The Dow continued to plummet last week, with investors heading for the hills to wait out the bear markets as the COVID-19 pandemic continues to exact its global toll. The bellwether index closed the week down 5% and has dropped a dramatic 33% since the beginning of the year. As far as the health care sector is concerned, the Nasdaq Biotech index is down about 18% year to date. COVID-19 certainly dominated the news flow last week including:
The European Commission offering up to €80 million (US$89.4 million) of funding to Curevac AG, to scale up development and production of a vaccine against the coronavirus in Europe, following reports that the U.S. administration had made an offer for the German biotech, in order to get exclusive control of its COVID-19 vaccine candidate.
The first attempt at using existing drugs to treat patients infected with SARS-CoV-2 has yielded disappointing results. In 200 hospitalized patients with severe COVID-19, a 14-day regimen of twice-daily treatment with Kaletra/Aluvia (lopinavir/ritonavir, Abbvie Inc.) did not hasten recovery when added to the standard of care. Chinese clinicians led by Bin Cao of the National Clinical Research Center for Respiratory Diseases reported their findings in the March 19, 2020, issue of The New England Journal of Medicine.
The Genentech arm of Roche Holding AG plans to move its interleukin-6 inhibitor, Actemra (tocilizumab), into a global phase III trial in patients with severe pneumonia associated with COVID-19 infection. The same drug is already undergoing – or soon will be – a number of investigator-initiated trials in China and in Italy and was included in treatment guidelines issued by China’s National Health Commission on March 3.
Avivagen Inc. accelerated plans for commercial launch of its OxC-Beta product as a supplement for human use in response to the COVID-19 pandemic. OxC-beta is a patent-protected product that first launched commercially in livestock applications to help remove antibiotics as growth promoters from the food chain, was subsequently launched in the companion animal market as a supplement, and is now being readied to launch in the U.S. market, initially for human use as a health supplement.
Mainz, Germany-based Biontech SE struck two deals in its Project Lightspeed, one for inside China and one for outside China, to develop and commercialize a COVID-19 messenger RNA (mRNA) prevention vaccine. Biontech is one of several companies developing mRNA vaccines to fight COVID-19. Others include Curevac AG, Zy Therapeutics Inc. in collaboration with Guanhao Biotech Co. Ltd., Moderna Therapeutics Inc., and Stermirna Therapeutics Co. Ltd. in collaboration with Tongji University.
Celltex Therapeutics Corp. has begun discussions with the FDA on a study using mesenchymal stem cells against COVID-19-type symptoms.
Entos Pharmaceuticals Inc. is developing a Fusogenix DNA vaccine to prevent COVID-19 infections. The Fusogenix platform is a proteo-lipid vehicle that uses a fusion mechanism to deliver its genetic payload directly inside cells.
Mannkind Corp. is adjusting research and development resources that were reserved for its pipeline of investigational products for treating serious lung diseases, with the goal of prioritizing work on new compounds that may have the potential to address the morbidity and mortality associated with respiratory viral infections, such as COVID-19. Specifically, the company has begun a collaboration with Immix Biopharma Inc. to prepare a dry powder formulation of a compound with the potential to treat acute respiratory distress syndrome, a complication of COVID-19.
Pfizer Inc. and Biontech SE plan to co-develop and distribute, excluding China, an mRNA-based coronavirus vaccine for preventing COVID-19 infection. The two intend to develop Biontech’s mRNA vaccine program, BNT-162, which is expected to enter the clinic in April.
Pneumagen Ltd. has initiated a new program to prevent and treat coronavirus COVID-19 infections using its carbohydrate binding modules (mCBMs). Pneumagen's lead mCBM, Neumifil, is being developed for universal treatment of respiratory tract infections, including influenza virus, respiratory syncytial virus and coronaviruses including COVID-19.
In its effort to find and develop a multi-antibody cocktail as prophylaxis or treatment of SAR-CoV-2, Regeneron Pharmaceuticals Inc. said it isolated hundreds of virus-neutralizing, fully human antibodies from humans who have recovered from COVID-19. From that candidate pool, Regeneron said it will select the top two antibodies for a cocktail treatment based on potency and binding ability to the SARS-CoV-2 spike protein.
Roche Holding AG said it began shipping the first allotment of its cobas SARS-CoV-2 test for COVID-19 to a network of 30 hospital and reference laboratories across the U.S. for automated, high-volume patient testing. Roche plans to ship an additional 400,000 tests per week to the laboratory testing sites across the nation that are set up to run the test immediately under the FDA’s Emergency Use Authorization guidelines.
Twist Bioscience Corp. announced the availability of research-use only target enrichment next-generation sequencing panels for viral detection and characterization of samples from patients testing positive for SARS-CoV-2, which causes COVID-19. The panels can be used for environmental monitoring and surveillance testing, while also providing insight into full sequence information to track viral evolution and strain origin.
Xortx Therapeutics Inc. is researching the use of XRx-101, a formulation of oxypurinol, to treat acute kidney and lung injury accompanying coronavirus infection and specifically for COVID-19 infection.
Deals of the week
Acelrx Pharmaceuticals Inc. will acquire Tetraphase Pharmaceuticals Inc. in an all-stock deal giving Tetraphase equity owners 14.6% of the company and up to $12.5 million in contingent value rights. Correvio Pharma Corp. agreed to the acquisition of its issued and outstanding shares by Advanz Pharma Corp. Ltd. The deal, which will be executed through Advanz Pharma’s wholly owned subsidiary, Mercury Pharma Group Ltd., represents a total consideration of approximately $76 million, including repayment of Correvio’s outstanding debt of approximately $48 million.
Dragonfly Therapeutics Inc. has expanded a strategic collaboration with Merck & Co. Inc. on the development of natural killer cell engager immunotherapies for oncology to add infectious disease and immune disorders. For $47.5 million up front, it's granting Merck the option to license exclusive rights to candidates developed using its TriNKET cell technology platform.
Public offerings: Compugen Ltd. closed its public offering of about 8.3 million ordinary shares priced at $9 per share for gross proceeds of about $75 million. Keros Therapeutics Inc. has filed with the SEC for an IPO to raise up to $86 million.
Other Public offerings: Clarus Therapeutics Inc. completed a senior debt financing of up to $75 million to accelerate the commercialization strategy and launch of Jatenzo (testosterone undecanoate), an oral softgel testosterone replacement therapy approved by the FDA to treat hypogonadism in men due to certain medical conditions. Oncoquest Inc., a subsidiary of Quest Pharmatech Inc., closed a private placement of $50 million at $20 apiece to Dual Industrial Co. Ltd. Protalix Biotherapeutics Inc. completed a $43.7 million private placement of common stock and warrants.
Venture funding: Circle Pharma Inc. raised $45 million in a series B financing. Design Therapeutics Inc., a startup developing new therapies for degenerative disorders caused by nucleotide repeat expansions, has raised $45 million in series A financing. Eureka Therapeutics Inc. closed a $45 million series E financing led by cell therapy company Lyell Immunopharma Inc. The company will use proceeds to advance its TCR-mimic and antibody-TCR Artemis programs, including its anti-AFP Artemis phase I/II trial in the U.S. for hepatocellular carcinoma. Oncoone Research & Development GmbH reported a €13 million (US$14.1 million) series A round. Sigilon Inc. raised $80.3 million in a series B financing aimed at supporting a first-in-human trial of its encapsulated cell therapy for hemophilia A, expected to start in the first half of 2020.
The FDA issued draft guidance encouraging the use of restricted delivery systems to limit the unintentional ingestion of oral liquid drugs and biologics by children. The guidance urges manufacturers to use a restricted delivery system such as a flow restrictor as part of the packaging of their oral products as an additional measure to reduce the risk of unintended ingestion. The draft describes the elements that should be considered in developing such systems. Comments on the draft should be submitted to Docket No. FDA-2020-D-0567 by May 18, 2020.
The Institute for Clinical and Economic Review (ICER) postponed indefinitely public meetings to review treatments for sickle cell disease, previously scheduled for March 26, and for cystic fibrosis (CF), previously scheduled for April 30. ICER said it is extending the public comment period on the CF Draft Evidence Report to March 25 and plans to publish the revised report on or about April 23. The institute also said that, after it publishes the draft evidence reports for nonalcoholic steatohepatitis on March 19 and for ulcerative colitis on April 15, additional deadlines and opportunities for public input will be pushed back approximately two to three months.
The U.S. Department of Health and Human Services (HHS) said it launched a public-private partnership to create a U.S.-based, high-speed, high-volume emergency drug packaging solution using low-cost prefilled syringes. Working with HHS' Office of the Assistant Secretary for Preparedness and Response, the new consortium for Rapid Aseptic Packaging of Injectable Drugs, or RAPID, will enable the Strategic National Stockpile to fill and finish, on a rapid basis, hundreds of millions of prefilled syringes to respond quickly and efficiently to widespread health emergencies, such as the novel coronavirus outbreak.
Word on the Street: Industry responses to the issues of the week
“The global coronavirus outbreak has heightened awareness around the vulnerability we have when it comes to American reliance on foreign-made medical supplies. When a public health emergency or national security crisis occurs in China or other countries that disproportionately provide us with medical supplies, the United States is at risk of a shortage of drugs or health care equipment. We have to develop a strategy to strengthen domestic production and supplies.”
Sen. Dick Durbin (D-Ill.), commenting last week on the introduction of a bipartisan bill that calls for the development of an action plan to reduce that reliance
“It is notable that the diagnostics community is coming together in a way we have not seen in our 20 years covering this industry. Regulators, lab professionals, and manufacturers are all in a frenetic fury to try and get testing up and running, and we generally see a sense of ‘in it together’ playing out.”
William Blair analyst Brian Weinstein, commenting in a March 14 note to investors
“What’s lacking in the cannabis space is science. There’s a lot of commercialization, but what doesn’t exist is a deep scientific understanding of the mechanistic impact of cannabinoids.”
Naheed Kurji, president and CEO of Cyclica Inc. The company, along with its partner, Neurotheryx Canada Ltd., created Nineteengale Therapeutics to find and develop cannabinoid-inspired drugs for bipolar disorder, anxiety and pain management