4D Pharma plc, of Leeds, U.K., and Longevity Acquisition Corp., a special purpose acquisition company based in Shanghai, will merge. The deal is worth up to $37.6 million to 4D. 4D said it plans to launch a new Nasdaq-listed American depositary shares program under the ticker symbol LBPS and be admitted to trading upon completion. 4D will become dual-listed and ordinary shares will continue to be traded on the Alternative Investment Market under the ticker symbol DDDD. 4D also said it will benefit from $14.6 million cash held by Longevity. 4D’s clinical programs target cancer, including a clinical collaboration with Merck & Co. Inc., of Kenilworth, N.J., along with programs for respiratory diseases, including COVID-19 and asthma, gastrointestinal diseases, preclinical programs targeting neurological diseases such as Parkinson’s disease and autoimmune diseases.
Amyris Inc., of Emeryville, Calif., and the Infectious Disease Research Institute signed collaboration and license agreements to advance a ribonucleic acid vaccine platform, including accelerating development of a COVID-19 vaccine. The collaboration combines the institute’s RNA vaccine platform, including its nanostructured lipid carrier platform, with Amyris's semisynthetic squalene. Amyris will co-own intellectual property developed to create the vaccine, any rights in any combination of institute materials and Amyris squalene, the preclinical and phase I trial data and the clinical study report.
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.
Bioinvent International AB, of Lund, Sweden, said it received a €2 million (US$2.36 million) milestone payment in its collaboration with Daiichi Sankyo Co., of Tokyo, by initiating a phase I trial with an anti-glycoprotein A repetitions predominant (GARP)-directed antibody, DS-1055.
Biovaxys Technology Corp., of Vancouver, British Columbia, said it entered a research collaboration with Ohio State University covering the company’s preclinical SARS-CoV-2 vaccine candidate, BVX-0320. Researchers from the organizations will study neutralizing antibodies generated by the agent against live SARS-CoV-2 virus.
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.
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.
Contrafect Corp., of Yonkers, N.Y., said it initiated an expanded access program to provide exebacase, its recombinantly produced lysin, for use in treating persistent bacteremia caused by methicillin-resistant Staphylococcus aureus (MRSA). The company is providing access under a treatment protocol available to clinical sites participating in the ongoing phase III study, which enables physicians to use exebacase to treat severely ill COVID-19 patients with persistent MRSA bacteremia, despite treatment with standard-of-care antibiotics.
Curevac NV, of Tubingen, Germany, disclosed data from preclinical studies of its investigational COVID-19 vaccine candidate, CVnCoV, in mice and hamsters. The vaccine candidate elicited balanced humoral and cellular immune responses, featuring high antibody titers and very good T-cell activation. It also induced favorable Th1 cytokine levels.
Entos Pharmaceuticals Inc., of Edmonton, Alberta, said it is receiving advisory services and funding of up to CA$5 million (US$3.8 million) from the National Research Council of Canada Industrial Research Assistance Program to support development of domestic COVID-19 vaccine candidates. Entos is developing a Fusogenix DNA vaccine called Covigenix that in preclinical studies has induced a strong neutralizing antibody response plus a potent and balanced T-cell response against SARS-CoV-2. The Canadian government support will help progress the vaccine research to phase I testing.
Geovax Labs Inc., of Atlanta, said it concluded a patent and biological materials license agreement with the National Institute of Allergy and Infectious Diseases (NIAID), a unit of the U.S. NIH, supporting development of the company’s vaccine against SARS-CoV-2. The agreement gives Geovax access to NIAID’s patent rights in the stabilized Spike protein and allows the company to use materials and patent rights owned by HHS agencies in combination with its technology to create a modified vaccinia ankara virus-virus like particle, or MVA-VLP, candidate aiming to prime and/or boost the immune system against COVID-19. Geovax also gained nonexclusive rights to develop, manufacture and commercialize a resulting COVID-19 vaccine. Financial terms were not disclosed.
Hemoshear Therapeutics LLC, of Charlottesville, Va., said it entered a research collaboration and service agreement with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan. Under the terms, Hemoshear will receive an up-front payment and funding to develop a new human tissue-based model of a rare liver disease using the company's Reveal-Tx Platform, which combines physiological and computational models of disease to identify novel treatment approaches and select drug candidates in a human-relevant disease context. Hemoshear has an ongoing three-year collaboration with Takeda to discover and develop therapeutics for liver diseases, including nonalcoholic steatohepatitis.
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.
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.
New data from Innocan Pharma Corp., of Herzliya, Israel, and Calgary, Alberta, demonstrated that exosomes have the ability to enhance alveolar fluid clearance and promote epithelial and endothelial recovery through secretion of protective factors. The company also said its data show that the non-psychoactive reagent in cannabis (CBD) can significantly reduce lung damage induced by cytokine storms caused by COVID-19. Innocan is developing CDB-loaded exosomes to treat COIVD-19.
Kamada Ltd., of Rehovot, Israel, will manufacture an investigational COVID-19 plasma-derived immunoglobulin therapy under a supply agreement with Israeli health authorities. Kamada, which is partnered on the development of the therapy with Lucca, Italy-based Kedrion Biopharma SpA, will manufacture the product, to be supplied to the Israeli Ministry of Health, from convalescent plasma collected by the Israeli National Blood Services, a division of Magen David Adom, and additional Israeli medical institutions. The initial order to be supplied in the next few months is sufficient to treat about 500 hospitalized patients. The companies' U.S. clinical development of a plasma-derived IgG product as a potential COVID-19 treatment is expected to begin in early 2021 pending IND acceptance by the FDA.
Medicago Inc., of Quebec City, said it reached an agreement to supply the Canadian government with up to 76 million doses of its COVID-19 vaccine, subject to Health Canada approval. Medicago will also receive CA$173 million (US$131.6 million) in funding support from the government of Canada for its vaccine research and development, and for the construction of its Quebec City manufacturing facility. Medicago announced successful production of coronavirus virus-like particle in March. It initiated preclinical trials with financial support from the government of Quebec and began phase I testing in July. Phase II trials are expected to start in early November, with phase III to begin shortly after, in December.
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.
Medipharm Labs Corp., of Toronto, said its wholly owned subsidiary, Medipharm Labs Australia Pty Ltd., entered a new white-label supply agreement with Sunco Green Pharmaceutical Pty Ltd., marking its 12th supply agreement to bring GMP-certified finished cannabis-based products to the Australian and New Zealand markets.
Nonprofit scientific research organization IAVI and Serum Institute of India Pvt. Ltd., of Pune, India, said they entered an agreement with Merck & Co. Inc., of Kenilworth, N.J., to develop SARS-CoV-2 neutralizing monoclonal antibodies co-invented by IAVI and Scripps Research to address the COVID-19 pandemic. If the cross-reactive SARS-CoV-2 neutralizing antibody candidates being advanced through the partnership are shown to be efficacious in clinical trials, either as a single antibody or a potential combination of both candidates, Merck will lead commercialization in developed countries. Serum Institute will lead global manufacturing as well as commercialization in low- and middle-low-income countries, including India.
Moderna Inc., of Cambridge, Mass., said it concluded a supply agreement with the Ministry of Public Health of Qatar for mRNA-1273, its vaccine candidate against COVID-19.
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.
Neumentum Inc., of Morristown, N.J., said it agreed to an exclusive development and commercialization license for NTM-001 in China with Nuance Biotech Co. Ltd., of Shanghai. The alcohol-free formulation of ketorolac in a pre-mixed bag for continuous 24-hour intravenous infusion is designed to treat moderately severe acute pain requiring analgesia at the opioid level, usually in a postoperative setting. Neumentum expects to receive an up-front payment of $3 million and is eligible for development, regulatory and sales milestone payments of up to $50 million as well as low-double-digit percentage royalty payments on net sales. Neumentum also granted Nuance a nonexclusive option to develop and commercialize NTM-001 in certain Asian Pacific countries and territories outside China.
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.
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.
Peptc Vaccines Ltd., of London, part of Treos Bio Ltd., said preclinical data published in bioRxiv showed peptide vaccine PolyPEPI-SCoV-2, administered with Montanide ISA 51VG adjuvant, was safe in two mouse models and elicited highly specific, TH1-biased CD8+ and CD4+ T-cell responses against all four structural proteins of the SARS-CoV-2 virus. PolyPEPI-SCoV-2 vaccination also induced humoral responses, as measured by total mouse IgG for BALB/c and human IgG for CD34+ humanized mouse models. Binding antibodies can act in cooperation with the vaccine-induced CD8+ killer T cells against viral reservoirs to help rapid viral clearance. The study also showed that PolyPEPI-SCoV-2 defines natural CD8+ and CD4+ T-cell responses observed in asymptomatic/mild COVID-19 patients one to five months after symptom onset. In tests of blood samples from 17 donors, the PolyPEPI-SCoV-2-specific CD8+ T-cell repertoire used for recovery from COVID-19 was extremely diverse: donors recognized on average seven different vaccine peptides out of nine; 87% of donors had multiple vaccine-specific T cells against three SARS-CoV-2 structural proteins and 53% against all four.
Poseida Therapeutics Inc., of San Diego, and Tscan Therapeutics Inc., of Waltham, Mass., said they formed a research collaboration and license agreement to explore development of T-cell receptor (TCR)-T-cell therapies to treat COVID-19. The alliance will combine Poseida’s allogeneic T-cell platform and Tscan's immunodominant epitopes and TCR sequences for the development and commercialization of allogeneic TCR-T-cell therapies. The agreement gives Poseida access to Tscan's data and intellectual property related to TCR sequences and targets of potential value to treat COVID-19. Tscan will provide TCR expertise and additional guidance. Financial terms were not disclosed.
Precision Nanosystems Inc. (PNI), of Vancouver, British Columbia, said it received a commitment of up to CA$18.2 million (US$13.8 million) in support from the Canadian government under the Innovation, Science and Economic Development's Strategic Innovation Fund to develop a COVID-19 vaccine. PNI will use the investment to advance a COVID-19 mRNA vaccine candidate to clinical trials.
PTC Therapeutics Inc., of South Plainfield, N.J., said Chugai Pharmaceutical Co. Ltd., a member of the Roche Group, of Basel, Switzerland, filed an NDA for Evrysdi (risdiplam) for spinal muscular atrophy in Japan, triggering a $7.5 million milestone payment to PTC from Roche.
Resverlogix Corp., of Calgary, Alberta, said its late-stage candidate, apabetalone, was featured in an article in Medicine in Drug Discovery that highlighted the link between BET proteins and COVID-19. The paper noted that the two most frequently mentioned causes of multi-organ damage produced by SARS-CoV-2 are direct viral toxicity and cytokine-release syndrome, with damage involving organs and systems where apabetalone previously showed clinical benefits. As a direct inhibitor of BET proteins with the potential to counter inflammation, the authors proposed apabetalone as a potential therapeutic with likely efficacy against COVID-19.
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.
SOM Biotech SL, of Barcelona, Spain, said preclinical results presented at IDWeek 2020 demonstrate that eravacycline is a potent inhibitor of the SARS-CoV-2 3CL protease. Eravacycline, a tetracycline-related antibiotic approved for use against gram-negative pathogens, was identified using an AI-based screening technology (SOMAIPRO), that analyzed a database of clinically tested compounds in search of inhibitors of SARS-CoV-2 3CL protease, a viral protein essential for coronavirus infection and replication in host cells. Covalent docking calculations demonstrated that eravacycline establishes a covalent bond with Cys145 in the catalytic domain of the SARS-CoV-2 3CL protease. In vitro experiments confirmed inhibition of the protease with an IC50 in the low micromolar range. Eravacycline also inhibited the infection of SARS-CoV-2 in VeroE6 cells and showed no toxicity when applied alone. The studies also showed the drug can inhibit the 3CL proteases of other related coronaviruses, such as SARS-CoV and MERS-CoV, suggesting that it could be repositioned for the treatment of beta-coronavirus infections. A phase II study is planned for testing in hospitalized COVID-19 patients.
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.
Union Therapeutics A/S, of Hellerup, Denmark, said it added UNI-91103 (intranasal niclosamide) for preventing COVID-19 to its pipeline. The nasal spray will be used in treatment trials combined with Union's inhalation product, UNI-91104, which continues development for treating COVID-19. UNI-91103 has been tested in 44 healthy volunteers without significant safety concerns and is ready for tests in COVID-19 patients as well as subjects at risk of contracting COVID-19, the company said.