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Ayala Pharmaceuticals, Inc. (OTCQX: ADXS) is a publicly traded, clinical-stage oncology company that focuses on the development and commercialization of small molecule therapeutics. The company primarily targets rare tumors and aggressive cancers through its innovative treatments. Ayala's leading candidate, AL102, is an investigational small molecule gamma secretase inhibitor currently in the Phase 3 RINGSIDE study for the treatment of desmoid tumors. The promising data from Phase 2 shows significant anti-tumor activity and high overall response rates.
Ayala's strategic vision was further enhanced by its merger with Biosight Ltd., which brought aspacytarabine (BST-236), a novel proprietary anti-metabolite for first-line treatment in unfit acute myeloid leukemia (AML), into its portfolio. AL102 has received FDA Fast Track and Orphan Drug Designations for the treatment of desmoid tumors, highlighting its potential impact in oncology.
Recently, Ayala entered into a definitive asset purchase agreement with Immunome, Inc. to sell AL102 and related drug candidate AL101. This agreement, valued at over $50 million, will allow Immunome to advance AL102 through clinical trials and towards potential commercialization. The transaction is expected to be completed by the end of Q3 2024, pending regulatory approvals.
Ayala is committed to advancing its remaining pipeline, which includes aspacytarabine (BST-236) for AML. Despite the sale of its key assets, Ayala continues to focus on developing impactful treatments within oncology, leveraging its expertise and the clinical data it has gathered.
For more information, please visit www.ayalapharma.com.
Advaxis, Inc. has initiated a Phase 1 clinical study of ADXS-504, an off-the-shelf neoantigen immunotherapy, targeting biochemically recurrent prostate cancer. Conducted at Columbia University, this study represents the first evaluation of ADXS-504 in this patient group. The trial will assess safety, tolerability, and preliminary clinical responses, involving 9-18 participants receiving the treatment every four weeks. ADXS-504 aims to elicit T cell responses against multiple tumor antigens, potentially delaying the start of androgen blockade therapy. The company aims to expand its ADXS-HOT program with this new application.
Advaxis, a clinical-stage biotechnology company, will present data from its Phase 1/2 study of ADXS-503 combined with Pembrolizumab for treating metastatic non-small cell lung cancer at the Non-Small Cell Lung Cancer Drug Development Summit on July 15, 2021. The presentation by Andres Gutierrez, M.D. focuses on the potential of neoantigen immunotherapies to overcome resistance to PD-1 inhibitors. The session will take place virtually at 9:30 AM EDT.
Advaxis is dedicated to advancing immunotherapy products using bioengineered Listeria monocytogenes.
The merger between Advaxis and Biosight aims to establish Biosight Therapeutics, focusing on advancing clinical-stage oncology programs, particularly aspacytarabine (BST-236) for treating Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS). Post-merger, the company expects approximately $50 million in cash. Key milestones in the next 12-18 months include Phase 2 trial results and new trials. The merger has received unanimous board approval, with Biosight shareholders owning 75% of the new entity, which will trade as BSTX on Nasdaq.
Advaxis, Inc. (ADXS) announced Phase 1/2 trial data for ADXS-503 at ASCO 2021, demonstrating a 44% disease control rate in patients who previously failed KEYTRUDA®. The therapy showed durable clinical benefits, including stable disease for over a year and partial responses. The company plans to expand its ADXS-HOT program with a new study in early prostate cancer. Financially, Advaxis reported cash reserves of $48.1 million, providing a runway into Q3 2023, alongside increased R&D expenses of $4.34 million for the quarter.
Advaxis, Inc. (NASDAQ: ADXS) announced positive updated results from its ongoing Phase 1/2 study of ADXS-503 in combination with KEYTRUDA®. The study revealed a disease control rate of 44% in patients with non-small-cell lung cancer (NSCLC) who progressed on pembrolizumab. Notably, durable clinical benefits were observed, with some patients maintaining stable disease beyond one year. The combination therapy exhibited a favorable safety profile. The company aims to expand its clinical research, including a Phase 1 study for ADXS-504 targeting early prostate cancer.
Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company, has announced it will present data from Part B of its Phase 1 study on ADXS-503, in combination with pembrolizumab, at the ASCO Annual Meeting on June 4-8, 2021. The presentation will focus on an off-the-shelf multi-neoantigen vector designed for patients with metastatic non-small cell lung cancer (NSCLC) who have progressed on pembrolizumab. The session is scheduled for June 4, 2021, at 9:00 AM (EDT), with abstract number 2616.
Advaxis, Inc. (NASDAQ: ADXS) announced a major milestone in its partnership with OS Therapies for the ADXS-HER2 program aimed at treating osteosarcoma. The recent financing by OS Therapies triggered a milestone payment to Advaxis, enhancing its financial resources as it advances its ADXS-HOT neoantigen program. Advaxis aims to further develop ADXS-503 and ADXS-504, with ongoing clinical studies showing promise. The press release highlights the potential of these therapies, which integrate advanced immunotherapy technology to stimulate anti-tumor immune responses.
Advaxis, Inc. (NASDAQ: ADXS) has received a second milestone payment regarding its licensing agreement for ADXS31-164 (ADXS-HER2) with OS Therapies for treating osteosarcoma. OS Therapies is responsible for a clinical study, having recently secured financing. Advaxis stands to gain additional milestone payments and royalties from future sales. The funding supports Advaxis's ADXS-HOT neoantigen program, with ongoing clinical studies for ADXS-503 in NSCLC and ADXS-504 for prostate cancer expected to enter the clinic shortly.
Advaxis, Inc. (Nasdaq: ADXS) announced a definitive agreement with institutional investors for the purchase of 17,577,400 shares of common stock, 7,671,937 pre-funded warrants, and registered warrants for 11,244,135 shares, generating total proceeds of approximately $14 million. The offering is priced at $0.7921 per share and $0.7911 per pre-funded warrant. The funds will support research initiatives, including the ADXS-HOT program, and potential investments in other businesses. The offering follows SEC regulations and is executed by A.G.P./Alliance Global Partners.
Advaxis (ADXS) has collaborated with Precision for Medicine to develop a novel flow cytometry assay to evaluate PD-1 expression as a pharmacodynamic biomarker in T cells during PD-1 blockade. The assay can determine PD-1 expression independent of receptor status, including both free and drug-bound PD-1. Data presented at the AACR Annual Meeting 2021 indicate that patients treated with ADXS-503 in combination with KEYTRUDA displayed significant activation of immune responses, offering insights into enhanced treatment strategies in non-small cell lung cancer (NSCLC). The ongoing Phase 1/2 trial aims to establish the safety and clinical activity of ADXS-503.
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