On July 21, 2024 GC Cell Corporation (hereinafter referred to as "GC Cell"; 144510:KOSDAQ) and Lukas Biomedical Co., Ltd. (hereinafter referred to as "Lukas," TWSE 6814) reported that it has formally signed an international strategic cooperation agreement (Press release, GC Cell, JUL 21, 2024, View Source [SID1234644995]).

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GC Cell is a fully integrated pioneer in cell and gene therapy and a subsidiary of the renowned Korean-listed pharmaceutical group GC Biopharma Corp.

This collaboration aims to increase awareness of autologous T cell therapy as well as to expand the patient access market through leveraging each other’s strengths in innovative cell treatment areas. By sharing cutting-edge research projects, clinical trial data, regulatory knowledge across multiple countries, and exploring clinical research, market development, and various activities for cancers and other challenging diseases, both parties strive to accelerate drug development and establish a platform for precision medicine solutions. This partnership seeks to bring the benefits of innovative cell therapy to a wider range of patients.

Having successfully completed clinical trials in Japan and Korea, GC Cell’s Immuncell-LC autologous T cell therapy obtained approval from the Ministry of Food and Drug Safety (MFDS) in 2007 following favorable Phase IV trials. With a track record of over 10,000 treatment cases, GC Cell has been obtaining successful clinical and commercial records in Korea. Lukas’s LuLym-T memory T cell cultivation technology originated from Japanese National Cancer Center and GC LTEC, formerly Lymphotec, a subsidiary of Green Cross Group. Based on the licensing agreement with originator of the technology and the tech transfer from the company, Lukas has brought this technology to Taiwan for market expansion and further enhancement.

Taiwan’s government has demonstrated significant commitment to the advancement of the regenerative medicine sector. Following the implementation of the Special Regulations on Regenerative Medicine, the Regenerative Medicine Act was enacted on June 4 this year. Lukas’s LuLym-T cell therapy technology, supported by international clinical trials and evidence-based data generated by GC Cell, aligns closely with Taiwan governmental policies and regulations. It appears poised to secure a five-year conditional approval under the new regulations, thus establishing Lukas as a prominent player in Taiwan’s cell therapy landscape, with a focus on domestic growth and global market expansion. Presently, Lukas has entered agreements with 13 medical institutions, including National Taiwan University Hospital, Chang Gung Memorial Hospital, and Taipei Veterans General Hospital, to conduct Phase II clinical trials focused on preventing liver cancer recurrence and exploring combined immunotherapy with chemotherapy/radiotherapy for head and neck cancer at Taipei Veterans General Hospital.

Lukas’ Chairman, Dr. Eric Tang, highlighted that GC Cell and Lukas will collaborate through a Joint Committee (JC) to exchange expertise and experience in researching memory T cell technology for various cancers in their respective countries. This collaboration involves sharing clinical and commercial knowledge, insights, and strategies, as well as exploring opportunities for cross-licensing and conducting joint clinical trials (IITs and SITs) in each other’s regions. Moreover, they aim to discuss the opportunities to jointly explore new international markets, joint investment and beyond.

James Park, CEO of GC Cell, stated, "This strategic cooperation agreement represents a pivotal milestone in accelerating the advancement of innovative cell therapies in Korea and Taiwan and also in establishing global network and ecosystem of Cell and Gene Therapy. Looking ahead, we are committed to accelerating the global expansion of Immuncell-LC through the continuous exchange of clinical research data and the establishment of a strong, long-term partnership between our two companies."

Dr. Eric Tang, Chairman of Lukas stated that: "In addition to our clinical trial for preventing liver cancer recurrence, the Taiwanese government’s implementation of the Special Regulations on Regenerative Medicine has allowed us to apply our LuLym-T cell technology on advanced stage cancer patients with various types of solid tumors. We have accumulated vast clinical experience in concomitant use of LuLym-T cell together with conventional treatment, such as: chemotherapy, radiotherapy, and checkpoint inhibitors. We are able to achieve significant prognostic improvements using a multi-modality treatment paradigm for advanced stage cancers and we hope we will be able to help more cancer patients in need by sharing our experience with other countries".

This strategic cooperation represents a significant step toward a shared vision of improving patient outcomes through innovative cell therapies and precision medicine.

About Immuncell-LC

Immuncell-LC is the only commercially available treatment option of early-stage HCC. It is primarily composed of autologous, cultured blood-derived T lymphocytes with proven efficacy through a large-scale Phase 3 clinical trial which reduced the risk of recurrence by 37% and decreased the mortality rate by 79% compared to the control group. To date, Immuncell-LC has been administered to over 10,000 patients in South Korea without serious adverse events. 

On July 19, 2024, CASI Pharmaceuticals, Inc., a Cayman Islands incorporated company ("CASI" or the "Company") reported that, with respect to the Company’s previously announced dispute with Juventas Cell Therapy Ltd. ("Juventas"), a court of P.R.C. issued an asset freezing order against Juventas in aid of the arbitration proceedings CASI initiated at the Hong Kong International Arbitration Centre (the "HKIAC") in connection to Juventas’s purported termination of the parties’ agreements with respect to the commercialization of CNCT19 (the "Arbitration Proceeding") (Press release, CASI Pharmaceuticals, JUL 19, 2024, View Source [SID1234644980]).

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In an order dated July 15, 2024 and received by CASI on July 18, 2024, the First Intermediate People’s Court of Tianjin Municipality, where Juventas is headquartered, granted CASI’s application to freeze Juventas’s assets while the Arbitration Proceeding is ongoing and decided to freeze up to RMB 190 million in Juventas’s bank accounts or seize and freeze Juventas’s other assets of equivalent value (the "Asset Freezing Order"). The Asset Freezing Order took effect upon issuance and the court has taken steps to enforce the Asset Freezing Order.

The Company will continue to vigorously assert and enforce its rights against Juventas through all available legal means. The Company cannot predict right now the final outcome of the Arbitration Proceeding or how the parties’ dispute would ultimately be resolved.

On July 19, 2024 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for rare and ultrarare diseases, reported the grant of 19,875 restricted stock units of the company’s common stock to 14 newly hired non-executive officers of the company. The awards were approved by the compensation committee of the company’s board of directors and granted under the Ultragenyx Employment Inducement Plan, with a grant date of July 16, 2024, as an inducement material to the new employees entering into employment with Ultragenyx in accordance with Nasdaq Listing Rule 5635(c)(4) (Press release, Ultragenyx Pharmaceutical, JUL 19, 2024, View Source [SID1234644978]).

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The restricted stock units vest over four years, with 25% of the underlying shares vesting on each anniversary of the grant date, subject to the employee being continuously employed by the company as of such vesting dates.

On July 19, 2024 Purple biotech presented its corporate presentation (Presentation, Purple Biotech, JUL 19, 2024, View Source [SID1234644977]).

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On July 19, 2024 Biodexa Pharmaceuticals PLC ("Biodexa" or the "Company") (Nasdaq: BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, reported that it has entered into definitive agreements with certain institutional investors to sell an aggregate of (i) 5,050,808 American Depositary Shares (the "Depositary Shares") (each Depositary Share representing 400 of the Company’s ordinary shares, nominal value £0.001 per share) and (ii) 278,975 pre-funded warrants exercisable for Depositary Shares, at a purchase price of $0.94 per Depositary Share (or $0.9399 per pre-funded warrant) in a registered direct offering (Press release, Biodexa Pharmaceuticals, JUL 19, 2024, View Source [SID1234644976]).

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The gross proceeds from the offering are expected to be approximately $5.0 million, before deducting placement agent fees and other estimated offering expenses. The Company anticipates that the proceeds of this offering will be used to fund its development programs, including to provide the final match payment with respect to a $17 million grant from the Cancer Prevention Research Institute of Texas (CPRIT) and initiate the Phase 3 clinical trial of eRapa in Familial Adenomatous Polyposis (FAP), for working capital and for general corporate purposes.
In a concurrent private placement, the Company has also agreed to issue and sell unregistered Series J warrants to purchase up to an aggregate of 5,329,783 Depositary Shares (the "Series J Warrants") and unregistered Series K warrants to purchase up to an aggregate of 5,329,783 Depositary Shares (the "Series K Warrants"). The offering is expected to close on or about July 22, 2024, subject to the satisfaction of customary closing conditions.

The pre-funded warrants have an exercise price of $0.0001 per Depositary Share, will be immediately exercisable and will not expire. The Series J Warrants have an exercise price of $1.00 per Depositary Share, will be immediately exercisable and will expire on the fifth anniversary of the issuance date. The Series K Warrants have an exercise price of $1.00 per Depositary Share, will be immediately exercisable and will expire on the first anniversary of the issuance date.

Ladenburg Thalmann & Co. Inc. acted as sole placement agent in connection with the offering.

In connection with the offering, the Company has also agreed to amend the exercise price of existing Series E warrants to purchase an aggregate of 978,233 Depositary Shares, existing Series G warrants to purchase an aggregate of 2,443,995 Depositary Shares and existing Series H warrants to purchase an aggregate of 3,236,345 Depositary Shares that were previously issued in December 2023, May 2022 and May 2022, respectively, held by investors participating in the offering, such that, effective upon the closing of the offering, the amended warrants will have an exercise price of $1.00 per share.

The Depositary Shares (or pre-funded warrants in lieu thereof) are being offered pursuant to a shelf registration statement on Form F-3 (File No. 333-267932), which was declared effective by the United States Securities and Exchange Commission ("SEC") on October 26, 2022. A prospectus supplement relating to the Depositary Shares and pre-funded warrants will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, may be obtained, when available, from Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, New York 10019 or by email at [email protected].

The private placement of the Series J Warrants and Series K Warrants are being made in a transaction not involving a public offering and the securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Pursuant to the securities purchase agreement, the Company has agreed to file a registration statement with the SEC registering the resale of the ordinary shares underlying the Depositary Shares issuable upon the exercise of the Series J Warrants and Series K Warrants issued in the private placement.

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 offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.