Day: June 1, 2024

In 17 EGFR wild-type (EGFRwt) non-small cell lung cancer (NSCLC) patients who failed chemotherapy and PD-1/PD-L1, AFM24 plus atezolizumab achieved 4 objective responses; 3 of 4 responses were ongoing for more than 7 months and progression free survival (PFS) was 5.9 months Objective responses were also seen in 4 of 13 response-evaluable EGFR mutant (EGFRmut) NSCLC patients confirming the activity of AFM24 and atezolizumab in heavily pretreated NSCLC patients In both NSCLC cohorts, the combination therapy shows a manageable safety profile Company to host a conference call / webcast today at 6:00 p.m. CDT / 7:00 p.m. EDT to discuss the updated data from the AFM24-102 trialMANNHEIM, Germany, June 01, 2024 (GLOBE NEWSWIRE) — Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their...

Results from Phase 1 dose escalation trial of BDTX-1535 in GBM patients demonstrated a favorable safety and tolerability profile, and encouraging anti-tumor activity and duration of treatment Initial data from Phase 0/1 “trigger” (“window of opportunity”) investigator-sponsored trial demonstrated BDTX-1535 achieved clinically meaningful drug levels in brain tumor tissue CAMBRIDGE, Mass., June 01, 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 additional data from the Phase 1 dose escalation trial of BDTX-1535 in patients with recurrent glioblastoma (GBM), and initial data from a phase 0/1 “trigger” (“window of opportunity”) investigator-sponsored trial at...

An additional 19 patients have been enrolled since January 2024 bringing the total to 37 of whom 25 were evaluable for efficacy SYS6002 (CRB-701) demonstrated 44% ORR and 78% DCR in mUC and 43% ORR and 86% DCR in cervical cancer to date at doses ≥ 1.2mg/Kg No dose limiting toxicities (DLTs) have been observed to date in doses up to and including 4.5 mg/Kg (cohort 7) Three cases of skin rash (including one grade 3) and one case of grade 1 neuropathy seen to date; all were resolved Early PK data demonstrate consistently lower levels of free MMAE than enfortumab vedotin across all doses in study including 4.5 mg/KgNORWOOD, Mass., June 01, 2024 (GLOBE NEWSWIRE) — Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), announced today, that the Poster [#296] Clinical Update Related to the First-In-Human...

Media Release COPENHAGEN, Denmark, and MAINZ, Germany; June 1, 2024Initial data from the ongoing Phase 2 trial showed a 12-month overall survival (OS) rate of 69% and median overall survival (mOS) of 17.5 months in patients with previously treated PD-L1-positive mNSCLC treated with combination of acasunlimab with pembrolizumab every six weeks Data from this ongoing Phase 2 study to inform the planned pivotal Phase 3 trial, which is expected to start before the end of 2024Genmab A/S (Nasdaq: GMAB) and BioNTech SE (Nasdaq: BNTX) today announced initial data from the Phase 2 GCT1046-04 trial (NCT05117242) evaluating acasunlimab (DuoBody-PD-L1x4-1BB), an investigational bispecific antibody also known as GEN1046/BNT311, as monotherapy and in combination with pembrolizumab in patients with PDL(1)-positive mNSCLC who had disease progression...

Initial data from the ongoing Phase 2 trial showed a 12-month overall survival rate of 69% and a median overall survival of 17.5 months in patients with previously treated PD-L1-positive metastatic non-small cell lung cancer treated with a combination of acasunlimab and pembrolizumab every six weeks Data from this ongoing Phase 2 study to inform the planned pivotal Phase 3 trial, which is expected to start before the end of 2024COPENHAGEN, Denmark, and MAINZ, Germany, June 1, 2024 — Genmab A/S (Nasdaq: GMAB, “Genmab”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced initial data from the ongoing Phase 2 trial (NCT05117242) evaluating acasunlimab (DuoBody-PD-L1x4-1BB), an investigational bispecific antibody also known as GEN1046/BNT311, as monotherapy and in combination with pembrolizumab in patients with PD-L(1)-positive metastatic...

–  WTX-124 was shown to be clinically active and generally well-tolerated in patients who were relapsed/refractory to immune checkpoint inhibitor therapy – –  Encouraging single agent clinical activity with three objective responses, including a durable confirmed complete response – –  Monotherapy recommended dose for expansion selected and expansion arms open for enrollment – –  Preliminary data on WTX-124 administered to patients in combination with pembrolizumab showed that the combination was generally well-tolerated with enhanced immune activation in tumors – –  Company to host webcast to review these data on Monday, June 3, 2024, at 8:00 am ET – WATERTOWN, Mass., June 01, 2024 (GLOBE NEWSWIRE) — Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq: HOWL),...

Newly Launched Technology Will Be on Display at ASSFN in Nashville from June 1 – 4ClearPoint Neuro Announces Full Market Release of SmartFrame OR™ and ClearPoint PRISM® 3T Laser Therapy SystemNewly Launched Technology Will Be on Display at ASSFN in Nashville from June 1 – 4Animation of a ClearPoint Prism Neuro Laser Therapy SystemSOLANA BEACH, Calif., June 01, 2024 (GLOBE NEWSWIRE) — ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announces full market release of its SmartFrame OR platform and ClearPoint Prism Neuro Laser Therapy System at the 2024 Biennial Meeting of the American Society of Stereotactic and Functional Neurosurgery from Saturday, June 1st – Tuesday,...

NEW YORK, June 01, 2024 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced the publication of preclinical GD2-SADA data at the 2024 American Society of Clinical Oncology (“ASCO”) Annual Meeting, taking place May 31 through June 4, 2024, in Chicago, IL. The published abstract titled “Preclinical characterization of pretargeted radioimmunotherapy with GD2-SADA, a self-assembling and disassembling bispecific fusion protein” characterizes the binding properties of GD2-SADA across several GD2-expressing cell lines and lanthanide metal-DOTA complexes, while also demonstrating its anti-tumor efficacy...

Objective response rate of 39% with manageable safety profile in patients with non-small cell lung cancer (NSCLC) harboring EGFR Exon 20 insertion mutations treated with zipalertinib who had progressed after prior amivantamab treatment CAMBRIDGE, Mass., June 01, 2024 (GLOBE NEWSWIRE) — Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced positive initial data in patients receiving zipalertinib after prior treatment with amivantamab enrolled in its pivotal Phase 2b REZILIENT1 clinical trial. As of a January 12, 2024 data cut-off, 31 patients had been enrolled. Patients had received a median of three prior systemic anti-cancer regimens, including prior platinum-based chemotherapy, prior anti-PD1/L1 therapy, and prior epidermal growth factor...