On January 14, 2022 Co-Founder and Chief Executive Officer, S. Roy Kimura, Ph.D, shared details on Modulus Discovery reported that it’s portfolio and pipeline strategy, at the virtual 40th Annual J.P. Morgan Healthcare Conference (Press release, Modulus Discovery, JAN 14, 2022, View Source [SID1234605481]). The recording and slides of the presentation are available at the following links:

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On January 14, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or the "Company"), an Australianbased clinical stage radiopharmaceutical company developing next-generation products to address the growing need for the use of radiopharmaceuticals in oncology, reported to release its first Annual Newsletter as a listed entity for the calendar year ending 31 December 2021 (Press release, Clarity Pharmaceuticals, JAN 14, 2022, View Source [SID1234605475]).

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Despite the unprecedented challenges imposed by the global pandemic, this year has been extraordinary for Clarity.

Not only have we completed the largest biotechnology Initial Public Offering (IPO) on the Australian Securities Exchange (ASX), raising $92 million, but also significantly progressed clinical development of our pipeline of Targeted Copper Theranostics (TCT), commencing three new trials this year (including two trials in prostate cancer), closing a diagnostic trial of SAR-Bombesin following the exciting preliminary results, and expanding the theranostic trial in neuroblastoma to five sites. To support our clinical growth and take full advantage of therapeutic, manufacturing and logistical benefits of TCT, Clarity has been actively extending its manufacturing and logistical footprint. We have also progressed our preclinical and discovery programs and continued bolstering our IP portfolio to support the comprehensive platform of TCT.

Our team is excited to further build on the important milestones we have achieved to date and continue delivering on our ultimate goal of developing better treatments for children and adults with cancer in the new year

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).