Drugs / IMM-BCP-01
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | COVID-19 | 2021-11-29 | “submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for IMM-BCP-01” immunome.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05429021 | Jun 2022 → Jan 2023 | COVID-19 | Immunome, Inc. | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2022-07-06 | Immunome, Inc. | Results Immunome’s COVID-19 Cocktail Retains Neutralizing Activity Against the Most Prevalent Omicron Subvariants* in the US, BA.4/5 and BA.2.12.1 immunome.com ↗
Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, today announced that their cocktail (IMM-BCP-01) retained activity against the BA.4/5 and BA.2.12.1 subvariants in pseudovirus testing. |
| 2022-05-19 | Immunome, Inc. | Results Immunome Announces Data Demonstrating COVID-19 Antibody Cocktail Potently Clears Omicron BA.1 Variant in Hamster Model and Retains Activity Against BA.2 Subvariant immunome.com ↗
Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, today announced that it published data demonstrating that its COVID-19 antibody cocktail, IMM-BCP-01, potently cleared the Omicron variant (BA.1) of SARS-CoV-2 when tested in vivo in hamsters. |
| 2022-03-28 | Immunome, Inc. | Regulatory Immunome Reports Fourth Quarter and Full Year 2021 Financial Results immunome.com ↗
We are pleased the FDA has given us a safe-to-proceed notification and lifted the clinical hold for our Investigational New Drug (IND) application, |
| 2022-03-11 | Immunome, Inc. | Regulatory FDA Lifts Clinical Hold on Immunome’s IMM-BCP-01 IND Application for the Treatment of COVID-19 immunome.com ↗
Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug (IND) application for its antibody cocktail (IMM-BCP-01), for the treatment of SARS-CoV-2 (COVID-19). |
| 2022-02-08 | Immunome, Inc. | Results Immunome’s Antibody Cocktail Effective Against SARS-CoV-2 Omicron Variant in In Vitro Live Virus Testing immunome.com ↗ |
| 2022-01-10 | Immunome, Inc. | Regulatory Immunome Provides Update on Investigational New Drug Application for IMM-BCP-01 for the Treatment of COVID-19 immunome.com ↗
The Company received a clinical hold letter from the U.S. Food and Drug Administration (FDA) in response to its recently submitted IND requesting further information related to the preparation and administration of IMM-BCP-01 at clinical sites. |
| 2021-11-29 | Immunome, Inc. | Regulatory Immunome Announces Submission of an Investigational New Drug (IND) Application for IMM-BCP-01 for the Treatment of COVID-19 immunome.com ↗ |
| 2021-10-20 | Immunome, Inc. | Results Immunome Announces Submission for Publication of Pre-clinical Research Detailing the Importance of Antibody Cocktail for SARS-CoV-2 Treatment and Prophylaxis immunome.com ↗
In preclinical testing, the antibodies exhibit combinatorial effects against multiple SARS-CoV-2 strains, including CDC variants of concern, and significantly reduces viral load in the lungs of hamsters infected with a SARS-CoV-2 reference strain. |
| 2021-09-07 | Immunome, Inc. | Results Immunome Antibody Cocktail (IMM-BCP-01) Neutralizes SARS-CoV-2 Lambda and Delta Plus Variants in Pre-clinical Testing immunome.com ↗ |
| 2021-07-20 | Immunome, Inc. | Results Immunome Antibody Cocktail (IMM-BCP-01) Neutralizes the SARS-CoV-2 Delta Variant in Pre-clinical Testing immunome.com ↗
Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, 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. |
| 2021-04-26 | Immunome, Inc. | Results Immunome SARS-CoV-2 Antibody Cocktail Neutralizes UK, South Africa, Brazil and California Variants in Preclinical Testing; Progressing Towards IND Filing immunome.com ↗
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. |
| 2021-02-01 | Immunome, Inc. | Results Immunome’s Research Reveals a Broad Super Responder Memory B Cell Response to the SARS-CoV-2 Virus immunome.com ↗
Findings support the potential of Immunome’s approach to developing IMM-BCP-01 as an optimized antibody cocktail for the treatment and prophylaxis of COVID-19 |
All press releases naming this drug 14 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IMM-BCP-01 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05429021 ↗ |
| Route | Intravenous | “intravenous (IV) IMM-BCP-01” NCT05429021 ↗ |