Circle Pharma - Series D Investment, Sep 3, 2024
Circle Pharma, a clinical-stage biopharmaceutical company focused on developing cell-permeable macrocycles as a new class of therapies, announced the closing of a $90 million Series D financing round led by The Column Group, with participation from Nextech Invest and Euclidean Capital. The funds will support the clinical development of their first-in-class cyclin A/B inhibitor, CID-078, and further advance their macrocycle platform. CEO David Earp expressed gratitude for the investor support, highlighting the opportunity to progress their pipeline of innovative therapies targeting cancer and other serious diseases.
Full Article: Circle Pharma Closes $90 Million Series D Financing to Advance Innovative Oral Macrocycle Therapies
7 Hills Pharma - Clinical Trial Updates, Sep 3, 2024
7 Hills Pharma, a clinical-stage company developing first-in-class integrin activators to enhance cancer immunotherapies, announced that their first cancer patient has been safely dosed with alintegimod, an integrin-targeted agonist designed to boost T cell activation in patients resistant to immune checkpoint inhibitors. Supported by awards from the Cancer Prevention and Research Institute of Texas and the National Cancer Institute, this Phase 1b/2a study marks a significant milestone. Chief Medical Officer Lionel D. Lewis expressed gratitude, emphasizing the importance of this step in advancing safer, more effective immunotherapy options for challenging cancers.
ArsenalBio - Series C Investment, Sep 4, 2024
Arsenal Biosciences, a clinical-stage cell therapy company, has raised $325 million in an oversubscribed Series C funding round to advance its CAR T-cell therapies for solid tumors. The funding, backed by major investors including ARCH Venture Partners, Regeneron Ventures, and Bristol-Myers Squibb, will support ArsenalBio’s lead programs, expand its therapeutic pipeline, and enhance its manufacturing capabilities. The company’s T cell engineering technology is showing promise in early trials, including its candidate AB-2100, which is in Phase 1/2 trials for clear-cell renal cell carcinoma and has received Fast Track designation from the FDA.
Full Article: ArsenalBio Announces $325 Million Financing to Advance Programmable Cell Therapy Programs Through Clinical Development
OncoC4 - Clinical Trial Updates, Sep 4, 2024
OncoC4 has dosed the first patient in its Phase 1 trial evaluating ONC-841, a novel SIGLEC10-blocking antibody for solid tumors. This first-in-human trial will assess the safety, efficacy, and pharmacokinetics of ONC-841, designed to enhance anti-tumor immunity by blocking the SIGLEC10-CD24 interaction that allows tumors to evade the immune system. The study will test seven dose levels across multiple centers in the U.S., with initial data expected in 2025. ONC-841 represents a potential breakthrough in immunotherapy, activating NK cells, macrophages, and T cells to fight cancer.
Full Article: OncoC4 Announces First Patient Dosed in Phase 1 Trial for Novel SIGLEC10 Immune Checkpoint Inhibitor ONC-841 for Solid Tumors
Context Therapeutics - Executive Changes, Sep 4, 2024
Context Therapeutics has appointed Dr. Karen Smith and Dr. Luke Walker to its Board of Directors. Dr. Smith brings over 20 years of oncology drug development experience, having led programs at Jazz Pharmaceuticals, Allergan, and AstraZeneca. Dr. Walker, with a background in clinical development, has overseen key oncology programs at Harpoon Therapeutics and Seagen. Their expertise will support Context's growth and advancement of T cell-engaging bispecific therapies.
Full Article: Context Therapeutics Appoints Dr. Karen Smith and Dr. Luke Walker to Board of Directors
ALX Oncology - Clinical Trial Updates, Sep 5, 2024
ALX Oncology has dosed the first patients in its UMBRELLA Phase 1/2 trial, in partnership with Sanofi, to evaluate the combination of evorpacept and SARCLISA® (isatuximab-irfc) in relapsed or refractory multiple myeloma (RRMM). Evorpacept, a CD47-blocking therapeutic, may resensitize tumors to SARCLISA, a CD38-targeting antibody, which is used in RRMM treatment. The trial aims to assess safety, efficacy, and dosage of the combination therapy, with ALX providing evorpacept and Sanofi leading the trial. This partnership seeks to improve patient outcomes by addressing resistance to CD38-based treatments.
IN8bio - Workforce Reduction/Layoffs, Sep 5, 2024
IN8bio is halting patient enrollment in its Phase 2 trial for INB-400, a gamma-delta T-cell therapy for glioblastoma, while exploring partnerships for the program. As part of this shift, the biotech is laying off half of its workforce, reducing staff from 37 to 19, and cutting executive pay. The company is refocusing on its INB-100 program for AML, which has shown promising results, with no relapses reported in treated patients. Funds from the reorganization will support continued enrollment in the INB-100 trial.
Full Article: IN8bio Halting Phase 2 Glioblastoma Trial and Laying Off Nearly Half of Workforce to Focus on Leukemia
Medigene - FDA Clearance, Sep 5, 2024
Medigene has received FDA clearance for its Investigational New Drug (IND) application for MDG1015, a T cell receptor (TCR)-guided therapy targeting advanced gastric cancer, ovarian cancer, myxoid/round cell liposarcoma, and synovial sarcoma. The Phase 1 trial, EPITOME1015-I, will assess the safety, feasibility, and efficacy of MDG1015, which features enhanced anti-tumor activity and the ability to counteract PD-L1 immunosuppression. Medigene plans to initiate the trial by the end of 2024, with early data expected in late 2025, pending additional financing.
NextPoint Therapeutics - New Drug Candidate, Sep 6, 2024
NextPoint Therapeutics has introduced NPX372, a novel CD3 bispecific antibody targeting the B7-H7 (HHLA2) axis, a unique receptor upregulated in various solid tumors like colorectal and lung cancer. NPX372 redirects T cell-mediated cytotoxicity toward B7-H7-positive tumors, offering high specificity and potential as a monotherapy. Preclinical studies show strong anti-tumor responses with a favorable safety profile, and NextPoint is advancing the Investigational New Drug (IND) application. This development builds on NextPoint's expertise in precision immunotherapy, aiming to deliver targeted treatments for solid tumors.
Full Article: NextPoint Therapeutics Announces First-in-Class CD3 Bispecific Antibody NPX372 Targeting B7-H7 Axis for Solid Tumors
Merck & Daiichi Sankyo - Positive Trial Data, Sep 7, 2024
Merck and Daiichi Sankyo reported that their antibody drug conjugate ifinatamab deruxtecan (I-DXd) showed promising results in the Phase 2 IDeate-Lung01 trial for pretreated extensive-stage small cell lung cancer (ES-SCLC). At a 12 mg/kg dose, the treatment achieved an objective response rate of 54.8%, which was selected for further study in the Phase 3 IDeate-Lung02 trial. The drug demonstrated encouraging survival rates and intracranial responses, offering potential as a first-in-class B7-H3 directed therapy for this challenging cancer type.
Full Article: Merck & Daiichi Sankyo’s Ifinatamab Deruxtecan Shows Promising Results in Phase 2 Lung Cancer Trial
Rigel Pharmaceuticals - Clinical Trial Updates, Sep 7, 2024
Rigel Pharmaceuticals has initiated a Phase Ib/II clinical trial of REZLIDHIA (olutasidenib) combined with decitabine and venetoclax for patients with mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML). The trial, sponsored by MD Anderson Cancer Center, aims to determine the safety, tolerability, and complete remission rate in newly diagnosed and relapsed/refractory patients. This trial marks the first under Rigel's multi-year partnership with MD Anderson, exploring olutasidenib's potential in AML and other hematologic cancers, as well as its use in lower-risk conditions.
Full Article: Rigel Enrolls First Participant in Phase Ib/II AML Treatment Regimen Trial
