On October 13, 2024 Xspray Pharma (publ) (Nasdaq Stockholm: XSPRAY) reported that the Company has obtained results from the bioequivalence studies with the generic product candidate HyNap-Dasa ANDA C (Press release, Xspray, OCT 13, 2021, View Source [SID1234649573]). The results show that the bioequivalence with the reference product Sprycel was achieved in fed but not in fasting subjects due to the high variability of Sprycel. The Company now chooses to focus entirely on the improved version, Dasynoc, which has achieved bioequivalence with a 30 percent lower dose than Sprycel, and decides to end development of the generic version of dasatinib.

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"We have been developing the generic and the improved versions of dasatinib, Dasynoc, in parallel, but now we choose to focus on Dasynoc since the market value is high not only during, but also after the end of the patent window. A shorter time in the patent window decreases the importance of the generic version in our product portfolio. An important consequence of this decision is to free up the capacity to accelerate the development of our current product candidates in the pipeline with longer patent window. The development of Dasynoc has been rapid and we can take advantage of the clinical improvements that amorphous formulations of protein kinase inhibitors (PKIs) provide for patients, doctors and payers", says Per Andersson, CEO of Xspray Pharma.

Submission for the market approval for Dasynoc in the USA is scheduled as planned for the fourth quarter this year, in accordance with the 505(b)(2) procedure.

On October 13, 2021 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported an agreement with the Broad Institute for the distribution of a customized next-generation sequencing (NGS) target enrichment exome panel designed for the identification and research of a wide range of cancer, rare and inherited disease genes from patient samples (Press release, Twist Bioscience, OCT 13, 2021, View Source [SID1234591190]). Twist will market this expert-developed exome panel as the Twist Alliance Clinical Research Exome.

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The Twist Alliance Clinical Research Exome helps support the Broad Institute Genomics Platform and was designed using validated data from clinical patient samples. The panel leverages Twist’s flexible NGS platform to easily and quickly customize content, resulting in a comprehensive survey of the exome with supplemental enrichment of clinically relevant areas of the genome related to cancer as well as rare and inherited diseases. By leveraging the best-in-class uniformity of Twist NGS probes, the assay enables a per sample cost and throughput efficiency that Broad has already leveraged to process more than 250,000 samples to date, keeping it on the leading edge of exome sequencing.

"Exome sequencing has long been a key part of our sequencing efforts for large cancer and germline research studies. Our development with Twist has leveraged many of our learnings on the technical side and pulls in knowledge from collaborating investigators to provide an enhanced exome that will increasingly span both research and clinical applications in which results are returned to patients" said Stacey Gabriel, senior director of the Broad Institute Genomics Platform.

The Twist Alliance Clinical Research Exome will be available for customers in mid-October. The full design of this panel includes the Twist Core exome, the mitochondrial genome, and additional validated coding and non-exonic regions of interest such as the ACMG73 genes, supplemental coverage of regions from OMIM and COSMIC, and specific Broad-defined targets. To see Broad’s Director of Genomics Research and Development Brendan Blumenstiel presenting data on the panel, visit: View Source

"Typically, in cancer research studies, there is a great need to focus sequencing efforts on particular genes or mutations but often with a small number of samples available. Leveraging the Broad’s vast expertise, together we have developed a specialized custom panel that enables deeper sequencing, producing validated genetic variants that could be used for therapeutic intervention," said Emily M. Leproust, PhD, chief executive officer and co-founder of Twist Bioscience. "We are thrilled to bring this important tool to our customers to drive deep insights into research and potentially therapeutic development."

About Twist Alliance Panels

In partnership with leading research institutions from around the world, Twist has curated a collection of high-quality target enrichment panels for applications ranging from carrier screening to cancer diagnostics and whole exome sequencing. The Twist Alliance Panels combine the strengths of precise, highly uniform oligonucleotide synthesis with the specialty expertise of leading scientific research partners.

Well designed, custom target enrichment panels enable increased sequencing depth on target genes while reducing overall

On October 13, 2021 University of Zurich reported that discovered that antidepressants, such as selective serotonin reuptake inhibitors (SSRIs), could slow pancreatic and colon cancer growth in mice (Press release, University of Zurich, OCT 13, 2021, View Source [SID1234591412]). Furthermore, in some cases, when antidepressants are combined with immunotherapy, the tumor could entirely disappear.

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Selective serotonin reuptake inhibitors 2016
Because the drugs the researchers used in their study are already FDA-approved, they could rapidly be available for cancer patients if human clinical trials confirmed the findings from the animal studies. The study was published in Science Translational Medicine.

Another animal study led by a team from the University of British Columbia showed that a drug used in cancer care could reinstate memory in mice with Alzheimer’s disease.

Axitinib2DACS.svg
The drug named Axitinib is FDA-approved to treat cancer. However, clinical trials are needed to see if the drug will show the same promising results in humans. The study was published in The Lancet.

On Oct. 13, 2021 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, reported the closing of its previously announced concurrent but separate underwritten public offerings of 17,064,511 shares of its common stock, including the exercise in full by the underwriters of their option to purchase an additional 2,225,805 shares of common stock, at a price to the public of $1.55 per share and 774,194 shares of its Series X Convertible Preferred Stock at a price to the public of $15.50 per share (Press release, Cidara Therapeutics, OCT 13, 2021, View Source [SID1234636982]). The gross proceeds to Cidara from these offerings, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $38.5 million.

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Cantor Fitzgerald & Co. acted as the sole book-running manager for each offering. Wedbush PacGrow acted as the lead manager. Needham & Company, Maxim Group LLC and Aegis Capital Corp. acted as co-managers.

The securities described above were offered by Cidara pursuant to a shelf registration statement, which has been declared effective by the Securities and Exchange Commission (SEC). The offering was made only by means of a prospectus and prospectus supplements. Final prospectus supplements and the accompanying prospectus relating to the offerings have been filed with the SEC and are available for free on the SEC’s website located at View Source Copies of the final prospectus supplements and the accompanying prospectus relating to these offerings may be obtained from: Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 4th Floor, New York, New York 10022, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On October 13, 2021 Lixte Biotechnology Holdings, Inc. (Nasdaq: LIXT) reported entry into a collaboration with the Netherlands Cancer Institute, Amsterdam (NKI) , one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, to identify the most promising drugs to be combined with LB-100, and potentially LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations (Press release, Lixte Biotechnology, OCT 13, 2021, View Source [SID1234591171]).

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The pre-clinical studies are directed by Professor René Bernards (NKI), a leader in using genome wide functional genetic techniques to identify effective drug combinations, new drug targets, and mechanisms of resistance to cancer drugs. Using this technology, prof. Bernards’ group identified the now FDA-approved combination of BRAF and EGFR inhibitors for a group of colon cancer patients (Nature 483, 100-103, 2012), and more recently reported the identification of a new two drug regimen for liver cancer, which in preliminary Phase 1 clinical trials appears to be more active than standard therapy (Nature 595, 730–734, 2021).

Dr. John S. Kovach, CEO and founder of Lixte, said "We are extremely pleased to have the opportunity to collaborate with Professor Bernards and his excellent group. There are many pre-clinical studies demonstrating the ability of our lead compound, LB-100, an inhibitor of protein phosphatase 2A, to potentiate the activity of different cytotoxic drugs. Its ubiquitous activity and low toxicity have made it challenging to select the most promising clinical targets for this novel compound. A targeted approach to cancer treatment has been a long-standing research goal. Prof. Bernards’ approach makes it possible to select among a multitude of compounds those most likely to be effective when combined with a second drug and/or in cancers with a particular molecular abnormality. The possibility of identifying which drug in combination with LB-100 and in which type of tumor is most likely to be beneficial is a very exciting prospect."

Professor Bernards commented, "We are excited to work with Lixte to identify the most powerful drug combinations of LB-100 for cancer therapy. Our unbiased genetic approach to identify synthetic lethal drug targets of LB-100 has proven its utility in our previous studies."