The FDA has approved Amgen’s (NASDAQ:AMGN) expansion of the Kyprolis (carfilzomib) prescribing information to include its use in combination with Darzalex (daratumumab) plus dexamethasone (DKd) in two dosing regimens — once weekly and twice weekly — for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM) who have received one to three previous lines of therapy.
Friday, August 21, 2020
FDA Ad Com Oct. 9 for Alkermes schizophrenia, bipolar disorder med
The FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet virtually on Friday, October 9, to review and discuss Alkermes plc’s (NASDAQ:ALKS) marketing application seeking approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder.
The FDA’s action date is November 15.
ALKS 3831 is a once-daily, oral atypical antipsychotic drug candidate designed to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain.
ScPharma in supply agreement with West Pharma
ScPharmaceuticals (NASDAQ:SCPH) perks 10% premarket after entering into a supply agreement with West Pharmaceutical Services (NYSE:WST), pursuant to which the Company has agreed to purchase the SmartDose drug delivery system developed by West (the Product).
Under the terms of the Agreement, West will provide with 100% of the Company’s requirements for the Product in the U.S.
The Agreement has an initial term of five years, which will renew automatically for successive one-year terms unless SCPH or West provides nine months’ notice of intent not to renew.
Nano-X Imaging prices upsized IPO at $18, trading starts today
Nano-X Imaging (NNOX) has priced its IPO of ~9.2M ordinary shares (from ~5.9M) at $18, the high end of its previously announced range of $16-18.
Underwriters’ over-allotment is an additional ~1.4M shares. Closing date is August 25.
Trading kicks off today.
Pfizer/BioNTech add data on new Covid vax candidate; eye Oct. market application
Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) announce additional Phase 1 safety and immunogenicity data from their ongoing U.S. study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which has advanced into Phase 2/3 evaluation.
In a Phase 1 study in the U.S. that enrolled 195 participants, at 7 days after a second dose of 30μg, BNT162b2 elicited SARS-CoV-2–neutralizing geometric mean titers (GMTs) in younger adults (18-55 years of age) that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV-2 convalescent patients, In older adults (65-85 years of age), the vaccine candidate elicited a neutralizing GMT 1.6 times the GMT of the same panel, demonstrating strong immunogenicity in both groups.
The companies previously announced that BNT162b2-vaccinated human participants displayed a favorable breadth of epitopes recognized in T cell responses specific to the SARS-CoV-2 spike antigen, compared to the BNT162b1 candidate, and that BNT162b2 demonstrated concurrent induction of high magnitude CD4+ and CD8+ T cell responses against the receptor binding domain (RBD) and against the remainder of the spike glycoprotein that is not contained in the BNT162b1 vaccine candidate.
Further, across all populations, BNT162b2 was well-tolerated, with mild-to-moderate fever in fewer than 20% of the participants.
Systemic events after administration of BNT162b2 were milder than those with BNT162b1. Overall, after Dose 1, systemic events reported by participants 65-85 years old who received BNT162b2 were similar to those who received placebo.
After the second 30μg dose of BNT162b2, only 17% of participants 18-55 years old and 8% of participants 65-85 years old reported fever, compared to 75% of 18-55-year-old participants and 33% of 65-85-year-old participants administered a second dose of 30μg of BNT162b1.
These results informed the selection of the BNT162b2 candidate for the pivotal Phase 2/3 global study in up to 30K participants, which has enrolled more than 11K participants thus far.
The companies are continuing to analyze data from the Phase 1 trials in the U.S. and Germany.
Assuming positive results, Pfizer and BioNTech plan to seek regulatory approval as early as October. If they get the nod, they plan to supply up to 100M doses worldwide by year-end and ~1.3B doses by the end of 2021.
Thursday, August 20, 2020
More Pfizer/BioNTech Data On Their Actual Vaccine Candidate
When we last heard from the Pfizer/BioNTech vaccine program, they had picked a different candidate than the one that they had already published on (BNT162b1). Today they’ve released more data about the actual candidate, BNT162b2. And it seems pretty clear why they went with it.
This preprint describes a head-to-head study (NCT04368728) between their two candidates, in a rather wide-ranging trial with 13 different treatment groups varying by the age of the volunteers (18-55 or 65-85) and the vaccine dose (10, 20, or 30 micrograms, each in two doses 21 days apart, with one group getting a single 100 microgram shot). Each group had 12 people dosed with a vaccine candidate and 3 placebo controls.
Overall, the “b2” vaccine produced fewer reactions on injection, and milder systemic reactions such as fever, body ache, etc. Older patients tended to have less reaction than younger ones, with both candidates. This is something to keep in mind – the other day, I was wondering if the mild reactions to the SinoPharm inactivated virus vaccine might indicate that it was raising less of a response, but that is clearly not always the case (I’ve updated that earlier post with a link to this one as well).
The antibody response in the two vaccines was quite similar, and they both showed the same trends (for example, lower neutralizing antibody response in the older patients, one-third to one-half, which will be something watch for when we get efficacy data). The booster shot was definitely needed – antibody titers were far better after the second injection. And while the 20 microgram dose was definitely better than the 10, the 30 microgram dose was slightly better in some groups but not in others. The Phase III, though, will be two doses of the 30 microgram, since it also had no worse safety signals.
The difference between the two candidates is that the b1 vaccine encodes the RBD of the Spike domain, presented as a trimer, while the b2 is the full-length Spike with a few mutations to make it more stable. The b1 therefore has more actual RNA molecules in it than the b2, but the lipid nanoparticle formulation is the same. The paper notes that it’s not clear why the b2 candidate has significantly fewer side effects – the number of RNAs could be part of it, but these effects are also known to depend on the particular RNA sequences involved, so who knows? The authors also mention that they expect a wider variety of T-cell responses from the full-length antigen in the b2 vaccine, but that this study did not include T-cell characterization. Pfizer’s own comments lead one to believe that this is what they’re seeing, but was that based on data or on expectations? At any rate, they say that this will be reported separately, and I look forward to seeing it.
But what I look forward to the most is seeing how all of these Phase I profiles translate to the real world of protection from the damned coronavirus. We’re going to learn more about immunological correlates more quickly than we have ever learned for any pathogen before. There are so many different platforms in trials now, each with their differences, and we will be getting piles of data in rapid succession from trials of tens of thousands of people all over the world. No one would have ever set up such a gigantic experimental landscape under non-emergency conditions; from the clinical perspective it’s an unprecedented immunological Woodstock.
And we’re going to have to get prepared for it. There are several believable outcomes (good, bad, and just plain mixed) that I don’t think that the general public has anticipated, and those will be the subject of a coming post!
US COVID-19 database reportedly returning to CDC control
The US Department of Health and Human Services will instruct hospitals to report key coronavirus statistics to the Center for Disease Control and Prevention, according to a new report in the Wall Street Journal, reversing a Trump administration move from July that ordered hospitals to report data to a central database in Washington.
The WSJ cites White House coronavirus response coordinator Deborah Birx, who this week told hospital executives and government officials in Arkansas that the current framework for reporting new COVID-19 cases was “an interim system,” and that data collection responsibilities would soon return to the CDC.
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