MVR-C5252

SHENZHEN, China, Oct. 26, 2022 /PRNewswire/ -- ImmVira announced its successful signing of Series-C+ financing transaction documents with the first batch of investors recently. This round of financing was initiated by China Merchants China Direct Investments Limited with participation of Lifebay and Unifortune Group. To facilitate a number of ongoing follow investor's continued interest, the Company will keep the round open for a period of not more than two months. Interested investors can follow the agreed-on valuation and terms reached by lead investor and Company. Dr. Grace Zhou, Chairwoman and CEO of ImmVira said, "We appreciate recognition and trust from our investors in the current challenging capital market environment. The successful signing with the lead investor as well as continuous indication of interest from a number of co-investors is a meaningful representation of the potential value of ImmVira. We intend to use this capital to make new breakthroughs in vector-as a delivery mechanism treatments and further advance our OvPENS new drug development platform. We believe ImmVira's unique insights in application of vector-based treatments represent a distinctive exceptional return to risk for our shareholder partners. " ImmVira has made numerous progress and breakthroughs since the closing of Series C financing. For pipeline research and development, MVR-T3011 IT (intratumoral injection) program is accelerating Phase II clinical study in the U.S. and China with encouraging efficacy-related immune signals identified in HNC, sarcoma, and along with other indications; MVR-T3011 IV (intravenous injection) program has achieved preliminary robust safety results and validated clinical biological activities in Phase I clinical study in U.S. and China; MVR-C5252 (targeting Glioma) program has successfully obtained IND clearance and ODD from FDA, and will initiate clinical trial shortly; MVR-T7 series (combo with CAR-T/ADC/BiTE) program has completed in-house pilot-scale manufacturing, and is currently under negotiation with multiple partners for IND application of combination treatment; In addition, Company has officially launched its non-viral vector - engineered exosome pipelines with completion of first three product design and is expediting CMC development and IND filing process. In areas of business collaborations, Company has established a clinical research partnership with Roche and will conduct clinical study on the combination therapy of MVR-T3011 IT and Roche's MEK inhibitor Cobimetinib in the U.S.; and has reached a co-develop agreement with China Resources Biopharmaceutical Co., Ltd to jointly promote the clinical development of MVR-C5252 targeting glioma in the Greater China. The funds raised from this round of financing will be mainly used to support the clinical trials of mono and combo therapies of three pipelines under clinical stage in both U.S. and China, the subsequent IND applications of oncolytic virus and exosome product pipelines, and the discovery and PoC of new candidates, and enhancements to the OvPENS technology platform. About ImmVira ImmVira is a biotechnology company focused on development of new generation novel drug vectors driven by clinical benefits in oncology and non-oncology fields. Leveraging naturally evolved delivery mechanisms and proprietary precise gene engineering technology, our products include replicating and non-replicating herpes simplex virus vector and drug delivery exosome. The company has developed science, technology and know-how to support ongoing research, development and commercialization of best-in-class mono and combo therapies on the OVPENS (Open Vector+ Potent, Enabling, Novel & Safe) platform. Our clinical stage and development stage pipelines target a wide range of solid tumors and hematologic malignancies as an initial validation of vector capability in oncology, to be used as single agent or combination treatment solutions for cancer patients at different stages, unresponsive to immunotherapy or with rare tumors, by various administration methods including intratumoral, as well as first-in-class intravenous and intraperitoneal/pleural/vesical injections. The first three oncolytic virus products are undergoing six Phase I or Phase II clinical trials in both United States and China. SOURCE ImmVira

Sarah Silbiger/Getty Images Every week, the U.S. Food and Drug Administration reviews drug applications, grants various designations to drugs and medical devices and approves therapies. It’s difficult to keep up, but don’t worry, BioSpace has you covered. Daiichi Sankyo and AstraZeneca reported Friday that the FDA has approved Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable or metastatic non-small cell lung cancer whose tumors have activating HER2 mutations. This follows the August 6 approval of Enhertu for adults with unresectable or metastatic HER2-low breast cancer. The FDA nod is for patients who have received previous chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. Guardant Health reported Friday that the FDA has approved its Guardant360 CDx liquid biopsy test as a companion diagnostic for select patients with unresectable or metastatic HER2-mutant non-small cell lung cancer whose tumors have activating HER2 mutations for treatment with Daiichi Sankyo and AstraZeneca’s Enhertu. Merck reported Tuesday that the FDA found contamination of some samples of its type 2 diabetes drug Januvia (sitagliptin). The contamination was nitrosamine Nitroso-STG-19 (NTTP). The agency will allow continued distribution, but the company is working to improve quality control mechanisms. Bayer announced Monday that the FDA has approved a supplemental New Drug Application (sNDA) for its oral androgen receptor inhibitor darolutamide in combination with docetaxel for patients with metastatic hormone-sensitive prostate cancer. The approval was based on data from the Phase III ARASENS trial. ImmVira, based in Shenzhen, China, reported that the FDA has granted its new oncolytic herpes simplex virus product MVR-C5252 Orphan Drug Designation. The therapy is targeting malignant glioma. The drug, developed on ImmVira’s OvPENS new drug development platform, is designed to achieve on-target malignant gliocyte killing while maintaining a solid safety profile. Attralus’s 124I-AT-01 (iodine (I-124) evuzamitide) received Orphan Drug Designation from the FDA as a diagnostic for the management of transthyretin amyloidosis (ATTR). The product utilizes Attralus’s pan-amyloid binding peptide as an amyloid-specific imaging agent. Relmada Therapeutics received Fast Track designation from the FDA for REL-1017, a novel NMDA receptor channel blocker being developed as a monotherapy for major depressive disorder. The drug is being assessed in a registrational Phase III trial in this indication. It is also being studied in two pivotal Phase III studies as a potential adjunctive treatment for MDD. MaaT Pharma announced Wednesday that the FDA has maintained the clinical hold on MaaT013. The drug is being developed for steroid-resistant acute graft-versus-host disease. The hold will continue while the agency awaits more data on how the drug was developed. Cure Rare Disease (CRD) received the greenlight to conduct a Phase I trial of CRD-TMH-001, a CRISPR-based therapeutic to treat muscle promoter and exon 1 mutations in the dystrophin gene for Duchenne muscular dystrophy (DMD). Bodyport received 501(k) clearance from the FDA for its noninvasive biomarker platform, the Bodyport Cardiac Scale, which can assess measures of heart function and fluid status. CereVasc announced the FDA has approved an investigational device exemption (IDE) application to initiate a pilot trial of the eShunt System in patients who develop communicating hydrocephalus post aneurysmal subarachnoid hemorrhage. Lexaria Bioscience Corp. received a positive full written response from the FDA from its pre-IND meeting regarding DehydraTECH-CBD for the treatment of hypertension. aTyr Pharma received Fast Track designation from the FDA for efzofitimod for pulmonary sarcoidosis, a type of interstitial lung disease. The drug is a first-in-class immunomodulator against neuropilin-2. The Menarini Group and Stemline Therapeutics reported that the FDA has accepted their NDA for elacestrant, a selective estrogen receptor degrader for patients with ER+/HER2- advanced or metastatic breast cancer. It has been given a PDFUA date of February 17, 2023. Aro Biotherapeutics received Orphan Drug Designation from the FDA for ABX1100, an investigational Centyrin-siRNA conjugate targeting the Gys1 gene in the muscle, for the treatment of Pompe disease.