On January 15, 2021 Taiho Pharmaceutical Co., Ltd. reported its establishment of a new headquarters, Taiho Oncology Europe GmbH in Zug, Switzerland, as a clinical development and commercial base for its pharmaceutical business in Europe (Press release, Taiho, JAN 15, 2021, View Source [SID1234574014]).

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Taiho Oncology Europe is established as a subsidiary of Taiho Pharmaceutical. Together with Taiho Pharmaceutical, Taiho Oncology, Inc. (Princeton, New Jersey), a subsidiary of Taiho Pharmaceutical, will support its operation in Europe.

Taiho Oncology Europe will be responsible for the European commercialization of futibatinib (development code; TAS-120), an FGFR inhibitor currently under development as a new oral anti-cancer agent, after obtaining marketing approval. Futibatinib is not yet approved in any country worldwide.

Taiho Pharmaceutical will further promote its globalization through Taiho Oncology Europe, and will strive to continue its contribution to cancer patients and caregivers worldwide.

On January 14, 2021 Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) reported results from the extra bioequivalence study in fasting healthy volunteers conducted with the Company’s leading product candidate HyNap-Dasa (Press release, Xspray, JAN 14, 2021, View Source [SID1234575598]). The results are in line with previous bioequivalence studies, but the results show that the study design is robust. Xspray Pharma will already next week start the previously communicated bioequivalence studies with modified formulations. Xspray Pharma has recently received positive results for an improved version of Sprycel, based on HyNap-Dasa, and will initiate registration studies for that product during Q1 2021 with the aim to submit for marketing approval according to the 505(b)(2) procedure during Q2 2021.

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The recently conducted bioequivalence study in fasting healthy volunteers was of the same size and design as the study reported under Q3 2020. The results show that the study was well conducted and included a sufficient number of subjects, but that formal bioequivalence was not achieved. In both studies, markedly poor absorption of dasatinib was observed in a few subjects given the reference product Sprycel which was not seen in subjects given the HyNap-Dasa formulation. While the EMA finalized guidance on dasatinib bioequivalence allows the exclusion of the data for these poorly absorbing subjects, US FDA does not.

"This confirms the results of the previous study and our primary focus is now on the two modified formulations of HyNap-Dasa. These are optimized to achieve bioequivalence and enable an ANDA submission. I am glad that we, as promised, can start the first of these studies already next week. At the same time, we are now expanding our product portfolio with an improved product based on the results of the successful study with omeprazole," says Per Andersson, CEO of Xspray Pharma. "We continue to work on commercial partnerships according to plan and can now offer both an improved and a generic version, which strengthens the value of our HyNap-Dasa product portfolio."

Xspray Pharma’s program for registration studies during H1 2021

Improved version of Sprycel – HyNap-Dasa 505(b)(2)
The study with the improved version of HyNap-Dasa, reported on December 30, 2020, proved that HyNap-Dasa can be taken concomitantly with omeprazole, which is not possible with Sprycel. Based on these positive results showing a clinically relevant improvement potential, Xspray Pharma will initiate a registration study during Q1 2021. The results will form the basis for submission for the improved product in accordance with the 505(b)(2) procedure planned during Q2 2021. Xspray Pharma has also begun work on an application for Orphan Drug Designation (ODD) for this product candidate.

Generic version of Sprycel – HyNap-Dasa ANDA
The work to achieve bioequivalence between HyNap-Dasa and Sprycel continues with two modified formulations of HyNap-Dasa developed together with an expert group of reputable external advisors.

The first formulation involves a minor modification, and a bioequivalence study is planned to start next week. No further stability studies are required for this formulation which, provided positive results, makes the ANDA submission during Q2 2021 possible.

The second formulation is slightly more modified for which reason some stability studies will need to be conducted. The Company expects to start bioequivalence studies with this formulation during Q2 2021 and provided positive results, submit an ANDA in Q3 2021 at the earliest.

Improved version of Nilotinib – HyNap-Nilo 505(b)(2)
As announced in December 2020, Xspray Pharma’s product candidate HyNap-Nilo has received Orphan Drug Designation (ODD) from the FDA for the treatment of chronic myeloid leukemia (CML). A clinical trial program with two different formulations has been initiated.

On January 14, 2021, vTv Therapeutics LLC ("vTv LLC"), a subsidiary of vTv Therapeutics Inc., reported that it entered into the First Amendment to License Agreement with Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. ("Huadong") (the "First Amendment") to amend the License Agreement previously entered into between vTv LLC and Huadong on December 21, 2017 (the "Original Agreement") (Filing, 8-K, vTv Therapeutics, JAN 14, 2021, View Source [SID1234574174]). The First Amendment eliminates vTv LLC’s obligation to sponsor a Phase 2 Multi-Region Clinical Trial and corresponding obligation to contribute up to $3.0 million in support of such trial. The First Amendment also reduces the total potential development and regulatory milestone payments of $25.0 million under the Original Agreement by $3.0 million.

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On January 14, 2021 Lantern Pharma (Nasdaq: LTRN), a clinical-stage biopharma company using its proprietary RADR artificial intelligence ("A.I.") platform to transform cancer drug development and identify patients who will benefit from its targeted oncology therapeutics, reported the pricing of a public offering of 4,285,715 shares of its common stock at a public offering price of $14.00 per share, for gross proceeds of $60 million, before deducting underwriting discounts and offering expenses (Press release, Lantern Pharma, JAN 14, 2021, View Source [SID1234574056]). In addition, Lantern Pharma has granted the underwriters a 45-day option to purchase up to an additional 642,856 shares of common stock at the public offering price, less the underwriting discount, to cover over-allotments. All of the shares of common stock are being offered by Lantern Pharma.

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The offering is expected to close on January 20, 2021, subject to satisfaction of customary closing conditions.

ThinkEquity, a division of Fordham Financial Management, Inc., is acting as sole book-running manager for the offering. Colliers Securities LLC is acting as co-manager for the offering.

A registration statement on Form S-1 (File No. 333-251992) relating to the shares was filed with the Securities and Exchange Commission ("SEC") and became effective on January 14, 2021. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, by email at [email protected]. The final prospectus will be filed with the SEC and will be available on the SEC’s website located at View Source

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

On January 14, 2021 Orion Biotechnology Holding SA., a biotechnology company focused on precision engineering small protein therapeutics, reported that its drug discovery project was awarded funding of CHF 0.9M from Innosuisse, the Swiss Innovation Agency (Press release, Orion Biotechnology, JAN 14, 2021, View Source [SID1234574045]). The project will allow Orion, in collaboration with the University of Geneva, to further expand and optimize drug discovery capabilities using its novel platform. The proprietary platform driven by Dr. Oliver Hartley and his team at the University of Geneva delivers a novel approach to G Protein-Coupled Receptor (GPCR) targeting by precision-engineering natural peptide and protein analogs that bind to GPCR targets with both enhanced potency and tailored signaling activity. The Innosuisse grant funds 50 percent of the project costs, covering research to be carried out collaboratively by Orion Biotechnology and the University of Geneva.

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"We are very excited to receive this grant from Innosuisse, which will contribute to further innovative research & development under our drug discovery platform," stated Mark Groper, CEO of Orion Biotechnology Holding SA and President of Orion Biotechnology Canada. "This support will advance our new approach to GPCR-targeting and accelerate the development of next generation therapeutics. Orion’s platform technology has demonstrated its ability to generate first-in-class GPCR-targeted therapeutics with best-in-class potency. This Innosuisse-funded project will further enhance Orion’s ability to target valuable GPCRs that have proved challenging using established discovery approaches."