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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 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.
Advaxis, Inc. (OTCQX: ADXS) announced a one-for-80 reverse stock split effective June 6, 2022. This decision follows the approval by stockholders on March 31, 2022, to implement a reverse split within a specified range. The split aims to enhance the company's position for strategic initiatives and facilitate approval for listing on The Nasdaq Capital Market. Each 80 shares will convert to one share, and adjustments will be made to stock options and warrants. Fractional shares will be cashed out based on the stock's closing price on the split date.
Advaxis, Inc. (OTCQX: ADXS) announced updated results from its ADXS-503 clinical trial, showing a 14% overall response rate (ORR) and a 36% disease control rate (DCR) among patients who previously progressed on KEYTRUDA®. In the first-line setting (Part C), DCR reached 67%. The trial assesses safety, tolerability, and immune responses in combination with KEYTRUDA® for metastatic NSCLC. Notably, durable clinical benefits were linked to immune activation involving NK cells and T-cells. Enrollment for further evaluation continues, aiming for an ORR of ≥20% in patients failing KEYTRUDA®.
Advaxis, Inc. (OTCQX: ADXS) announced its participation in the ASCO Annual Meeting, scheduled for June 3-7, 2022. The company will present data from two studies: a Phase 2 study of ADXS-503 in combination with pembrolizumab for metastatic non-small cell lung cancer and a Phase 1 study of ADXS-504 for biochemically recurrent prostate cancer. Key presentations include:
- Abstract #9038: ADXS-503 in NSCLC on June 6, 2022, 8-11 AM CDT.
- Abstract #9042: Immunogenicity in NSCLC on June 6, 2022, 8-11 AM CDT.
- Abstract #TPS5115: ADXS-504 on June 6, 2022, 1:15-4:15 PM CDT.
Advaxis, Inc. (ADXS) announced promising results from the KEYNOTE-46 Phase 1/2 trial, which evaluated ADXS-PSA combined with KEYTRUDA® in metastatic castration-resistant prostate cancer (mCRPC). Patients receiving the combination therapy showed a median overall survival (OS) of 33.7 months compared to 7.8 months with ADXS-PSA alone. For those with visceral metastasis, the OS was notably improved to 16.4 months. The study demonstrated that the therapy is safe, with manageable side effects. Advaxis continues to explore further development of Listeria monocytogenes-based immunotherapies.
Advaxis, Inc. (OTCQX: ADXS) announced its financial results for Q1 2022 and provided updates on its Phase 1/2 trial of ADXS-503 in NSCLC. The study yielded a 15.4% overall response rate and a 46% disease control rate with durable benefits. The company reported reduced R&D expenses of $1.7 million versus $2.6 million in Q1 2021 and decreased G&A expenses of $2.5 million from $3.0 million year-over-year. Advaxis also announced a $5 million convertible redeemable preferred stock offering. As of January 31, 2022, cash and equivalents stood at $36.5 million.
Advaxis, Inc. (OTCQX: ADXS) reported its fiscal year 2021 results, showcasing a focus on immunotherapy development. Key highlights include updated clinical data from the Phase 1/2 trial of ADXS-503 in NSCLC, revealing a 15% overall response rate and a 67% disease control rate in newly diagnosed subjects. The company initiated a Phase 1 trial for ADXS-504 targeting early prostate cancer. Financially, Advaxis ended the year with $41.6 million in cash, reporting a net loss of $17.9 million, down from $26.5 million in FY 2020.
Advaxis, Inc. (OTCQX: ADXS) announced a private placement agreement for 1,000,000 shares of Series D convertible redeemable preferred stock, totaling $5,000,000. Each share is priced at $4.75 with a 5% discount. The shares are convertible into common stock at $0.25 per share, contingent on stockholder approval for a reverse stock split. The offering is expected to close on January 31, 2022. This move aims to strengthen the company's financial position amid ongoing clinical development of its immunotherapy products.
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