Oncology Venture A/S Issues 1,619,912 Shares in Exchange for Previously Annulled Warrants

On October 6, 2020 Oncology Venture A/S ("OV" or the "Company") reported that a small group of recipients has received a total of 1,619,912 shares in Oncology Venture A/S (Press release, Oncology Venture, OCT 6, 2020, View Source [SID1234568159]).

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The share issue was announced on 21 August 2020 and concerns warrants of certain OV employees, board members, and consultants who were previous holders of warrants in Oncology Venture Sweden AB. These warrants have since been annulled, and the share issue announced today concludes the related clean-up of the obligations related to this annulment, incurred prior to departure of the prior management team.

Following the share issue, the registered share capital of Oncology Venture A/S is nominal DKK 9,668,713.15 divided into 193,374,263 shares of nominal DKK 0.05 each.

For additional information, please see the relevant press release announcing the issue published on 21 August 2020:

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HUYA Bioscience International Submits HBI-8000 Monotherapy for Adult T-cell Leukemia/Lymphoma for Regulatory Approval in Japan

On October 6, 2020 HUYA Bioscience International (HUYABIOTM ), the leader in accelerating global development of China’s pharmaceutical innovations, reported the submission of a regulatory application to the Japanese Pharmaceuticals and Medical Devices Agency for HBI-8000 monotherapy for relapsed or refractory (R/R) adult T-cell leukemia/lymphoma (ATL) (Press release, HUYA Bioscience, OCT 6, 2020, View Source [SID1234568175]).

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Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "The submission of the regulatory application in Japan for R/R ATL is a significant milestone for HUYABIO. The durability and strong immuno-oncology properties of HBI-8000 sets the stage for improved cancer treatment of both solid and liquid tumors. We look forward to drug approval and a positive impact on the quality of life of these patients."

The new drug application is based on data from a Phase 2b study that involved 23 patients with aggressive ATL in Japan. These patients all had advanced disease either refractory or relapsed after receiving mogamulizumab and had few effective treatment options. HBI-8000 40mg orally administered twice weekly resulted in disease response in a clinically meaningful proportion of patients with an acceptable safety profile.

"Aggressive ATL is primarily a disease of the elderly with a poor three-year survival rate of 25%. There are few effective treatment options. It remains to be an important unmet medical need in Japan and a challenging public health issue. Clinical data from HBI-8000 has shown the promise to fulfill such a need. Orphan Drug Designation has been granted to HBI-8000 for R/R ATL, and peripheral T-cell lymphoma", said Dr. Bob Goodenow, President of HUYABIO.

About HBI-8000

HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylase (HDAC) and suppresses the expression of the viral oncogene HTLV-I bZIP factor, nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and the inflammasome in ATL cells. Furthermore, HBI-8000 may induce latent viral antigen expression making ATL cells more sensitive to immune cytotoxicity targeting.

Transgene, NEC and BostonGene Announce Strategic Collaboration for Two Ongoing Clinical Trials for Patients with Ovarian and Head & Neck Cancers

On October 6, 2020 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, NEC Corporation (NEC; TSE: 6701), a leader in IT and network technologies, and BostonGene Corporation (BostonGene), a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, reported a strategic collaboration for two ongoing Phase 1 clinical trials of TG4050, an individualized therapeutic vaccine for ovarian and head & neck cancers based on Transgene’s proprietary myvac platform and NEC’s AI-driven Neoantigen Prediction System in Europe and the United States (Press release, NEC, OCT 6, 2020, View Source [SID1234568106]).

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Transgene’s myvac platform brings together a series of highly innovative technologies, such as viral genome engineering, to achieve high-speed modular manufacturing of bespoke immunotherapies.

TG4050 is an individualized cancer vaccine based on the myvac platform; it is based on an optimized viral platform for cancer vaccination and integrates NEC’s artificial intelligence capabilities. This therapeutic vaccine aims at stimulating the immune system of patients to induce a T-cell response against tumor-specific antigenic alterations, called neoantigens. These neoantigens are derived from genomic mutations and selected using NEC’s Neoantigen Prediction System, an advanced AI technology that has already been applied in the field of oncology. TG4050 has been designed to target up to 30 patient-specific neoantigens. Transgene is sponsoring two Phase 1 trials that are expected to deliver a first proof of concept of this virus-based individualized approach.

As part of the collaboration, BostonGene will conduct genomic and transcriptomic analyses of primary patient tumors collected from patients enrolled in these two clinical trials to identify predictors of response to TG4050 and the cancer cell-intrinsic and -extrinsic factors that may mediate each patient’s response to the vaccine. BostonGene’s platform integrates the genomic and transcriptomic analyses to simultaneously assess the activity of the tumor and the microenvironment through the identification of significant somatic alterations, evaluation of gene expression, estimation of tumor heterogeneity and classification of the microenvironment.

BostonGene generates a Tumor Portrait Report, involving the data-driven, visually appealing and self-explanatory tumor schematics elegantly depicting tumor activity, tumor cellular composition, and functionality of the immune-microenvironment and other tumor-associated processes. The comprehensive report will provide insights into the individual oncogenic state and immunogenicity of the patient’s tumor.

"BostonGene’s unique solution and deep expertise in Next Generation Sequencing (NGS) analysis provide us with the detailed profiles of a tumor and its micro-environment. These Tumor Portrait Reports will help us look at our patient data in light of the current published evidence and could help us accelerate the development of TG4050," said Éric Quéméneur, Pharm.D., Ph.D., Executive VP, Chief Scientific Officer of Transgene. "This novel way of analyzing patient data is part of an ambitious translational program that supports the development of our myvac platform. By integrating these types of approaches into our studies, we seek to build an integrated framework for the use of viral-based immunotherapeutics."

"NEC looks forward to strengthening its collaboration with BostonGene through these trials of TG4050. BostonGene’s advanced analysis of NGS among cancer patients provides excellent profiling that we believe will add important insight into the understanding of each patient’s tumor environment and how it reflects on the clinical outcomes of our treatment," said Osamu Fujikawa, Senior Vice President at NEC Corporation.

"BostonGene is proud to support Transgene and NEC during these critical Phase 1 clinical trials," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "This collaboration represents our ongoing commitment to improve immunotherapy options and transform personalization of treatment for cancer patients."

About TG4050
TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene’s myvac technology and powered by NEC’s longstanding artificial intelligence (AI) expertise. This virus-based therapeutic vaccine encodes neoantigens (patient-specific mutations) identified and selected by NEC’s Neoantigen Prediction System. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary data allowing it to accurately prioritize and select the most immunogenic sequences.

TG4050 is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to recognize and destroy tumor cells based on their own neoantigens. This individualized immunotherapy is developed for each patient and can be produced in a very short time frame.

This best-in-class candidate is being evaluated in two Phase 1 clinical trials for patients with ovarian cancers (new windowNCT03839524) and HPV-negative head and neck cancers (new windowNCT04183166).

About myvac
myvac is a viral vector (MVA) based, individualized immunotherapy platform that has been developed by Transgene to target solid tumors. myvac-derived products are designed to stimulate the patient’s immune system, recognize and destroy tumors using the patient’s own cancer specific genetic mutations. Transgene has set up an innovative network that combines bioengineering, digital transformation, established vectorization know-how and unique manufacturing capabilities. Transgene has been awarded "Investment for the Future" funding from Bpifrance for the development of its platform myvac. TG4050 is the first myvac-derived product being evaluated in clinical trials.

About NEC’s Neoantigen Prediction System
NEC’s neoantigen prediction utilizes its proprietary artificial intelligence (AI), such as graph-based relational learning, which is combined with other sources of data to discover candidate neoantigen targets. NEC comprehensively evaluates the candidate neoantigens with a primary focus placed on its in-house major histocompatibility complex (MHC) binding affinity prediction trained on public and proprietary datasets. These allow NEC to effectively prioritize the numerous candidate neoantigens identified in a single patient.

Genprex to Present at the Alliance for Regenerative Medicine’s Virtual Cell and Gene Meeting on the Mesa

On October 6, 2020 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, reported that it will be presenting at the Alliance for Regenerative Medicine’s (ARM) virtual Cell and Gene Meeting on the Mesa, taking place October 12-16, 2020 (Press release, Genprex, OCT 6, 2020, View Source [SID1234568142]). Michael Redman, Executive Vice President and Chief Operating Officer of Genprex, will lead the company’s presentation.

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The 2020 Cell and Gene Meeting on the Mesa will be delivered in a virtual format over the course of five days where attendees will be able to watch company presentations on-demand, in addition to two live-streaming panels each day. The Cell and Gene Meeting on the Mesa is the sector’s foremost annual conference, bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures. Tackling the commercialization hurdles facing the cell and gene therapy sector today, this meeting covers a wide range of topics from clinical trial design to alternative payment models to scale-up and supply chain platforms for advanced therapies.

Press Release Oncology Venture calls third investment tranche under its share subscription agreement with Global Corporate Finance

On October 6, 2020 Oncology Venture A/S ("OV" or the "Company") reported that it has called upon Global Corporate Finance (GCF) to invest in the Company in a directed share issue in accordance with the Company’s share subscription agreement with GCF (Press release, Oncology Venture, OCT 6, 2020, View Source [SID1234568160]). A total of 5,370,617 shares at a price per share of SEK 1.7438 is issued to Global Corporate Finance.

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The share price is fixed at SEK 1.7438 per share of nominal DKK 0.05 share and has been calculated as 95% of the daily volume weighted average price (VWAP) of the Company’s shares for the five (5) consecutive trading days following 24 September 2020, the date of the draw down notice from OV.

The registered share capital of Oncology Venture will after the conversion be nominal DKK 9,937,244 divided into 198,744,880 shares of nominal DKK 0.05 each.

The investment is the third investment tranche Oncology Venture has requested from Global Corporate Finance (New York City, NY, U.S.). Oncology Venture may call upon up to a total investment of SEK 50 million in a series of tranches, no single tranche may exceed SEK 10 million.

For further information on the conditions and structure of the financing agreement; please, refer to the press release concerning the agreement published by Oncology Venture on May 6, 2020.