Be Biopharma to Present at the 42nd Annual J.P. Morgan Healthcare Conference

On December 29, 2023 Be Biopharma, Inc. ("Be Bio"), a company pioneering the discovery and development of Engineered B Cell Medicines (BCMs), reported that Chief Executive Officer Joanne Smith-Farrell,Ph.D., will present at the 42nd Annual J.P. Morgan Healthcare Conference being held at the Westin St. Francis in San Francisco, CA on Wednesday, January 10, 2024 (Press release, Be Biopharma, DEC 29, 2023, View Source [SID1234638846]).

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42nd Annual J.P. Morgan Healthcare Conference
Presentation Date: Wednesday, January 10, 2024
Presentation Time: 8:30 am PT

About Engineered B Cell Medicines – A New Class of Cellular Medicines

The B cell is a powerful cell that produces thousands of proteins per cell per second at constant levels, over decades. Precision genome editing can now be used to engineer B Cells that produce therapeutic proteins of interest, driving a new class of cellular medicines – Engineered B Cell Medicines (BCMs) – with the potential to be durable, allogeneic, redosable and administered without pre-conditioning. The promise of BCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas.

Natera to Participate in the 42nd Annual J.P. Morgan Healthcare Conference

On December 29, 2023 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported that it will participate in the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Tuesday, Jan. 9, 2024 at 3:45 p.m. PT (6:45 p.m. ET) (Press release, Natera, DEC 29, 2023, View Source [SID1234638845]). Members of Natera’s management will deliver a presentation and host a Q&A with the investment community at the conference.

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A live webcast may be accessed through the investor relations section of the Natera website at investor.natera.com. A replay of the event will be available shortly following the conference.

Clover Announces Positive Phase Ⅰ Results for SCB-219M for Treatment of Chemotherapy-Induced Thrombocytopenia (CIT)

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.

IDEAYA Biosciences Announces Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

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.

TiumBio Secures KRW 38.5 Billion in Anticipation of Upcoming Clinical Data

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.