Alphamab Oncology Co. Ltd., of Suzhou, China, said its subsidiary, Jiangsu Alphamab Biopharmaceuticals Co. Ltd., has entered a clinical supply agreement with New York-based Pfizer Inc. to advance a clinical study of KN-026 in combination with Ibrance (palbociclib) in patients with previously treated locally advanced and/or metastatic HER2-positive breast cancer. Jiangsu Alphamab, as the study sponsor, will oversee and run the trial, and Pfizer will supply palbociclib, an oral CDK4/6 inhibitor. The phase Ib/II trial is an open-label study, aiming to evaluate efficacy, safety and tolerability of KN-026 in combination with palbociclib in patients with locally advanced unresectable or metastatic HER2-positive breast cancer.
Arcturus Therapeutics Inc., of San Diego, said it will use Duke-NUS' genetic correlation system to advance its COVID-19 vaccine, LUNAR-COV19. The partners first discussed their work together on March 10.
Bold Therapeutics Inc., of Vancouver, British Columbia, said recent developments have suggested the potential utility of its lead drug, BOLD-100, as an antiviral agent. BOLD-100's main mechanism of action is to inhibit stress-induced up-regulation of GRP78, a common receptor for viral recognition of host cells. The recent publication, titled "COVID-19 spike-host cell receptor GRP78 binding prediction," in the March 10, 2020, issue of Journal of Infection, identified GRP78 as a potential binding site for COVID-19. Other published literature has suggested that inhibiting or blocking GPR78 can reduce viral loads or viral replication in Ebola, Japanese encephalitis virus and dengue virus. Bold, which previously completed a phase I monotherapy study of BOLD-100 in advanced cancers showing the drug was generally well-tolerated, said it has ample cGMP clinical product available and an open IND/CTA in the U.S. and Canada, respectively, allowing for potentially rapid clinical development.
CG Oncology Inc., of Irvine, Calif., has negotiated an exclusive license, development and commercialization agreement with Kissei Pharmaceutical Co. Ltd. for its oncolytic immunotherapy candidate, CG-0070, for Japan, South Korea, Taiwan and other Asian countries with the exception of China. Under terms of the agreement, CG Oncology will receive a licensing fee of $10 million in cash, with the potential for an additional $100 million in development and commercial milestone payments and could receive royalties on sales of CG-0070 in the territories licensed. The company will also receive a $30 million equity investment from Kissei. Further financial details of the agreement were not disclosed.
Cytodyn Inc., of Vancouver, Wash., said that, according to diagnostic partner Incelldx Inc., a companion diagnostic developed to determine the efficacy and dosing of leronlimab in severe cases of COVID-19 showed that after three days of therapy, the immune profile from the first four patients dosed approached normal levels and levels of cytokines involved in the cytokine storm were much improved. Within three days following treatment with leronlimab, all four patients saw immunological benefit, with significant reductions in IL-6 and TNF-alpha. Shares of Cytodyn (OTCQB:CYDY) rose 46% to $1.37 on March 27.
Dicerna Pharmaceuticals Inc., of Lexington, Mass., said in response to the COVID-19 pandemic it has reevaluated its ongoing clinical development milestones, including the Phyox 2 pivotal trial of nedosiran for primary hyperoxaluria (PH), where it is working closely with local institutional review boards to implement a protocol amendment that would allow for the transition of remaining site visits to at-home nurse visits for drug administration and safety follow-up. Based on current enrollment and temporary suspension of further clinical trial activities at multiple sites, the company no longer expects to complete enrollment in the study in the second quarter of 2020 as previously projected and is reevaluating the clinical plan. For the Phyox 3 long-term multidose trial of nedosiran for PH, patients with PH are permitted to roll over into the trial from any previous nedosiran trial in which they have participated. The company continues to believe that its $720 million in cash, cash equivalents and marketable securities will be sufficient to fund operations into 2023.
Enanta Pharmaceuticals Inc., of Watertown, Mass., said it is making adjustments to some of its ongoing clinical studies in response to the COVID-19 pandemic and has paused recruitment and dosing in its Argon-2 phase IIb NASH study this week, and paused further recruitment in part 2 of a phase Ia/Ib study of EDP-514 in nuc-suppressed hepatitis B patients. The company is continuing to prepare to initiate two phase II respiratory syncytial virus studies of EDP-938 in pediatric and transplant patients later this year. It reports sufficient cash resources to bridge them across the current COVID-19 disruption.
Epivax Oncology Inc., of New York, said it has reduced the timeline from biopsy to vaccine to under four weeks for its personalized neoantigen therapeutic cancer vaccines. The company’s neopeptides are patient specific designed using its in-silico neoantigen prediction platform powered by machine learning-based algorithms.
Equillium Inc., of La Jolla, Calif., provided an update on its clinical development programs in its year-end financial report, noting that it paused enrollment in the EQUIP trial for uncontrolled asthma and the EQUALISE trial for lupus nephritis. The firm is continuing to enroll patients in the EQUATE study for patients with acute graft-vs.-host disease given the acute life-threatening severity of the disease. The company reiterated guidance that its cash on hand is sufficient to fund operations into the second half of next year. It ended the year with cash, cash equivalents and short-term investments totaling approximately $53.1 million.
Eton Pharmaceuticals Inc., of Deer Park, Ill., said it has acquired U.S. marketing rights to Alkindi Sprinkle from Cardiff, U.K.-based Diurnal Group plc. The product’s new drug application is under review with the FDA for approval as a replacement therapy for pediatric adrenal insufficiency, including congenital adrenal hyperplasia in patients from birth to less than 17 years of age. The application has been assigned a PDUFA date of Sept. 29, 2020. Eton estimates that the product, a taste-neutral sprinkle (granule) formulation of hydrocortisone, represents a $100 million market opportunity with approximately 5,000 pediatric patients suffering from adrenal insufficiency in the U.S. Eton paid Diurnal $3.5 million in cash and issued 379,474 shares of common stock, representing approximately $1.5 million based on Eton’s average 15-day trailing stock price. Upon commercial launch of the product, Diurnal will receive a cash milestone payment of $2.5 million. It will also be entitled to commercial milestone payments based on a scale of certain net sales thresholds. In conjunction with the transaction, Eton has raised $7.8 million from the sale of 2.6 million shares of common stock at $3 per share. In addition, the company’s credit facility with SWK Holdings was amended to allow the immediate option to draw $2 million of debt financing and to draw an additional $3 million after the approval of Alkindi Sprinkle.
Flywheel Exchange, a research data platform and Imbio LLC, an AI-driven medical imaging company specializing in lung analysis, both based in Minneapolis, have teamed up to help global researchers accelerate understanding and treatment for COVID-19. Beginning March 30, Flywheel's platform, including Imbio's lung analysis tools, will be made available free of charge to COVID-19 academic and clinical researchers.
Ibio Inc., of New York, has extended its joint development work with Azargen Biotechnologies, of Stellenbosch, South Africa, by developing and manufacturing Azargen’s biosimilars at Ibio’s facility in Bryan, Texas. Ibio said it intends to transfer its manufacturing system to Azargen to produce biological medicines for Africa. The companies’ original agreement was signed in 2018. Last September, Azargen tabbed Ibio to manufacture research quantities of rituximab for bioanalytical testing. Now Ibio will manufacture and characterize more quantities for preclinical studies comparing plant-made rituximab to the original molecule using genetically engineered mammalian cells.
First results from an artificial intelligence (AI)-enabled search for a COVID-19 antiviral treatment from Innoplexus AG, of Eschborn, Germany, showed hydroxychloroquine as one of the most prominently identified upcoming drugs. Hydroxychloroquine is a derivative of chloroquine, which has antimalarial and anti-inflammatory activities. While smaller studies with hydroxychloroquine alone showed mixed results in fighting COVID-19, the company said its trial prediction engine suggests overall more limited response rates (a shorter and less severe disease trajectory than would be seen in the absence of the drug) for ongoing and upcoming clinical trials for hydroxychloroquine alone. According to the AI-based analysis, a combination of chloroquine and tocilizumab, a drug approved to treat severe rheumatoid arthritis respectively, might be a path. Tocilizumab is thought to interrupt the process of cytokine release syndrome, a form of inflammatory response that can occur as a COVID-19 complication.
Revance Therapeutics Inc., of Newark, Calif., said it paused its phase II Juniper trial for adult upper limb spasticity due to limitations placed upon the study by COVID-19. Enrollment in the trial of its neuromodulator product, daxibotulinumtoxinA for injection (DAXI), is halted due to challenges due to subject assessments while social distancing is required. Revance has multiple clinical trials for DAXI underway, including the ASPEN-1 phase III study and the ASPEN open-label safety study (OLS) in cervical dystonia and a phase II trial for plantar fasciitis. The ASPEN-1 and plantar fasciitis trials are fully enrolled with all subjects dosed and past the primary endpoint visit. Enrollment for ASPEN-OLS is ongoing. Revance plans to report top-line results for the ASPEN-1 cervical dystonia and phase II plantar fasciitis trials in the second half of 2020.
Rising Pharma Holdings Inc., of East Brunswick, N.J., said it is collaborating with the Division of Infectious Disease and International Medicine at the University of Minnesota, Department of Infectious Disease on a clinical trial exploring hydroxychloroquine as preventive treatment for coronavirus disease 2019 (COVID-19).
Sanofi Pasteur, of Paris, and Translate Bio Inc., of Lexington, Mass., will collaborate on an mRNA vaccine for COVID-19, leveraging a 2018 agreement between them to develop mRNA vaccines for infectious diseases. Translate is producing multiple mRNA constructs and said it will use its mRNA platform to discover, design and manufacture a number of SARS-CoV-2 vaccine candidates. Sanofi will provide support from its external research networks to advance vaccine candidates for development. Translate said it has established 100-gram single-batch production with its clinical-stage mRNA therapeutics platform. Build-out is underway of a dedicated manufacturing space through a contract manufacturing partner to accommodate at least two 250-gram batches per month. This is Sanofi’s second collaboration to develop a COVID-19 vaccine candidate. In February, Sanofi announced a collaboration with the U.S. Biomedical Advanced Research and Development Authority to advance a recombinant, protein-based vaccine candidate against COVID-19.
Vaxil Bio Ltd., of Ness-Ziona, Israel, said it now has non-GMP material and can begin its preclinical program to test the candidate’s efficacy against COVID-19. The candidate is based on a signal peptide technology using the company’s bioinformatics platform. The candidate is also based on in vivo experiments testing a tuberculosis signal peptide vaccine.
Vertex Pharmaceuticals Inc., of Boston, said it is working with clinical trial sites to enable virtual visits and home delivery of study drugs. However, depending on the disease, stage of development and type of study, Vertex said it will temporarily pause enrollment in certain studies and may delay some new study starts. The company has multiple global studies underway spanning various diseases, modalities and development stages. It did not specify which studies may be impacted. Vertex officials also said it is confident its supply chain can continue to supply its approved medicines to patients.
Vyripharm Biopharmaceuticals LLC, of Houston, said it will repurpose development of a theranostic platform for diagnosing, monitoring and treating viral infections such as COVID-19, SARS and MERS. The company said it will use radiopharmaceuticals for detection and diagnosis with the ability to incorporate combination therapies to interrupt the replication of the virus. The drug platform will integrate antiviral and anti-CB1 antagonist analogues for nuclear medicine imaging applications. The therapeutic application will begin with a CB1 antagonist, an antiviral therapeutic formulation and followed by a short course of radiotherapeutic regimen in combination or in a dose-related response manner.