On January 18, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its fourth quarter and full year 2021 financial results will be released on Tuesday, February 1, after the market closes (Press release, Gilead Sciences, 18 18, 2022, View Source [SID1234605596]). At 4:30 p.m. Eastern Time that day, Gilead’s management will host a webcast to discuss the company’s fourth quarter and full year 2021 financial results and will provide a business update.

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A live webcast will be available on the investor relations page of View Source and will be archived on www.gilead.com for one year.

On January 18, 2022 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its fourth quarter and full year 2021 financial results on Wednesday, January 26, 2022 after the financial markets close (Press release, Vertex Pharmaceuticals, 18 18, 2022, View Source [SID1234605595]). The company will host a conference call and webcast at 4:30 p.m. ET. To access the call, please dial (866) 501-1537 (U.S.) or +1 (720) 545-0001 (International).

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The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.

On January 18, 2022 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its partner Juventas Cell Therapy Ltd (Juventas), for CNCT19, an investigational CD-19 directed CAR-T therapy, for the treatment of patients with Acute Lymphoblastic Leukemia (ALL) (Press release, CASI Pharmaceuticals, 18 18, 2022, View Source [SID1234605594]).

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CNCT19 is currently being developed independently by Juventas to meet the urgent clinical needs of patients with hematologic malignancies globally. The National Medical Products Administration (NMPA) has granted CTA approval for CNCT19 in two indications (relapsed/refractory B-All and B-NHL) in Nov. 2019. Currently, the Phase II clinical trials of CNCT19 (for both B-ALL and B-NHL) are in progress. Positive clinical data for adult and pediatric patients with relapsed/refractory B-ALL has been presented at the December 2021 ASH (Free ASH Whitepaper) annual meeting, which further demonstrated its safety and efficacy profile. CNCT 19 is expected to be the first domestic CD19 directed CAR-T product in China with independent intellectual property rights.

Dr. Wei-Wu He, CASI’s Chairman, and CEO commented, "Our partner Juventas continues to make encouraging progress in developing their CD19 CAR-T therapy. The Orphan Drug Designation, from the FDA, and the Breakthrough Designation status, granted by the China Center of Drug Evaluation (CDE) in December 2020, represent significant milestones that demonstrate our belief that CNCT19’s commercialization will not only be successful in China, but potentially on a global scale. CASI has worldwide co-commercial rights of CNCT19, and will start the global commercialization process according to CNCT19’s regulatory progress outside China."

On January 18, 2022 InnoCare Pharma (HKEX: 09969) and Keymed Biosciences (HKEX: 02162) jointly reported that the first patient in China has been dosed in clinical trial of CM355, a CD20xCD3 bispecific antibody developed by a joint venture between the two companies, for the treatment of CD20+ B-cell malignancies (Press release, InnoCare Pharma, 18 18, 2022, View Source [SID1234605593]).

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CM355 binds to CD20 on the tumor cells and CD3 on the T cells, redirects and activates T cells to eradicate tumor cells through T-cell Directed Cellular Cytotoxicity (TDCC) in the treatment of CD20+ B-cell malignancies.

Non-Hodgkin lymphomas are the main type of CD20+ B-cell malignancies, accounting for 80%-90%, which include diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

Dr. Jasmine Cui, Co-Founder, Chairwoman and CEO of InnoCare, said: "There is still a big gap in terms of the 5-year survival rate of lymphoma patients between China and Europe & US. As two innovative biotech companies, we are making every effort to develop more innovative drugs to address unmet clinical needs. We are fully confident that the CD20xCD3 bispecific antibody has great potential in the clinical development for B-cell lymphoma."

Dr. Chen Bo, Co-founder, Chairman and CEO of Keymed Biosciences, said: "We are very pleased that we have taken the first step in evaluating the potential clinical benefits of CM355 for lymphoma patients. Preclinical studies have shown the high-potency and manageable safety of CM355. This means good treatment prospects for lymphoma patients. We look forward to working with InnoCare to conduct this clinical study efficiently, and eventually provide more innovative, effective, safe and economic treatment options for patients to extend their survival and improve their prognosis."

On January 18, 2022 ImmVira reported that it’s breakthrough product MVR-T3011 IV, global first clinical-stage oncolytic herpes simplex virus (oHSV) via intravenous injection, has recently completed first 2 cohorts dose-escalation of U.S. Phase I clinical study, and demonstrated good safety and tolerability results (Press release, Immvira, JAN 18, 2022, View Source [SID1234605591]).

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Late stage patients with pancreatic, colon, lung, and endometrial cancer have been enrolled for the first two dose levels. MVR-T3011 IV has showed good safety and tolerability data at the first two dose levels tested with no dose limiting toxicities (DLT) or treatment-related severe adverse events (SAEs). ImmVira will continue exploring safety and tolerability for higher doses, and determine recommended phase II dose (RP2D) based on integrated analysis of preliminary efficacy and pharmacokinetics/pharmacodynamics (PK/PD) data.

Intravenous administration (IV) has long been a big challenge for the research and development of oncolytic viruses, especially oHSV. Most oncolytic viruses cannot overcome multiple obstacles, such as being neutralized and eliminated by antibodies, while present potential risks, such as a large number of viruses inducing cytokine storm in the body when entering the blood stream. The ideal design of intravenous oncolytic virus requires that the virus effectively reach tumor site with sufficient potency to replicate to fully exert anti-cancer effects while maintain a high safety profile. Additionally, the virus can escape from elimination of neutralizing antibodies to allow repeated administration.

MVR-T3011 IV, ImmVira’s proprietary 3-in-1 oHSV, is a novel genetic engineered oHSV which aims to achieve the most favorable profile of attenuated HSV-1 with replication potency in tumor cells and highly restricted replication in normal cells, to achieve the breakthrough of intravenous administration of oHSV. In addition, MVR-T3011 IV carries two latest and well-validated exogenous immune modulatory genes, namely PD-1 antibody and IL-12, and these exogenous payloads are only expressed when virus selectively replicates in tumor cells after intravenous injection, thus achieving synergistic antitumor effect, promoting immunoreaction in the localized tumor microenvironment and ensuring tumor-specific delivery of exogenous therapeutic proteins.

ImmVira’s CEO Dr. Guoying Zhou said, "The good news from MVR-T3011 IV clinical study is inspiring. Leveraging our proprietary OvPENS new drug R&D platform, we will continue to accelerate the clinical development process of MVR-T3011 IV and its combination with other cancer treatments, so that tumor patients will benefit from intravenous administered oncolytic virus products as soon as possible!"