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Thursday, August 17, 2023

Bruker to Acquire PhenomeX in All-Cash Transaction

 Bruker Corporation (Nasdaq: BRKR) and PhenomeX Inc. (Nasdaq: CELL) today announced that they have signed a definitive agreement for Bruker to acquire PhenomeX for $1.00 per share in an all-cash transaction. The proposed acquisition values PhenomeX at a total equity value of approximately $108 million. PhenomeX is a functional cell biology company that provides single-cell biology research tools to deliver deep insights into cellular function and new perspectives on phenomes and genotype-to-phenotype linkages.

PhenomeX was formed in early 2023 through the combination of Berkeley Lights and IsoPlexis, and PhenomeX currently has an installed base of more than 400 instruments. PhenomeX provides single-cell biology workflows with instruments, software and molecular biology reagents. The PhenomeX products include the key Beacon® Optofluidic platform, as well as the IsoLight® and IsoSpark® proteomics barcoding platform. The Beacon Optofluidic system enables researchers to accelerate biologics product development by functional characterization of tens of thousands of single cells in parallel, while maintaining the cells in a healthy state for further genomic and proteomic profiling, connecting phenotype with genotype and other multiomic information. The Protein Barcoding Suite includes the IsoLight® and IsoSpark® instruments, which automate multiplexed measurements of the extracellular proteome and of the intracellular proteome of single cells for translational research.

Dr. Mark R. Munch, President of the Bruker NANO Group, commented: “The unique single-cell analysis platforms of PhenomeX are enabling researchers to more rapidly and precisely unlock new insights in functional cell biology research leading to important discoveries across the large and rapidly growing markets of antibody therapeutics, cell line development, cell therapy and gene therapy. This acquisition will mark Bruker’s entry into single-cell biology research tools, which complements Bruker’s emerging spatial biology business - in support of our transformational Project Accelerate 2.0 strategy.”

https://www.biospace.com/article/releases/bruker-corporation-and-phenomex-inc-announce-definitive-agreement-for-bruker-to-acquire-phenomex-in-all-cash-transaction/

Boehringer Initiates Phase III Obesity Trials, Seeks to Challenge Novo and Lilly

 Boehringer Ingelheim is looking to challenge Novo Nordisk and Eli Lilly in the lucrative obesity market, advancing its weight-loss injectable into pivotal studies. The company announced Thursday it will initiate three Phase III trials for its glucagon/GLP-1 receptor dual agonist with patient enrollment planned before the end of the year. 

In a Phase II trial, overweight or obese participants on survodutide saw close to 19% weight loss after 46 weeks of treatment. Weight reduction had not plateaued at the 46-week mark, suggesting additional weight loss could occur with longer treatment, the company said.  

Up to 40% of participants who reached the highest two doses achieved a weight loss of at least 20%, suggesting survodutide to be at least as effective if not more than the competition. 

For the moment, Novo Nordisk’s Wegovy stands alone in its approval to treat obesity. Patients on Wegovy reported an average weight reduction of just under 10% in people with overweight or obesity and Type 2 diabetes (T2D). 

Lilly’s Mounjaro seems more effective. A clinical trial comparing Lilly’s T2D drug head-to-head with Wegovy for weight loss is under way, to be completed by December 2024. A Phase III trial of Mounjaro compared to placebo resulted in 15.7% body weight reduction for those on the highest dose after about 18 months. Just under a third of participants reported a 20% weight loss. 

An FDA nod for an obesity indication for Lilly is anticipated by the end of 2023. 

With an estimate that 2.7 billion adults will be overweight or obese by 2025, the potential for weight-loss drugs like Novo’s, Lilly’s and Boehringer’s is massive. Morgan Stanley analysts predict the global obesity drug market to reach $50 billion by 2030.  

Oral formulations are also underway. Novo Nordisk is testing an oral formulation of semaglutide. A once-daily dose of 50 mg resulted in weight loss of just over 15% compared to placebo in overweight or obese adults without T2D. 

Pfizer is also working on an oral weight-loss drug, danuglipron. Phase II study results show a similar weight loss to Novo Nordisk’s injectable.  

Survodutide was co-invented by Boehringer and Zealand Pharma. The injection is also in a Phase II study for adults with nonalcoholic steatohepatitis (NASH) and liver fibrosis, with or without T2D. 

https://www.biospace.com/article/boehringer-initiates-phase-iii-obesity-trials-seeks-to-challenge-novo-and-lilly-/

Nuvectis: Orphan Drug Designation Granted by the FDA for Treatment of Cholangiocarcinoma

 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced that NXP800 was granted Orphan Drug Designation by the United States Food and Drug Administration (“FDA”) for the treatment of cholangiocarcinoma.

https://finance.yahoo.com/news/nuvectis-pharma-announces-orphan-drug-120000651.html

Pieris Milestone: Boston Pharmaceuticals' Initiation of Phase 1/2

 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company focused on novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases and cancer, today announced that the Company has achieved an undisclosed milestone payment from Boston Pharmaceuticals. The milestone is based on dosing the first patient in a Boston Pharmaceutical-sponsored phase 1/2 study of BOS-342 (formerly PRS-342), a 4-1BB/GPC3 immuno-oncology antibody-Anticalin fusion (Mabcalin™) bispecific protein, which was discovered by Pieris and licensed to Boston Pharmaceuticals and designed to provide a potent costimulatory bridge to exert tumor killing activity through the recruitment of T-cells.

The open-label phase 1/2 study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BOS-342. The Phase 1 dose escalation portion of the study is expected to enroll adults with hepatocellular carcinoma (HCC) that progressed on at least one prior treatment and establish a recommended Phase 2 dose. If pursued, the Phase 2 portion of the study will evaluate efficacy, as measured by overall response rate.

The study is funded and conducted by Boston Pharmaceuticals, who exclusively licensed worldwide rights to BOS-342 in April 2021. In addition to the milestone announced today, Pieris could potentially be entitled to receive up to approximately $350 million in development, regulatory and sales-based milestone payments, and tiered royalties on sales of BOS-342.

https://finance.yahoo.com/news/pieris-pharmaceuticals-announces-milestone-achievement-120000275.html

CRISPR upped to Buy by Citi

 From Neutral

https://finviz.com/quote.ashx?t=CRSP&ty=c&ta=1&p=d

BeiGene started at Buy by Jefferies

Target $287 

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

D.C. Circuit Hands Down Major Free Speech Victory For Pro-Life Group

  by Jonathan Turley,

The U.S. Court of Appeals for the D.C. Circuit has handed down a major victory for free speech against the District of Columbia.  In Frederick Douglass Foundation v. District of Columbia, Judge Neomi Rao reversed district court judge James E. Boasberg who dismissed the challenge by pro-life protesters who alleged that they were treated differently from Black Lives Matter (BLM) protesters. The selective enforcement of city ordinances gave what Judge Rao called “a monopoly in expressing its views . . . the antithesis of constitutional guarantees.”

The contrast in these cases was raised by a few commentators and sites in prior years.

In the summer of 2020, the city allowed thousands of Black Lives Matter protesters to take over streets in D.C. without any permit. The police watched as protesters wrote slogans and slurs on stores, streets, and sidewalks with paint and chalk. No one was arrested.

However, later two pro-life advocates in a protest in front of a D.C. Planned Parenthood facility were immediately arrested when they chalked “Black Pre-Born Lives Matter” on a public sidewalk.

Chief Judge Boasberg previously held that they had no right to challenge the selective enforcement of the laws. They simply had to plead guilty and accept that their views were not given the same official tolerance.

Judge Rao reversed the trial court and said this is precisely what the First Amendment is meant to prevent. The D.C. Circuit noted that such selective prosecution cases are based on one of the hardest claims to prove: “Selective enforcement claims must clear a high hurdle. Because the lawful exercise of prosecutorial discretion does not violate the Constitution, disparate enforcement of a neutral ordinance based on viewpoint is unlawful only when the prosecutorial factors are similar, and ‘unlawful favoritism’ remains the predominant explanation for the government’s targets.”

While reaffirming the ruling under the Equal Protection Clause, the court reversed on free speech grounds:

The First Amendment prohibits government discrimination on the basis of viewpoint. “To permit one side … to have a monopoly in expressing its views … is the antithesis of constitutional guarantees.” City of Madison Joint Sch. Dist. No. 8 v. Wis. Emp. Relations Comm’n, 429 U.S. 167, 175–76 (1976). The protection for freedom of speech applies not only to legislation, but also to enforcement of the laws. This case concerns a constitutional challenge to the selective enforcement of the District of Columbia’s defacement ordinance against some viewpoints but not others.

In the summer of 2020, thousands of protesters flooded the streets of the District to proclaim “Black Lives Matter.” Over several weeks, the protesters covered streets, sidewalks, and storefronts with paint and chalk. The markings were ubiquitous and in open violation of the District’s defacement ordinance, yet none of the protesters were arrested. During the same summer, District police officers arrested two pro-life advocates in a smaller protest for chalking “Black Pre-Born Lives Matter” on a public sidewalk.

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Viewpoint discrimination, whether by legislative enactment or executive action, violates the First Amendment. “Once a forum is opened up to assembly or speaking by some groups, government may not prohibit others from assembling or speaking.” Police Dep’t of Chi. v. Mosley, 408 U.S. 92, 96 (1972). We hold the Foundation has plausibly alleged the elements of a free speech selective enforcement claim. We may reasonably infer from the Foundation’s complaint, first, that its members were similarly situated to other protesters who were not arrested and, second, that the District engaged in viewpoint discrimination by enforcing the defacement ordinance against individuals chalking “Black Pre-Born Lives Matter” but not against individuals painting and chalking “Black Lives Matter.”

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The First Amendment prohibits the government from favoring some speakers over others. Access to public fora must be open to everyone and to every message on the same terms. The District may act to prevent the defacement of public property, but it cannot open up its streets and sidewalks to some viewpoints and not others. During the summer of 2020, the District arrested individuals chalking “Black Pre-Born Lives Matter” on the sidewalk, while making no arrests against the many individuals marking “Black Lives Matter” on sidewalks, streets, and other property.”

Once again, the media virtually ignored the sharply different treatment and this case despite its obvious importance to free speech.  Moreover, the D.C. government spent considerable money and time to defend its right to arrest certain protesters while allowing others to commit the same acts.

Here is the opinion: Frederick Douglass Foundation v. District of Columbia,

https://www.zerohedge.com/political/monopoly-expressing-its-views-dc-circuit-hands-down-major-free-speech-victory-pro-life