Acorda Therapeutics Inc., of Ardsley, N.Y., stands to collect a $15 million milestone payment from Cambridge, Mass.-based Biogen Inc. as a result of Biogen’s ex-U.S. net sales of Fampyra (dalfampridine) exceeding $100 million over the four consecutive quarters ending with the third quarter of 2020. The drug is approved for walking impairment in adults with multiple sclerosis. Shares of Acorda (NASDAQ:ACOR) closed Oct. 20 at 96 cents, up 27 cents, or 39%.
Affimed NV, of Heidelberg, Germany, and Nkmax America Inc., of Santa Ana, Calif., signed a clinical collaboration agreement to investigate the combination of AFM-24, a CD16A/EGFR-targeted innate cell engager, with the autologous NK cell product SNK-01. The companies plan to explore the combination in a first-in-human proof-of-concept trial in patients with EGFR-expressing tumors. The agreement follows a previous collaboration between the two companies in the preclinical setting to better understand the combined activity of their respective platforms.
Atriva Therapeutics GmbH, of Tubingen, Germany, and the European Investment Bank (EIB) concluded a €24 million (US$28.3 million) financing agreement Oct. 20 to enable the company’s development and clinical testing of a novel therapy treating severe respiratory infections with RNA viruses. Atriva’s ATR-002, an oral small molecule, has been proven to block the viral propagation of SARS-CoV-2 in preclinical trials, the company noted, and the drug could become a much-needed therapeutic option for patients with moderate to severe COVID-19 symptoms who require hospitalization.
Baudax Bio Inc., of Malvern, Pa., provided an update on the launch of its pain drug, Anjeso (meloxicam). More than 50 institutions have added Anjeso to their formularies. The average order size has increased 75% since the launch. Also, effective Oct. 19, the company entered exchange agreements with holders of its short dated (13 months) series B warrants and long dated (five year) series A warrants providing for the immediate exchange of 0.2 shares of common stock per warrant, for either all series A warrants or series B warrants held by each holder, at the holder’s election.
New preclinical data from Chelation Partners Inc., of Halifax, Nova Scotia, show that its anti-infective, iron-binding polymer, DIBI, reduced leukocyte adhesion, improved capillary blood flow and decreased key plasma cytokines levels, which are markers of efficacy in sepsis. The model showed DIBI improved survival of infected mice and improved survival when used in combination with the antibiotic imipenem. The data also showed seven-day survivors treated with two doses of DIBI and imipenem were completely free of systemic infection. DIBI is also being developed as a daily I.V. therapy for hospitalized COVID-19 patients, to be administered early to suppress progression of dysregulated inflammatory response, acute respiratory distress syndrome and secondary infections.
The Henry M. Jackson Foundation for the Advancement of Military Medicine Inc. (HJF) and Citranvi Biosciences LLC, of Chapel Hill, N.C., said they inked an exclusive licensing agreement to develop vaccine technologies to prevent cytomegalovirus and Epstein-Barr virus infections. The licensed technology can be used to produce recombinant proteins in multimeric form, increasing the ability of the vaccines to generate protective antibodies. Foundational research was conducted by DoD researchers at the Uniformed Services University of the Health Sciences (USU) and patented by HJF under the USU-HJF joint office of technology transfer. Financial terms were not disclosed.
CNS Pharmaceuticals Inc., of Houston, said the company's U.S. manufacturer, Pharmaceutics International Inc., has completed manufacturing for berubicin, CNS’ lead drug candidate for treating glioblastoma multiforme. CNS said it implemented a dual-track drug product manufacturing strategy to mitigate COVID-19-related delay risks, diversify its supply chain and provide for localized availability of berubicin. The company engaged two manufacturers for berubicin on different continents. In Italy, it engaged BSP Pharmaceuticals SpA, which expects to complete manufacturing before 2020 ends.
New data from Gigagen Inc., of South San Francisco, detailed the technical foundation of its approach for the affinity maturation of monoclonal antibodies discovered via its leading single-cell microfluidic technology platform. Affinity maturation is commonly used for antibody optimization when developing new drugs. The company is leveraging the platform to develop monoclonal antibodies with binding and affinity profiles against selected oncology targets. The company’s antibody affinity maturation approach includes a mutagenesis strategy, which enables combinatorial mutagenesis of individual amino acids in handpicked regions of a target gene, which can be leveraged to generate proteins with enhanced functionalities.
Hikma Pharmaceuticals plc and Arecor Ltd., both of London, said they inked an exclusive agreement to co-develop a ready-to-administer injectable medicine in the U.S. through Hikma's affiliate, Hikma Pharmaceuticals USA Inc. The agreement extends a co-development agreement the companies formed in January 2020. The additional candidate is in development using Arecor's drug formulation technology platform, Arestat, which is designed to enhance the properties of existing therapeutic proteins and peptides. Hikma plans to seek approval for the candidate under the FDA’s 505(b)(2) regulatory pathway, with a filing expected in 2023. Under terms of the royalty-based agreement, Arecor is set to receive an up-front payment and additional payments based on development, regulatory and commercial milestones, with Hikma assuming responsibility for manufacturing and commercialization.
Immunic Inc., of New York, and the European Investment Bank signed a €24.5 million (US$28.99 million) financing agreement to support Immunic's ongoing phase II CALVID-1 trial of its lead asset, IMU-838, in patients with moderate COVID-19. The financing is also intended to support expansion of the CALVID-1 trial into a confirmatory phase III trial and the commercial-scale manufacturing for IMU-838. Immunic AG, the German subsidiary of Immunic, will receive the loan in three tranches upon completion of predefined milestones. IMU-838 is a selective immune modulator for inhibiting intracellular metabolism of activated immune cells by blocking the enzyme DHODH and exhibits a host-based antiviral effect.
Focus Fund GP LLC, of Shreveport, La., and The University of Texas MD Anderson Cancer Center have launched Cancer Focus Fund LP, an oncology-focused investment fund to support advancement of investigational cancer therapies from late preclinical development through phase I and phase Ib/II trials by small to midsize biopharmaceutical companies.
Molecular diagnostics firm Incelldx Inc., of San Carlos, Calif., said it will collaborate on a phase I SARS-CoV2 trial assessing maraviroc (Selzentry, Viiv Health Care Inc. and Pfizer Inc./Celsentri, Viiv Healthcare Inc. and Pfizer Inc.) in hospitalized individuals diagnosed with the coronavirus. The trial is seeking to establish whether one-week treatment with the CCR5 antagonist at its approved dosage to treat HIV is safe and tolerable in people infected with SARS-CoV-2. Incelldx is set to perform a maraviroc-specific CCR5 receptor occupancy assay using its Incellkine Ruo Cytokine Storm quantification panel.
Intrommune LLC, of New York, said it expanded its partnership with the integrated research organization Circuit Clinical, also of New York, which will oversee development of Intrommune’s lead candidate, INT-301, through the IND process and a phase Ib study expected to begin in the fourth quarter of 2020. INT-301 is an immunomodulator in development to treat peanut allergies using a toothpaste delivery system.
During a presentation at the American Association for Cancer Research virtual special conference on tumor immunology and immunotherapy, Kineta Inc., of Seattle, presented preclinical data showing that its anti-VISTA antibodies carry unique sequences, with the selected lead candidates exhibiting potencies in the subnanomolar range. The data also suggested the human anti-VISTA antibodies are specific and cross-react with cyno-VISTA but not mouse-VISTA. In CT26 tumor models, a VISTA antagonist induced antitumor response as a monotherapy and in combination therapies with anti-PD-L1 or anti-CTLA4 agents.
Medigene AG, of Planegg, Germany, said it concluded a service agreement with Cytovant Sciences HK Ltd., a unit of Roivant Sciences Ltd., of Basel, Switzerland, to support process development activities for the manufacturing of dendritic cell (DC) vaccines. The pact extends Medigene's license and cooperation agreements with Roivant/Cytovant covering three T-cell receptor projects and Medigene's DC vaccine program targeting WT-1 and PRAME in acute myeloid leukemia for greater China, South Korea and Japan. Under the service agreement, Medigene will use its expertise to support Roivant/Cytovant in establishing processes to manufacture the DC vaccine and to advance these processes toward automated manufacturing. Financial terms were not disclosed.
Mindset Pharma Inc., of Toronto, said it began confirmatory in vivo studies with Intervivo Solutions Inc., also of Toronto, to assess the efficacy, safety and pharmacological properties of Mindset's portfolio of patent-pending psychedelic drug candidates, with the goal of selecting one or more lead candidates to advance to proof-of-concept trials.
Nascent Biotech Inc., of San Diego, said it received initial COVID-19 in vitro results from its collaboration with Syracuse University showing that pritumumab blocked viral entry into cells. Based on the findings, the vimentin modulator will be advanced to laboratory-based animal studies.
Nevakar Inc., of Bridgewater, N.J., and Zhaoke Ophthalmology Pharmaceutical Ltd. (ZKO), of Hong Kong, said they formed an exclusive licensing agreement to develop and commercialize NVK-002 in greater China, South Korea and Southeast Asian territories. ZKO agreed to develop and obtain regulatory approval for NVK-002 in the contractual territory, where ZKO will manufacture, launch, distribute and support the product’s commercialization. Nevakar is entitled to receive up to $102 million in regulatory and sales milestone payments and tiered sales-based royalties on net sales in the contractual territory. NVK-002, a topical ophthalmic solution, is in phase III development to slow the progression of myopia in children.
Organicell Regenerative Medicine Inc., of Miami, said it inked an agreement with Regenerative Care Network to collaborate on clinical research projects investigating use of Organicell’s lead therapeutic, Zofin, to treat heart failure with preserved ejection fraction. The partners are expected to conduct trials of the acellular biologic therapeutic at medical institutions in Dallas and Houston following the filing and approval of an IND application by the FDA and institutional review board approval of the planned study.
Oric Pharmaceuticals Inc., of South San Francisco, said it inked an exclusive license agreement with privately held Voronoi Inc., of Incheon, South Korea, securing global rights outside the People’s Republic of China, Hong Kong, Macau and Taiwan to develop and commercialize ORIC-114, a preclinical epidermal growth factor receptor and human epidermal growth factor receptor 2 inhibitor with potency against exon 20 insertion mutations. Oric made a one-time payment to Voronoi of $5 million in cash and $8 million in Oric common shares (NASDAQ:ORIC), based on a price of $28.24 per share, which represented a premium of 25% to the 30-day trailing volume-weighted average trading price of the stock. Oric agreed to make additional payments of up to $111 million for development and regulatory milestones and up to $225 million for sales milestones for the first licensed product. If Oric pursues a second licensed product, it stands to make additional milestone payments of up to $272 million. Voronoi also is eligible for tiered mid-single- to low double-digit royalties on net sales in Oric’s territory. Oric assumed responsibility for development activities and expenses in the licensed territory and expects to initiate a global phase I/II tumor-agnostic trial in genetically defined cancers during the second half of 2021. On Oct. 20 Oric shares gained 82 cents to close at $25.08.
Parexel International Corp., of Waltham, Mass., said that its biotech division formed a strategic collaboration with Synairgen plc, of Southampton, U.K., to conduct a pivotal phase III study of SNG-001, an inhaled formulation of IFN-beta-1a, to treat people hospitalized with COVID-19. The double-blind, placebo-controlled trial is expected to enroll 900 participants across approximately 20 countries.
Proteonic BV, of Leiden, the Netherlands, said it licensed its 2G Unic technology for boosting therapeutic protein production to Immunomedics Inc., of Morris Plains, N.J. Under the agreement, Immunomedics gains commercial rights for application of the technology platform to develop specified proprietary products from mammalian cells. Financial details of the agreement were not disclosed.
Revive Therapeutics Ltd., of Toronto, said it signed a supply agreement with Havn Life Sciences Inc., of Vancouver, British Columbia, to source naturally derived psychedelic compounds, such as psilocybin, for use in future IND-enabling studies and clinical trials under FDA guidelines.
Samsung Biologics Co. Ltd., of Incheon, South Korea, said it partnered with Dinona Inc., also of South Korea, which further expands its CDO capabilities to provide a full scope of its development services from cell line development, process development, to nonclinical and clinical material manufacturing. Under the agreement, Samsung and Dinona will collaborate for fast track development of DNP-019, a potential COVID-19 antibody therapy.
The Cystic Fibrosis Foundation expanded its research collaboration with Synspira Therapeutics Inc., of Framingham, Mass., committing up to $14 million in additional funding to develop a non-porcine enzyme replacement therapy and a novel treatment to help fight drug-resistant infections. The new funding will be used to advance preclinical development and early stage clinical trials for Synspira’s non-porcine enzyme replacement therapy, SNSP-003. If successful, the enzyme therapy could offer a more effective alternative to people with cystic fibrosis who struggle with digestion, the company said.
Tetra Bio-Pharma Inc., of Ottawa, reported preclinical results of cannabinoid-based therapy ARDS-003 in a model of lung injury, demonstrating an anti-inflammatory effect in induced pulmonary fibrosis (IPF). To date, no animal model of COVID-19 has been established, so models of inflammation-driven respiratory conditions leading to pulmonary fibrosis are currently being used to evaluate the effectiveness of treatments to mitigate the organ disfunction seen in COVID-19. Administration of ARDS-003 to animals in which lung tissue has been inflamed, using the bleomycin-induced IPF model, showed the drug was able to reduce the levels of key inflammatory cytokine markers, such as IL-6. That anti-inflammatory effect was reflected in reduced fibrosis when the lung tissue was analyzed after 20 days of treatment. ARDS-003 was further studied using models of inflammation in human lung cells and was similarly found to reduce the effects of fibrosis-associated inflammatory pathways. Tetra plans to submit an application to begin phase I testing.
Tscan Therapeutics Inc., of Waltham, Mass., said research was published in Immunity using the company’s target discovery platform, T-Scan, to identify precise epitope targets in the SARS-CoV-2 virus that are recognized by the T cells of convalescent patients. Researchers found that T cells typically recognize between three and eight targets in coronavirus that are shared among patients with the same human leukocyte antigen (HLA) type. Most of those targets were not located in the Spike protein, a concerning finding as current vaccine development efforts are focused on eliciting an antibody response to the Spike protein. The findings highlight the potential need for second-generation vaccines that incorporate those targets, given T cells play an important role in mediating long-term immunity to the virus, as well as the development of T-cell based diagnostics and T-cell therapies, the company said. The Tscan study also showed that patients’ T cells do not cross-react with seasonal coronaviruses that cause the common cold, decreasing the likelihood that prior exposure to those viruses confers immunity to COVID-19.
Vifor Pharma Group, of St. Gallen, Switzerland, and Cara Therapeutics Inc., of Stamford, Conn., said they signed a license agreement for commercialization of Korsuva (difelikefalin) injection for the treatment of chronic kidney disease-associated pruritus in the U.S. dialysis market for non-Fresenius Medical Care clinics under a Cara 60%, Vifor Pharma 40% profit-sharing arrangement. Under the terms, Cara will receive an up-front payment of $100 million in cash and an equity investment of $50 million. In addition, Cara will be eligible to receive an equity investment upon U.S. regulatory approval of I.V. Korsuva, as well as milestone payments dependent on achieving commercial targets, which together could total up to $290 million.