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Tuesday, February 14, 2023

BioXcel Unveils Complete Data From BXCL701/Keytruda Combo Study In Prostate Cancer

BioXcel Therapeutics Inc
BTAI-0.34%+ Free Alerts
announced full data from its Phase 2a trial of BXCL701 in combination with Merck & Co Inc's
MRK-0.74%+ Free Alerts
Keytruda (pembrolizumab) in small cell neuroendocrine (SCNC) variant metastatic castration-resistant prostate cancer (mCRPC) patients.
The trial included patients after at least one prior line of chemotherapy for locally advanced or metastatic prostate cancer.
In the evaluable patient cohort (n = 28), 7 (25%) patients achieved a composite response, the trial's primary endpoint.
Partial response (PR) was observed in 5 (20%) patients (4 confirmed PR, one unconfirmed PR). The disease control rate was 48% (12 patients).
The median duration of response for both composite responses and partial responses was 6+ months as of the data cutoff on December 19, 2022.
6 out of 34 patients (18%) in the safety population experienced serious adverse events (SAEs) possibly related to or related to BXCL701 or pembrolizumab, and 6 (18%) patients discontinued any drug due to a treatment-related AE.
The company plans to initiate a randomized trial evaluating BXCL701 plus pembrolizumab versus BXCL701 monotherapy.

https://www.benzinga.com/general/biotech/23/02/30898342/bioxcel-therapeutics-unveils-complete-data-from-bxcl701keytruda-combo-study-in-prostate-cancer-su

What's Going On With Monopar Therapeutics

Monopar Therapeutics Inc
MNPR+0.55%+ Free Alerts
opened enrollment for the fifth dose level cohort in the open-label Phase 1b camsirubicin Maximum Tolerated Dose trial for advanced soft tissue sarcoma (ASTS), a diverse type of cancer that typically develops in the body's connective tissue.
The cohort dose is at an increased dose of 650 mg/m2, nearly 2.5x the highest dose evaluated in any prior camsirubicin clinical trial.
The company said that no drug-related cardiotoxicity has been observed with camsirubicin treatment.
It compares favorably to the well-documented dose-restricting cardiotoxicity experienced with doxorubicin treatment, the current first-line treatment for ASTS.
17% of camsirubicin patients in the trial have experienced low-grade hair loss; another 8% have experienced over 50% hair loss, versus approximately 50% of doxorubicin-treated patients reporting some amount of hair loss, with the majority of these patients experiencing >50% hair loss.
8% of camsirubicin patients in the trial have experienced low-grade mild oral mucositis compared to the roughly 35-40% of doxorubicin-treated patients.
"So far, camsirubicin has demonstrated a favorable safety profile at up to the 520 mg/m2 dose level assessed to date," said Dr. Cranmer."
EF Hutton writes that having established proof-of-concept in sarcoma, camsirubicin could be developed in another dozen cancer indications, where doxorubicin is still the backbone of treatment.
It reiterates the Buy rating and a price target of $24.

https://www.benzinga.com/general/biotech/23/02/30906428/whats-going-on-with-monopar-therapeutics-shares-today

MoonLake started at Overweight by Cantor

Target $23

https://finviz.com/quote.ashx?t=MLTX&p=d

Opdivo, with CABOMETYX,Shows Durable Survival in First-Line Advanced Renal Cell Carcinoma

Data to be featured at ASCO GU 2023 demonstrate continued overall survival, progression-free survival and objective response rate benefits with Opdivo in combination with CABOMETYX compared to sunitinib, regardless of IMDC risk score

These three-year data – with a median follow-up of 44 months – from CheckMate -9ER represent the longest reported follow-up in any Phase 3 trial with an immunotherapy-tyrosine kinase inhibitor regimen in this population

In an exploratory biomarker analysis, median progression-free survival and overall survival were improved with the combination of Opdivo and CABOMETYX regardless of PD-L1 status

Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (NASDAQ: EXEL) today announced three-year (36.5 months minimum; 44.0 months median) follow-up results from the Phase 3 CheckMate -9ER trial, demonstrating sustained survival and response rate benefits with the combination of Opdivo® (nivolumab) and CABOMETYX® (cabozantinib) versus sunitinib in the first-line treatment of advanced renal cell carcinoma (RCC). Additionally, a biomarker analysis showed that improvements in median progression-free survival (PFS) and overall survival (OS) were sustained with the combination of Opdivo and CABOMETYX regardless of PD-L1 status. These updated results will be featured in one oral and one poster presentation at the American Society of Clinical Oncology (ASCO) 2023 Genitourinary Cancers Symposium from February 16-18, 2023.

https://finance.yahoo.com/news/opdivo-nivolumab-combination-cabometyx-cabozantinib-220000099.html

"World's First" Unvaccinated Dating Service Launches In Hawaii

by Allen Stein via The Epoch Times,

Nowadays, online dating seems less a game of hit or miss than medical truth or dare, given the deal-breaker question, “Are you vaccinated?”

Businesswomen Shelby Thomson and Heather Pyle of Maui, Hawaii, found the online dating game a frustrating experience for the un-jabbed at the height of the COVID-19 vaccine rollout in 2021.

Faced with discrimination and censorship, many unvaccinated people lost jobs and relationships because they chose to remain unvaccinated. The un-jabbed “didn’t have the option to say they were unvaccinated” to potential online dating partners, Thomson said.

A health worker draws out Moderna vaccine during a drive-through COVID-19 vaccine clinic at St. Lawrence College in Kingston, Ont., on Jan. 2, 2022. (The Canadian Press/Lars Hagberg)

“They were only allowed to be vaccinated. And you had to have this badge in your [online] profile.”

Too often, the unvaccinated would hear on dating sites, “Swipe left”—move on.

In May 2021, the two business partners, moms, and best friends launched “Unjected,” a dating app for the unvaccinated, on the Google and Apple stores.

“We started seeing people wanting to find partners,” Thomson said of their unvaccinated friends.

However, soon after the app’s launch, Thomson and Pyle started receiving hate emails, then negative publicity in the media. Apple decided to remove “Unjected” from the app store, claiming it provided medical disinformation.

“We tailored everything and played this chess game until it [met] Apple standards,” Thomson recalled. But it still wasn’t enough.
“It took us until July 31 to get banned.”

When Google threatened to follow suit, Thomson and Pyle pulled the plug on both media giants, and Unjected.com went live using the web domain host GoDaddy in August 2021.

“We decided—OK—the big-tech world is not our friend. They don’t want us to exist in this realm. They’ll always go out of their way to ensure we’re censored or taken down.”

Thomson said “Unjected” is more than a dating service for the unvaccinated. It’s also a blood bank database and a fertility bank for the unvaccinated.

The dating service alone boasts 110,000 subscriptions in 85 countries and 3,000 to 5,000 new clientele every month, Thomson said.

Pandemic of Censorship

“Unjected was founded to help us easier connect in a world of medical discrimination and censorship,” according to Unjected’s online introduction.
“We all have a lot in common when it comes to being conscious about our choices, and we think that there are great connections to be made when like-minded people gather in the same social space.”

Thomson said 2021 was the fastest-growing year for the new dating site because so many unvaccinated people had lost their jobs in the pandemic.

“The [vaccine] mandates were heavily enforced. Now, we’re seeing the trend differently. People are starting to realize things they didn’t before,” Thomson said.

...

Ironically, “Unjected” clients include conservative Republicans and liberal Democrats, and many others concerned about the safety of mRNA vaccines.

“It’s such a melting pot—also politically speaking, it’s authentic people coming together,” Thomson said. “We have 70-year-old grandmas looking for friends. Many members said they used to be die-hard liberals.”

Like everything else, Thomson said it’s about making choices free of coercion.

https://www.zerohedge.com/covid-19/worlds-first-unvaccinated-dating-service-launches-hawaii

Fear Of Death, PTSD Are Army Recruiters' Biggest Hurdles: Govt Survey

The U.S. Army is coming off its worst recruiting performance in decades, and says young Americans' fear of death and mental illness are the biggest reasons they won't sign up.

That conclusion comes from surveys of 16- to 28-year-olds conducted last spring and summer, officials say. The Army shared general findings with the Associated Press, but not the full details of the survey results, methodology or questions posed.

The Army had ambitions to recruit 60,000 soldiers in 2022, but fell a whopping 25% short of the objective. Trying to put a dent in its growing deficit -- and ignoring its 2022 results -- the service implausibly aspires to recruit 65,000 in 2023.

"I would say it is a stretch goal," Army Secretary Christine Wormuth tells Associated Press, apparently with a straight face. Wormuth never served in the military but has held a variety of Defense Department posts, along with a revolving-door swing at the RAND Corporation.

According to the Army's surveys, the top four reasons young people reject the idea of Army service:

Fear of death
Worries about falling victim to post-traumatic stress disorder
Leaving friends and family
The feeling that Army service would amount to "putting my life on hold"

After those reasons, there was a steep drop-off. Other deterrents included concerns about discrimination against women and minorities, a general distrust of the military, misgivings about living conditions on bases, being stuck in an unwanted job, the now-rescinded Covid vaccine mandate and feelings that Army is going "woke."

**A U.S. Humvee burns in Baghdad's al-Mansour neighborhood on Sept. 22, 2004** (Khalid Mohammed/AP via *NBC News*)

Maj. Gen. Alex Fink, who holds the corporate-sounding title of "Chief of Army Enterprise Marketing," emphasizes to AP that Army "wokeness" -- though frequently invoked by GOP legislators -- was cited by only about 5% of young people surveyed.

Young people "just don’t see the Army as something that’s relevant,” says Fink. "They see us as revered, but not relevant in their lives.”

To fill its emptying ranks, the Army's rolling out new programs and incentives. Increasingly under pressure to lower the standards for who's deemed service-worthy, one program cultivates the bottom of the barrel by helping academic- and fitness-impaired recruits overcome their weaknesses, via up to 90 days of extra academic or fitness training.

The Army is also going to throw extra financial incentives at recruiters, with bonuses of up to $4,500 a quarter for beating their individual goals. One thing that's sure to incentivize: recruiters plumbing new depths of unethical behavior -- they already carry a well-earned reputation for dishonesty.

One pilot program is particularly cringeworthy: Privates and privates first class can actually score a promotion in rank for convincing someone to enlist. (Limit: One promotion per soldier.)

Judging from the article, AP and senior military officials spent little or no time discussing how the Army will try to overcome the top two turn-offs: death and PTSD.

If researchers dove deeper into these concerns, they'd probably find many young people particularly dread the idea of being maimed, killed or mentally ravaged in a war that has no moral or national-interest justification...which is pretty much the only kind of war the Pentagon wages anymore.

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