On December 17, 2021 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, reported that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for Silmitasertib, a highly selective inhibitor of casein kinase 2 (CK2) to treat patients with Medulloblastoma (Press release, Senhwa Biosciences, DEC 17, 2021, View Source [SID1234597382]).

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The FDA grants ODD status to drugs and biologics that are intended to treat, prevent or diagnose a rare disease or condition with a prevalence of fewer than 200,000 people in the U.S. ODD affords certain financial incentives to support clinical development, exemption from user fees and the potential for up to seven years of market exclusivity in the U.S. upon marketing approval.

"We are pleased to receive ODD for Silmitasertib for Medulloblastoma, a rare, severe pediatric disease for which there are no approved targeted therapies. ODD represents an important regulatory milestone that has the potential to expedite the clinical development of Silmitasertib, a potent and selective CK2 inhibitor," said Dr. John Soong, Chief Medical Officer of Senhwa Biosciences.

Senhwa’s clinical partner, the Pediatric Brain Tumor Consortium (PBTC, www.pbtc.org), is currently conducting a Phase I/II and Surgical Study of Silmitasertib in both children and adults with recurrent sonic hedgehog (SHH) () driven Medulloblastoma. This study is taking place at the PBTC’s participating member academic medical centers and children’s hospitals across the United States. The PBTC is sponsoring this clinical trial and is funded through the Consortium grant awarded by the US National Institute of Health – Cancer Therapy Evaluation Program (CTEP).

Medulloblastoma is the most common cancerous brain tumor in children, but no targeted therapy is currently available. In addition to ODD, Silmitasertib was granted Fast Track Designation and Rare Pediatric Disease (RPD) Designation from the US FDA on Aug 17, 2021 and July 6, 2020, respectively. If certain criteria are met with the RPD Designation, Senhwa would be eligible for a transferrable Priority Review Voucher (PRV). The PRV allows its recipient an expedited review process of any one of its new drug products from a ten-month to a six-month timeframe.

About Silmitasertib

Silmitasertib is a first-in-class small molecule drug that targets the CK2 pathway and acts as a CK2-inhibitor. Clinical studies thus far have shown CX-4945 to be well-tolerated in humans. In addition to COVID-19, Silmitasertib is currently under development in several oncology programs in adults and children with recurrent/advanced or metastatic cancer. To date, three Phase I trials and one Phase II trial of Silmitasertib in cancer patients have been completed; currently, there are two ongoing Phase II studies of Silmitasertib. The US FDA granted Silmitasertib key drug designations: Orphan Drug Designation for the treatment of Cholangiocarcinoma in December 2016, Rare Pediatric Disease Designation in July 2020 for the treatment of Medulloblastoma, Fast Track Designation in August 2021 for the treatment of recurrent Sonic Hedgehog driven Medulloblastoma and an eIND for the treatment of a patient with severe COVID-19 in August 2020.

On December 17, 2021 Addex Therapeutics Ltd (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported that it has entered into a definitive agreement with Armistice Capital LLC, a healthcare-focused institutional investor, pursuant to which the Company agreed to sell 3,752,202 shares in the form of 625,367 American Depositary Shares ("ADSs") at a gross purchase price of $6.50 per ADS, which is equivalent to CHF 1.00 per share (Press release, Addex Therapeutics, DEC 17, 2021, View Source [SID1234597444]). Each ADS represents six shares. Additionally, Addex has agreed to issue to Armistice Capital unregistered warrants to purchase up to 9,230,772 shares in the form of 1,538,462 ADSs (the "Unregistered Warrants"), as well as unregistered pre-funded warrants to purchase up to 5,478,570 shares in the form of 913,095 ADSs (the "Unregistered Pre-Funded Warrants" and together with the Unregistered Warrants, the "Warrants") in a concurrent private placement. The Unregistered Warrants have an exercise price of $6.50 per ADS, will become exercisable in 60 days after their date of issuance and will expire six years from their date of issuance. The Unregistered Pre-Funded Warrants have been funded to the amount of $6.49 with $0.01 payable on exercise.

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The gross proceeds to Addex, before deducting placement agent fees and other offering expenses, will be $10.0 million. Addex intends to use the net proceeds from this offering to advance its clinical and preclinical pipeline.

The closing of the offering is expected to occur on or about December 21, 2021, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The shares (but not the Warrants or the shares underlying the Warrants) are being offered by Addex pursuant to a "shelf" registration statement on Form F-3 that was originally filed on April 7, 2021 and declared effective by the Securities and Exchange Commission ("SEC") on April 13, 2021 and the base prospectus contained therein (File No. 333-255089). The offering of the shares is being made only by means of a prospectus supplement that forms a part of the registration statement. Electronic copies of the prospectus supplement and accompanying base prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

The Warrants and shares underlying the Warrants are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares underlying the Warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the Warrants and underlying shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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 December 17, 2021 Bristol Myers Squibb (NYSE:BMY) reported that it will announce results for the fourth quarter of 2021 on Friday, February 4, 2022 (Press release, Bristol-Myers Squibb, DEC 17, 2021, View Source [SID1234597366]). During a conference call at 8 a.m. ET on February 4, 2022, company executives will review financial results and address inquiries from investors and analysts.

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Investors and the general public are invited to listen to a live webcast of the call at View Source or by using this link which becomes active 15 minutes prior to the scheduled start time and entering your information to be connected. Investors and the public can also access the live webcast by dialing in the U.S. toll free 877-502-9276 or international +1 313-209-4906, confirmation code: 2150568. Materials related to the call will be available at the same website prior to the conference call.

A replay of the webcast will be available on View Source approximately three hours after the conference call concludes. A replay of the conference call will be available beginning at 11:30 a.m. ET on February 4 through 11:30 a.m. ET on February 18, 2022 by dialing in the U.S. toll free 888-203-1112 or international +1 719-457-0820, confirmation code: 2150568.

On December 17, 2021 Genoscience Pharma, a clinical stage biotechnology company developing unique lysosomotropic drug candidates for the treatment of cancer, auto-immune and infectious diseases through autophagy modulation, reported the licensing of its PPT-1 inhibitor, GNS561, in cholangiocarcinoma indication, to GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases (Press release, GenoScience, DEC 17, 2021, View Source [SID1234597409]). GENFIT will develop and commercialize investigational treatment with GNS561 in cholangiocarcinoma, in the United States, Canada and Europe, including the United Kingdom and Switzerland.

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Under the agreement, GENFIT is committed to taking a €3 million ($3.4M) equity stake in Genoscience Pharma through the subscription of new ordinary shares. GENFIT will also contribute clinical and regulatory milestone payments and tiered royalties (financial terms not disclosed). The first payable milestone is contingent on positive results from the phase 2 clinical trial in cholangiocarcinoma, which is expected to start in the first half of 2022.

GNS561 is a novel clinical-stage autophagy/PPT1 inhibitor developed by Genoscience Pharma in cholangiocarcinoma indication, which is an orphan disease. The inhibitor has completed preclinical studies and a phase 1b trial confirming the rationale for targeting cholangiocarcinoma, a rare liver malignancy with high mortality and with limited treatment options.

"This is a great step for the development of GNS561 as a new potential treatment option in liver cancer, as it offers an innovative mechanism of action for patients with high unmet needs," said Philippe Halfon, CEO of Genoscience Pharma. "We believe that GENFIT is a highly qualified partner for the development of GNS561 in cholangiocarcinoma and we will provide GENFIT with our expertise in oncology to support their development plan. On our side, we will pursue the development of GNS561 in other oncology indications as well as research in other therapeutic areas."

"This decision fully aligns with our strategic roadmap by broadening our asset portfolio within our cholestatic disease franchise, through the addition of an innovative drug candidate with the potential to address considerable unmet needs for patients," said Pascal Prigent, CEO of GENFIT. "The scientific rationale, together with preclinical and clinical evidence, supports further development of the asset, and our plan is to start the phase 2 program in the first half of 2022. We believe that GNS561’s mechanism of action is very promising. Given the current landscape, standard of care and lack of marketed options, and based on KOL opinions, we will interact with regulatory agencies to investigate accelerated paths to approval, post phase 2."

About cholangiocarcinoma
Cholangiocarcinoma is a type of cancer that forms in the slender tubes (bile ducts) that carry the digestive fluid bile. Cholangiocarcinoma occurs mostly in people over the age of 50. Cholangiocarcinoma is divided into intrahepatic and extrahepatic types based on where the disease occurs in the bile ducts. Cholangiocarcinoma is often diagnosed when it is advanced, making successful treatment difficult to achieve. Several risk factors of chronic inflammatory damage and increased cellular turnover have been established, such as primary sclerosing cholangitis, a cholestatic liver disease, liver flukes, biliary tract cysts, hepatolithiasis and toxins. Treatment options for cholangiocarcinoma are limited and associated with high rates of tumor recurrence and short survival times.

About GNS561
GNS561 is a PPT-1 (Palmitoyl Protein Thioesterase-1) inhibitor that blocks autophagy. Autophagy is activated in tumor cells in response to certain conditions, due to tumor cell growth in advanced cancers. One of the key organelles implicated in the autophagy process is the lysosome. By entering the lysosome and binding to its target, GNS561 has an important inhibiting activity on late-stage autophagy, which leads to tumor cell death. GNS561 is an investigational compound and has not been registered by any regulatory authority.

On December 17, 2021 Shanghai Bao Pharmaceutical Co., Ltd. (Bao) and Shanghai Medicilon Inc. (Medicilon) reported that it signed an innovative drug IND R&D service strategy collaboration agreement (Press release, Shanghai Medicilon, DEC 17, 2021, View Source [SID1234597766]).

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Yanjun Liu, Chairman of Bao Pharmaceuticals; Zheng Wang, General Manager of Bao Pharmaceuticals; Chunlin Chen, Founder & CEO of Medicilon and Jinna Cai, Chief Commercial Officer of Medicilon, attended the signing ceremony to witness the collaboration event.

At the signing ceremony, Mengxian Yu, Deputy Secretary of the Party Committee and Mayor of Luodian Town, Baoshan District, delivered a speech, expressing sincere congratulations on the cooperation between the two parties and expressing the government’s high hopes and wishes for the project, "Bao Pharmaceutical is the first batch of companies to settle in the North Shanghai Biopharmaceuticals Industrial Park, and has a clear leading advantage in the differentiated competition of biopharmaceuticals. Medicilon is a leading professional biopharmaceuticals service company. For this collaboration, the government of Baoshan will give full support in terms of policy and environment. It is hoped that the collaboration between the two parties will be smooth and fruitful at an early stage to promote the higher-quality development of the North Shanghai Biopharmaceuticals Industrial Park."

Dr. Chunlin Chen, Founder & CEO of Medicilon, delivered a speech, thanking the government for supporting and witnessing this collaboration. In addition, Dr. Chen briefly introduced the development of Medicilon, and emphasized that Medicilon will gather a team of experts to promote the implementation of the project with high quality and efficiency. It is also hoped that in the long-term strategic collaboration between the two parties, many new drug R&D projects of Bao Pharmaceutical will be promoted to the clinic as soon as possible.

Yanjun Liu, Chairman of Bao Pharmaceuticals, said in his speech, "Medicilon is a professional and influential CRO, and Bao Pharmaceuticals is a specialty pharmaceutical company focusing on recombinant protein drugs and antibody drugs. The two parties will rely on Baoshan Luodian, a place that is favorable in time, place, and people, and complement each other’s strengths."

Bao Pharmaceutical and Medicilon reached a strategic collaboration
The two parties conducted in-depth exchanges and discussions on future collaboration, and formally signed a strategic collaboration agreement. At the same time, Medicilon awarded Bao Pharmaceuticals the title of "Innovative Drug IND R&D Service Strategic Partner". We are convinced that the in-depth collaboration between the two innovative companies will not only promote the research and development of recombinant protein drugs and antibody drugs in China, but will also have a profound impact on global new drug research and development.

In the future, Medicilon will continue to be an unswerving new drug enabler, helping global innovation partners to accelerate the development of new drugs, and forge ahead for the unfinished business of human health.