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.
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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.
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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.
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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.
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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.
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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.
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