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!"

On January 18, 2022 Medivir AB (Nasdaq Stockholm: MVIR-B) reported that the World Health Organization (WHO) has selected the International Nonproprietary Name (INN) fostroxacitabine bralpamide as the official generic name for the company’s patented candidate drug MIV-818, which is in clinical development in primary liver cancer (Press release, Medivir, 18 18, 2022, View Source [SID1234605592]).

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Medivir’s main project, fostroxacitabine bralpamide (MIV-818), is the company’s proprietary candidate drug with a unique mechanism of action, which makes fostroxacitabine bralpamide attractive to be combined with a multitude of other drugs for the treatment of hepatocellular carcinoma (HCC). In the ongoing study, fostroxacitabine bralpamide is administered in two different combinations, either with Lenvima, a tyrosine kinase inhibitor, or with Keytruda, an anti-PD-1 checkpoint inhibitor.

– "We are now able to use a generic name for our candidate drug, and for us that is an important step towards a product for the treatment of HCC," said Magnus Christensen, interim CEO and CFO of Medivir.

For further information, please contact:
Magnus Christensen, Interim CEO and CFO, Medivir AB
Phone: +46 (0)8 5468 3100
E-mail: [email protected]

About fostroxacitabine bralpamide
Fostroxacitabine bralpamide (also named MIV-818) is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC and other forms of liver cancer. Fostroxacitabine bralpamide has completed a phase 1b monotherapy study, and a combination study in HCC was recently initiated.

About primary liver cancer
Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are 42,000 patients diagnosed with primary liver cancer per year in the US and current five-year survival is 11 percent. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

On January 18, 2022 Compugen Ltd. (NASDAQ-GM: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the United States Patent and Trademark Office (USPTO) has granted Compugen a new patent covering method of use for COM701, Compugen’s potential first-in-class therapeutic antibody targeting PVRIG, or back-up anti-PVRIG antibody, in triple combination with any anti-PD-1 and any anti-TIGIT antibody for the treatment of cancer (Press release, Compugen, 18 18, 2022, https://www.prnewswire.com/news-releases/compugen-expands-com701-intellectual-property-portfolio-with-new-us-patent-covering-triple-combination-use-with-anti-pd-1-and-anti-tigit-antibodies-301462635.html [SID1234605590]).

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U.S. Patent No. 11,225,523 titled "Triple Combination Antibody Therapies" augments previously issued patents by expanding and protecting the use of COM701 for treating cancer patients, to include the triplet combination of COM701 with any anti-PD-1 antibody and any anti-TIGIT antibody.

"We are focused on maintaining our first mover advantage in the clinic, as the only company with monotherapy, doublet and triplet combination clinical studies evaluating PVRIG, TIGIT, and PD-1. We believe that this patent protection of triple combination regimens further strengthens our leadership position as we continue to execute on our clinical programs based on our DNAM axis hypothesis to treat patients with inflamed and less inflamed tumors who are not responding to current standard of care." said Anat Cohen-Dayag, Ph.D., President and Chief Executive Officer of Compugen.

U.S. Patent No. 11,225,523 is expected to expire no earlier than August 2037 in the United States.

About COM701

COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint discovered computationally by Compugen, blocking the interaction with its ligand, PVRL2. In pre-clinical studies, blockade of PVRIG by COM701 has demonstrated potent, reproducible enhancement of T cell activation, consistent with the desired mechanism of action of activating T cells in the tumor microenvironment to generate anti-tumor immune responses. Compugen has identified PVRIG and TIGIT as key parallel and complementary inhibitory pathways in the DNAM axis, which also intersect with the well-established PD-1 pathway. Research from Compugen suggests that these three pathways have different dominance in different tumor types and patients, implying that to induce effective antitumor responses, certain patient populations may require the blockade of different combinations of these three pathways. To test this hypothesis, Compugen has established a science-driven, biomarker informed clinical program, which evaluates different combinations of these axis members across tumor types. Compugen is the only company with clinical assets targeting both PVRIG and TIGIT in its portfolio allowing it to explore the potential of blocking these parallel and complementary members of the DNAM axis comprehensively to drive robust immune responses.