On April 26, 2022 Servier reported that treatment has gained official approval from China’s National Medical Products Administration (NMPA) to be used for patients with metastatic pancreatic cancer (Press release, Servier, APR 26, 2022, View Source [SID1234612954]).

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Pancreatic cancer is called the "emperor

Pancreatic cancer is called the "emperor of all cancers" due to its insidious symptoms, high degree of malignancy and high fatality rate. There were 124,994 new cases of pancreatic cancer and 121,853 deaths in China in 2020[1]. Thus, there are huge needs for treatment options as the incidence of pancreatic cancer is increasing year by year.

No other treatment for pancreatic cancer indications had become available in Mainland China since 1999. There is still a high unmet medical need for the treatment of pancreatic cancer.

For Stephane Mascarau, General Manager of Servier Tianjin Pharmaceutical, "This approval marks an important step forward for Servier to play a key role in oncology in China".

As cancer is the second leading cause of death worldwide2, Servier’s ambition is to become a recognized player in oncology, initiating therapeutic progress where the need is greatest. Therefore, the Group dedicates more than 50% of its R&D budget to this field.

On April 26, 2022 VBL Therapeutics (Nasdaq: VBLT), a late-clinical stage biotechnology company focused on developing first-in-class therapeutics for difficult-to-treat malignant solid tumors and immune or inflammatory indications, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ofra-vec (ofranergene obadenovec or VB-111) in combination with paclitaxel for the treatment of platinum-resistant ovarian cancer (Press release, VBL Therapeutics, APR 26, 2022, View Source [SID1234612970]).

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"We are pleased to receive FDA Fast Track designation for ofra-vec in platinum-resistant ovarian cancer. The Fast Track designation can facilitate the process towards potential registration and, importantly, may help expedite the time to market for ofra-vec, if approved," said Prof. Dror Harats, M.D., chief executive officer of VBL Therapeutics. "The readout of the progression free survival primary endpoint in the OVAL trial will be an important milestone for VBL in the second half of this year. We believe that, if positive, this will support a Biologics License Application submission to the FDA."

Ofra-vec is VBL Therapeutics’ investigational anti-cancer, gene-based agent in development to treat a wide range of solid tumors. The lead clinical program for ofra-vec is the OVAL Phase 3 registration-enabling trial in recurrent platinum-resistant ovarian cancer patients. VBL recently completed patient enrollment of 409 patients in this global trial being conducted at centers in the United States, Europe, Israel and Japan. In addition, the Independent Data Safety Monitoring Committee (DSMC) unanimously recommended to continue the trial as planned, following review of unblinded data from 370 randomized patients.

About the OVAL Trial

OVAL (VB-111-701/GOG-3018) is an international Phase 3 randomized, pivotal registration-enabling clinical trial comparing a combination of ofra-vec (ofranergene obadenovec or VB-111) and paclitaxel to placebo plus paclitaxel, in adult patients with recurrent platinum-resistant ovarian cancer. The OVAL trial has two primary endpoints: progression free survival (PFS) and overall survival (OS). Successfully meeting either primary endpoint has the potential to support a Biologics License Application (BLA). Meeting the PFS endpoint, with a top-line readout anticipated in the second half of 2022, could accelerate BLA submission by approximately one year, subject to discussions with the U.S. Food and Drug Administration. A top-line readout of the OS primary endpoint is anticipated in 2023. OVAL is being conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the field of gynecologic malignancies. For more information, refer to Clinicaltrials.gov NCT03398655.

About Ofra-Vec (ofranergene obadenovec; `VB-111`)

Ofra-vec is an investigational anti-cancer, gene-therapy agent in development to treat a wide range of solid tumors. Ofra-vec is a unique biologic agent designed to use a dual mechanism to target solid tumors. Its mechanism combines the blockade of tumor vasculature with an anti-tumor immune response. Ofra-vec is administered as an IV infusion once every 6-8 weeks. It has been observed in past clinical research to be generally well-tolerated in >300 cancer patients and demonstrated activity signals in an "all comers" Phase 1 trial as well as in three tumor-specific Phase 2 trials. Ofra-vec has received orphan designations for the treatment of ovarian cancer and for the treatment of glioma by the European Commission. The FDA granted ofra-vec orphan designation for the treatment of malignant glioma and fast track designation for the treatment of rGBM and the treatment of platinum-resistant ovarian cancer. Ofra-vec demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer (NCT01229865) and platinum-resistant ovarian cancer (NCT01711970).

On April 26, 2022 MAIA Biotechnology, Inc., a targeted therapy, immuno-oncology company focused on developing potential first-in-class oncology drugs ("MAIA"), reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to THIO, a telomere-targeting agent currently in development to evaluate its activity in multiple cancer indications, for the treatment of hepatocellular carcinoma (HCC) (Press release, MAIA Biotechnology, APR 26, 2022, View Source [SID1234612987]).

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"Receipt of Orphan Drug Designation for THIO is an important milestone for MAIA," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "The designation provides further momentum for the THIO program, which we are committed to advancing as quickly as possible for patients in need, like those living with HCC."

"Patients living with HCC currently have limited treatment options that are often ineffective. After completing standard-of-care therapy, patients with HCC tend to have poor outcomes with little to no improvement from treatment," said Mihail Obrocea, M.D., Chief Medical Officer of MAIA. "The FDA’s decision to grant ODD to THIO is an important recognition of MAIA’s unique scientific approach of telomere-targeting and the potential we have with THIO to deliver a first-in-class oncology drug to patients."

The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S. if the drug is ultimately approved for its designated indication.

Sergei Gryaznov, Ph.D., Chief Scientific Officer of MAIA, added, "We are pleased to have received ODD from the FDA for THIO since we have been preparing for clinical studies to evaluate the ability of THIO to enhance and extend the immune system’s response to fight cancer. We look forward to continuing to advance THIO and to dosing our first patient in the upcoming Phase 2 studies."

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in non small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On April 26, 2022 SCYNEXIS, Inc. (Nasdaq: SCYX) reported the closing of its previously announced underwritten public offering of common stock, pre-funded warrants and warrants (Press release, Scynexis, APR 26, 2022, View Source [SID1234613005]). The shares and warrants were sold at a public offering price of $3.00 per share and accompanying warrants, and the pre-funded warrants were sold at a public offering price of $2.999 per pre-funded warrant and accompanying warrants. The total gross offering proceeds to SCYNEXIS from this offering were $45.0 million, before deducting the underwriting discount and other estimated offering expenses, and excluding the exercise of any pre-funded warrants or warrants. All of the shares of common stock, pre-funded warrants and warrants were offered by SCYNEXIS.

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At closing, SCYNEXIS issued 3,333,333 shares of its common stock, pre-funded warrants to purchase an aggregate of 11,666,667 shares of common stock and warrants to purchase an aggregate of 15,000,000 additional shares of its common stock. The pre-funded warrants were issued to certain purchasers who have elected to purchase them in lieu of shares of common stock in this offering, as those purchasers would otherwise have exceeded 19.99% (or such lesser percentage as required by the investor) beneficial ownership of our common stock immediately following the offering. The shares of common stock, pre-funded warrants and warrants were issued separately. The warrants have a seven-year term and an exercise price of $3.45 per share. The pre-funded warrants and the warrants are exercisable immediately. The warrants were certificated and are being delivered to the investors by physical delivery following the closing. There is no established public trading market for the pre-funded warrants or the warrants, and SCYNEXIS does not expect a market to develop.

In addition, SCYNEXIS has granted the underwriters a 30-day option to purchase up to an additional 2,250,000 shares of common stock and/or warrants to purchase up to 2,250,000 shares of common stock, at their respective public offering prices, less the underwriting discounts and commissions.

Guggenheim Securities, LLC and Cantor Fitzgerald & Co. served as joint book-running managers for the offering. Ladenburg Thalmann & Co. Inc. and Maxim Group LLC served as co-lead managers for the offering. Aegis Capital Corp, Brookline Capital Markets, a division of Arcadia Securities, LLC, and WBB Securities LLC served as co-managers for the offering.

A shelf registration statement relating to the securities being sold in this offering was filed with the U.S. Securities and Exchange Commission (the "SEC") on December 31, 2020, and was declared effective on January 8, 2021. The offering was made only by means of a preliminary and final prospectus supplement and accompanying prospectus. Copies of the preliminary and final prospectus supplements and accompanying prospectus relating to the proposed public offering may be obtained by contacting: Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, New York 10017, or by telephone at (212) 518-9544 or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022, or by email at [email protected]. The final terms of the offering were disclosed in the final prospectus supplement filed with the SEC.

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

On April 26, 2022 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company developing the next generation of therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that it has opened patient enrollment in the Phase 1b clinical trial of PH-762 for the treatment of advanced melanoma (Press release, Phio Pharmaceuticals, APR 26, 2022, View Source [SID1234612955]).

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"We are excited to advance our first-in-human clinical trial for our lead program, PH-762, to treat patients with melanoma. The start of this clinical study marks a significant milestone for Phio and our INTASYL therapeutic platform," said Dr. Gerrit Dispersyn, President and CEO of Phio. "This is an important study for patients with advanced melanoma as well, since currently, there are no neoadjuvant treatment options approved for these patients. In addition, the clinical program for PH-762 to treat melanoma is supported by a robust set of preclinical data generated over the past several years. These data show that local treatment of PH-762 inhibits not only local tumor growth, but also elicits an abscopal effect or systemic immune response in distal, untreated tumors."

The Phase 1b study, which is being conducted at the Gustave Roussy Institute, one of the largest cancer centers in Europe, will evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of PH-762 in a neoadjuvant setting in subjects with advanced melanoma. The clinical study will feature a dose escalation of PH-762 monotherapy and is designed to allow for a data driven evaluation of the recommended Phase 2 dose. This is the first clinical trial with PH-762.

PH-762, activates immune cells to better recognize and kill cancer cells. It does so by reducing the expression of PD-1, a clinically validated target for immunotherapy. PD-1 is expressed by T cells and prevents them from killing cancer cells. When PH-762 reduces PD-1 expression, the "brakes" on the immune system are released and activates the T cells to kill the cancer cells. PH-762 is being developed as a standalone drug therapy with local administration to a tumor. In addition, it is also being developed as a critical component of cellular immunotherapy, more specifically to improve tumor cell killing capability of adoptively transferred tumor infiltrating lymphocyte (TIL) therapy.