On January 13, 2022 Xspray Pharma (publ) (Nasdaq Stockholm: XSPRAY) reported that the US Food and Drug Administration (FDA) has agreed to review the company’s application for market approval for Xspray Pharma’s product candidate, Dasynoc (dasatinib) in the US under the 505(b)(2) process (Press release, Xspray, JAN 13, 2022, View Source [SID1234650014]).

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In November 2021, Xspray Pharma submitted an application for market approval in the US of the product candidate Dasynoc to the FDA under the Section 505(b)(2) NDA process, the registration pathway that applies to improved drugs. After an initial review, the FDA has now agreed to conduct a comprehensive review of Xspray Pharma’s application.

"This gratifying news marks an important milestone for Xspray Pharma. We are ready to develop a portfolio of improved PKI drugs that could enable a better quality of life for patients while creating value for the company. This news is entirely in line with our expectations, since the amorphous structure of Dasynoc means that the product is an improvement over the current market leader," says Xspray Pharma’s CEO Per Andersson.

The FDA’s review of Dasynoc will be completed within ten months, but the time span could be altered depending on potential questions during the review process. The application will also be supplemented with lower dosages, at a time to be determined in consultation with the FDA. As previously communicated, Xspray Pharma estimates that a launch in the market, assuming approval from the FDA, could take place in 2023.

"We see a number of key advantages with Dasynoc for patients, physicians and payers. Xspray Pharma’s product can be administered at a lower dosage than the reference product, which is expected to yield fewer side effects in patients. Studies have also shown that the product is not affected by the pH value in the stomach, which is why in comparison to the reference product it can be used in combination with proton-pump inhibitors in the concurrent treatment of peptic ulcers – a commonly occurring need in patients. Xspray Pharma’s product has also displayed significantly lower variability, which means that uptake of the active substance into the body is even," Per Andersson says.

Xspray Pharma’s application consists of the results from the registrational studies on healthy volunteers, where bioequivalence was achieved at an approximately 30 percent lower dosage than the reference product Sprycel. The application includes Dasynoc for the treatment of acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML), which are blood cancer illnesses in an area where only one new drug has been registered over a ten-year period.

On January 13, 2022 Celsion Corporation (NASDAQ: CLSN), a clinical-stage development company focused on DNA-based immunotherapy and next-generation vaccines, reported the closing of its previously announced registered direct offering with certain institutional investors to purchase 50,000 shares of Series A convertible redeemable preferred stock and 50,000 shares of Series B convertible redeemable preferred stock (Press release, Celsion, JAN 13, 2022, View Source [SID1234605486]). Each share of Series A and Series B preferred stock had a purchase price of $285, representing an original issue discount of 5% of the $300 stated value of each share, resulting in net proceeds of approximately $28.5 million, before deducting placement agent’s fees and other estimated offering expenses.

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A.G.P. /Alliance Global Partners acted as the sole placement agent in connection with the offering.

This offering was made pursuant to an effective shelf registration statement on Form S-3 (333-254515), which was declared effective by the Securities and Exchange Commission on March 30, 2021. The offerings were made by means of a prospectus supplement and a prospectus that form a part of the registration statement. Copies of the final prospectus supplements and accompanying prospectus relating to the registered direct offering may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022 at (212) 624-2060.

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 January 13, 2022 APIM Therapeutics (APIM), a clinical stage biotech company, focusing on the development of novel peptide therapeutics targeting PCNA (Proliferating Cell Nuclear Antigen), reported the publication of research data of ATX-101 in glioblastoma preclinical models in the peer reviewed journal Cancers (Press release, APIM Therapeutics, JAN 13, 2022, View Source,c3485004 [SID1234605480]).

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The article entitled "ATX-101, a Peptide Targeting PCNA, has antitumor efficacy alone or in combination with Radiotherapy in murine models of human glioblastoma" investigated ATX-101, the lead compound of APIM’s development program, in a panel of human glioblastoma (GBM) and patient-derived glioma-initiating cells (GICs) in vitro and in vivo alone or in combination with Radiotherapy (RT). The study was a collaboration between APIM Therapeutics and the laboratory of Dr. Festuccia at the Department of Biotechnological and Applied Clinical Sciences, Laboratory of Radiobiology, University of L’Aquila, Italy.

In the study, it was shown that ATX-101 has anticancer activity as a single agent in vitro and in vivo. Furthermore, ATX-101 potentiated the effect of RT in both subcutaneous and intracranial xenograft tumor models. ATX-101 affected key oncogenic signaling pathways such as AKT/mTOR and DNA-PKcs; a correlation between high AKT activation and sensitivity to ATX-101 was also observed. Finally, ATX-101 increased the levels of γH2AX, DNA fragmentation, and apoptosis when combined with RT.

"The results obtained in glioblastoma models are in agreement with previous preclinical investigations of ATX-101 conducted in a large variety of tumor models" said Professor Marit Otterlei, CSO of APIM Therapeutics. "Our data suggest that targeting the stress regulatory mechanisms of PCNA holds therapeutic promise in glioblastoma tumors".

"The fact that ATX-101 exhibits therapeutic activity and potentiates the effect of RT in GBM opens up new clinical development opportunities for APIM Therapeutics" stated Dr. Kostas Alevizopoulos, CEO of APIM. "This could help provide a new therapeutic option for this deadly disease to be tested in human clinical trials."

The article co-authored by Dr M. Otterlei, Dr C. Festuccia and coworkers and published in Cancers (January 7, 2022) can be accessed here: View Source

About ATX-101

ATX-101 is a first-in-class, cell penetrating peptide featuring a novel PCNA-interacting motif (AlkB homolog 2 PCNA Interacting Motif or APIM). In preclinical experiments, it was shown that APIM-containing proteins bind to PCNA and mediate processes of escape mechanisms and survival of cancer cells. ATX-101 competitively inhibits interaction of PCNA with APIM-containing protein complexes resulting in cancer cell death and altered cellular signaling. These properties translate in anticancer effects of ATX-101 as demonstrated in several preclinical models in vitro and in vivo. Currently, ATX-101 is in clinical development for ovarian cancer (phase 1b/2a) and sarcoma (phase 2).

On January 13, 2022 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with sarcomas, pediatric cancers, and other cancers, reported a definitive agreement with DeuteRx, LLC to acquire an oral, small molecule targeted protein degradation portfolio (Press release, Salarius Pharmaceuticals, JAN 13, 2022, View Source [SID1234605477]). The acquisition includes a lead drug candidate that Salarius has renamed SP-3164 (formerly DRX-164), the related patent family, including issued composition of matter patents, and the opportunity to develop additional undisclosed cancer-fighting assets in the targeted protein degradation space. Targeted protein degradation takes advantage of the body’s own degradation system to promote the selective elimination of disease-causing proteins.

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"This strategic acquisition is a transformative event for Salarius that significantly expands our development pipeline while building upon the momentum of our lead clinical-stage candidate, seclidemstat, our existing infrastructure and our scientific expertise," stated David Arthur, Chief Executive of Salarius Pharmaceuticals. "SP-3164 provides entry into the exciting field of protein degradation, a fast-growing area of cancer drug research that is attracting substantial interest from some of the world’s largest pharmaceutical companies because of the potential advantages of protein degraders, including the ability to go after previously undruggable cancer-promoting targets."

SP-3164 is a next-generation cereblon-binding molecular glue. Molecular glues are small molecules that commandeer the body’s normal protein-degradation processes and induce selective elimination of cancer-causing proteins. Derived from avadomide, SP-3164 was developed by using deuterium-enabled chiral switching (DECS), a unique strategy that utilizes deuterium to stabilize the preferred, active (S)-enantiomer from the first-generation compound, avadomide. This creates a new molecular entity with the potential for increased efficacy and improved safety. Salarius plans to develop SP-3164 as a potential treatment for hematological cancers and solid tumors and plans to begin the first clinical trial in 2023.

Mr. Arthur continued, "In addition to advancing seclidemstat, our goal at Salarius is to develop a multiprong internal pipeline and advance cancer therapies that address the unmet needs of patients and, by doing so, generate value for patients and shareholders. With SP-3164, Salarius plans to enter the protein degradation space which generated global sales of over $15 billion dollars in 2020. Funded with existing financial resources, this acquisition capitalizes on our strong cash position and our seclidemstat momentum."

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As part of the agreement, Salarius and DeuteRx will collaborate to complete SP-3164 development activities and collaborate on the research and development of future products.

Under the terms of the agreement, DeuteRx will receive from Salarius an upfront payment consisting of $1.5 million in cash and 1 million shares of restricted stock. Based upon the success of SP-3164, DeuteRx is also entitled to receive up to $53 million in future clinical and regulatory event-driven milestone payments and sales achievement milestone payments of up to $135 million, as well as escalating royalties on net sales. Additionally, DeuteRx is eligible to receive event-driven clinical, regulatory and sales achievement milestone payments of up to $84 million, as well as escalating royalties on net sales, for each of two future products.
"DeuteRx is excited to collaborate with the team at Salarius to advance SP-3164 and additional programs for the benefit of patients in need of better treatment options," said Sheila DeWitt, Ph.D., President and CEO of DeuteRx. "Our agreement with Salarius aligns with our goal to partner with innovative companies to unlock the value of our DECS technology platform and our differentiated drug candidates. I look forward to seeing this exciting new therapy advance through the clinic."
Conference Call Information:
Salarius Pharmaceuticals will host a conference call and live audio webcast on Thursday, January 13, 2022, at 8:30 a.m. EST, to discuss the asset acquisition agreement with DeuteRx. Interested participants and investors may access the conference call by dialing:
(833) 423-0481 (U.S.) or (918) 922-2375 (international)
Conference ID: 6528776
Investors may submit questions to Salarius prior to the conference call by e-mail to lsher@tiberend.com. Please use the e-mail subject heading "Salarius/DeuteRx Acquisition" to ensure that the information is received. Salarius’ management will respond to select questions during the conference call.
An audio webcast will be accessible via the Investors Events and Presentations section of the Company’s website View Source An archive of the webcast will remain available for 90 days beginning at approximately 8:30 a.m. ET, on January 13, 2022.

About SP-3164
SP-3164, formerly DRX-164, is the next-generation, deuterium-stabilized (S)-enantiomer of avadomide. DRX-164 was developed by DeuteRx LLC. Avadomide is one of the most extensively studied molecular glues, a class of targeted protein degraders. It has been studied in more than 400 subjects across 10 clinical trials for patients with hematological cancers and solid tumors and has demonstrated efficacy when used as a single agent and when used in combination

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therapy. SP-3164 is a patent-protected new molecular entity with the potential for increased efficacy and improved safety compared to avadomide.
Avadomide is a 1:1 mixture of two mirror-image compounds ((R)- and (S)-enantiomers) that interconvert in vitro and in vivo. Using deuterium, DeuteRx stabilized each enantiomer and characterized their dramatically different pharmacological properties. In in vitro studies, SP-3164, the deuterium-stabilized (S)-enantiomer, has been shown to be the active enantiomer as it is primarily responsible for the cereblon-binding and the anti-inflammatory activity of avadomide1. As a result, in a preclinical efficacy model, SP3164 exhibited the anti-tumorigenic activity while the (R)-enantiomer appears to promote tumor growth2. Based upon preclinical results to date, SP-3164 has the potential to exhibit a better therapeutic profile than avadomide and will be the first stabilized, single enantiomer cereblon-binding protein degradation agent to enter the clinic.

On January 13, 2022 Galapagos NV (Euronext & NASDAQ: GLPG) reported that its supervisory board created 30,000 subscription rights under a new employee subscription right plan (Press release, Galapagos, JAN 13, 2022, View Source [SID1234605476]).

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On 13 January 2022, the supervisory board of Galapagos approved a subscription right plan intended for an employee of a subsidiary of the Company (not intended for members of the management board of the Company), within the framework of the authorized capital. Under this subscription right plan, 30,000 subscription rights were created (subject to acceptance). The subscription rights have an exercise term of eight years as of the date of the offer and an exercise price of €46.18 (the closing price of the Galapagos share on Euronext Amsterdam and Brussels on the day preceding the date of the offer). Further details are available on the Galapagos website.

Galapagos’ total share capital currently amounts to €354,582,005.11; the total number of securities conferring voting rights is 65,552,721, which is also the total number of voting rights (the "denominator"), and all securities conferring voting rights and all voting rights are of the same category. The total number of rights to subscribe to not yet issued securities conferring voting rights is (i) 8,579,287 subscription rights under several outstanding employee subscription right plans, which equals 8,579,287 voting rights that may result from the exercise of those subscription rights, and (ii) one subscription right issued to Gilead Therapeutics to subscribe for a maximum number of shares that is sufficient to bring the shareholding of Gilead and its affiliates to 29.9% of the actually issued and outstanding shares after the exercise of the subscription right. This excludes the 30,000 subscription rights of the newly issued subscription right plan, which were created subject to acceptance. Galapagos does not have any convertible bonds or shares without voting rights outstanding.