On January 25, 2023 QSAM Biosciences presenting its Corporate Presentation (Filing, 8-K, QSAM Biosciences, JAN 25, 2023, View Source [SID1234626552]).

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On January 25, 2023 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology is designed to make immune cells more effective in killing tumor cells, reported that the Company’s Board of Directors has approved a reverse stock split of its shares of common stock at a ratio of 1-for-12 (Press release, Phio Pharmaceuticals, JAN 25, 2023, View Source [SID1234626549]). The reverse stock split will become effective at 12:01 a.m. Eastern Time on January 26, 2023 and the Company’s common stock will open for trading on The Nasdaq Capital Market on a post-split basis on January 26, 2023 under the Company’s existing trading symbol, "PHIO." At such time, the Company’s common stock will also commence trading with a new CUSIP number, 71880W402.

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The reverse stock split is being implemented to increase the per share trading price of the Company’s common stock, for the purpose of ensuring a share price high enough to comply with the minimum $1.00 bid price requirement for continued listing on The Nasdaq Capital Market.

At the effective time of the reverse stock split, every twelve (12) shares of Phio common stock issued and outstanding will be combined into one (1) share of common stock issued and outstanding, with no change to the par value of $0.0001 per share. This will reduce the Company’s outstanding common stock from approximately 13.7 million shares to approximately 1.1 million shares. No fractional shares of common stock will be issued as a result of the reverse stock split and instead holders of Phio common stock will receive a cash payment in lieu of fractional shares to which they would otherwise be entitled. The shares underlying the Company’s outstanding equity awards and warrants will also be adjusted accordingly. The reverse stock split affects all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s common stock, except for adjustments that may result from the treatment of fractional shares.

The Company has retained its transfer agent, Computershare Trust Company, N.A. ("Computershare"), to act as its exchange agent for the reverse split. Shareholders with shares held in certificate form will receive from Computershare instructions regarding the exchange of their certificates. Shareholders that hold shares in book-entry form or hold their shares in brokerage accounts are not required to take any action and will see the impact of the reverse stock split reflected in their accounts, subject to brokers’ particular processes. Beneficial holders of Phio common stock are encouraged to contact their bank, broker, custodian or other nominee with questions regarding procedures for processing the reverse stock split.

Additional information regarding the reverse stock split is available in the definitive proxy statement filed with the U.S. Securities and Exchange Commission on November 30, 2022 by the Company.

On January 25, 2023 Onxeo S.A. (Euronext Growth Paris: ALONX), hereafter "Onxeo" or the "Company", a clinical-stage biotechnology company specializing in the development of innovative tumor specific drugs targeting tumor DNA Damage Response (DDR) and driver oncogenes, reported an update on the clinical development program of its first-in-class drug candidate AsiDNATM (Press release, Onxeo, JAN 25, 2023, View Source [SID1234626548]).

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Onxeo activated its first US clinical study site, Next Oncology San Antonio. This phase 1b/2 multicenter, basket trial intends to assess the safety and preliminary activity of AsiDNATM in combination with olaparib in patients with recurrent ovarian, breast and metastatic castration-resistant prostate cancer (mCRPC) who have progressed on previous PARP inhibitor therapy. The primary endpoint of the study will assess the safety and tolerability of the combination as well as to determine the recommended Phase 2 dose. Key secondary endpoints will assess the preliminary activity and duration of response for the combination.

Shefali Agarwal, Chairwoman of the Board of Directors and CEO, said: "We are delighted with the initiation of this important clinical trial in the US to further explore the potential of our first-in-class drug candidate, AsiDNATM. This investigational product has been in clinical development in Europe for the last few years, in recurrent solid tumors. In clinical studies AsiDNATM appears to be well tolerated with encouraging clinical activity in the studied patients till date. The activation of this first study in the US is an important next step towards its global clinical development.

The recent encouraging activity observed from the preliminary data in the REVOCAN study indicates the potential of AsiDNATM to re sensitize patients to PARP therapy which potentially addresses an unmet need and could meaningfully impact patients living with recurrent ovarian cancer who have progressed on an initial treatment with a PARP inhibitor. Additionally, this lays a strong foundation for our next first in class drug candidate OX425 which is sourced from the same proprietary PlatON platform and is a PARP/DDR specific decoy agonist thereby possibly not inducing tumor resistance to treatment. This profile represents a potential differentiation in safety and activity from other targeted therapies such as PARP inhibitors and we are on track to file an IND in mid- 2023".

The REVOCAN study is an open label, multicenter, phase 1b/2 study evaluating the safety and efficacy of AsiDNATM, in combination with PARP inhibitors in patients with relapsed platinum sensitive ovarian cancer already under treatment with a PARP inhibitor. The study is sponsored by Gustave Roussy Cancer Campus, Grand Paris, led by Dr Patricia PAUTIER and supported by ONXEO. The study team recently completed its first interim analysis (IA) of 10 patients. The combination of AsiDNATM and PARPi was generally well tolerated with no new safety signals or dose limiting toxicities. The IA also demonstrated encouraging clinical activity with six patients achieving a stable disease (SD) and one patient demonstrating a complete response (CR) with disease control rate of around 70%. The study continues to enroll patients. The detailed results of the IA will be published by the investigator.

Additionally, AsiDNATM is being evaluated in Children and young adults with recurrent high-grade glioma (HGG). This phase 1b/2 trial, sponsored by Institut Curie, is being conducted within the framework of the European ITCC consortium. The trial is evaluating the safety and clinical activity of AsiDNATM in combination with radiotherapy in children or young adults with recurrent HGG. The trial has already been opened at 8 clinical trial sites in France and 5 patients have been enrolled. To date, the combination has been well tolerated. Further trial site activation is planned for 2023 in Italy, the Netherlands, and Germany.

On January 25, 2023 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company developing monoclonal antibodies that target various cancer types, reported the completion of the dosing period of their Phase I Clinical Trial evaluating the safety and dose tolerance of Pritumumab ("PTB") as a treatment for Brain Cancer (Press release, Nascent Biotech, JAN 25, 2023, https://www.nascentbiotech.com/nascent-completes-dosing-requirement-in-final-cohort-of-phase-i-clinical-trial/ [SID1234626545]).

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The completion of dosing for the fifth and final Phase I cohort completes safety and dose escalation. The Company will now prepare to submit data and the Phase II Clinical Protocol to the United States Food and Drug Administration (the "FDA") for evaluation. As the trial remains open for all active and follow-up participants enrolled, we look forward to providing more data on the safety and tolerability of Pritumumab.

PTB is a natural human antibody that binds to Cell surface Vimentin (also referred to as ectodomain vimentin), a protein expressed on the surface of epithelial cancers. PTB is used as a targeted immunotherapy which seeks out only cancer cells while sparing healthy cells.

On January 25, 2023 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported the initiation of patient dosing in its Phase 1 clinical trial of XMT-2056, the company’s lead Immunosynthen product candidate (Press release, Mersana Therapeutics, JAN 25, 2023, View Source [SID1234626544]).

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XMT-2056 is a systemically administered Immunosynthen STING agonist ADC that is designed to target a novel HER2 epitope and locally activate STING signaling in both tumor-resident immune cells and in tumor cells to provide the potential to treat patients with HER2-high or -low tumors as monotherapy or in combination with standard-of-care agents. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to XMT-2056 for the treatment of gastric cancer.

"We believe this trial will give us important insights into XMT-2056’s tolerability and clinical activity profile across a range of solid tumors while also helping to demonstrate the differentiated nature of our Immunosynthen platform, which is designed to take ADCs beyond the cytotoxic realm by enabling innate immune activation," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "Given the preclinical activity XMT-2056 has demonstrated as a monotherapy and in combination with multiple agents, including standard-of-care HER2 therapies, we believe XMT-2056 may offer a differentiated and highly complementary therapeutic approach. We are excited to have candidates derived from all three of our ADC platforms in active clinical trials, demonstrating our continued innovation and leadership within the ADC space."

The multicenter Phase 1 open-label trial will investigate XMT-2056 in previously treated patients with advanced/recurrent solid tumors expressing HER2, including breast, gastric, colorectal and non-small-cell lung cancers. The dose escalation and dose expansion portions of the trial will evaluate and characterize the relationship of safety, tolerability and exposure of XMT-2056 and the ADC’s effect on patient responses by overall response rate, duration of response and disease control rate.

Mersana recently entered into an agreement with GSK that provides GSK with an exclusive option for a global license to co-develop and commercialize XMT-2056. Under the terms of the agreement, Mersana received an upfront option purchase fee of $100 million and is eligible to receive up to $1.36 billion in the form of an option exercise payment and development, regulatory and commercial milestone payments if GSK exercises its option. Mersana has retained options to profit-share and to co-promote in the United States. If it exercises its profit-share option, Mersana will be eligible to receive tiered royalties on net sales of licensed products outside of the United States. If Mersana does not elect to profit-share, it is eligible to receive double-digit tiered royalties on global net sales. If GSK opts into the license, the effectiveness of the license grant may be subject to customary closing conditions, including review under the Hart-Scott-Rodino Act.