In case you haven't heard, Tessera Therapeutics Inc. is working on techniques to write genes into the genome of patients. Tessera, which was developed in Flagship Pioneering Inc.'s Flagship Labs and became a stand-alone incorporated company two years ago, recently came out of stealth mode to highlight its Gene Writing platform based on mobile genetic elements, such as transposons and retrotransposons.
Multiple sessions at the American Association for Cancer Research Virtual Annual Meeting II covered how COVID-19 is affecting cancer patients, from how clinical trials needed to be modified during the pandemic to how real-world evidence can play a role now and in the future.
At a session of the American Association for Cancer Research Virtual Annual Meeting II, multiple FDA regulators gave presentations on various topics to help drug companies understand the ever-evolving oncology regulation.
Targeted therapy offers an opportunity for personalized medicine that's specific for a patient's tumor, but the hyper-focused treatment creates possibilities for cells to mutate and become resistant to the therapy.
Almost all solid tumors are treated with multiple drugs because the combinations have better efficacy than single-agent treatments. But finding those combinations can be difficult in an ever-growing sea of pair-wise combinations.
Bolstered by the success of CTLA4 and PD-(L)1 antibodies, companies are exploring new targets to encourage the immune system to attack tumors. "While these agents have demonstrated efficacy in a proportion of cancer patients, there clearly is room for improvement to lift the tail of the curve," Michele Teng, associate professor at the QIMR Berghofer Medical Research Institute, told the audience at the clinical trials plenary session of the American Association for Cancer Research Virtual Annual Meeting II, where researchers presented data from a pair of immunotherapies looking to build on the success targeting PD-(L)1.
The pandemic hasn't kept biotechs from going public. In fact, through the first five or so months of the year, the industry has raised more than $3.3 billion through IPOs, more capital than biotechs have raised during the first five months of any of the previous 20 years.
Women, black and Hispanic/Latinx participants were underrepresented in pivotal clinical trials for drugs approved from 2007 to 2017, according to a new report by the Tufts Center for the Study of Drug Development. In the pivotal clinical trials, 44.9% of patients were women. Participants who identified as black or of African descent were the most underrepresented participant group, representing 5.4% of participants in clinical trials.
TG Therapeutics Inc. got a dose of good news when the independent data safety monitoring board recommended that the UNITY-CLL study be stopped early for superior efficacy after an interim analysis showed its umbralisib and ublituximab combination (U2) helped patients with chronic lymphocytic leukemia (CLL).
