CanVirex’s lead candidate Mevacil for the treatment of cancer

On February 17, 2023 CanVirex reported that it has moved forward in the development of its lead candidate Mevacil for the treatment of cancer (Press release, CanVirex, FEB 17, 2023, View Source;utm_medium=rss&utm_campaign=moving-forward-in-the-development-of-canvirexs-lead-candidate-mevacil-for-the-treatment-of-cancer [SID1234627397]).

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CanVirex is in preparation of a phase I/IIa trial to assess safety and tolerability of Mevacil in patients with advanced-stage solid cancers.

Mevacil is a proprietary, oncolytic measles virus that encodes the genetic information for the cytokine interleukin 12 (IL-12) on its viral genome. Thus, during viral replication, cancer cells not only amplify the oncolytic agent, but also produce therapeutic IL-12 themselves.

IL-12 is one of the most potent inducers of anti-tumor immunity through various direct and indirect effects on immune cells. However, based in its potency, IL-12 can induce unspecific immune reactions after systemic administration which can cause severe toxicities. By using an IL-12-armed oncolytic measles virus, IL-12 production is restricted to the tumor site. In addition, virus-induced cancer cell death releases tumor antigens and danger signals which alert the immune system. Consequently, the immune stimulatory IL-12 is provided in an environment that has already been stimulated to induce an anti-tumor immune response. Thus, IL-12 activity is directed to develop its full potential towards the induction of an anti-tumor immune response.

In a preclinical study, Mevacil induced complete tumor remissions (CR) in 90% of mice suffering from murine colorectal adenocarcinomas, a CR rate which has not been achieved by other immunotherapies in this study, including immune checkpoint inhibition. More strikingly, when tumors were re-implanted into previously cured mice, tumors were completely rejected by the murine immune system. Thus, Mevacil treatment induced a protective, systemic anti-tumor immunity. Based on these promising preclinical results, Mevacil has the potential to outperform current immunotherapies, especially in patients who are resistant to immune checkpoint inhibition.

A major challenge in the development of oncolytic measles virus-based therapeutics is the manufacturing of the measles vector at high yields under current Good Manufacturing Practice (cGMP). To overcome this challenge, CanVirex has partnered with IDT Biologika, a biopharmaceutical company that develops and manufactures vaccines and biologics for human and animal health. Prior to entering the clinical phase, drug candidates needs to be manufactured under cGMP conditions to comply with regulatory requirements, a task requiring state-of-the-art manufacturing infrastructure, expertise and industrial scale capabilities. Consequently, a technology transfer of CanVirex’s cGMP manufacturing technology has been initiated to IDT and we are excited to announce that the tech transfer run and a confirmation run under cGMP-like conditions were successful. We are looking forward to reaching our next milestones with IDT, which include the implementation of an engineering run and generation of Clinical Trial Material (CTM).

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

AbbVie has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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Guardant Health to Participate in Upcoming March Investor Conferences

On February 17, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company will be participating in the following investor conferences (Press release, Guardant Health, FEB 17, 2023, View Source [SID1234627391]).

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Citi 2023 Healthcare Services, MedTech, Tools & HCIT Conference in New York City, NY
Fireside Chat on Wednesday, March 1st at 3:30 p.m. Eastern Time / 12:30 p.m. Pacific Time
Cowen 43rd Annual Health Care Conference in Boston, MA
Fireside Chat on Wednesday, March 8th at 10:30 a.m. Eastern Time / 7:30 a.m. Pacific Time
Interested parties may access a live and archived webcast of the presentation on the "Investors" section of the company website at: www.guardanthealth.com.

Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On February 17, 2023 Scholar Rock (NASDAQ: SRRK; "The Company"), a Phase 3, clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that the Company granted inducement equity awards covering an aggregate of 285,000 shares of its common stock to two newly hired employees, consisting of inducement stock options to purchase an aggregate of 255,000 shares of common stock and inducement restricted stock units ("RSUs"), covering an aggregate of 30,000 shares of its common stock (Press release, Scholar Rock, FEB 17, 2023, View Source [SID1234627390]).

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The awards are subject to all terms and conditions and other provisions set forth in the Company’s 2022 Inducement Equity Plan ("The Plan") and form of stock option agreement thereunder.

The Plan, which was adopted by the Company’s board of directors on June 16, 2022, is used exclusively for the grant of equity awards to individuals who were not previously employees of Scholar Rock, or following a bona fide period of non-employment, as an inducement material to such individuals entering into employment with Scholar Rock, pursuant to Nasdaq Listing Rule 5635(c)(4).

The options have an exercise price of $10.00, which is equal to the closing price of Scholar Rock’s common stock on February 13, 2023. The stock option award will vest with respect to 25% of the shares of common stock underlying the award on the first anniversary of each employee’s start date, and the remaining 75% of the shares of common stock underlying the Stock Option Award will vest in 12 equal quarterly installments thereafter. Vesting for RSUs will be in four equal annual installments. All vesting related to inducement awards is subject to the employees’ continuing service at the Company through the applicable vesting date.

About Scholar Rock

NS Pharma Announces First Patient Enrolled in Phase 2 Study to Assess Efficacy and Safety of NS-018 Compared to Best Available Therapy (BAT) in Patients With Myelofibrosis

On February 17, 2023 NS Pharma, Inc. reported the first patient enrollment in a Phase 2 clinical study of NS-018 (ilginatinib), an investigational treatment for myelofibrosis (MF), a rare and incurable blood cancer (Press release, NS Pharma, FEB 17, 2023, View Source [SID1234627389]).

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The Phase 2b study is an open-label, multicenter, randomized, controlled, 2-arm study to assess the efficacy and safety of orally administered NS-018 versus best available therapy in subjects with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis with severe thrombocytopenia (Platelet Count <50,000/μL).

ClinicalTrials.gov identifier: NCT04854096
(View Source)

About Myelofibrosis (MF)
MF is caused by buildup of excessive scar tissue in the bone marrow, which impairs the body’s ability to produce blood cells.1 In addition to impaired blood cell production, MF often leads to enlargement of the spleen (splenomegaly) which can lead to feelings of abdominal pain and pressure.1 Other common symptoms include fatigue, bone pain, fever, and weight loss.1 MF can be diagnosed at any age but is most common in men and women 65 years or older.1 The median survival of patients with MF is approximately six years.1 Several gene mutations are associated with MF, and the most common mutation is to the Janus kinase 2 (JAK2) gene.2

About NS-018
NS-018 is a highly selective and potent inhibitor of JAK2 developed by scientists from Nippon Shinyaku and was recently granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA).