On September 25, 2025 Biostar Pharma, Inc., the US wholly-owned subsidiary of Beijing Biostar Biopharmaceutical Co., Ltd. ("Biostar," stock code: 2563.HK) which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, reported that its core pipeline product Utidelone has once again been granted as Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA), for the treatment of pancreatic cancer (Press release, Biostar, SEP 25, 2025, View Source [SID1234656246]). This marks the third ODD granted to Utidelone by the FDA, following prior designations for breast cancer brain metastases and gastric cancer.

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Pancreatic cancer is a highly malignant tumor known as the "king of cancers" due to its insidious early symptoms, difficulty in diagnosis, rapid progression, strong invasiveness, and poor prognosis. The five-year survival rate is only approximately 10%, far lower than that of other common cancers, making it the lowest among all malignant tumors. Currently, there is no clearly effective treatment for pancreatic cancer. Combination regimens based on gemcitabine remain the main clinical treatment, but due to the high tendency of pancreatic cancer cells to develop resistance to gemcitabine, treatment outcomes are often unsatisfactory.

The potential of Utidelone in treating pancreatic cancer has been well validated in both non-clinical and clinical studies. Preclinical data show that Utidelone can significantly inhibit the proliferation and colony-forming ability of pancreatic cancer cells and exhibits strong anti-tumor activity in pancreatic cancer models. When combined with gemcitabine, Utidelone markedly reduces the IC50 value of gemcitabine without compromising its anti-tumor effect, and the combination demonstrates stronger anti-tumor activity compared with the traditional paclitaxel plus gemcitabine regimen. At the 2024 CSCO Annual Meeting, Biostar presented preliminary results from a multicenter, single-arm Phase II clinical study evaluating Utidelone combined with gemcitabine as first-line treatment for unresectable advanced pancreatic cancer. As of the report date, 20 advanced pancreatic cancer patients which were unresectable and ineligible for local treatment had been enrolled, with 11 completing their first efficacy evaluation. Among them, 3 patients achieved partial response (PR), and 5 achieved stable disease (SD); the objective response rate (ORR) was 27.27%, while the disease control rate (DCR) reached 72.72%. The median overall survival (mOS) was 9.57 months.

About Orphan Drug

An orphan drug is used to treat a rare disease that affects fewer than 200,000 patients in the US. Orphan drug development presents several major challenges including difficulties in patient recruitment, small market size and low return for the pharmaceutical companies. To encourage drug development for the benefit of rare disease patients, an ODD granted by the FDA provides many incentives such as tax relief on clinical trial costs, opportunity to apply for grants to support clinical trials, waiver of new drug application fee, acceleration for regulatory pathway, and the potential to receive 7 years of marketing exclusivity in the US market upon product approval.

About Utidelone

Utidelone is a new-generation genetically engineered microtubule inhibitor, and has similar mechanism of action with that of taxanes while demonstrating multiple advantages, including better anti-tumor activity, broader anti-tumor spectrum, better safety profile with very low hematologic toxicity, effective against multidrug-resistant tumors, less prone to developing drug resistance, capability of crossing the blood-brain barrier to prevent and treat brain tumors, and high oral bioavailability. Biostar has developed two formulations of Utidelone: injection (UTD1) and capsule (UTD2). UTD1 has been launched in China in 2021 for the treatment of metastatic breast cancer (MBC), who have progressed after at least one anthracycline- or taxane-containing chemotherapy regimen. The phase III study data showed that UTD1 plus capecitabine achieved both PFS and OS benefits versus capecitabine for heavily pretreated MBC patients, and the results were orally presented twice at ASCO (Free ASCO Whitepaper) annual meetings and published in prestigious journals.

On September 25, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that the Japan Patent Office has issued a patent covering the Company’s proprietary use of Ampligen (Rintatolimod) in combination with checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) for the treatment of cancer (Press release, AIM ImmunoTech, SEP 25, 2025, View Source [SID1234656229]).

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"We remain committed to strengthening our global intellectual property protection for Ampligen as we continue to advance its clinical development. This Japan patent – which does not expire until December 20, 2039 – further strengthens our intellectual property portfolio in one of the world’s largest oncology markets and enhances exclusivity around combination therapies that address high-need cancer indications. Importantly, this patent further reinforces our ability to advance our clinical pipeline, secure strategic collaborations, and capture value in the growing global immuno-oncology sector. The scope of this patent enhances the value for any future strategic oncology transactions," AIM ImmunoTech CEO Thomas K. Equels stated.

The allowed claims in Japan cover an agent for treating cancer consisting of Ampligen in combination with a checkpoint inhibitor. The claims are broad, encompassing multiple cancer types, including pancreatic cancer, skin cancer, colorectal cancer, ovarian cancer, melanoma, breast cancer/triple negative breast cancer, head and neck tumors, bladder cancer, renal cell carcinoma, and lung cancer. The claims also capture specific dosing regimens, administration routes, and synergistic therapeutic effects observed when Ampligen is combined with checkpoint inhibitors.

AIM also holds a U.S. patent (expires August 9, 2039) for methods involving use of Ampligen as part of a combination oncology therapy when paired with an anti-PD-L1 antibody and a patent in the Netherlands (expires December 19, 2039) for the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors, such as Keytruda (pembrolizumab), Opdivo (nivolumab) and Imfinzi (durvalumab).

The combination of these compounds is designed to work synergistically to enhance the effectiveness of the treatment. AIM believes this novel approach could revolutionize the treatment landscape for cancers that have historically been challenging to treat, such as pancreatic cancer and advanced recurrent ovarian cancer. In fact, in collaboration with AstraZeneca, Ampligen is in a Phase 2 clinical trial combined with AstraZeneca’s durvalumab (an anti-PD-L1) for the treatment of metastatic pancreatic cancer. AIM recently released a DURIPANC Mid-Year Interim Clinical Progress Update showing promising signs of superior Progression-Free Survival and Overall Survival, as well as no significant toxicity.

Similarly, a Phase 2 study in collaboration with Merck Sharp & Dohme LLC in advanced recurrent ovarian cancer combing Ampligen with Keytruda has been completed and we expect the final data report within the next two months.

On September 25, 2025 Jacobio Pharmaceuticals (1167.HK) reported that its Chairman and Chief Executive Officer, Dr. Yinxiang Wang, together with concerted parties, have recently increased their shareholding in the Company by 11.06 million shares, representing a total investment of approximately HK$96.34 million (Press release, Jacobio Pharmaceuticals, SEP 25, 2025, View Source [SID1234656247]). This action underscores their strong confidence in the Company’s long-term growth prospects.

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In addition, the Company’s share repurchase plan with an upper limit of HK$100 million, which was approved by the Board in July 2025, has already led to the repurchase of 326,400 shares, with a cumulative payment of HK$2.67 million. The Company will continue to implement the repurchase plan based on market conditions.

In the interim results for 2025 released earlier, Jacobio reported multiple encouraging R&D achievements. The Company continues to focus on two major R&D pillars – KRAS and iADC – with core programs making steady progress, further demonstrating Jacobio’s competitiveness and growth potential in the global biopharmaceutical sector.

Within the KRAS pathway, Jacobio has established a comprehensive development strategy. In May 2025, the Company’s KRAS G12C inhibitor, Glecirasib, was approved by the National Medical Products Administration (NMPA) for second-line monotherapy in KRAS G12C mutant non-small cell lung cancer (NSCLC) and successfully launched in China. This milestone not only marked Jacobio’s first commercial entry into the Chinese market but also triggered a milestone payment of RMB 50 million from its partner Allist. At the same time, Glecirasib is being evaluated in combination with the SHP2 inhibitor sitneprotafib for first-line NSCLC.

Beyond its marketed product, Jacobio’s pan-KRAS inhibitor JAB-23E73 has shown important progress. In the dose-escalation phase of its Phase I clinical trial, multiple confirmed partial responses (PRs) have been observed, with favorable safety and pharmacokinetic (PK) profiles consistent with expectations. Full Phase I data are expected to be released in the first half of 2026, which will mark a critical milestone for the global pan-KRAS landscape. Meanwhile, the Company is actively advancing next-generation KRAS inhibitors. The EGFR-KRAS G12D tADC project, which utilizes EGFR as the targeting antibody and KRAS G12D as the payload to enable precise and efficient treatment, is expected to submit an IND application in the second half of 2026.

In its other R&D pillar, iADC, Jacobio also maintains a leading position. The Company is developing JAB-BX467, a HER2-STING iADC candidate. By using a STING agonist as the payload, this innovative program is designed to convert "cold tumors" into "hot tumors," offering a novel treatment option for solid tumors where PD-1 monotherapy has limited efficacy. The program is currently at the preclinical stage, with IND submission planned for the second half of 2026.

As an innovation-driven biotechnology company, Jacobio is already positioned among the global leaders in KRAS and iADC research, with a clear development roadmap and significant commercial potential. The Company believes that its current share price does not fully reflect the value of its pipeline or its long-term growth potential. The decision by the Chairman and concerted parties to increase their shareholding by nearly HK$100 million not only demonstrates the strong alignment of interests between management and shareholders but also underscores their unwavering confidence in the Company’s long-term value creation.

On September 25, 2025 Verismo Therapeutics, a clinical-stage CAR T company developing a novel KIR-CAR platform technology, reported the successful manufacture of its first clinical cell product using lentiviral vector supplied by Miltenyi Bioindustry, a dedicated CDMO division of Miltenyi Biotec (Press release, Verismo Therapeutics, SEP 25, 2025, View Source [SID1234656248]). The batch was produced for STAR-101, a Phase 1 clinical trial evaluating Verismo’s lead pipeline SynKIR-110 targeting mesothelin. This marks a major milestone in the clinical trial and lays the groundwork for later-stage development of SynKIR-110 for the treatment of solid tumors.

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This collaboration ensures a reliable supply chain and is an important step in preparation for Phase 2 and beyond, including use in commercial applications. Miltenyi Bioindustry is a leader in translating gene-edited cell therapy products into the clinic, including design, construction, and production of lentiviral vectors, from research through GMP manufacturing.

"Our collaboration with Miltenyi Bioindustry plays a key role as we scale our programs," said Dr. Bryan Kim, CEO of Verismo Therapeutics. "This partnership reflects Verismo’s commitment to ensuring manufacturing continuity and Phase 2 clinical readiness."

Stefan Miltenyi, founder and CEO at Miltenyi Biotec, added: "We’re proud to continue supporting Verismo’s efforts with our viral vector platform. Their work in next-generation CAR T therapies reflects the innovation we strive to enable."

On September 25, 2025 Celyad Oncology (Euronext: CYAD) (the "Company"), reported its financial results for the first half year 2025 ended June 30, 2025 (Press release, Celyad, SEP 25, 2025, View Source [SID1234656232]).

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First Half 2025 financial review

As of June 30, 2025, the Company’s Treasury position amounted to €0.8 million.

After due consideration of detailed budgets and estimated cash flow forecasts for the years 2025 and 2026, the Company projects that its existing cash and cash equivalents will be sufficient to fund its estimated operating and capital expenditures into the fourth quarter of 2025.

Key financial figures for first half 2025, compared with the first half of 2024 and full year 2024, are summarized below:

Selected key financial figures (€ millions) Half Year 30 June 2025 Half Year 30 June 2024 Full Year 31 December 2024
Revenue – – 0.2
Research and development expenses (2.1) (1.5) (3.2)
General and administrative expenses (1.7) (1.7) (3.2)
Other income/(expenses) 0.1 0.2 0.4
Operating loss (3.7) (3.1) (5.9)
Loss for the period/year (3.7) (3.0) (5.9)
Net cash used in operations (3.3) (2.8) (5.7)
Cash and cash equivalents 0.8 6.2 4.2

Research and Development (R&D) expenses were €2.1 million in June 2025 as compared to €1.5 million during the same period in 2024, an increase of €0.6 million. The increase in the Company’s R&D expenses was primarily driven by the increase of the IP costs related to the licensing activities as well as the increase of the expenses linked to the redevelopment of the catheter.

General and Administrative (G&A) expenses remained stable with €1.7 million in June 2025 as in June 2024.

Net loss for the first half of 2025, was €3.7 million, or €(0.09) per share, compared to a net loss of €3.0 million, or €(0.07) per share, for the same period in 2024.

Net cash used in operations was €3.3 million for the first half of 2025 compared to €2.8 million for the first half of 2024. The increase of €0.5 million was primarily driven by the global increase of IP activities and catheter development costs.

As of June 30, 2025, the Company had cash and cash equivalents of €0.8 million. No capital increase occurred in the first half of 2025. The total number of basic shares outstanding was 41.4 million like in December 31, 2024.

The interim financial report for first half 2025 of the Company can be found on our website: View Source