Privately held Aligos Therapeutics Inc., of South San Francisco, expanded its licensing agreement with Atlanta’s Emory University to include and advance technology developed at the school related to Aligos’ capsid assembly modulator (CAM) program in chronic hepatitis B. The license expansion builds on an existing agreement in which Aligos acquired from Emory an exclusive license to technology regarding a novel class of non-nucleoside class-II CAMs, small molecules that disrupt viral capsid assembly.
Amgen Inc., of Thousand Oaks, Calif., said it supports further study of AMG-634, a phosphodiesterase type 4 inhibitor, for treating tuberculosis and erythema nodosum leprosum, an inflammatory cutaneous and systemic complication of leprosy. Amgen acquired AMG-634 as part of its acquisition of Otezla (apremilast) from Celgene Corp. in 2019. AMG-634 is in phase II studies led by The Aurum Institute NPC and The Leprosy Mission Nepal.
Avita Medical Ltd., of Cambridge, U.K., said the Federal Court of Australia approved the redomiciliation of the company and its subsidiaries, Avita Group, from Australia to the U.S. The move makes Avita Medical, a company incorporated in Delaware, the Avita Group’s parent company. The company’s shares will be suspended from trading on the ASX from close of trading June 23. Avita is a regenerative medicine company developing treatments for burns, chronic wounds and aesthetics indications.
Biosig Technologies Inc., of Westport, Ct., its subsidiary, Viralclear Pharmaceuticals Inc., and Catalent Inc., of St. Petersburg, Fla., agreed to develop a treatment for adults with advanced COVID-19. Catalent will develop a solution and a solid oral dosage form of Viralclear’s broad-spectrum antiviral agent, merimepodib. Viralclear will investigate merimepodib’s potential to fight the SARS-CoV-2 virus, either as a standalone treatment or in combination with other antiviral agents or immune modulators.
Cancer Research UK said it may cut £150 million per year from its research funding as the COVID-19 pandemic hinders its income. In April, Cancer Research UK cut £44 million in funding across its research portfolio because of the pandemic. The re-evaluation of the charity’s financial position now raises the potential impact to £150 million of funding cuts per year while the charity recovers. The charity is now preparing for a 30% fall in income in the 2020/21 financial year, with further losses in the next year, following temporary closures of its shops and major fundraising events being canceled during the COVID-19 crisis.
Boston’s CARB-X said it awarded up to $3.83 million to the University of Queensland’s Institute for Molecular Bioscience in Brisbane, Australia, to develop antibiotics for treating drug-resistant bacterial infections. The institute is eligible for an additional $7.03 million if the project meets certain development milestones, for a total award of up to $10.86 million. The project aims to identify cyclic peptides that maintain their antibacterial potency against polymyxin-resistant gram-negative pathogens, but with fewer side effects. The goal is to develop a safer antibiotic to replace last-resort polymyxin class antibiotics, such as colistin. This is CARB-X’s first award to an Australian entity.
Century Therapeutics LLC, of Philadelphia, said it acquired Empirica Therapeutics Inc., of Hamilton, Ontario, to leverage its induced pluripotent stem cell-derived allogeneic cell therapies against glioblastoma (GBM). Empirica’s multi-omics platform, combined with patient-derived, therapy-adapted models of recurrent GBM, has led to the discovery and validation of novel brain tumor targets, Century said. Empirica’s preclinical models of recurrent GBM have demonstrated the potential of CAR T-cell therapy in GBM, the company added. No financial details were disclosed.
Positive results of an in vitro study by Everest Medicines Ltd., of New York, Boston and San Diego, show Xerava (eravacycline) demonstrated markedly greater potency against drug-susceptible and resistant mycoplasmas than tetracycline, azithromycin, moxifloxacin and clindamycin. Those results suggest Xerava merits further clinical study as a potential therapeutic option to macrolides and existing antibiotics for treating some respiratory infections caused by human mycoplasmas, the company said. Susceptibility testing showed that, in addition to greater potency, Xerava demonstrated minimal inhibitory concentrations of less than 0.25 µg/ml in almost all 134 isolates tested, including 37 macrolide-, tetracycline- and/or fluoroquinolone-resistant organisms.
Doctors and scientists from multiple international health care research institutes, led by Alex Spyropoulos, professor at the Feinstein Institutes for Medical Research, analyzed the first set of data from the MARINER clinical trial. The team looked at the extended treatment of 10 mg rivaroxaban for 45 days and if it reduced major arterial and venous thromboembolic events like venous thromboembolism (VTE), pulmonary embolism and stroke. Results showed that VTE, stroke, myocardial infarction and cardiovascular death were significantly reduced by 28% without an increase in major bleeding. Early research suggests COVID-19 patients are prone to suffer arterial thromboembolism, including strokes and death, as well as venous thrombosis both in the hospital and after discharge. In the trial, 4,909 patients were assigned to the rivaroxaban treatment group and 4,913 patients in the placebo group. Additional results show that symptomatic lower extremity deep vein thrombosis reduced 80% in those treated with rivaroxaban. In 2019, the FDA approved a 10-mg dose of rivaroxaban to treat hospitalized medically ill patients with extended thromboprophylaxis.
Frontier Scientific Inc., of Logan, Utah, said it has identified and developed multiple synthetic processes to produce stannous protoporphyrin, the active pharmaceutical ingredient of Dallas-based Renibus Therapeutics Inc.'s experimental COVID-19 therapy, RBT-9. The drug, awarded fast track status by the FDA, will be tested in a phase II study in COVID-19 patients at high risk of deteriorating health due to age or co-morbid conditions such as kidney or cardiovascular disease. The drug developer has also enlisted Cascade Chemistry Inc., of Eugene, Ore., to produce the API.
Illumina Inc., of San Diego has selected seven early stage companies to join the first global cohort of its Illumina Accelerator program, which is focused on partnering with entrepreneurs to build breakthrough genomics startups. Among the therapeutics companies that won Illumina's support, which includes access to seed investment and Illumina tools, were Alchemab Therapeutics Ltd., an antibody therapeutics company from London, and Medic Life Sciences Inc., a drug discovery company in the San Francisco Bay Area.
Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., received $71 million funding from the U.S. Department of Defense to support the large-scale manufacture of a device it created to deliver its DNA vaccine candidate, INO-4800, directly into the skin and the procurement of 2,000 of the devices. Interim results of a phase I studies of INO-4800 will be available later this month, while a phase II/III efficacy trial is planned to begin in July or August, the company said.
Itm Isotopen Technologien München AG, of Munich, Germany, said it partnered with Toronto-based Point Biopharma Inc. to support clinical development of PNT-2002, a 177Lu-PSMA radiopharmaceutical candidate for the treatment of metastatic castrate-resistant prostate cancer. A phase III trial of the candidate, for which Itm will supply its no-carrier-added Lutetium-177 Endolucinbeta, is expected to begin enrolling patients in the fourth quarter. Additionally, both parties signed a long-term commercial agreement for the supply of Endolucinbeta following potential marketing approval of PNT-2002. Further terms of the agreements were not disclosed.
Leo Lens Technology Inc., of San Diego, doing business as Leo Lens Pharma, said its lead asset, a therapeutic contact lens that delivers preservative-free bimatoprost to the eye to treat glaucoma for one week, is ready for IND submission. The company plans to submit an IND in the coming months and proceed to a phase IIa trial of the combo, called LL-BMT1, later this year.
Linnaeus Therapeutics Inc., of Haddonfield, N.J., said it entered a clinical collaboration agreement with Kenilworth, N.J.-based Merck & Co. Inc. to evaluate the combination of its lead investigational product candidate, LNS-8801, and Merck's anti-PD-1 therapy, Keytruda (pembrolizumab), in patients with selected advanced solid tumors. LNS-8801 is an orally bioavailable small molecule that is a highly specific and potent agonist of the G-protein estrogen receptor, Linnaeus said. Under the terms of the agreement, Linnaeus will conduct a phase II study in patients who had previously responded to anti-PD-1 therapy and have since progressed.
Mateon Therapeutics Inc., of Agoura Hills, Calif., said it selected Iqvia to manage its C001 phase II trial of OT-101, a TGF-beta therapeutic, in combination with standard of care in hospitalized COVID-19 patients.
Millendo Therapeutics Inc., of Ann Arbor, Mich., said it has engaged SVB Leerink to support a strategic review of the company after a pivotal study of its experimental Prader-Willi syndrome therapy, livoletide, failed to show a statistically significant improvement in hyperphagia, or insatiable hunger, and food-related behaviors vs. placebo earlier this year. The company finished its first quarter with $58.9 million in cash and equivalents. In the interim, its team has filed an IND to study the NK3R antagonist MLE-301 for the treatment of vasomotor symptoms, also known as hot flashes and night sweats, in menopausal women. It also completed an interim review of an open-label phase IIb study of the ACAT1 inhibitor nevanimibe in classic congenital adrenal hyperplasia. Results of that study led management to decide against further investment in the program.
Miragen Therapeutics Inc., of Boulder, Colo., said a preclinical test of its experimental idiopathic pulmonary fibrosis medicine, MRG-229, demonstrated mechanistic biomarker regulation and antifibrotic activity in vitro using human model systems. In addition, subcutaneous administration of the candidate induced the reversal of pathologic fibrotic gene expression and resulted in a "significant reduction" of fibrosis in the most commonly employed preclinical animal model of pulmonary fibrosis, it said. High doses of MRG-229 in preclinical toxicology studies in rats showed no clinically significant toxicity. Company shares (NASDAQ:MGEN) fell 14.1% to $1.22 on June 23.
Palatin Technologies Inc., of Cranbury, N.J., said it is developing melanocortin 1 receptor agonist PL-8177 as a treatment for patients with COVID-19 after a preclinical test in multiple inflammatory disease models and a lung injury model showed it reduced inflammation, protected lung tissue and reduced lung fibrosis. With preclinical and phase I studies of the drug complete, Palatin is now planning to submit an IND in the third quarter in support of a desired phase II trial initiation in the fourth quarter. The placebo-controlled adaptive phase II study would evaluate the candidate in people with moderate or severe COVID-19. Meanwhile, it's pursuing research and development grants to support the work.
Principia Biopharma Inc., of South San Francisco, said it will be entitled to a $50 million milestone payment from partner Sanofi SA, of Paris, triggered by the start of Sanofi’s phase III trial testing SAR-442168 in relapsing multiple sclerosis.
Scenic Biotech BV, of Amsterdam, secured a €3.1 million (US$3.1 million) Innovation Credit from the Dutch government. The funds will be used to advance the company's lead CD47/glutaminyl-peptide cyclotransferase-like inhibitor immuno-oncology program through preclinical development toward clinical studies.
Schrödinger Inc., of New York, said it's expanding its work to discover new antiviral therapies for COVID-19. The company is leading the computational design work in an alliance of major biopharma companies collaborating on the COVID-19 initiative, including Osaka, Japan-based Takeda Pharmaceutical Co. Ltd., Basel, Switzerland-based Novartis AG, Foster City Calif.-based Gilead Sciences Inc. and Shanghai-based Wuxi Apptec. To date, it has evaluated four different protein targets for the initiative and used Alphabet Inc.'s Google Cloud to support "ultra-large" virtual screens for two of the targets. Google has now donated to Schrödinger credits for high-powered parallel computing to enable rapid exploration of chemical space.
Specialty generics company Teligent Inc., of Buena, N.J., received notice that it has regained compliance with the Nasdaq listing rule requiring listed firms to maintain a minimum bid price of $1 per share. Company shares (NASDAQ:TLGT) closed at $3.05 on June 23 following an earlier one-for-10 reverse stock split.
Thermo Fisher Scientific Inc., of Waltham, Mass., and Daiichi Sankyo Co. Ltd., of Tokyo, expanded their partnership by signing a new agreement to co-develop a companion diagnostic that will utilize Thermo Fisher's next-generation sequencing-based Oncomine Dx Target Test. The test will be designed to identify non-small-cell lung cancer (NSCLC) patients with HER2 mutations who may be eligible for Enhertu (fam-trastuzumab deruxtecan), which is currently in global phase II development for HER2-mutated or HER2-overexpressing NSCLC.