Immorna Biotherapeutics receives U.S. FDA IND clearance to conduct Phase 1/2 study of JCXH-211 IV
- Immorna Biotherapeutics received FDA IND clearance for JCXH-211 IV, a self-replicating mRNA encoding IL-12 protein.
- The Phase 1/2 study will be multi-center, open-label, and will assess safety, tolerability, and preliminary efficacy.
- The study aims to determine the recommended Phase 2 dose (RP2D) for JCXH-211 IV in combination with a checkpoint inhibitor.
- JCXH-211 IV has shown superior tumor-eradicating potency in preclinical models and excellent safety in nonclinical studies.
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IDEAYA announces positive interim phase 2 monotherapy expansion data for IDE397 in MTAP-deletion urothelial and lung cancer
- IDE397 showed a 39% overall response rate (ORR) with 1 complete response (CR) and 6 partial responses (PRs) in 18 evaluable patients.
- The disease control rate (DCR) was 94%, with 1 CR, 6 PRs, and 10 stable diseases (SD).
- 78% of patients experienced tumor shrinkage, and 81% had a ctDNA molecular response rate (MRR) with >50% ctDNA reduction.
- The adverse event profile was favorable, with only 5.6% grade 3 or higher drug-related AEs and no drug-related serious adverse events (SAEs).
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Hinova Pharmaceuticals receives FDA Fast Track designation for HP518 for treatment of AR+ triple-negative breast cancer
- Hinova Pharmaceuticals has been granted FDA Fast Track designation for HP518, an investigational drug for AR+ triple-negative breast cancer (TNBC).
- HP518 is a potent PROTAC AR degrader showing efficacy in AR+ TNBC, with promising antitumor activity and a favorable safety profile in preclinical studies.
- The Fast Track designation aims to expedite the development and review process for drugs addressing serious conditions and unmet medical needs.
- Hinova plans to update the existing IND for TNBC development and is committed to accelerating HP518's development.
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Biostar Pharma announces FDA clearance of the IND application for a phase 2 study of utidelone injection (UTD1) in HER2- breast cancer brain metastasis
- Biostar Pharma received FDA clearance for a phase 2 study of Utidelone Injection (UTD1) in HER2- breast cancer brain metastasis (BCBM).
- The study, BG01-2402, will evaluate the efficacy of Utidelone Injection combined with capecitabine in HER2- BCBM patients.
- The trial will be conducted at 10-15 sites in the US, targeting the enrollment of 120 patients.
- Primary endpoint is CNS-ORR; secondary endpoints include PFS, DOR, and OS.
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iTeos announces first patient dosed in GALAXIES Lung-301 phase 3 study, earning $35 million in milestones from GSK
- iTeos has dosed the first patient in the GALAXIES Lung-301 Phase 3 trial for belrestotug + dostarlimab.
- The trial is a global, randomized, double-blind study comparing belrestotug + dostarlimab to placebo + pembrolizumab in advanced, unresectable, or metastatic PD-L1 high NSCLC.
- This milestone triggers $35 million in development payments from GSK.
- iTeos and GSK's collaboration includes a $625 million upfront payment, with potential additional milestones and profit-sharing agreements.
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Bio-Path Holdings provides clinical update and expansion plans
- Bio-Path Holdings is advancing its DNAbilize platform with significant progress in clinical trials for multiple cancer indications.
- The company has developed a molecular biomarker package to enhance the success of prexigebersen treatment in oncology studies.
- A Phase 2 clinical trial for prexigebersen in Acute Myeloid Leukemia (AML) is ongoing, with plans to complete enrollment in the next 18 months.
- Bio-Path is preparing for preclinical studies to evaluate prexigebersen as a potential treatment for obesity, leveraging existing safety data from leukemia patients.
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Myricx Bio announces £90m ($114m) series A financing to advance its novel NMTi-ADC therapeutics into clinical development
- Myricx Bio raised £90m ($114m) in series A financing co-led by Novo Holdings and Abingworth.
- Funds will be used to develop Myricx's N-Myristoyltransferase inhibitor (NMTi) ADC payload platform and advance its pipeline.
- New investors include British Patient Capital, Cancer Research Horizons, and Eli Lilly, alongside founding investors Brandon Capital and Sofinnova Partners.
- Myricx plans to establish laboratory operations in London and expand its management and R&D teams.
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Xpovio approved for new indication in DLBCL in China
- Xpovio (selinexor) approved as monotherapy for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) in China.
- Approval supported by the SEARCH study, which showed a significant overall response rate among 60 Chinese patients.
- Xpovio is an oral drug with a novel mechanism of action, currently being developed for multiple indications.
- Antengene has submitted NDAs for Xpovio in other ASEAN markets, with approvals anticipated in the second half of 2024.
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Olverembatinib approved for commercialization in Macau China
- Ascentage Pharma's olverembatinib has been approved by the Pharmaceutical Administration Bureau (ISAF) of Macau SAR for treating TKI-resistant CML-CP and CML-AP.
- Olverembatinib is the first third-generation BCR-ABL1 inhibitor approved by China's NMPA and targets BCR-ABL1 mutants, including the T315I mutation.
- The drug is being jointly commercialized in China by Ascentage Pharma and Innovent Biologics.
- Olverembatinib has received multiple designations, including Priority Review and Breakthrough Therapy by China's NMPA, and Orphan Drug and Fast Track by the US FDA.
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IASO Bio and Innovent enhance strategic collaboration in cell therapy
- IASO Bio and Innovent have agreed on a new strategic collaboration involving FUCASO® (Equecabtagene Autoleucel).
- IASO Bio will purchase Innovent's rights to FUCASO® and obtain a global commercial license for the product.
- Innovent will acquire an 18% stake in IASO Bio as part of the agreement.
- FUCASO® is approved by the NMPA for treating relapsed/refractory multiple myeloma and has IND applications for other indications.
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