IMM-BCP-01 / Immunome - LARVOL DELTA

IMM-BCP-01 in Mild to Moderate COVID-19 (clinicaltrials.gov) - P1 | N=9 | Terminated | Sponsor: Immunome, Inc. | N=36 ➔ 9 | Recruiting ➔ Terminated; Business decision to discontinue the study based on strategic prioritization.

Enrollment change • Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

IMM-BCP-01, a patient-derived anti-SARS-CoV-2 antibody cocktail, is active across variants of concern including Omicron BA.1 and BA.2. (PubMed, Sci Immunol) - "These antibodies decreased Omicron SARS-CoV-2 infection in the lungs of Syrian golden hamsters in vivo, and potently induced antiviral effector response in vitro, including phagocytosis, ADCC, and complement pathway activation. Our pre-clinical data demonstrated that the three antibody cocktail IMM-BCP-01 could be a promising means for preventing or treating infection of SARS-CoV-2 variants of concern, including Omicron BA.1 and BA.2, in susceptible individuals."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

IMM-BCP-01 in Mild to Moderate COVID-19 (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Immunome, Inc.

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

[PREPRINT] Preclinical Efficacy of IMM-BCP-01, a Highly Active Patient-Derived Anti-SARS-CoV-2 Antibody Cocktail (bioRxiv) - “Here, we describe the pre-clinical characterization of an antibody cocktail, IMM-BCP-01, that consists of three unique, patient-derived recombinant neutralizing antibodies directed at non-overlapping surfaces on the SARS-CoV-2 spike protein….These antibodies decreased SARS-CoV-2 infection in the lungs of Syrian golden hamsters, and efficacy in vivo efficacy was associated with broad antiviral neutralizing activity against multiple SARS-CoV-2 variants and robust antiviral effector function response, including phagocytosis, ADCC, and complement pathway activation. Our pre-clinical data demonstrate that the three antibody cocktail IMM-BCP-01 shows promising potential for preventing or treating SARS-CoV-2 infection in susceptible individuals.”

Preclinical • Preprint • Infectious Disease • Novel Coronavirus Disease

Immunome Antibody Cocktail (IMM-BCP-01) Neutralizes the SARS-CoV-2 Delta Variant in Pre-clinical Testing (Businesswire) - "Immunome, Inc....announced today that its three-antibody cocktail (IMM-BCP-01) has demonstrated potent neutralizing activity against the SARS-CoV-2 Delta variant in pre-clinical pseudovirus testing. Furthermore, IMM-BCP-01 showed in-vitro activity via non-neutralizing mechanisms, such as complement fixation, which Immunome expects will enable viral clearance....The Company plans to submit an IND application with the U.S. Food and Drug Administration (FDA) this quarter."

IND • Preclinical • Infectious Disease • Novel Coronavirus Disease

Immunome Announces Additional $4.3 Million Award by DOD following Positive Preclinical Testing Results on COVID-19 Variants of Concern (Businesswire) - "Immunome, Inc....announced a $4.3 million increase awarded by the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), in collaboration with the Defense Health Agency (DHA), for the continued development of an antibody cocktail (IMM-BCP-01) to combat SARS-CoV-2 and its variants....The additional funding is to support expansion of the clinical study following feedback from the FDA. Immunome is continuing efforts towards an IND filing for IMM-BCP-01 in late 2Q/early 3Q 2021."

Financing • IND • Infectious Disease • Novel Coronavirus Disease

Immunome SARS-CoV-2 Antibody Cocktail Neutralizes UK, South Africa, Brazil and California Variants in Preclinical Testing; Progressing Towards IND Filing (Businesswire) - "In Syrian hamsters infected with live SARS-CoV-2 virus (USA-WA1/2020), IMM-BCP-01 reduced lung viral load as a treatment and prophylaxis. Live virus studies demonstrated full neutralization by IMM-BCP-01 of CDC-designated 'Variants of Concern,' South Africa (B.1.351) and UK (B.1.1.7), as well as the U.S. and European reference strains USA-WA1/2020 and BavPat1/2020....Immunome anticipates filing an IND for its IMM-BCP-001 program in late Q2/early Q3 2021."

IND • Preclinical • Infectious Disease • Novel Coronavirus Disease

Abzena Selected by Immunome to Develop and Manufacture Antibody Cocktail for Immunome’s COVID-19 Antibody Based Treatment (Businesswire) - "Immunome, Inc....announced that Abzena was selected as Immunome’s partner research organization for IMM-BCP-01, an investigational therapeutic antibody cocktail for the treatment of COVID-19 being developed to target multiple SARS-CoV-2 antigens. Abzena will work with Immunome to produce the antibody cocktail for clinical testing....'We selected Abzena as our Contract Development and Manufacturing Organization (CDMO) partner due to scientific expertise, flexibility and ability to execute on our timeline...'"

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease