if i was to guess at a percent,
perhaps it would be 25% protection for the person wearing the mask, and 75% for the general public.
much the same reason a surgeon wears a mask. again just a opinion.
In addition to providing a bit more protection from COVID to those giving the vaccinations, it also helps protect against Ken Paxton should patients get infected while in line and suffer apparent harm from the vaccine.
"Different product" in this context merely means that (if issued) the PRV can be used to expedite the FDA review of the NDA or BLA for any product.
Thanks for Clarification, it’s too bad because that ~$100mm would have been non-dilutive so now they will hit the market with Raise, dang!!
I thought it was more about ‘different product’, and hence accepted but ‘active ingredient’ makes sense..
About the Rare Pediatric Disease Priority Review Voucher Program
The Rare Pediatric Disease Priority Review Voucher Program is intended to encourage development of new drug and biological products for the prevention and treatment of certain rare pediatric diseases. Under this program, upon approval, the US Food and Drug Administration awards priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. “The voucher can be redeemed to receive priority review of a subsequent marketing application for a “DIFFERENT PRODUCT”. PRVs may be sold or transferred, and there is no limit on the number of times a PRV can be transferred.
BLUE didn’t get a priority-review voucher for FDA approval of Lyfgenia because the FDA deemed that the “active ingredient” in Lyfgenia is the same as in BLUE’s Zynteglo, which was approved in 2022 for beta thalassemia (#msg-169711368).
This is a seemingly odd interpretation by the FDA of the term, “active ingredient,” but the FDA is given broad discretion by the legal system in these kinds of decisions.
Exactly! At my CVS there was no segregated waiting area for vaccinations—those awaiting vaccination were in the same open area where people queued for cashiers. I'm truly baffled by the observation in #msg-173393175.
PFE's qD Danuglipron warrants an entry in the "may surprise" group, IMO, even though we both consider the program high-risk.
UPDATED-List of ORAL Weight loss candidates.
12/9/23 – Added Roche/Carmot’s CT996. I’m speculating that of the $2.7B plus $400 mill in milestones Roche is paying for Carmot, the majority was for their ORAL CT996 compound based on the market cap of GPCR. In addition to CT996, Roche also got an injectable Obesity NME with a different MOA (CT388 GLP1/GIP completed ph1) and a Type 1 Diabetes drug (CT868 GLP1/GIP completed ph1). Added some observations. Also cleaned up formatting.
This has become a very crowded field. Structure Therapeutics (GPCR) currently has the most interesting compound. Others which have we will soon find out more on are VKTX's VK2809, AZN's ECC5004, Kallyope's Hormone NME's and Roche/Carmot’s CT-996.
Here is an updated list of ORAL weight loss drugs currently in trials listed in possible commercial success tiers:
Most Interesting NME's
Owner Drug MOA Comments
GPCR GSBR-1290 GLP1 Structure Therapeutics -Significant weight loss in 28day Phase 1 (up to 4.9%)
VKTX VK2809 GLP1/GIP In phase 1- peptide
PFE PF-06954522 GLP-1 GLP1 for Type 2 Diabetes - just entered Ph1- very little info
AZN ECC5004 GLP-1 In Phase 1- small molecule GLP1- AZN paid 185mill + up to 1.8B milestones + royalties for compound.
Kallyope K757&K833 Hormone New oral nutrient receptor agonists that stimulate the secretion of multiple appetite-suppressing satiety hormones
AMGN Not Named Undisclosed Probably oral version of AMG 133 which activates GLP1 but inhibits GIP
RHHBY CT996 GLP1 In phase 1- small molecule. From Carmot- Roche paid 2.7B for Carmot to acquire this Ph1 asset and 2 others
LLY Orforglipron GLP1 In phase 3- No comment at last CC
NOVO Rybelsus GLP1 Semaglutide- approved for Diabetes only but used off label
TERN TERN-601 GLP1 Management discussing this drug in combination- not competitive standalone?
Not going forward
PFE Lotiglipron GLP1 Discontinued due to elevated liver enzymes
PFE PF-06882961 GLP1 Danuglipron BID- Small Molecule- completed ph1 and in ph2b
being covid does not
seem to be a big concern, for most people, perhaps the thinking is that people coming in
for a shot at this time, may not be feeling the best. IMO.
Thanks for correction!
Mufaso. Thx for the excellent DD
BI has three Phase 3 trials running for Surodutide
At our local CVS, all vaccinated people sit for fifteen minutes in chairs in the same aisle as people who are waiting in line to pick up prescriptions. The chairs are about a foot apart, and the aisle is approximately four feet wide.
This maximizes the number of people in close contact with one another for the maximum amount of time.
Meanwhile, the rest of the store is usually pretty empty.
Maybe they’re trying to drum up business in their cough and cold section…
ALT's Pemvidutide MOA is a peptide-based GLP-1/glucagon dual receptor agonist. Regarding my "concern" about adding Glucagon to a GLP-1 drug, I would offer the following:
Survodutide is not advancing. See Dew’s #msg-172204950
>>> Anixa Biosciences and Cleveland Clinic Present Positive New Data from Phase 1 Study of Breast Cancer Vaccine
DECEMBER 06, 2023
– Antigen-specific T cell responses were observed at all dose levels –
– IFN? and IL-17, immune-mediated biomarkers of T cell activation, increased over time from baseline –
– Vaccine was safe and well tolerated –
– Conference call to commence today at 6:30 p.m. ET –
SAN JOSE, Calif., Dec. 6, 2023 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced new and updated positive results from the Phase 1 clinical trial of its breast cancer vaccine. The trial is being conducted in collaboration with Cleveland Clinic with funding by a grant from the U.S. Department of Defense.
The data were presented at the 2023 San Antonio Breast Cancer Symposium by G. Thomas Budd, M.D., staff physician at Cleveland Clinic Cancer Institute and principal investigator of the study, in a poster entitled "Phase I Trial of alpha-lactalbumin vaccine in high-risk operable triple negative breast cancer (TNBC) and patients at high genetic risk for TNBC."
Patients who had been curatively treated for TNBC received three vaccinations given once every two weeks. IFN? and IL-17, which are T cell immune response indicators (cellular immunity), and antibody production (B cell humoral immunity) were measured to evaluate the vaccination effect. Data from the 16 patients treated to date showed that:
The majority of patients developed ELISpot (T-cell) responses that met the rigorous protocol-specified definition of an immune response, with a measurable but lesser magnitude of response noted in the remaining patients.
12 (75%) of the women had antigen-specific IFN? and/or IL-17 ELISpot responses that were observed at all dose levels, while ELISA antibody responses were observed at Dose Level 2 and higher.
A statistically significant (P = 0.03) increase in IFN? over baseline (Day 0) was observed by Day 56; while a significant (P = 0.0001) increase in IL-17 over baseline was observed by Day 14.
Among the doses studied, Dose Level 1 (10 mcg a-lactalbumin/10 mcg zymosan) was determined to be a usable immunologic dose as well as the maximum tolerated dose (MTD).
No significant side effects were observed, at the MTD, besides irritation at the sites of injection. No myalgias, flu-like symptoms, or aberrant laboratory values were noted.
Anixa and Cleveland Clinic plan to investigate additional intermediate dose levels and continue studying the vaccine's safety and immunologic effects in two additional patient cohorts.
The first cohort, which opened for enrollment in August 2023, is evaluating the combination of the Company's breast cancer vaccine with Keytruda® (pembrolizumab) in post-operative patients found to have residual disease following neoadjuvant chemo-immunotherapy.
The second cohort will investigate the safety and immunologic effects of the vaccine in patients who are BRCA1, BRCA2, or PALB2 mutation positive and are planning prophylactic risk-reducing mastectomies.
"The data from our Phase 1 trial to date has exceeded our expectations, and we are pleased with our progress. This vaccine is designed to direct the immune system to destroy TNBC cancer cells through a mechanism that has never previously been utilized for cancer vaccine development," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "We look forward to reviewing additional data as the trial continues to completion, and we are in the planning stages of the Phase 2/3 studies of this vaccine. Our goal is to initially evaluate the vaccine's ability to prevent recurrence of cancer in survivors, and continue with extension studies to eventually determine its effectiveness in preventing the initial onset of TNBC."
"There is a large unmet need for preventing TNBC, an aggressive form of breast cancer with few targeted treatment options available," said Dr. Budd, Cleveland Clinic. "We are encouraged by the data gathered to date and look forward to determining the optimal vaccine dose in additional patient cohorts. Our hope is that future studies will demonstrate that the antigen-specific T cell responses we observed translate to the prevention of breast cancer recurrence."
Anixa is the exclusive worldwide licensee to the novel breast cancer vaccine technology invented at Cleveland Clinic, the site of the Phase 1 trial. The grant from the U.S. Department of Defense was made directly to Cleveland Clinic.
Conference Call Information
Anixa is pleased to invite all interested parties to participate in a conference call, during which this new data will be discussed.
Conference Call Details:
Anixa management, with special guest speakers
Date and time:
Today, December 6, 2023, at 6:30 p.m. ET
Registration Link to receive your dial-in number and unique PIN
Available at www.anixa.com under "Events & Presentations"
About Triple-Negative Breast Cancer
One in eight women in the U.S. will be diagnosed with an invasive breast cancer at some point in their lives. Approximately 10-15% of those diagnoses are TNBC, however TNBC accounts for a disproportionately higher percentage of breast cancer deaths and has a higher rate of recurrence. This form of breast cancer is twice as likely to occur in African-American women, and approximately 70% to 80% of the breast tumors that occur in women with mutations in the BRCA1 genes are triple-negative breast cancer.
About Anixa Bioscience's Breast Cancer Vaccine
Anixa's breast cancer vaccine takes advantage of endogenously produced proteins that have a function at certain times in life, but then become "retired" and disappear from the body. One such protein is a breast-specific lactation protein, a-lactalbumin, which is no longer found post-lactation in normal, aging tissues, but is present in the majority of triple-negative breast cancers. Activating the immune system against this "retired" protein provides preemptive immune protection against emerging breast tumors that express a-lactalbumin. The vaccine also contains an adjuvant that activates an innate immune response, which allows the immune system to mount a response against emerging tumors to prevent them from growing. This vaccine technology was invented by the late Dr. Vincent Tuohy, who was the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research in the Department of Inflammation and Immunity at Cleveland Clinic's Lerner Research Institute. Dr. Tuohy was inventor of the technology, which Cleveland Clinic exclusively licensed to Anixa Biosciences. He was entitled to a portion of the commercialization revenues received by Cleveland Clinic and also held equity in Anixa.
About Anixa Biosciences, Inc.
Anixa is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. Anixa's therapeutic portfolio consists of an ovarian cancer immunotherapy program being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR- T, known as chimeric endocrine receptor T-cell (CER-T) technology. The Company's vaccine portfolio includes a novel vaccine being developed in collaboration with Cleveland Clinic to prevent breast cancer – specifically triple negative breast cancer (TNBC), the most lethal form of the disease – as well as a vaccine to prevent ovarian cancer. These vaccine technologies focus on immunizing against "retired" proteins that have been found to be expressed in certain forms of cancer. Anixa's unique business model of partnering with world-renowned research institutions on clinical development allows the Company to continually examine emerging technologies in complementary fields for further development and commercialization. To learn more, visit www.anixa.com or follow Anixa on Twitter, LinkedIn, Facebook and YouTube.
Is it also the worst day for any drug that the FDA gave a blackbox warning that taking this drug may cause cancer?
Re: Oral weight-loss drugs
I've included a link to the latest version of this compilation in the Intro box of the Biotech Values board. The link is immediately below the link for Recent Biotech Buyouts.
Hat tip to Mufaso for maintaining this compilation!
CNBC just completed an interview with the CEO of Vertex. They used to make interviews available to anyone who wanted to see them. I’ve noticed that some of the interviews require the person to have a subscription to CNBC Pro in order to watch them.
I was out of the room when the interview started so I’ve missed most of it. My impression of the CNBC interviewer was that she was both biased and racist.
i.e. Price is far too high for a disease affecting blacks.
CEO corrected the interviewer advising that the disease affects both browns and blacks. … and I mentioned treatment centres that vertex had established in several locations where most of the affected population occurs.
Unfortunately, I did not fully understand whether treatment was being offered at no charge to the patient or whether there was still a substantial fee that the patient had to cover.
Great , thanks! J/k….this co. Reminds me of Rvnc, over charge for FDA approved drug ( diff circumstances, however) so I’d imagine lower pricing model…the PRV would have brought in ~$100mm+, so now go to WS and dilute!! The cancer part was known, so prob less pressure on SP!! IMHO
CNBC just did a repeat of your post that I am responding to.
Everything you said in your post was confirmed by CNBC. (Or copied by them)
Spoke too soon, wtf!! Well if Adam Feuerstein says so, he’s pretty accurate but wondering if Dew has a take on this???
$VRTX $CRSP Casgevy $2.2 million, no black box.
$BLUE Lyfengia $3.1 million, black box.
Bluebird will have to lower its price, right? How can it not?
My guess is the PRV disappoint and Cap raise will dilute big time now!!
Also, Bluebird confirmed to us that it DID NOT get a pediatric rare disease voucher for this approval.
Recall, the company had presold the voucher for $100M, assuming it would get one.
Mufaso. thx for your DD
Can you explain this comment
INTS—(+130%)—reports phase-2 data_for intra-tumoral treatment_in early-stage breast cancer…
SABCS presentation poster:
GLP-1 Drugs Linked to Lower Colorectal Cancer Risk for Diabetes Patients Association strongest in patients with overweight, obesity
Taking glucagon-like peptide 1 (GLP-1) receptor agonists for type 2 diabetes was associated with greater reductions in colorectal cancer (CRC) risk compared with several other diabetes medication classes, a nationwide cohort study found. This is of course expected as obesity is associated with a number of comorbidities.