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Day: September 14, 2024

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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Sutro Biopharma Announces Updated Data from Phase 1b Study of Luvelta in Combination with Bevacizumab at ESMO 2024

– 4.3 mg/kg of luveltamab tazevibulin (luvelta) in combination with standard dose of bevacizumab (15 mg/kg) every 3 weeks resulted in a 56% objective response rate in patients with late-stage ovarian cancer and was selected to be the recommended phase 2 dose (RP2D) – – Luvelta in combination with bevacizumab demonstrated encouraging preliminary antitumor activity (35% response rate) across all explored dose ranges – – Expansion at RP2D is ongoing with an additional 23 patients enrolled to date; expansion data are expected in the first half of 2025 – – No new safety signals were observed compared with either agent alone – SOUTH SAN FRANCISCO, Calif., Sept. 14, 2024 (GLOBE NEWSWIRE) — Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering...

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Immunocore presents Phase 1 data of brenetafusp, an ImmTAC bispecific targeting PRAME, in patients with ovarian cancer

Immunocore presents Phase 1 data of brenetafusp, an ImmTAC bispecific targeting PRAME, in patients with ovarian cancer Brenetafusp is clinically active as monotherapy and in combination with chemotherapy in heavily pre-treated, platinum-resistant ovarian cancer patients T cell fitness gene expression signature in blood is an important parameter of clinical activity for tebentafusp in uveal melanoma and for brenetafusp across different tumor types (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 14 September 2024) Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, today presented Phase...

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Avacta Reports Updated Phase 1 Clinical Data of AVA6000 at the European Society for Medical Oncology (ESMO) Congress Demonstrating Multiple Ongoing, Durable Responses in Solid Tumors

This announcement contains inside information for the purposes of Article 7 of the UK version of Regulation (EU) No 596/2014 which is part of UK law by virtue of the European Union (Withdrawal) Act 2018, as amended (“MAR”). Upon the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.                                                    14 September 2024 Avacta Group plc (“Avacta” or “the Group” or “the Company”) Avacta Reports Updated Phase 1 Clinical Data of AVA6000 at the European Society for Medical Oncology (ESMO) Congress Demonstrating Multiple Ongoing, Durable Responses in Solid Tumors AVA6000 is safe and well-tolerated in both study arms: every three weeks (Q3W) and every two weeks (Q2W) dosing, with an early lack of serious cardiac...

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Black Diamond Therapeutics Presents Real-World Treatment Practices and Patient Outcomes in Newly Diagnosed NSCLC Patients with Non-Classical Mutations at the European Society for Medical Oncology (ESMO) Congress 2024

Treatment data were analyzed from 3,276 cases of patients with newly diagnosed EGFR mutant NSCLC from Guardant Health Analyses of patients with non-classical EGFR mutations reveal that the majority receive frontline chemotherapy and the remainder are treated with osimertinib or afatinib Short time to treatment discontinuation ranging from four to eight months demonstrates clear unmet need for patients with non-classical EGFR mutant NSCLC CAMBRIDGE, Mass., Sept. 14, 2024 (GLOBE NEWSWIRE) — Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, today presented a poster analyzing real-world treatment outcomes for newly diagnosed non-small cell lung cancer (NSCLC) patients with non-classical EGFR mutations...

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Acrivon Therapeutics Reports Positive Endometrial Cancer Data from Ongoing ACR-368 Registrational Intent Phase 2 Study at ESMO, Advancement of ACR-2316 into Clinic Ahead of Timelines, and Progress on its AP3 Interactome for Proprietary Data Analysis

Confirmed overall response rate (ORR) = 62.5% (95% CI, 30.4-86.5) observed in prospectively-selected ACR-368 OncoSignature-positive (BM+) patients with endometrial cancerAchieved statistically significant segregation of responders in BM+ vs BM- subgroups based on OncoSignature patient selection (p-value = 0.009)ACR-368 endometrial cohort data maturing with all responders still on therapy; mDoR not yet reached (~6 months at time of data-cut)Endometrial cancer now anticipated to be the first tumor type with potential for ACR-368 accelerated regulatory approvalIND clearance and initial sites activated ahead of timelines for ACR-2316 with first-in-human dosing anticipated in Q4 2024AP3 Interactome generating proprietary, actionable insights, leveraging in-house data and delivering algorithm-based machine learning-enabled pathway...

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Transgene and BioInvent’s Oncolytic Virus BT-001 Shows Promising Antitumor Activity in Ongoing Phase I/IIa Trial in Solid Tumors that Failed Previous Treatments

Preliminary data presented at ESMO 2024 demonstrate that BT-001 induces tumor regression in patients who failed previous anti-PD(L)-1 treatment In a patient with a heavily pretreated leiomyosarcoma, BT-001 was able to modulate the tumor microenvironment, turning a “cold” tumor to “hot”, enhancing the potential of T cell infiltration and a shift to PD(L)-1 positivity Early signs of efficacy with clinical responses observed with BT-001 in combination with KEYTRUDA® (pembrolizumab), in 2 of 6 patients who failed previous treatmentStrasbourg, France, and Lund, Sweden, September 14, 2024, 9:05 a.m. CET – 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...

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NuCana Presents Encouraging Data on NUC-7738 in Combination with Pembrolizumab in PD-1 Inhibitor Refractory and Resistant Melanoma Patients at the ESMO Congress 2024

Combination of NUC-7738 plus Pembrolizumab Resulted in Prolonged Progression Free Survival, a Compelling Disease Control Rate including Partial Responses, and a Favorable Safety Profile BARCELONA, Spain, Sept. 14, 2024 (GLOBE NEWSWIRE) — NuCana plc (NASDAQ: NCNA) presented final data from the Phase 2 NuTide:701 study at the ESMO Congress on NUC-7738 in combination with pembrolizumab for patients with metastatic melanoma who were refractory to or had relapsed on prior PD-1 inhibitor therapy. In this cohort of 12 patients, most of whom had received at least two prior lines of PD-1 inhibitor therapy, nine (75%) achieved disease control, including two patients who achieved Partial Responses. One of these patients, who had received two prior lines of PD-1 inhibitor-based therapy and had progressed on their latest treatment of ipilimumab...

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