IMUNON announces 11.1 month increase in overall survival in patients with newly diagnosed, advanced ovarian cancer treated with IMNN-001
- Phase 2 OVATION 2 Study shows IMNN-001 with standard chemotherapy extends median overall survival (OS) by 11.1 months.
- Patients receiving three or more doses of IMNN-001 saw a 15.7 month increase in median OS.
- Patients on maintenance PARP inhibitor therapy had a hazard ratio of 0.41, with median OS not yet reached.
- IMUNON plans to initiate a registrational Phase 3 study in Q1 2025.
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Umoja Biopharma announces FDA clearance of IND application for UB-VV111, a CD19 directed in situ CAR T for hematologic malignancies
- UB-VV111 is the first in situ generated CD19 CAR-T cell therapy to be evaluated in humans for hematologic malignancies.
- The Phase 1 study will be a dose escalation and confirmation study to evaluate safety, tolerability, and clinical antitumor activity.
- The study will enroll subjects with relapsed/refractory large-B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL).
- First patient expected to be dosed by the end of 2024.
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Darzalex Faspro-based quadruplet regimen approved in the U.S. for newly diagnosed multiple myeloma
- The U.S. FDA approved Darzalex Faspro in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for newly diagnosed multiple myeloma patients eligible for autologous stem cell transplant (ASCT).
- Approval is based on the Phase 3 PERSEUS study, which showed a 60% reduction in the risk of disease progression or death with D-VRd compared to VRd.
- The study demonstrated deeper responses with D-VRd, including higher minimal residual disease (MRD) negativity rates.
- The safety profile of D-VRd was consistent with known profiles for Darzalex Faspro and VRd.
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Zurletrectinib shows strong intracranial activity against NTRK fusion-positive tumors
- Zurletrectinib is a next-generation TRK inhibitor with high brain penetration and strong intracranial activity.
- It is effective against TRKA, TRKB, and TRKC WT kinases, as well as resistance mutations TRKA G595R and TRKA G667C.
- In xenograft models, zurletrectinib inhibited tumor growth at doses 30 times lower than selitrectinib.
- In a CNS pharmacokinetic study, zurletrectinib showed superior brain penetration and antitumor activity compared to selitrectinib and repotrectinib.
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FibroGen announces topline results from two late-stage pamrevlumab pancreatic cancer studies and provides corporate update
- Pamrevlumab arm in PanCAN’s Precision Promise study did not meet the primary endpoint of overall survival.
- LAPIS study in locally advanced, unresectable pancreatic cancer also did not meet the primary endpoint of overall survival.
- Pamrevlumab was generally safe and well tolerated across both studies.
- FibroGen to implement significant cost reduction plan, including terminating pamrevlumab R&D and reducing U.S. workforce by 75%.
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Processa Pharmaceuticals announces FDA clearance of IND application for a Phase 2 clinical trial of NGC-Cap in breast cancer
- FDA has cleared Processa Pharmaceuticals' IND application for NGC-Cap.
- The Phase 2 trial will enroll patients with advanced or metastatic breast cancer.
- The trial will compare two doses of NGC-Cap to monotherapy capecitabine in 60-90 patients.
- Initial data from the trial is expected by mid-2025.
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Kexing Biopharm's albumin-bound paclitaxel granted EU market approval
- Kexing Biopharm's Apexelsin® (generic to Abraxane®) received European Commission approval on July 28, 2024.
- Apexelsin® offers improved safety and higher patient compliance compared to solvent-based and liposomal paclitaxel.
- ESMO guidelines recommend it for metastatic pancreatic cancer, NSCLC, and as a second-line option for breast cancer.
- The approval enhances Kexing Biopharm's competitiveness and marks a significant milestone in its European market expansion.
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Georgiamune announces first patient dosed in a first-in-class phase 1 cancer treatment trial of GIM-531
- Georgiamune Inc. has dosed the first patient in a phase 1 clinical trial for GIM-531, an oral therapy targeting advanced cancer patients.
- GIM-531 is a first-in-class selective T regulatory cell inhibitor, addressing indications not covered by existing immunotherapies.
- The trial will evaluate safety, pharmacokinetics, pharmacodynamics, and early anti-tumor activity in patients with advanced solid tumors.
- Following dose escalation, two additional study cohorts will explore GIM-531 as a single agent and in combination with anti-PD-1 for advanced melanoma.
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LTZ Therapeutics announces over $20 million Series A financing for development of its myeloid engager-based immunotherapy pipeline
- LTZ Therapeutics completed a Series A financing round of over $20 million, led by Lapam Capital with participation from GL Ventures, K2 Venture Partners, and Shunwei Capital.
- The funds will be used to advance LTZ’s Myeloid Engager pipeline, including the IND process and Phase 1 clinical study of LTZ-301, as well as IND-enabling work for LTZ-232.
- LTZ aims to enhance the phagocytic function of monocytes and macrophages to foster anti-tumor immunity, leveraging reverse translational science and myeloid biology.
- The company has raised approximately $50 million since its founding in 2022.
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MacroGenics achieves $100 million milestone in retifanlimab collaboration with Incyte
- MacroGenics announced a $100 million milestone achievement from Incyte for the development of ZYNYZ (retifanlimab-dlwr).
- ZYNYZ is a PD-1 inhibitor for treating metastatic or recurrent locally advanced Merkel cell carcinoma.
- The collaboration with Incyte began in 2017, with MacroGenics receiving an upfront payment of $150 million and a total of $215 million in milestones to date.
- MacroGenics remains eligible for up to $540 million in potential future milestones and receives tiered royalties on worldwide net sales of ZYNYZ.
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