On December 29, 2023 Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global commercial-stage biotechnology company, reported positive preliminary safety, efficacy and pharmacokinetics data in a Phase Ⅰ clinical trial evaluating SCB-219M, an innovative thrombopoietin receptor agonist (TPO-RA) mimetic bispecific Fc-fusion protein produced from CHO cells, for the treatment of cancer patients with chemotherapy-induced thrombocytopenia (CIT) (Press release, Clover Biopharmaceuticals, DEC 29, 2023, View Source;results-for-scb-219m-for-treatment-of-chemotherapy-induced-thrombocytopenia-cit-302023365.html [SID1234638843]).

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All cancer patients enrolled to-date (n=9) receiving chemotherapy plus a single subcutaneous dose of SCB-219M observed platelet counts maintained or recovered at >75 x 109/L (threshold level for CIT) after one week, with responses durable through at least three weeks (i.e. through the chemotherapy cycle). In comparison, following administration of the same chemotherapy (but without SCB-219M) in the same cancer patients prior to enrolling into the trial, all evaluable patients had observed platelet counts drop to <75 x 109/L between one and three weeks. The durable preliminary efficacy and pharmacokinetic profile observed for SCB-219M are potentially supportive of dosing intervals ≥2-weeks. If further confirmed, this profile could enable convenient dosing of SCB-219M synchronized with any given patient’s chemotherapy regimen, typically 2-3 weeks per cycle. A favorable safety and tolerability profile for SCB-219M has also been observed to-date, with no serious adverse events (SAEs) and no dose-limiting toxicity (DLT) identified.

Dr. Yongsheng Wang, Associate Director of West China Hospital Cancer Center at Sichuan University and Principal Investigator for the SCB-219M Phase Ⅰ Trial commented: "We are encouraged by the Phase Ⅰ results to-date for SCB-219M, and we look forward to the continued evaluation of SCB-219M, as we believe the management of CIT remains a pressing unmet medical need for patients undergoing cancer treatment."

"We are pleased to announce positive Phase Ⅰ results for SCB-219M demonstrating rapid and durable efficacy along with a favorable safety profile," said Dr. Peng Liang, Chairman, Chief Scientific Officer of Clover and inventor of SCB-219M. "The preliminary results suggest that SCB-219M has a potentially differentiated profile compared to the current standard of care treatments for CIT and CTIT. In contrast to current biologic treatment options for CIT in China requiring daily injections[1] and globally requiring weekly injections[2], the durable efficacy and pharmacokinetics of SCB-219M observed to-date could enable convenient dosing synchronized with any given patient’s chemotherapy regimen."

The Phase Ⅰ trial is a multi-center, open-label, dose escalation and dose expansion study, that is exploring the safety, tolerability, immunogenicity, pharmacokinetics, and efficacy of SCB-219M administered subcutaneously in cancer patients with CIT. In addition to West China Hospital Cancer Center at Sichuan University, other participating sites in this clinical trial include Sichuan Provincial People’s Hospital and Chengdu No. 6 People’s Hospital. A Phase Ⅰb trial evaluating repeated dosing of SCB-219M in CIT and CTIT patients is planned to initiate in 2024.

CIT is a serious, chemotherapy-associated complication observed in a wide range of cancer patients. Incidence of CIT can occur in greater than 50%[3] of patients undergoing standard chemotherapy regiments, and can have detrimental impacts on treatment outcome, resulting in chemotherapy dose delay or dose reduction, and potentially fatal bleeding events.

On December 29, 2023 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that, on December 28, 2023, the Compensation Committee of IDEAYA’s Board of Directors granted non-qualified stock options to purchase an aggregate of 18,500 shares of the Company’s common stock to a newly hired employee (Press release, Ideaya Biosciences, DEC 29, 2023, View Source [SID1234638842]). The stock options were granted under the IDEAYA Biosciences, Inc. 2023 Employment Inducement Incentive Award Plan (2023 Inducement Plan) as an inducement material to such individual’s entering into employment with IDEAYA in accordance with Nasdaq Listing Rule 5635(c)(4).

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The 2023 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of IDEAYA, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with IDEAYA, pursuant to Nasdaq Listing Rule 5635(c)(4).

The stock options have an exercise price of $35.83 per share, which is equal to the closing price of IDEAYA’s common stock on The Nasdaq Global Select Market on the date of grant. The stock options have a 10-year term and will vest over four years, with 25% of the options vesting on the first anniversary of the vesting commencement date and the remaining 75% of the options vesting in equal monthly installments over the three years thereafter. Vesting of the stock options is subject to such employee’s continued service to IDEAYA on each vesting date.

On December 29, 2023 TiumBio Co., Ltd. (KOSDAQ: 321550), a clinical-stage biopharmaceutical company focusing on discovering and developing innovative therapeutics for patients with rare and incurable diseases, reported the completion of a stock financing of 2,320,185 shares of its convertible preferred shares at a price of KRW 8,620 per share in a private placement (Press release, TiumBio, DEC 29, 2023, View Source [SID1234638841]). TiumBio sold the stock to SK Chemicals Co., Ltd. securing 20 billion won to fund its development of lead pipeline assets.

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With a financing of convertible bonds of 18.5 billion won closed in October this year, TiumBio now has approximately 40 billion won ($31 million) in cash and available-for-sale securities, which is expected to fund operations into 2025.

TiumBio was spun off and founded by Hun-taek Kim, who served as the head of Innovation R&D Center at SK Chemicals. SK Chemicals boasts a rich history of more than 30 years in researching and developing novel drugs.

The funds will be primarily allocated to support its clinical programs that include a Phase 2 trial of merigolix, a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist, in endometriosis, and a Phase 1b trial of TU2218, a first-in-class oral immune-oncology therapy targeting TGF-β and VEGF, in combination with pembrolizumab, and a Phase 1 trial of TU7710, a recombinant protein designed to treat people with hemophilia who have inhibitors.

"With investors believing in our vision for developing breakthrough therapies, we are committed to patients who suffer from incurable diseases," said Hun-taek Kim, Ph.D., MBA, Founder and CEO at TiumBio. "we look forward to sharing results with all stakeholders from the ongoing Phase 2 trial in endometriosis and the Phase 1b trial of TU2218 in advanced solid tumors, expected in the first half of 2024," he added.

On December 29, 2023 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported that as an inducement to entering into employment with the Company, on December 28, 2023, the Company’s Board of Directors approved "inducement" grants to 32 new employees under Rule 5635(c)(4) of the NASDAQ Listing Rules (Press release, Arrowhead Pharmaceuticals, DEC 29, 2023, View Source [SID1234638840]). The grants entitle employees, in aggregate, to receive up to 53,700 restricted stock units. The grants are outside the Company’s stockholder-approved equity incentive plans and vest annually over four years.

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On December 29, 2023 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress" or "Company"), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, reported that it has entered into a definitive agreement for the issuance and sale of 3,303,305 shares of its common stock and warrants to purchase up to 3,303,305 shares of common stock at a combined offering price of $3.33 per share of common stock and accompanying warrant priced at-the-market under Nasdaq rules (Press release, Fortress Biotech, DEC 29, 2023, View Source [SID1234638839]). The warrants have an exercise price of $3.21 per share, are immediately exercisable, and will expire five years following the date of issuance.

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The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $11.0 million. Fortress expects to use the net proceeds from the offering for its operations, including, but not limited to, general corporate purposes, which may include research and development expenditures, clinical trial expenditures, license or acquisition of new products, and working capital.

Roth Capital Partners is acting as exclusive placement agent for the offering. The offering is expected to close on or about January 3, 2024, subject to the satisfaction of customary closing conditions.

The securities described above are being offered pursuant to a registration statement on Form S-3 (File No. 333-258145), which was declared effective by the Securities and Exchange Commission (the "SEC") on July 30, 2021. The offering is being made only by means of a prospectus which is a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Additionally, when available, electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained from Roth Capital Partners, LLC at 888 San Clemente Drive, Newport Beach, CA 92660, or by phone at (800) 678-9147 or email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there by 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.