Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today announced it has received approval from the French National Agency for the Safety of Medicines and Health Products (ANSM) to proceed with a Phase I/IIa study of the novel oncolytic Vaccinia virus BT-001. This announcement follows the approval received in December 2020 from the Belgian health authorities. The first patient is expected to be enrolled in this trial in the upcoming weeks.
BT-001 IS AN ONCOLYTIC VIRUS GENERATED WITH TRANSGENE’S INNOVATIVE INVIR.IO™ PLATFORM
BT-001 is based on the patented Invir.IO™ oncolytic virus (VVcopTK-RR-), and has been engineered to encode both a Treg-depleting human recombinant anti-CTLA4 antibody generated by BioInvent’s proprietary n-CoDeR®/F.I.R.S.T™ platforms, and the human GM-CSF cytokine. By selectively targeting the tumor microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoral response and greatly increase the safety and tolerability profile of the anti-CTLA4 antibody. BT-001 is being co-developed through a 50/50 collaboration between Transgene and BioInvent.
IN FRANCE, FOUR CLINICAL CENTERS WILL ENROLL PATIENTS
"The development of BT-001 is progressing well and we are pleased to start this clinical trial in France with patients being enrolled across the country in four reference clinical centers, and in other hospitals in Europe. BT-001 is a highly innovative oncolytic virus, that has been designed to achieve a strong anti-tumor response by combining multiple mechanisms of action. We would like to thank the investigators and the clinical teams for their support and look forward to treating the first patients with this first Invir.IO™ generated oncolytic virus candidate to enter clinical development” said Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene.
In France, the BT-001 Phase I/IIa trial will be conducted in four clinical centers: the Bergonié Institute (Bordeaux), the Gustave Roussy Institute (Paris area), the Centre Léon Bérard (Lyon) and the Hôpital Saint-Louis (Paris).
This international study will enroll up to 48 patients with metastatic/advanced solid tumors in its Phase I part followed by expansion cohorts in its Phase IIa part. The trial will evaluate the administration of BT-001 as a single agent and in combination with pembrolizumab, an anti-PD1.
About the trial The trial is a multicenter, open-label, dose-escalation Phase I/IIa trial evaluating BT-001 alone or in combination with pembrolizumab. The trial has been approved in Europe (France and Belgium) and will be next conducted in the USA. The Phase I will be divided into two parts. Part A will enroll up to 36 patients with metastatic/advanced solid tumors, who have already been pretreated, including with immunotherapies. Patients will receive single agent, intra-tumoral administrations of BT-001, in cutaneous or palpable subcutaneous lesions or easily injectable lymph nodes, to select the recommended dose and best regimen. Part B will explore the combination of intra-tumoral injections of BT-001 with pembrolizumab, an anti-PD1 targeting agent in 12 patients. The Phase IIa will evaluate the combination regimen in several patient cohorts with different tumors types. These expansion cohorts will offer the possibility of exploring the activity of this approach to treat other malignancies not traditionally addressed with this type of treatment.
About BT-001 BT-001 is a best-in-class oncolytic virus developed with Transgene’s Invir.IO™ platform. Invir.IO™’s viruses are based on the patented large capacity Vaccinia virus Copenhagen strain genetically modified with the double deletion TK-RR-. This optimization enhances the safety profile of the virus. From this, BT-001 is engineered to encode both a highly differentiated Treg depleting anti-CTLA4 antibody and the human GM-CSF cytokine. The recombinant antibody recognizing human CTLA4 was generated by BioInvent’s proprietary n-CoDeR®/F.I.R.S.T™ platforms. The use of an oncolytic virus to deliver the anti-CTLA4 locally and selectively in the tumor microenvironment allows high intratumoral concentrations of both transgenes eliciting a stronger and more effective antitumor response. By reducing systemic exposure to a very low level, this local therapeutic activity furthermore allows to increase the safety and tolerability profile of the anti-CTLA4 antibody. Preclinical data have shown that BT-001 has potential for broad single agent activity, and that selective tumor-localized delivery of anti-CTLA4 may allow for a better tolerated, sustained and more effective combination therapy with antibodies targeting the PD-1/PDL1 axis.A multicenter, open-label, dose-escalation Phase I/IIa trial evaluating BT-001 alone or in combination with pembrolizumab has been approved in Europe (France and Belgium) and should be next conducted in the USA.The scientific and clinical development of the oncolytic virus candidate BT-001 is a 50/50 collaboration between BioInvent and Transgene.
About Transgene Transgene (Euronext: TNG) is a publicly traded French biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.The Company’s clinical-stage programs consist of two therapeutic vaccines (TG4001 for the treatment of HPV-positive cancers, and TG4050, the first individualized therapeutic vaccine based on the myvac® platform) as well as two oncolytic viruses (TG6002 for the treatment of solid tumors, and BT-001, the first oncolytic virus based on the Invir.IO™ platform).With Transgene’s myvac® platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac® approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC.With its proprietary platform Invir.IO™, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses. Transgene has an ongoing Invir.IO™ collaboration with AstraZeneca.Additional information about Transgene is available at: www.transgene.frFollow us on Twitter: @TransgeneSA
Disclaimer Transgene This press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. There can be no guarantee that (i) the results of pre-clinical work and prior clinical trials will be predictive of the results of the clinical trials currently underway, (ii) regulatory authorities will agree with the Company’s further development plans for its therapies, or (iii) the Company will find development and commercialization partners for its therapies in a timely manner and on satisfactory terms and conditions, if at all. The occurrence of any of these risks could have a significant negative outcome for the Company’s activities, perspectives, financial situation, results and development. For a discussion of risks and uncertainties which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risques”) section of the Universal Registration Document, available on the AMF website (https://www.amf-france.org) or on Transgene’s website (www.transgene.fr). Forward-looking statements speak only as of the date on which they are made, and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.
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DPW Holdings, Inc. (NYSE American: DPW) a diversified holding company ("DPW,” or the "Company”) announced that the Company has complied with all requirements of the Final Order in the Derivative Action and that Howard Ash has joined its board of directors (the "Board”).
As previously disclosed, the United States District Court in the Central District of California (the "Court”) issued a preliminary order on April 15, 2020 (the "Preliminary Order”) approving a Motion for Preliminary Approval of Settlement in the derivative action filed on July 31, 2018. The Preliminary Order approved a definitive settlement agreement dated February 24, 2020 (the "Settlement Agreement”), that was intended to settle the derivative litigation captioned Ethan Young and Greg Young, Derivatively on Behalf of Nominal Defendant, DPW Holdings, Inc. v. Milton C. Ault, III, Amos Kohn, William B. Horne, Jeff Bentz, Mordechai Rosenberg, Robert O. Smith, and Kristine Ault and DPW Holdings, Inc., as the nominal defendant (Case No. 18-cv-6587) (the "Derivative Action”).
As previously disclosed, the Company subsequently announced the issuance of the final order (the "Final Order”), which approved the terms of the Settlement Agreement. On July 16, 2020, the Court entered a Judgment based upon the Final Order (the "Judgement”).
Under the terms of the Final Order approving the Settlement Agreement, the Board has implemented certain reforms to the Company’s bylaws, committee charters, corporate governance policies, and the composition of the Board, including the resignation of Amos Kohn as a member of the Board and as the Company’s President and the appointment of two new independent directors, one of whom, Ms. Jodi Brichan, was appointed to the Board on December 30, 2019. As of August 13, 2020, the Company had fully complied with its obligations under the Final Order and the Judgment.
On August 13, 2020, as noted above, the Company appointed Mr. Ash to the Board.
Mr. Ash will also serve on the audit, compensation and nominating and governance committees.
"I am delighted to join the board of DPW Holdings, Inc. I look forward to bringing my experience to the board and playing a role in the continuing development of the company in realizing and fulfilling its vision,” said Howard Ash.
DPW’s CEO and Chairman, Milton "Todd” Ault, III said, "We are excited to have Howard join our board. We will greatly benefit from his CEO and public company board experience as well as his global operations expertise as DPW continues to execute its strategy of diversified, profitable global growth,” he adds.
Howard Ash is an accomplished executive with extensive experience in business and finance, who served as CEO, COO and CFO to a variety of high profile, international companies. Mr. Ash continues to serve as Chairman of Claridge Management since 2000. Mr. Ash was a director of Net Element, Inc., (NASDAQ-NETE) from June 13, 2016 through July 13, 2020 serving as Chairman of both the Audit and Compensation committees, as well as the Nominating and Governance Committees during his tenure. He served as Chief Operating Officer of BioCard Corporation from 1997 to 2007. He served as Chief Operating Officer of CITA Americas, Inc. from 1996 to 1997. Mr. Ash served as Chief Executive Officer of IEDC Marketing, Inc. from 1992 to 1996. He held a CFO/Chief Strategist position at Abrams, Ash & Associates from 1990 to 1992. Mr. Ash currently serves on the Advisory Board of the UK based E2Exchange, the Institute of Entrepreneurs, since 2011, and is the only non-UK citizen holding that position. Mr. Ash served from 2009 to 2014 in a senior development and strategic capacity for One Laptop Per Child, a global NGO created to provide educational opportunities providing laptops to the world’s poorest children. Prior Chairmanships include the 2009 through 2012 term for the Sturge Weber Foundation, a non-profit organization dedicated to curing this rare but fatal syndrome affecting children. Previously, Mr. Ash was an Advisory Board Member to Edge Global Investment Limited which forged a strategic partnership with the Africa Forum, consisting of 37 former Heads of State and Government. Mr. Ash started an interest-free micro-loan society in 1987 that has provided more than $15 million in micro-loans throughout the United States and Israel. In 1999, Mr. Ash founded the Circle of Life Resource Center, Inc., a food bank in Miami, Florida that feeds several hundred families per week. Howard earned a Bachelor of Commerce degree, with Honors in Accounting and Law from the University of Witwatersrand (South Africa) in 1980. The Company believes that Mr. Ash’s extensive experience as a business and finance executive and member of multiple oversight bodies, provides him with the necessary skills to be qualified to serve as a director of the Company.
While Amos Kohn resigned as a member of the Board and as the Company’s President, he remains the President and CEO of the Company’s wholly owned subsidiary, Coolisys Technologies Corp. The Company acknowledges and thanks Amos for his more than a decade of service as President and looks forward to exciting developments expected from his continued leadership at Coolisys Technologies Corp.
For more information on DPW Holdings and its subsidiaries, the Company recommends that stockholders, investors and any other interested parties read the Company’s public filings and press releases available under the Investor Relations section at www.DPWHoldings.com or available at www.sec.gov.
About DPW Holdings, Inc.
DPW Holdings, Inc. is a diversified holding company pursuing growth by acquiring undervalued businesses and disruptive technologies with a global impact. Through its wholly and majority-owned subsidiaries and strategic investments, the Company provides mission-critical products that support a diverse range of industries, including defense/aerospace, industrial, telecommunications, medical, and textiles. In addition, the Company extends credit to select entrepreneurial businesses through a licensed lending subsidiary. DPW’s headquarters are located at 201 Shipyard Way, Suite E, Newport Beach, CA 92663; www.DPWHoldings.com.
This press release contains "forward looking statements” 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. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "believes,” "plans,” "anticipates,” "projects,” "estimates,” "expects,” "intends,” "strategy,” "future,” "opportunity,” "may,” "will,” "should,” "could,” "potential,” or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and the Company undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect the Company’s business and financial results are included in the Company’s filings with the U.S. Securities and Exchange Commission, including, but not limited to, the Company’s Forms 10-K, 10-Q and 8-K. All filings are available at www.sec.gov and on the Company’s website at www.DPWHoldings.com.
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