebius, Esq. Foley & Lardner LLP is a prominent law firm with global reach and specialized expertise in Life Sciences intellectual property and strategic counsel.

About ZetaMet (Zeta-BC-003) – Lead Drug Candidate:
ZetaMet is a groundbreaking molecular pathway drug, targets metastatic breast cancer in bone, ceasing lytic activity, inhibits pain, and regenerates new bone all via locoregional administration, 30-minute outpatient procedure, without systemic limitation, minimizing skeletal related events (SRE) while increasing survival rates.

ZetaMet has been awarded 2x FDA Breakthrough Designations and has been approved in the treatment of 8x Compassionate Use stage 4 cancer patients in the US and Canada. ZetaMet has demonstrated cross-species efficacy at consistent concentrations, with findings published in several peer-reviewed journals—underscoring its translational promise from lab to clinic. Notably, these individuals had previously failed to respond to standard treatments such as chemotherapy, surgery, and radiation.

Zetagen has successfully completed enrollment of phase 2a clinical trial for the treatment of metastatic breast cancer to the spine, University of British Columbia, preliminary results available upon request and full study results anticipated November 2025.

About ZetaMast (Zeta-MBC-005)
ZetaMast is a proprietarydrug-eluting hydrogel carrier designed for locoregional administration, controlled releaseof small molecules in treatment of multifocal, unresectable, liver metastases from breast cancer with potential to increase survival rates.

Zetagen has completed preclinical studies, drug elution refinement, toxicity testing and a dose optimization study, results published in peer-review journal PLOS-One.

Zetagen plans to file an IND with the FDA this fall and upon approval conduct a Phase 1b dose escalation study early 2026.

About ZetaPrime (Zeta-PBC-007)
ZetaPrime is a neo-adjuvant treatment for primary HR+ breast cancer, engineered for a locoregional administration following diagnosis. Utilizing a proprietary hydrogel-like lipid carrier, formulation enables controlled release of two small molecules— one being our novel molecular entity, and the ability to deliver other companies CDK4 or CDK4/6 protein inhibitor and any anticancer therapeutic. Designed for solubility within adipose tissue, approach targets primary breast cancer, aiming to mitigate off-target effects, reduce necessity for lumpectomies and mastectomies, postpone radiation exposure, and enhance patient survival.

On July 28, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported it will jointly present a poster on updated data from the Phase I part of the Phase I/IIa study of BT-001 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting (Press release, Transgene, JUL 28, 2025, View Source [SID1234654577]). ESMO (Free ESMO Whitepaper) will take place in Berlin, Germany, from October 17 to 21, 2025.

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Poster details

Title: "Updated clinical results of BT-001, an oncolytic virus expressing an anti-CTLA4 mAb, administered in combination with pembrolizumab in patients with advanced solid tumors."

Abstract number: 2828

Authors: C. Lebbe, R. Bahleda, E. Ezine, B. Baroudjian, M. Sakkal, E. Rowinski, A. Vinceneux, S. Champiat, K. Bidet Huang, N. Stojkowitz, H. Makhloufi, A. Sadoun, A. Ropenga, M. Semmrich, A. McAllister, M. Chisamore, P. Cassier

The abstract will be available on ESMO (Free ESMO Whitepaper)’s website on October 13, 2025, at 00:05 CEST.

BT-001 is an oncolytic virus generated using Transgene’s Invir.IO platform and its patented large-capacity VVcopTK-RR- oncolytic virus, which has been engineered to encode both a Treg-depleting recombinant human anti-CTLA-4 antibody generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms, and the human GM-CSF cytokine. BT-001 is being co-developed as part of a 50/50 collaboration on oncolytic viruses between Transgene and BioInvent. In the Phase I part of this study, as monotherapy and in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), BT-001 has been shown to be well tolerated. BT-001 also showed the first signs of efficacy with clinical response in two out of six refractory patients, thirteen patients evaluated in total, when given in combination with pembrolizumab, with shrinkage of injected and non-injected lesions. Treatment with BT-001 converted "cold" tumors into "hot" ones, and induced T-cell infiltration, as well as PD(L)-1 expression in the tumor microenvironment (See press release from September 14, 2024 here).

The ongoing Phase I/IIa study (NCT04725331) is a multicenter, open label, dose-escalation study evaluating BT-001 as a single agent and in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab). The last patient in the Phase I part was enrolled in August 2024.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On July 28, 2025 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported that it has secured a €37.5 million, 4-tranche financing from the European Investment Bank (EIB) (Press release, MaaT Pharma, JUL 28, 2025, View Source [SID1234654558]). The financing will support the advancement of its late-stage hemato-oncology clinical programs including the lead-asset Xervyteg, recently partnered with Clinigen in Europe, and currently under regulatory review by the European Medicines Agency (EMA) for the treatment of acute Graft-versus-Host Disease (aGvHD) and the second drug candidate, MaaT033, currently being evaluated in a Phase 2b randomized controlled trial in improving survival for patients receiving allogeneic stem cell transplants.

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With robust cGMP manufacturing, proprietary therapies, and a development platform, MaaT Pharma is a global leader in microbiome-based oncology, pioneering full-ecosystem therapies to improve survival in oncology. Since completing enrollment in the ARES trial for Xervyteg (MaaT013) in October 2024, MaaT Pharma has steadily advanced its roadmap, reporting topline results in January 2025, submitting the Marketing Authorization Application with the European Medicines Agency in June 2025, and signing an exclusive agreement for marketing and distribution in Europe with Clinigen in July 2025.

The €37.5 million financing from the EIB follows a rigorous due diligence process by the EIB and further confirms MaaT Pharma’s innovation, strategic vision and operational maturity. This funding is part of a global financial strategy to support the Company’s development that combines various non-dilutive and dilutive sources to best preserve shareholder value.

Eric Soyer, Chief Financial Officer, MaaT Pharma, said: "We are grateful for the confidence shown in MaaT Pharma and the support from the EIB, which is a further foundation towards the next phase of MaaT Pharma’s growth on bringing the potential first microbiome-based therapy to market in Europe. Each operational and financing step strengthens our track record. Following the regulatory submission to the EMA for Xervyteg(MaaT013) and our recent partnership with Clinigen for its commercialization, the EIB financing represents another step in reinforcing the Company’s financial position. As previously announced, MaaT Pharma intends to fund its plans and development programs while preserving shareholder value in the best manner possible with a mix of non-dilutive and dilutive financial sources, and the recent announcements of both partnership financing with the Clinigen agreement and debt financing with the EIB agreement, are benchmarks to reflect that strategy."

Summary of the main terms and conditions of the Loan and Warrants

The loan would be available in four (4) tranches, respectively of €3.5 million for Tranche A, €6.0 million for Tranche B, €8.0 million for Tranche C, and €20.0 million for Tranche D, each tranche with Warrants attached. Disbursement of Tranches 2 to 4 are subject to operational and financing conditions. All Tranches are redeemable after a grace period of 4 years from the date of drawing, with reimbursement over a period of 2 years (Tranche A, B and C, i.e. a maturity of 6 years) to 4 years (Tranche D, i.e. a maturity of 8 years). Each tranche will bear interests at 7%, it being provided that some interests will be deferred and paid at maturity and for Tranche C and Tranche D part of the interest will be paid quarterly.

MaaT Pharma will issue warrants to the benefit of EIB at the time of (and subject to) disbursement of each tranche in a number depending, for each relevant tranche, on the amount of the relevant tranche and the average price per share paid by investors in the context of equity injection made prior to disbursement of the relevant tranche (except for tranche A where the average price per share over the last trading days preceding the date of execution of the financing agreement). Each warrant will give right to subscribe to one share at a price per warrant equal to 99% of the average price over a period of 5 trading days preceding the issuance of each Warrant. The Warrants may be exercised at any time following maturity of Tranche A. The Warrants will have a 20-year term.

EIB and MaaT Pharma have also agreed on (i) a put option to the benefit of EIB under which MaaT Pharma undertook to acquire from EIB all or part of the Warrants upon occurrence of certain events and (ii) a call option to the benefit of MaaT Pharma under which EIB undertook to sell all its Warrants, upon occurrence of a public tender offer over the securities issued by MaaT Pharma.

The Warrants are not transferable, except to affiliates of EIB or except in case of occurrence of certain events (including maturity date of Tranche D). In case of transfer of Warrants to third party, MaaT Pharma shall benefit from a preemptive right to acquire the Warrants first.

MaaT Pharma was assisted in this transaction by Mr. Eric Briole and by Van Lanschot Kempen as Financial Advisors and McDermott Will & Emery as Legal Advisor.