Agex Therapeutics Inc., of Alameda, Calif., and Lineage Cell Therapeutics Inc., of Carlsbad, Calif., and ES Cell International Pte Ltd. (ESI), a subsidiary of Lineage, said they broadened their collaborative relationship with regard to ESI stem cell lines. ESI cell lines are cGMP-compatible, registered with the NIH, and widely studied as a potential source for the industrial-scale manufacture of any cell type in the human body. Neither party made nor received any cash payments in connection with the arrangement. Lineage has acquired exclusivity for the use of ESI cell lines in spinal cord injury and certain oncology indications, and Agex said it has gained greater flexibility and independence to support its efforts toward licensing certain technologies and cell lines to third parties.
Ascletis Pharma Inc., of Shanghai, through its Gannex subsidiary, and Galmed Pharmaceuticals Ltd., of Tel-Aviv, Israel, disclosed a research agreement aiming at a combination therapy, comprising Ascletis’ ASC-41, a THR-beta agonist, and Galmed’s Aramchol (arachidyl amido cholanoic acid), an SCD 1 inhibitor, for the treatment of nonalcoholic steatohepatitis. The financial details were not disclosed.
Asia Green Biotechnology Corp., of Calgary, Alberta, signed an agreement with Pathway Rx Inc., of Lethbridge, Alberta, and PNW Biosciences Inc. in which the three companies have determined to act collaboratively to affect the clinical development and commercialization of the Cannabis sativa varieties for prevention and for treatment of COVID-19 and other infectious diseases to which Pathway Rx owns the rights. Asia Green and PNW have previously entered licensing agreements with Pathway to assist Pathway in studying those varieties and possibly other versions of the strains for their efficacy in humans and to eventually seek approval of those products as new drugs and as over-the-counter health products
Atomwise Inc., of San Francisco, and GC Pharma, formerly known as Green Cross Corp., of Yongin, South Korea, said they will collaborate to develop hemophilia therapies. The companies said they will explore potential targets with the goal of developing an orally administrable drug. Targets will be virtually screened for small molecules using Atomwise’s artificial intelligence platform, which can screen 16 billion compounds for potential hits in less than two days.
Berg LLC, of Framingham, Mass., disclosed results of a COVID-19 study, which identifies a genetic factor that might in part account for the prevalence of the disease in African American populations and offers insight into the use of existing ACE inhibitors and angiotensin receptor blockers to manage serious clinical symptoms. The study, titled "Ethnic Prevalence of Angiotensin Converting Enzyme Deletion (D) Polymorphism and COVID-19 Risk: Rationale for use of Angiotensin Converting Enzyme Inhibitors/Angiotensin Receptor Blockers," was done in collaboration with scientists from Oxford and Virginia Commonwealth University. It was published in the Journal of Racial and Ethnic Health Disparities.
Caladrius Biosciences Inc., of Basking Ridge, N.J., received trademark registration from the Japan Patent Office (JPO) for the company’s use of Honedra as the brand name for CLBS-12, its Sakigake-designated product candidate for the treatment of critical limb ischemia and Buerger’s disease. Also, the JPO awarded Caladrius a new patent, the fourth granted in Japan to Caladrius for its CD34+ cellular therapy technology.
China SXT Pharmaceuticals Inc., of Taizhou, said it was notified by Nasdaq of a 180-day extension, or until March 8, 2021, to regain compliance with the market’s minimum $1 bid price requirement.
Chromadex Corp., of Los Angeles, disclosed preclinical research published in Investigative Ophthalmology & Visual Science finding that Niagen (nicotinamide riboside) prevented light-induced retinal damage in mice. That research paves the way for future preclinical and clinical studies exploring the relationship between NAD+ levels and preservation of long-term ocular health, the company said. The study was led by an investigator at Emory University and the Atlanta VA Center for Visual and Neurocognitive Rehabilitation.
Cleave Therapeutics Inc., of San Francisco, signed a preclinical research collaboration with Jazz Pharmaceuticals plc, of Dublin. Cleave will conduct preclinical research studies evaluating CB-5339, its second-generation, small-molecule VCP/p97 inhibitor, in combination with Jazz’s Vyxeos (daunorubicin, cytarabine) liposome for injection, approved in the U.S. and Europe for newly diagnosed therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes. CB-5339 plays a key role in DNA damage repair and has demonstrated preclinical activity and synergy in combination with DNA-damaging agents, Cleave said.
Datavant Inc., of San Francisco, disclosed two agreements with Johnson & Johnson, of New Brunswick, N.J., through the latter’s Janssen Research & Development LLC, to help link multiple real-world and clinical data sources with a goal to accelerate initiatives to build better medicines. Under the first agreement, Janssen gains access to Datavant's privacy-protecting linking technology. Under the second, Janssen will offer guidance and insights to Datavant's strategy in relation to new product and service offerings.
Eveliqure Biotechnologies GmbH, of Vienna, disclosed the award of a contract from the U.S. National Institute of Allergy and Infectious Diseases, with the intent to fund the development of its vaccine candidate, ShigETEC, through phase II testing. The base award is $215,093 with a total contract value of $20.6 million if all contract options are exercised. The options are staged along milestones, covering an IND filing, manufacture of clinical trial material and several human challenge studies to prove the efficacy of the vaccine, which targets Shigella and enterotoxigenic Escherichia coli.
Global Blood Therapeutics Inc., of South San Francisco, and Biopharma-Middle East and Africa, of Dubai, United Arab Emirates, said they will collaborate to distribute Oxbryta (voxelotor) tablets in Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the United Arab Emirates, where there are thought to be more than 100,000 people, ages 12 and older, living with sickle cell disease. Oxbryta is a once-daily, oral therapy that inhibits hemoglobin polymerization, the cause of sickling and destruction of red blood cells. The sickling process causes low hemoglobin due to red blood cell destruction, which impairs adequate oxygen delivery to the tissues and organs. Oxbryta received FDA approval in November 2019 for treating patients 12 and older.
Gigagen Inc., of South San Francisco, said it initiated large-scale manufacturing of its recombinant hyperimmune drug for COVID-19, GIGA-2050, with Waisman Biomanufacturing and Goodwin Biotechnology Inc. Large-scale production of GIGA-2050 will support an IND and phase I studies in COVID-19. The GMP product will be subjected to nonclinical GLP toxicology and pharmacokinetics studies in fall 2020. Gigagen said it expects to reach the clinic in early 2021.
Ibio Inc., of New York, said it has selected IBIO-201, the company’s new subunit vaccine, as its lead candidate for preventing SARS-CoV-2 infection. Ibio said preclinical immunization studies with IBIO-200 and IBIO-201, combined with select adjuvants from the Infectious Disease Research Institute induced anti-SARS-CoV-2 antibodies. Additional data from cell-based pseudovirus neutralization assay testing demonstrated that IBIO-201 induced the production of more anti-spike neutralizing antibodies than IBIO-200 in immunized mice, the company said.
Inveniai LLC, of Guilford, Conn., and Prism Biolab Co. Ltd., of Yokohama, Japan, said they plan to build a pipeline of therapeutic candidates addressing diseases in the gut associated with dysfunction of the gut-brain-axis and inflammasome dysregulation. Inveniai will use its platform to identify and validate relevant targets. Prism will use its platform to design small-molecule candidates against targets validated by Inveniai.
Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, said it has completed the sale of its rights, title and interest in Xermelo (telotristat ethyl) to Tersera Therapeutics LLC, of Lake Forest, Ill. Lexicon received $160.4 million in cash at closing, composed of a $155 million up-front payment and additional payments for inventory and other closing considerations. Lexicon may receive additional milestone payments of up to an aggregate of $65 million for development and commercialization of telotristat ethyl in patients with biliary tract cancer. Additionally, Lexicon will be eligible to receive midteens royalties on net sales of Xermelo in biliary tract cancer. Tersera offered employment to 28 Lexicon employees. Lexicon said it plans to realign its business around its research and development assets, with a focus on its LX-9211 neuropathic pain program, now in phase II development, while reducing its debt by fully repaying a $150 million secured term loan. LX-9211 is an oral, selective small-molecule inhibitor of AAK1.
The University of Sheffield said it launched Modulus Oncology, of Sheffield, U.K., to develop a drug discovered by university scientists targeting pancreatic, relapsed breast and other cancers. With funding from the Wellcome Trust and other grants, the team developed adrenomedullin-2 receptor antagonists designed to block the hormone’s role in tumor growth and metastasis without adversely affecting its role in helping to control blood pressure. The spin-out is in discussions with life science investors for seed and series A investments to fund human proof-of-concept trials, with the goal of entering the clinic within two years.
Monopar Therapeutics Inc., of Wilmette, Ill., and Northstar Medical Radioisotopes LLC, of Tyler, Texas, which are jointly developing urokinase plasminogen activator receptor-targeted radio-immunotherapeutics (uPRITs) to treat severe COVID-19 infection, said they formed a collaboration with the University of Texas Health Science Center at Tyler (UTHSCT) and its Texas Lung Injury Institute. The partnership is designed to evaluate uPRIT candidates in vitro and in vivo to facilitate the selection and IND-enabling development of a candidate that could move into human trials at UTHSCT in people with severe COVID-19 infection.
Nkmax America Inc., of Santa Ana, Calif., which is developing natural killer (NK) cell therapies, said it formed a trial collaboration and supply agreement with Merck KGaA, of Darmstadt, Germany, and Pfizer Inc., of New York, to evaluate the safety and tolerability of SNK-01, its autologous NK cell therapy, in solid tumors in combination with the anti-PD-L1 therapy avelumab (Bavencio), co-developed and co-commercialized by the pharma companies. Nkmax America will sponsor the study by adding a study arm to an existing U.S. phase I trial in refractory solid tumors. Merck and Pfizer agreed to supply avelumab. Under the trial amendment, up to 18 people with solid tumor types refractory to conventional treatment and independent of PD-L1 status will receive SNK-01 plus a checkpoint inhibitor until progression or unacceptable toxicity. Enrollment of that arm is expected to begin in September 2020, with all parties having access to the data.
Ocugen Inc., of Malvern, Pa., said it was notified by Nasdaq of a 180-day extension, or until March 8, 2021, to regain compliance with the market’s minimum $1 bid price requirement.
Otsuka Pharmaceutical Co. Ltd., of Tokyo, said its Astex subsidiary and the University of Texas MD Anderson Cancer Center formed a collaboration aimed at accelerating the clinical evaluation of Astex’s pipeline of products for patients with certain types of leukemia, including myelodysplastic syndromes, chronic myelomonocytic leukemia and acute myeloid leukemia (AML). The pact will combine MD Anderson’s clinical trials infrastructure and expertise with Astex’s clinical pipeline products. The initial focus will be on evaluating Astex’s oral hypomethylating agent, Inqovi (decitabine, cedazuridine), in combinations with other therapies.
PDL Biopharma Inc., of Incline Village, Nev., said it closed the sale of wholly owned subsidiaries Noden Pharma DAC and Noden Pharma USA to Stanley Capital for a transaction value of up to $52.8 million in cash, including a closing payment of $12.7 million and $33 million in 12 equal quarterly installments, plus two potential contingent payments totaling approximately $3.3 million. PDL expects to receive an additional $3.9 million in four equal quarterly installments due primarily to incremental cash accumulated in the business since the deal was reached on July 31, 2020.
Pfizer Inc., of New York, and Biontech SE, of Mainz, Germany, reported preliminary preclinical data from their BNT-162b2 mRNA-based vaccine program against SARS-CoV-2. In a nonhuman primate study, immunization with the nucleoside-modified messenger RNA, or modRNA, candidate protected rhesus macaques against SARS-CoV-2 infection. In a viral infection model, macaques that received two injections with 100 µg BNT-162b2 and those that received saline control injections were challenged 55 days after the second immunization with a viral inoculum of approximately 1 million plaque-forming units of SARS-CoV-2 via intranasal and intratracheal routes. Following immunization with the study vaccine, no viral RNA was detected in the lower respiratory tract of the animals, while evidence of viral RNA remained in most non-immunized animals. BNT-162b2 induced SARS-CoV-2 neutralizing antibodies along with viral antigen-specific CD4+ and CD8+ T cells in the vaccinated-macaques. Almost no IL-4 producing CD4+ cells were detectable, indicating a TH1-biased response. In a preclinical mouse model, a single intramuscular immunization of BNT-162b2 (0.2, 1 or 5 µg) generated B- and T-cell immune responses in BALB/c mice, and SARS-CoV-2 pseudovirus neutralizing activity increased steadily to day 28, the last day for which titers were reported. CD4+ and CD8+ T cells from splenocytes isolated from BNT-162b2-immunized mice were positive for IFN-gamma and IL-2, producing high levels of TH1 cytokines but minute amounts of TH2 cytokines, also suggesting a TH1-biased T-cell adaptive immune response. The manuscript describing the preclinical data is undergoing scientific peer review and available in preprint at Biorxiv. Separately, the companies said they concluded exploratory talks with the European Commission (EC) for a proposed supply of 200 million doses of the vaccine candidate to EU member states, with an option for 100 million additional doses, paving the way to begin contract negotiations. Deliveries would start by year-end 2020, subject to clinical success and regulatory authorization for BNT-162b2. Doses for Europe would be produced in Biontech’s German manufacturing sites and in Pfizer’s manufacturing site in Belgium, with the EC leading the process to allocate the vaccine among EU member states.
Presage Biosciences Inc., of Seattle, said it formed a research collaboration with Takeda Pharmaceutical Co. Ltd., of Tokyo, involving the use of its comparative in vivo oncology, or CIVO, intratumoral microdosing platform to evaluate multiple oncology candidates and combinations in phase 0 trials. The agreement, which includes evaluation of a specified investigational agent and options for additional projects over several years, called for undisclosed up-front and milestone payments to Presage.
Redx Pharma plc, of Alderley Park, U.K., said it formed a research collaboration with Jazz Pharmaceuticals plc, of Dublin, to discover and develop drug candidates for two cancer targets on the Ras/Raf/MAP kinase pathway, with Redx assuming responsibility for research and preclinical development activities up to IND submission. Redx is set to receive an up-front payment of $10 million, followed by an additional $10 million in year two, provided research work continues. Following delivery of an IND-ready molecule, Redx is eligible for up to $200 million in development, regulatory and commercial milestone payments for each program, along with tiered royalties in the mid-single digits. In exchange, Jazz will own intellectual property to the assets and, following IND submission, will oversee development, manufacturing, regulatory activities and commercialization. The research pact follows the 2019 sale of Redx’s preclinical pan-RAF inhibitor program to Jazz to treat RAF and RAS mutant tumors, with a pan-RAF collaboration between the companies ongoing.
Tscan Therapeutics Inc., of Waltham, Mass., said it plans to file two IND applications in 2021 in its liquid tumor program. The first candidate, the HLA antigen modulator TSC-100, will be used to engineer donor T cells to prevent relapse in HA-1-positive patients with acute myeloid leukemia, myelodysplastic syndromes or adult acute lymphoblastic leukemia undergoing hematopoietic stem cell transplant therapy. A second T-cell receptor (TCR)-engineered therapy, TSC-101, is targeting similar treatment of individuals who express HA-2. In April 2020, Novartis AG, of Basel, Switzerland, tapped the company to discover and develop TCR-engineered T-cell therapies for up to three solid tumor targets.
Valneva SE, of Saint Herblain, France, said it signed a new contract, lasting up to three years, with the U.S. Department of Defense (DoD) to supply its Japanese encephalitis vaccine, Ixiaro. The new contract spans a total of three years (one base year, plus two option years) with a base-year value of $61 million. The DoD has the option to purchase a total of $76 million to $105 million worth of Ixiaro across the two option years. Deliveries for the base-year will commence in the fourth quarter of 2020.
Versatope Therapeutics Inc., of Lowell, Mass., said it was awarded a phase I Small Business and Innovation Award from the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. NIH to develop a vaccine to prevent Clostridioides difficile and to protect against recurring disease using exosome-like bacterial vesicles. The funding will support early stage manufacturing, stability and preclinical studies. The grant amount was not disclosed, but in 2019 Versatope landed a $17.9M NIAID grant for its universal flu vaccine program.