June 6, 2024 - 🧬 [nGram] Today’s Oncology Scoop: BridgeBio Doses First Patient, AbbVie Starts Ph. 3 Trial, Replimune Positive Data

  1. BridgeBio Oncology Therapeutics announces first patient dosed with BBO-8520 in the Ph. 1 ONKORAS-101 trial for KRASG12C NSCLC
    • BridgeBio Oncology Therapeutics has dosed the first patient in the ONKORAS-101 trial for BBO-8520.
    • BBO-8520 is a first-in-class, orally bioavailable small molecule inhibitor targeting KRASG12C.
    • The trial will enroll patients pre-treated with first-generation KRASG12C inhibitors and those with no prior KRASG12C targeted therapy experience.
    • BBO-8520 aims to address adaptive resistance mechanisms and has shown substantial tumor growth inhibition in preclinical models.
    • The ONKORAS-101 study will be conducted across the US, Australia, Canada, and the EU.
    • This marks an important advancement for BridgeBio Oncology Therapeutics as a clinical-stage organization.
    Read more

  2. AbbVie advances oncology pipeline with start of multiple myeloma phase 3 clinical trial for investigational asset ABBV-383
    • ABBV-383 is a BCMA bispecific antibody T-cell engager being evaluated in relapsed/refractory multiple myeloma (r/r MM).
    • The CERVINO Phase 3 trial will assess the efficacy, safety, and tolerability of ABBV-383 monotherapy compared to standard available therapies (SATs).
    • Patients in the trial must have received at least two prior lines of therapy and will be randomized 1:1 to receive either ABBV-383 or SAT.
    • The dual primary endpoints are progression-free survival and overall response rate, with secondary endpoints including overall survival and complete response rate.
    • Approximately 140 sites globally will enroll around 380 patients.
    • ABBV-383 features bivalent BCMA-binding domains and a low-affinity CD3 binding domain, designed for monthly dosing.
    Read more

  3. Nutcracker Therapeutics demonstrates enhanced activity of B cell lymphoma candidate NTX-472 at the 2024 ASCO annual meeting
    • Nutcracker Therapeutics presented a poster on NTX-472, a preclinical drug candidate for B cell lymphoma, at the 2024 ASCO Annual Meeting.
    • NTX-472 is a multispecific antibody targeting CD20, CD19, and CD47, showing improved tumor killing and B cell depletion in vitro.
    • In vivo studies in cynomolgus monkeys showed rapid B cell depletion with no detectable binding to red blood cells.
    • NTX-472 is being developed as a trispecific immunotherapy with a differentiated therapeutic and safety profile.
    • Nutcracker Therapeutics previously presented data on NTX-471, an mRNA therapeutic candidate targeting CD47, at SITC 2023.
    Read more

  4. Replimune announces positive topline primary analysis data from IGNYTE clinical trial of RP1 plus nivolumab in anti-PD1 failed melanoma
    • Primary endpoint data shows a 12-month overall response rate (ORR) of 33.6%.
    • Biologics license application (BLA) submission intended for 2H 2024.
    • First patient expected to be enrolled in IGNYTE-3 confirmatory trial in Q3 2024.
    • The trial included 140 patients who received RP1 plus nivolumab after confirmed progression on prior anti-PD1 therapy.
    • Responses were highly durable, with all responses lasting more than 6 months and a median duration of response exceeding 35 months.
    • RP1 combined with nivolumab was well-tolerated, with mainly Grade 1-2 side effects and a low incidence of Grade 3-4 events.
    Read more

  5. Amgen announces positive results for phase 3 trial evaluating uplizna for treatment of IgG4-related disease
    • Amgen's Phase 3 trial (NCT04540497) for UPLIZNA (inebilizumab-cdon) met its primary endpoint, showing an 87% reduction in IgG4-RD flares compared to placebo.
    • The trial also met all key secondary endpoints, including annualized flare rate and flare-free, treatment-free complete remission.
    • No new safety signals were identified, and the safety profile was consistent with known data for UPLIZNA.
    • MITIGATE is the first placebo-controlled trial providing class 1 evidence for treating IgG4-RD, conducted at 80 sites in 22 countries.
    • Amgen plans to file for U.S. approval based on these results, followed by other key markets.
    • The trial was supported by Mitsubishi Tanabe Pharma and Hansoh Pharma, with marketing authorizations in various Asian countries.
    Read more

  6. Orca Bio announces completion of patient enrollment for the Precision-T Phase 3 study of Orca-T
    • Orca Bio has completed enrollment for the Precision-T Phase 3 clinical study.
    • The study is evaluating Orca-T, an allogeneic T-cell immunotherapy, against standard alloHSCT in AML, ALL, and high-risk MDS patients.
    • Precision-T is a randomized, open-label multicenter study with 187 patients enrolled, exceeding the original target of 174.
    • Primary endpoint: survival free from moderate-to-severe chronic graft versus host disease (GvHD).
    • Secondary endpoints: time to moderate-to-severe chronic GvHD, GRFS, and overall survival.
    • Topline results are expected in the first half of 2025.
    Read more