Repare Therapeutics - Clinical Trial Updates, Oct 14, 2024
Repare Therapeutics has initiated its Phase 1 POLAR clinical trial by dosing the first patient with RP-3467, a Polθ ATPase inhibitor, both alone and in combination with the PARP inhibitor olaparib. This marks Repare's fourth clinical program, aiming to evaluate the safety and preliminary efficacy of RP-3467 in approximately 52 patients with advanced solid tumors, including ovarian, breast, prostate, and pancreatic cancers. The trial's primary objectives include assessing safety and determining a recommended Phase 2 dose for the combination therapy.
Full Article: Repare Therapeutics doses first patient in Phase 1 clinical trial of RP-3467, a Polθ ATPase inhibitor
Lutris Pharma - Clinical Trial Updates, Oct 15, 2024
Lutris Pharma has completed enrollment of 117 patients in its Phase 2 trial of LUT014, a topical B-Raf inhibitor for metastatic colorectal cancer (mCRC) patients who develop dose-limiting acneiform rash from EGFR inhibitor therapy. The trial, conducted at 20 international sites, evaluates the safety and efficacy of two LUT014 gel strengths compared to placebo. The primary endpoint is the reduction of acneiform lesion severity after 28 days of treatment. Topline results are expected in Q1 2025, with potential to address this significant toxicity and improve patient outcomes.
Full Article: Lutris Pharma completes enrollment in Phase 2 trial of LUT014 for the treatment of EGFRi-induced acneiform rash in patients with metastatic colorectal cancer
Topas Therapeutics - Positive Trial Data, Oct 15, 2024
Topas Therapeutics has announced positive topline results from its Phase 2a trial of TPM502, a nanoparticle-based therapy for celiac disease. This trial marks the first clinical proof of concept for Topas’ platform, demonstrating antigen-specific tolerogenic effects. The double-blind, placebo-controlled study showed a clear dose-response in antigen-specific markers of tolerance following gluten challenge, with effects persisting through follow-up. TPM502 was safe at all doses tested, positioning the therapy for further development. Topas plans to present full data at an upcoming conference and publish the findings.
Full Article: Topas Therapeutics announces positive topline results from Phase 2a trial evaluating TPM502 in patients with celiac disease
C4 Therapeutics - C-Suite Changes, Oct 15, 2024
C4 Therapeutics has appointed Paige Mahaney, Ph.D., as their new Chief Scientific Officer (CSO), effective October 28, 2024, succeeding Stewart Fisher, Ph.D., who will retire and serve as senior scientific advisor through 2024. Dr. Mahaney brings over 25 years of experience in drug discovery and development, previously leading teams at Exelixis and Boehringer Ingelheim. Her expertise will further C4T's mission in targeted protein degradation. Dr. Fisher's tenure at C4T since 2016 advanced the company's platform and clinical pipeline, with notable achievements in developing innovative degraders.
Full Article: C4 Therapeutics appoints Paige Mahaney, Ph.D., Chief Scientific Officer
Bright Peak Therapeutics - Clinical Trial Updates, Oct 17, 2024
Bright Peak Therapeutics has dosed the first patient in its Phase 1/2a trial for BPT567, a bifunctional PD1-IL18 immunoconjugate designed to enhance anti-tumor activity by combining checkpoint blockade with targeted delivery of IL-18 to T cells in the tumor microenvironment. Preclinical studies have shown promising synergistic effects, with potential efficacy in both PD-1-sensitive and resistant tumors. The trial aims to explore BPT567's potential to treat patients who have not responded to conventional PD-1 inhibitors or progressed after prior therapies, addressing significant unmet needs in cancer treatment.
Full Article: Bright Peak Therapeutics announces dosing of first patient in Phase 1/2a clinical trial of BPT567, a first-in-class bifunctional PD1-IL18 immunoconjugate
Sanofi - Company Updates, Oct 17, 2024
Sanofi is making a significant move into the radioligand space with a €300 million ($326 million) investment in a new France-based venture with Orano Med, following a $110 million upfront deal for a neuroendocrine tumor treatment. The new entity, under the Orano Med brand, will focus on next-generation radioligand therapies using lead-212 alpha-emitting isotopes. Sanofi's CEO, Paul Hudson, highlighted the partnership as a strategic step to advance cancer treatment, combining biopharma and nuclear technology expertise. The investment will accelerate the development of Orano Med's radioligand pipeline, including therapies like AlphaMedix.
Full Article: Sanofi returns to Orano with €300M investment for new radioligand pioneer
LaNova Medicines - Clinical Trial Updates & Series C Investments, Oct 18, 2024
LaNova Medicines has initiated a Phase 1 clinical trial in China for LM-299, an anti-PD-1/VEGF bispecific antibody, aimed at treating advanced solid tumors, following promising preclinical results. The biotech also completed a $42 million Series C1 financing round, led by Sino Biopharmaceuticals, to advance its pipeline, including LM-302 and LM-108, with Phase III and Phase II trials underway. LaNova plans to submit an IND for a US Phase 1 trial of LM-299 in 2024. CEO Dr. Crystal Qin emphasized the company’s focus on innovative, globally competitive cancer therapies.
Full Article: LaNova Medicines announces initiation of Phase 1 clinical trial of anti-PD-1/VEGF bispecific antibody LM-299 and completion of $42M Series C1 financing
Evergreen Theragnostics - Clinical Trial Updates, Oct 18, 2024
Evergreen Theragnostics has launched a Phase 2 trial of 68Ga-EVG321 for small cell lung cancer (SCLC) in the European Union after receiving approval from the European Medicines Agency (EMA). The radioligand imaging agent targets CCK2R, a receptor highly expressed in SCLC, and aims to provide tumor-specific delivery of radiation. CEO James Cook emphasized the trial’s significance in developing novel treatments for SCLC and expanding radioligand therapies. The study will assess the distribution of 68Ga-EVG321 in patients, laying the groundwork for future theragnostic applications with a 68Ga/177Lu-EVG321 pairing.
Full Article: Evergreen Theragnostics opens CCK2-View, a Phase 2 small cell lung cancer clinical trial in the European Union
Gilead - Fail Trial Results, Oct 18, 2024
Gilead Sciences has withdrawn Trodelvy as a treatment for advanced bladder cancer in the U.S. following a failed confirmatory trial. The decision, made after discussions with the FDA, affects Trodelvy’s accelerated approval for urothelial cancer patients who had previously received a PD-1/L1 inhibitor and chemotherapy. Trodelvy remains approved for breast cancer. The TROPiCS-04 study did not meet its goal of extending patients' lives compared to chemotherapy, and the failure follows another setback in non-small cell lung cancer, casting doubt on Trodelvy’s future in solid tumors.
Full Article: Gilead withdraws Trodelvy from bladder cancer after trial flop
