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May 2022 FDA awards Phase 1/2a clinical trial to study the effects of Immunis’ platform immunomodulatory product STEM on muscular atrophy in patients with knee osteoarthritis
Immunis Announces FDA Clearance and Clinical Site for Phase 1/2a Clinical Trial Investigating Muscle Atrophy
Immunis Closes $10 Million Financing Round
IRVINE, Calif. — August 3, 2022 — Immunis Inc., a private biotechnology company developing a novel treatment for age and disease-related immune decline, has closed a $10M Series A First Closing financing led by Remiges Ventures with participation by several other healthcare investment firms. Strategic investor, Continuum Health Ventures, which supports thesis-driven startups at the intersection of health and technology in the digital health and longevity sectors, also joined the round. Proceeds will support clinical assessment of Immunis’ immunomodulatory secretome product in an FDA-awarded Phase 1/2a clinical trial targeting muscle atrophy, which is an age, disuse and disease-associated condition experienced by 100% of the population.

“The completion of this financing round reflects strong asset development, an outstanding team and a focused strategy,” said Dr. Hans S. Keirstead, Chairman of Immunis.

An inevitable consequence of aging is decline of immune system health. Immune system degeneration manifests many degenerative conditions within the body, including muscle atrophy. Mitigating the loss of muscle and improving muscle recovery are unmet medical needs. Immunis’ unique secretome treatment, IMM01-STEM, addresses both medical needs using natural immunomodulators with potent cytoskeletal remodeling properties.

“This is a first-in-sector immunomodulatory secretome product, and Immunis is excited to be entering human clinical testing,” said Dr. Tom Lane, Chief Science Officer of Immunis. “The secretome is all natural, all human and represents a perfectly balanced set of immune modulators in naturally occurring, relevant physiological concentrations.”

About Immunis Inc.

Immunis is a private biotechnology company developing a novel immunomodulatory secretome product for the various manifestations of age and disease-related immune decline. The STEM product line leverages Immunis’ leading-edge capabilities in stem cell technology to deliver all natural, all human immune modulators in their natural, relative physiological concentrations.

About STEM-MYO

Immunis’ FDA-awarded Phase 1/2a clinical trial is an open-label dose escalation study to assess the safety and tolerability of IMM01-STEM in elderly participants with muscle atrophy associated with knee osteoarthritis (KOA). Up to 18 patients will be enrolled in the trial and randomly assigned to an IMM01-STEM dose cohort. Treatment will be administered in the form of intramuscular injections twice a week, for four weeks (8 injections total). Male or female patients are eligible for the study if they satisfy the following criteria: (1) 50 to 75 years of age at the time of signing the informed consent, (2) have grade 2 or 3 knee osteoarthritis as defined by Kellgren-Lawrence analyses, (3) have quadricep weakness (<7.5N/kg), (4) can ambulate >50 feet unassisted, (5) are negative for human immunodeficiency virus, hepatitis B surface antigen (HBsAg) and hepatitis C at the Screening Visit and (6) have a body mass index (BMI) of <40kg/m2. For additional information about Immunis’ trial participant qualifications, please visit:  www.immunisbiomedical.com

Cautionary Note Regarding Forward-Looking Statements

This communication contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as applicable. Forward-looking statements include, but are not limited to, statements regarding our plans, beliefs, expectations and assumptions, as well as other statements that are not necessarily historical facts. You are cautioned that these forward-looking statements are only predictions and involve risks and uncertainties. Further, any forward-looking statement speaks only as of the date as of which it is made, and we do not intend to update or revise any forward-looking statements. This communication also contains market data related to our business and industry which includes projections that are based on several assumptions we believe are reasonable and most significant to the projections as of the date of this communication. If any of our assumptions prove to be incorrect, our actual results may significantly differ from our projections based on these assumptions. This communication is neither an offer to sell nor a solicitation of an offer to buy any of the securities described herein.

 

 

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