Boehringer Ingelheim GmbH, of Ingelheim, Germany, said an additional analysis of real-world data confirmed sequential Gilotrif (afatinib) followed by osimertinib provided a median overall survival of nearly four years in U.S.-treated patients with EGFR mutation-positive non-small-cell lung cancer. The afatinib-osimertinib sequence was associated with a combined median time on treatment (time to treatment failure; TTF) of 28.4 months overall. Similar TTF was also observed across several subgroups, including patients with EGFR Del19-positive disease (30.3 months), patients with ECOG PS 0/1 (32.7 months) and in patients 65 and older (34.1 months).
Bristol Myers Squibb Co., of New York, licensed its fourth TriNKET immunotherapy drug candidate from Dragonfly Therapeutics Inc., of Waltham, Mass. Since the original 2017 collaboration focusing on hematology malignancies, the companies have agreed to two additional collaborations across solid tumors and autoimmune disease.
New data from Gigagen Inc., of South San Francisco, highlighted a new class of polyclonal antibody drugs, recombinant hyperimmunes, comprising thousands to tens of thousands of antibodies, the company said. The antibodies are derived from donor B cells and are produced recombinantly at large scale in mammalian cells. For applications such as GIGA-2050 to treat COVID-19, the result is similar to recombinant convalescent serum, which combines the advantages of recombinant antibodies such as purity, consistency and potency, with the advantages of plasma-derived antibodies such as proven efficacy, diversity, polyvalence and in vivo affinity maturation. Gigagen demonstrated consistent production of the GIGA-2050 drug candidate, a mixture of 12,500 anti-coronavirus antibodies and showed greater IgG purity than reference plasma-derived drugs.
Ibio Inc., of New York, said IBIO-201 demonstrated an ability to elicit anti-SARS-CoV-2 immune response in preclinical studies. Anti-SARS-CoV-2 spike titers to IBIO-201 were observed 21 days after immunization. Titers continued to increase over the 42-day study. Distinct, favorable Th1 and Th2 immune profiles were observed. Ten distinct preclinical study arms for the IBIO-201 antigen-adjuvant combinations have been concluded, including combinations delivered via intramuscular and intranasal routes, and datasets are under evaluation, the company said.
Partnering with Monopar Therapeutics Inc., of Wilmette, Ill., and Northstar Medical Radioisotopes LLC, of Beloit, Wis., Isotherapeutics Group LLC, of Arlington, Texas, will develop and manufacture a radio-immuno-therapeutic (RIT) for treating severe COVID-19. Isotherapeutics will modify Monopar’s urokinase plasminogen activator receptor (uPAR)-targeted antibody, MNPR-101, by making conjugates allowing attachment of therapeutic radioisotopes supplied by Northstar to create a platform of uPAR-targeted RIT candidates to be evaluated as treatments for severe COVID-19. Isotherapeutics plans to advance a clinical candidate identified from the platform through GMP manufacturing for Monopar and Northstar to take into first-in-human trials.
Novocellbio Co. Ltd., of Incheon, South Korea, said the autologous NK cell treatment agent NOVO-NK killed the human-derived COVID-19 coronavirus. Monkey kidney cells (VeroE6 cells) infected with the COVID-19 coronavirus (SARS-CoV-2) were treated with NOVO-NK cell and the therapy agent was successful in decreasing COVID-19’s effects in various controlled time periods, and the COVID-19 coronavirus was almost killed within six hours, the company said. NOVO-NK also increases a patient’s immunity, reducing the risk of reinfection arising from viruses’ or cancer cells’ mutation, the company added.
Pharmamar SA, of Madrid, Spain, said it signed a licensing agreement with Istanbul’s Onko Ilac San ve Tic AS to commercialize the marine-derived cancer drug Yondelis (trabectedin) in Turkey. Pharmamar will receive a nondisclosed up-front payment and will be eligible for additional remunerations, including regulatory milestone payments. Pharmamar will retain exclusive production rights of the product and will sell the product to Onko for clinical and commercial use. Trabectedin is provided by Janssen Pharmaceutical NV, a unit of New Brunswick-based Johnson & Johnson, to patients in Turkey for treating soft tissue sarcoma and, through this license, Onko will pursue regulatory approval for the indication of relapsed ovarian cancer. Former product licensee Janssen will continue to commercialize until its marketing authorization is formally transferred to Onko.
Pieris Pharmaceuticals Inc., of Boston, signed a clinical trial collaboration and supply agreement with Eli Lilly and Co., of Indianapolis, to evaluate the safety and efficacy of combining Pieris' PRS-343, a 4-1BB/HER2 bispecific for HER2-positive tumors, with Lilly's Cyramza (ramucirumab), a VEGFR2 antagonist FDA-approved for multiple types of solid tumors, and paclitaxel for the second-line treatment of patients with HER2-positive gastric cancer in a phase II study. Lilly will supply Pieris with ramucirumab for the study as well as collaborate on data from the trial. Pieris is working toward the start of the study later this year.
Secura Bio Inc., of Las Vegas, agreed to purchase the global rights to Copiktra (duvelisib) from Verastem Inc., of Boston, for all oncology indications. Copiktra is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and gamma involved in the signaling that leads to malignant B cells proliferation and cancer. It’s indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma after at least two prior therapies and relapsed or refractory follicular lymphoma after at least two prior systemic therapies. The transaction will be partially funded with a $70 million debt financing led by Athyrium Capital Management LP.