On April 19, 2022 The University of Camerino (UniCam) reported that has extended its strategic business partnership with CureLab Oncology Inc., a clinical-stage biotech company, to develop anti-cancer immunotherapy for humans, and has signed a similar agreement with CureLab Veterinary Inc. to reapply this medicine for treatment of companion animals (Press release, CureLab Oncology, APR 19, 2022, View Source [SID1234612855]).

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In 2012, the university signed a strategic partnership agreement with CureLab Oncology for researching the DNA plasmid coding p62/SQSTM1 gene (p62) that resulted in patents being granted in more than 20 countries. Subsequently, initial p62 plasmid clinical trials have shown great promise in treating the deadliest forms of ovarian and breast cancer. Given this success, CureLab Oncology and UniCam have agreed to extend their partnership./p>

As a first result of the prolonged partnership agreement, scientists from UniCam and CureLab just published a paper in the journal General and Comparative Endocrinology, one of the top scientific journals focused on animal science and zoology. The choice of a journal was based on a concomitant agreement that UniCam signed with CureLab Veterinary, which licensed the p62 IP for application in cats, dogs, and horses. Earlier, this scientific team successfully treated 10 out of 11 dogs with breast cancer.

"UniCam has a well-established School of Biosciences and Veterinary Medicine," said Prof. Guido Favia, director of the school. "This new partnership with CureLab Veterinary, based on both scientific and clinical strength, brings attractive development opportunities for the entire school."

"We are very pleased to continue our partnership with CureLab Oncology," said Prof. Maria Giovanna Sabbieti of the School of Biosciences and Veterinary Medicine at UniCam. "The new clinical data released by CureLab Oncology paves the road to even more new discoveries in our laboratory, while at the same time, our lab data helps CureLab target new applications for its p62 product."

"Our partnership with CureLab Veterinary opens up new opportunities for the research on bone and inflammatory-based diseases of domestic and farm animals," said Dr. Dimitrios Agas of the School of Biosciences and Veterinary Medicine at UniCam.

"CureLab Veterinary is very pleased to be working with the University of Camerino to explore translational studies in the areas of osteoarthritis, cancer, aging and age-associated diseases to improve and extend the lives of our four-legged family members," said Robert Devlin, DVM, MBA, of CureLab Veterinary.

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On April 19, 2022 Provectus (OTCQB: PVCT) reported that, in conjunction with the filing of the Company’s preliminary 2022 proxy statement (Pre-14A), Provectus’ Board of Directors (Board) seeks approvals at the Company’s 2022 Annual Meeting of Stockholders on June 22nd for the authority to (Press release, Provectus Biopharmaceuticals, APR 19, 2022, View Source [SID1234612589]):

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Reverse stock split proposal: Amend the Company’s Certificate of Incorporation (as amended by the Series D and D-1 Certificates of Designation) to effect a reverse stock split of the Company’s common stock, Series D Convertible Preferred Stock, and Series D-1 Convertible Preferred Stock at a ratio of between 1-for-10 and 1-for-50, and to make corresponding amendments to the Series D and D-1 Certificates of Designation to provide for the proportional adjustment of certain terms upon a reverse stock split, and

Authorized share reduction proposal: If and only if the reverse stock split proposal is approved, amend the Company’s Certificate of Incorporation (as amended by the Series D and D-1 Certificates of Designation) to decrease the number of authorized shares of Provectus’ common and preferred stocks by the same reverse stock split ratio determined by the Board.

At the 2022 Annual Meeting, stockholders will also vote on proposals for the election of directors, approval of the compensation of the Company’s named executive officers, and ratification of the Company’s independent registered public accounting firm. Subject to review by and/or comments from the Securities and Exchange Commission (SEC) on the Pre-14A, the Company will file its definitive 2022 proxy statement thereafter.

On April 19, 2022 ImmVira reported that, company has reached a cooperation agreement with Roche to establish clinical research partnership recently, to conduct clinical studies in the U.S. on the combination therapy of ImmVira’s MVR-T3011 IT and Roche’s MEK inhibitor cobimetinib, to evaluate the safety and efficacy of this combo strategy (Press release, Immvira, APR 19, 2022, View Source [SID1234612577]).

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MVR-T3011, ImmVira’s proprietary 3-in-1oncolytic herpes simplex virus ("oHSV"), is a novel genetically engineered oHSV which aims to achieve the most favorable profile of attenuated HSV-1 with replication potency in tumor cells. The incorporation of two latest and well-validated exogenous genes, PD-1 antibody and IL-12, further enhances immune responses in the tumor microenvironment. MVR-T3011 IT clinical trials started in 2020 and are currently in Phase II in both the U.S. and China. Single agent treatment has demonstrated good safety profile and preliminary efficacy results.

In 2021, ImmVira research group published a scientific paper, "Enhancing Therapeutic Efficacy of Oncolytic Herpes Simplex Virus with MEK Inhibitor Trametinib in Some BRAF or KRAS-Mutated Colorectal or Lung Carcinoma Models". In vitro and in vivo anti-tumor studies showed that, treatment with MEKi augmented oHSV oncolytic activity in BRAF V600E-mutated tumor cells and the combination treatment enhanced virus replication mediated by down-regulation of STAT1 and PKR expression or phosphorylation in BRAF V600E-mutated tumor cells as well as BRAF wt/KRAS-mutated tumor cells. Furthermore, a significant synergistic therapeutic efficacy was shown in vivo for BRAF wt/KRAS-mutated tumor models, when a combination of MEK inhibition and oHSV expressing PD-1 blockade antibody and IL-12.

"This combo clinical study further demonstrates the potential ability of MVR-T3011 to further extend clinical benefit to a wide range of approved treatment programs. This is also the first combination therapy other than checkpoint inhibitor of our core oncolytic products, and the first application of from scientific exploration to clinical studies. We are particularly pleased to collaborate with Roche with their leadership in the industry, global footprint and a deep pocket of established as well as novel programs driven by the inspiring purpose of doing now what patients need next," said Dr. Grace Zhou, CEO of ImmVira.

"Based on OvPENS new drug R&D platform, ImmVira will continue to push forward the envelope of vector-based oncology solutions. Leveraging a unique approach to modify the tumor environment, our pipeline of single agent and combo programs aims to become a new generation of safer and more effective therapies to address the increasingly complex cancer patients’ needs worldwide."

On April 19, 2022 Keymed Biosciences (2162.HK) reported that the U.S. Food and Drug Administration (FDA) granted CMG901 Fast Track Designation as monotherapy for the treatment of unresectable or metastatic gastric and gastroesophageal junction cancer which have relapsed and/or are refractory to approved therapies (Press release, Keymed Biosciences, APR 19, 2022, View Source [SID1234612519]). This is another milestone after CMG901 received Orphan-drug Designation from the FDA.

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Among all the Claudin 18.2-targeted drugs, CMG901 is the first and only one which received this FDA designation so far. This designation was granted based on the phase 1 studies that assessed the safety, tolerability, pharmacokinetic (PK), and preliminary efficacy of CMG901. The dose-escalation stage of Phase I clinical trial of CMG901 in subjects with solid tumors is about to be completed in China, and the dose-expansion stage is expected to be initiated in the second quarter of 2022.

Fast Track Designation is one of the FDA’s programs to accelerate the clinical development and review of new drugs to meet the unmet medical needs of serious diseases.

About CMG901

CMG901 is the first Claudin 18.2 ADC to obtained IND approval in China and in the U.S. CMG901 consists of three components: a monoclonal antibody targeting Claudin 18.2, a cleavable linker and a potent cytotoxic payload (MMAE). Claudin 18.2 has been identified as a highly selective molecule that is widely expressed in multiple solid tumors, including gastric cancer and pancreatic cancer, suggesting that Claudin 18.2 is an ideal target for tumor therapeutic development.

CMG901 can cause tumor cell death by several mechanism:

CMG901 binds to Claudin 18.2 positive cell via its monoclonal antibody portion. After binding, CMG901 will be internalized into lysosome by tumor cells and release the cytotoxic payload, leading to cell cycle arrest and apoptosis of the tumor cells.
CMG901 can stimulate cellular and soluble immune effectors that activate antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) to destroy the Claudin 18.2 positive cells.
Preclinical studies suggest that CMG901 can effectively kill gastric cancer cells with much stronger antitumor potency than zolbetuximab analog or the unconjugated antibody of CMG901. Meanwhile, CMG901 also shown good tolerance and favorable safety profile in preclinical studies.