Keymed Biosciences Reports H1 2024 Interim Results

August 27, 2024, CHENGDU, China – Keymed Biosciences Inc. (HKEX: 02162) has released its interim results for the first half of 2024, along with significant updates on its pipeline products and corporate activities.

Product Pipeline Progress:

Stapokibart (CM310) (IL-4Rα Antibody)

1. Atopic Dermatitis (AD): In June 2024, long-term efficacy and safety data from a Phase III clinical trial for Stapokibart in treating moderate-to-severe AD were presented at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2024. Results at week 52 showed rates of 92.5% and 77.1% for achieving EASI-75 and EASI-90, respectively. Additionally, 67.3% achieved an IGA score of 0 or 1 point with a reduction of ≥ 2 points from baseline. The long-term treatment showed consistent improvement in dermatitis symptoms and quality of life, with no new safety concerns over 52 weeks.

2. Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): Stapokibart's 52-week treatment and safety follow-up for CRSwNP Phase III clinical study were completed, and in June 2024, the new drug application was accepted by the NMPA for priority review.

3. Seasonal Allergic Rhinitis (SAR): The unblinding and statistical analysis of the Phase III clinical study for SAR were completed, meeting the primary endpoints. The new drug application was accepted by the NMPA in April 2024.

4. Adolescent Moderate-to-Severe AD: A Phase III clinical study evaluating Stapokibart's efficacy and safety in adolescents with moderate-to-severe AD started in February 2024.

5. Prurigo Nodularis: A Phase III clinical study began in May 2024 to evaluate Stapokibart in prurigo nodularis subjects.

6. Asthma and COPD: Partner CSPC initiated Phase II/III clinical studies for treating moderate-to-severe asthma and COPD.

CMG901/AZD0901 (Claudin 18.2 ADC)

AstraZeneca conducted multiple clinical studies for CMG901 (AZD0901) targeting advanced solid tumors. Notably, a Phase III international study started comparing CMG901 monotherapy with other treatments for advanced or metastatic gastric and gastroesophageal junction (G/GEJ) cancer expressing Claudin 18.2. Initial doses were administered to the first patient in April 2024. Phase I clinical study results presented in June 2024 at the American Society of Clinical Oncology (ASCO) Annual Meeting indicated confirmed objective response rate (ORR) and disease control rate (DCR) were 35% and 70%, respectively, for high-expressing Claudin 18.2 G/GEJ cancer patients.

CM313 (CD38 Antibody)

Progress continued on a Phase I study evaluating CM313 for multiple hematological malignancies, including RRMM and lymphoma. Additionally, a Phase Ib/IIa clinical study for SLE patients is ongoing. A research paper on CM313 for immune thrombocytopenia was published in The New England Journal of Medicine in June 2024, showing significant efficacy. An IND application was submitted to further assess CM313 in primary immune thrombocytopenia.

CM326 (TSLP Antibody)

In May 2024, a Phase II study began to evaluate CM326 for CRSwNP patients. CSPC also initiated a Phase II study for moderate-to-severe asthma treatment.

Other Product Developments

1. CM355/ICP-B02 (CD20xCD3): A Phase I/II trial for relapsed or refractory NHL is ongoing, with dose escalation completed.
2. CM336 (BCMAxCD3): A Phase I/II study for safety and efficacy in RRMM is proceeding.
3. CM350 (GPC3xCD3): A Phase I/II study for advanced solid tumors continues.
4. CM369/ICP-B05 (CCR8 Antibody): A Phase I study for advanced solid tumors and NHL is ongoing.
5. CM383 (Aβ Protofibrils): A Phase I study in healthy subjects began, focusing on safety and pharmacokinetics.
6. CM380 (GPRC5DxCD3): An IND application was submitted for a Phase I/II study in relapsed or refractory multiple myeloma.

Corporate Highlights:

Out-Licensing Collaboration: In July 2024, Keymed entered an out-license agreement with Belenos, granting exclusivity for CM512 and CM536 outside Greater China. Keymed received an upfront payment of $15 million and will obtain 30.01% equity in Belenos, with potential additional payments up to $170 million and tiered royalties on net sales.

Manufacturing and Commercialization: Keymed expanded its cGMP-compliant production capacity to 18,600 liters to meet growing commercialization needs. The company actively recruits talent for various operational aspects.

Financial Highlights: As of June 30, 2024, Keymed held RMB 2.58 billion in cash. R&D expenses increased by RMB 81 million to RMB 331 million, with revenue reaching RMB 54.6 million, primarily from the CMG901 license milestone payment.

Keymed Biosciences remains committed to advancing its diverse pipeline and preparing for broader commercialization initiatives.

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