BeiGene signs deal with Singlomics for neutralizing COVID-19 antibodies
BeiGene Ltd. (BGNE) announced that it has inked a new deal with Singlomics Biopharmaceuticals Co. for developing, manufacturing and commercializing various anti-COVID-19 antibodies, including DXP-593 and DXP-604. Under the terms of this collaboration, BeiGene will be responsible for these antibodies outside of greater China.
It is expected that a Phase 1 randomized, double-blind, and placebo-controlled clinical trial will be started. The enrollment of nearly 30 healthy subjects for the trial will likely begin in September. The participant recruitment for the Phase 1/2 multinational trial in patients with mild to moderate COVID-19 is also expected to be started in early October.
The terms of the collaboration grants BeiGene exclusive rights in ex-China for its pre-clinical assets DXP-593 and DXP-604. The right will also applicable to a series of antibody sequences that could target the COVID-19 virus. Lai Wang, Ph.D. of BeiGene said, “We are looking forward to initiating clinical trials for this exciting program and to contribute to the worldwide efforts in developing novel treatments for patients with COVID-19.”
BeiGene is looking to develop one or more of these antibodies globally outside of greater China. The company will pay an upfront payment to Singlomics, in addition to potential payments contingent upon the achievement of various commercial and regulatory milestones. Singlomics is also eligible for tiered royalties, up to double-digits, on future product sales.
Singlomics used high-throughput single-cell sequencing of convalescent blood samples from recovered patients with COVID-19 for identifying multiple antibodies. These antibodies have shown the potential to neutralize SARS-CoV-2 in various pre-clinical studies.
DXP-593 and DXP-604 are SARS-CoV-2 neutralizing antibody drug candidates. DXP-593 demonstrated strong neutralization potency in preclinical testing, with an IC50 of 1.2 ng/mL and 15 ng/mL against pseudotyped and authentic SARS-CoV-2, respectively. It also showed robust therapeutic and prophylactic efficacy in SARS-CoV-2-infected rodent models.
DXP-604 has also showed high potency and it works by binding to a different epitope from DXP-593. Both DXP-593 and DXP-604 have demonstrated the potential to be incorporated in a cocktail treatment option that could prevent resistance due to viral mutation.
Singlomics Biopharmaceuticals is a biotech company. It mainly focuses on antibody drug discovery and development for various indications such as infectious ailments and autoimmune diseases. The company uses its single cell sequencing platforms for this purpose.
BeiGene is a global, commercial-stage biotechnology company and has presence in various countries including the United States and Europe. The company has two products in its market product portfolio. These products are BTK inhibitor BRUKINSA and anti-PD-1 antibody tislelizumab. The former is available in China and the United States while the latter is marketed in China.
BeiGene has collaboration with various global pharma companies such as Celgene and Amgen. Earlier this year, Amgen acquired 20.5 percent stake in BeiGene at nearly $2.8 billion. The collaboration will work towards boosting its position in oncology segment in China. The company recently reported receiving the approval for BRUKINSA in China for treating adult patients suffering from lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who were given at least one prior therapy.
UroGen flunks Phase 2 RTGel combo study
UroGen Pharma Ltd. (URGN) provided update for its Phase 2 APOLLO clinical trial of a RTGel hydrogel formulation in combination with BOTOX® intravesical instillation. The trial aimed to assess the potential of the combo in treating overactive bladder (OAB) and urinary incontinence. The study did not fulfill the primary endpoint of showing improvement in overactive bladder symptoms.
Phase 2 APOLLO Trial is a multi-center, randomized, double-blind, placebo-controlled, single-treatment, two-stage, dose-finding clinical trial. The first stage of the trial consisted of a placebo-controlled, dose escalation design. The second stage follows a randomized, placebo-controlled design. The primary endpoint of the trial was measured by the decrease in urinary incontinence episodes per day. It is surmised that the failure of achieve primary endpoint may have been caused by Botox’s inability to permeate the urothelium.
The combination was found to be safe and well tolerated while its extended dwell time was up to 10 hours following initial instillation. The combination was administered through a standard urinary catheter and the participants reported their satisfaction with the convenience of hydrogel administration. Dr. Mark Schoenberg, CMO at UroGen said, “The topline data from this trial reinforces that our RTGel technology could be combined with a substantial library of molecules to deliver therapy where dwell time may improve outcomes and we look forward to our continued collaboration with AbbVie as they develop their portfolio of toxin proteins.”
UroGen is collaborating with AbbVie (ABBV) for developing this treatment. The Phase 2 trial was carried out by AbbVie under the terms of the agreement. BOTOX® injection into the bladder is approved as a pharmacologic therapy for treating overactive bladder in adults where other types of medications did not work or could not be taken. AbbVie had acquired the product as a part of its buyout of Allergen Inc.
Matinas BioPharma reports progress for ENHANCE-IT study
Matinas BioPharma Holdings Inc. (MTNB) reported that it has competed enrolment for the ENHANCE-IT study comparing MAT9001 against Vascepa®. The trial aims to assess the drug candidate’s potential to reduce triglyceride levels and other important lipid markers. It will also evaluate bioavailability and blood levels of eicosapentaenoic acid (EPA) and other omega-3 fatty acids.
ENHANCE-IT is an open-label, randomized, 28-day crossover study. It is now fully enrolled and has recruited both male and female participants with elevated triglycerides. At least 50 percent of the participants have TG level equal to or more than 200 mg/dL. The trial incorporates two 28-day treatment periods. There will be a washout period of at least 28 days in between treatments. The trial is being conducted over eight sites in the United States.
The participants will be given MAT9001 and Vascepa, each being administered as 2g twice daily with food in accordance with currently approved Vascepa labeling. At the baseline, various lipid parameters such as triglycerides, Total-, LDL-, VLDL-, HDL-, and non-HDL cholesterol, apolipoproteins A1, B and C3, and PCSK9 along with omega-3 blood levels. These parameters will be measured again at the end of each treatment period.
The primary endpoint of the trial is the percent change from baseline to end-of-treatment in plasma triglycerides. James J. Ferguson, M.D., Chief Medical Officer of Matinas said, “Successful completion of ENHANCE-IT enrollment is a key milestone for Matinas, and this study will provide important data for both MAT9001 and Vascepa. We believe the data generated in this clinical trial should further differentiate MAT9001’s superior clinical profile over Vascepa.”
Matinas BioPharma is a clinical-stage biopharmaceutical company. Its lead drug candidate MAT9001 is a prescription-only omega-3 fatty acid-based composition, primarily containing EPA and DPA. The company is also working on MAT2203 for treating serious invasive fungal infections.
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