RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
Argenx (NASDAQ:ARGX) has entered into two new research agreements with Chugai and the Clayton Foundation to broaden its antibody engineering capabilities.
Through these agreements, the company can access world-class Fc engineering technologies to expand the therapeutic properties of future antibody candidates that emerge from its Immunology Innovation Program.
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Argenx and Chugai have entered into a research license and option agreement under which argenx may access Chugai’s SMART-Ig (“Recycling Antibody” and part of “Sweeping Antibody” technology) and ACT-Ig (Antibody half-life extending technology).
The company and the Clayton Foundation have entered into a non-exclusive research agreement under which argenx may access the Clayton’s proprietary DHS mutations to extend the serum half-life of therapeutic antibodies.
Imbio, a provider of artificial intelligence (AI) solutions for medical imaging analysis, has partnered with Roche (OTCQX:RHHBY) unit, Genentech, to develop quantitative imaging diagnostics for lung diseases.
The multi-year agreement leverages Imbio’s technical, regulatory and commercial expertise to build and deploy AI technology for use in research, clinical trials, and clinical practice.
“Imaging biomarkers have the potential to significantly improve patient diagnosis, selection and understanding of response to therapy,” said James Sabry, M.D., Ph.D., Global Head of Roche Pharma Partnering.
Ocugen (NASDAQ:OCGN) has entered into an agreement with privately held, Kemwell Biopharma to manufacture OCU200, Ocugen’s novel biologic product candidate in preclinical development for treating severely sight-threatening diseases like Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Wet Age-Related Macular Degeneration (Wet-AMD).
Under this agreement, Kemwell will manage all CMC and clinical manufacturing activities as well as provide OCU200 supplies for IND-enabling toxicology studies and Phase 1/2a clinical trials.
Ocugen is planning to initiate IND-enabling studies, including GLP toxicology studies next year. DME is the first targeted indication for OCU200, and the Company plans to advance into Phase 1/2a trials in H1 2022.
Based on early clinical success in DME, the Company will evaluate broader indications such as DR and Wet-AMD.
OCGN up 4% premarket.
The first patient has been dosed in a China-based Phase 2/3 study, MAHOGANY, evaluating Zai Lab’s (NASDAQ:ZLAB) margetuximab, combined with a checkpoint inhibitor, with or without chemo, for the first-line treatment of HER2-positive gastric cancer or gastroesophageal junction cancer.
The PD-1 inhibitor will be either retifanlimab or tebotelimab, both developed by MacroGenics (NASDAQ:MGNX).
Margetuximab is an HER2-targeting monoclonal antibody. The company has exclusive development and commercialization rights in Greater China (also includes tebotelimab) under a 2018 agreement with MacroGenics.
Pluristem Therapeutics (NASDAQ:PSTI) has received approval from the Israeli Ministry of Health to commence patient enrollment in Israel for its COVID-19 Phase II clinical trial, under the protocol that was approved by the Germany’s regulatory agency.
A total of 40 patients hospitalized with severe COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS) will be enrolled in Israel and Germany.
The primary efficacy endpoint of the Phase II European study is the number of ventilator free days during the 28 days of the study. Safety and survival follow-up will be conducted up to week 52.
The Phase II COVID-19 European trial expanded to Israel is in addition to other coronavirus clinical programs, including a Phase II study and an Expanded Access Program in the U.S., and a compassionate use program in Israel.
PSTI is currently trading at $10.30. Shares have rallied over 160% YTD.
