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]).

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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.

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.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.

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]).

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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.

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.

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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)."

On June 11, 2021 Shanghai Yingli Pharmaceuticals Ltd (Yingli Pharma), a clinical stage pharmaceutical company providing new therapies for cancer and metabolic diseases, reported the topline data from a clinical trial sponsored by the company at the annual meeting of the European Hematology Association (EHA) (Free EHA Whitepaper) being held June 9-17, 2021 (Press release, Yingli Pharmaceutical, JUN 11, 2021, View Source [SID1234583915]).

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The study entitled ‘A Phase 2 study of an oral PI3Kδ inhibitor YY-20394 in patients with relapsed or refractory follicular lymphoma’ will be presented at EHA (Free EHA Whitepaper) by Dr. Lugui Qiu, a lead investigator from Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China. This is a registration study that enrolled 93 relapsed or refractory Follicular Lymphoma (FL) patients having received 2 or more prior systemic therapies and was conducted at 32 clinical sites in China. Linperlisib was evaluated as a monotherapy for safety, tolerability and efficacy at recommended phase 2 dose of 80 mg once daily. Following a data cutoff on March 15, 2021, the fully enrolled study was analyzed for 89 evaluable patients. The Overall Response Rate (ORR) was 79.5%, with 12.4% Complete Response, 67.4% Partial Response, and 16.1% Stable Disease, combining to achieve a Disease Control Rate of 96.6%. Previously, the Phase 1 study of linperlisib had shown similar preliminary efficacy of 90% ORR in 10 patients with r/r FL. As of the data cutoff for the Phase 2, the median Progression Free Survival was 11.8 months, and the Duration of Response was 12.3 months. Forty seven patients were continuing to receive linperlisib treatment.

Follicular Lymphoma is increasingly harder to treat if patients progress on previous therapies, usually immuno-chemotherapy is a mainstay as a prior treatment. On this study, 65% of the patients had received 3 or more prior systemic treatments, and all patients had previously received rituximab-based therapies.

The safety data from the FL Phase 2 study indicated that linperlisib was generally safe and tolerable with manageable adverse events. Most of the adverse events were Grade 1 and Grade 2. The most common (>5%) treatment related hematologic adverse events of ≥ Grade 3 were neutropenia (15.1%), leukocytopenia (5.4%), lymphocytopenia (5.4%). The most common (>5%) treatment related non-hematologic adverse events of ≥ Grade 3 were pneumonia (15.1%).

Dr. Lugui Qiu, a prinicipal investigator on the study, stated "FL is complicated as the relapsed and refractory patients tend to progress rapidly, requiring aggressive therapies. From the clinical findings with linperlisib treatment of FL patients, we are seeing durable responses for most patients. Patients are in desperate need of effective therapies that target these lymphoma key signaling pathways and therapies that are oral medications, easy for patients to use outside of a clinic."

Dr. Zusheng Xu, General Manager of Yingli Pharma commented "We are excited to be developing Linperlisib for the treatment of lymphomas and solid tumors. Linperlisib is a next-generation PI3Kδ-selective inhibitor. The clinical data suggest that Linperlisib might be a potentially advantageous treatment option for patients. We have applied a linperlisib marketing approval in China in relapsed or refractory FL, based on the data from this phase II registration study. We hope to broaden the use of linperlisib and are exploring its anti-tumor activities in different indications in additional clinical trials."

Dr. Qiu also indicated "It is a major step that Linperlisib has been accepted by the NMPA for the NDA application, and we are very optimistic about the outcome."

About Linperlisib

Linperlisib (YY-20394) is a highly selective and potent PI3Kδ inhibitor that has shown a favorable safety profile, exciting anti-tumor activities, and good PK and pharmaceutical properties as an oral once-a-day agent in late-stage clinical development. A phase 1 clinical trial was completed in 2020 demonstrating linperlisib to be a safe and tolerable agent, and a recommended phase 2 dose of 80 mg QD was established. Linperlisib was awarded NMPA Breakthrough Therapy status in China, leading to the current trial. In addition, linperlisib received FDA Orphan Drug Designations for FL, CLL/SLL, and T cell lymphoma. A clinical trial in r/r FL is launching in the US. Multiple linperlisib clinical trials being conducted in other lymphomas, solid tumors, and in combination with gemcitabine/oxaliplatin in r/r DLBCL. Preliminary results from a PTCL Phase1b study were reported at ASCO (Free ASCO Whitepaper) 2021, indicating an overall response rate of 70% with 33% CRs in 30 evaluable patients with r/r PTCL, a difficult to treat and aggressive form of lymphoma.