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Wednesday, February 10, 2021

Therapeutic Solutions International Acquires Stem Cell Therapy

 Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today acquisition of the JadiCell™, cell therapy, for use in the treatment of acute respiratory distress syndrome and other lung pathologies. 

"Having worked with the Team at Therapeutic Solutions International for over 4 years, I am glad to place our highly promising and clinically advanced stem cell therapy into this innovative and cutting-edge company," said Dr. Amit Patel, inventor of the JadiCell. "Therapeutic Solutions International is unique in that it is currently running clinical trials in the area of nutraceuticals, as well as developing preclinical and clinical stage immunotherapies.  There are numerous synergies to be had with the existing work and expertise in the Company."

"While there is a lot of excitement about various approaches to lung inflammation, there are very few therapies that not only potently block pathological immunity while concurrently induce regeneration of pulmonary tissues," said Dr. James Veltmeyer, Chief Medical Officer of the Company.  "To date, by far the most promising regenerative therapy our scientists have worked with for acute respiratory distress syndrome (ARDS) has been the JadiCell.  I am honored to work with our team of experts such as Dr. Francesco Marincola and Dr. Santosh Kesari in leading the JadiCell through Phase III and into the hands of patients."

"It is a significant accomplishment to acquire rights to this extremely promising and cost-effective technology that is scalable and functions as a 'cellular drug,'" said Famela Ramos, Vice President of Business Development. "To our knowledge this is the only stem cell therapy for lung pathologies that does not require animal components and can be generated in sufficient quantities to address the multi-billion-dollar market of ARDS."

"Dr. Patel and his team have been strong collaborators with us since our first licensing deal using the JadiCell for Chronic Traumatic Encephalopathy," stated Timothy Dixon, President and CEO of the Company. "Having worked with these cells, we appreciate that to date they are by far the most effective at production of cytokines, stimulation of regeneration, and inhibition of pathological inflammation.  We are extremely confident in our ability to take these cells to the finish line in treatment of end stage lung disease."

https://www.prnewswire.com/news-releases/therapeutic-solutions-international-acquires-stem-cell-therapy-that-successfully-completed-fda-double-blind-placebo-controlled-efficacy-study-for-lung-disease-301225932.html

Galapagos, Gilead End ISABELA Phase 3 Trials in IPF

 Galapagos NV (Euronext & Nasdaq: GLPG) and Gilead Sciences (Nasdaq: GILD) today announced the decision to halt the ISABELA Phase 3 clinical studies with the investigational autotaxin inhibitor ziritaxestat in patients with idiopathic pulmonary fibrosis. The decision is based on the recommendations of the Independent Data Monitoring Committee (IDMC) which, following a regular review of unblinded data, concluded that ziritaxestat’s benefit-risk profile no longer supported continuing these studies. Detailed data of the ISABELA studies will be presented at future medical meetings.

All clinical trials with ziritaxestat, including the long-term extension of the Phase 2a NOVESA trial in systemic sclerosis, will be discontinued.

https://finance.yahoo.com/news/galapagos-gilead-discontinue-isabela-phase-140000279.html

Panbela Updates on Current Trial, Decision to Hold Administration of SBP-101

 

  • Panbela is studying patients with pancreatic cancer testing investigative agent SBP-101 when used in combination with standard of care agents gemcitabine and nab-paclitaxel

  • Panbela’s independent data safety monitoring board (DSMB) recommended SBP-101 be held for ongoing patients in order to obtain additional safety information but will continue with the standard drug regimen

  • All other trial activities continue

Sema4, AI-driven Genomic Clinical Data Platform, to Merge with CM Life Sciences

 

  • Transaction combines Sema4’s leading AI- and machine learning-powered integrated genomic and clinical open-architecture data platform, with CM Life Sciences, the leading life science-focused SPAC, led by institutional investors Casdin Capital and Corvex Management.

  • Combination is expected to provide up to $793 million in cash proceeds to shareholders and Sema4, accelerating organic and inorganic growth and fueling the company’s mission to transform health outcomes and decision making.

  • Financing includes a fully committed PIPE of $350 million from leading growth and life science investors including Casdin Capital, Corvex Management, Fidelity Management & Research Company LLC, Counterpoint Global (Morgan Stanley), Perceptive Advisors, SB Management, a subsidiary of SoftBank Group Corp, funds and accounts advised by T. Rowe Price Associates Inc and Viking Global Investors, and existing investors including fund and accounts managed by Blackrock and Deerfield Management.

  • Sema4 board at closing to include Nat Turner Co-Founder of Flatiron Health (a Roche Company), Emily Leproust CEO of Twist Biosciences (NASDAQ: TWST) and Eli Casdin, CIO of Casdin Capital.

'Why Cancer Genetics Shares Are Moving'

 The shares of biotech firm Cancer Genetics (NASDAQ:CGIX) surged more than 160% in pre-market trading on Wednesday morning. Earlier this week, the New Jersey provider of preclinical services filed an SEC form S-4 indicating its board approved the proposed merger with StemoniX. CGIX stock more than doubled on news of the deal announced on Aug. 24.

CGIX stock holders will be asked to vote on the merger on March 24. The holders will also be asked to approve a reverse stock split proposal. That proposal would give the company’s board the discretion to effect a reverse split in the range from one share for two shares, to one share for 10.

reverse stock split is typically undertaken by companies seeking to consolidate existing shares into fewer, proportionally more valuable, shares, usually boosting the stock’s price as a result.

The filing follows Cancer Genetics’ closing on Feb. 1 of a private placement of about $10 million. This was done by issuing about 2.76 million common shares and warrants to purchase a similar amount at a combined purchase price of $3.625 per share.

CGIX Merger Seeks to Speed Drug Development

The proposed merger is an attempt to reduce the time and labor required to bring new drugs to market, Jay Roberts, CEO of Cancer Genetics, said in August. “We are at unique time in the drug discovery industry as the convergence of technological innovations in both biology and software will transform conventional workflows in time and accuracy,” he said in a statement then.

Effectively a preclinical services company, CGIX operates its vivoPharm subsidiary supporting clinical diagnostic offerings at early stages to pharmaceutical industry, biotechnology companies and academic research centers.

With the merger, both companies can now collaborate on drug discovery and development for two major areas: advanced animal models and relevant human high-throughput organoid platforms.

https://investorplace.com/2021/02/cgix-stock-why-cancer-genetics-shares-are-rocketing-higher-today/

Bio-Path Gets 3rd U.S. Patent to Manufacture of Platform Tech

 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced that the United States Patent and Trademark Office has granted U.S. Patent No. 10,898,506 titled, "P-ethoxy nucleic acids for liposomal formulation." The new patent builds on earlier patents granted that protect the platform technology for DNAbilize®, the Company’s novel RNAi nanoparticle drugs.

In addition, the United States Patent and Trademark Office has mailed an Issue Notification for a patent related to the Company’s lead product candidate, prexigebersen, in combination with either a cytidine analogue, such as decitabine, or the Bcr-Abl tyrosine kinase inhibitors dasatinib and nilotinib. Prexigebersen is a liposomal formulation containing the antisense oligodeoxynucleotide targeting growth factor receptor-bound protein 2 (Grb2). The new patent is scheduled to issue as U.S. Patent No. 10,927,379 on February 23, 2021.

“Our innovative DNAbilize platform improves upon the drawbacks of traditional approaches, which are limited by the toxicity induced by either the DNA backbone or the lipid delivery,” said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. “DNAbilize overcomes these challenges by combining a neutral charge P-ethoxy DNA backbone with a neutral charge liposome. The result is a high payload liposome with DNA safely delivered inside non-toxic cell membrane-like molecules, allowing us to deliver antisense DNA in high doses to target cells through the blood and lymphatic system with no evidence of toxicity in patients in clinical trials to date, in contrast to other lipid delivery technologies with dose limiting toxicities.”

https://finance.yahoo.com/news/bio-path-receives-third-u-120000403.html

New Frontier receives proposal to go private in nearly $1.72 bln deal

 New Frontier Health Corp said onWednesday it received an offer to be bought out by a consortiumof investors in a deal that values the healthcare serviceprovider at nearly $1.72 billion.

The company said in a statement it received a preliminarynon-proposal binding letter from a buyer-group, includingPresident Carl Wu, Carnival Investments, Vivo Capital Fund IX,Max Rising International Ltd, a company affiliated with Carl Wu,among others to "go private".

The group offered to acquire outstanding shares of NewFrontier Health, which operates private hospitals, outpatientclinics and medical centers, for $12 in cash, representing apremium of 23.6% to the company's closing price on Tuesday.

New Frontier Health was formed after blank-check company NewFrontier Corp acquired United Family Healthcare, one of thelargest private operators in China, from private equity firm TPGand Shanghai Fosun Pharmaceutical Group Co Ltd for$1.4 billion in 2019.

A special committee of the Board will be formed to considerthe proposal letter and cautioned that there is no assurancethat any definitive offer will be made by the buyer-group, NewFrontier said.

https://finance.yahoo.com/news/1-frontier-receives-proposal-private-112251033.html