Although public offerings slowed considerably in March as a result of the steepest stock market declines in history during that period, global biopharmaceutical companies managed to collectively generate just over $16 billion in the first quarter from a record number public and private transactions. Only the first quarter of 2018 saw more cash raised in the past decade, according to BioWorld data. Deal volume, at 347, established a 10-year record for the number of transactions in the first three months of the year. Public offerings, including IPOs, represented approximately 52% of the first-quarter financings. The industry also fared relatively well in terms of dealmaking so far this year, even as the markets have plummeted and partnering events have moved to a virtual format. While no deals during the first quarter made the biopharma top 20 list, there were 13 with projected values of $1 billion or more.

Deals of the week

Alnylam Pharmaceuticals Inc. and Dicerna Pharmaceuticals Inc. formed a development and commercialization collaboration on investigational RNAi therapeutics for the treatment of alpha-1 antitrypsin (A1AT) deficiency-associated liver disease. Regeneron Pharmaceuticals Inc. and Zai Lab Ltd. formed a strategic collaboration to develop and commercialize REGN-1979 (odronextamab), a CD20/CD3 modulator and the lead asset from Regeneron’s bispecific antibody platform, in mainland China, Hong Kong, Taiwan and Macau. Regeneron is set to receive $30 million up front and is eligible for up to $160 million in regulatory and sales milestones. Second Genome Inc. signed a potential $1.5 billion deal with Gilead Sciences Inc. that is paying $38 million up front. Second Genome will deploy its Microbiome Analytics Platform – designed to harness microbiome-related scientific insights to boost treatment effects by stratifying patients – plus other discovery and development tools. The contract calls for the tie-up to last four years, though it could be stretched to six.

COVID-19 research, trials and government action

The EMA has activated a COVID-19 task force to coordinate and accelerate the European regulatory response to the pandemic. The task force, which has been established under the authority of the EMA’s human medicines committee, is intended to take a lead role in shaping the development, authorization and post-approval surveillance of drugs and vaccines for treating or preventing COVID-19 infection.

Ansun Biopharma Inc. released positive results from a four-patient study of its DAS-181 candidate, which is being developed for the treatment of severe COVID-19 infection. The clinical-stage recombinant biologic was evaluated as a 10-day treatment regimen of nebulized DAS-181 administered to four patients with severe bilateral viral pneumonia and hypoxemia. It seems that it may help reduce or eliminate some of the most significant symptoms associated with COVID-19. Arcturus Therapeutics Inc. plans to initiate a clinical trial for its COVID-19 vaccine, also known as LUNAR-COV19, a very low dose, potential single-shot, self-replicating mRNA vaccine that is devoid of any viral material or co-adjuvants. Axon Neuroscience SE is developing a promising vaccine candidate against COVID-19 that contains only selected epitopes capable of inducing desirable T-cell and B-cell-mediated immune responses to prevent interaction of the virus Spike (S) glycoprotein with its target human cells. CSL Behring LLC and SAB Biotherapeutics Inc. said their partnership to combat the coronavirus pandemic with the rapid development of SAB-185, a COVID-19 therapeutic candidate, is on track for clinical evaluation by early summer. Cytovia Inc. is expanding its programs to help address the current COVID-19 crisis. The company works with natural killer cells. Using a bifunctional approach has the potential to minimize virus escape from the immune response, thereby inhibiting the intensification of the inflammation leading to acute respiratory syndrome. Epivax Inc. is using advanced computational tools to accelerate a COVID-19 vaccine candidate (EPV-CoV19) for health care workers into clinical trials in six months. The company is partnering with the Gaia Vaccine Foundation to crowd-source funds for the project and its pledge to make a free license available to developing countries who qualify. Glaxosmithkline plc and Vir Biotechnology Inc. signed a binding agreement to enter a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration will use Vir’s monoclonal antibody platform technology to accelerate existing and identify new antiviral antibodies that could be used as therapeutic or preventive options to help address the COVID-19 pandemic and future outbreaks.

The Harrington Discovery Institute at University Hospitals in Cleveland said it launched an initiative that galvanizes its transatlantic network of academic institutions, foundations and philanthropic partners to accelerate promising, near-term therapies to treat COVID-19 and its complications and battle future pandemic threats. In advancing its portfolio of 120 drugs-in-the-making at 54 academic centers in North America and the U.K., Harrington said it has developed a model that has enabled scientists in academia to accelerate their breakthrough drug discoveries toward trials in patients. Immunomic Therapeutics Inc. said that together with Epivax Inc. and Pharmajet Inc., it is developing a nucleic acid vaccine candidate against COVID-19, leveraging its Universal Intracellular Targeted Expression platform, previously used to create vaccine candidates for rabies, yellow fever, dengue fever, hepatitis C and SARS. Izana Bioscience Ltd. has become the third company to supply an anti-GM-CSF antibody for compassionate use against COVID-19, announcing namilumab, currently in phase IIb testing in the treatment of rheumatoid arthritis and ankylosing spondylitis, will be used to treat 20 patients with severe respiratory symptoms. Mateon Therapeutics Inc. said its antiviral screening program found artemisinin, a derivative of the Asian herb Artemisia annua that has been used to treat malaria, inhibits SARS-CoV-2, from multiplying. The company said it will seek support to evaluate clinical proof-of-concept studies. Medicinova Inc. will initiate a clinical trial of MN-166 (ibudilast) for acute respiratory distress syndrome caused by COVID-19. The study will be conducted by Yale’s Advanced Therapies Group. MN-166 is an oral, small-molecule macrophage migration inhibitory factor inhibitor and phosphodiesterase -4 and -10 inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. Mesoblast Ltd. said the FDA gave it the green light to test its allogeneic mesenchymal stem cell product candidate remestemcel-L in patients with acute respiratory distress syndrome (ARDS) caused by COVID-19. Oncology Pharma Inc. and Kalos Therapeutics Inc. have amended terms of their collaboration exploring potential COVID-19 treatments by proposing they investigate Kalos’ lead drug, KTH-222 (alone and/or in combination with anti-viral drugs), as part of monitoring viral loads in cancer patients infected with COVID-19 or in undiagnosed but symptomatic patients. Oxford Biomedica plc joined a consortium led by the Jenner Institute, Oxford University, to rapidly develop, scale up and manufacture a potential vaccine candidate for COVID-19, called ChAdOx1 nCov-19. That vaccine candidate is expected to be the U.K.'s first COVID-19 vaccine in clinical trials later this month. Pfizer Inc. and Biontech Inc. agreed to develop a COVID-19 vaccine and scale manufacturing capacity. Biontech will contribute multiple mRNA vaccine candidates as part of its BNT-162 COVID-19 vaccine program. Biontech will receive an up-front $185 million payment, including an equity investment of approximately $113 million, and is eligible to receive future milestone payments of up to $563 million for a potential total consideration of $748 million. Redhill Biopharma Ltd. received authorization from the Italian National Institute for Infectious Diseases and Central Italian Ethics Committee for an expanded access program allowing immediate compassionate use of opaganib (Yeliva, ABC-294640), in Italy for patients with confirmed COVID-19 infection with life-threatening clinical manifestations. About 160 patients will be treated in three major hospitals in northern Italy, one of the pandemic’s epicenters. Relief Therapeutics Holding AG said aviptadil has entered FDA clinical trials at Thomas Jefferson University Hospital in Philadelphia for the treatment of acute respiratory distress syndrome in COVID-19. Samsung Biologics Co. Ltd. and Vir Biotechnology Inc. entered a manufacturing agreement under which Samsung Biologics will perform large-scale manufacturing services for Vir’s SARS-CoV-2 monoclonal antibody program. Theravance Biopharma Inc. is advancing TD-0903, a lung-selective nebulized JAK inhibitor into clinical development to assess its utility in preventing the cytokine storm associated with acute lung injury in patients hospitalized due to COVID-19. Tiziana Life Sciences plc has developed investigational new technology to treat COVID-19 infections, which consists of direct delivery of anti-IL-6 receptor monoclonal antibodies into the lungs using a handheld inhaler or nebulizer. Vanda Pharmaceuticals Inc. and the University of Illinois at Chicago said they entered a research partnership focused on the investigation of small molecules with the potential to treat COVID-19.

Researchers from the not-for-profit Intermountain Healthcare and University of Utah Health in Salt Lake City have launched two clinical trials to test the effectiveness and safety of two drugs – hydroxychloroquine and azithromycin – to treat patients with COVID-19.

A new, worldwide coalition of plasma companies is seeking to develop and deliver a hyperimmune immunoglobulin therapy for fighting COVID-19. Takeda Pharmaceutical Co. Ltd. and CSL Behring LLC created the initiative, with Biotest AG, the U.K.’s Bio Products Laboratory, France’s LFB SA and Switzerland’s Octapharma AG joining to begin developing a single, unbranded anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin treatment for individuals with serious complications from COVID-19.

Financial transactions

Public offerings: Keros Therapeutics Inc., a company developing treatments for hematological and musculoskeletal disorders, has raised $96 million from its IPO, selling 6 million shares at $16, the high end of its proposed range. Zentalis Pharmaceuticals Inc. closed its IPO for total gross proceeds of approximately $190 million.

Other public offerings: Chiasma Inc. entered a revenue interest financing agreement with Healthcare Royalty Partners for up to $75 million to support the ongoing development and planned commercial launch of its investigational octreotide capsules product candidate, (Mycapssa), for the maintenance treatment of adults with acromegaly. Mersana Therapeutics Inc. raised gross proceeds of approximately $65 million through its at-the-market facility.

Venture funding: Amphista Ltd. raised $7.5 million in a series A found. Deerfield Management Co. LP closed an $840 million Deerfield Healthcare Innovations Fund ll. Remegen Ltd. has raised about $100 million in a private round led by Lilly Asia Ventures and Lake Bleu Capital to advance its autoimmune, oncology and ophthalmology drug candidates. Tango Therapeutics Inc. raised $60 million from a series B round.

Regulatory news

In looking at 637 new drug applications and biologic license applications submitted to the FDA from fiscal 2014 through fiscal 2018, the U.S. Government Accountability Office found that although review times varied across the agency’s drug divisions, the FDA met its goal of completing 90% of the reviews within specified deadlines.

Following reports of shortages of several drugs needed to treat patients with COVID-19 infections, the U.S. Drug Enforcement Administration announced it is increasing its aggregate production quotas for certain controlled substances identified by the Department of Health and Human Services as impacted by the pandemic. The agency issued a final order increasing the 2020 quotas by 15% for fentanyl, morphine, hydromorphone, codeine, ephedrine and pseudoephedrine, as well as controlled substance intermediates that are essential to the production of those schedule II drugs.

Word on the Street: Industry responses to the issues of the week

“Evidence suggests that anti-GM-CSF therapy has the potential to change the way patients’ immune systems respond to the virus.”
Someit Sidhu, chief executive and co-founder of Oxford, U.K.-based based Izana Bioscience Ltd., which has become the third company to supply an anti-GM-CSF antibody for compassionate use against COVID-19, announcing namilumab, currently in phase IIb testing in the treatment of rheumatoid arthritis and ankylosing spondylitis, will be used to treat 20 patients with severe respiratory symptoms

“We’re going to be evaluating whether an injection of our cells intravenously can tone down the immune system just enough, so it gets rid of the virus but doesn’t destroy your lungs at the same time.”
Silviu Itescu, CEO, Mesoblast Ltd., which will test its allogeneic mesenchymal stem cell product candidate remestemcel-L in patients with acute respiratory distress syndrome

“We very deliberately stayed out of partnering discussions for the first couple years. It took a while to figure out how to do this. We wanted to understand what we had before selling off parts of it.”
Michael Gilman, CEO, Arrakis Therapeutics Inc., which signed a collaboration and license agreement with Roche Holding AG

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