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Biosight Announces Initiation of Phase 2 Clinical Trial of Aspacytarabine for MDS and AML

·9 min read

U.S. Based Phase 2 Trial will Evaluate Aspacytarabine in Second Line Relapsed/Refractory MDS and AML across 18 Sites

Builds Upon Ongoing Phase 2 Investigator Sponsored Study with the Groupe Francophone des Myélodysplasies

AIRPORT CITY, Israel, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Biosight Ltd., a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, today announced the initiation of a Phase 2 trial to evaluate aspacytarabine (BST-236), Biosight’s proprietary antimetabolite, as a second line treatment for patients with relapsed or refractory myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). The multi-center study will be conducted across 18 leading U.S. and Israeli sites including Memorial Sloan Kettering Cancer Center and The University of Texas MD Anderson Cancer Center.

“Biosight has built a strong foundation of compelling data that suggests that aspacytarabine may serve as a more tolerable and effective standard of care treatment for patients with AML,” said Dr. Ruth Ben Yakar, Chief Executive Officer of Biosight. “The initiation of this multi-center, U.S. based, Phase 2 study is an important step forward in the development of aspacytarabine, seeking to address unmet needs in the treatment of patients with relapsed or refractory AML and MDS. We are proud to be continuing our momentum in the clinic and look forward to collaborating with leading academic medical centers as we progress the study.”

Eytan Stein, M.D., Hematologic Oncologist at Memorial Sloan Kettering Cancer Center and lead investigator of the study said “I’m encouraged by the results from Biosight’s Phase 2b trial to be presented at the 63rd American Society of Hematology (ASH) Annual Meeting. The efficacy achieved in a challenging population, across key measures including complete remission and MRD (-) rates, duration of response and overall survival, are noteworthy. Furthermore, these results were particularly impressive as they were achieved with a favorable safety and tolerability profile in patients who are unfit for intensive chemotherapy. Patients with relapsed or refractory AML and MDS have limited treatment options and poor prognoses, with many patients unable to tolerate intensive chemotherapy. I look forward to leading this new Phase 2 study to evaluate the potential of aspacytarabine which may ultimately become the standard of care for relapsed or refractory MDS and AML patients for whom currently there are no effective treatments.”

The Phase 2 open label multi-center study will assess the safety and efficacy of BST-236 as a single agent in adult patients unfit for standard therapy with AML or higher-risk (HR)MDS who fail to respond to, or have relapsed following, first line therapy. A similar study in patients with relapsed/refractory AML and MDS is ongoing in collaboration with the European cooperative group, Groupe Francophone des Myélodysplasies (GFM). Approximately 40 adult patients with relapsed and/or refractory AML and approximately 40 adult patients with relapsed and/or refractory HR MDS will be enrolled into the two studies. Primary endpoints include complete remission (CR) rate in AML patients and Overall Response Rate (ORR) in MDS patients, with ORR defined as the proportion of patients who achieve a CR or partial response (PR) per proposal for modification of the International Working Group (IWG) criteria for MDS, 2006.

About Aspacytarabine (BST-236)

Aspacytarabine is a novel proprietary anti-metabolite. It is composed of cytarabine covalently bound to asparagine, acting as a pro-drug of cytarabine. Cytarabine has served 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.

Aspacytarabine was granted FDA Fast Track Designation for treatment of AML patients unfit for standard chemotherapy, and FDA and EMA Orphan Drug Designations, which entitle Biosight to seven and ten years of market exclusivity in the U.S. and Europe, respectively, upon aspacytarabine marketing approval for the treatment of AML in each territory.

Interim results from an ongoing Phase 2b study evaluating aspacytarabine as a single-agent first-line AML therapy demonstrate safety and single-agent activity, and additional studies are ongoing to evaluate aspacytarabine as a second line treatment for patients with relapsed or refractory MDS or AML. For more information regarding the Phase 2b clinical study of BST-236, please visit www.clinicaltrials.gov.

About Biosight Ltd.

Biosight is a private Phase 2 clinical stage biotech company developing innovative therapeutics for hematological malignancies and disorders. Biosight’s lead product, aspacytarabine (BST-236), is an innovative proprietary anti-metabolite which addresses unmet medical needs by enabling high-dose chemotherapy with reduced systemic toxicity. Aspacytarabine is currently being investigated as a single agent in a Phase 2b clinical trial, which recently completed enrollment, for the first-line treatment of AML. Interim results demonstrate tolerability with promising efficacy in the challenging population of AML patients unfit for intensive standard-of-care chemotherapy. Additional Phase 2 studies are ongoing in patients with relapsed/refractory AML and MDS, including a study in collaboration with the European cooperative group, Groupe Francophone des Myélodysplasies (GFM). For additional information, please visit www.biosight-pharma.com.

Important Additional Information and Where to Find It

In connection with the proposed business combination between Biosight and Advaxis, Inc. (“Advaxis”) pursuant to the Agreement and Plan of Merger and Reorganization, dated July 4, 2021 by and among Advaxis, Biosight and other parties referenced therein (the “Merger Agreement”), Advaxis filed with the U.S. Securities and Exchange Commission (the “SEC”) a definitive proxy statement/prospectus contained in a registration statement on Form S-4, as amended, and Advaxis has mailed the definitive proxy statement/prospectus and other relevant documentation to Advaxis stockholders. This press release does not contain all the information that should be considered concerning the proposed transaction. It is not intended to form the basis of any investment decision or any other decision in respect of the proposed business combination. BIOSIGHT STOCKHOLDERS, ADVAXIS STOCKHOLDERS AND OTHER INTERESTED PERSONS ARE ADVISED TO READ THE DEFINITIVE PROXY STATEMENT/PROSPECTUS IN CONNECTION WITH THE SOLICITATION OF PROXIES FOR THE SPECIAL MEETING TO BE HELD TO APPROVE THE TRANSACTIONS CONTEMPLATED BY THE PROPOSED BUSINESS COMBINATION BECAUSE THESE MATERIALS CONTAIN IMPORTANT INFORMATION ABOUT BIOSIGHT, ADVAXIS AND THE PROPOSED TRANSACTION. The definitive proxy statement/prospectus was mailed to Advaxis stockholders of record as of September 19, 2021. Stockholders are also able to obtain a copy of the definitive proxy statement/prospectus free of charge at Advaxis’ website at www.advaxis.com or by written request to Advaxis at 9 Deer Park Drive, Suite K-1, Monmouth Junction, NJ, Attention: Igor Gitelman, VP of Finance and Chief Accounting Officer. The proxy statement/prospectus and other documents relating to the proposed transaction can also be obtained free of charge from the SEC’s website at the SEC’s website at www.sec.gov or from Advaxis by contacting Advaxis’ external Investor Relations firm, LifeSci Advisors, LLC, at tim@lifesciadvisors.com.

Completion of the proposed transactions is subject to approval by the stockholders of Advaxis and certain other conditions. The proposed transaction is expected to close shortly after the special meeting assuming all conditions are met.

Participants in the Solicitation
Biosight and Advaxis and their respective directors and executive officers may be considered participants in the solicitation of proxies with respect to the proposed transaction. Information regarding such directors and executive officers, including a description of their interests, by security holdings or otherwise, in the proposed transaction are set forth in the definitive proxy statement/prospectus filed with the SEC regarding the proposed transaction. Stockholders, potential investors and other interested persons should read the definitive proxy statement/prospectus carefully before making any voting or investment decisions. These documents can be obtained free of charge as described in the preceding paragraph.

Forward-Looking Statements

This communication contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statements that express the current beliefs and expectations of management, including but not limited to statements related to the risk that the proposed transaction may not be completed in a timely manner or at all, which may adversely affect Biosight’s and/or Advaxis’ business and the price of the common stock of Advaxis; the failure of either party to satisfy any of the conditions to the consummation of the proposed transaction, including the adoption of the Merger Agreement by Advaxis’ stockholders and the receipt of certain governmental and regulatory approvals; uncertainties as to the timing of the consummation of the proposed transaction; the occurrence of any event, change or other circumstance that could give rise to the termination of the Merger Agreement; the effect of the announcement or pendency of the proposed transaction on Biosight’s and/or Advaxis’ business relationships, operating results and business generally; risks that the proposed transaction disrupts current plans and operations and the potential difficulties in employee retention as a result of the proposed transaction; risks related to diverting management’s attention from Biosight’s and/or Advaxis’ ongoing business operations; the outcome of any legal proceedings that may be instituted against Biosight and/or Advaxis related to the Merger Agreement or the proposed transaction; unexpected costs, charges or expenses resulting from the proposed transaction; Biosight’s and Advaxis’ respective history of net operating losses and uncertainty regarding their ability to achieve profitability; expected clinical development of their drug product candidates, statements about their respective balance sheet positions, including the sufficiency of their cash and cash equivalents to fund obligations into the future, and statements related to the goals, plans and expectations for their ongoing clinical studies, including the study announced by this press release. These and other risks are discussed in Advaxis’ filings with the SEC, including, without limitation, the definitive proxy statement on Schedule 14A, filed on October 29, 2021, its Annual Report on Form 10-K, filed on January 22, 2021, and its periodic reports on Form 10-Q and Form 8-K. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Biosight and Advaxis caution readers not to place undue reliance on any forward-looking statements, which speak only as of the date they were made. Biosight and Advaxis undertake no obligation to update or revise forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise.

Contact:
Chuck Padala
646-627-8390
LifeSci Advisors, LLC