Deqi Pharma announces Phase Ib study data of Celiniso in the treatment of T and NK cell lymphoma at the ASH annual meeting

Deck Pharmaceuticals Co.
, Ltd.
(abbreviated as "Decki Pharmaceuticals", Hong Kong Stock Exchange stock code: 6996.
HK) announced today that the company will hold an offline and online combination in Atlanta, USA from December 11 to 14, 2021.
The 2021 American Society of Hematology (ASH) annual meeting announced the data of the open phase Ib TOUCH study of Celinisol (ATG-010) for the treatment of relapsed or refractory T and NK cell lymphoma (study registration) No.
NCT04425070, please see below for more details on this study)
.
The TOUCH study enrolled patients with relapsed or refractory T and NK cell lymphoma who had received at least first-line systemic treatment in the past
.
The main study endpoints are overall response rate (ORR) and safety
.
In China, 26 patients received ATG-010 combined with GemOx treatment
.
Among them, 50% of patients were diagnosed as peripheral T-cell lymphoma-non-specific (PTCL-NOS), 26.
9% of patients were extranodal NK/T-cell lymphoma (ENKTL); 50% of patients had received at least 3-line treatment in the past, 57 % Of patients have previously received treatment with gemcitabine-containing regimens
.
ATG-010 combined with GemOx treatment showed better efficacy, and the remission rate and PFS performance of patients with PTCL-NOS and ENKTL were more prominent
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The ORR of the total population was 46.
2%, the CR rate was 26.
9%, and the median PFS was 2.
7 months
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For the two subtypes of PTCL-NOS and ENKTL, the ORR was 53.
8% and 57.
1%, the CR rate was 30.
8% and 28.
6%, and the median PFS was 4.
4 months and 4.
7 months, respectively
.
The safety of ATG-010 combined with GemOx is controllable
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Common adverse events (TEAEs) ≥ Grade 3 during the treatment period are mainly hematological toxic events (decreased platelet count, decreased neutrophil count, and anemia)
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Non-hematological adverse events are usually low-grade and reversible, most of which are gastrointestinal events
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After active supportive treatment and drug adjustments, these adverse events are generally controllable
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Professor Huang Huiqiang from the Lymphoma Center of Sun Yat-sen University Cancer Hospital said: “PTCL and NKTCL are highly heterogeneous and highly invasive, and their incidence in China is significantly higher than that in Western countries.
However, the existing treatment programs are not effective, especially for difficult The prognosis of patients with recurrence is poor, so they can only choose conventional chemotherapeutics for salvage treatment, but the remission rate is low and the maintenance time is short, especially for most of the older people and/or with multiple comorbidities and not Patients who are suitable for transplantation have a large number of unmet clinical needs.
The
TOUCH study provides us with a new idea.
Celiniso is the first and only oral selective nuclear export protein inhibitor of its kind.
The mechanism of action is different, and the combined use can achieve synergistic results.
Clinical data shows that the efficacy and safety of the combined GemOx program are encouraging.
What is more commendable is the data for the Chinese population, which has more practical guidance for Chinese patients Significance, I believe Celiniso will become a new weapon for the treatment of these patients, and bring new hope for these patients!" Dr.
Kevin Lynch, Chief Medical Officer of Deqi Pharmaceuticals, said: "The Phase Ib TOUCH study shows that the TOUCH study is positive and effective.
The data on sex and safety are exciting
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At present, patients with T and NK cell lymphoma who have received multi-line therapy have urgent clinical needs for new therapeutic drugs
.
We will actively promote these studies and look forward to launching ATG-010 Joint expansion of the GemOx program to further explore the safety and effectiveness of the combination therapy
.
" Dr.
Mei Jianming, founder, chairman and CEO of Deqi Pharmaceuticals, said: “ATG-010 is the first business of Deqi Pharmaceuticals Innovative drug at the development stage.

ATG-010 has been approved for marketing in South Korea and is expected to be approved for marketing in China around the end of this year.
The
TOUCH study is one of 10 clinical studies currently underway by Deqi Pharmaceuticals around ATG-010 These studies represent Deqi Pharmaceutical’s unremitting efforts in developing new combination therapies for cancer patients who urgently need effective treatment drugs.

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While we are looking forward to making more progress in the clinical development of ATG-010, we need to express our sincere gratitude to all the partners, researchers and patients who participated in the study
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"Abstract details: XPO1 inhibitor (ATG-010) combined with the chemotherapy regimen selected by the investigator for the treatment of relapsed and refractory (R/R) peripheral T-cell lymphoma (PTCL) and extranodal NK/T who have received multiple lines of therapy in the past Cell Lymphoma (NKTL) Patients: Preliminary Results of a Multicenter, Single Arm Phase Ib Study (TOUCH Study) (Abstract #2452) Session: Hodgkin’s Lymphoma and T/NK Cell Lymphoma: Clinical and Epidemic Pathology Progress: Poster Presentation II Date and Time: Sunday, December 12, 2021, Eastern Time; 6:00 PM – 8:00 PM Venue: Georgia International Convention Center Hall B5 About the announcement at the 2021 ASH Annual Meeting Abstracts about ATG-010 and other SINE drugs Karyopharm Therapeutics, a partner of Deqi Pharmaceuticals, also released another 17 abstracts about Celiniso and eltanexor at this year’s ASH annual meeting
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About the SINE drug SINE (selective nuclear Exportin inhibitors) drugs are agonists that act on the nuclear exportin Exportin 1 (XPO1)
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Currently, there are three oral administrations: ATG-010 (celinisol), ATG-016 (eltanexor) and ATG-527 (verdinexor) SINE drugs are undergoing clinical development for the treatment of related indications
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Deqi Pharmaceuticals has obtained the development and commercialization rights of these three drugs in multiple Asia-Pacific markets through an exclusive licensing agreement with Karyopharm Therapeutics (Karyopharm)
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About ATG-010/ Celiniso/ XPOVIO® Celiniso is currently the first and only oral XPO1 inhibitor approved by the US FDA, and it is also the first to be used for the treatment of multiple myeloma and diffuse large B Drugs for cell lymphoma
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By inhibiting the nuclear export protein XPO1, it promotes the nuclear storage and activation of tumor suppressor proteins and other growth regulatory proteins, and down-regulates the levels of multiple oncogenic proteins in the cytoplasm, and induces tumor cell apoptosis, while normal cells are not affected
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Based on its unique mechanism of action, Celinisol can be combined with many other drugs to improve efficacy
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Celiniso has been approved by the US FDA for the treatment of relapsed/refractory multiple myeloma (RRMM) and relapsed/refractory diffuse large B-cell lymphoma (RRDLBCL)
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Deck Pharmaceuticals has obtained Celiniso's marketing authorization through the priority review process in South Korea
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The company is currently conducting 10 clinical trials of Celinisole for the treatment of relapsed/refractory/advanced solid tumors and hematological tumors in mainland China (three of which are jointly carried out by Deqi Pharmaceutical and Karyopharm)
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About Deqi Pharmaceuticals Deqi Pharmaceuticals Co.
, Ltd.
(abbreviated as "Deqi Pharmaceuticals", Hong Kong Stock Exchange stock code: 6996.
HK) is a leading R&D-driven biopharmaceutical company dedicated to providing leading patients in Asia-Pacific and even the world Therapies to treat tumors and other life-threatening diseases
.
Since its official operation in 2017, Deqi Pharmaceuticals has established a rich product pipeline that extends from pre-clinical to clinical stages through cooperative introduction and independent research and development
.
At present, Deck Pharmaceuticals has 15 products under development, of which 5 products have Asia-Pacific rights including the Greater China market, and 10 products have global rights
.
Deck Pharma has obtained 20 clinical approval documents (IND) in the United States and multiple Asia-Pacific markets, and submitted 6 new drug listing applications (NDA), of which Celiniso has been granted priority approval for new drug listing applications in Korea
.
With the vision of "Doctors have no boundaries, innovation and sustainability", Deqi Pharmaceuticals will focus on the early R&D, clinical research, drug production and commercialization of the first and best-in-class therapies to solve urgent clinical needs
.