San Diego-based Amplyx Pharmaceuticals closed a Series C extension round worth $53 million, bringing the Series C round total to more than $90 million.
San Diego-based Amplyx Pharmaceuticals closed a Series C extension round worth $53 million, bringing the Series C round total to more than $90 million. The round was led by Sofinnova Investment, with existing investors including New Enterprise Associates, Lundbeckfonden Ventures, Arix Bioscience, Pappas Capital, RiverVest Venture Partners, 3x5 Partners and BioMed Ventures participating. New equity investment from Pfizer and Adage Capital Management rounded out the financing.
The company plans to use the monies raised to advance clinical development of its fosmanogepix and MAU868. Fosmanogepix is a novel broad-spectrum antifungal agent being studied for life-threatening fungal infections. The company recently wrapped a Phase II trial of the drug for Candida infections. The drug showed a high level of treatment success in the first 10 patients treated. Additional Phase II trials are ongoing in Aspergillus and other mold infections, in addition to infections caused by multi-drug-resistant Candida auris.
MAU868 is a potent neutralizing monoclonal antibody with activity against BK virus. It is beginning Phase II clinical development for the prevention or treatment of often life-threatening illnesses associated with BKV infection in transplant patients.
“The current pandemic highlights the continued need for the development of safe and effective antimicrobial agents able to address emerging threats,” said Ciara Kennedy, president and chief executive officer of Amplyx. “This impressive syndicate of investors shares Amplyx’s commitment to bringing life-saving, innovative medicines to patients with compromised immune systems.”
The company announced today as well that it was advancing the fosmanogepix program. Topline data from the Phase II Candida trials is expected in July, but the initial analysis of the first 10 patients showed success, as mentioned above.
Candidemia is a major cause of morbidity and mortality in the healthcare setting. The current trial of C. auris is a multi-center, open-label Phase II trial.
“There is an urgent need for effective new antifungal agents, especially those with activity against Candida auris and Aspergillus,” said Thomas F. Patterson, chief, division of infectious diseases, UT Health San Antonio. “These infections are increasingly difficult to treat, and the rise in the rate of infections is alarming. The need for safe and effective therapies with new and different mechanisms of actions is critical, especially with the growing number of immunocompromised patients who are at increased risk for developing these life-threatening infections.”
In September 2019, Amplyx licensed MAU868 from Novartis for an undisclosed amount. BKV reactivation happens after kidney transplantation and can cause BKV nephropathy, a leading cause of renal allograft failure. This BKV reaction also happens in patients who have received hematopoietic stem cell transplants (HSCT) and can lead to hemorrhagic cystitis, an inflammatory condition of the bladder that can be life-threatening.
BK virus is one of 13 known polyomaviruses, with antibodies to BKF identified in 80 to 90% of adults globally, suggesting previous infection or exposure.
MAU868 is a novel human monoclonal antibody directed against the major viral capsid protein of BKV called VP1. MAU868 neutralizes all four genotypes of BKV. It also has neutralizing activity against a closely related JC virus which causes progressive multifocal leukoencephalopathy.
