Senhwa Biosciences Announces Dose Escalation Initiation of the Phase I Trial of Pidnarulex as a Treatment for Advanced Hematological Malignancies

TAIPEI and SAN DIEGO,Aug. 25,2021 -- Senhwa Biosciences,Inc. (TPEx: 6492),a drug development company focused on first-in-class therapeutics for oncology,rare diseases,and novel coronaviruses,today announced the initiation of Dose Escalation within the Phase I Investigator Initiated Trial (IIT) of Pidnarulex for the treatment of advanced hematological malignancies. After evidence of human efficacy was observed in patients with specific biomarkers and resistant to standard treatments,including chemotherapeutics,the Phase I study was redesigned to further determine the Recommended Phase II Dose.

This open-label dose escalation Phase I IIT study of Pidnarulex is sponsored by the Peter MacCallum Cancer Center (PMCC),in Australia,focusing on various haem cancers,including multiple myeloma,T-cell non-Hodgkin lymphoma,acute myeloid leukaemia and myelodysplastic syndrome. Senhwa is providing the study supplies and the Investigational Product,Pidnarulex,which is intravenously administered on 4-week cycles.

The preliminary results from the preceding portion of the Phase I study,completed in 2017,demonstrated that among the 16 evaluable patients,one patient experienced a partial response after the Pidnarulex treatment,while five patients had stable disease. The PMCC was invited to the 59th American Society of Hematology annual meeting on 11th December,2017,and presented a poster on these findings.

"The multiple myeloma patients enrolled in the initial portion of the Phase I study were resistant to other therapies; however,fifty percent of the multiple myeloma patients treated with Pidnarulex were able to stabilize their conditions. We here at Senhwa will continue to work at providing alternative therapeutics for treatment resistant cancers," said Dr. John Soong,Chief Medical Officer of Senhwa Biosciences.

"We look forward to the outcome of this study and we hope that the findings may inspire more collaborative opportunities to determine if Pidnarulex is effective in treating various forms of haem cancers," said Tai-Sen Soong,the Chief Executive Officer of Senhwa Biosciences.

Hematological cancers affect populations worldwide,notably,there are more than 160,000 new cases of multiple myeloma worldwide per year. The global drug market for multiple myeloma is expected to reach USD 37.5 billion by 2024,according to the forecast of Grand View Research,a leading market research firm.

About Pidanrulex (CX-5461)

Specific mutations within the Homologous Recombination (HR) pathway may be exploited by Pidnarulex through a synthetic lethality approach by targeting the DNA repair defects in Homologous Recombination Deficiency (HRD) tumors. Specifically,Pidnarulex is designed to stabilize DNA G-quadruplexes of cancer cells which leads to disruption of the cell's replication fork. While acting in concert with HR pathway deficiencies,such as BRCA1/2 mutations,replication forks stall and cause DNA breaks,ultimately resulting in cancer cell death. On the other hand,PMCC postulates a different mechanism of action. Specifically,it is thought that Pidanrulex acts as a RNA Pol I Inhibitor.

About Senhwa Biosciences

Senhwa Biosciences,Inc. is a drug development company focusing on the innovation of first-in-class DNA Damage Response therapeutics and addressing unmet medical needs in oncology. Headquartered in Taiwan,with an operational base in San Diego,California,Senhwa is well-positioned to oversee the development of its compounds.

Silmitasertib (CX-4945) and Pidnarulex (CX-5461),both with novel mechanisms of action as anti-cancer drugs for the treatment of multiple indications,are the core products in Senhwa Bioscience's pipeline. Clinical trials are currently ongoing in Australia,Canada,United States,Korea,and Taiwan.

Visit Senhwa Biosciences website for more details: www.senhwabio.com

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