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COVID-19 roundup: biopharmas scramble to reassess clinical timelines; plus CEPI-Dynavax, and emergency approvals for Vero, Fosun

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More than a dozen biopharmas Thursday announced delays or disruptions to clinical programs and regulatory timelines as companies begin to turn their attention to managing their trials through the COVID-19 crisis. The setbacks came as regulators granted emergency access to Vero’s portable nitric oxide delivery system and Fosun’s diagnostic, and Dynavax and CEPI expanded their partnership to boost vaccine potency.

According to a joint survey from BioCentury and BIO, concerns over trial delays due to the COVID-19 pandemic have been accelerating. On-the-fly protocol amendments are fast becoming a necessity, and companies want assurance regulators will be flexible with the resulting data sets (see “Companies Seek Regulatory Flexibility”).

bluebird bio Inc. (NASDAQ:BLUE), Intercept Pharmaceuticals Inc. (NASDAQ:ICPT), MyoKardia Inc. (NASDAQ:MYOK) and Vir Biotechnology Inc. (NASDAQ:VIR) were among the companies warning of clinical, regulatory and commercial delays.

bluebird expects completion of its rolling BLA submission for β thalassemia gene therapy LentiGlobin (Zynteglo - Europe) to be delayed until mid-2021. It added that if the delay occurs, the company may seek approval in a broader patient population, including patients with β00 genotypes and pediatric patients.

The Cambridge, Mass.-based gene therapy company also reset expectations for the timing of its BLA submission of Lenti-D to treat cerebral adrenoleukodystrophy (CALD) to mid-2021 from year-end, and said the commercial launch of Zynteglo in Germany would shift to next half from this half.

The company’s MAA submission for Lenti-D and BLA submission for idecabtagene vicleucel, which is partnered with Bristol Myers Squibb (NYSE:BMY) remain on track to occur by year-end and this half, respectively.

It also noted BMS had already disclosed that enrollment had been paused in three studies of idecabtagene -- KarMMa-2, KarMMa-3 and KarMMa-4 studies -- to treat multiple myeloma.

Intercept’s delays include a rescheduled FDA advisory committee meeting, originally slated for April 22 and tentatively now June 9, to discuss an NDA for obeticholic acid to treat liver fibrosis due to non-alcoholic steatohepatitis (NASH). The PDUFA date for application is June 26.

Intercept also said its two Phase III NASH studies are fully enrolled but that it has paused screening and enrollment in some trials evaluating obeticholic acid for primary biliary cholangitis.

Although MyoKardia has suspended enrollment for two trials of mavacamten as well as new studies that were to start 2Q20, it doesn’t expect clinical or regulatory delays for the therapy. Mavacamten is in the fully enrolled Phase III EXPLORER-HCM study to treat obstructive hypertrophic cardiomyopathy (HCM). It also doesn’t expect delays for a Phase IIa trial evaluating danicamtiv in patients with stable heart failure. Readouts from those studies are due in 2H20.

Vir announced delays for three clinical programs: VIR-2482, a prophylactic mAb for flu; VIR-3434, an HBV neutralizing mAb; and VIR-1111, an HIV T cell vaccine. Phase II testing of VIR-2482 has been pushed back to 4Q20; it will take place in the Northern Hemisphere, rather than next quarter in the Southern Hemisphere. Phase I testing of VIR-3434 and VIR-1111 will both begin next half instead of this half.

The company has been on the forefront of mAb development to treat COVID-19. On Wednesday, it said Phase I/II testing for its first two mAbs against SARS-CoV-2 could begin in 3-5 months (see “COVID-19 Roundup: Vir Advances mAbs”).

Adjuvants, emergency approvals

Dynavax Technologies Corp. (NASDAQ:DVAX) said Thursday it will provide its toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018, to support COVID-19 vaccine development via its partnership with the Coalition for Epidemic Preparedness Innovations. CEPI and Dynavax will seek to identify and collaborate with other vaccine developers whose programs could benefit from use of the adjuvant, which is used in the company’s marketed HBV vaccine, Heplisav-B.

The first partner, the University of Queensland, was announced March 2.

FDA has granted expanded access emergency use to Vero Biotech LLC’s Genosyl inhaled nitric oxide delivery system to treat cardiopulmonary symptoms associated with COVID-19. The system is tankless and can be used to delivery nitric oxide in outpatient and home settings.

The move could alleviate demand for hospital beds and reduce the need for ventilators.

Nitric oxide is used to treat respiratory distress syndrome in adults. The company is working with academic infectious and cardiopulmonary disease experts to determine whether Genosyl could treat COVID-19’s pulmonary symptoms.

And on the diagnostic front, China’s National Medical Products Administration (NMPA) granted emergency approval to a qualitative SARS-CoV-2 nucleic acid detection kit from Shanghai Fosun Pharmaceutical Group Co. Ltd. (Shanghai:600196; HKEX:2196). The test detects the virus’ ORF1ab, N and E genes and, when automated, can give results in two hours.

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.

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