Eli Lilly (NYSE:LLY) and Amgen (NASDAQ:AMGN) announce a global antibody manufacturing collaboration to increase the supply capacity available for Lilly’s potential COVID-19 therapies.
Through this collaboration, the two companies will have the ability to quickly scale up production and serve more patients if Lilly’s antibody therapies prove successful and receive regulatory approval.
The FDA has accepted ChemoCentryx’s (NASDAQ:CCXI) New Drug Application (NDA) for avacopan, an orally-administered selective complement 5a receptor inhibitor, for the treatment of ANCA-Associated Vasculitis and has set July 7, 2021 as the Prescription Drug User Fee Act (PDUFA) goal date for the avacopan NDA.
The FDA also indicated that it may hold an advisory committee meeting to discuss the application per guidelines for new molecular entities.
ANCA-associated vasculitis is a group of disorders characterized by destruction and inflammation of small vessels.
Hepion Pharmaceuticals (NASDAQ:HEPA) jumped ~11% in premarket in reaction to positive data from a study of CRV431 conducted by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH).
CRV431 demonstrated positive antiviral activity against SARS-CoV-2, and showed to inhibit production of infectious virus with almost five-times greater potency than the positive control compound in the study. The concentration of CRV431 required to inhibit virus production by 90% was 1.5 µM versus 7.3 µM for the positive control compound. Also the drug candidate did not show significant cellular toxicity.
In preclinical studies, the drug showed encouraging action in COVID-19 models.
CRV431 Phase 2 study in NASH is ongoing.
Telehealth company, Amwell has priced its upsized IPO of ~41.2M shares of Class A common stock at $18.00/share for total gross proceeds of ~$742M.
Initially, Amwell had planned to sell 35M shares at $14-16.
Underwriters’ over-allotment is an additional ~6.2M shares, from Amwell and certain stockholders of the company.
Trading kicks off September 17. Closing date is September 21.
Utilization of Amwell’s platform to deliver care during the COVID-19 crisis increased dramatically, accounting for 77% of the 2.2M total visits performed during three months ended June 30, 2020, versus 50% of the over 700K visits for the three months ended March 31, 2020.
https://seekingalpha.com/news/3614813-google-backed-amwell-prices-upsized-ipo-above-range-18
MetLife (NYSE:MET) agrees to acquire Versant Health, owner of Davis Vision and Superior Vision, for $1.675B in cash, broadening its vision benefits offerings under its U.S. group benefits unit.
The business is being acquired from an investor group led by Centerbridge Partners and including FFL Partners.
Expected to be accretive to EPS and free cash flow with high teens internal rate of return; the business also provides the advantages of low capital intensity and predictable underwriting.
MET will become the third-largest U.S. vision insurer by membership.
Will finance the deal with cash on hand.
MET expects to complete its current buyback authorization by the end of 2020.
Targets completion of the acquisition in Q4.
Conference call at 8:30 AM.
ImmunoPrecise Antibodies (OTCQB:IPATF) announces a research collaboration with Zymeworks (NYSE:ZYME) giving the Company access to Zymeworks’ Azymetric and EFECT platforms for the further development of its multiple antibody candidates to fight COVID-19.
Under the terms of the agreement, IPA will transform its previously tested and potent SARS-CoV-2 neutralizing antibodies into bispecific and multispecific antibodies using the Zymeworks’ platforms.
These sets of candidates will be thoroughly tested using SARS-CoV-2 spike protein provided by the National Research Council Canada, prior to pre-clinical manufacturing for animal studies.
https://seekingalpha.com/news/3614905-immunoprecise-teams-up-zymeworks-for-covidminus-19-antibody
Bristol Myers Squibb (NYSE:BMY) announces updated results from a Phase 3 clinical trial, CheckMate-214, comparing the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) to Pfizer’s (NYSE:PFE) Sutent (sunitinib) in first-line renal cell carcinoma (RCC) patients.
Intermediate- and poor-risk patients (n=847):
Median overall survival (OS) in the O+Y group was 48.1 months versus 26.6 months in the sunitinib group. The four-year OS rate was 50.0% versus 35.8% for sunitinib.
The overall response rate (ORR) favored O+Y, 65% vs. 50%.
Median duration of response (DOR) was not reached in the O+Y group compared to 19.7 months in the sunitinib group.
In the intent-to-treat population (n=1,096), median OS was not reached in O+Y arm compared to 38.4 months in the sunitinib arm. Four-year OS rates were 53.4% and 43.3%, respectively. ORR favored O+Y, 65% vs. 52%. The complete response rate for O+Y was 11% vs. 3% with sunitinib. Median DOR was not reached compared to 23.7 months in the sunitinib arm.
The safety profile of O+Y was “manageable” using established treatment algorithms.
Nick Botwood, M.D., VP, interim head, Oncology Development says, “We have now evaluated Opdivo plus Yervoy in multi-year Phase 3 trials across RCC, melanoma, non-small cell lung cancer and mesothelioma, and in all of these studies, we have seen improved survival compared to the existing standard of care. The four-year results from CheckMate -214 build on our understanding of and leadership in addressing advanced RCC, reinforcing the potential for durable, long-term survival benefits with Opdivo plus Yervoy in the first-line setting. Taken as a whole, these data provide further evidence for the value of distinct but complementary dual checkpoint inhibition in the treatment of advanced cancers.”
