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Tuesday, August 29, 2023

Ginkgo, Google Cloud to Build Next Gen Platform for Biological Engineering and Biosecurity

 

  • Ginkgo and Google Cloud enter strategic five-year cloud and AI partnership

  • Ginkgo to pioneer new large language models for biological engineering applications, powered by Google Cloud's Vertex AI platform

  • Ginkgo intends to make Google its primary cloud services provider, benefiting from access to next-generation computational infrastructure and AI technologies

  • Partnership to include funding from Google Cloud to enable Ginkgo's development of foundation models and fine-tuned applications

Celularity in Multi-Year Research Collaboration Services Agreement With Regeneron

 Celularity Inc. (Nasdaq: CELU) (Celularity), a biotechnology company developing allogeneic cell therapies and biomaterial products, announced today a multi-year Research Collaboration Services Agreement with Regeneron Pharmaceuticals, Inc. (Regeneron) to support the research of Regeneron’s allogeneic cell therapy candidates.

The agreement’s initial focus is the research on a targeted allogeneic gamma delta chimeric antigen receptor (CAR) T-cell therapy owned by Regeneron designed to enhance proliferation and potency against solid tumors. The research will take place at Celularity’s state-of-the-art facility located in Florham Park, N.J. Financial terms were not disclosed.

“The agreement with Regeneron announced today is an important milestone for Celularity that recognizes our expertise in the research of cellular therapies, including the engineering of CAR-T cells. We believe that this relationship paves the way for future industry collaborations leveraging our world class cell therapy facilities and capabilities,” said Robert J. Hariri, M.D., Ph.D., Celularity’s CEO, Chairman and Founder. “We have long admired the exceptional scientific legacy at Regeneron and welcome the opportunity to collaborate with a world leader in innovative medicines.”

https://finance.yahoo.com/news/celularity-announces-multi-research-collaboration-130000885.html

HCA, Google Cloud to Bring Generative AI to Hospitals

 HCA Healthcare, Inc. (NYSE:HCA), one of the nation’s leading healthcare providers, and Google Cloud today announced a new collaboration designed to use generative AI technology to improve workflows on time-consuming tasks, such as clinical documentation, so physicians and nurses can focus more on patient care.

This expanded work with Google Cloud is part of a strategic partnership announced in 2021 that includes safeguards to protect patient privacy and the security of data. HCA Healthcare’s partnership with Google Cloud, as well as its multi-year implementation of MEDITECH Expanse which began in 2022, are key elements of HCA Healthcare’s work to advance its digital transformation.

https://finance.yahoo.com/news/hca-healthcare-collaborates-google-cloud-120000709.html

Insider Trade At Aclaris

 James Loerop, Chief Business Officer at Aclaris Therapeutics (NASDAQ:ACRS), reported a large insider buy on August 28, according to a new SEC filing.

What Happened: A Form 4 filing from the U.S. Securities and Exchange Commission on Monday showed that Loerop purchased 14,705 shares of Aclaris Therapeutics. The total transaction amounted to $99,958.

Aclaris Therapeutics shares are trading up 12.58% at $7.43 at the time of this writing on Tuesday morning.

https://uk.investing.com/news/stock-market-news/massive-insider-trade-at-aclaris-therapeutics-3137884

Inspira Expands Agreement for Trials of INSPIRA™ ART Respiratory Medical Devices

 Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira"), a company dedicated to advancing acute respiratory care by enabling breathing without lungs, announced today that it has signed a further Service Agreement to supplement its previously announced Strategic Agreement with Innovimed Sp. z o.o ("Innovimed") for planned clinical trials (clinical pilot studies) of the INSPIRA™ ART medical devices.

The extended agreement covers any European country. The company to-date have signed summary distribution agreements with Innovimed in Poland, Czech Republic and Slovakia, subject to completion of product development and regulatory approval, potentially generating over $130 million in revenues for the Company over seven years.

The Company medical devices are aimed at significantly reducing mortality rates and the risk of coma, bacterial infections, and other related risks that are prevalent in legacy invasive mechanical ventilation systems used today in twenty million patients every year.

https://www.biospace.com/article/releases/inspira-signs-agreement-expansion-with-innovimed-for-clinical-trials-of-inspira-art-respiratory-medical-devices/

FibroGen Misses Primary Endpoint in Phase 3 Clinical Study in Duchenne

  FibroGen, Inc.,  (NASDAQ: FGEN) today announced topline data from the Phase 3 LELANTOS-2 trial of pamrevlumab for the treatment of ambulatory patients with Duchenne muscular dystrophy (DMD) on background systemic corticosteroids. The study did not meet the primary endpoint of change in the North Star Ambulatory Assessment (NSAA) total score from baseline to week 52 (placebo-corrected mean difference -0.528 points; 95% CI -2.308 to 1.251; p=0.5553). Secondary endpoints measured by change from baseline at week 52 in 4-stair climb velocity, 10-meter walk/run test, time to stand, time to loss of ambulation, and proportion of patients with greater than 10 seconds in the 10-meter walk/run test were also not met.

https://www.biospace.com/article/releases/fibrogen-announces-topline-results-from-lelantos-2-a-phase-3-clinical-study-of-pamrevlumab-in-ambulatory-duchenne-muscular-dystrophy/

Lilly’s Cholesterol Pill Shows Early Promise in Phase I Study

 A first-in-human Phase I trial showed that Eli Lilly’s investigational oral lipoprotein(a) inhibitor muvalaplin was safe and could elicit sharp reductions in concentrations of the cholesterol formation.

The study, published Monday in the medical journal JAMA, demonstrated that the pill lowered Lp(a) levels within 24 hours of the first administration. Subsequent muvalaplin doses led to further Lp(a) reductions.

The placebo-adjusted decrease in Lp(a) reached a maximum of 63% to 65% in the muvalaplin arm. Of the 114 participants, more than 90% achieved plasma Lp(a) levels lower than 50 mg/dL. These promising signals of efficacy did not come with worrying safety signals, according to the JAMA study. Muvalaplin also did not significantly alter plasminogen levels or activity.

“Muvalaplin is the first oral agent specifically developed to lower levels of Lp(a) by disrupting its formation,” the study’s authors wrote, adding that the drug candidate also represents a novel treatment option for targeting Lp(a).

Lilly has taken muvalaplin into Phase II assessments, according to its website, and is developing the small molecule Lp(a) for cardiovascular diseases.

In atherosclerotic cardiovascular diseases, there sometimes remains a residual likelihood of cardiovascular events despite optimally suppressed levels of low-density lipoprotein (LDL) cholesterol. This points to the need of addressing other risk factors and potentially related biomarkers, among them Lp(a).

A variant of LDL cholesterol, Lp(a) that carries an apolipoprotein(a) molecule covalently bound to apolipoprotein(B). According to the Centers for Disease Control and Prevention, high Lp(a) levels have been tied to worse risks of heart attack or stroke, particularly in people with family histories of these conditions. Lp(a) also plays a role in the narrowing of the aortic valve.

Muvalaplin, an oral small molecule inhibitor of Lp(a), works by disrupting the covalent bond between apolipoprotein(a) and apolipoprotein(B), thereby preventing the formation of the complete Lp(a) molecule.

“This drug is a gamechanger in more ways than one. Not only do we have an option for lowering an elusive form of cholesterol, but being able to deliver it in an oral tablet means it will be more accessible for patients,” Stephen Nicholls, director of Monash University’s Victorian Heart Institute who led the trial, said in a statement.

Beyond muvalaplin, Lilly has also started working on other Lp(a)-directed therapies. In October 2018, the company signed a licensing and research collaboration deal with Dicerna Pharmaceuticals to develop RNA interference-based treatments for cardiometabolic indications. This partnership gave rise to lepodisiran, a siRNA candidate whose Investigational New Drug application was approved in May 2021.

Lepodisiran is now currently in Phase II development for diabetes and obesity.

In June 2023, Lilly signed another collaboration contract, this time with Verve for a one-time gene editing program targeting Lp(a).

https://www.biospace.com/article/lilly-s-cholesterol-pill-shows-promise-in-phase-i-study/