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Xspray Pharma reports positive results from a study with dasatinib during omeprazole treatment

On December 30, 2020 Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) reported that it has received positive preliminary results from a bioavailability study in healthy volunteers with an improved HyNap-Dasa version of the reference drug Sprycel, demonstrating that absorption of HyNap-Dasa is not dependent on the gastric pH level (Press release, Xspray, DEC 30, 2020, View Source [SID1234649571]). HyNap-Dasa is being developed both as a generic and improved version of the marketed drug Sprycel (dasatinib).

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The preliminary results from the bioavailability study demonstrates that solubility and absorption of Xspray Pharma’s amorphous version of dasatinib, HyNap-Dasa, is not dependent on the gastric acidity (pH level). Xspray Pharma has earlier announced positive preliminary data for a sub-group of the subjects in the study.

As disclosed in Sprycel US labelling, the uptake is dependent on the patient’s gastric acidity. Increased pH dramatically decreases dasatinib´s solubility and absorption. The results from Xspray Pharma’s clinical study show that HyNap-Dasa is not affected during omeprazol treatment which increases the gastric pH. The results from the current conducted study shows a minor absorbtion increase of 8%, measured as area under the curve (AUC) after treatment with 40 mg of omeprazole (proton pump inhibitor) daily for five days. This can be compared to publiced data for Sprycel where AUC was reduced by 43% in combination with omeprazole. In 2019, Sprycel was the leading drug for the treatment of chronic myeloid leukaemia (CML) in sales, with global and US sales of 2,11 and 1,19 billion dollar, respectively.

"We have now demonstrated that our amorphous HyNap-Dasa formulation, produced in our commercial supply chain, can eliminate the pH dependent absorption seen in the crystalline reference product. This will allow for long-lasting acid suppressing medication also for CML patients treated with dasatinib. There are also patients with no production of hydrochloric acid in the stomach (achlorhydria) resulting in high gastric pH. These patients will have the chance to get a better dasatinib product for their cancer therapy," says Per Andersson, CEO of Xspray Pharma. "For many of the amorphous drug candidates we decide to develop, we will have the possibility to develop either a generic or an improved version, or both where we see a clinical and commercial rationale. This makes multiple registration pathways also for our lead product candidate possible and will not only increase Xspray Pharma’s value proposition to potential partners, but also broaden the commercial possibilities for Xspray Pharma as a company".

BiocurePharm, Korea (“BPK”) Announces the Submission of IND Application for Phase 1 Trial of CD19 CAR-T Therapy

On December 30, 2020 Biocure Technology Corp. ("CURE" or the "Company") (CSE:CURE; OTCQB: BICTF) BiocurePharm, Korea ("BPK"), a subsidiary of Biocure Technology Inc. ("CURE") reported that BiocurePharm Korea ("BPK") and Pharos Vaccine Inc. ("PVI") have jointly submitted an Investigational New Drug ("IND") application to the Korean Ministry of Food and Drug Safety ("KFDS") to proceed with clinical trial Phase 1 for CD19 CAR-T therapy to treat Acute Lymphocyte Leukemia ("ALL") (Press release, Biocure Technology, DEC 30, 2020, View Source [SID1234628750]).

CD19 CAR-T is an immune cell therapy for relapse and refractory B-cell precursor acute lymphoblastic leukemia, demonstrating a significantly high CR ("Complete Remission") rate as an individual medical prescription for a custom-made product for an individual patient.

BPK plans to conduct a clinical trial at two renowned hospitals in Korea, Seoul A-San Medical Center and Seoul St. Mary`s Hospital upon the approval of the IND application by KFDS. BPK anticipates the completion of the Phase 2 clinical trial no later than the first half of 2023. Once completed and pending positive results in the clinical trials, the drug would be released for commercialization in Korea and potentially internationally.

Dr. Sang Mok Lee, CEO and President of Biocure and BPK, states "This is an important milestone for the Company to advance its CAR T technology. We are about to start a clinical trial in Korea and are confident that if we have positive outcomes from the Korean clinical trial, this should enable the therapy to be readily available and offer affordable CAR T Therapy to save more lives."

Scientists develop new drug that targets pathway found in several hard-to-treat cancers

On December 30, 2020 Cancer Research UK reported that scientists have finally found a way to target the KRAS mutation – a common mutation found in several hard-to-treat cancers (Press release, Cancer Research UK, DEC 30, 2020, View Source [SID1234573621]).

By targeting two components of the KRAS signalling pathway, a new drug was much better at stopping the growth of pancreatic tumours with a KRAS mutation in mice compared to standard KRAS inhibitors, which only block one component of the pathway.

The drug, which has already shown promise in one sarcoma patient whose tumour had a KRAS mutation, will next be tested in patients with a variety of cancers in a larger Phase II clinical trial. The results are published in Annals of Oncology(link is external) today (Wednesday).

Changes to the KRAS gene, which is important in controlling cell growth, can lead to cells growing and dividing out of control to form tumours. Mutations in KRAS are found across 25% of cancers and are commonly found in several hard-to-treat cancers, including pancreatic, lung and colorectal tumours*.

Despite the prominent role of KRAS mutations in cancers and clear need for new treatments, scientists have been working for decades trying to find ways to target this pathway. Researchers say the main issue is because current KRAS inhibitors only target one component of the signalling pathway.

Now, a team of researchers led by Professors Caroline Springer and Richard Marais at the Cancer Research UK Manchester Institute have developed a new drug called CCT3833, which blocks two pathways in the KRAS signalling pathway called RAF and SRC.

The scientists tested CCT3833 in pancreatic, colorectal and lung cancer cell lines that had KRAS gene changes, as well as pancreatic tumours in mice, and compared the new drug with other standard KRAS inhibitors**.

Results showed that CCT3833 was able to restrict the growth of the cancer cells. It was also more effective in killing the cancer cells compared with other KRAS inhibitors. This was even more apparent when using 3D spherical tumour models, or ‘mini tumours’, which bridge the environment of cells grown in the lab and tumours in the body.

When tested in mouse models of pancreatic cancer with KRAS mutations, CCT3833 was more effective than other drugs in preventing cancer growth. CCT3833 also reduced tumour size.

The study also describes the results of an early phase clinical trial of the drug tested in 31 patients with solid tumours. Whilst primarily designed to test safety, one patient in the trial who had a KRAS-mutant tumour that was growing larger after failing to respond to standard treatment had their tumour reduce in size for 8 months after receiving CCT3833.

The team is now planning to investigate the drug in further clinical trials.

Professor Caroline Springer, director of the drug discovery unit at the Cancer Research UK Manchester Institute, said: "Faulty KRAS signalling in cancer was identified over 35 years ago and yet, we still cannot block this pathway effectively. Our new drug stops the function of two critical growth pathways in KRAS-driven cells and has shown to be more effective than current drugs that only block one part of the pathway. We now need to run broader clinical trials to see how many cancer patients could benefit from this drug."

Professor Richard Marais, director of the Cancer Research UK Manchester Institute, said: "Cancers with a KRAS gene change have been notoriously difficult to treat. Because current drugs that target KRAS are only able to block one part of the pathway, cancer cells can easily outmanoeuvre treatments. It’s extremely encouraging to see that the impressive effects of the drug in the lab are already also showing promise in early-stage trials that include hard-to-treat cancers."

Michelle Mitchell, chief executive of Cancer Research UK, said: "This study has built upon almost 20 years of Cancer Research UK-funded research, and shows the importance of investing in basic research in the lab, which unpicks the biology of cancer. Breakthroughs in science are all about small steps that can lead to great change, and these results have brought us closer to a potential new option for people with these difficult-to-treat cancers."

Histogen Announces Pricing of $14.0 Million Upsized Public Offering

On December 30, 2020 Histogen Inc. (Nasdaq: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, reported that it has it has priced a public offering of an aggregate of 14,000,000 shares of common stock (or common stock equivalents offered through the issuance of pre-funded warrants), together with accompanying warrants to purchase up to an aggregate of 14,000,000 shares of common stock, at an effective public offering price of $1.00 per share and accompanying warrant. Each share of common stock (or common stock equivalent offered through the issuance of a pre-funded warrant) will be sold in the offering with one warrant to purchase one share of common stock (Press release, Conatus Pharmaceuticals, DEC 30, 2020, View Source [SID1234573478]). The warrants have an exercise price of $1.00 per share, are immediately exercisable, and expire five years following the date of issuance.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds of the offering are expected to be $14.0 million, prior to deducting placement agent’s fees and other estimated offering expenses payable by Histogen and assuming none of the warrants issued in the public offering are exercised for cash. The offering is expected to close on or about January 5, 2021, subject to the satisfaction of customary closing conditions.

Histogen intends to use the net proceeds from the offering for working capital and general corporate purposes, which may include continued development of products for our CCM, hECM and HSC programs, further research and development, capital expenditures and general and administrative expenses.

The securities described above are being offered by Histogen pursuant to a registration statement on Form S-1 (File No. 333-251491) previously filed with and declared effective by the U.S. Securities and Exchange Commission ("SEC") on December 30, 2020, and an additional registration statement on Form S-1 filed pursuant to Rule 462(b), which became automatically effective on December 30, 2020. The offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the preliminary prospectus and, when available, electronic copies of the final prospectus relating to the offering may be obtained for free by visiting the SEC’s website at www.sec.gov or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by email at [email protected] or by telephone at 646-975-6996.

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

Axial Therapeutics to Present at the ACCESS CHINA Forum @JPM WEEK 2021

On December 30, 2020 Axial Therapeutics Inc., a clinical-stage biotechnology company dedicated to building a unique class of gut-restricted therapeutics for central nervous system (CNS) disorders and conditions, reported that management will participate in a keynote presentation at the ACCESS CHINA Forum @JPM WEEK 2021 Conference on Tuesday, January 5, 2021 at 8:00 PM EST (Press release, Axial Biotherapeutics, DEC 30, 2020, View Source [SID1234573417]).