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Advaxis announced the completion of its merger with Ayala Pharmaceuticals, effective January 19, 2023. The combined entity will operate under the name Ayala Pharmaceuticals, primarily focused on the development of AL102 for treating desmoid tumors. Advaxis will retain its stock symbol ADXS on OTC, with plans to uplist to Nasdaq, though success is not guaranteed. The management team includes Kenneth Berlin as CEO and a board comprising experienced members from both companies. The merger aims to enhance development capabilities for oncology therapeutics, particularly targeting rare cancers.
Advaxis, Inc. (OTCQX: ADXS) reported progress in its Phase 1 clinical study for ADXS-504, targeting biochemically recurrent prostate cancer. Enrollment at the second dose level is expanding following completion of dose escalation, with the drug exhibiting good tolerability and no serious adverse events reported. Four of six patients are still participants, and immune response data is being collected. ADXS-504 aims to generate T cell responses against multiple tumor antigens, potentially improving tumor control. The trial at Columbia University is designed to enhance understanding of safety and efficacy.
Ayala Pharmaceuticals and Advaxis have announced a definitive merger agreement, creating a combined company focusing on oncology therapeutics. Ayala stockholders will own approximately 62.5% of the new entity, while Advaxis stockholders will hold about 37.5%. The merger aims to advance Ayala’s AL102, under Phase 2/3 RINGSIDE study for desmoid tumors, alongside Advaxis’s ADXS-504 for prostate cancer. The combined company intends to pursue a Nasdaq listing and expects to leverage added cash and infrastructure to enhance its clinical portfolio.
Advaxis announces the completion of the first dose level and the initiation of enrollment for the second dose level in the ADXS-504 study for biochemically recurrent prostate cancer. Preliminary results indicate that ADXS-504 monotherapy is safe and well-tolerated. The company plans to present clinical data and PSA values at an upcoming medical conference. Financially, Advaxis reported R&D expenses of $2.2 million, up from $1.7 million YoY, while G&A expenses decreased to $2.1 million from $2.7 million. The company maintains a cash runway into Q3 2024.
Advaxis has reported progress on its Phase 1 study of ADXS-504, an off-the-shelf neoantigen therapy for biochemically recurrent prostate cancer. The study has completed safety evaluations of the first dose level and is moving to the second dose level. Initial results indicate ADXS-504 is safe and well-tolerated, with mild side effects. The therapy aims to generate T cell responses against 24 tumor antigens, potentially enhancing tumor control. Data from both dose levels will be presented at an upcoming medical conference.
Advaxis, a clinical-stage biotechnology company, announced its Q2 financial results for the period ending April 30, 2022, alongside significant clinical updates. The company reported a notable reduction in R&D expenses, totaling $1.5 million, down from $4.3 million year-over-year, due to discontinued studies. Advaxis highlighted encouraging clinical data for ADXS-503 in combination with KEYTRUDA at the 2022 ASCO Annual Meeting, showing a 67% disease control rate in a first-line setting. Additionally, a 1-for-80 reverse stock split was executed to aid NASDAQ listing efforts.
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