Enliven Therapeutics announces positive data update from Phase 1 clinical trial of ELVN-001 in chronic myeloid leukemia
- Updated Phase 1 data presented at ESH-iCMLf 26th Annual John Goldman Conference.
- Reported cumulative MMR rate of 44% (8/18) by 24 weeks, with stable or deepening responses between weeks 12 and 24.
- ELVN-001 remains well-tolerated with no dose reductions reported; 39 patients enrolled with a median treatment duration of 20 weeks.
- ELVN-001 is a potent, highly selective small molecule kinase inhibitor targeting the BCR-ABL gene fusion, the oncogenic driver for CML.
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Estrella Immunopharma achieves complete response in first patient treated with CD19-redirected ARTEMIS T-cells
- First patient in STARLIGHT-1 Phase I/II trial achieved complete response one month post-infusion.
- Patient had high-risk follicular lymphoma and no treatment-related serious adverse events were observed.
- STARLIGHT-1 trial aims to assess safety and determine the Recommended Phase II Dose (RP2D) for EB103.
- EB103 utilizes ARTEMIS technology to target and destroy CD19-positive cancer cells.
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Primary endpoint met in phase 3 comparative clinical study of Perjeta biosimilar candidate HLX11
- Shanghai Henlius Biotech and Organon announced that the phase 3 trial for the Perjeta biosimilar HLX11 met its primary endpoint.
- The study compared the efficacy and safety of HLX11 with reference Perjeta in HER2-positive, HR-negative early or locally advanced breast cancer.
- Patients were randomized 1:1 to receive either HLX11 or reference Perjeta in combination with trastuzumab and docetaxel.
- The primary endpoint was the total pathological complete response (tpCR) rate assessed by an Independent Review Committee.
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Genentech to acquire Regor's next-generation CDK inhibitors for breast cancer
- Genentech will acquire Regor's CDK inhibitors for an upfront payment of $850 million.
- Regor is eligible for additional cash payments based on future milestones.
- Genentech will handle clinical development, manufacturing, and commercialization globally.
- Regor will continue managing two ongoing Phase 1 trials to completion.
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PureTech-invented KarXT receives FDA approval for the treatment of schizophrenia in adults
- KarXT (xanomeline and trospium chloride), invented by PureTech, has received FDA approval for treating schizophrenia in adults.
- The approval triggers milestone payments totaling $29 million to PureTech under agreements with Royalty Pharma and Karuna Therapeutics.
- PureTech is entitled to potential future payments and approximately 2% royalties on net annual sales over $2 billion.
- KarXT, now marketed as Cobenfy by Bristol Myers Squibb, addresses tolerability challenges in neuropsychiatric treatments.
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FDA approves new mechanism of action drug for schizophrenia treatment
- The FDA has approved Cobenfy (xanomeline chloride and trospium) capsules for oral use in treating schizophrenia in adults.
- Cobenfy is the first antipsychotic to target cholinergic receptors instead of dopamine receptors.
- Efficacy was demonstrated in two 5-week, multicenter, randomized, double-blind, placebo-controlled studies.
- Participants on Cobenfy showed significant symptom reduction on the Positive and Negative Syndrome Scale (PANSS) compared to placebo.
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FDA approves Bristol Myers Squibb’s COBENFY for schizophrenia treatment
- The FDA has approved COBENFY (xanomeline and trospium chloride) for treating schizophrenia in adults.
- COBENFY is the first new class of medicine for schizophrenia in decades, targeting M1 and M4 receptors without blocking D2 receptors.
- Approval is based on data from the EMERGENT clinical program, including three placebo-controlled trials and two open-label trials.
- In Phase 3 trials, COBENFY showed significant reductions in schizophrenia symptoms compared to placebo, with a favorable safety profile.
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Prime Medicine announces strategic research collaboration and license agreement with Bristol Myers Squibb
- Prime Medicine to receive $110 million upfront, with potential for more than $3.5 billion in milestones.
- Collaboration focuses on developing ex vivo T-cell therapies using Prime Medicine’s Prime Editing and PASSIGE technology.
- Bristol Myers Squibb will handle development, manufacturing, and commercialization.
- Prime Medicine will support gene editing strategy and reagent development.
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Akeso's cadonilimab receives second indication approval from NMPA for first-line treatment of gastric/GEJ cancer
- Akeso's PD-1/CTLA-4 bispecific antibody, cadonilimab, approved by NMPA for first-line treatment of locally advanced unresectable or metastatic gastric/GEJ adenocarcinoma.
- Approval based on COMPASSION-15/AK104-302 study, showing significant survival benefits across all PD-L1 expression levels.
- Median overall survival (mOS) for cadonilimab regimen reached 15.0 months, compared to 10.8 months in the control group.
- Phase III clinical study (AK109-301) initiated for cadonilimab combined with pulocimab for second-line treatment of advanced gastric cancer.
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Septerna initiates phase 1 trial for SEP-786 in hypoparathyroidism
- Septerna has started dosing participants in a Phase 1 clinical trial for SEP-786, an oral small molecule PTH1R agonist.
- The trial includes single-ascending dose (SAD) and multiple-ascending dose (MAD) phases to assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD).
- SEP-786 aims to provide a convenient, disease-modifying treatment for hypoparathyroidism, potentially normalizing serum calcium levels.
- The trial will enroll up to 180 healthy adult participants, with dosing already underway in the SAD portion.
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