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Monday, August 21, 2023

NYC Council to grill Adams admin over billions spent on no-bid migrant contracts

 The City Council will scrutinize billions of dollars in no-bid contracts the Adams administration has doled out to cope with the Big Apple’s massive migrant influx.

Councilwoman Gale Brewer (D-Manhattan), who chairs the powerful Committee on Oversight and Investigations, told The Post she will hold a hearing in the fall on the “emergency” deals — which have prompted a slew of complaints from left-and right-wing pols.

“There’s so many issues here so I feel it’s most a look at the contracts and the programs they’re providing,” Brewer said.

Councilwoman Inna Vernikov (R- Brooklyn) said she was blown away by reports of asylum seekers who claimed they were misled by DocGo, a COVID testing-turned-migrant-shelter firm, on a $432 million contract to relocate migrants upstate

 “Taxpayers need a lot more transparency on the services provided — whether it’s transportation, security, medical or shelter,” said Vernikov, who was joined by Councilman Robert Holden (D-Queens) in first asking Brewer to hold the Oversight committee hearing.

Vernikov plans to introduce a bill this fall mandating the city create a public website to track taxpayer spending on migrants.

“The sanctity of taxpayer dollars cannot be overlooked,” she said.

bus, migrants
A busload of migrants arriving at a Hudson Valley hotel. Some migrants claim shelter operator DocGo misled them before transporting them upstate.
TheImageDirect.com

Migrants now staying at Albany hotels have complained that DocGo workers promised better living conditions if they fled upstate, and that security guards hired by the company threatened them.

The migrant services contracts were pushed through under a state of emergency declared by the mayor in October and were not reviewed by City Comptroller Brad Lander’s office.

As of May 18,134 migrant-services contracts totaling $3.1 billion have been handed out, of which, only 47, or 19%, were reviewed by the comptroller, records show.

hotel
Migrants have been transported to various upstate hotels in an effort to relieve overfull New York City shelters.
AP

Adams last week estimated the price tag for the migrant crisis could hit $12 billion over the next three years.

Nearly 100,000 migrants have flooded the Big Apple so far.

Holden said the city should have learned its lesson during the pandemic when it “overspent” by fast-tracking billions in emergency contracts for masks, goods, and services.

“We really need answers from the Adams administration on why they’re doing so many no-bid contracts,” said Holden, who blamed President Biden’s lax border policies for the city’s migrant crisis. “I understand it’s an emergency, but it shouldn’t be abused.”

migrants upstate
The migrant crisis could hit $12 billion over the next three years, according to Mayor Eric Adams.
Kevin C. Downs for NY Post
Councilman Justin Brannan (D-Brooklyn) agreed and said a hearing is needed.

“I think we learned from COVID that especially in the fog of a crisis, in order to protect the fiscal interests of our city, safeguards must still be in place with proper vetting when it comes to emergency procurement,” said Brannan, who chairs the Finance Committee.

The administration is “in constant communication with elected leaders” about migrant issues, including “holding detailed briefings on budget projections,” a spokesperson for the mayor said.

https://nypost.com/2023/08/19/nyc-council-to-hold-hearing-over-adams-migrant-contracts/

Moderna, CARsgen Join Forces Combining mRNA Cancer Vaccine with CAR T

 Moderna and China’s CARsgen Therapeutics are collaborating to combine their respective mRNA therapeutic cancer vaccine with a solid tumor CAR T cell therapy, the Chinese biotech announced on Monday.

Under the agreement, the companies are looking to evaluate Moderna’s investigational Claudin18.2 mRNA cancer vaccine in combination with CARsgen’s Claudin18.2 CAR T cell candidate (CT041) in preclinical and Phase I studies.

Lin Guey, Moderna’s CSO of external research, said in a statement that Claudin18.2 is a “promising therapeutic target to potentially treat multiple cancer types with high unmet medical need.” He added that the partnership with CARsgen will “explore the potential synergy of CAR-T with an investigational mRNA cancer vaccine that encodes for the Claudin18.2 protein.”

An isoform of Claudin18, the Claudin18.2 protein is a highly selective biomarker with limited expression in normal tissues and often abnormal expression in various malignant tumors. Given this specific expression pattern, Claudin18.2 has emerged as a unique molecule for targeted therapy in different cancers, particularly those originating in the stomach.

CT041, an autologous CAR T cell product, was granted Regenerative Medicine Advanced Therapy (RMAT) Designation by the FDA in January 2022 for the treatment of advanced gastric cancer and gastroesophageal junction cancer with Claudin18.2-positive tumors. In October 2020, the candidate received Orphan Drug designation from the regulator also for the treatment of GC and GEJ.

In May 2023, CARsgen announced the initiation of patient enrollment in a Phase II trial for CT041 in the U.S. for the treatment of Claudin 18.2–positive advanced gastric cancer and gastroesophageal junction cancer in patients who have failed at least two prior lines of systemic therapies.

CARsgen CEO and CSO Zonghai Li in a statement described CT041 as the “most advanced solid tumor CAR-T in development” and noted that it “continues to show promise in treating gastric and pancreatic cancers.” Li said that “attacking tumors with CAR T-cell therapy in combination with a cancer vaccine could potentially provide greater clinical benefit to patients,” noting Moderna’s leadership in the field of mRNA-based vaccines and therapeutics.

In July 2023, Moderna and Merck announced the initiation of a pivotal Phase III high-risk melanoma trial combining the companies’ mRNA-based personalized cancer vaccine with Merck’s blockbuster Keytruda checkpoint inhibitor. After a successful Phase IIb trial in stage III/IV melanoma patients with high risk of recurrence after surgery, the companies are running a Phase III study in an expanded population that includes stage IIb–IV patients. The study will enroll around 1,089 patients at more than 165 sites and in over 25 countries.

https://www.biospace.com/article/moderna-carsgen-join-forces-combining-mrna-cancer-vaccine-with-car-t/

Roche, Exelixis’ Drug Combo Bounces Back with Late-Stage Prostate Cancer Win

 The combination of Roche’s Tecentriq (atezolizumab) and Exelixis’ Cabometyx (cabozantinib) met one of the primary endpoints in the pivotal Phase III CONTACT-02 trial, significantly improving progression-free survival in patients with metastatic castration-resistant prostate cancer, according to interim data released Monday by the companies.

In terms of overall survival (OS), however, the combination regimen was only able to elicit a “trend toward improvement” which fell short of statistical significance, the companies reported. CONTACT-02 will continue to its next planned analysis of OS.

In terms of safety, the trial found no new signals of concern and the overall adverse event profile was consistent with the known side effects of the individual therapies.

The companies did not provide specific survival data in its announcement but promised to do so at an upcoming medical conference. Roche and Exelixis, together with international partners Ipsen and Takeda, will also discuss CONTACT-02’s data with the FDA, Exelixis’ Chief Medical Officer Vicki Goodman said in a statement.

Despite having been treated with novel hormonal therapies, many metastatic castration-resistant prostate cancer (mCRPC) patients still face poor prognoses of less than two years, Goodman said. Patients whose cancers progress despite treatment need new treatment options, and early results from CONTACT-02 highlight the potential of the Tecentriq-Cabometyx combo to fill this need, she added.

Neither Tecentriq nor Cabometyx is approved for prostate cancer.

The combination regimen leverages the mechanistic synergy between the two therapies. Cabometyx, a tyrosine kinase inhibitor, works by making a tumor more sensitive to immune responses. Tecentriq is a PD-1/PD-L1 blocker that works by preventing cancer cells from evading the immune system and boosting the body’s natural cytotoxic response.

To see this synergistic promise through to the market, Roche and Exelixis signed a clinical trial collaboration agreement in February 2017 and launched a Phase Ib study to target locally advanced or metastatic solid tumors.

The partnership, however, has recently yielded mostly disappointing results. In December 2022, the partners suffered a Phase III defeat in non-small cell lung cancer when data from the CONTACT-01 study showed that Tecentriq with Cabometyx could not significantly improve OS in the second-line setting.

A few months later, in March 2023, the companies stumbled againthis time in renal cell carcinomawith data from the CONTACT-03 study showing no significant benefit to progression-free survival after treatment with the combination regimen.

Orchestra BioMed Q2 update

 

  • U.S. Food and Drug Administration (“FDA”) granted Investigational Device Exemption (“IDE”) approval with conditions for Virtue SAB® coronary in-stent restenosis (“ISR”) U.S. pivotal study (in collaboration with Terumo Corporation (“Terumo”)); study expected to start before the end of 2023

  • BackBeat CNT™ global pivotal study in hypertensive pacemaker patients (in collaboration with Medtronic) on track for initiation in the second half of 2023

Timber Pharmaceuticals to be Acquired by LEO Pharma

 

  • Transaction Provides Timber Stockholders with Upfront Cash Consideration and Downstream Value through Contingent Value Rights

  • Total Transaction Value of up to $36 million

  • Transaction Expected to Close in the 4th Quarter of 2023, subject to closing conditions and stockholder approval

Timber Pharmaceuticals, Inc. (“Timber” or the “Company”) (NYSE American: TMBR) today announced that it has entered into a definitive agreement to be acquired by LEO US Holding, Inc. (“LEO Pharma”), a wholly-owned subsidiary of LEO Pharma A/S, in a total transaction value of up to $36 million with (i) an initial upfront consideration of $14 million and (ii) up to an additional $22.0 million in contingent value rights (CVRs) payable upon achievement of certain milestones described below. All of the issued and outstanding shares of capital stock and other equity interests of Timber will be converted into the right to receive the initial upfront consideration, less the payments for certain outstanding warrants that contain a Black Scholes cash payout value. For example, based on a current estimate of the Black Scholes value of such warrants of approximately $5.1 million, subject to change based on the assumptions detailed below, Timber expects the initial amount per share to be paid to Timber stockholders to be approximately $2.62 based on approximately 3.4 million shares of Timber common stock and restricted stock issued and outstanding as of August 20, 2023.

The current estimated value to stockholders is based on an implied value assigned to certain outstanding warrants based on Black Scholes option pricing model as of August 18, 2023. This value will not be finalized until the closing of the merger and is subject to increase or decrease based on certain variables, including the actual trading price of Timber at the time of the merger and the trading volatility of Timber common stock prior to the merger.

Sunday, August 20, 2023

Moderna, Pfizer's Updated COVID Shot Shows Effectiveness v. Eris' In Early Human, Preclinical Studies

 Moderna Inc 

 announced that preliminary clinical trial data confirm its updated COVID-19 vaccine for the fall 2023 vaccination season showed a significant boost in neutralizing antibodies against EG.5 and FL.1.5.1 variants

These results suggest that Moderna's updated COVID-19 vaccine may effectively target the expected circulating variants of COVID-19 during the upcoming vaccination season.

The World Health Organization (WHO) recently classified the EG.5, or "Eris," strain as a variant of interest. 

EG.5 is now the dominant variant in the U.S., according to the Centers for Disease Control and Prevention (CDC), while accounting for a growing proportion of cases across the globe. The FL 1.5.1, or "Fornax," variant is also beginning to surge in parts of the U.S.

"These new results, which show that our updated COVID-19 vaccine generates a robust immune response against the rapidly spreading EG.5 and FL 1.5.1 strains and reflects our updated vaccine's ability to address emerging COVID-19 threats," said Stephen Hoge, M.D., President of Moderna.

In addition to demonstrating a human immune response against the EG.5 and FL 1.5.1 strains, Moderna previously presented the only clinical trial data confirming that its updated COVID-19 vaccine showed robust human immune responses across the key circulating XBB strains at the June 2023 FDA VRBPAC. 

Moderna has confirmed an antibody response against current strains of concern with this new trial data.

Moderna has submitted its updated COVID-19 vaccine to the FDA, the European Medicines Agency, and other regulators. Pending authorization, it will be ready for fall vaccination with sufficient global supply.

Pfizer Inc 

 also said that its updated COVID-19 shot showed neutralizing activity against the "Eris" subvariant in a study conducted on mice.

Pfizer and its partner BioNTech SE 

 have created versions of their shots aimed at the XBB.1.5 subvariant.

EG.5 accounted for about more than 17% of COVID-19 cases in the United States, according to the latest government data.

In the U.S., COVID-19-related hospitalizations are up more than 40% off of recent lows hit in June but are still more than 90% below peak levels during the January 2022 Omicron outbreak.

EG.5 has also been detected in China, South Korea, Japan, and Canada, among other countries.

https://www.benzinga.com/general/biotech/23/08/33912067/moderna-pfizers-updated-covid-shot-shows-effectiveness-against-eris-variant-in-early-human-precli