Beroni Group, of New York and Sydney, which is working on a solution using nanobody technology for COVID-19, said it signed an agreement with Genscript Biotech Corp., of Piscataway, N.J., to conduct antibody characterization and optimization through humanization and affinity maturation with the objective of increasing the antibody affinity to target the antigen by five- to 10-fold. Genscript will perform a pseudovirus neutralization assay with the candidate antibody, produce and characterize the humanized antibodies and use its Precise Mutagenesis Library and Fast Screening for Expression, Biophysical-Properties and Affinity platform to carry out affinity maturation and purification of the antibodies. The process is expected to take 15 to 18 weeks.
Beyondspring Inc., of New York, said it initiated an expanded access program to enable doctors across the U.S. to use its late-stage asset, plinabulin, to prevent cancer patients’ chemotherapy-induced neutropenia (CIN), both alone and in combination with G-CSFs, the current standard of care, during the COVID-19 pandemic. The first patient was enrolled at Redlands Community Hospital in California on July 28. In response to COVID-19, the National Comprehensive Cancer Network recently updated its treatment guidelines for the prophylaxis of CIN, with the objective of preserving hospital and ER resources for COVID-19 patients and maximizing protection for cancer patients against CIN development.
Cytovia Therapeutics Inc., of New York, said it licensed from Proteonic BV, of Leiden, the Netherlands, its 2G Unic technology for boosting recombinant protein production. Under the terms, Cytovia gains nonexclusive, worldwide commercial rights for application of the technology to the development of a number of its NK Engager multifunctional antibodies. Cytovia said it aims to bring cancer therapeutics to clinical trials starting in 2021.
Fibrogenesis Inc., of Houston, reported preclinical data showing that Pneumoblast with activated monocyte or endothelial cells demonstrated significant inhibition of tissue factor expression. Tissue factor is the key molecule inducing blood clotting in COVID-19 patients. Treatment of activated monocytes with Pneumoblast resulted in a 77% reduction of tissue factor expression as compared to untreated monocytes (p<0.001). The mixture of mesenchymal stem cells with activated monocytes resulted in a 13% inhibition of tissue factor expression (p=0.01). Furthermore, in activated endothelial cells, Pneumoblast decreased expression of tissue factor by 80% (p<0.001), whereas mesenchymal stem cells resulted in a 30% (p=0.01) reduction.
Genecentric Therapeutics Inc., of Durham, N.C., said it entered a research collaboration with Janssen Research & Development LLC, a unit of New Brunswick, N.J.-based Johnson & Johnson, around RNA-based drug response biomarkers for non-muscle invasive bladder cancer. The research will involve the application of Genecentric’s advanced RNA-based molecular profiling platform to elucidate potential signatures of disease progression and drug response to standard-of-care therapy, including the role of genomic alterations in the fibroblast growth factor receptor. Financial terms were not disclosed.
Helix Biopharma Corp., of Richmond Hill, Ontario, said it extended its collaboration agreement with Moffitt Cancer Center for an additional year. To date, the two have developed a new pancreatic adenocarcinoma mouse model suitable for testing the company's lead clinical compound, L-DOS47, alone or in combination with immunotherapies. Preliminary data showing how L-DOS47 may work with immunotherapy were shown in American Association for Cancer Research meeting in 2019. In this next stage, Helix and Moffit intend to build on those early successes and provide additional preclinical support in using L-DOS47 with immunotherapies as clinical support.
Hepion Pharmaceuticals Inc., of Edison, N.J., said a paper published in PLOS One further elucidates antiviral activities of cyclophilin inhibitor CRV-431, its lead candidate, currently in phase IIa testing for nonalcoholic steatohepatitis fibrosis. Data from the study, in which mice were implanted with human hepatocytes and subsequently infected with hepatitis C virus (HC), showed vehicle-treated mice demonstrated HCV replication reaching peak viremia at nine weeks post-infection, while HCV infection was completely abolished in mice given CRV-431. In addition, no viral rebound was observed five months following a single CRV-431 administration, indicating the possibility of the complete suppression of an established viral infection.
Ikena Oncology Inc., of Boston, said results from a preclinical collaboration with Memorial Sloan Kettering Cancer Center, published in Nature Communications, describes the activity of aryl hydrocarbon receptor (AHR) blockade, alone and in combination with anti-PD-1 immunotherapy and further supports the potential of IK-175, Ikena’s internally developed, orally administered, selective AHR antagonist currently in phase I testing. The study, which included use of an Ikena AHR antagonist similar to IK-175, showed that AHR blockade reverses the IDO/TDO-mediated immunosuppression that allows a tumor to evade the immune system and is a key driver of tumor growth and progression. Results also supported a previously undescribed role for AHR signaling in regulatory T cells to modulate tumor-associated macrophages and mediate immune resistance. Work demonstrated that AHR inhibition, in combination with immune checkpoint blockade, led to prolonged survival in tumor-bearing mice when compared to single-agent anti-PD-1 treatment.
Mammoth Biosciences Inc., of South San Francisco, said it exclusively licensed from the University of California at Berkeley a new CRISPR protein family, Casɸ, for research, development and commercialization in all fields. The discovery comes from the labs of Mammoth’s co-founder and CRISPR pioneer Jennifer Doudna at UC Berkeley and Chan Zuckerberg, Biohub investigator, and University of California professor Jill Banfield. Mammoth said the Casɸ family is a set of enzymes that opens up new frontiers due to its properties in many areas that have proved challenging for therapeutic uses of CRISPR so far, such as precision of editing, delivery of the CRISPR protein for in vivo applications, a limited targeting range and simultaneous edits. The discovery of Casɸ and the initial characterization has been published in Science.
Monopar Therapeutics Inc., of Wilmette, Ill., disclosed its plan to develop a test to potentially triage COVID-19 patients into those likely vs. unlikely to progress to severe respiratory failure. The test would use Monopar’s monoclonal antibody, ATN-658, to detect soluble urokinase plasminogen activator receptor (suPAR) in COVID-19 patient plasma. A suPAR test for COVID-19 patients, if successful, could identify those at high risk for severe respiratory failure, facilitating earlier therapeutic interventions or allowing for the staging of patients to an optimal treatment based on their disease characteristics, the company said.
Nicox SA, of Sophia Antipolis, France, said it signed an exclusive license agreement with Itrom Pharmaceutical Group, of Dubai, for the registration and commercialization of Zerviate (cetirizine ophthalmic solution), 0.24% for the treatment of ocular itching associated with allergic conjunctivitis in Gulf and Arab markets, including the Kingdom of Saudi Arabia, the United Arab Emirates and Qatar. Nicox said Itrom will be able to rely on the U.S. NDA to support the regulatory submission for Zerviate and is expected to obtain approvals without the need for further clinical studies. Under the terms, Nicox is eligible to receive 15% royalties on net sales in certain key countries, and 10% in other countries. Nicox will also receive a license fee on signature and may receive a future milestone payment upon product launch.
Novome Biotechnologies Inc., of South San Francisco, said it has taken assignment to certain microbial intellectual property (IP), and has nonexclusively licensed foundational CRISPR/Cas9 IP controlled by Caribou Biosciences Inc., a Berkeley, Calif.-based CRISPR genome editing company, to expand its therapeutic pipeline and platform capabilities. Under the terms of an assignment agreement, Novome acquired ownership of certain IP and preclinical projects related to undisclosed therapeutic areas. Additionally, pursuant to a license agreement, Novome received a nonexclusive license to foundational CRISPR/Cas9 IP controlled by Caribou for genetic modification of bacterial species for administration as therapeutics in humans. Specific terms were not disclosed. Novome will have full control of development, manufacturing and commercialization of any product candidates covered by either the assignment agreement or the license agreement.
PDL Biopharma Inc., of Incline Village, Nev., said it entered a settlement agreement related entities of Defined Diagnostics LLC resolving previously reported litigation relating to loans made to Wellstat Diagnostics by PDL. The loans totaling $44.1 million were made pursuant to a loan agreement between Wellstat Diagnostics and PDL dated August 2013, and the notes were carried on PDL's balance sheet for $51.4 million as of June 30, 2020. Under terms of the settlement, the parties agreed Wellstat would pay an amount of $7.5 million on signing of the agreement and either $5 million by Feb. 10, 2021, and $55 million by July 26, 2021, or $67.5 million by July 26, 2021. Upon payment, PDL will transfer to Wellstat Diagnostics on an "as is" and "where is" basis certain assets currently owned by PDL that were obtained through the company's credit bid in 2017 for the assets of Wellstat Diagnostics. If the Wellstat Parties fail to make payment in full by July 26, 2021, PDL shall be authorized to record and confess judgment against the Wellstat for an amount of $92.5 million or such lesser amount as may be owed under the agreement.
Therapeutics Solution International Inc., of Oceanside, Calif., said it formed Campbell Neurosciences, a new division dedicated to approaching suicide as a biological disorder and developing science-based diagnostic tools and interventions. Campbell Neurosciences, to be headed by Kalina O’Connor, aims to develop a suicide risk score based on science and seeks to develop various therapeutic approaches.