Adamis Pharmaceuticals Corp., of San Diego, said a study of hamsters challenged with SARS-CoV-2, the virus that causes COVID-19, resulted in decreased inflammation in the lungs of animals treated with the antioxidant Tempol compared to controls. The results demonstrated that incubation of Tempol significantly suppresses multiple inflammatory cytokines from cells taken from COVID-19 patients, the company said. The results are consistent, the company added, with results of in vitro cytokine data from Stanford University. Tempol has demonstrated potent anti-inflammatory, anticoagulant and antioxidant activity, according to Adamis.
Altimmune Inc., of Gaithersburg, Md., said preclinical data for its single-dose intranasal COVID-19 vaccine candidate, AdCOVID, showed complete protection against lethal challenge and dramatic reduction in viral replication. The data, obtained in the K18-hACE2 transgenic mouse model, showed a single intranasal dose provided 100% protection against a lethal challenge from the SARS-CoV-2 virus. An initial immunogenicity analysis showed mean antibody levels of about 1 mg/mL, suggesting that the serum IgG antibody response against the spike protein was robust, Altimmune added.
Aeterna Zentaris Inc., of Charleston, S.C., said it exercised its option to enter an exclusive worldwide sublicensable patent and know-how license agreement for a potential COVID-19 vaccine in preclinical development that was invented at Germany’s Julius-Maximilians-University Wuerzburg. The company also entered an agreement with the university to conduct supplementary research activities and preclinical development studies on the vaccine. The vaccine technology developed at the school uses the typhoid fever vaccine Salmonella Typhi Ty21a as a carrier strain and has the potential to be an orally active, live-attenuated bacterial vaccine to prevent SARS-CoV-2 infection leading to COVID-19, according to Aeterna Zentaris.
Amring Pharmaceuticals Inc., of Berwyn, Pa., said it will commercialize an unnamed commercial product from Amzell BV, of Hoofddorp, the Netherlands. Amring also said it will invest an undisclosed amount in the development through the clinic and the FDA approval process. Amring is a subsidiary of Sever Life Sciences BV, also of Hoofddorp.
Following concern around thrombotic events, Astrazeneca plc, of Cambridge, U.K., said a review of all available safety data of more than 17 million people vaccinated in the EU and U.K. with COVID-19 Vaccine Astrazeneca showed no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country. So far across the EU and U.K., the company added, there have been 15 events of DVT and 22 events of pulmonary embolism reported among those given the vaccine, based on the number of cases the company has received as of March 8. This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines, the company added.
Aveo Oncology Inc., of Boston, said it will regain rights to its clinical-stage humanized IgG1 monoclonal antibody that targets ErbB3, AV-203, outside of North America following the voluntary termination of its collaboration and license agreement by Canbridge Life Sciences Ltd., of Beijing. Canbridge has begun transferring all preclinical data and materials to Aveo. The transfer of rights and termination of the collaboration and license agreement become effective Sept 5. Aveo has completed a phase I, open-label, dose-escalation study of AV-203 in patients with advanced solid tumors. In the study, one patient had a dose-limiting adverse event and the recommended phase II dose, or RP2D, is 20 mg/kg. One of two neuregulin-positive patients had a partial response. Neuregulin, the only known ligand for ErbB3, is a potential biomarker that may prove to be predictive of AV-203 antitumor activity, the company added.
Biovaxys Technology Corp., of Vancouver, British Columbia, said it entered a bioproduction deal with Wuxi Biologics Ltd., part of Shanghai-based Wuxi Apptec, to produce SARS-CoV-2 s-proteins required by Biovaxys for BVX-0320, its COVID-19 vaccine candidate, and for its Covid-T immunodiagnostic program. Financial terms were not disclosed.
Bright Minds Biosciences Inc. (BMB), of Vancouver, British Columbia, said studies conducted with its 5-HT2C agonists show robust efficacy in rodent models of opioid self-administration as a treatment for opioid use disorder. The study used a validated model involving male rats trained to stably self-administer fentanyl. BMB’s compound dose-dependently suppressed fentanyl infusions in rats at potentially clinically relevant doses, with the highest doses having a more than 50% reduction in fentanyl intake. In addition, the compound did not overtly alter spontaneous behaviors of animals in the study.
Destiny Pharma plc, of Brighton, U.K., said it entered a nonclinical evaluation agreement with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, to evaluate the preclinical safety of a dermal formulation of XF-73. Destiny will use NIAID's preclinical services program to complete the preclinical safety studies that will support the planned clinical development in serious wound infections. Destiny will provide the XF-73 formulation to be tested, and the project is planned to complete in 2022.
Genevant Sciences Ltd., of Vancouver, British Columbia, and Basel, Switzerland, said it entered a global collaboration and license deal with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, for the discovery, development and commercialization of LNP-delivered nucleic acid therapeutics directed to previously inaccessible drug targets in hepatic stellate cells to treat liver fibrosis. Under the terms, Genevant is initially eligible to receive up to $600 million in up-front and milestone payments, plus royalties on future product sales. Takeda has exclusive rights to Genevant’s LNP technology for a specified number of selected hepatic stellate cells targets.
Gilead Sciences Inc., of Foster City, Calif., and Merck & Co. Inc., of Kenilworth, N.J., said they entered an agreement to co-develop and co-commercialize long-acting treatments in HIV that combine Gilead’s investigational capsid inhibitor, lenacapavir, and Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, into a two-drug regimen. The first clinical studies of the oral combination are expected to begin in the second half of 2021. Under the terms, Gilead and Merck will work as partners, sharing operational responsibilities, as well as development, commercialization and marketing costs, and any future revenues. Across the oral and injectable formulation programs, Gilead and Merck will share global development and commercialization costs 60%/40%, respectively. For long-acting oral products, Gilead will lead commercialization in the U.S. and Merck will lead commercialization in the EU and rest of the world. For long-acting injectable products, Merck will lead commercialization in the U.S. and Gilead will lead commercialization in the EU and rest of the world. Both will co-promote in the U.S. and other certain major markets. Merck and Gilead will share global product revenues equally until product revenues surpass certain pre-agreed per formulation revenue tiers. Upon passing $2 billion a year in net product sales for the oral combination, the revenue split will adjust to 65% Gilead and 35% Merck for any revenues above the threshold. Upon passing $3.5 billion a year in net product sales for the injectable combination, the revenue split will adjust to 65% Gilead and 35% Merck for any revenues above the threshold. Beyond the potential combinations of lenacapavir and islatravir, Gilead will have the option to license certain of Merck’s investigational oral integrase inhibitors to develop in combination with lenacapavir. Reciprocally, Merck will have the option to license certain of Gilead’s investigational oral integrase inhibitors to develop in combination with islatravir. Each company may exercise its option for an investigational oral integrase inhibitor of the other company following completion of the first phase I trial of that integrase inhibitor. Upon exercise of an option, the companies will split development cost and revenues, unless the non-exercising company decides to opt out. Both companies currently have oral once-weekly integrase inhibitors in preclinical development.
Horizon Therapeutics plc, of Dublin, said it completed its acquisition of Viela Bio Inc., of Gaithersburg, Md. The $3.05 billion deal is expected to expand Horizon’s rare disease pipeline.
Lattice Biologics Ltd., of Belgrade, Mont., said it will change its business strategy to focus on the psychedelics and cannabis markets through the creation of a new life sciences subsidiary. The company will focus on the research and commercialization of psychedelic products in combination with its stem cell-based regenerative compounds while leveraging its distribution expertise.
Magenta Therapeutics Inc., of Cambridge, Mass., presented preclinical data at the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation from its MGTA-117 targeted antibody-drug conjugate conditioning program, showing the drug significantly increased median survival vs. a multiday treatment of cytarabine in multiple human leukemic xenograft murine models designed to mimic untreated and refractory acute myeloid leukemia (AML). Hematopoietic stem cell transplant can often be a curative treatment for patients with AML, but there is a need for safer and more effective targeted conditioning agents, the company said.
Mersana Therapeutics Inc., of Cambridge, Mass., said preclinical data published in Molecular Cancer Therapeutics describes its dolaflexin antibody-drug conjugate (ADC) platform, which is designed to overcome limitations of the most common ADC platforms with two key features: a higher drug-antibody ratio and a proprietary auristatin with a controlled bystander effect. Data from a separate study showed that Dolaflexin-based ADC XMT-1536, which targets the solid tumor lineage antigen SLC34A2/NaPi2b, resulted in target expression-dependent activity in a series of non-small-cell lung cancer adenocarcinoma patient-derived xenografts (PDX) as well as profound activity in a panel of ovarian adenocarcinoma PDXs. Pharmacokinetic analyses showed approximately dose-proportional exposure across animal species as well as high serum stability of the conjugate, and systemic free AF-HPA and AF concentrations remaining low in all animal species.
Newron Pharmaceuticals SpA, of Milan, Italy, said it reached agreement with partner Zambon SpA, also of Milan, regarding a potentially pivotal study to evaluate the efficacy of safinamide in Parkinson’s disease patients with levodopa-induced dyskinesia. Positive results from the study could result in a label extension for safinamide, subject to regulatory approval. Under the agreement, Newron will sponsor the study and be responsible for its development and execution, as well as leading on all related regulatory interactions. Newron and Zambon will evenly share the cost of the study.
Point Biopharma Inc., of Toronto, and Therapeutics Acquisition Corp., d/b/a Research Alliance Corp. I (NASDAQ:RACA), a special purpose acquisition company sponsored by RA Capital Management, said they entered a business combination agreement. Upon closing, RACA will be renamed Point Biopharma Global Inc. and will list on Nasdaq under the ticker PNT. A group of investors committed to participate in the transaction through a common stock private investment in a public equity (PIPE) of about $165 million at $10 per share. Investors in the PIPE include lead investor RA Capital, as well as Johnson & Johnson Innovation – JJDC Inc., Surveyor Capital (a Citadel company), Farallon Capital Management LLC, BVF Partners LP, Boxer Capital, Sphera Healthcare, Woodline Partners LP, Suvretta Capital, Fairmount Funds and Perceptive Advisors. Assuming no redemptions are exercised, the combined company is expected to receive net proceeds of about $300 million at the closing of the transaction. The funding will be used to help Point complete its two phase III trials for radioligands in prostate and neuroendocrine cancers, as well as advance an early stage pipeline and complete construction on a manufacturing facility. Point’s management team will lead the combined firm post-closing, with Joe McCann named as CEO. David Lubner, one of the directors of RACA, will be joining the board. The transaction is expected to be completed by midyear 2021.
PTC Therapeutics Inc., of South Plainfield, N.J., reported results at the 2021 Muscular Dystrophy Association Virtual Clinical and Scientific Conference from a real-world study of patients with Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy (BMD) who switched from prednisone to Emflaza (deflazacort) following the FDA approval. The primary reason the majority of patients chose to switch was a desire to delay disease progression to improve the benefit and tolerability. Results found that during the six-month average follow-up after switching, among charts with Clinical Global Impression recorded, most patients' disease progression improved or stabilized during steroid treatment, with a shift toward improvement after switching. Switching was reported as "very" or "somewhat" effective at addressing primary reasons in 95% of patients with DMD and 90% of patients with BMD.
Resverlogix Corp., of Calgary, Alberta, said preclinical findings posted on preprint server Biorxiv indicated a strong rationale for use of apabetalone, a bromodomain and extraterminal (BET) protein inhibitor, as a therapeutic for COVID-19. ACE2 and DPP4 are key proteins used by SARS-CoV-2 to gain entry into human cells, and data showed treatment with apabetalone reduces the expression of both ACE2 and DPP4 at the surface of human lung epithelial cells. Apabetalone also prevents human SARS-CoV-2 infection of human lung epithelial cells at comparable levels to the antiviral remdesivir (Gilead Sciences Inc.), the company said. It has disclosed plans for an open-label study to assess apabetalone in COVID-19.
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, disclosed a mutual agreement with IDT Biologika GmbH (IDT), a contract development and manufacturing organization, to utilize capacity at IDT previously reserved for Takeda’s dengue vaccine candidate (TAK-003) to manufacture the single-shot COVID-19 vaccine developed by the Janssen Pharmaceutical Cos., of New Brunswick, N.J.-based Johnson & Johnson. At the end of a three-month period, the capacity will be returned to Takeda to resume critical manufacturing for the planned launch of its dengue vaccine, subject to regulatory approvals.
Tevogen Bio Inc., of Metuchen, N.J., said it is partnering with Biocentriq, a New Jersey-based cell and gene therapy development and manufacturing center, to support clinical manufacturing of Tevogen’s investigational COVID-19 treatment. Under the terms, experts from both entities will collaborate to produce Tevogen’s COVID-19-targeted T cells. An IND for Tevogen’s antigen-specific T-cell therapy, TVGN-489, is under review at the FDA.
Timber Pharmaceuticals Inc., of Woodcliff Lake, N.J., earned the final tranche of a $1.5 million grant from the FDA's Office of Orphan Product Development for randomizing 50% of the patients in its phase IIb study testing TMB-001 (topical isotretinoin) in patients with moderate to severe congenital ichthyosis.
Urogen Pharma Ltd., of Princeton, N.J., said it entered an exploratory immunotherapy sponsored research agreement with the Johns Hopkins University to study the potential of checkpoint inhibitors combined with Rtgel in glioblastoma multiforme. Johns Hopkins researchers expect to begin nonclinical research of Rtgel combined with drugs targeting PD-1 and CTLA4, respectively, in the second quarter of 2021. Urogen’s Rtgel technology is a reverse-thermal hydrogel that may increase dwell time of current therapies and exposure of active drugs, potentially improving the therapeutic effects of existing products. Financial terms of the deal were not disclosed.
Veracyte Inc., of South San Francisco, said it completed its acquisition of Decipher Biosciences Inc., of San Diego. Under the terms, $600 million in cash was paid to Decipher security holders and Decipher has become a wholly owned subsidiary of Veracyte.