After being hit with the major financial market meltdown when the COVID-19 outbreak decimated U.S. capital markets during March that saw the valuations of public biopharmaceutical companies developing new medicines plummet, it appears that they have put that reversal behind them with a dramatic price surge in April. As a result, the BioWorld Drug Developers index recorded an almost 20% increase to end the period down 11% year-to-date. (See BioWorld Drug Developers index, below.)
According to Cowen & Co. analysts, writing in their April Biotechnology Thermometer report, the positive performance was driven by the expectations that the biopharma industry will deliver COVID-19 therapies and vaccines quickly. “The industry's perception has improved significantly, increasing generalist interest.” That has been coupled, the report explains, by the fact that investors have not been fazed by COVID-related disruptions to the timelines of clinical programs, with studies being delayed or postponed as a result.
Hopes for an early vaccine
Leading gainer during April was Cambridge, Mass.-based Moderna Inc., whose shares (NASDAQ:MRNA) jumped 54%, with investors believing the company’s mRNA vaccine candidate, mRNA-1273, targeting coronavirus (SARS-CoV-2), appears promising and that nucleic acid-based vaccines can be developed extremely rapidly compared to protein-based vaccines. The vaccine encodes for a prefusion stabilized form of the Spike (S) protein and was selected in collaboration with investigators from the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH.
The first patient in an NIH-led trial was dosed with mRNA-1273 in mid-March and by late-April the company reported it had submitted an investigational new drug application to the FDA to evaluate mRNA-1273 in phase II and late-stage studies if supported by safety data from the NIAID-led phase I study.
The phase II study, which will enroll 600 healthy participants across two cohorts of adults, ages 18 to 55 (n=300) and older adults ages 55 and above (n=300), will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.
J.P Morgan’s Cory Kasimov, commenting on Moderna’s COVID-19-related trials updates in its first-quarter financials said, “The next key catalyst will be initial results from the phase I study in May/June, and we continue to believe the data is likely to be directionally promising.”
The company also received a $483 million commitment from the Biomedical Advanced Research and Development Authority to accelerate the vaccine candidate and enable the company to supply millions of doses per month this year and tens of millions per month in 2021 if the vaccine candidate is successful in the clinic.
In anticipation of future manufacturing capacity, Moderna entered a 10-year strategic collaboration agreement with Lonza Ltd., of Basel, Switzerland. Technology transfer is expected to begin in June with the first batches of mRNA-1273 manufactured at Lonza U.S. in July. The companies plan to establish additional production suites across Lonza’s worldwide facilities to manufacture the material equivalent to up to 1 billion doses of mRNA-1273 per year for use globally.
Other therapies on the radar
It wasn’t all COVID-19 clinical news that spurred the index, as shares of Exelixis Inc. (NASDAQ: EXEL) spiked 44% in April on news that, together with Bristol Myers Squibb Co., data on CheckMate -9ER, a pivotal phase III trial evaluating Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) compared to sunitinib in previously untreated advanced or metastatic renal cell carcinoma, met its primary endpoint of progression-free survival at final analysis, as well as the secondary endpoints of overall survival at a prespecified interim analysis and objective response rate. The companies said they plan to submit detailed results at an upcoming medical conference.
New Haven, Conn.-based Biohaven Pharmaceutical Holding Co. Ltd., saw its shares rise 38% last month. The company reported that it is collaborating with Cove, a company providing specialized care and access to innovative treatments for migraine sufferers via telemedicine services in the U.S. The arrangement will allow telemedicine evaluation for migraine sufferers during those times of limited access to routine office visits. Using Cove, patients consult with independent health care providers and may be prescribed the company’s recently FDA-approved Nurtec ODT (rimegepant), a calcitonin gene-related peptide receptor antagonist, along with other migraine treatments. The company has also put in place an agreement with Medison Pharma Ltd., of Petach Tikva, Israel, to distribute Nurtec ODT in Israel.
The positive performance of the index has held firm so far this month, with its value up 8%. Fueling the increase has been Rockville, Md.-based Macrogenics Inc., with its shares (NASDAQ: MGNX) jumping a whopping 182% last week. In its first-quarter financial results, the company reported that it anticipates a PDUFA action date in December for margetuximab in combination with chemotherapy as a treatment for patients with metastatic HER2-positive breast cancer. The FDA indicated its plan to schedule an Oncologic Drugs Advisory Committee meeting in the second half of the year. Margetuximab is being evaluated in SOPHIA, a phase III trial testing the combination with chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer.