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Johnson & Johnson Q1 2022 Results

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Provectus Biopharmaceuticals Seeks Stockholder Approval at 2022 Annual Meeting for Authority to Undertake Reverse Split of Outstanding Equities and Reduce Number of Authorized Equities by Same Ratio

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]):

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.

ImmVira enters clinical development in combination therapy of MVR-T3011 IT and MEK inhibitor in the U.S.

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]).

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."

FDA granted CMG901 Fast Track Designation for unresectable or metastatic gastric and gastroesophageal junction cancer which have relapsed and/or are refractory to approved therapies

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.

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.

Global Leaders to Present Breakthroughs in Liquid Biopsy, Early Cancer Detection at S.E.E. Summit

On April 19, 2022 Teen Cancer America reported the science and excitement behind liquid biopsies, and their potential to change the global paradigm in early cancer detection, will go mainstream for the first time (Press release, Teen Cancer America, APR 19, 2022, View Source [SID1234612514]).

The historic S.E.E. Summit (Safer, Easier, Earlier) is a free, virtual event created by cancer survivor/journalist Jamie Reno and Teen Cancer America, the national non-profit founded by Roger Daltrey and Pete Townshend of The Who. The online conference will feature leading biotechnology executives, researchers, oncologists, and patient advocates explaining the game-changing impact of liquid biopsy blood tests in ways that everyone can understand.

Breakthroughs in genomics have accelerated the ability of liquid biopsies to identify biomarkers in the blood that can detect cancer very early. These advancements represent a major milestone for cancer screening, diagnosis and treatment as a non-invasive alternative to tissue biopsy.

Produced by The Special Event Company, the summit will include pre-recorded segments featuring preeminent liquid biopsy experts from Caris Life Sciences, Exact Sciences/Thrive, Grail, Guardant, IV BioHoldings (IVBH), Natera, Pillar Biosciences and StageZero Life Sciences. The recorded presentations will alternate with two live panel discussions that will include leading scientists, oncologists, patients and patient advocates.

The event takes place on Thursday, April 21 beginning at 12 p.m. ET, 9 a.m. PT. Online attendance is free, and registration is available at this LINK. S.E.E. Summit run-of-show:

9:00 – Welcome

Simon Davies – Executive Director, Teen Cancer America
Jamie Reno – Healthline journalist, author, cancer survivor and advocate
9:10 – IV BioHoldings

Marty Keiser – Founder & CEO
9:25 – Natera

Dina Scaglione – Director Oncology Marketing
Adham Jurdi MD – Medical Director
9:40 – Grail

Joshua Ofman MD – President and Chief Medical Officer
9:55 – Panel #1 – Advocates

Hilary Gan – Hospital Programs and Services Director, Teen Cancer America (breast cancer survivor)
Christabel K. Cheung, PhD, MSW – Assistant Professor, University of Maryland School of Social Work; Member, University of Maryland Greenbaum Comprehensive Cancer Center; Collaborating Member, University of Hawaii Cancer Center (Non-Hodgkin’s lymphoma cancer survivor)
Judy Fulmer – Prevention Chair, PREP4 Gold (parent of a teen cancer survivor)
10:40 – Guardant

Michele Rest – Senior Director of Corporate Communications
AmirAli Talasaz – Co-founder & Co-CEO
10:55 – StageZero Life Sciences

James Howard-Tripp – Chairman & CEO
11:10 – Caris Life Sciences

Rob Clark – Sr. Vice President, Chief Communications Officer
David Spetzler PhD – President and Chief Scientific Officer
11:25 – Panel #2 – Scientists/Physicians

Jerome Madison – VP Pharma and Provider Relations, Trapelo Health
David Shulman MD – Attending Physician, Pediatric Oncology, Sarcoma Center, Dana-Farber/Boston Children’s Cancer and Blood Disorders Center
Aditya Bagrodia MD, FACS – Urologic Oncologist, Associate Professor of Urology, Disease Team Co-Leader, Genitourinary Cancer, UC San Diego Health
Umberto Malapelle – Secretary of the International Society of Liquid Biopsy; Professor in Anatomic Pathology in School of Medicine, University of Naples Federico
Abhijat Kitchlu MD – Department of Medicine, Division of Nephrology at the University of Toronto
12:10 – Exact Sciences/Thrive

Isaac Kinde, MD, PhD – VP Technology Assessment
12:25 – Pillar Biosciences

Randy Pritchard – CEO
12:40 – Concluding remarks from Jamie Reno and Simon Davies

"This is the first event to bring the science of liquid biopsy out of stealth mode," said Reno. "Our goal is to share information about this growing sector in ways that scientists appreciate but consumers, healthcare professionals, potential investors and the media can also understand."

The organizations participating in the S.E.E. Summit plan to extend the program into a series of educational media initiatives to educate and inform cancer patients, healthcare professionals, and the general public.

"Liquid biopsy is a major step forward in cancer detection among all age groups, but it is especially significant for our work at TCA," said Davies. "Late detection and misdiagnosis are not uncommon for teens and young adults with cancer, so we’re thrilled to help bring this good news to mainstream audiences for the first time."

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Johnson & Johnson Q1 2022 Results

Provectus Biopharmaceuticals Seeks Stockholder Approval at 2022 Annual Meeting for Authority to Undertake Reverse Split of Outstanding Equities and Reduce Number of Authorized Equities by Same Ratio

ImmVira enters clinical development in combination therapy of MVR-T3011 IT and MEK inhibitor in the U.S.

FDA granted CMG901 Fast Track Designation for unresectable or metastatic gastric and gastroesophageal junction cancer which have relapsed and/or are refractory to approved therapies

Global Leaders to Present Breakthroughs in Liquid Biopsy, Early Cancer Detection at S.E.E. Summit