Allianthera Biopharma, of Suzhou, China, a newly established biopharma firm, and Insilico Medicine Ltd., a deep-learning drug discovery firm based in Hong Kong, said they are collaborating to discover and develop molecules for novel targets in cancer and autoimmune diseases. Terms were not disclosed.
Immunoprecise Antibodies Ltd., of Victoria, British Columbia, said it identified antibody 23-H7, which preclinical data to date show produces protective antiviral effects in SARS-CoV-2 (COVID-19)-infected Syrian hamsters via an uncommon mechanism of action. While 23-H7 is able to perturb the interaction between the receptor binding domain (RBD) and the host receptor ACE2, its epitope is not located on the mutation prone RBD/ACE2 interface, unlike the spike protein regions targeted by current, commercial SARS-CoV-2 therapies. As a result, 23-H7 is anticipated to be less vulnerable to escape mutations within the spike protein/ACE2 binding interface. In vivo results showed, when administered as a passive vaccine, 24 hours prior to infecting Syrian hamsters with the SARS-CoV-2-D614G, 23-H7 resulted in undetectable replication-competent virus titer in the lungs of four of the five animals four days post infection, with the remaining animal showing a replication competent viral titer barely above the lowest level of detection. In vitro analyses revealed that 23-H7 can co-exist on the SARS-CoV-2 spike protein with antibodies from several other epitope families, as well as antibodies directly blocking the RBD/ACE2 interface, and is able to work synergistically when combined with antibodies from other epitope families in (pseudo)virus neutralization assays.
Isotopia Molecule Imaging Ltd., of Petach Tikva, Israel, said it launched a collaboration with Molecular Targeting Technologies Inc., of West Chester, Pa., for the supply of medical radioisotope no-carrier-added 177Lu (n.c.a. 177Lu) to support clinical development of its targeted radiotherapeutic products. 177Lu is a beta-emitting radiopharmaceutical precursor with a half-life of 6.7 days and a maximum energy of 0.5 MeV, corresponding to a maximum soft-tissue penetration of approximately 1 mm from its binding site. It is used in precision oncology for targeted radionuclide therapy.
Istari Oncology Inc., of Durham, N.C., said data published in Nature Communications showed that intratumoral PVSRIPO, via unique activation of antigen-presenting cells (APCs) in the tumor microenvironment, stimulates functional CD8+ T-cell responses capable of mediating effective, systemic antitumor immunity. Previously research has demonstrated the importance of APCs, especially dendritic cells, in stimulating antigen-specific immunity. The current research demonstrates that nonlethal infection of APCs by PVSRIPO triggers a distinctive pattern of robust, sustained type-I/III IFN secretion, with minimal release of unwanted proinflammatory cytokines, due to PVSRIPO’s selective effect on a specific signaling pathway. The result is effective generation of functional antitumor CD8+ T cells. The functionality of those cells was confirmed by methods in which antitumor T cells generated in tumor-bearing mice treated with PVSRIPO could be transferred to untreated tumor-bearing mice, resulting in decreased cancer growth.
Lassen Therapeutics Inc., of San Diego, said it is collaborating with Cedars Sinai Medical Center. The collaboration will study the role of IL-11 signaling and its inhibition in lung fibrosis, particularly idiopathic pulmonary fibrosis, and the potential therapeutic effect of monoclonal antibodies that block that signaling in preclinical models. IL-11, a member of the IL-6 family of cytokines, is a central mediator of fibrosis. Terms of the deal were not disclosed.
Medicenna Therapeutics Corp., of Toronto, presented preclinical data at the virtual Cytokine-Based Cancer Immunotherapies Summit, showing that MDNA-11, a long-acting IL-2 Superkine that preferentially binds the IL-2 beta receptor on immune cells, led to tumor growth inhibition and complete responses in a murine MC38 tumor model, both alone and in combination with PD-1 therapy. Separate data showed the ability of MDNA-413, an IL-13 super-antagonist, to suppress myeloid-derived suppressor cells and M2a polarization of tumor-associated macrophages, which are known to accumulate in the tumor microenvironment and promote cancer growth.
Clinical research organization Open Orphan plc, of London, said subsidiary Hvivo Ltd. opened a COVID-19 characterization study at the Royal Free London NHS Foundation Trust. The first three healthy volunteers completed their quarantine phase with no safety concerns and were discharged from the unit. Follow-up visits and monitoring are expected for up to one year. The virus characterization study will inoculate up to 90 volunteers between the ages of 18 and 30 years to identify the most appropriate dose of the SARS-CoV-2 virus needed to cause COVID-19 infection in a safe and controlled environment.
Pfizer Inc., of New York, said peer-reviewed real-world findings, published online in Breast Cancer Research, showed that first-line therapy with Ibrance (palbociclib) in combination with letrozole was associated with improved progression-free survival of 20.0 months vs. 11.9 months with letrozole alone (p<0.0001) in women with HR-positive, HER2-negative metastatic breast cancer. The analysis was conducted at median follow-up of approximately two years, after balancing for baseline demographic and clinical characteristics. In the retrospective observational analysis, median overall survival was not reached among people in the Ibrance group vs. 43.1 months among those in the letrozole group (p=0.0002). Data for the analysis was collected from the Flatiron Health de-identified longitudinal database, a real-world cohort that includes more than 1,400 women with HR-positive, HER2-negative metastatic disease with any extent of visceral disease.
Preprint findings reported by University of British Columbia researchers showed that a single dose of BNT-162b2, the COVID-19 vaccine from New York-based Pfizer Inc. and Mainz, Germany-based Biontech SE, produces a much weaker antibody response in long-term care residents than it does in younger healthy adults, findings that raise questions about the optimal timing of the second dose of vaccine for older adults. Samples from 18 long-term care residents and 12 health care workers from the same network of long-term care facilities were taken before vaccination and provided a baseline against which the researchers could measure changes after participants received their first dose of vaccine. Not only did the long-term care residents produce lower levels of antibodies than staff members after the first dose, the antibodies they did produce were less adept at blocking the SARS-CoV-2 virus from binding to its target cells.
Pieris Pharmaceuticals Inc., of Boston, said Seagen Inc., of Bothell, Wash, made a strategic equity investment in Pieris as part of an ongoing collaboration between the companies. In addition, the companies entered a clinical trial collaboration agreement to evaluate the safety and efficacy of combining Pieris' cinrebafusp alfa (PRS-343), a 4-1BB/HER2 bispecific candidate, with Seagen's Tukysa (tucatinib), a small-molecule tyrosine kinase HER2 inhibitor, for the treatment of gastric cancer patients expressing lower HER2 levels as part of the upcoming phase II study to be conducted by Pieris. The companies have also amended their existing immuno-oncology collaboration agreement around joint development and commercial rights for the second of up to three products in the alliance. Under the amended and restated agreement, Pieris' option to co-develop and co-commercialize the second of three programs in the collaboration has been amended to provide it with a co-promotion option in the U.S., with Seagen solely responsible for the development and overall commercialization of that program. Under the co-promotion option, Pieris will also be entitled to increased royalties from that program in the event that it chooses to exercise the option. In connection with the amendment, on March 24, 2021, in a private placement transaction, Seagen made an equity investment of $13 million in Pieris through the purchase of about 3.7 million newly issued shares of Pieris common stock at a price of $3.51 per share.
Redhill Biopharma Inc., of Tel Aviv, Israel, Astrazeneca AB and Astrazeneca Pharmaceuticals LP, part of Cambridge, U.K.-based Astrazeneca plc, and Nektar Therapeutics Inc., of San Francisco, said they entered a settlement and license agreement with MSN Pharmaceuticals Inc. and MSN Laboratories Pvt. Ltd., resolving their patent litigation in the U.S. in response to MSN’s ANDA seeking approval by the FDA to market a generic version of Movantik (naloxegol). Under the terms of the settlement agreement, MSN may not sell a generic version of Movantik in the U.S. until Oct. 1, 2030, (subject to U.S. FDA approval) or earlier under certain circumstances.
Russian Direct Investment Fund, of Moscow, and the Institute of Virology, Vaccines and Sera Torlak said they inked a deal to produce the COVID-19 vaccine Sputnik V in Serbia, which will become the first country in southern Europe to produce the vaccine. The vaccine could be exported to other countries of the region at a later stage. Production of Sputnik V is due to start by May 2021 at facilities of the Torlak Institute, Serbia’s national vaccine producer supplying health care institutions in the country with vaccines for the compulsory immunization program.
Twist Bioscience Corp., of South San Francisco, said it signed a partnership agreement with Kyowa Kirin Pharmaceutical Research Inc., a subsidiary of Kyowa Kirin Co. Ltd., of Tokyo, to discover antibodies for therapeutic use against an undisclosed G protein-coupled receptor (GPCR) target molecule. Under the terms, Twist Biopharma, a division of Twist Bioscience, will leverage its “Library of Libraries” for biologics discovery and its discovery capabilities to discover novel GPCR target specific antibodies for Kyowa Kirin. Twist received an up-front payment upon signing, and Kyowa Kirin retains an option to obtain development and commercial rights to any antibodies resulting from the agreement.