RE:RE:AstraZeneca's ADC disappoints - on severe adverse eventsAntibody drug conjugates (ADCs) like Astrazeneca / Daiichi Sankyo's HER2-targeting Enhertu, Gilead's Trodelvy, Roche's Kadcyla, or Seagen's Adcetris/Padcev/Tivdak are smaill-molecule drugs which have FDA black box warnings.
The recently passed Inflation Reduction Act (IRA) takes an unfavorable view on small molecules, which are provided 9 years of FDA market exclusivity, which contrast to biologicals, that are provided 13 years of FDA market exclusivity on approval.
ONCY's pelareorep can be combined with any of the antibodies and conjugate linker to produce a bispecific that is considered a biologic by the FDA, rather than a small molecule, described above, thus providing the pelareorep-antibody-conjugate 13 years of market exclusivity that the newly passed IRA provides.
Also the IRA and the FTC's decision to review large M&A deals (those viewed as anti-competitive and in excess of US$25 Billion} could serve to curtail Pfizer's plans to acquire Seagen for US$43 Billion, and benefit ONCY's putative US$10-$15 Billion acquisition.
https://pubs.rsc.org/en/content/articlelanding/2021/nj/d0nj04134c