Acacia Pharma Group plc, of Cambridge, U.K., said it was assigned the U.S. license to Byfavo (remimazolam) by Cosmo Pharmaceuticals NV, of Dublin, with the consent of Paion AG, of Aachen, Germany, the original developer. Byfavo is designed as a very rapid onset/offset intravenous benzodiazepine sedative for use during invasive medical procedures in adult patients lasting 30 minutes or less, such as during colonoscopy and bronchoscopy.
Anheart Therapeutics Co. Ltd., of Hangzhou, China, said it has, through subsidiary Anheart Therapeutics Inc., out-licensed clinical development and commercialization rights to its next-generation ROS1/NTRK inhibitor, taletrectinib, to South Korea-based Newg Lab Co. Ltd. in the Republic of Korea market. Under the terms, Anheart will receive $7 million in total milestone payments and royalty payments at double-digit rates. Newg Lab will be responsible for development, market authorization and commercialization activities for taletrectinib in Korea. Anheart also will allow Newg Lab to join its phase II multiregional trial for non-small-cell lung cancer with ROS1/NTRK mutations.
Basilea Pharmaceutica Ltd., of Basel, Switzerland, said that its license partner, New York-based Pfizer Inc., launched the antifungal Cresemba (isavuconazole) in Taiwan, triggering a second milestone payment of $500,000 related to the Asia-Pacific territory from Pfizer to Basilea. In June 2017, Basilea entered a licensing agreement with Pfizer for isavuconazole in Europe (excluding the Nordic countries), Russia, Turkey and Israel. The agreement was extended in November 2017 to China, including Hong Kong and Macao, and 16 countries in the Asia-Pacific region. Basilea is eligible for regulatory and sales milestone payments of $630 million in addition to receiving midteen royalties on in-market sales of Cresemba.
Bold Therapeutics Inc., of Vancouver, British Columbia, said BOLD-100, an anti-resistance ruthenium-based small molecule that selectively inhibits stress-induced up-regulation of GRP78, a resistance, survival and proliferation pathway common across cancers, successfully inhibits live SARS-CoV-2 within a therapeutic range. Recent evidence suggests that GRP78 plays a critical role in host recognition, viral entry and viral replication, the company added.
Bridge Biotherapeutics Inc., of Seongnam, South Korea, will partner with Baselaunch, a Basel area-based biotech venture accelerator and incubator. Baselaunch has increased the funding per venture to a maximum of $0.5 million. Bridge is developing therapeutics for high unmet needs, including ulcerative colitis, fibrotic diseases and cancers.
Can-Fite Biopharma Ltd., of Petach Tikva, Israel, said it amended its phase II COVID-19 study protocol based on FDA input and will file an IND before the end of July. The study is a pilot trial in a population of hospitalized patients receiving standard supportive care. Eligible patients are those diagnosed with moderate COVID-19. Forty patients will be randomly assigned in a 1-to-1 ratio to the trial arms of piclidenoson, an A3 adenosine receptor agonist, 2 mg twice daily or placebo and treated for up to 28 days. Efficacy will be assessed through standard measures of clinical and respiratory status at day 29, including the proportion of patients alive and free of respiratory failure, as well as the proportion discharged home without need for supplemental oxygen.
CNS Pharmaceuticals AG, of Houston, said it will implement a dual-track drug product manufacturing strategy for berubicin to mitigate COVID-19-related risks and reduce inefficiencies by engaging Pharmaceutics International Inc., of Hunt Valley, Md., and BSP Pharmaceuticals SpA, of Latina Scalo, Italy. Having European and U.S. manufacturers also provides localized availability of berubicin for the upcoming studies in Poland and the U.S., CNS said. Berubicin is being developed to treat glioblastoma multiforme.
Dyadic International Inc., of Jupiter, Fla., said it entered a new collaboration with an undisclosed top five global pharmaceutical company. Dyadic’s platform manufactures protein-based biologics and will produce two different types of compounds in the collaboration. The biopharmaceutical gene expression platform is based on the fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila).
Eloxx Pharmaceuticals Inc., of Waltham, Mass., said research published in the Journal of Pharmacology and Experimental Therapeutics demonstrates that ELX-02 mediates read-through of premature stop codons while maintaining the fidelity of stop codons found at the end of healthy transcripts. That finding indicates that translation integrity is preserved with target-therapeutic exposure of ELX-02, consistent with the favorable tolerability profile. ELX-02 is currently in phase II trials in cystic fibrosis patients with nonsense mutations.
Evoke Pharma Inc., of Solana Beach, Calif., said it initiated commercial manufacturing of Gimoti (metoclopramide) nasal spray with its manufacturing partner, Patheon Biologics NV, of Durham, N.C., and Amsterdam. Gimoti was approved by the FDA in June for treating adults with acute and recurrent diabetic gastroparesis. Evoke plans to launch Gimoti in the fourth quarter of 2020.
Idbiologics Inc., of Palo Alto, Calif., said results published in Nature demonstrate the ability of ultra-potent monoclonal antibodies to completely neutralize the SARS-CoV-2 virus. Those antibodies neutralize the SARS-CoV-2 virus with similar potencies as monoclonal antibodies already published in peer-reviewed journals, the company said. Earlier this year, Idbiologics licensed IDB-003, one of the monoclonal antibodies identified, and is developing it to treat SARS-CoV-2, the virus causing the COVID-19 illness. The company intends to initiate a phase I trial in the third quarter of this year.
Moleculin Biotech Inc., of Houston, said it entered an agreement with Sterling Pharma USA LLC, of Cary, N.C., for U.S. production of WP-1122, a 2-deoxy-D-glucose ester-type prodrug, for treating COVID-19. Moleculin is preparing to request an IND and said it wanted to ensure it had a reliable source of drug supply in the U.S. The company also said it is expanding preclinical studies for the IND to include testing multiple analogues of WP-1122 against various viruses in vitro and, potentially, in vivo.
Octapharma AG, of Lachen, Switzerland, reported top-line results from a retrospective study in 93 critically ill COVID-19 patients showing that IVIG treatment reduces inflammation, which is associated with poor clinical outcomes and death, and points to an increase in survival, when compared to a control group. Early treatment of COVID-19 patients with systemic immune modulators such as IVIG may reduce aberrant immune responses and the subsequent inflammatory responses, which are observed in the severe stages of acute respiratory distress syndrome. Octagam (5% and 10%) is a polyvalent IVIG preparation that is approved in more than 80 countries worldwide for the treatment of immunodeficiency and other immune disorders.
Orchard Therapeutics Inc., of Boston, signed two worldwide royalty-bearing license agreements with Glaxosmithkline plc, of London, for use of lentiviral stable cell line technology (LV-SCLT) for Orchard’s investigational hematopoietic stem cell gene therapies for Wiskott Aldrich syndrome and transfusion-dependent beta-thalassemia. The LV-SCLT permanently and stably enables all the lentiviral vector components to be introduced into a cell line in one step. Selection and expansion of a resulting clonal producer line in either suspension or adherent culture can deliver consistent levels of high titer lentiviral production comparable to those seen using conventional methods, the companies said.
A team from Rensselaer Polytechnic Institute in New York published work in Antiviral Research suggesting that a common FDA-approved drug might be useful in treating COVID-19. In humans, the SARS-CoV-2 virus binds to an ACE2 receptor, and the researchers hypothesized that blood-thinner heparin would offer a potential target. In a binding assay, the researchers found that heparin bound to the trimeric SARS-CoV-2 spike protein at 73 picomoles, a measure of the interaction between the two molecules. In addition to the direct binding assay, the team tested how strongly three heparin variants – including a non-anticoagulant low-molecular-weight heparin – bind to SARS-CoV-2, and used computational modeling to determine the specific sites where the compounds bind to the virus. All the results confirm heparin as a promising candidate for the decoy strategy. The researchers have subsequently initiated work on assessments of antiviral activity and cytotoxicity in mammalian cells.
Samsung Biologics Co. Ltd., of Songdo, South Korea, and Immuneoncia Therapeutics Inc., of Yongin, South Korea, signed a contract development organization (CDO) contract to develop and manufacture five candidate molecules, expanding upon the two companies' existing partnership first established in 2018. Samsung has made a total of 55 CDO projects, 29 of which were signed with returning clients. Under the extended deal with Immuneoncia, Samsung will provide a full scope of CDO services from cell line development, process development, nonclinical and clinical material manufacturing, to IND submission support for global clinical trials of five candidates.
Tiziana Life Sciences plc, of London, disclosed a ratio change to its sponsored Level 3 American depositary receipt program. The corporate action, which is a 2.5-for-1 forward split for the purposes of the Nasdaq listing, is equivalent to a share subdivision in the U.K. and will have the effect of increasing the number of American depositary shares in issue. It has no effect on the number of underlying shares in issue or the nominal value of the ordinary shares.
TLC Biopharmaceuticals Inc., of South San Francisco, said a pre-print version of a manuscript on TLC’s strategy to treat COVID-19 disease with targeted delivery of inhalable liposomal hydroxychloroquine has been made publicly available. Titled “A Strategy to Treat COVID-19 Disease with Targeted Delivery of Inhalable Liposomal Hydroxychloroquine: A Non-clinical Pharmacokinetic Study,” the manuscript has been submitted for publication and is currently under peer review. Thirty-fold exposure in the lungs was achieved at a low dose while reducing systemic and cardiac toxicities.
Twist Bioscience Corp., of South San Francisco, said customer Vanderbilt University Medical Center (VUMC) published preclinical data using potently neutralizing antibodies as a potential therapy for preventing and treating COVID-19 in humans. Twist worked with VUMC to supply synthetic genes and antibody fragments in specific sequences that resembled antibodies isolated from two people who had been sick with SARS-CoV-2, the virus that causes COVID-19. The VUMC team and colleagues then tested the antibodies in small animals and nonhuman primates, with data published in Nature.
Valbiotis SAS, of La Rochelle, France, said it will receive the first milestone payment of CHF3 million (US$3.2 million) from Nestlé Health Science, connected with the first patient visit in the phase II/III Reverse-IT study to assess Totum-63 for reduction of type 2 diabetes metabolic risk factors.
Vivasc Therapeutics Inc., of Pittsburgh, said it received a research grant from the NIH National Heart, Lung and Blood Institute, valued at about $327,000, for continued development of CTP-amio, the company’s lead compound, for the treatment of arrhythmias. Vivasc’s Cardiac Targeting Peptide (CTP) has been shown to deliver therapeutic cargo (oligonucleotides, peptides, proteins, nanoparticles, etc.) to cardiomyocytes, and the company’s lead compound is a conjugation of CTP with FDA-approved anti-arrhythmic drug amiodarone. The award will accelerate the development of CTP-amio and will set the stage for larger animal model studies and full pharmacology/toxicity studies of CTP-amio in preparation for filing an IND for a phase I trial.
Zyus Life Sciences Inc., of Saskatoon, Saskatchewan, reached a milestone in the development of COVID-19 vaccine components by achieving plant-based expression, isolation and purification of a potential antigen for a vaccine, providing proof of concept for plant-based COVID-19 antigen production. Over the past months, Zyus researchers have been working to determine whether plants can offer an alternative method of antigen production to traditional production methods for vaccines. Plant-based antigen production, leveraging Zyus’ biotechnology platform, offers the potential to produce large quantities of vaccine-quality antigens rapidly and efficiently, the company said.