Breakthrough Approval in Novel Bladder Cancer Treatment

[Everything Zen]

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-immunitybios-bladder-cancer-therapy-2024-04-22/

I worked on this project for two years before I was promoted to managing a pancreatic cancer trial for the company so this is especially meaningful to me.

April 22 (Reuters) - The U.S. health regulator approved on Monday ImmunityBio's (IBRX.O), opens new tab combination therapy to treat a type of bladder cancer, marking an end to the company's efforts to bring its therapy to the market.
The agency's green light is a shot in the arm for ImmunityBio, which had reiterated doubts in a regulatory filing, opens new tab last month about its ability to remain in business.
Last year, the U.S. Food and Drug Administration (FDA) declined clearance for the therapy, Anktiva, over deficiencies found during pre-license inspection of the company's contract manufacturing firms.


The therapy works by activating types of disease-fighting white blood cells called natural killer (NK) cells and T-cells to create long-term immunity in the body.
ImmunityBio said Anktiva will be available in the U.S. markets by mid-May 2024, but did not respond to a request seeking details on the therapy's label pricing.
The drug is used in combination with the Bacillus Calmette-Guérin (BCG) vaccine, which is mainly used against tuberculosis, but also as a common treatment for some forms of bladder cancer.


The combination aims to treat patients with a form of bladder cancer, which is unresponsive to the vaccine and in which the disease has not spread. This is seen in about 75-85% patients of bladder cancer, the company said.
Bladder cancer patients currently have to undergo a procedure called surgical ablation and either get chemotherapy or BCG vaccine as a standard treatment.
The last decade has seen the approval of Merck's (MRK.N), opens new tab Keytruda, but there is a chance of recurrence, said ImmunityBio's executive chairman Patrick Soon-Shiong.

 

[Shula]

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-immunitybios-bladder-cancer-therapy-2024-04-22/

I worked on this project for two years before I was promoted to managing a pancreatic cancer trial for the company so this is especially meaningful to me.

April 22 (Reuters) - The U.S. health regulator approved on Monday ImmunityBio's (IBRX.O), opens new tab combination therapy to treat a type of bladder cancer, marking an end to the company's efforts to bring its therapy to the market.
The agency's green light is a shot in the arm for ImmunityBio, which had reiterated doubts in a regulatory filing, opens new tab last month about its ability to remain in business.
Last year, the U.S. Food and Drug Administration (FDA) declined clearance for the therapy, Anktiva, over deficiencies found during pre-license inspection of the company's contract manufacturing firms.


The therapy works by activating types of disease-fighting white blood cells called natural killer (NK) cells and T-cells to create long-term immunity in the body.
ImmunityBio said Anktiva will be available in the U.S. markets by mid-May 2024, but did not respond to a request seeking details on the therapy's label pricing.
The drug is used in combination with the Bacillus Calmette-Guérin (BCG) vaccine, which is mainly used against tuberculosis, but also as a common treatment for some forms of bladder cancer.


The combination aims to treat patients with a form of bladder cancer, which is unresponsive to the vaccine and in which the disease has not spread. This is seen in about 75-85% patients of bladder cancer, the company said.
Bladder cancer patients currently have to undergo a procedure called surgical ablation and either get chemotherapy or BCG vaccine as a standard treatment.
The last decade has seen the approval of Merck's (MRK.N), opens new tab Keytruda, but there is a chance of recurrence, said ImmunityBio's executive chairman Patrick Soon-Shiong.

So proud of you, Zen!!! You are truly amazing!


If you ever go back to the office/lab, take me for bring your groupies to work day! That has got to be incredibly fulfilling work.

 

[Rastafarai]

Wonderful trailblazing accomplishment @Everything Zen !!! And this is why I encourage more of our youth to pursue the health sciences field. Such a rewarding field, where your work can change and save lives.

 

[Everything Zen]

Thank you! It is truly rewarding work. Even though it was public knowledge since Patrick owns the LA Times and both patients disclosed that they were being treated on clinical trials under his company and at his private institution- I also can proudly say that I managed the cellular therapy component of both Senator Harry Reid and Alex Trebek’s treatment regimen of their care for a period of time before they both passed away.

Former Sen. Harry Reid says his cancer is in remission

Former Nevada Sen. Harry Reid, who revealed in 2018 that he had pancreatic cancer, says he's in remission after experimental treatment.

www.latimes.com

Alex Trebek opens up on his battle with cancer, experimental new treatment and new memoir

Alex Trebek talks about his new memoir out tomorrow, battle with cancer and an experimental treatment he's doing that appears to be working.

abcnews.go.com

 

[Shula]

You are totally everything I wish I could’ve grown up to be! You’re taller than me, but I just picked you up and I’m spinning you around in my head.

This just makes me so happy to hear of YOU and your work having such incredible impact where it counts! So much of life and work is foolishness. What you do really matters. I’m going to start praying for you to end up where YOU want to be and that it is peaceful, rewarding, productive, and very conducive to what works best for Zen. Now you know I gotta go brag about you to my girls. Yes, I know I sound ridiculously childish, but this is the stuff of life that excites me. Most everything else is meh. Plus, you did gymnastics, my other childhood passion. I could not possibly be more proud of you. I hope you’re being good to yourself; you deserve it!

 

[Everything Zen]

Don’t sleep on ImmunityBio stock y’all. This narcissistic may have actually pulled this off. Anktiva is looking like it could be the next Keytruda. I was able to escape with a scrap of sanity and 800 shares of RSUs. Patrick is also a minor owner of the LA Lakers and partly responsible for helping Kobe Bryant recover when he tore his Achilles tendon. I got so tired of hearing him talk about him palling around with Kobe after he passed. He’s considered to be one of if not the world’s richest doctors.

ImmunityBio, Serum Institute of India Agree on an Exclusive Arrangement for Global Supply of Bacillus Calmette-Guerin (BCG) Across All Cancer Types

CULVER CITY, Calif., May 02, 2024--ImmunityBio, Inc. (NASDAQ: IBRX), has signed an exclusive global arrangement with the Serum Institute of India, the world’s largest manufacturer of vaccines by number of doses produced, to supply ImmunityBio with Bacillus Calmette-Guerin (BCG). The agreement...

finance.yahoo.com

 

[Iwander]

What pancreatic can trial are you working on?

 

[Everything Zen]

^^^ @Iwander Currently I don’t work in pancreatic cancer but when I did I was the Clinical Study Manager for the QUILT-88 trial at the company.

ClinicalTrials.gov

clinicaltrials.gov

I was the manager of MCLA-128-CL03 at my previous company before I got laid off. That was focused on prostate and NSCLC with NRG1 fusions

ClinicalTrials.gov

clinicaltrials.gov

 

[Ganjababy]

Congratulations. You are such an inspiration and I am so proud of you. This is my favourite poem dedicated to you.

Still I Rise​

BY MAYA ANGELOU
You may write me down in history
With your bitter, twisted lies,
You may trod me in the very dirt
But still, like dust, I'll rise.

Does my sassiness upset you?
Why are you beset with gloom?
’Cause I walk like I've got oil wells
Pumping in my living room.

Just like moons and like suns,
With the certainty of tides,
Just like hopes springing high,
Still I'll rise.

Did you want to see me broken?
Bowed head and lowered eyes?
Shoulders falling down like teardrops,
Weakened by my soulful cries?

Does my haughtiness offend you?
Don't you take it awful hard
’Cause I laugh like I've got gold mines
Diggin’ in my own backyard.

You may shoot me with your words,
You may cut me with your eyes,
You may kill me with your hatefulness,
But still, like air, I’ll rise.

Does my sexiness upset you?
Does it come as a surprise
That I dance like I've got diamonds
At the meeting of my thighs?

Out of the huts of history’s shame
I rise
Up from a past that’s rooted in pain
I rise
I'm a black ocean, leaping and wide,
Welling and swelling I bear in the tide.

Leaving behind nights of terror and fear
I rise
Into a daybreak that’s wondrously clear
I rise
Bringing the gifts that my ancestors gave,
I am the dream and the hope of the slave.
I rise
I rise
I rise.

 

[Black Ambrosia]

Don’t sleep on ImmunityBio stock y’all. This narcissistic may have actually pulled this off. Anktiva is looking like it could be the next Keytruda. I was able to escape with a scrap of sanity and 800 shares of RSUs. Patrick is also a minor owner of the LA Lakers and partly responsible for helping Kobe Bryant recover when he tore his Achilles tendon. I got so tired of hearing him talk about him palling around with Kobe after he passed. He’s considered to be one of if not the world’s richest doctors.

ImmunityBio, Serum Institute of India Agree on an Exclusive Arrangement for Global Supply of Bacillus Calmette-Guerin (BCG) Across All Cancer Types

CULVER CITY, Calif., May 02, 2024--ImmunityBio, Inc. (NASDAQ: IBRX), has signed an exclusive global arrangement with the Serum Institute of India, the world’s largest manufacturer of vaccines by number of doses produced, to supply ImmunityBio with Bacillus Calmette-Guerin (BCG). The agreement...

finance.yahoo.com

You're a present day Hidden Figure in my mind. I'm here from all the gems you're dropping.