1st Biotherapeutics Inc., of Seongnam, South Korea, and Twoxar Pharmaceuticals Inc., of Mountain View, Calif., said they plan to advance three drug leads aimed at the treatment of glioblastoma into in vivo efficacy testing less than one year from launching their drug discovery collaboration. Under their 2019 partnership, Twoxar identified a set of drug discovery hits with the potential to slow, stop or reverse the progression of glioblastoma. Twoxar and 1st Biotherapeutics then selected leads from the initial set to test in preclinical efficacy models.
Arecor Ltd., of Cambridge, U.K., said it achieved a second milestone with an undisclosed pharma partner, triggering a second milestone payment under terms of an exclusive global, royalty-bearing license agreement executed in October 2017 that gave the partner rights to further develop, manufacture and commercialize a superior formulation of a biosimilar product developed by Arecor using its Arestat platform. With the stable liquid formulation meeting intellectual property and improved thermostability specifications for both intravenous and subcutaneous formulations, the partner is expected to initiate pivotal studies to advance the candidate toward commercialization.
Atrin Pharmaceuticals LLC, of Doylestown, Pa., reported preliminary results from a collaborative genomics analysis following a collaboration with Predictive Technology Group Inc., of Salt Lake City, to improve predictive selection of individuals most likely to respond and least likely to experience side effects from treatment with Atrin’s DNA damage and repair (DDR) candidates. The collaborative genomics analysis using Predictive’s assays in individuals with a specific tumor type found an excess of DDR mutations in cancer cells compared with normal tissue. The analysis identified 92 genes as protein responders to the serine threonine protein kinase ATR inhibitor ATRN-119. Atrin said 18 of these are known TIER 1 cancer-driver genes, and well-characterized mutations were found in three dominant genes. Both in vitro and animal studies confirmed synthetically lethal interactions between ATRN-119 treatment and alteration of the three key cancer-causing genes. The overlap between DDR genes responding to ATRN-119 and those mutated in cancer cells suggests that genetic markers underlying response and resistance will be critical to optimizing patient selection in upcoming ATRN-119 studies.
Auris Medical Holding AG, of Zug, Switzerland, said an article describing the antiepileptic and anticonvulsive activity of betahistine in a mouse model, published in Epilepsy & Behavior and written by an independent Iranian research group, presented outcomes on seizure scores, memory deficits, depression and neuronal loss in the murine epilepsy model. Seizure was induced by treatment with pentylenetetrazole (PTZ), a common protocol in epilepsy studies. The researchers found that pretreatment and repetitive treatment with intraperitoneal betahistine entirely prevented the induction of generalized tonic-clonic seizures and significantly diminished seizure intensity. Further, it decreased cell death in the hippocampus and cortex, suggesting a neuroprotective effect, and ameliorated the memory deficit and depression induced by PTZ in the animals.
Certara Inc., of Princeton, N.J., acquired modeling and simulation technology assets from In Silico Biosciences Inc., of Lexington, Mass. for an undisclosed amount. The assets include multiple integrated quantitative systems pharmacology modules of brain physiology and pathology that were developed for the study of neurodegenerative conditions, including Alzheimer’s, Parkinson’s and Huntington’s diseases.
Dyadic International Inc., of Ness Ziona, Israel, is collaborating with The Israel Institute for Biological Research (IIBR) to use Dyadic's C1 gene expression platform to express targets discovered by IIBR to create a vaccine and monoclonal antibodies to combat the outbreak of COVID-19.
Immunos Therapeutics AG, of Schlieren, Switzerland, selected Probiogen AG, of Berlin, for development and large-scale GMP manufacturing projects using Probiogen's Directedluck Transposase technology. Financial details of the deal weren't disclosed.
Index Pharmaceuticals Holding AB, of Stockholm, published data on the mechanism of its Toll-like receptor 9 agonist, cobitolimod, in the Journal of Crohns and Colitis. The drug mediated immunomodulatory effects in a colitis model as well as in blood and tissue samples of ulcerative colitis patients, which led to rebalancing of the mucosal Th17/Treg cell response.
Lunac Therapeutics Ltd., of Leeds, U.K., and Domainex Ltd., Cambridge, U.K., are partnering to discover an inhibitor of the protease target, activated factor XII, as an anticoagulant therapy with the potential to have reduced risk of bleeding compared to current offerings. Terms of the deal weren't disclosed.
Mallinckrodt plc, of Staines-upon-Thames, U.K., reached an agreement in principle to settle the opioid-related claims against the company. Mallinckrodt will pay $300 million after its specialty generics subsidiaries emerge from chapter 11, $200 million on the first and second anniversaries of emergence and $150 million on the third through eighth anniversaries of emergence for a total of $1.6 billion, most of which will go into a trust to fund opioid-addiction treatment and related efforts. The trust will also receive warrants to buy shares of the company that would represent approximately 19.99% of the Mallinckrodt's fully diluted outstanding shares. The specialty genetics businesses will also have to abide by certain agreed-upon operating covenants. Shares of Mallinckrodt (NYSE:MNK) jumped 58 cents, or 13.9%, to $4.75 on Tuesday.
Moderna Inc., of Cambridge, Mass., released its first batch of MRNA-1273, a vaccine against the coronavirus that causes COVID-19. MRNA-1273 expresses the spike protein, which is necessary for membrane fusion and host cell infection. The vaccine has been shipped to the National Institute of Allergy and Infectious Diseases for a planned phase I study in the U.S. Shares of Moderna (NASDAQ:MRNA) closed up $5.17, or 27.8%, to $23.76 on Tuesday.
Omass Therapeutics Ltd., of Oxford, U.K., completed its acquisition of assets and capabilities from Excellerate Biosciences Ltd., of Nottingham, U.K., Through the deal, Omass gets a team focused on membrane protein pharmacology. Terms of the deal weren't disclosed.
Oncologie Inc., of Waltham, Mass., is collaborating with Moffitt Cancer Center to genetically characterize and classify the microenvironment of tumors from Moffitt's patients to elucidate how treatments affect clinical outcomes. The project will initially focus on patients with gastric and gastrointestinal cancers.
Peptilogics Inc., of Pittsburgh, was awarded $2.56 million from CARB-X to fund the development of peptide antibiotics against drug-resistant bacteria. The company could receive up to $9.61 million in additional funding if milestones are met. The project will initially focus on serious infections associated with implants, such as prosthetic knees and hips, and includes funding for Peptilogics’ lead compound, PLG-0206.
Point Biopharma, of Toronto, launched with plans to develop radiopharmaceutical drugs. It anticipates the first pipeline candidate entering clinical trials in 2020.
Proteostasis Therapeutics Inc., of Boston, recently published nonclinical data regarding the mechanism of action of nesolicaftor (PTI-428) and noted that amplifiers bind directly to poly(rC)-binding protein 1 (PCBP1). PCBP1 belongs to a family of RNA-binding proteins regulating cystic fibrosis transmembrane conductance regulator (CFTR) production just before the protein folds and assembles itself for delivery to the cell membrane, where it regulates ion flow. The authors said binding of amplifiers for PCBP1 is specific to CFTR because the binding affinity is enhanced through a portion of mRNA only present in CFTR. That leads to improved stability of CFTR mRNA and results in greater CFTR protein production, the authors concluded. The findings were published in the online version of the Journal of Cystic Fibrosis.
Redhill Biopharma Ltd., of Tel Aviv, Israel, acquired global rights to Movantik (naloxegol) from Cambridge, U.K.-based Astrazeneca plc, excluding Europe, Canada and Israel. Redhill is paying Astrazeneca $52.5 million up front with another non-contingent payment of $15 million 18 months after the deal closes. Redhill will also take over the sales-based royalties and potential milestone payments Astrazeneca must pay to San Francisco-based Nektar Therapeutics Inc., the company that created Movantik. Astrazeneca will continue manufacturing and supplying Movantik to Redhill during the transition period. In 2015, Astrazeneca inked a co-commercialization deal with Daiichi Sankyo Co. Ltd., of Tokyo, for Movantik in the U.S. That will also be transferred to Redhill. Redhill plans to head up all U.S. commercialization activities and will continue to split costs and pay sales-related commissions to Daiichi Sankyo. Movantik is a once-daily, oral, peripherally acting mu-opioid receptor antagonist approved by the FDA to treat opioid-induced constipation in adults with chronic noncancer pain.
Spring Bank Pharmaceuticals Inc., of Hopkinton, Mass., will collaborate with Basel, Switzerland-based Roche Holding AG to co-administer SB-11285, Spring Bank’s intravenously (I.V.)-administered STING (STimulator of INterferon Gene) agonist with Roche’s PD-L1 checkpoint inhibitor, atezolizumab (Tecentriq), in patients with advanced solid tumors. In the fourth quarter of 2019, Spring Bank dosed the first patient in the monotherapy dose-escalation component of phase Ia trial, which will be followed by a combination dose-escalation of I.V. SB-11285 with checkpoint inhibitor Opdivo (nivolumab, Bristol-Myers Squibb Co.) and with atezolizumab as an additional arm added to the combination dose-escalation segment of the phase Ia trial. By the end of 2020, Spring Bank plans to generate sufficient data from its phase Ia/1b I.V. STING agonist program to enter a phase II trial.
In a type B meeting, the FDA and Tetra Bio-Pharma Inc., of Ottawa, Ontario, decided the first indication for Tetra’s cannabinoid-based Caumz will be treating cancer cachexia patients who have an incurable and malignant cancer that is refractory to treatment. Cancer cachexia is a multifactorial syndrome defined by an ongoing loss of skeletal muscle mass, with or without loss of fat mass, that cannot be fully reversed by conventional nutritional support and leads to progressive functional impairment. The agreed diagnostic criterion for cachexia was weight loss greater than 5% or weight loss greater than 2% in individuals already showing depletion according to current bodyweight and height (body-mass index <20 kg/m2) or skeletal muscle mass (sarcopenia). The FDA confirmed that Caumz would be eligible for waivers of some of the standard nonclinical toxicology studies, the company said.
In an agreement with Trianni Inc., of San Francisco, Artizan Biosciences Inc., of New Haven, Conn., will use the Trianni Mouse, a transgenic mouse R&D platform to discover fully human monoclonal antibodies. No financial terms were announced. Trianni specializes in antibody discovery technology. Artizan targets inflammatory disease with microbiota-targeted therapies.
Vir Biotechnology Inc., of San Francisco, and Wuxi Biologics Co. Ltd., of Shanghai, will collaborate to advance and produce human monoclonal antibodies to treat the coronavirus (COVID-19). The companies will work together on the clinical development, manufacturing and commercialization of Vir’s antibodies. Wuxi will conduct cell line development, process and formulation development, and initial manufacturing for clinical development. If the antibodies receive regulatory approvals, Wuxi has the rights to commercialize therapies in greater China, and Vir has the rights to commercialize therapies in all other markets worldwide. No financial details were released.