Tracker

Amneal gets FDA approval for generic fluphenazine

Fluphenazine Hydrochloride is the generic version of Prolixin for treatment of schizophrenia. Prolixin was originally marketed by Bristol-Myers Squibb (BMS), but has been discontinued. 

According to IQVIA™, a leading healthcare data and analytics provider, U.S. annual sales for Fluphenazine Hydrochloride Tablets for the 12 months ended May 2020 were approximately $143 million. 

Karyopharm gains on adcom uncertainty for Glaxo candidate

Karyopharm’s Xpovio (selinexor) was approved a year ago, and the company has been investigating the drug in multiple indications, including mid-stage lymphoma and brain cancer. 

Expanded use of selinexor for the treatment of adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy, was approved in June 2020. 

Kiadis licenses pre-clinical K-NK-cell programs to Sanofi, with total potential deal value of €875 million, plus royalties

As part of the agreement, Kiadis will receive a €17.5 million up front payment and will be entitled to receive up to €857.5 million upon Sanofi’s achievement of preclinical, clinical, regulatory and commercial milestones. Kiadis will also receive up to low double-digit royalties based on commercial sales of approved products resulting from this agreement. The total deal will be over $1 billion. 

Natural killer (NK) cells are the human body’s first line of defense against cancer and infections. Antibodies work synergistically with NK cells to kill tumor cells in a process called antibody-dependent cell-mediated cytotoxicity (ADCC). Treatment of multiple myeloma with anti-CD38 antibodies, such as Sanofi’s Sarclisa, deplete the patients’ own NK cells, as natural NK cells also express CD38. Kiadis’ CD38KO K-NK cells are NK cells that have been modified to prevent expression of CD38, and are thus resistant to this effect. Therefore, adjunctive infusion of CD38KO K-NK cells will reinvigorate the natural synergy between NK cells and antibodies to kill tumor cells, optimizing efficacy.

Moderna completes enrollment in ph 2 study of mRNA-1273, ready for ph 3 in 30000 participants

Moderna has finalized the phase 3 study protocol based on feedback from the U.S. FDA. The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants at the 100 µg dose level in the U.S. and is expected to be conducted in collaboration with NIAID, subject to regulatory approval. Moderna has completed manufacture of vaccine required to start the phase 3 study. With the phase 3 dose at 100 μg, the company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021. 

-1273 is an vaccine against *redacted* encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from the VRC. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of -1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the FDA granted -1273 Fast Track designation.