On August 20, 2025 Circle Pharma, Inc., a clinical-stage biopharmaceutical company pioneering next-generation targeted macrocycle therapeutics for difficult-to-treat cancers, reported a Nature publication describing robust pre-clinical tumor suppression and novel mechanistic insights from inhibiting the binding of certain protein substrates (that bind via RxL motifs) to cyclins A and B in E2F-high tumor cells (Press release, Circle Pharma, AUG 20, 2025, View Source [SID1234655399]). Circle Pharma’s oral cyclin A/B RxL inhibitor, CID-078, is a first-in-class, orally bioavailable macrocycle with dual cyclin A and B RxL inhibitory activity that is being evaluated in a Phase 1 clinical trial for patients with advanced solid tumors.

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Cyclins (including cyclins A and B) are a family of proteins that function as master regulators of the cell cycle by binding to and activating their catalytic partners, the cyclin-dependent kinases (CDKs). Cancers driven by high E2F activity, such as small cell lung cancer (SCLC) and other tumors with RB1 alterations, have an overactive cell cycle that leads to uncontrolled tumor cell proliferation. In preclinical models, cyclin A/B RxL inhibitors:

Blocked the cyclin A-E2F interaction, triggering aberrant sustained E2F activity, DNA damage, and replication stress.
Subsequently disrupted the cyclin B-Myt1 interaction, removing a critical safety brake and forcing damaged tumor cells through division, causing tumor cell death.
Produced robust anti-tumor activity, including in chemotherapy-resistant SCLC patient-derived xenograft models.
The publication, which was co-authored by scientists from Circle Pharma and the Dana-Farber Cancer Institute, Harvard Medical School, the University of Texas Southwestern Medical Center, and the University of Oxford, can be accessed here (doi: 10.1038/s41586-025-09433-w).

"We are excited to have the novel biology and compelling anti-cancer effects of the cyclin A/B RxL inhibitors developed at Circle recognized within the broader scientific community through this publication in Nature," said David J. Earp, J.D., Ph.D., president and chief executive officer of Circle Pharma. "This work underscores the capabilities of our MXMO platform to generate oral, cell-permeable macrocycle therapies, such as CID-078, including for historically undruggable targets such as cyclins. With our first-in-human Phase 1 study of CID-078 well underway, we are eager to see the innovative research outlined in this publication translate into new, high-impact therapeutic options for people living with cancer."

"These findings build upon previous work and reveal additional gain-of-function mechanisms through which cyclin A/B RxL inhibition triggers apoptosis in cancer cells, further supporting this approach for E2F-driven cancers, such as cancers with RB1 alterations, which includes nearly all SCLCs, up to half of triple-negative breast cancers, and subsets of other solid tumors," said Matthew G. Oser, M.D., Ph.D., senior author of the publication and associate professor of medicine at Dana-Farber Cancer Institute and Harvard Medical School. "Circle Pharma’s cell-permeable, oral macrocycles are designed to overcome the limitations of other therapeutic modalities and are ideally positioned to access cyclins and other historically undruggable targets, offering exciting potential for patients with cancer."

About CID-078, Circle Pharma’s Oral Cyclin A/B RxL Inhibitor Program

CID-078 is an orally bioavailable macrocycle with dual activity blocking protein-protein interactions between both cyclins A and B and key substrates that bind to them via conserved RxL motifs. CID-078 selectively targets tumor cells with oncogenic alterations that cause cell cycle dysregulation, including alterations in the tumor suppressor RB1. In pre-clinical studies, Circle Pharma’s cyclin A/B RxL inhibitors have been shown to potently and selectively disrupt the protein-to-protein interaction between cyclins A and B and their key substrates and modulators, including E2F (a substrate of cyclin A) and MYT1 (a modulator of cyclin B). Preclinical studies have demonstrated the ability of these cyclin A/B RxL inhibitors to cause single-agent tumor regressions in multiple in vivo models. A multi-center Phase 1 clinical trial (NCT06577987) is currently enrolling patients with advanced solid tumors harboring RB1 alterations.

On August 20, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the Chinese National Intellectual Property Administration (CNIPA) has issued a Notice of Allowance for a new patent related to its breast cancer vaccine technology (Press release, Anixa Biosciences, AUG 20, 2025, https://ir.anixa.com/news/detail/1094/anixa-biosciences-receives-notice-of-allowance-from-chinese-national-intellectual-property-administration-for-patent-covering-breast-cancer-vaccine-technology [SID1234655398]). This patent, exclusively licensed from Cleveland Clinic, will provide composition of matter protection for the Company’s novel approach to breast cancer treatment and prevention in China.

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With this allowance, Anixa continues to expand the international scope of its intellectual property portfolio, reinforcing its leadership in the field of cancer immunotherapy. The Chinese patent complements patents issued in the United States and other key global jurisdictions, and represents an important step toward future regulatory and commercial efforts outside the U.S.

"This newly allowed patent further illustrates the continued recognition of the novelty and potential of our breast cancer vaccine," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "As we continue advancing clinical development in the U.S., this allowance further strengthens our ability to pursue strategic global opportunities in regions with a high burden of breast cancer."

Breast cancer has become the most commonly diagnosed cancer among women in China, with incidence rising steadily over the past two decades and hundreds of thousands of new cases each year. As one of the world’s largest and fastest-growing patient populations, addressing this challenge is a critical public health priority, requiring innovative preventative solutions such as Anixa’s vaccine.

Anixa’s vaccine is based on immunizing against human α-lactalbumin, a protein associated with lactation that is aberrantly expressed in certain types of breast cancer. This "retired" protein strategy, developed at Cleveland Clinic and licensed exclusively to Anixa, aims to selectively prime the immune system to prevent tumor formation while avoiding harm to normal tissue.

By reinforcing its global patent estate, Anixa is laying the groundwork for future international development and commercialization strategies. The Company’s broader vaccine platform also targets other high-incidence cancers and is designed to transform how the medical community approaches cancer prevention.

On August 20, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported key highlights from its R&D event held on 19 August 2025 (Press release, Alligator Bioscience, AUG 20, 2025, View Source [SID1234655397]). The event featured presentations from Alligator’s management and scientific leadership, outlining Alligator’s clinical progress, upcoming milestones, and strategic outlook.

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Key takeaways from the event include:

Mitazalimab – Phase 3 readiness: Long-term follow-up data continue to demonstrate encouraging overall survival in metastatic pancreatic cancer, supporting the confirmed regulatory path and planned initiation of a Phase 3 trial.
Scientific insights: New translational biomarker data further expand and strengthen the rationale for mitazalimab in pancreatic cancer and other solid tumors, underscored by myeloid and T-cell activation and their correlation with improved clinical outcomes.
Trial completion and CMC status: The final, 30-month, data read-out from OPTIMIZE-1 is expected during Q3 2025. The trial will thereafter be finalized, with mitazalimab being provided to patients still on treatment, and sites with ongoing patients remain open under limited, risk-based monitoring; manufacturing of Phase 3 material has been successfully completed.
Investigator-initiated trials (IITs): Based on the significant investigator interest Alligator is engaged in a number of externally funded exploratory and Phase 2 clinical trials with mitazalimab across pancreatic, gastrointestinal and other solid tumors to expand mitazalimab’s future clinical use. Individual trials are expected to start during H2 2025 and the first half of 2026.
Pipeline updates: The HER2 antibody HLX22 (developed by Chinese Henlius) has entered a global Phase 3 trial in gastric cancers. Alligator expects to receive the next development milestone within 6–12 months, and estimates that its share of the future royalties will amount to SEK 150–400 million annually.
Strategic outlook: With a reduced burn-rate, Alligator is well positioned to advance mitazalimab into registrational trials together with a partner, and in parallel explore additional development options for the asset. Together mitazalimab and HLX22 represent a significant financial upside for Alligator. Other pipeline assets and technologies represent additional future development and income opportunities.

On August 20, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported the completion of patient enrollment of SANOVO, a China Phase III study of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) as a first-line treatment in certain non-small cell lung cancer ("NSCLC") patients whose tumors harbor epidermal growth factor receptor ("EGFR") mutation and MET overexpression (Press release, Hutchison China MediTech, AUG 20, 2025, https://www.hutch-med.com/sanovo-phiii-enrollment-completion/ [SID1234655371]). The last patient was enrolled on August 18, 2025.

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This Phase III trial is a blinded, randomized, controlled study in previously untreated patients with locally advanced or metastatic NSCLC with activating EGFR mutations and MET overexpression. The study will evaluate the efficacy and safety of TAGRISSO in combination with ORPATHYS comparing to TAGRISSO alone, a standard-of-care treatment option for these patients. The primary endpoint of the study is progression free survival ("PFS") as assessed by investigators. Other endpoints include PFS assessed by an independent review committee, overall survival (OS), objective response rate ("ORR"), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety. Additional details may be found at clinicaltrials.gov, using identifier NCT05009836.

Topline results from the SANOVO study are estimated to be reported in the second half of 2026, followed by submission of results for presentation at an appropriate medical congress. If favorable, the results would enable a supplementary New Drug Application submission to China’s National Medical Products Administration ("NMPA").

ORPATHYS is an oral, potent and highly selective MET tyrosine kinase inhibitor ("TKI") being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. TAGRISSO is a third-generation, irreversible EGFR TKI.

About NSCLC and MET aberrations
Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths.[1] Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.[2] The majority of NSCLC patients (approximately 75%) are diagnosed with advanced disease, and approximately 10-15% of NSCLC patients in the US and Europe and up to 40-50% of patients in Asia have EGFR-mutated ("EGFRm") NSCLC.[3],[4],[5],[6],[7]

MET is a tyrosine kinase receptor that has an essential role in normal cell development. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is one of the mechanisms of de novo or acquired resistance to EGFR TKI for metastatic EGFRm NSCLC.[8],[9]

About ORPATHYS
ORPATHYS (savolitinib) is an oral, potent and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

ORPATHYS is approved in China and is marketed by AstraZeneca for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. ORPATHYS is also approved in China for the treatment of patients with locally advanced or metastatic EGFRm-positive non-squamous NSCLC with MET amplification after disease progression on EGFR tyrosine kinase inhibitor therapy, in combination with TAGRISSO.

It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines.

About TAGRISSO
TAGRISSO (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. TAGRISSO (40mg and 80mg once-daily oral tablets) has been used to treat more than one million patients across its indications worldwide and AstraZeneca continues to explore TAGRISSO as a treatment for patients across multiple stages of EGFRm NSCLC.

There is an extensive body of evidence supporting the use of TAGRISSO in EGFRm NSCLC, and it is the only targeted therapy shown to improve patient outcomes across all stages of the disease.

In late-stage disease, TAGRISSO demonstrated improved outcomes as monotherapy in the FLAURA Phase III trial and in combination with chemotherapy in the FLAURA2 Phase III trial. TAGRISSO is also being investigated in this setting in combination with ORPATHYS (savolitinib) in the SAFFRON Phase III trial and in combination with DATROWAY (datopotamab deruxtecan or Dato-DXd) in the TROPION-Lung14 and TROPION-Lung15 Phase III trials.

TAGRISSO also showed improved outcomes in early-stage disease in the NeoADAURA and ADAURA Phase III trials and in locally advanced stages in the LAURA Phase III trial. As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, TAGRISSO is also being investigated in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.

About ORPATHYS and TAGRISSO Combination Development in EGFR-mutated NSCLC
Among patients who experience disease progression following treatment with a third-generation EGFR TKI, approximately 15-50% present with MET aberration, depending on the sample type, detection method and assay cut-off used. TAGRISSO is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. Treatment with ORPATHYS in combination with TAGRISSO has been studied extensively in these patients in the TATTON (NCT02143466) and SAVANNAH (NCT03778229) studies. The encouraging results led to the initiation of several Phase III trials in this setting including the SACHI trial in China (NCT05015608) and the global SAFFRON trial (NCT05261399), as well as the SANOVO trial in China (NCT05009836).

This combination represents a promising chemotherapy-free oral treatment strategy to address mechanisms of resistance in this advanced setting. Positive data from the SACHI randomized Phase III trial led to the filing of a third NDA in China. Strong data from the SAVANNAH single-arm Phase II study was recently presented at the European Lung Cancer Congress (ELCC) in March 2025 demonstrated high, clinically meaningful and durable ORR, with consistent safety results. The SAFFRON randomized Phase III trial is progressing. Following AstraZeneca’s consultation with the US Food and Drug Administration ("FDA"), we look forward to completing the SAFFRON trial as soon as possible to support potential US and other global registration filings.

SACHI: The SACHI China Phase III study evaluated the combination of ORPATHYS and TAGRISSO for the treatment of patients with EGFRm, MET-amplified locally advanced or metastatic NSCLC after progression on EGFR TKI compared to platinum-based doublet chemotherapy. Results were presented at the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2025. Based on the data from the SACHI study, the combination of ORPATHYS and TAGRISSO received approval from the China NMPA for the treatment of patients with locally advanced or metastatic EGFR mutation-positive non-squamous NSCLC with MET amplification after disease progression on EGFR TKI therapy in June 2025.

SAFFRON: In 2023, ORPATHYS and TAGRISSO received Fast Track Designation from the US FDA in this setting. The global SAFFRON Phase III trial is currently ongoing to assess the ORPATHYS plus TAGRISSO combination versus platinum-based doublet chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC following progression on treatment with TAGRISSO. Patients are being prospectively selected using the high MET level cut-off identified in SAVANNAH.

On August 19, 2025 WuXi Biologics (Cayman) Inc. ("WuXi Biologics" or "the Group", stock code: 2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO) service company offering end-to-end solutions for biologics discovery, development and manufacturing, reported its unaudited interim results for the first half of 2025 ("Reporting Period").

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Financial Highlights

Revenue: The Group’s revenue for the Reporting Period increased by 16.1% YoY to RMB9,953.2 million. The growth was primarily driven by: (i) the continued success of the Group’s "Follow and Win the Molecule" strategies, supported by its leading technology platforms, best-in-industry timelines and strong execution record; (ii) an expanded range of services offered across the biologics value chain – including discovery, pre-IND development, and clinical and commercial manufacturing – with notable momentum in fast-growing platforms such as antibody-drug conjugates (ADCs), and bi- & multi-specific antibodies; (iii) growth in research services revenue, underpinned by the Group’s cutting-edge technologies; and (iv) increased utilization of both existing and newly expanded capacity, including the ramp-up of the Group’s manufacturing facility in Europe.

Gross Profit and Gross Profit Margin: IFRS gross profit increased 27.0% YoY to RMB4,252.9 million, while adjusted gross profit rose 19.2% YoY to RMB4,543.4 million. IFRS gross profit margin reached 42.7%, with adjusted gross profit margin at 45.6%. The improvement in gross profit margin was primarily driven by favorable volume and mix, enhanced efficiency and process optimization achieved through the Group’s WBS and digitalization initiatives.

EBITDA and EBITDA Margin: EBITDA grew 50.5% to RMB4,221.8 million, while adjusted EBITDA increased 20.6% YoY to RMB4,305.2 million. EBITDA margin reached 42.4%, and adjusted EBITDA margin expanded to 43.3%.

Net Profit and Net Profit Attributable to Owners of the Company: IFRS net profit rose 54.8% YoY to RMB2,756.6 million, while net profit attributable to owners of the Company grew 56.0% to RMB2,339.3 million. This growth was primarily driven by higher gross profit, the gains from the Group’s investment and asset divestiture activities.

Adjusted Net Profit: Adjusted Net Profit for the period increased 11.6% YoY to RMB2,840.0 million, with an adjusted net profit margin of 28.5%.

Basic Earnings Per Share (EPS): Basic EPS rose 56.8% from RMB 0.37 for the six months ended June 30, 2024 to RMB 0.58 for the six months ended June 30, 2025. Diluted EPS increased by 57.1% from RMB 0.35 to RMB 0.55 over the same period.

(Press release, WuXi Biologics, AUG 19, 2025, View Source [SID1234661836])