Alvotech and Teva announce U.S. FDA approval of additional presentation of SELARSDI
- The FDA approved SELARSDI 130 mg/26 mL for intravenous infusion, expanding its label to include Crohn’s disease and ulcerative colitis.
- Previously, SELARSDI was approved for subcutaneous injection for plaque psoriasis and psoriatic arthritis.
- The U.S. launch for all indications is expected in Q1 2025.
- Alvotech and Teva's partnership includes nine biosimilar products, with SELARSDI and SIMLANDI already approved by the FDA.
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Synergy CHC Corp. prices $10.35 million initial public offering
- Synergy CHC Corp. announced the pricing of its IPO at $9.00 per share, with 1,150,000 shares offered.
- The shares will trade on the Nasdaq Global Market under the ticker 'SNYR' starting October 23, 2024.
- Net proceeds are expected to be $8.4 million, or $9.9 million if underwriters purchase additional shares.
- Funds will be used to repay certain promissory notes and for general corporate purposes.
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BriaCell reports outperforming metastatic breast cancer patients and standard-beating survival data
- BriaCell's Phase 2 study shows a 55% one-year survival rate for metastatic breast cancer patients, surpassing current standards.
- Notable patient outcomes include survival over 2 years, even after failing prior treatments like CPIs and ADCs.
- The study involved 54 heavily pre-treated patients, with 37 receiving the Phase 3 formulation.
- Ongoing Phase 3 trial aims to confirm these results, with interim data expected in the second half of 2025.
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AvenCell raises $112 million in series B funding led by Novo Holdings
- AvenCell Therapeutics secured $112 million in Series B funding, led by Novo Holdings.
- New investors include F-Prime Capital, Eight Roads Ventures Japan, Piper Heartland Healthcare Capital, and NYBC Ventures.
- Funds will accelerate clinical validation of AvenCell's universal switchable CAR-T cell therapy platform.
- Ongoing trials focus on AVC-101 and AVC-201 for relapsed/refractory acute myeloid leukemia (AML).
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BioAegis Therapeutics enrolls first patient in phase 2 trial for ARDS treatment
- BioAegis Therapeutics has initiated a Phase 2 trial for recombinant human plasma gelsolin (rhu-pGSN) in treating moderate-to-severe ARDS.
- The trial is a randomized, double-blind, placebo-controlled study involving 600 patients across the US, Canada, UK, and EU.
- Rhu-pGSN aims to modulate inflammation by interrupting the NLRP3 inflammasome and enhancing macrophage pathogen clearance.
- The study is supported by federal funds from the U.S. Department of Health and Human Services and BARDA.
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Recursion doses first patient in Phase 2 study of REC-3964 for recurrent C. diff infection
- REC-3964 is a novel, non-antibiotic small molecule targeting recurrent Clostridioides difficile infection.
- The Phase 2 ALDER trial will assess safety, tolerability, pharmacokinetics, and efficacy in approximately 80 participants.
- REC-3964 selectively inhibits the bacterial toxin, potentially reducing adverse events compared to antibiotics.
- Preclinical studies showed REC-3964's superiority over bezlotoxumab, with Phase 1 trials indicating good tolerability.
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Oncternal Therapeutics updates safety and efficacy data for ONCT-534 in prostate cancer study
- Oncternal Therapeutics shared updated data from its Phase 1/2 study of ONCT-534 for relapsed or refractory metastatic castration-resistant prostate cancer (mCRPC).
- The study included both once daily (QD) and twice daily (BID) dosing cohorts, with the BID schedule showing no Grade 3 or higher toxicities.
- One patient on 300 mg BID experienced a 50% reduction in PSA and a 16% reduction in target lesions.
- The company is exploring further BID dosing and earlier lines of therapy for ONCT-534.
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Genelux Corporation begins phase 2 trial for Olvi-Vec in non-small cell lung cancer
- The VIRO-25 trial will evaluate the efficacy and safety of Olvi-Vec combined with platinum-doublet chemotherapy and an immune checkpoint inhibitor against docetaxel in recurrent NSCLC.
- This trial marks the second clinical indication for Olvi-Vec via systemic administration.
- Interim results are expected by mid-2025.
- Olvi-Vec is a modified oncolytic vaccinia virus being developed for multiple cancer types.
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PDS Biotech announces design of prostate cancer trial combining androgen receptor inhibitor with immunocytokine
- PDS Biotech to present trial design at Cytokines 2024 in Seoul, South Korea.
- The study will evaluate PDS01ADC combined with Enzalutamide versus Enzalutamide alone.
- The trial targets biochemically recurrent prostate cancer without testosterone-lowering therapy.
- PDS Biotech plans to initiate a pivotal clinical trial in 2024 for advanced HPV16-positive head and neck cancers.
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Immunic announces positive outcome of interim analysis of phase 3 ENSURE program of vidofludimus calcium in relapsing multiple sclerosis
- The Independent Data Monitoring Committee (IDMC) confirmed that the phase 3 ENSURE trials are not futile and recommended continuing without changes.
- The ENSURE program, consisting of two identical trials, aims to evaluate the efficacy, safety, and tolerability of vidofludimus calcium in relapsing multiple sclerosis (RMS).
- Each trial is expected to enroll approximately 1,050 patients across more than 100 sites globally, with completion anticipated in 2026.
- The next milestone is the top-line readout of the phase 2 CALLIPER trial in progressive multiple sclerosis, expected in April next year.
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Data and safety monitoring board approves initiation of phase 2 of OCU410ST GARDian clinical trial for Stargardt disease
- The DSMB has approved the initiation of Phase 2 of the OCU410ST GARDian clinical trial for Stargardt disease.
- Phase 1/2 trial determined the high dose of OCU410ST as the maximum tolerated dose with no serious adverse events reported.
- Phase 2 will proceed with high and medium doses of OCU410ST, a novel gene therapy candidate.
- The trial is being conducted at six leading retinal surgery centers across the U.S.
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Ocuphire Pharma announces acquisition of Opus Genetics
- Ocuphire Pharma acquires Opus Genetics, forming a leading company in gene therapy for inherited retinal diseases.
- The combined company will be renamed Opus Genetics, Inc., and will trade under the ticker 'IRD' on Nasdaq.
- OPGx-LCA5 Phase 1/2 trial shows safety and visual improvement in early-onset retinal degeneration.
- The company plans to seek a strategic partner for the development of APX3330 for diabetic retinopathy.
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Lexicon completes screening in phase 2B study of LX9211 for diabetic peripheral neuropathic pain
- Lexicon Pharmaceuticals has completed screening for the Phase 2B PROGRESS study of LX9211.
- The study is a dose-ranging, randomized, double-blind, placebo-controlled trial for diabetic peripheral neuropathic pain (DPNP).
- Top-line data is now expected in Q1 2025, earlier than initially anticipated.
- LX9211 has received Fast Track designation from the FDA for DPNP.
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Indaptus Therapeutics announces clinical supply agreement with BeiGene to evaluate novel cancer treatment combinations
- Indaptus Therapeutics has entered a clinical supply agreement with BeiGene to evaluate a combination of BeiGene's PD-1 inhibitor, tislelizumab, and Indaptus' Decoy20.
- The planned clinical trial, expected to start in 2025, will explore the potential of this combination to treat various cancers, including liver, colon, and pancreatic.
- Preclinical studies showed promising results with Decoy20 and PD-1 inhibitors, achieving tumor eradication rates of 80-100%.
- Indaptus will seek FDA approval to initiate the trial, marking a significant step in advancing cancer treatment options.
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FDA accepts new drug application and grants priority review for TLX101-CDx brain cancer imaging agent
- The FDA has accepted the NDA for TLX101-CDx (Pixclara), a PET imaging agent for glioma, granting it priority review.
- Pixclara is designed to differentiate between progressive or recurrent glioma and treatment-related changes in both adults and children.
- The agent has been designated as an orphan drug and granted fast track status due to its potential to meet significant unmet medical needs.
- A PDUFA goal date is set for April 26, 2025, with a potential U.S. commercial launch later that year.
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