Alterity Therapeutics Ltd., of Melbourne, Australia, said new clinical and experimental pharmacology data for its lead drug candidate, ATH-434 (formerly PBT-434), have been selected for presentation at the 2020 International Congress of Parkinson's Disease and Movement Disorders and the American Neurological Association's annual meeting. Results from an experiment testing ATH-434 in an animal model of multiple system atrophy independently confirm and extend previous findings demonstrating that the drug reduces alpha-synuclein pathology, preserves neurons and improves motor performance. ATH-434 is an orally bioavailable, brain penetrant, small-molecule inhibitor of alpha-synuclein aggregation.
Applied Biomath Inc., of Concord, Mass., disclosed a collaboration with Verseau Therapeutics Inc., of Bedford, Mass., for the development and delivery of a systems pharmacology model that will be used for efficacious dose prediction for the treatment of cancer. An existing collaboration will be expanded in an effort to predict an efficacious dose for one of Verseau’s lead macrophage checkpoint inhibitor programs. Terms were not disclosed.
Beroni Group Ltd., of Sydney, provided an update on the development of the previously disclosed potential medical solution utilizing nanobody technology for detection and treatment of COVID-19 in collaboration with Tianjin University in China. After identifying the 24 specific nanobodies with high affinity to the new coronavirus N-protein and S-protein antigens through high-throughput screening in May, the scientific team has used structural biology, computational biology and biophysical methods to further analyze and improve the properties of those nanobodies. Out of the 24 nanobodies, 16 deal with the S-protein and can be used as antiviral therapeutics, and the other eight deal with the N-protein for use as a marker in diagnostic assays. The scientists have successfully established a prokaryotic expression and purification system for nanobodies in vitro, the company said.
Bryologyx Inc., of Danville, Calif., signed a Cooperative Research and Development Agreement with the U.S. National Cancer Institute to conduct a phase I trial with bryostatin-1 in pediatric and young adult patients with relapsing or refractory CD22-expressing acute lymphoblastic leukemia and lymphoma. The study, expected to start later this year, will be the first in patients to evaluate the ability of bryostatin-1 to up-regulate expression of CD22, a cancer immunotherapy target often down-regulated following antibody-drug conjugate or CAR T adoptive therapies. The company is planning future trials with bryostatin-1 to evaluate its ability to up-regulate other antigen targets associated with B-cell hematological malignancies.
Catabasis Pharmaceuticals Inc., of Boston, and the Bill & Melinda Gates Medical Research Institute agreed to assess CAT-5571 as a therapy to promote autophagy and treat persistent lung infections in patients with drug-sensitive and drug-resistant tuberculosis. Catabasis granted the institute a nonexclusive license to the oral small molecule and will furnish samples for preclinical research. CAT-5571 will be studied alone and in combination with the standard-of-care regimen in cell and animal models of Mycobacterium tuberculosis. In preclinical studies, CAT-5571 was shown to restore autophagy in mouse and human cells with the delta508-CFTR mutation and promote bacteria clearance, including that of Mycobacterium abscessus, from the cells, the company said.
Fresh preclinical data from Cocrystal Pharma Inc., of Bothell, Wash., showed that 3C-like protease inhibitors block coronavirus replication in vitro and improve survival in MERS-CoV-infected mice. The optimized compounds were effective against several human coronaviruses, including MERS-CoV, SARS-CoV and SARS-CoV-2 in an enzyme assay and in cell-based assays using Huh-7 and Vero E6 cell lines. Two selected compounds showed antiviral effects against SARS-CoV-2 in cultured primary human airway epithelial cells. In a mouse model of MERS-CoV infection, administration one day after virus infection increased survival from 0% to 100% and reduced lung viral titers and lung histopathology.
Eyepoint Pharmaceuticals Inc., of Watertown, Mass., and Imprimisrx, an ophthalmic-focused outsourcing facility and pharmaceutical compounding company, created a commercial alliance to promote Dexycu (dexamethasone intraocular suspension) 9% for treating postoperative inflammation following ocular surgery in the U.S. Imprimisrx will promote Dexycu to ophthalmologist, hospital and ambulatory surgical center (ASC) customers. Eyepoint is responsible for marketing, selling, pricing, manufacturing and contracting for Dexycu while also seeking additional volume-based agreements with ASCs and integrated health care networks. Imprimisrx could receive a commission on incremental sales that exceed prespecified volume targets. Eyepoint retains all commercial rights outside of the U.S.
Huya Bioscience International LLC, of San Diego, said it obtained exclusive licensed worldwide rights, outside of China, to the SHP2 inhibitor HBI-2376 from Suzhou Genhouse Pharmaceutical Co. Ltd., of Suzhou, China. SHP2 is a RAS signaling pathway component leading to activation of ERK/MAPK pathways in a variety of cancer cells. SHP2 interaction with PD-L1 inhibits T-cell activity in the tumor microenvironment.
Ideaya Biosciences Inc., of South San Francisco, said it received an up-front cash payment of $100 million from Glaxosmithkline plc, of London, from their partnership in synthetic lethality, which includes Ideaya's MAT2A, Pol Theta and Werner Helicase programs. Glaxo Group Ltd. said it purchased 1.33 million shares of Ideaya's common stock at $15 per share. Ideaya received proceeds from Glaxo Group of approximately $20 million.
Immune-Onc Therapeutics Inc., of Palo Alto, Calif., said it was awarded a Small Business Innovation Research Direct to Phase II grant from the U.S. National Cancer Institute. The grant, in the amount of $2.14 million over two years, will support development of IO-202, an antibody targeting leukocyte immunoglobulin-like receptor B4, for acute myeloid leukemia. In preclinical studies, IO-202 has shown evidence of activating T-cell cytotoxicity against leukemia cells and blocking tumor infiltration.
Innovation Pharmaceuticals Inc., of Wakefield, Mass., said an experiment in a human lung epithelial cell line with the live (or wild-type) virus showed that brilacidin, a polymer-based antibiotic, inhibited SARS-CoV-2 when administered post-infection. The results complement earlier experiments in the same lung cell line that showed brilacidin, when directly incubated with the live virus, exhibited potent inhibition, the company said.
Janone Inc., of Las Vegas, said it changed the name of its drug candidate TV-1001SR, a twice-daily oral, slow-release formulation of sodium nitrite, to JAN-101. Data from a JAN-101 phase IIa study for treating peripheral artery disease found no treatment-related reports of headaches or any differences between treatment and placebo groups in reports of dizziness. The study also reported a positive trend toward pain reduction and a significant improvement in nerve function, the company said.
Kriya Therapeutics Inc., of Palo Alto, Calif., said it secured a 51,350-square-foot manufacturing facility in Research Triangle Park, N.C., to support the scalable production of its pipeline of AAV-based gene therapies. The facility is designed to have a fully integrated process development lab, quality control and analytical development capability, pilot production suite and cGMP production infrastructure. Kriya plans to manufacture gene therapies at the facility using its scalable suspension cell culture manufacturing process at up to 2,000-liter bioreactor scale, with pilot production and full cGMP manufacturing infrastructure expected to be online in the first and second half of 2021, respectively.
Merck & Co. Inc., of Kenilworth, N.J., and Hanmi Pharmaceutical Co. Ltd., of Seoul, South Korea, said they forged an exclusive licensing agreement to develop, manufacture and commercialize efinopegdutide (formerly HM-12525A), Hanmi’s once-weekly glucagon-like peptide-1/glucagon receptor dual agonist, to treat nonalcoholic steatohepatitis. Merck received an exclusive license to develop, manufacture and commercialize efinopegdutide in the U.S. and globally in return for an up-front payment of $10 million to Hanmi, which also is eligible for up to $860 million in development, regulatory and commercialization milestone payments and double-digit royalties. Hanmi retained an option to commercialize efinopegdutide in Korea. Rights to the candidate, previously in development to treat severely obese individuals with and without diabetes, were returned to Hanmi in 2019 by Janssen Pharmaceutical NV, a unit of Johnson & Johnson, of New Brunswick, N.J.
Onconova Therapeutics Inc., of Newtown, Pa., said it was informed by Nasdaq that the company regained compliance with the minimum bid price requirement.
Partner Therapeutics Inc., of Lexington, Mass., said it inked a $35 million milestone-based other transaction agreement (OTA) with the U.S. Department of Defense to fund two studies of inhaled Leukine (sargramostim, rhu-granulocyte macrophage-colony stimulating factor) in people with COVID-19-associated acute hypoxemia. The firm fixed price agreement with the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense will fund the phase II studies to evaluate the effect of Leukine in improving outcomes, including oxygenation and percent of patients intubated. The first study, conducted under a U.S. IND application, is expected to begin in August, supplementing data from more than 60 participants who completed treatment in the ongoing SARPAC (sargramostim in patients with acute hypoxic respiratory failure due to COVID-19) trial at five hospitals in Belgium. Funding from the OTA also will support regulatory filings and expansion of production capacity to meet increased demand.
Preveceutical Medical Inc., of Vancouver, British Columbia, said it is preparing for clinical trials to test cannabinoid Sol-Gel in reducing the possibility of contracting coronavirus infections. The company retained CRO Veristat to assist with planning the clinical trial process. Preveceutical said it is looking for an expedited pathway such as fast-track or the coronavirus treatment acceleration program.
Recce Pharmaceuticals Ltd., of Sydney, reported activity against Helicobacter pylori bacteria in rats treated with its broad-spectrum synthetic polymer antibiotic candidate, RECCE-435. Five groups of 10 rats each were observed. In the three groups treated with the study drug (250 mg/kg, 500 mg/kg and 1,000 mg/kg), dose-dependent efficacy was seen at all doses, with significant reduction in bacterial load. No signs of toxicity were observed at any dosage. In an additional independent safety study, RECCE-435 doses of up to 500 mg/kg were administered to groups of five mice each twice daily for seven days vs. water, and data indicated their feeding habits were not affected by the drug.
Respirerx Pharmaceuticals Inc., of Glen Rock, N.J., said it exercised an option agreement with the UWM Research Foundation Inc., an affiliate of the University of Wisconsin-Milwaukee, for a patent license covering GABAA receptor neuromodulator intellectual property, including U.S. patents 9,006,233, 9,597,342 and 10,259,815 and a Canadian patent application. Respirerx agreed to provide payments covering patent costs and an annual license fee along with development and regulatory milestone payments and royalties on net product sales. The option exercise followed the closing of a $2 million funding commitment by Respirerx.
Resverlogix Corp., of Calgary, Alberta, said an article published in Cardiovascular Therapeutics showed that treatment with its bromodomain containing protein inhibitor, apabetalone, reduced the expression of acute phase response (APR) genes in cultured human liver cells and in mouse models of inflammation. The authors also reported that, in individuals with stable coronary artery disease, plasma concentrations of APR proteins, including C-reactive protein (CRP), were lowered in those who received apabetalone compared to those who received placebo with standard of care. In addition, select bromodomain and extraterminal (BET) protein inhibition by apabetalone reduced the occupancy of the BET protein BRD4 at the CRP promoter, down-regulating its transcription.
Sernova Corp., of London, Ontario, said it inked an exclusive global license with the University of Miami for rights to conformal coating immune protection technologies developed by scientists in the Diabetes Research Institute at the university’s Miller School of Medicine and at the University of Chicago. Sernova said the agreement broadened the technology scope of its immune protection conformal coating technologies and related intellectual property for its cell pouch platform.
Sonnet Biotherapeutics Holdings Inc., of Princeton, N.J., said it executed a letter of intent with New Life Therapeutics Pte. Ltd., of Singapore, to negotiate a license agreement for its SON-081 and SON-080 assets, both low-dose formulations of interleukin-6, to treat diabetic peripheral neuropathy (DPN) and chemotherapy-induced peripheral neuropathy (CIPN). The licensed territory is expected to include the ASEAN countries of Singapore, Malaysia, Indonesia, Thailand, the Philippines, Cambodia, Brunei, Vietnam, Myanmar and Laos. Sonnet received a $500,000 nonrefundable payment from New Life, with the letter of intent outlining an agreement that could provide Sonnet with up to $40 million in milestone payments and a 30% royalty on commercial sales. Upon execution of a definitive agreement, still to be negotiated, New Life will assume responsibility for a phase Ib/IIa pilot scale efficacy study with SON-081 in DPN, expected to initiate during the first half of 2021. Sonnet will conduct a pilot scale efficacy study with SON-080 in CIPN, also expected to begin during the first half of 2021.
Tarveda Therapeutics Inc., of Watertown, Mass., said a preclinical study evaluating T-2143, its Hsp90 binding miniature drug conjugate with a pan-PI3K payload, in solid tumors was published in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research. In the study, T-2143 showed rapid and sustained tumor accumulation of the conjugate, deep pathway inhibition and superior efficacy in tumor xenograft models vs. pan-PI3K inhibitor copanlisib (Aliqopa, Bayer AG) as monotherapy. Selective targeting of T-2143 and masking of the inhibitor active site also enabled mitigation of hyperglycemia, a dose-limiting side effect seen in pan-PI3K inhibitors, while driving higher tumor exposure and enhanced efficacy.
T-Cure Bioscience Inc., of Sherman Oaks, Calif., said it extended its ongoing research collaboration with the U.S. National Heart Lung and Blood Institute (NHLBI) through a Collaborative Research and Development Agreement (CRADA) to advance the company’s HERV-E targeting TCR therapy for renal cell cancer. Under the CRADA, T-Cure and NHLBI plan to develop a companion test to identify HERV-E transcripts in the tumors of patients. They will also seek to identify additional therapeutic candidates targeting HERV-E using T-Cure’s TCR discovery platform, Isort, and conduct various preclinical experiments. In addition, T-Cure expanded an existing license with NHLBI to encompass global rights for intellectual property related to the anti-HERV-E TCR candidate, which is in a phase I trial at NHLBI to treat metastatic clear cell renal cell carcinoma that failed an angiogenic inhibitor and a checkpoint inhibitor.
Tiziana Life Sciences plc, of London, said it signed agreements with four CROs to expedite development of TZLS-501, its fully human anti-interleukin-6 receptor monoclonal antibody designed to treat COVID-19. The company plans to initiate a study of the candidate, delivered as an aerosol to the lungs using a handheld nebulizer, in the first quarter of 2021, working with FHI Clinical Inc., of Durham, N.C.; STC Biologics Inc., of Newton, Mass.; Sciarra Laboratories Inc., of Hicksville, N.Y.; and ITR Laboratories Canada Inc., of Montreal.
Tonix Pharmaceuticals Holding Corp., of New York, said preclinical results of TNX-1900 (oxytocin solution for intranasal delivery) were posted at the American Academy of Neurology’s Sports Concussion Conference. The study investigated the efficacy of intranasal oxytocin in relieving pain and associated depressive behavior following traumatic brain injury (TBI). The data showed that intranasal oxytocin, but not intravenous oxytocin or vehicle, attenuated both reactive and spontaneous pain following mild TBI in an animal model. Intranasal oxytocin was also shown to attenuate post-TBI depressive and anxiety behaviors in the same animal model. Intranasal oxytocin was shown to result in high concentrations of oxytocin, primarily in the trigeminal ganglia. The research was sponsored by Trigemina Inc., which Tonix acquired in June 2020. In separate news, Tonix received a letter from Nasdaq stating that it had regained compliance with the minimum bid price requirement for continued listing.
Twist Bioscience Corp., of South San Francisco, and Seismic Bio Inc., of San Francisco, said they formed a partnership to discover and optimize antibodies to high-value immuno-oncology (I-O) targets. Twist Biopharma, a division of Twist Bioscience, will use its hyperimmune libraries, two fully human antibody libraries focused on the heavy chain complementary determining region 3 loop diversity involved in antigen recognition, to identify antibodies that bind to specified I-O targets. Seismic Bio will use those monoclonal antibodies as building blocks to create bispecific antibody therapeutics. Seismic agreed to pay Twist technology activity and milestone fees for compounds discovered through the agreement.
Vistagen Therapeutics Inc., of South San Francisco, received the $5 million up-front license payment from Everinsight Therapeutics Inc., of Shanghai, as part of their licensing and collaboration agreement for the clinical development and commercialization of PH-94B.
Xortx Therapeutics Inc., of Calgary, Alberta, and the Icahn School of Medicine at Mount Sinai, New York are partnering to study the incidence of acute kidney injury and hyperuricemia in nearly 4,000 patients hospitalized with COVID-19.