Advaxis Inc - ADXS stock

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OTC Symbol: ADXS | OTC Tier: OTCQX U.S.

About ADXS

Advaxis, Inc. (OTC: ACXS) is a clinical-stage biotechnology firm primarily concerned with creating and marketing Lm-based antigen delivery systems of its own intellectual property. The foundation of this immunotherapy is a platform technology that uses live attenuated Listeria monocytogenes (Lm) that has been bioengineered to release antigen/adjuvant fusion proteins. According to our projection engine, the stock's future price is forecast to be 3.667691319805 dollars, an increase of 241.181% after one year. This indicates that if you invest $100 right now, your current investment may be worth 341.181 dollars on Friday, December 29, 2023, assuming you wait until then to cash it in. Advaxis, Inc. is a clinical-stage biotechnology company based in the United States that specializes in the research, development, and sale of antigen-delivery devices based on the company's patented Listeria monocytogenes (Lm) technology. Advaxis was founded in 1999 and has grown to become one of the most successful biotechnology companies in the world.

Products

ADXS-PSA, the company's therapy for metastatic prostate cancer, is currently in Phase 2 clinical studies. ADXS-503, the company's non-small cell lung cancer treatment, is currently in Phase 1/2 clinical trials. ADXS-504, the company's therapy for prostate cancer, is currently in Phase 2 clinical studies. In addition, clinical studies are now being done employing immunotherapy produced by Lm Technology for illnesses such as those connected with the human papillomavirus (HPV) and prostate cancer. The company has created partnerships and collaborations with various firms, including Merck & Co., Inc., OS Therapies, LLC, Aratana Therapeutics Inc., Biocon Limited, Global BioPharma Inc., Knight Therapeutics Inc., and others. Since its foundation in 2002, Advaxis, Inc. has considered the town of Monmouth Junction in the state of New Jersey it is home.

AL102 for the Treatment of Desmoid Tumors

Ayala Pharmaceuticals announced the successful completion of an informative End-of-Phase-2 meeting with the U.S. Food and Drug Administration. Following the meeting, the company confirms that it has reached an agreement with the FDA on key aspects of the randomized Phase 3 component of the RINGSIDE study. AL102, the investigational drug being studied, has been granted Fast Track designation by the U.S. FDA for the treatment of progressing desmoid tumors, a rare disease for which there are currently no approved treatments. The FDA has accepted the company's selection of the 1.2 mg once daily dose for evaluation in the ongoing Phase 3 and has also approved the completed and proposed clinical pharmacology plan. In accordance with the previously agreed seamless Phase 2/3 design, enrollment in the Phase 3 segment of the RINGSIDE study began in November 2022 and is progressing as planned on a global scale, with a target enrollment of 156 patients. The Phase 3 portion of the RINGSIDE study is a double-blind, multi-center trial involving up to 156 patients with progressive disease. Participants are randomly assigned to receive either AL102 1.2mg once daily or a placebo. The primary endpoint of the study is progression-free survival (PFS), and secondary endpoints include objective response rate (ORR), duration of response (DOR), and patient-reported Quality of Life (QOL) measures.

ADXS-504 Trials

In July, 2021, Advaxis announced the commencement of a Phase 1 clinical study to assess ADXS-504 in patients with biochemically recurrent prostate cancer. This study, taking place at Columbia University Irving Medical Center, marks the first clinical evaluation of ADXS-504, which is Advaxis' off-the-shelf neoantigen immunotherapy drug candidate designed for early-stage prostate cancer. Dr. Mark Stein, an associate professor of medicine in the Division of Hematology/Oncology at Columbia University Vagelos College of Physicians and Surgeons, is leading the study as the principal investigator.

The Phase 1 open-label dose escalation study will primarily focus on evaluating the safety and tolerability of two dosage levels (1e7 and 1e8 CFU) of ADXS-504 monotherapy. The drug will be administered via infusion every four weeks for a total of six doses in 9-18 patients with biochemically recurrent prostate cancer. These patients exhibit elevated levels of prostate-specific antigen (PSA) in their blood following radical prostatectomy or radical radiotherapy (external beam or brachytherapy) and are not currently undergoing androgen ablation therapy. The study will also assess preliminary clinical and immune responses following treatment with ADXS-504 monotherapy.

ADXS-504 is an innovative immunotherapy based on the Listeria monocytogenes (Lm) platform. It is bioengineered to stimulate T cell responses against 24 tumor antigens, including 14 peptide antigens derived from commonly occurring and widely shared hotspot mutations in prostate cancer patients, as well as 10 peptide antigens derived from sequence-optimized tumor-associated antigens (TAAs) that exhibit differential or overexpression in prostate cancer. ADXS-504 aims to induce a broad set of effector T cells for tumor control by expressing multiple tumor antigen targets. Similar to Advaxis' other Lm-based immunotherapies, ADXS-504 is expected to elicit an innate immune response, followed by an adaptive response and the alteration of the immunosuppressive tumor microenvironment (TME). This is achieved through the reduction of regulatory T cells (Tregs) and myeloid-derived suppressor cell (MDSC) frequencies in the TME.

Merger with BioSight

Ayala Pharmaceuticals, Inc. and BioSight Ltd., a privately-owned pharmaceutical company specializing in innovative treatments for hematological malignancies and disorders, have officially agreed to merge in an all-stock transaction. After the merger is finalized, the newly combined company will adopt the name Ayala Pharmaceuticals, Inc. and will continue to be traded on the OTCQX under Ayala's existing ticker symbol ("ADXS").