Inimmune announces first cancer patient dosed in phase 1 clinical study using the immunotherapeutic INI-4001, a novel TLR7/8 agonist
- Inimmune has dosed the first patient in its Phase 1 clinical study of INI-4001 for advanced solid tumors.
- The study is an open-label, multiple-ascending dose, two-part trial to assess PK, safety, and tolerability.
- Phase 1a involves single dose escalation cohorts, followed by Phase 1b with concurrent administration of anti-PD-1 or anti-PD-L1 immunotherapy.
- Pre-clinical studies showed INI-4001 efficacy as monotherapy and in combination with anti-PD-1 therapy.
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Dren Bio announces strategic collaboration with Novartis to develop novel targeted myeloid engagers for cancer
- Dren Bio and Novartis have entered a strategic collaboration to develop bispecific antibodies for cancer.
- Dren Bio will receive $150 million upfront, including a $25 million equity investment from Novartis.
- Potential additional payments of up to $2.85 billion are tied to preclinical, clinical, regulatory, and commercial milestones.
- Novartis will take over development, manufacturing, regulatory, and commercialization activities after clinical candidate selection.
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Notable Labs receives FDA clearance to proceed with volasertib phase 2 study
- Notable Labs received FDA clearance to proceed with the Phase 2 study of volasertib for relapsed refractory acute myeloid leukemia (AML).
- The study will begin with a dose optimization lead-in and incorporate body-surface area dosing, prophylactic antibiotic treatment, and best supportive care.
- Initial data from the dose optimization lead-in is expected in Q4 2024, with selective enrollment of PMP-predicted responders to follow.
- Initial efficacy results are anticipated in H1 2025.
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Bio-Thera Solutions initiates integrated phase I / phase III clinical trial for BAT3306, a proposed biosimilar of Keytruda (pembrolizumab)
- Bio-Thera Solutions has started dosing in an integrated Phase I / Phase III clinical trial for BAT3306, a proposed biosimilar of Keytruda (pembrolizumab).
- The trial is a randomized, double-blind, parallel group, active control study comparing the pharmacokinetics, efficacy, and safety of BAT3306 to Keytruda in non-squamous non-small cell lung cancer (nsNSCLC) patients.
- Approximately 676 patients are expected to be enrolled in the study.
- Bio-Thera Solutions is also developing other biosimilars, including BAT1806 (tocilizumab), BAT1706 (bevacizumab), and BAT2206 (ustekinumab), among others.
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Ipsen and Day One enter into exclusive ex-U.S. licensing agreement to commercialize tovorafenib for the most common childhood brain tumor
- Ipsen secures ex-U.S. regulatory and commercial rights to tovorafenib for pediatric low-grade glioma (pLGG) and future indications.
- Day One receives approximately $111 million upfront and up to $350 million in milestone payments, plus double-digit tiered royalties.
- Tovorafenib is the first FDA-approved treatment for relapsed or refractory pLGG with BRAF fusion or V600 mutation.
- Ongoing Phase III trial, FIREFLY-2, is evaluating tovorafenib as a monotherapy for newly diagnosed children and young adults with RAF-altered low-grade glioma.
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OS Therapies announces positive safety data from Phase 1 clinical trial of OST-HER2 in HER2-expressing breast cancer
- OS Therapies reported positive safety data from a Phase 1 clinical trial of OST-HER2 in HER2-expressing solid tumors.
- The trial included 12 patients with HER2-positive cancers, showing OST-HER2 to be safe and well-tolerated.
- Positive preclinical efficacy data for OST-HER2 in multiple breast cancer models were also announced.
- The company is in discussions with the FDA for Breakthrough Therapy Designation for OST-HER2.
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AIM announces new positive data on Ampligen’s anti-tumor potential when used as part of a combination therapy
- AIM ImmunoTech Inc. published new pre-clinical data on Ampligen in the treatment of melanoma.
- Combination therapy with dendritic cell-based vaccines, anti-PD-L1 checkpoint inhibitors, and Ampligen showed slowed tumor growth and improved survival in a mouse model.
- The study, titled 'Therapeutic Anti-Tumor Efficacy of DC-Based Vaccines Targeting TME-Associated Antigens,' was published in the journal Vaccines.
- The data supports the ongoing development of Ampligen as an anti-tumor therapy.
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Predictive Oncology enters biomarker discovery market after successful retrospective ovarian cancer study yields compelling results
- Predictive Oncology expands its AI/ML-driven platform to include novel oncology biomarker discovery.
- The initiative follows a successful retrospective ovarian cancer study presented at the 2024 ASCO Annual Meeting.
- The study developed multi-omic machine learning models that predict short-term and long-term survival outcomes more accurately than clinical data alone.
- The biomarker discovery market is estimated to be $51.5 billion in 2024.
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Ariceum Therapeutics commences Phase 1 clinical trial in patients with recurrent glioblastoma
- Ariceum Therapeutics has started a Phase 1 clinical trial (CITADEL-123) for its Iodine-123 labelled PARP inhibitor, ATT001, in patients with recurrent glioblastoma.
- The trial, designed by Dr. Paul Mulholland, is being conducted at University College London Hospitals (UCLH) and will assess the safety and early efficacy of ATT001.
- The study includes a dose escalation phase followed by expansion cohorts, with potential future applications in primary glioblastoma.
- The trial follows the approval of a Clinical Trial Authorisation (CTA) by the UK's MHRA in February 2024, with additional sites expected to open in the UK and EU later this year.
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Chemomab Therapeutics announces positive phase 2 trial results for CM-101 in primary sclerosing cholangitis
- CM-101 achieved primary and secondary endpoints, demonstrating anti-fibrotic, anti-inflammatory, and anti-cholestatic effects.
- Statistically significant improvements in liver stiffness, pruritis, total bilirubin, and liver function tests were observed.
- The trial included 76 patients from the U.S., Europe, and Israel, with a 15-week treatment period.
- Chemomab is preparing for an End-of-Phase 2 meeting with the FDA and plans to initiate a Phase 3 trial in 2025.
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