Month: December 2015

BioTime Completes Distribution of Approximately 4.75 Million Shares of OncoCyte Corporation Common Stock

On December 31, 2015 BioTime, Inc. (NYSE MKT: BTX), a clinical-stage regenerative medicine company with a focus on pluripotent stem cell technology, has completed its previously reported distribution of approximately 4.75 million shares of common stock of its subsidiary OncoCyte Corporation ("OncoCyte") to BioTime shareholders (Press release, BioTime, DEC 31, 2015, View Source;p=RssLanding&cat=news&id=2125490 [SID:1234508648]). Regular way trading of OncoCyte common stock on the NYSE MKT is expected to begin on January 4, 2016 under the symbol OCX. The distributed shares represent approximately 18.69% of the outstanding shares of OncoCyte. As a result of the distribution of the shares, BioTime’s ownership of OncoCyte has been reduced from approximately 76.4% to approximately 58.55%.

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OncoCyte is primarily focused on the development of novel, non-invasive liquid biopsy diagnostic tests for the early detection of cancer. BioTime shareholders receiving OncoCyte stock will receive an Information Statement containing details regarding the distribution of OncoCyte common stock and OncoCyte’s business and management. The Information Statement is part of a Form 10 filed by OncoCyte with the Securities and Exchange Commission that may be found at the Commission’s website www.sec.gov or at OncoCyte’s website at www.oncocyte.com.

"This distribution is another example of the BioTime’s Board of Directors strategy to provide shareholder value from our assets while we focus our operations on the Company’s clinical-stage regenerative therapeutic candidates based on pluripotent stem cell technology," said Adi Mohanty, BioTime’s Co-Chief Executive Officer. "We look forward to participating as a major shareholder in the progress of OncoCyte as the Company’s management advances development of its molecular diagnostic products toward commercialization."

Any BioTime shareholder who sells their BioTime shares on or before December 31, 2015 will be selling their entitlement to receive OncoCyte shares to the buyer of their BioTime shares. BioTime shareholders are encouraged to speak to their financial advisor before making any financial decisions.

H2Biologics Licenses Worldwide, Exclusive Rights to Develop SD1-Granzyme B Drug Conjugate for Treatment of Mesothelin-Expressing Tumors

On December 31, 2015 H2Biologics reported that it has been granted a worldwide, exclusive license by the Research Development Foundation (RDF) for the use of human granzyme B (GrB), a naturally occurring serine protease, in developing an immunoconjugate with a human single domain antibody (SD1) that targets mesothelin-expressing tumors. Under this agreement and a license agreement with NIH for SD1, H2Biologics can target mesothelioma, pancreatic cancer, ovarian cancer, breast cancer, and lung adenocarcinoma (Press release, H2Biologics, DEC 31, 2015, View Source [SID:1234508651]).

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This group has generated a number of targeted anticancer therapeutic proteins using granzyme B as the payload and demonstrated potent anti-tumor killing in preclinical studies. The many, distinct advantages of using human GrB over conventional toxins are lower systemic toxicity and, therefore, a greater therapeutic index compared to other targeted therapeutic agents, and impressive biological activity without release of GrB from the antibody. The GrB payload has three distinct mechanisms of action resulting in cell death at nanomolar concentrations in cell culture. In vivo studies with GrB-based therapeutics show excellent antitumor efficacy in tumor xenograft models. H2Biologics has entered into a Sponsored Research Agreement with the Clayton Foundation to sponsor additional pre-clinical research under the direction of Dr. Rosenblum. Manufacturing of the designed constructs is expected to begin in January 2016.

H2Biologics will initially evaluate mesotheliomas in preclinical and clinical studies and later expand this evaluation to pancreatic, lung, and ovarian cancers that also express the target mesothelin. The anticipated safety and therapeutic advantages of this human antibody – human serine protease conjugate over other antibody-drug agents in development are minimal or no immunogenicity and toxicity and additive or synergistic effect of its multiple mechanisms of action when used in combination with other immunotherapeutics.

About H2Biologics Inc.
H2Biologics is a startup biotechnology company focusing on the in-licensing, development, and manufacture of targeted immunotherapeutics for the treatment of cancers with unmet needs. It leverages the experience of its team in design, manufacture, and development of improved therapeutic biologics.

About Research Development Corporation
Research Development Foundation is a non-profit supporting organization of the Clayton Foundation for Research and is responsible for filing patents and licensing intellectual property arising from medical discoveries made by the Clayton Foundation. The Foundation conducts or funds medical research programs at leading universities, hospitals and research institutions such as the University of Texas M.D. Anderson Cancer Center.

KaloBios Pharmaceuticals, Inc. Files For Chapter 11 Bankruptcy Protection

On December 30, 2015 KaloBios Pharmaceuticals reported that on December 29, 2015, it filed a voluntary petition for bankruptcy protection under Chapter 11 of Title 11 of the United States Bankruptcy Code (the "Bankruptcy Code") (Press release, KaloBios, DEC 30, 2015, View Source [SID:1234509361]). The filing was made in the United States Bankruptcy Court for the District of Delaware (the "Bankruptcy Court") (Case No. 15-12628).

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The Company will continue to manage and operate its business and assets as a "debtor-in-possession" under the jurisdiction of the Bankruptcy Court and in accordance with the applicable provisions of the Bankruptcy Code and the orders of the Bankruptcy Court.

BioTime Announces “When-Issued” Trading of Subsidiary OncoCyte Corporation in Connection With Planned Distribution

On December 30, 2015 BioTime, Inc. (NYSE MKT: BTX), a clinical-stage regenerative medicine company with a focus on pluripotent stem cell technology, reported that the common stock of its subsidiary OncoCyte Corporation ("OncoCyte") will begin trading today on a "when-issued" basis on the NYSE MKT under the symbol OCX WI. "Regular-way" trading of OncoCyte common stock on the NYSE MKT is expected to begin on January 4, 2016 under the symbol OCX (Press release, BioTime, DEC 30, 2015, View Source;p=RssLanding&cat=news&id=2125391 [SID:1234508644]).

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As previously announced, the Board of Directors of BioTime declared a pro rata distribution of shares of OncoCyte common stock to BioTime shareholders of record as of the close of business on December 21, 2015, the record date. As a result, on December 31, 2015, BioTime shareholders will receive one share of common stock of OncoCyte for every twenty BioTime common shares they held on the record date. Fractional shares of OncoCyte common stock will not be distributed to BioTime shareholders. Instead, the fractional shares of OncoCyte common stock will be aggregated and sold in the open market, with the net cash proceeds distributed pro rata to the BioTime shareholders who otherwise would have received fractional shares of OncoCyte common stock.

No action is required by BioTime shareholders to receive the distributed shares of OncoCyte common stock. BioTime shareholders who held BioTime common shares on the record date and do not sell those shares prior to December 31, 2015 will receive a book-entry account statement reflecting their ownership of OncoCyte common stock or their brokerage account will be credited with OncoCyte shares.

OncoCyte is primarily focused on the development of novel, non-invasive liquid biopsy diagnostic tests for the early detection of cancer. After the distribution of OncoCyte shares, BioTime’s ownership of OncoCyte will be reduced from approximately 76.4% to approximately 58.55%. An "Information Statement" containing details regarding the distribution of OncoCyte common stock and OncoCyte’s business and management is being mailed to BioTime shareholders. The Information Statement is part of a Form 10 filed by OncoCyte with the Securities and Exchange Commission that may be found at the Commission’s website www.sec.gov or at OncoCyte’s website at www.oncocyte.com.

Any BioTime shareholder who sells their BioTime shares on or before December 31, 2015 will be selling their entitlement to receive OncoCyte shares to the buyer of their BioTime shares. BioTime shareholders are encouraged to speak to their financial advisor before making any financial decisions.

This press release does not constitute any offer to sell or a solicitation of an offer to buy OncoCyte common stock.

Lixte Biotechnology Holdings, Inc. Announces Exclusive Licensing Of Their Lead Anti-Cancer Compound LB-100 For Potential Treatment Of Hepatocellular Carcinoma In Asia To Taipei Medical University

On December 30, 2015 Lixte Biotechnology Holdings, Inc. (OTCQB: LIXT) reported that it has granted an exclusive license of its lead anti-cancer compound, LB-100, for treatment of hepatocellular carcinoma (HCC) in Asia to Taipei Medical University (TMU) (Press release, Lixte Biotechnology, DEC 30, 2015, View Source [SID:1234508647]).

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LB-100 is not currently approved for treatment of HCC. Under the license, Taipei Medical University will determine the effectiveness of LB-100 against HCC in clinical trials conducted in compliance with both Taiwanese and American regulatory requirements. TMU will pay milestone and royalty payments to Lixte. Both parties recognize that development of improved therapy for HCC has been very challenging and that success cannot be guaranteed.

John S. Kovach M.D., founder and president of Lixte, said "LB-100 is a novel small molecule that in preclinical studies has activity against a number of different cancer types alone and, most prominently, in combination with cytotoxic drugs, including some known to be active against hepatocellular carcinoma. We welcome an opportunity to work with an outstanding group of investigators in Taiwan to assess the value of LB-100 against this all-too-common and devastating cancer."

HCC is the fifth most common cancer and third most common cause of cancer deaths worldwide, with the majority of those deaths in Asia. The World Cancer Research Fund International reported that 782,000 new cases were diagnosed in 2012 worldwide. There are approximately 35,000 new cases and 24,000 deaths from HCC annually in the US according to the National Cancer Institute.

Taipei Medical University has nine colleges, thirteen undergraduate schools, fifteen graduate institutes, as well as three affiliated hospitals with approximately three thousand beds. TMU is one of the largest health care systems in Taipei, providing teaching, research and clinical services. In 2012 they established the Taipei Cancer Center, the first world-class cancer center in Taiwan, combining cancer research, training and clinical treatment, dedicated to providing the full spectrum of services for adult and pediatric oncology.

About Lixte Biotechnology Holdings, Inc.

Lixte is a drug discovery company that uses biomarker technology to identify enzyme targets associated with serious common diseases and then design novel compounds to attack those targets. Lixte’s product pipeline encompasses two major categories of compounds at various stages of pre-clinical and clinical development that the Company believes have broad therapeutic potential not only for cancer but also for other debilitating and life-threatening diseases. Lixte’s unique phosphatase inhibitor, LB-100, is in a Phase I clinical trial at two NCI designated Comprehensive Cancer Centers and three US Oncology Research sites (see ClinicalTrials.gov: Identifier NCTO1837667).