VIR-5818
/ Sanofi, Vir Biotech
- LARVOL DELTA
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September 09, 2024
Vir Biotechnology Announces Closing of Exclusive Worldwide License Agreement With Sanofi for Multiple Potential Best-in-Class Clinical-Stage T-Cell Engagers
(Businesswire)
- "Vir Biotechnology...announced that the exclusive worldwide license agreement with Sanofi announced on August 1, 2024, has closed following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The agreement provides Vir with an exclusive worldwide license to three clinical-stage masked T-cell engagers (TCEs) with potential applications in a range of cancers and exclusive use of the proprietary PRO-XTEN masking platform for oncology and infectious disease....The clinical-stage assets Vir is licensing under the agreement are: (i) SAR446309 is a dual-masked HER2-targeted TCE in phase 1 clinical study including participants with metastatic treatment resistant HER2+ tumors such as breast and colorectal cancers; (ii) SAR446329 is a dual-masked PSMA-targeted TCE in phase 1 clinical study including participants with metastatic castration-resistant prostate cancer; (iii) SAR446368 is a dual-masked EGFR targeted TCE with an active IND."
Licensing / partnership • Breast Cancer • Colorectal Cancer • Metastatic Castration-Resistant Prostate Cancer
August 01, 2024
Vir Biotechnology Acts on Expanded Strategy of Powering the Immune System Through Exclusive Worldwide License Agreement with Sanofi for Multiple Potential Best-in-Class Clinical-Stage T-cell Engagers
(Businesswire)
- "Across its portfolio of clinical assets, below are anticipated upcoming catalysts: (i) SAR446309: Phase 1 monotherapy and combination study data expected in the second half of 2025; (ii) SAR446329: Phase 1 monotherapy study data expected in the second half of 2025; (iii) SAR446368: Phase 1 study to begin enrollment in the first quarter of 2025 or sooner."
New P1 trial • P1 data • Metastatic Castration-Resistant Prostate Cancer • HER-2
August 01, 2024
Vir Biotechnology Acts on Expanded Strategy of Powering the Immune System Through Exclusive Worldwide License Agreement with Sanofi for Multiple Potential Best-in-Class Clinical-Stage T-cell Engagers
(Businesswire)
- "Vir Biotechnology...announced that it has entered into an exclusive worldwide license agreement with Sanofi for three clinical-stage masked T-cell engagers (TCEs) and exclusive use of the protease-cleavable masking platform for oncology and infectious diseases, acquired by Sanofi from Amunix Pharmaceuticals. The clinical-stage assets include SAR446309 (AMX-818), a dual-masked HER2-targeted TCE; SAR446329 (AMX-500), a dual-masked PSMA-targeted TCE; and SAR446368 (AMX-525), a dual-masked EGFR-targeted TCE....As part of the strategic agreement with Sanofi, key employees with extensive scientific and development expertise in TCEs, and in-depth experience using the masking platform technology, will join Vir upon receipt of Hart-Scott-Rodino (HSR) Act clearance....Pursuant to this agreement, Sanofi will receive an upfront payment and is eligible to receive future development, regulatory and commercial net sales-based milestone payments and tiered royalties on worldwide net sales."
Licensing / partnership • Solid Tumor
June 07, 2024
KEYNOTE-D14: To Access the Safety and Effects of Intravenous Administration of AMX-818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
(clinicaltrials.gov)
- P1/2 | N=645 | Recruiting | Sponsor: Amunix, a Sanofi Company | Trial primary completion date: Dec 2026 ➔ Aug 2027
Combination therapy • Metastases • Trial primary completion date • Oncology • HER-2
March 12, 2024
KEYNOTE-D14: To Access the Safety and Effects of Intravenous Administration of AMX-818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
(clinicaltrials.gov)
- P1/2 | N=645 | Recruiting | Sponsor: Amunix, a Sanofi Company | Trial completion date: Dec 2026 ➔ Aug 2027
Combination therapy • Metastases • Trial completion date • Oncology • HER-2
January 25, 2024
KEYNOTE-D14: To Access the Safety and Effects of Intravenous Administration of AMX-818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
(clinicaltrials.gov)
- P1/2 | N=575 | Recruiting | Sponsor: Amunix, a Sanofi Company | Phase classification: P1 ➔ P1/2
Combination therapy • Metastases • Phase classification • Oncology • HER-2
May 28, 2023
XTEN Polypeptide-Masked Protease Activated T Cell Engagers: XPAT Proteins – A Novel Format to Mitigate On-Target, Off-Tumor Problem
(PEGS 2023)
- "XPAT proteins are conditionally active T cell engagers (TCEs) designed to exploit the dysregulated protease activity in tumors. In preclinical studies across multiple tumor targets, XPAT proteins demonstrated 1) strong masking of in vitro cytotoxicity by up to 4 logs; 2) potent in vivo efficacy at doses similar to the efficacious doses of unmasked TCE controls; and 3) masking increases tolerated Cmax in NHP by greater than 400-fold for HER2-XPAT."
Oncology • HER-2
March 31, 2023
Precision-activated T-cell engagers targeting HER2 or EGFR and CD3 mitigate on-target, off-tumor toxicity for immunotherapy in solid tumors.
(PubMed, Nat Cancer)
- "HER2-XPAT protein cleavage is low and similar in plasma samples from healthy and diseased humans and non-human primates, supporting translatability of stability to patients. EGFR-XPAT protein confirmed the utility of XPAT technology for tumor targets more widely expressed in healthy tissues."
Journal • Oncology • Solid Tumor • EGFR • HER-2
May 02, 2022
To Access the Safety and Effects of Intravenous Administration of AMX 818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
(clinicaltrials.gov)
- P1 | N=560 | Recruiting | Sponsor: Amunix, a Sanofi Company
Combination therapy • New P1 trial • Oncology • HER-2
March 23, 2022
AMX-818: Next generation conditionally active, masked T-cell engager for the treatment of HER2-expressing solid tumors
(AACR 2022)
- "While a razor-thin therapeutic index (TI) has been observed in hematologic malignancies for TCEs like blinatumomab, and similarly with CAR-Ts, developing solid tumor T-cell-directed therapies has been hampered by on-target off-tumor toxicities including cytokine release syndrome (CRS), other toxicities, and other challenges related to immunogenicity. Together with the data supporting stability of AMX-818 in plasma and healthy tissue and its preferential cleavage in tumors, the nonclinical data package supports further evaluation in a planned clinical trial. AMX-818 represents a promising solution to widen the TI for TCE activity in HER2-high and HER2-low expressing tumors."
Hematological Malignancies • Oncology • Solid Tumor • HER-2
April 10, 2022
"Cleavage of AMX-818 preferentially within tumors in vivo - hints to good therapeutic index, also PK profile shown #AACR22"
(@gerlach_d)
Preclinical • Oncology
April 10, 2022
"Active in HER2 high and HER2 low models - active in vitro and in vivo - AMX-818 #AACR22"
(@gerlach_d)
Preclinical • Oncology • HER-2
December 20, 2021
Sanofi to acquire Amunix immuno-oncology pipeline with next generation Conditionally Activated Biologics
(GlobeNewswire)
- "Sanofi announced today that it has entered into an agreement to acquire Amunix Pharmaceuticals, Inc., an immuno-oncology company leveraging its proprietary, clinically validated XTEN® and innovative universal protease-releasable masking technology platform, Pro-XTENTM, to discover and develop transformative T-cell engagers (TCE) and cytokine therapies for patients with cancer. Amunix’s pipeline, which includes lead candidate, AMX-818, a masked HER2-directed TCE, offers a strong strategic fit with Sanofi’s focus on developing potentially transformative cancer therapies in immuno-oncology....Sanofi expects to complete the acquisition in Q1 of 2022."
M&A • Oncology • Solid Tumor
September 30, 2021
[VIRTUAL] AMX-818, a novel prodrug HER2-XPAT T-cell engager (TCE) with potent T cell activation, proteolytic cleavage and efficacy in xenograft tumors, and wide safety margins in NHP (Non Human Primate)
(AACR-NCI-EORTC 2021)
- No abstract available
Clinical • Oncology • HER-2
April 12, 2021
Amunix Presents Preclinical Data at American Academy of Cancer Research (AACR) Annual Meeting from Lead Program AMX-818 Demonstrating Robust Efficacy in HER2 Tumor Models and Enhanced Safety
(GlobeNewswire)
- "Amunix Pharmaceuticals, Inc...announced data were presented from its lead program AMX-818 (HER2-XPAT), at the AACR Annual Meeting. The data demonstrate that AMX-818, a masked T cell engager (TCE) that targets HER2 expressing tumors, is preferentially activated, as designed, in the protease-rich tumor microenvironment leading to robust tumor regression in HER2 tumor models and in non-human primates (NHP) achieved concentrations approximately 450 times higher than the unmasked TCE without causing cytokine release syndrome (CRS) or systemic T cell activation characteristic of T cell engagers....Amunix expects to file a CTA for AMX-818 by the end of 2021."
Clinical • Cytokine release syndrome • Preclinical • Oncology • Solid Tumor
March 04, 2021
Amunix Raises $117 Million Series B Financing to Fund its Oncology Pipeline
(Amunix Press Release)
- “Amunix Pharmaceuticals, Inc…announced that it has raised $117 million Series B financing….Proceeds from the financing will fund the advancement into the clinic of AMX-818, a masked, protease-activated T cell engager (XPAT®) targeting HER2-expressing solid tumors, as well as support Amunix’s robust pipeline of earlier stage XPATs® and masked, protease-activated cytokines (XPACs™).”
Financing • Oncology • Solid Tumor
December 09, 2020
Amunix Presents Preclinical Data on AMX-818, a Protease-Activated HER2-Targeted T Cell Engager Prodrug, at SABCS 2020
(GlobeNewswire)
- "Amunix Pharmaceuticals, Inc...shared new data on AMX-818 (HER2-XPAT), the company’s lead clinical candidate T cell engager which targets HER2....Amunix presented a poster at SABCS, titled 'HER2-XPAT, A Novel Protease-Activatable Prodrug T Cell Engager (TCE), Engineered to Address On-Target, Off-Tumor Toxicity and Provide Large Predicted Safety Margins in Non-Human Primates'. The poster shows that Amunix’s XPAT technology can improve the toxicity profile of T cell engagers while maintaining their potency against solid tumors."
Preclinical • Oncology • Solid Tumor
September 18, 2020
ESMO: Amunix's T-cell engagers shrink solid tumors in animal models
(FierceBiotech)
- "In mouse models of HER2-positive solid tumors, a single dose of AMX-818 caused large tumors to shrink, Amunix reported at the virtual meeting of the European Society of Medical Oncology (ESMO)."
Preclinical • Oncology • Solid Tumor
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