Novavax announced its participation in a newly expanded Phase 2 clinical trial called Comparing COVID-19 Vaccine Schedule Combinations - Stage 3, led by the University of Oxford and funded by the UK Vaccines Taskforce and the National Institute for Health Research. Novavax' recombinant nanoparticle COVID-19 vaccine candidate, NVX-CoV2373, is one of the three COVID-19 vaccines that will be studied in adolescents to evaluate the potential for combined regimens that mix vaccines from different manufacturers to achieve immune protection against COVID-19. "Expanding our understanding of how different COVID-19 vaccines can be used to implement flexible vaccine programs across all age groups will be vital to ultimately controlling the pandemic," said Gregory M. Glenn, M.D., President of Research and Development, Novavax. "A mixed vaccination series could offer the potential to maximize the use of existing vaccine supply, increase the total number of individuals who can ultimately be vaccinated and accelerate rapid and equitable access across the globe." Com-COV3 will include at least 360 adolescents 12-16 years of age. Volunteers will receive an authorized vaccine as a first dose and then at least 8 weeks later will receive one of three different vaccines as a second dose. All participants will be randomly allocated at the time of the second dose to receive either a full dose or half dose of the same vaccine given for the first dose, a full dose of the Novavax vaccine or a half dose of a different authorized vaccine. The research will compare the immune system responses from those who receive a heterologous regimen to those who receive a homologous regimen.

Agenus presented final results from the Bal/Zal combination study at the European Society for Medical Oncology Virtual Conference 2021 in an abstract titled Balstilimab in combination with zalifrelimab: final results from a Phase 2 study in patients with recurrent/metastatic cervical cancer... The Phase 2 trial was conducted in 155 patients with recurrent/metastatic cervical cancer which has limited effective treatment options and disproportionately affects younger women. In the 125 evaluable patients, the objective response rate in all patients was 26%, with 9% of patients achieving a complete response, and 17% of patients achieving a partial response. The median duration of response was not reached after a 19.4-month median follow-up. Notably, responses were also observed in the PD-L1 negative and adenocarcinoma populations, with 9% of both patient groups achieving an ORR. Based on these observations, we predict more than half of the patients to be alive beyond 12 months. The Bal/Zal combination continued to show no unexpected toxicities and no new safety signals were identified. Steven O'Day, MD, Chief Medical Officer of Agenus, stated: "With a median follow-up of almost 2 years, the Bal/Zal combination showed high response rates, durable clinical activity, and promising overall survival results. Furthermore, later this year we expect to present new data on our next-generation CTLA-4 inhibitor AGEN1181, which we expect to further define the positive role this combination strategy could have in addressing unmet needs for cancer patients."

Coherus Biosciences and Shanghai Junshi Biosciences announced positive interim results from the pivotal study "JUPITER-06," a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab in combination with chemotherapy as a first-line therapy for patients with advanced or metastatic esophageal squamous cell carcinoma. The study met the co-primary endpoints with statistically significant and clinically meaningful improvements in progression free survival and overall survival for patients treated with the toripalimab and chemotherapy combination compared to chemotherapy alone. The results will be summarized by Dr. Feng Wang, Professor at Sun Yat-sen University Cancer Center, Guangzhou, in a mini-oral session during the ESMO Congress 2021 on Friday, September 17, 2021 at 12:05 pm Eastern Time. The abstract is now available on the ESMO website. "The findings of this interim analysis provide strong evidence that the addition of toripalimab to chemotherapy as a first-line treatment for advanced or metastatic ESCC patients has superior PFS and OS than chemotherapy alone," said Dr. Wang. "We look forward to updated analyses of overall survival of the JUPITER-06 study in the future and believe that these results will build a strong argument to support the use of toripalimab in combination with chemotherapy as a new standard first-line treatment in patients with advanced or metastatic ESCC." "A strong and consistent efficacy and safety profile is emerging for toripalimab across multiple tumor types as data read out from pivotal clinical trials in melanoma, nasopharyngeal carcinoma, urothelial cancer, lung cancer and now also esophageal squamous cell carcinoma," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "We believe toripalimab could be a potential new treatment choice where patients truly need better options. We will collaborate with Coherus to advance a BLA supplement for ESCC to make toripalimab available as quickly as possible for these patients in the U.S."

In a regulatory filing, McAfee CFO Venkat Bhamidipati disclosed the sale of 29,630 class A common shares of the company on September 14 at a price of $21.7125 per share.

In a regulatory filing, McAfee president and CEO Peter Leav disclosed the sale of 129,591 class A common shares of the company on September 14 at a price of $21.7125 per share.

ShotSpotter CFO Alan Stewart disclosed in a filing that he had purchased 5,000 shares of company stock at $34.74 per share between September 14 and September 15, for a total transaction value of $173,716.