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Month: September 2024

Investigational Rinatabart Sesutecan (Rina-S) Shows Promising Anti-Tumor Activity as Single Agent in Heavily Pretreated Patients with Ovarian and Endometrial Cancers in Phase 1/2 Clinical Trial

Media Release COPENHAGEN, Denmark; September 15, 2024Treatment with rinatabart sesutecan (Rina-S) showed encouraging response rate in heavily pretreated patients with ovarian cancer in dose expansion cohort Responses with Rina-S were observed across FRα expression levels Phase 3 trial will further evaluate the safety and efficacy of Rina-S at 120 mg/m2 in patients with advanced ovarian cancerGenmab A/S (Nasdaq: GMAB) announced today new data from the Phase 1/2 study of rinatabart sesutecan (Rina-S), an investigational folate receptor-alpha (FRα)-targeted, Topo1 antibody-drug conjugate (ADC), demonstrated a confirmed objective response rate (ORR) of 50.0% (95% CI) in ovarian cancer patients treated with Rina-S 120 mg/m2 once every 3 weeks (Q3W), regardless of FRα expression levels. These data were from the dose expansion part of a...

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Ipsen provides update on CONTACT-02 Phase III trial in metastatic castration-resistant prostate cancer following final overall survival analysis

Trial investigating Cabometyx® (cabozantinib) in combination with atezolizumab demonstrated a positive trend towards improvement for one of the primary endpoints of overall survival, but did not meet statistical significance Ipsen will not pursue regulatory submissions for the combination regimen in countries where we have commercialization rights (outside of the US and Japan) We remain confident in the proven profile of Cabometyx as a monotherapy and in combination with immunotherapy, across approved and potential future indicationsPARIS, FRANCE, 15 September 2024 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today detailed final overall survival (OS) data from the Phase III CONTACT-02 trial investigating the combination of Cabometyx® (cabozantinib) and atezolizumab in metastatic castration-resistant prostate cancer (mCRPC)....

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Lantheus Presents Results from the Primary Analysis of Phase 3 Pivotal SPLASH Trial in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer During ESMO Congress 2024

Study met its primary endpoint, demonstrating significant improvement in radiographic progression-free survival Overall Response Rate was 38.1% vs. 12.0% for the ARPI switch arm, including 9.3% Complete Responses Patients demonstrated statistically significant improvement in time to reduction of health-related quality of life (HRQoL) as measured by Functional Assessment of Cancer Therapy—Prostate (FACT-P) Interim Overall Survival Crossover Adjusted Hazard Ratio was

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23andMe Therapeutics Announces Phase 2 Results for Two Additional Cancer Cohorts and Correlative Biomarker Data from 23ME-00610 Study

23ME-00610 monotherapy demonstrates preliminary evidence of clinical benefit in clear-cell renal-cell carcinoma, with one confirmed partial response Higher tumor expression of CD200 and human genetics correlated with increased clinical benefit, suggesting potential value as patient selection biomarkers Greater response in “cold” tumors suggests opportunity in patients unable to benefit from PD-1/PD-L1 checkpoint inhibitors SUNNYVALE, Calif., Sept. 15, 2024 (GLOBE NEWSWIRE) — 23andMe Holding Co. (Nasdaq: ME) (“23andMe”), a leading human genetics and biopharmaceutical company, announced positive preliminary Phase 2 safety and efficacy data from its Phase 1/2a clinical trial covering two new patient cohorts from 23ME-00610 (’610), a first-in-class anti-CD200R1 antibody, at the European Society of Medical Oncology (ESMO) Congress 2024...

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23andMe Therapeutics Announces Positive In Vivo Results for 23ME-01473, a Dual-Mechanism ULBP6-Targeting Antibody Currently in a Phase 1 Trial

23ME-01473 inhibited tumor growth in a patient-derived xenograft mouse model of non-small cell lung cancer Elevated levels of soluble and tumor-bound ULBP6 confirmed in squamous cell carcinomas and a subset of adenocarcinomas, offering potential indications to assess clinical activity Phase 1 trial ongoing with first patient dosed in March 2024 SUNNYVALE, Calif., Sept. 15, 2024 (GLOBE NEWSWIRE) — 23andMe Holding Co. (Nasdaq: ME) (“23andMe”), a leading human genetics and biopharmaceutical company, announced nonclinical data supporting the anti-tumor activity of its first-in-class 23ME-01473 (’1473) antibody targeting the NKG2D ligand ULBP6 at the European Society of Medical Oncology (ESMO) Congress 2024 in Barcelona, September 13-17. In a poster presentation at the 2024 ESMO Congress, 23andMe Therapeutics presented new data showing...

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MacroGenics Announces Updated Efficacy & Safety Data from TAMARACK Phase 2 Study of Vobra Duo in mCRPC Patients at ESMO Congress 2024

Encouraging antitumor activity demonstrated with vobra duo as measured by 6-month landmark rPFS rate and ORR Patients remained on vobra duo through a median of 6 doses (ranging up to 12), representing an extension of treatment duration as compared to Phase 1 mCRPC dose expansion cohort Company expects to have mature median rPFS no later than early 2025 MacroGenics to host an investor call to review key data presented at ESMO and provide a general corporate update on Monday, September 16, 2024, at 8:00 a.m. ETROCKVILLE, MD, Sept. 15, 2024 (GLOBE NEWSWIRE) —  MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today presented updated efficacy and safety results from the TAMARACK Phase...

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MAX Power Mining Corp. Announces Results of Annual General and Special Meeting

VANCOUVER, British Columbia, Sept. 14, 2024 (GLOBE NEWSWIRE) — MAX Power Mining Corp. (CSE: MAXX; OTC: MAXXF; FRANKFURT: 89N) (“MAX Power” or the “Company”) announces the results of its annual general and special meeting (AGSM) of common shareholders held on September 13, 2024 in Burnaby, BC. Resolutions passed at the meeting included the appointment of D&H Group LLP as auditors for the ensuing year, approval of the Company’s stock option plan, approval of Company’s Advance Notice Policy and the re-election of Ravinder Mlait, Bryan Loree, William DeJong, and Thomas Clarke as directors. On behalf of the Board of Directors, Rav Mlait – CEOMAX Power Mining Corp.info@maxpowermining.comTel: 778-655-9266 Investor Relations:MarketSmart CommunicationsTel: 877-261-4466 Neither the Canadian Securities Exchange nor its Regulation...

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35/2024・Trifork Group AG – Reporting of transactions made by persons discharging managerial responsibilities and persons closely associated with them

Company announcement no. 35 / 2024 Schindellegi, Switzerland – 14 September 2024 Reporting of transactions made by persons discharging managerial responsibilities and persons closely associated with them Pursuant to the Market Abuse Regulation Article 19, Trifork Group AG (Swiss company registration number CHE-474.101.854) (“Trifork”) hereby notifies receipt of information of the following transactions made by a person or entity closely associated with a person discharging managerial responsibilities in Trifork.1. Details of the person discharging managerial responsibilities/person closely associateda) Name Blackbird II ApS2. Reason for the notificationa) Position/status Closely associated person to Jørn Larsen, CEO of Trifork Group AGb) Initial notification/ Amendment Initial notification3. Details of the issuer,...

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Medigene Presents Progress on KRAS Library and UniTope & TraCR Technology at ESMO 2024

Planegg/Martinsried, September 14, 2024. Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, presented updates for its T cell receptor (TCR) library targeting the Kirsten rat sarcoma viral oncogene homolog (KRAS) and also highlighted advancements of its UniTope and TraCR technology, which serves as a universal system for tagging and tracking recombinant TCRs (rTCRs) across multiple modalities, including T cell receptor engineered T cell (TCR-T) therapies, at the ESMO Congress 2024 taking place in Barcelona from September 13-17, 2024. The presented posters “Advancing a multi-dimension KRAS mutation-specific T cell receptor (TCR) library with a 3S TCR targeting the G12D mutation to address...

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Cullinan Therapeutics Presents Positive Updated Data from Module C of Zipalertinib Pivotal Phase 2b Study at ESMO 2024

Updated data show consistent objective response rate of 40% and manageable safety profile in patients with non-small cell lung cancer harboring epidermal growth factor receptor exon 20 insertion mutations treated with zipalertinib who progressed on or after prior amivantamab treatment Enrollment of pivotal Phase 2b trial complete ahead of schedule CAMBRIDGE, Mass., Sept. 14, 2024 (GLOBE NEWSWIRE) — Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today shared updated data in patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations receiving zipalertinib after prior treatment with amivantamab enrolled in Module C of its pivotal Phase 2b REZILIENT1 clinical trial. Findings...

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