Biopharma and life sciences organizations from across the globe provide updates on their pipelines and businesses.
Memo Therapeutics, a Switzerland-based antibody discovery and development company, initiated a Phase I study that will assess intravenous doses of the experimental MTX-005 that targets BK polyomavirus (BKV) infection in renal transplant patients.
The study will examine the safety, tolerability and pharmacokinetics of single and multiple ascending doses of the experimental treatment in up to 56 healthy adult volunteers. Memo’s MTX-005 is a therapeutic antibody candidate designed to neutralize all strains of BKV at extremely low concentrations.
For patients who undergo a kidney transplant, BKV is a significant concern. Memo noted in its announcement that the BKV is typically dormant, but the immunosuppression needed for transplant survival can trigger reactivation in up to 50% of the transplant population. Of those, 10% can progress to BKV associated nephropathy, which poses a serious threat to the transplant. There are currently no disease-modifying drugs available for this indication. Current treatment involves lowering immunosuppression, but that increases the risk of graft rejection reaction.
Memo Chief Medical Officer Jürgen Beck said MTX-005 possesses a 100x more potent neutralization capacity than benchmark antibodies and could be a game-changing treatment for patients.
“With 50,000 kidney transplant procedures carried out in the US and Europe alone, MTX-005 addresses a large and rapidly growing market, with an estimated size well beyond $1 billion,” Karsten Fischer, chief executive officer of Memo Therapeutics AG said in a statement. “We look forward to reporting phase 1 clinical data for our best- and potentially first-in-class antibody in the first half of 2023.”
Elsewhere around the globe:
Birmingham Biotech: U.K.-based Birmingham Biotech Ltd. and TannerLAC UK Limited entered into a licensing agreement for the distribution of Norizite Nasal Spray in Latin America. Norizite Nasal Spray is designed to help prevent infection from the inhalation of airborne viruses within the nasal passages. Under the license agreement, TannerLAC will be responsible for registering, commercializing, and promoting Norizite in Latin America.
SciSparc Ltd.: Based in Israel, SciSpark forged a collaboration with Polyrizon Ltd. to develop a unique technology for the treatment of pain based on SciSparc’s SCI-160 platform, and Polyrizon’s Trap and Target intranasal drug delivery technology to target the central nervous system. SciSparc’s top-tier investigational drug candidate, SCI-160, is an innovative and proprietary, non-opioid, CB2 receptor agonist intended for the treatment of pain. CB2R specific agonists have been found to be involved in mediating analgesic effects in the peripheral nervous system without psychotropic activity or significant side effects.
Revive Therapeutics: Toronto’s Revive Therapeutics announced it would advance its drug pipeline for inflammatory liver disorders, including Bucillamine in the prevention of ischemia-reperfusion injury during liver transplantation and Cannabidiol for autoimmune hepatitis due to the increasing concerns regarding the growing cases of acute hepatitis in children across the globe. The company also announced it intends to relocate its headquarters to the United States “to better access and support growing drug programs with Bucillamine and other products.”
Capitainer: Swedish medtech company Capitainer closed a $3.45 million fundraising effort that will be used to support the development of its new qDBS dried blood spot testing system. Capitainer has now firmly established that the home sampling system works for clinical use, with an impressive success rate with first time users. Patients can use Capitainer’s qDBS system to collect their own blood samples for diagnostic testing as a dried blood spot in the privacy of their home.
Elicera Therapeutics: Also based in Sweden, Elicera snagged $3 million in funding from the European Innovation Council (EIC) Accelerator Program that will be used to fund the company’s planned clinical phase I/II-study evaluating its CAR T-cell therapy ELC-301 in the treatment of B-cell lymphoma. A fourth generation cell therapy, ELC-301 targets the CD20 protein.
Transine Therapeutics: Another U.K.-based company, Transine raised £4.6 million (about $5.74 million) in additional seed funding. The funds will enable Transine to further explore its unique SINEUP platform and accelerate the development of its product portfolio, and lead programs in Central Nervous System and Ophthalmology indications with key in vivo data expected this year. New investor Epidarex Capital led the financing with participation from existing investors, the Dementia Discovery Fund.
HUTCHMED: Hong Kong-based HUTCHMED announced that Tazverik (tazemetostat) has been approved for use in China by the Health Commission and Medical Products Administration of Hainan Province for use in the Hainan Boao Lecheng International Medical Tourism Pilot Zone. The drug has been authorized under the Clinically Urgently Needed Imported Drugs program to be used for the treatment of certain patients with epithelioid sarcoma and follicular lymphoma consistent with the U.S. Food and Drug Administration labels.
Tazverik is a methyltransferase inhibitor of EZH2 developed by Epizyme, Inc. It is approved by the FDA for the treatment of certain patients with ES and certain patients with FL. In August 2021, HUTCHMED entered into a strategic collaboration with Epizyme to research, develop, manufacture and commercialize Tazverik in China, Hong Kong, Macau and Taiwan. Launched in 2013 and located in China, the Hainan Pilot Zone is a destination for international medical tourism and a global hub for scientific innovation.
Abivax SA: France-based Abivax published an article on its Phase IIa clinical study results for the treatment of moderate to severe active rheumatoid arthritis (RA) with obefazimod in the Annals of the Rheumatic Diseases. The abstract on the data has been selected for a poster presentation at the Annual European Congress of Rheumatology, EULAR 2022. Study data showed that 57% of patients who were treated with obefazimod were in remission after one year of treatment.
Amolyt Pharma: Also based in France, Amolyt announced positive results from the first cohort of its clinical proof of concept trial of AZP-3601, a potential treatment for hypoparathyroidism. The data showed that AZP-3601 was well-tolerated, and daily administration to patients enabled discontinuation of the standard of care while mean serum calcium was maintained within the target range. Detailed data from cohort 1 will be presented at an upcoming medical conference later this year. Full data is expected in the fall of 2022.
Healiva: Switzerland’s Healiva, a chronic wound-focused company, announced the acquisition of two innovative cell therapy assets from Smith+Nephew. The first asset, EpiDex, is an autologous epidermal equivalent that provides a surgery-free approach to healing chronic venous leg ulcers (VLUs). The second asset, now named healiva002, is an off-the-shelf, allogeneic cell therapy that has previously demonstrated clinical efficacy in healing VLUs resistant to standard treatments.
