Cancer Drug Developer “Biosight” Lists on Nasdaq

Biosight has merged with US immunotherapy company Advaxis at a company valuation of
$280 million and will trade under the BSTX sticker. The company’s investors (Arkin Holdings, Israel Biotechnology Fund (IBF), SBI Fund, Phoenix Assurance Company, Migdal Insurance, Primera Fund, Dubi Zahavi, and Raya Strauss) will receive 75% of the merged company. Advaxis has $50 million in cash in the company.

The merged company will be renamed Biosight Therapeutics. The proposed merger will create a public company that will prioritize the clinical advancement and commercialization of Biosight ’s lead product, aspacytarabine (BST-236). The combined company is expected to have approximately $50 million in cash, cash equivalents, and marketable securities at closing. Following the closing, which is expected to occur in the second half of 2021, Advaxis will be renamed Biosight Therapeutics and is expected to trade on the Nasdaq Capital Market under the ticker symbol “BSTX”.

Effective as of the closing of the transaction, Ken Berlin will be the President and Chief Executive Officer of the combined company. The senior leadership of the combined company will also include Roy Golan, as Chief Financial Officer, Andres Gutierrez, M.D., Ph.D., and Darrel Cohen, M.D., Ph.D. as Chief Medical Officers. Additionally, effective as of the closing of the merger, the Board of Directors of the combined company will be comprised of nine directors: six designated by Biosight and two to be designated by Advaxis, and Dr. David Sidransky will be nominated as Chairman of the Board.

Biosight is developing innovative cancer therapeutics for hematological malignancies and disorders. The combined company plans to advance its pipeline through multiple clinical trials, and anticipates the following milestones over the next 12-18 months:

• The company’s lead asset, BST-236 (aspacytarabine), has been investigated in a multi-center Phase 2 study in the US and Israel as a single agent, first-line treatment of Acute Myeloid Leukemia (AML) for patients who are unfit for standard chemotherapy.

According to Arkin Holdings head of pharma division, Dr. Pini Orbach, “The drug works with 40% in the trial showing complete remission from AML with few side-effects. Many of the patients were seriously ill.” For more information regarding this Phase 2b clinical study of BST-236, visit www.clinicaltrials.gov.

  • An additional Phase II trial in Europe to evaluate BST-236 in second-line relapsed/refractory Myelodysplastic Syndrome (MDS) and AML has begun. (An additional Phase II is planned for the US.) The investigator-sponsored trial is being led by Dr. Pierre Fenaux of the Groupe Francophone des Myelodysplasies (GFM), the French Study Group of the European Myelodysplastic Syndromes. (MDS) Cooperative Group (EMSCO). GFM is a non-profit organization comprised of most French hematology centers that conducts and sponsors clinical trials and translational research and coordinates diagnostic and therapeutic guidelines for MDS;
  • Initiation in the U.S. of a second, Phase 2 trial of aspacytarabine in patients with relapsed/refractory AML and higher-risk MDS;
  • Results from the ongoing Phase 1/2 trial with ADXS-503 in combination with pembrolizumab in non-small cell lung cancer; and
  • Results from the Phase 1 trial of ADXS-504 in biochemically recurrent prostate cancer.

“This new trial is an important step forward in expanding the reach of aspacytarabine to a broader patient population addressing the unmet needs in the treatment of relapsed/refractory AML and MDS, ” said Dr. Ruth Ben Yakar, Chief Executive Officer of Biosight , “initiating an additional trial furthers our clinical momentum, building on updated, encouraging data from our ongoing first-line Phase 2b study presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and the receipt of Orphan Medicinal Product Designation for the European Medicines Agency. GFM is an ideal partner to expand the clinical evaluation into MDS with their extensive network of hematology centers, including registered centers of excellence, and we look forward to applying their expertise in clinical trials, treatments, and diagnostics as we advance this Phase 2 trial.”

Professor Pierre Fenaux, M.D., Ph.d., Head of Hematology at Hospital Saint Louis in Paris and founding member and Chairman of GFM, said, “The first-line Phase 2b data that was presented at ASCO, with demonstrated efficacy across key measures including encouraging complete remission and negative minimal residual disease rates, duration of response and overall survival, further increase my conviction that aspacytarabine may serve as a more tolerable, end effective standard of care treatment for patients with both AML and MDS. We are thrilled to be collaborating with Biosight to advance this potentially transformative treatment for relapsed or refractory MDS.”

About Biosight Ltd. 

Biosight is a private Phase 2 clinical-stage biotech company developing innovative therapeutics for hematological malignancies and disorders. The company’s investigational product, aspacytarabine (BST-236) is an innovative proprietary anti-metabolite that addresses unmet medical needs by enabling high-dose chemotherapy with reduced systemic toxicity.

It is composed of cytarabine covalently bound to asparagine, acting as a pro-drug of cytarabine. Cytarabine serves as the backbone of AML therapy for over 45 years due to its superior efficacy. However, it is associated with severe bone marrow, gastrointestinal and neurological toxicities which significantly limit its use, especially in older and medically compromised patients. Due to its unique pharmacokinetics and metabolism, aspacytarabine enables high-dose therapy with lower systemic exposure to free cytarabine and relative sparing of normal tissues. As such, aspacytarabine may serve as a new therapy for AML and other hematological malignancies and disorders, including for older adults who are unfit for intensive therapy.

For additional information, visit Biosight Ltd.  www.biosight-pharma.com .

About Advaxis, Inc.

Advaxis, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into single immunotherapy and are designed to access and direct antigen-presenting cells to stimulate tumor T cell immunity, activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable T cells to eliminate tumors. For additional information visit www.advaxis.com.

Source: Intrado Newswire

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