Concerns about the escalating global spread of COVID-19 panicked the markets big time at the close of the month. With investors rushing to the sidelines, it only took five days for the Dow Jones Industrial Average to drop more than 10% from its all-time high, getting close to the 30,000 mark. That dramatic reversal brought back memories of the financial crisis of 2008, and the event writes itself into the history books as the fastest market correction of all time.
Coronavirus brings funding response from U.S. government…
The U.S. Senate passed by a vote of 96-1 the spending bill for the outbreak of the new coronavirus (COVID-19). The bill provides $7.8 billion in new funds to tackle the outbreak and another $490 million in existing funds for telehealth, all with the aim of speeding the response to the pathogen.
…and biopharmaceutical companies
More and more companies are rising to the coronavirus challenge. Vir Biotechnology Inc. and Alnylam Pharmaceuticals Inc. are among the latest companies, with the announcement that they are expanding an infectious disease collaboration begun three years ago to take on the coronavirus. The effort now includes developing and commercializing RNAi therapies targeting SARS-CoV-2, the virus that triggers COVID-19, by researching siRNAs identified by Alnylam. Sihuan Pharmaceutical Holdings Group Ltd. said it has initiated clinical trials of broad-spectrum antiviral favipiravir to treat COVID-19. China now has six clinical trials investigating the drug, originally developed for influenza and also tested against Ebola virus disease. Arcturus Therapeutics Holdings Inc. said it is partnering with Duke-NUS Medical School, a collaboration between Duke University and the National University of Singapore, to develop a vaccine to treat the coronavirus COVID-19 for Singapore. The alliance will employ the company’s STARR technology, which combines self-replicating RNA with LUNAR – a nanoparticle nonviral delivery system – to produce proteins inside the human body, together with a platform developed at Duke-NUS allowing rapid screening of vaccines for effectiveness and safety. Algernon Pharmaceuticals Inc. is exploring the use of NP-120 (ifenprodil) as a treatment for the coronavirus that causes COVID-19. The drug reduced acute lung injury and improved survival in mice infected with H5N1 influenza virus. Generex Biotechnology Corp. has signed a contract covering the use of computational tools developed by Epivax Inc. to predict epitopes that can be used to generate peptide vaccines against the nCOV-2019 coronavirus using Ii-Key technology from Nugenerex Immuno-Oncology (formerly Antigen Express Inc.), a wholly owned Generex subsidiary. Immunoprecise Antibodies Ltd., through its subsidiary, Talem Therapeutics, and Evqlv Inc., announced a new collaboration aimed at accelerating the global effort to develop lead therapeutic and vaccine candidates against the SARS-CoV-2 virus. Takeda Pharmaceutical Co. Ltd. said it has started development of TAK-888, an anti-SARS-CoV-2 polyclonal hyperimmune globulin product to treat high-risk individuals with COVID-19. The drug will be made from the plasma of patients who have successfully recovered from the disease.
As a result of those new announcements, the list of biopharma companies and nonprofit entities, including academia, working feverishly to find a vaccine or antiviral treatment to address the rapidly spreading coronavirus (COVID-19) has more than doubled, increasing from about 30 a few weeks ago to 71 as of March 6.
FDA gives green light to MM combo
Sanofi SA won FDA clearance of the intravenously given CD38-directed cytolytic antibody Sarclisa (isatuximab-irfc) in combination with pomalidomide (Pomalyst, Celgene Corp.) and dexamethasone (dex) for adults with multiple myeloma (MM) who have received at least two prior therapies, including lenalidomide (Revlimid, Celgene Corp.) and a proteasome inhibitor. Sarclisa gained the go-ahead, well in advance of its April 30 PDUFA date, based on the results of a 307-patient study. Enrolled were subjects with relapsed/refractory MM who had failed at least two prior therapies, including lenalidomide and a proteasome inhibitor.
Deals of the week
Gilead Sciences Inc. will acquire Forty Seven Inc. for $4.9 billion, or $95.50 per share in cash, bringing in-house magrolimab, an anti-CD47 monoclonal antibody being developed to treat several cancers, including myelodysplastic syndrome, acute myeloid leukemia and diffuse large B-cell lymphoma. SVB Leerink analyst Geoffrey Porges said the deal represents “a reasonable late-stage oncology asset for Gilead to acquire, but [we] do not see it as a foundational oncology platform for Gilead.”
Abpro Therapeutics Inc. has granted an exclusive license to Abpro Bio Co. Ltd., the former Ugint Co. Ltd., to develop and commercialize two bispecific antibodies in Asian markets, including greater China, Japan and South Korea. Abpro will receive up to $1.1 billion from Abpro Bio, including a $30 million up-front equity investment and an additional $1.05 billion based on clinical milestones, post-approval payments and royalties as the antibodies progress through clinical development and regulatory approvals.
Cytoo SA has established a research collaboration with Asklepios Biopharmaceutical Inc. aimed at selecting a gene therapy candidate for a rare muscle disorder. GW Pharmaceuticals plc regained exclusive commercialization rights to Sativex (delta-9-tetrahydrocannabinol; THC) and cannabidiol (CBD) in the U.K. from Bayer AG. Sativex also has certain minor cannabinoids and other noncannabinoid components for treating spasticity due to multiple sclerosis.
Public offerings: Imara Inc. has set terms for its IPO and plans to raise up to $76 million by offering 4.5 million shares at a price range of $16 to $18. The company is developing and commercializing therapeutics to treat hemoglobinopathies. NLS Pharmaceutics Ltd. has filed to raise up to $40 million in an IPO in the U.S. The number of shares to be offered and the price range for the proposed offering have not yet been determined. Oric Pharmaceuticals Inc. filed to raise up to $86 million in an IPO and plans to list on Nasdaq under the symbol ORIC. Passage Bio Inc. priced its IPO of 12 million shares at $18 each for gross proceeds of $216 million. Zogenix Inc. said it priced an underwritten public offering for expected gross proceeds of approximately $200.2 million.
Other public offerings: Bridgebio Pharma Inc. has priced $475 million aggregate principal amount of 2.5% convertible senior notes due 2027 in a private offering to qualified institutional buyers.
Venture funding: Akouos Inc., a precision genetic medicine company developing potential gene therapies to restore, improve or preserve hearing, said it has raised $105 million in an oversubscribed series B financing. Amunix Pharmaceuticals Inc. said it completed an oversubscribed $73 million series A financing led by Omega Funds. Evonetix Ltd. closed its series B financing of $30 million (£23 million). Immunocore Ltd. has closed a series B round that will bring in more than $130 million to support its T-cell receptor programs in cancer and extending the reach of the technology into infectious and autoimmune diseases. The funding comes 12 months after a complete corporate remake of the company, which is now largely run by former employees of Astrazeneca plc’s Medimmune biologics division. Keros Therapeutics Inc. raised $56 million in a series C round. Pliant Therapeutics Inc., which is focused on discovering and developing therapies for the treatment of fibrosis, said it raised $100 million from a series C financing round to support the continued clinical development of PLN-74809 in idiopathic pulmonary fibrosis and primary sclerosing cholangitis, as well as its ongoing drug discovery programs targeting other fibrotic diseases. Xilio Therapeutics Inc., the new name of Akrevia Therapeutics, which is developing tumor-selective immuno-oncology therapies, said it closed a $100.5 million series B financing.
The FDA released 33 new draft product-specific guidances and 10 revised ones to help streamline generic drug development. The new guidances address treatments for diseases such as amyotrophic lateral sclerosis, diabetes, HIV, lung cancer and melanoma. Included among the guidances are 38 for drugs that have no generic competition, 14 of which are considered complex products. Comments on the guidances should be submitted by May 2.
The Institute for Clinical and Economic Review (ICER) said it plans to assess the comparative clinical effectiveness and value of lentiglobin from Cambridge, Mass.-based Bluebird Bio Inc. for the treatment of beta-thalassemia. Lentiglobin is an investigational gene therapy marketed in Europe under the brand name Zynteglo. An FDA decision in the U.S. is expected by late 2020. ICER’s evidence report on beta-thalassemia will be reviewed during a public meeting of the New England Comparative Effectiveness Public Advisory Council in July 2020.
Word on the Street: BioWorld's favorite quotes of the week
“AI-based drug screening can shorten the time from hit identification to preclinical candidate selection. The conventional method of drug development takes two to three years from hit to preclinical candidate; however, our screening platform with Azoth’s AI technology will shorten the period to around one year.”
Ho-sang Moon, chief technology officer MBD Co. Ltd., which has partnered with Azothbio Inc. for rare cancer drug development using an AI-powered drug discovery platform
“Such a violent reversal caught investors off guard and left them dazed and a bit shell-shocked. Most find that there are far more questions than answers about the impact of COVID-19 on health and the economy, and therefore there is a wide range of opinions with little consensus.”
Cowen & Co. analysts, writing in their monthly Biotech Thermometer report on the downturn in the financial markets
"I think there's a lot of innovation happening in big pharma, but obviously there's much more innovation happening outside of big pharma. What we are looking for in partners is really someone who complements our knowledge and our expertise."
Ioannis Sapountzis, corporate senior vice president of business development at Boehringer Ingelheim Inc., speaking at the Biocom 10th Annual Global Life Sciences Partnering conference