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DELYTACT® Oncolytic Virus G47∆ Approved in Japan for Treatment of Patients with Malignant Glioma

On June 12, 2021 Daiichi Sankyo Company reported that it has received conditional and time-limited approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Delytact (teserpaturev/G47?), an oncolytic virus, for the treatment of patients with malignant glioma (Press release, Daiichi Sankyo, JUN 11, 2021, View Source [SID1234594392]).

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Delytact previously received SAKIGAKE Designation and Orphan Drug Designation from the MHLW for this indication and is now the first oncolytic virus to be approved in any region of the world for treatment of malignant glioma or any type of primary brain cancer. Daiichi Sankyo has been collaboratively developing Delytact with Dr. Tomoki Todo of the Institute of Medical Science, The University of Tokyo, and is the Marketing Authorization Holder of Delytact in Japan.

The approval of Delytact in Japan is based on results of a single-arm phase 2 clinical trial evaluating Delytact in patients with residual or recurrent glioblastoma, the most common and aggressive form of malignant glioma.1 The trial met its primary endpoint for one-year survival rate in an interim analysis. Results of the study will be submitted for publication by Dr. Todo.

"With the approval of Delytact in Japan we can now offer the first-ever oncolytic virustherapy option to patients with glioblastoma and other malignant gliomas that are not controlled with currently available treatments," said Wataru Takasaki, PhD, Executive Officer, Head of R&D Division in Japan, Daiichi Sankyo. "Delytact is the fourth oncology medicine to be approved in Japan for Daiichi Sankyo over the past two years and we are grateful for the opportunity to collaborate with Dr. Todo to deliver this truly innovative treatment modality to patients and physiciansin Japan."

Glioma, which originatesin glial cells in brain tissue, represents almost 80 percent of all malignant primary brain tumors. Glioma is classified from grade I to IV based on the level of malignancy.

The phase 2 open-label, single-arm, non-randomized, single-centerstudy conducted by Dr. Todo of the Institute of Medical Science, The University of Tokyo, evaluated the safety and efficacy of G47? (Delytact) in adult patients with glioblastoma who had been treated with radiotherapy and temozolomide chemotherapy and had one residual tumor or one recurrent lesion after the initial treatment.

The primary endpoint of the trial is one-year survival rate after initiation of Delytact therapy, analyzed using historical control. Secondary endpoints include progression-free survival, overall survival and overall response rate.

Delytact (teserpaturev/G47?) is a genetically engineered oncolytic herpes simplex virus type 1 (HSV-1) developed by Dr. Todo and his colleagues. Delytact has triple mutation within the viral genome that cause augmented and selective replication in cancer cells and enhanced induction of antitumor immune response while retaining high safety features. Delytact is currently the first third generation oncolytic HSV-1 to be evaluated in humans.

Delytact has received conditional and time-limited approval in Japan for the treatment of patients with malignant gliomas based on the phase 2 study results. Continued approval for this indication may be contingent upon verification and description of clinical benefit and safety in a post-market comparative clinical study. Delytact is not approved for any use outside of Japan.

BeyondSpring to Host First Quarter Financial Results and Corporate Update Conference Call on June 16, 2021

On June 11, 2021 BeyondSpring Inc. ("BeyondSpring") (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, reported that management will host a conference call to report its financial results for the first quarter ended March 31, 2021 and provide an update on recent corporate events on June 16, 2021 at 8:30 AM Eastern Time (Press release, BeyondSpring Pharmaceuticals, JUN 11, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-to-host-first-quarter-financial-results-and-corporate-update-conference-call-on-june-16-2021 [SID1234585697]).

The conference call may be accessed by dialing 877-451-6152 (U.S.) or 201-389-0879 (International) and referencing conference ID: 13720525. A live webcast will be available on BeyondSpring’s website at www.beyondspringpharma.com under "Events & Presentations" in the Investors section. An archived replay of the webcast will be available for 90 days.

Entry into a Material Definitive Agreement

On June 11, 2021, OncoCyte Corporation (the "Company") reported that it entered into an at-the-market sales agreement (the "Agreement") with BTIG, LLC, as sales agent and/or principal (the "Agent") pursuant to which the Company may sell up to an aggregate of $50,000,000 of shares of Company common stock (the "Shares") from time to time through the Agent (the "ATM Offering") (Filing, 8-K, Oncocyte, JUN 11, 2021, View Source [SID1234583944]). If the Company determines to sell Shares directly to BTIG, as principal (each such transaction, a "Principal Transaction"), the Company and BTIG will enter into a separate agreement that governs such Principal Transaction.

Under the Agreement, the Company will set the parameters for the sale of Shares, including the number of Shares to be issued, the time period during which sales are requested to be made, limitations on the number of Shares that may be sold in any one trading day and any minimum price below which sales may not be made. Sales of the Shares, if any, under the Agreement may be made in transactions that are deemed to be an "at the market offering" as defined in Rule 415 under the Securities Act of 1933, as amended, including sales made directly on the Nasdaq Stock Market LLC or sales made to or through a market maker other than on an exchange. The Company will pay the Agent a commission equal to 3.0% of the gross proceeds of any Shares sold through the Agent under the Agreement. The Agreement contains customary representations, warranties and agreements by the Company, indemnification obligations of the Company and the Agent, other obligations of the parties and termination provisions. The Company has no obligation to sell any of the Shares, and may at any time suspend offers under the Agreement.

Offers and sales of the Shares by the Company under the Agreement, if any, will be made pursuant to the Company’s previously filed Registration Statement on Form S-3 (File No. 333-256650) that was declared effective by the Securities and Exchange Commission (the "SEC") on June 8, 2021, as supplemented by a prospectus supplement related to the ATM Offering filed with the SEC on June 11, 2021.

ImmVira completed the first dosing for Phase II of MVR-T3011 (intratumoral injection) in the U.S. and China

On June 11, 2021 ImmVira reported that in the Phase II Clinical Trials of its leading oncolytic virus product, MVR-T3011* as intratumoral administration (MVR-T3011 IT), ImmVira has completed the first dosing in both China and the U.S. on May 28 2021 and June 11 2021, respectively (Press release, Immvira, JUN 11, 2021, View Source [SID1234583938]).

MVR-T3011, ImmVira’s proprietary next-generation, genetically modified oncolytic herpes simplex virus ("oHSV"), is developed on a novel virus backbone design driven by ImmVira’s innovative insights in oncolytic viruses and superior gene recombinant technology. The incorporation of two exogenous genes, PD-1 antibody and IL-12, further enhances immune responses. MVR-T3011 is ImmVira’s first pipeline undergoing clinical trial and includes intratumoral administration of MVR-T3011. Phase I clinical trials commenced in China in April 2020 and commenced in the United States and Australia in September 2020. Data collected from these preliminary Phase I clinical studies have demonstrated a favorable safety profile and promising efficacy profile. No dose-limiting toxicities have been observed in participants.

The U.S. Phase IIa portion of the study consists of two parts: (i) MVR-T3011 as a single agent for melanoma and metastatic solid tumors; (ii) MVR-T3011 in combination with pembrolizumab for non-small-cell lung carcinoma. The China Phase IIa (MVR-T3011 as a single agent) study targets head and neck cancer, sarcoma and breast cancer. These multi-center studies cover various indications providing highly efficient and cost-effective clinical development strategy to rapidly advance clinical development for MVR-T3011 across regions.

"Leveraging the OvPENS new drug R&D platform, ImmVira is a pioneer in the field," said Dr. Grace Zhou, Chairwoman of the Board of ImmVira. "ImmVira will make best use of its long-term experience and creative insights in oncolytic virus to construct broader product pipelines and provide effective, innovative and safe single-agent as well as combined oncolytic virotherapies for the anti-tumor market." Professor Bernard Roizman has resigned from as Chairman of the Board in February 2020 due to personal health reason and he has not held any positions in ImmVira and its subsidiaries since then. Dr. Grace Zhou has been appointed as Chairwoman of the Board since February 2020.

* Note: MVR-T3011 is the pipeline designation representing T3011, the product code registered in the US and China for clinical trials.

HiFiBiO Therapeutics Announces Publication in Science Advances of its High-Throughput Functional Screening for Next-Generation Cancer Immunotherapy

On June 11, 2021 HiFiBiO Therapeutics, a multinational biotechnology company with unique expertise in immune modulation and single-cell science, reported a publication in Science Advances with its collaborators at Nankai University, ShanghaiTech University, and Jiao Tong University about the development of a high-throughput droplet-based approach to identify novel antibodies with functional readouts beyond simple binding (Press release, HiFiBiO Therapeutics, JUN 11, 2021, View Source [SID1234583928]). Innovative therapeutics such as bispecific T-cell engager (BiTE) antibodies and agonist antibodies against costimulatory receptors can reach their full potential through such functional screening.

This approach improves upon conventional screening by allowing for the analysis and screening of functional antibodies at the single-cell level with unprecedented throughput, allowing for more diverse candidates and successful hits. To demonstrate the technical capabilities of the platform, researchers successfully identified functional antibodies for CD40 agonism with low frequency (<0.02%) in two rounds of screening. Additionally, the versatility of the system was shown by combining an anti-Her2 x anti-CD3 BiTE antibody library with functional screening, enabling efficient identification of active anti-Her2 x anti-CD3 BiTE antibodies.

"Our single-cell microfluidic platform’s robustness and versatility has enabled the efficient and unbiased discovery of active antibodies with markedly increased throughput and accuracy," said Bingqing Shen, PhD, Director, Antibody Discovery of HiFiBiO Therapeutics. "We look forward to further leveraging our technology towards identification of functional antibodies for agonist and bispecific antibodies to ensure a sustainable pipeline of next generation novel immunotherapies."

"This technology addresses two main bottlenecks plaguing conventional screening methods for novel immunotherapies, namely, candidate functionality and diversity in a high throughput manner," said Professor Zhang, "Functional droplet-based screening enables direct linking of antibody discovery to functional outcomes which could optimize screening efforts significantly and accelerate the antibody drug discovery process. I can envision that the platform can be applied to screening of other types of molecules such as cytokines and to high-throughput analysis of cell-cell interactions. For example, dendritic cells expressing a library of neoantigens are co-encapsulated with tumor-infiltrating T cells to map the pairs of cognate antigens and T cell receptors (TCRs)."