AskGene Pharma Dosed First Patient in Phase 3, Pivotal Trial of ASKB589 in First-Line Advanced Gastric and Gastroesophageal Junction Cancers

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Camarillo, California, January 26, 2024 – AskGene Pharma Inc. announces dosing of the first patient at a participating site in China for the Phase III pivotal trial of ASKB589. ASKB589 is a CLDN18.2 targeting antibody that is being tested in combination with CAPOX and a PD-1 inhibitor. This combination therapy is intended for the first-line treatment patients with advanced, recurrent, or metastatic gastric cancer (GC) and gastroesophageal junction (GEJ) cancer in China. This study marks the first pivotal clinical trial for triple combination therapy using an anti-claudin 18.2 antibody alongside a PD-1 inhibitor and chemotherapy, for the initial treatment of G/GEJ cancer patients (NCT04632108).

Jian-Feng (Jeff) Lu, Ph.D., CEO of AskGene, commented: “We are very happy that our pivotal phase 3 program has successfully started in China with the enrollment of the first patient. The promising results of Phase 1/2 study of triple combination suggest that the combination of ASKB589, PD-1 inhibitor, and chemotherapy may be a transformative treatment option for gastric or gastroesophageal junction adenocarcinoma and support exploring the combination in patients with earlier stages of disease. The triple combination represents an innovative approach which aims to leverage the full potential of targeted therapy, immunotherapy and chemotherapies.”

The multicenter, randomized, double-blind, standard-of-care controlled Phase 3 trial (NCT06206733) has a planned enrollment of 780 patients. Patients will receive ASKB589 plus tislelizumab and CAPOX or placebo plus tislelizumab and CAPOX on day 1 of each 3-week cycle. The primary endpoint of the trial is progression free survival (PFS), with overall survival (OS), objective response rate (ORR), duration of response (DOR) and safety serving as secondary endpoints.

The latest Phase I/II clinical results presented at ASCO GI (the American Society of Clinical Oncology Gastrointestinal Cancer Symposium) in January 2024 demonstrate an encouraging anti-tumor activity and a manageable safety profile for ASKB589 combination therapy with CAPOX and a PD-1 inhibitor1. Among 45 CLDN18.2 moderate to high patients (determined by a validated proprietary companion diagnostic kit) with measurable disease and at least one post-treatment tumor assessment in the 6 mg/kg dose-expansion phase, 36 (80.0%) patients achieved Partial Response (PR) and 9 (20.0%) achieved Stable Disease as the best overall tumor response per RECISTv1.1. Disease Control Rate (DCR) was 100%.

About ASKG589

ASKB589 is a second generation anti-CLDN18.2 humanized monoclonal antibody with ADCC enhancement. To support the Phase 3 pivotal trial, more than 200 patients have been enrolled into 2 Phase I/II studies, including ASKB589 monotherapy, combination with chemotherapy, and combination with PD-1 inhibitor and chemotherapy. No dose limiting toxicity (DLT) has been observed so far, with monotherapy up to 20 mg/kg, and combination therapy up to 15 mg/kg.  A maximum tolerated dose (MTD) has not yet been reached. ASKB589 is intended for treatment of G/GEJ cancer, pancreatic cancer, and additional cancer types which express CLDN18.2.

AskGene has also developed a sensitive and specific CLDN18.2 immunohistochemistry-based companion diagnostic kit, which is used to support ASKB589 Phase III program.

About AskGene Pharma

AskGene Pharma, founded in 2012 in Camarillo, California, is dedicated to the discovery and development of novel antibodies and fusion protein therapeutics.  It has established the proprietary SmartKine® cytokine prodrug platform, which significantly improves the developability of cytokines for oncology and inflammation indications.  AskGene has multiple programs in clinical and preclinical developments.  In addition to the cytokine programs, AskGene is also developing ASKB589, an anti-CLDN18.2 monoclonal antibody currently in Phase 3 for G/GEJ cancer, and ASKG712, a bifunctional molecule targeting both VGEF and ANG-2 pathways currently in phase 1 development for ophthalmology indications.

Forward-looking statement Disclaimer

This press release contains forward-looking statements that involve risks, uncertainties, and assumptions. These forward-looking statements reflect the Company’s views at the time such statements were made with respect to future events and are not a guarantee of future performance or developments. All statements other than statements of historical fact may be deemed as forward-looking, including but not limited to: any statements regarding plans, strategies and objectives for the future management of operations, including but not limited to, our clinical development and commercialization plans; predictions of any financial information; any statement of historical results that may indicate trends in our business development; statements of any expectations or beliefs regarding future events, potential markets or market size, technological developments, product lines, clinical data, results, experiments or their implications, enforceability of intellectual property rights, competitive advantage or our position in the industry; and any hypothetical statements of the items mentioned.

Reference:

1Peng Z, Shen L, He Y, et. Al. A phase Ib/II study of ASKB589 (anti-Claudin 18.2 [CLDN18.2] monoclonal antibody) combined with CAPOX and PD-1 inhibitor as first-line treatment for locally advanced, relapsed and metastatic gastric/gastro-esophageal junction (G/GEJ) adenocarcinoma. ASCO GI 2024, Abstract # 317, Poster # E17.

AskGene Presents Interim Results of ASKB589 (anti-CLDN18.2 antibody) in Combination with CAPOX and PD-1 Inhibitor at ASCO-GI 2024

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Camarillo, California, January 18, 2024 – AskGene Pharma Inc. presented encouraging clinical results for ASKB589, an anti-CLDN18.2 antibody, at the American Society of Clinical Oncology Gastrointestinal Cancer Symposium (ASCO-GI 2024) in San Francisco on January 18-20, 2024.

The results were from clinical trial NCT05632939, a Phase Ib/II, two-part, dose escalation and expansion study to evaluate the safety, tolerability, and anti-tumor activities of ASKB589 in combination with chemotherapy (CAPOX) and a PD-1 inhibitor as a first-Line treatment in patients with locally advanced, relapsed and metastatic gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma. As of December 20, 2023, a total of 62 patients with positive CLDN18.2 expression were dosed Q3W with ASKB589 combined with CAPOX and PD-1 inhibitor: 9 patients received ASKB589 at 6 mg/kg (n=3) and 10 mg/kg (n=6) in the dose escalation and 53 patients at 6 mg/kg in the dose expansion. Most of the enrolled patients had moderate to high CLDN18.2 expression (83.9%) and PD-L1 CPS ³1 (59.7%).

ASKB589 was safe and tolerated at both 6 and 10 mg/kg. No dose-limiting toxicity was observed, and maximum tolerated dose (MTD) was not identified during the escalation phase of the study. Most adverse events (AEs) were of mild severity (grade 1 or 2).  The most common AEs were hypoalbuminemia (77.4%), nausea (66.1%), anemia (56.5%), neutrophil count decreased (54.8%), and vomiting (51.6%). No patients discontinued the treatment due to AEs.

Among 45 CLDN18.2 moderate to high patients (determined by a validated proprietary companion diagnostic kit) with measurable disease and at least one post-treatment tumor assessment in the 6 mg/kg dose- expansion phase, 36 (80.0%) patients achieved partial response and 9 (20.0%) achieved stable disease as the best overall tumor response per RECISTv1.1. Disease control rate was 100%. As of the cutoff date, 41(77.3%) out of the 53 patients in the dose expansion group were still on treatment.

In summary, ASKB589 plus CAPOX and PD-1 inhibitor as a first-line treatment in patients with G/GEJ cancer demonstrated good safety and tolerability. Adding a PD-1 inhibitor to ASKB589 plus CAPOX in patients with moderate to high CLDN18.2 expression resulted in encouraging anti-tumor activities with deep and durable responses. Based on the interim results of this study, NMPA greenlighted the Phase 3 study of ASKB589 in combination with CAPOX and PD-1 inhibitor as a first-line treatment in CLDN18.2 moderate to high (≥40% 2+/3+ staining) patients with advanced G/GEJ cancer in China.

Jian-Feng (Jeff) Lu, Ph.D., CEO of AskGene, commented: “Claudin 18.2 has recently been validated as a new molecular target that demonstrates clinical benefit for patients with gastric and gastroesophageal cancer.  Our study shows that triple combination of ASKB589, chemotherapy, and PD-1 inhibitor can be administered safely in patients and results in a very high rate of deep and durable responses, as well as a 100% disease control rate.  We have initiated the registrational trial and expect to enroll the first patient soon”.

Presentation Details

  • Title: A Phase Ib/II Study of ASKB589 (Anti-CLDN18.2 Monoclonal Antibody) in Combination with CAPOX and PD-1 Inhibitor as a First-Line Treatment of Locally Advanced, Relapsed and Metastatic G/GEJ Cancer (NCT05632939)
  • Principle Investigator: Dr. Lin Shen, Peking University Cancer Hospital
  • Presenter: Dr. Zhi Peng, Peking University Cancer Hospital
  • Abstract #: 317
  • Poster #: E17

About NCT05632939

The NCT04632108 study is a Phase Ib/II, two-part, dose escalation and expansion study to evaluate the safety, tolerability, and anti-tumor activities of ASKB589 in combination with chemotherapy (CAPOX) and a PD-1 inhibitor as a first-Line treatment in patients with locally advanced, relapsed and metastatic G/GEJ cancer. The study includes ASKB589 dose escalation (6 and 10 mg/kg) and expansion study of ASKB589 (6 mg/kg) combined with CAPOX and PD-1 inhibitor. Patients with positive CLDN18.2 expression (any tumor cell with ≥1+ membrane staining) determined by the central lab have been enrolled.

About ASKB589

ASKB589 is an innovative biological drug discovered and developed by AskGene.  It is a recombinant humanized monoclonal antibody targeting CLDN 18.2.  The drug mediates antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) through high-affinity binding to CLDN18.2-expressing cancer cells.  ASKB589 is intended for treatment of G/GEJ cancer, pancreatic cancer, and additional cancer types which express CLDN18.2. 

About AskGene Pharma

AskGene Pharma, founded in 2012 in Los Angeles, California, is dedicated to the discovery and development of novel antibodies and fusion protein therapeutics.  It has established the proprietary SmartKine® cytokine prodrug platform, which significantly improves the developability of cytokines for oncology and inflammation indications.  AskGene has multiple programs in clinical and preclinical developments.  In addition to the cytokine programs, AskGene is also developing ASKB589, an anti-CLDN18.2 monoclonal antibody currently in Phase 3 for G/GEJ cancer, and ASKG712, a bifunctional molecule targeting both VGEF and ANG-2 pathways currently in phase 1 development for ophthalmology indications.

AskGene Pharma Received Clearance to Commence Pivotal Phase III Clinical Trial in China for ASKB589

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Camarillo, California, October 16, 2023 – AskGene Pharma Inc. announces that the Center for Drug Evaluation (CDE) of the Chinese National Medicinal Product Administration (NMPA) has granted clearance for the initiation of a Phase III clinical trial to evaluate the efficacy and safety of ASKB589 (anti-CLDN18.2 monoclonal antibody) in combination with CAPOX (capecitabine and oxaliplatin) and a PD-1 inhibitor for the first-line treatment of CLDN18.2 positive, inoperable, locally advanced, recurrent or metastatic gastric and esophagogastric junction (G&GEJ) cancer in China.  The Phase III initiation marks AskGene’s entry into the first tier of pivotal clinical studies for anti-claudin 18.2 antibody targeted therapy for gastric cancer.

ASKG589 Clinical Progress

ASKB589 is a second generation anti-CLDN18.2 humanized monoclonal antibody with ADCC enhancement. To support the Phase III study, more than 200 patients have been enrolled into a number of Phase I/II studies, including ASKB589 monotherapy, combination with chemotherapy, and combination with PD-1 inhibitor and chemotherapy. No dose limiting toxicity (DLT) has been observed so far, with monotherapy up to 20 mg/kg, and combination therapy up to 15 mg/kg. Thus, a maximum tolerated dose (MTD) has not yet been reached, indicating that ASKB589 is well-tolerated.

The Phase I/II clinical results were first presented at ASCO GI (the American Society of Clinical Oncology Gastrointestinal Cancer Symposium) in January 2023, and later at IGCC (the International Gastric Cancer Congress) in June 2023. For those patients in the Phase II dose expansion study with measurable lesions, at least one post-treatment tumor assessment, medium to high CLDN18.2 expression, and treatment with 6 or 10 mg/kg ASKB589 in combination with CAPOX (capecitabine and oxaliplatin), the investigator-confirmed objective response rate (cORR) was 79.2%, and the disease control rate (DCR) was 95.8%.

In order to better identify patients who can benefit from the treatment, AskGene has also developed a CLDN18.2 immunohistochemistry-based companion diagnostic kit. With its high sensitivity and selectivity, the diagnostic kit will become an essential component of the ASKB589 Phase III program.

The approval of Phase III clinical trial is a major milestone for ASKB589 as an innovative patient-centered first-line treatment of G&GEJ cancer. The combination therapy targets both CLDN18.2 and PD-1, and could provide a more effective treatment by boosting both innate and adaptive immune responses.

Barbara Hickingbottom, J.D., M.D., Chief Medical Officer of AskGene, commented: “Claudin 18.2 has recently been validated as a new molecular target that demonstrates the potential for clinical benefit for patients with gastric and gastroesophageal cancer. Our Phase I/II clinical trial shows that ASKB589, particularly in combination with chemotherapy or PD-1 plus chemotherapy, can be administered safely in patients with these types of cancer and results in a high rate of deep and durable responses, as well as a remarkable disease control rate. The clearance for starting the registrational trial marks a major milestone for the clinical development ASKB589. We look forward to conducting an efficient and successful Phase III trial and advancing ASKB589 to meet the significant unmet medical needs of gastric and gastroesophageal cancer patients in China and beyond.”

About Gastric Cancer

Gastric cancer, also known as stomach cancer, is one of the most common cancers in the world, with more than 1 million new cases and 769,000 deaths each year worldwide.  It ranks fifth in incidence rate among malignant tumors and fourth in mortality.   According to data from the World Health Organization, there were approximately 480,000 new gastric cancer cases and 370,000 deaths in China in 2020, accounting for 44% and 48.6% of the global gastric cancer new cases and deaths, respectively.

About ASKB589

ASKB589 is an innovative biological drug discovered and developed by AskGene. It is a recombinant humanized monoclonal antibody targeting CLDN18.2. ASKB589 is among the top 3 most advanced therapies against this target with no marketed drugs yet. ASKB589 mediates antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) through high-affinity binding to cancer cells. Enrollment in dose escalation for ASKB589 as monotherapy and in combination with CAPOX chemotherapy was completed in 2022. Enrollment continues in expansion cohorts of first-line advanced or metastatic patients with CLDN18.2-positive G&GEJ cancers that are being treated with ASKB589 in combination with chemotherapy. In addition to G&GEJ cancers, ASKB589 is being tested in clinical trials for other CLDN18.2-positive solid tumors such as pancreatic cancer. A pivotal study of ASKB589 in the treatment of gastric cancer has received CDE approval and is under way.

About AskGene Pharma

AskGene Pharma, founded in 2012 in Los Angeles, California, is dedicated to the discovery and development of novel antibody and fusion protein therapeutics. It has established the proprietary SmartKine® cytokine prodrug platform, which significantly improves the developability of cytokines for oncology and inflammation indications. AskGene has multiple programs in clinical and preclinical developments. In addition to the first-in-class cytokine prodrug programs in clinical state, AskGene is actively advancing several programs with the potential of being best-in-class or first-in-class into late-stage or mid-stage clinical development.

Forward-looking statement Disclaimer

This website contains forward-looking statements that involve risks, uncertainties and assumptions. These forward-looking statements reflect the Company’s views at the time such statements were made with respect to future events and are not a guarantee of future performance or developments. All statements other than statements of historical fact may be deemed as forward-looking, including but not limited to: any statements regarding plans, strategies and objectives for the future management of operations, including but not limited to, our clinical development and commercialization plans; predictions of any financial information; any statement of historical results that may indicate trends in our business development; statements of any expectations or beliefs regarding future events, potential markets or market size, technological developments, product lines, clinical data, results, experiments or their implications, enforceability of intellectual property rights, competitive advantage or our position in the industry; and any hypothetical statements of the items mentioned.

AskGene Achieves “First in Human” Milestone for ASKG915, A First-in-Class Anti-PD-1/IL-15 Prodrug for the Treatment of Solid Tumors

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Camarillo, California, August 21, 2023 – AskGene Pharma Inc. is pleased to announce that the first patient has been dosed at Columbia University Irving Medical Center in New York City in the phase I clinical trial of ASKG915. The study is an open label, multi-regional phase I clinical trial evaluating the safety, tolerability, and pharmacokinetics of ASKG915 as a single agent in patients with selected advanced solid tumors. ASKG915 is the first anti-PD-1/IL-15 prodrug in clinical development in the world.

Barbara Hickingbottom, J.D., M.D., Chief Medical Officer of AskGene commented: “Cytokines are natural immune stimulants, which cannot be used widely due to their short half-lives and narrow therapeutic windows. AskGene uses its proprietary technology of SmartKine® to overcome these challenges. We already have on-going clinical studies of ASKG315 (an IL-15 prodrug) and an IL-2 prodrug through a partnership. With ASKG915, we expand our platform to include a molecule that should produce both full anti-PD-1 and IL-15 effects. Such molecules may be able to treat both patients who have failed anti-PD-1 treatment, as well as those who need the extra boost of IL-15 to achieve a response to checkpoint inhibitor therapy. FIH dosing of ASKG915 is an important milestone towards making this next-generation immunotherapy available to patients in need. We are very excited about the progress made so far and look forward to the upcoming POC data from our clinical studies in the future.”

About ASKG915

ASKG915 is the world’s first anti-PD-1 antibody / IL-15 prodrug fusion molecule to enter clinical development. The molecule can achieve tumor targeting through the anti-PD-1 antibody and be locally activated at the tumor site. It is also designed to allow a high enough dose so that the anti-PD-1 antibody has full PD-1 blockage functionality. Preclinical data showed that ASKG915 has extended PK, significantly better efficacy than anti-PD-1 antibody monotherapy, and an expanded therapeutic window. ASKG915 is expected to benefit patients who are not responding to current anti-PD-1 antibody therapies. A multi-regional phase I clinical trial in the US and China was started in Aug 2023.

About AskGene Pharma

AskGene Pharma, founded in 2012 in Los Angeles, California, is dedicated to the discovery and development of novel antibody and fusion protein therapeutics. It has established the proprietary SmartKine® cytokine prodrug platform, which significantly improves the developability of cytokines for oncology and inflammation indications. AskGene has multiple programs in clinical and preclinical developments. In addition to the first-in-class cytokine prodrug programs in clinical state, AskGene is actively advancing several programs with the potential of being best-in-class or first-in-class into late-stage or mid-stage clinical development.

Forward-looking statement Disclaimer

This website contains forward-looking statements that involve risks, uncertainties and assumptions. These forward-looking statements reflect the Company’s views at the time such statements were made with respect to future events and are not a guarantee of future performance or developments. All statements other than statements of historical fact may be deemed as forward-looking, including but not limited to: any statements regarding plans, strategies and objectives for the future management of operations, including but not limited to, our clinical development and commercialization plans; predictions of any financial information; any statement of historical results that may indicate trends in our business development; statements of any expectations or beliefs regarding future events, potential markets or market size, technological developments, product lines, clinical data, results, experiments or their implications, enforceability of intellectual property rights, competitive advantage or our position in the industry; and any hypothetical statements of the items mentioned.

AskGene IGCC 2023 Oral Presentation: Latest Results of ASKB589 Phase I/II Trial

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Camarillo, California, June 16, 2023 – AskGene Pharma Inc. today gave an oral presentation at the 15th International Gastric Cancer Congress (IGCC 2023) in Yokohama, Japan of the latest clinical results from NCT04632108 for ASKB589, an anti-CLDN18.2 antibody, for the treatment of solid tumors.

Presentation Details

  • Title: A Phase I/II Study of ASKB589 (Anti-CLDN18.2 Monoclonal Antibody) in Patients with Solid Tumors
  • Session: Oral 26 – Clinical Study
  • Date and Time: Friday, June 16, 2023 16:50-17:22 Local Time
  • Abstract Number: 01074
  • Leading PI: Dr. Lin Shen, Professor from Peking University Cancer Hospital

NCT04632108 is a first-in-human study evaluating the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of ASKB589 as a monotherapy and in combination with chemotherapy in patients with advanced solid tumors. The study includes ASKB589 monotherapy dose escalation and expansion (Part A) and dose escalation and expansion of ASKB589 combined with CAPOX (capecitabine and oxaliplatin) (Part B). Patients in dose escalation were enrolled regardless of the expression of CLDN18.2, while patients in the dose expansion were only enrolled if their tumors tested positive for CLDN18.2 by a diagnostic assay at a central laboratory.

As of April 25, 2023, for the 24 patients with measurable lesions, at least one post-treatment tumor assessment, medium to high CLDN18.2 expression, and treatment with 6 and 10 mg/kg ASKB589 in combination with CAPOX (capecitabine and oxaliplatin ), the investigator-confirmed objective response rate (cORR) was 79.2%, and the disease control rate (DCR) was 95.8%.

Efficacy of 1st Line Treatment with ≥ 6mg/kg ASKB589 and CAPOX for CLDN18.2 Positive G&GEJ Cancer Patients (n=24)

Dataset with ≥ 1 Efficacy Evaluation6mg/kg
(N=13)		10mg/kg
(N=11)		Total
(N=24)
Objective Response Rate (Confirmed, PR+CR)84.6%72.7%79.2%
Disease Control Rate (PR+CR+SD)92.3%100.0%95.8%
Median Progression-Free Survival (days)Not ReachedNot ReachedNot Reached
Median Overall Survival (days)Not ReachedNot ReachedNot Reached

In addition to demonstrating deep and durable anti-tumor activity, ASKB589 also demonstrated good safety and tolerability.  As of April 25, 2023, with a total of 106 patients enrolled in the study, escalation of monotherapy treatment has reached a dose of 20mg/kg, and escalation of ASKB589 in combination with chemotherapy has reached a dose of 15mg/kg with no dose-limiting toxicity (DLT) having been observed. Thus, a maximum tolerated dose (MTD) for ASKB589, either as monotherapy or in combination with chemotherapy, has not yet been reached. In addition, for treatment with ASKB589 at 6 and 10 mg/kg combined with CAPOX, the majority of adverse events (AEs) were grade 1-2, and the most common AEs were GI toxicities, including nausea, vomiting, loss of appetite, and hypoalbuminemia. 

Dr. Lin Shen, the PI of this clinical study, commented: “This latest clinical phase II data reflects the success of ASKB589’s design as an antibody with stronger target binding activity and ADCC function than its competitors.  Both the 6 mg/kg and 10 mg/kg dose groups have shown encouraging safety and efficacy. We look forward to seeing the differentiating advantages of this innovative drug against this high potential target.  We hope to advance this drug to pivotal clinical trials as soon as possible, bringing hope to gastric cancer patients.”

AskGene has also developed a CLDN18.2 immunohistochemistry-based companion diagnostic kit with high sensitivity and specificity, which will be used to select patients for treatment in future clinical trials.

Conclusions

ASKB589 at a dose of ≥ 6 mg/kg combined with CAPOX has demonstrated encouraging anti-tumor activity, in addition to good safety and tolerability, for the first-line treatment of patients with advanced/metastatic G and GEJ cancer that is CLDN 18.2 positive. ASKB589 is therefore positioned to become a next-generation anti-CLDN18.2 antibody.

Gastric cancer is one of the most common cancers in the world with more than 1 million new cases and 769,000 deaths each year worldwide. It ranks fifth in incidence rate among malignant tumors and fourth in mortality. According to data from the World Health Organization, there were approximately 480,000 new gastric cancer cases and 370,000 deaths in China in 2020, accounting for 44% and 48.6% of the global gastric cancer new cases and deaths, respectively.

About ASKB589

ASKB589 is an innovative biological drug discovered and developed by AskGene. It is a recombinant humanized monoclonal antibody targeting CLDN18.2. ASKB589 is among the top 3 most advanced therapies against this target with no marketed drugs yet. ASKB589 mediates antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) through high-affinity binding to cancer cells. Enrollment in dose escalation for ASKB589 as monotherapy and in combination with CAPOX chemotherapy was completed in 2022. Enrollment continues in expansion cohorts of first-line advanced or metastatic patients with CLDN18.2-positive G&GEJ cancers that are being treated with ASKB589 in combination with chemotherapy. In addition to G&GEJ cancers, ASKB589 is being tested in clinical trials for other CLDN18.2-positive solid tumors such as pancreatic cancer. A pivotal study of ASKB589 in the treatment of gastric cancer is being planned.

About AskGene Pharma

AskGene Pharma, founded in 2012 in Los Angeles, California, is dedicated to the discovery and development of novel antibody and fusion protein therapeutics. It has established the proprietary SmartKine® cytokine prodrug platform, which significantly improves the developability of cytokines for oncology and inflammation indications. AskGene has multiple programs in clinical and preclinical developments. In addition to the first-in-class cytokine prodrug programs in clinical state, AskGene is actively advancing several programs with the potential of being best-in-class into late-stage clinical development, including ASKB589 and ASKG712, a dual-targeting antibody for the treatment of ophthalmology indications.

Forward-looking statement Disclaimer

This website contains forward-looking statements that involve risks, uncertainties and assumptions. These forward-looking statements reflect the Company’s views at the time such statements were made with respect to future events and are not a guarantee of future performance or developments. All statements other than statements of historical fact may be deemed as forward-looking, including but not limited to: any statements regarding plans, strategies and objectives for the future management of operations, including but not limited to, our clinical development and commercialization plans; predictions of any financial information; any statement of historical results that may indicate trends in our business development; statements of any expectations or beliefs regarding future events, potential markets or market size, technological developments, product lines, clinical data, results, experiments or their implications, enforceability of intellectual property rights, competitive advantage or our position in the industry; and any hypothetical statements of the items mentioned.

AskGene Will Give an Oral Presentation on the Latest Clinical Results for ASKB589 at IGGC 2023

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Camarillo, California, June 2, 2023 – AskGene Pharma Inc. is pleased to announce its participation in the prestigious 15th International Gastric Cancer Congress (IGCC 2023), scheduled to take place on June 14-17, 2023 in Yokohama, Japan. At the conference, AskGene will give an oral presentation on the latest clinical results of NCT04632108 for ASKB589, an anti-CLDN18.2 antibody, on June 16, 2023. The presenter will be the leading principal investigator Dr. Lin Shen, professor from Peking University Cancer Hospital.

IGCC is a world renowned biennial global academic conference sponsored by the International Gastric Cancer Association (IGCA). IGCC 2023 will be a hybrid online/offline conference.

Presentation Details

  • Title: A phase I/II study of ASKB589 (Anti-Claudin 18.2 (CLDN18.2) monoclonal antibody) in patients with solid tumors
  • Session: Oral 26 – Clinical Study
  • Date and Time: Friday, June 16, 2023 16:50-17:22 Local Time
  • Abstract Number: 01074
  • Leading PI: Dr. Lin Shen, professor from Peking University Cancer Hospital.

About NCT04632108

The NCT04632108 study is a first-in-human study evaluating the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of ASKB589 as a monotherapy and in a combination chemotherapy in patients with advanced solid tumors. The study includes ASKB589 monotherapy dose escalation and expansion (Part A) and dose escalation and expansion of ASKB589 combined with CAPOX (capecitabine and oxaliplatin) (Part B). Patients in the dose escalation were enrolled regardless of the expression of CLDN18.2, while patients in the dose expansion were only enrolled if their tumors tested positive for CLDN18.2 by a central laboratory assay. Enrollment in dose escalation for ASKB589 as monotherapy and in combination with CAPOX chemotherapy was completed in 2022. Enrollment continues in expansion cohorts of first-line advanced or metastatic patients with CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma that is being treated with ASKB589 in combination with chemotherapy.

About ASKB589

ASKB589 is an innovative biological drug discovered and developed by AskGene. It is a recombinant humanized monoclonal antibody targeting claudin 18.2. The drug mediates antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) through high-affinity binding to cancer cells. In addition to gastric and gastroesophageal junction cancers, ASKB589 is being tested in clinical trials for other CLDN18.2-positive solid tumors such as pancreatic cancer. A pivotal Phase III study of ASKB589 in the treatment of gastric cancer is being planned.

About AskGene Pharma

AskGene Pharma, founded in 2012 in Los Angeles, California, is dedicated to the discovery and development of novel antibody and fusion protein therapeutics. It has established the proprietary SmartKine® cytokine prodrug platform, which significantly improves the developability of cytokines for oncology and inflammation indications. AskGene has multiple programs in clinical and preclinical developments. In addition to the first-in-class cytokine prodrug programs in clinical state, AskGene is actively advancing several programs with the potential of being best-in-class into late-stage clinical development, including a pivotal clinical study of ASKB589 and a clinical study of ASKG712, a dual-targeting antibody for the treatment of ophthalmology indications.

Forward-looking statement Disclaimer

This website contains forward-looking statements that involve risks, uncertainties and assumptions. These forward-looking statements reflect the Company’s views at the time such statement was made with respect to future events and are not a guarantee of future performance or developments. All statements other than statements of historical fact may be deemed as forward-looking, including but not limited to: any statements regarding plans, strategies and objectives for the future management of operations, including but not limited to, our clinical development and commercialization plans; predictions of any financial information; any statement of historical results that may indicate trends in our business development; statements of any expectations or beliefs regarding future events, potential markets or market size, technological developments, product lines, clinical data, results, experiments or their implications, enforceability of intellectual property rights, competitive advantage or our position in the industry; and any hypothetical statements of the items mentioned.

AskGene Presents Encouraging Clinical Results on ASKB589 at ASCO-GI 2023

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Camarillo, California, January 24, 2023 – AskGene Pharma Inc. presented encouraging clinical results for ASKB589, an anti-CLDN18.2 antibody, at the American Society of Clinical Oncology Gastrointestinal Cancer Symposium (ASCO-GI 2023) in San Francisco on January 19-21, 2023.

The results were from clinical trial NCT04632108, a Phase I/II, two-part, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of ASKB589 monotherapy (Part A) and in combination with chemotherapy (Part B) in patients with advanced solid tumors.  In Part A, patients with heavily pre-treated solid tumors received ASKB589 at doses ranging between 0.3 and 20 mg/kg every 3 weeks (Q3W).  In Part B, doses of ASKB589 ranging from 3 to 15 mg/kg were given in combination with chemotherapy Q3W.  The majority of the enrolled patients had gastric or gastroesophageal junction (G/GEJ) cancer (77.5% for Part A; 91.1% for Part B).

As of January 04, 2023, a total of 85 patients were treated with ASKB589 (40 patients received monotherapy and 45 patients received ASKB589 in combination with capecitabine and oxaliplatin (CAPOX)).  The highest dose of monotherapy tested was 20 mg/kg, and the highest dose of ASKB589 in combination with chemotherapy was 15 mg/kg. ASKB589 was safe and well tolerated both as monotherapy and in combination with chemotherapy.  No dose-limiting toxicity was observed during the escalation phase of the study in Part A or Part B.  A maximum tolerated dose (MTD) was therefore not identified for either monotherapy or combination therapy.  The majority of adverse events were of mild severity (grade 1 or 2).  The most common adverse events were gastrointestinal related events, including nausea (50% for monotherapy; 64.4% for combination therapy) and vomiting (45% for monotherapy and 73.3% for combination therapy), which were generally resolved within one week.

Among the 21 patients with CLDN 18.2-positive G/GEJ cancer who received ≥ 10 mg/kg ASKB589 monotherapy, two (2) patients had partial response (PR).  One of these patients has continued in PR at 35 weeks.  Among the 24 patients with CLDN 18.2-positive G/GEJ cancer who received ≥ 6 mg/kg ASKB589 combined with CAPOX chemotherapy as first-line treatment for metastatic or unresectable advanced disease, the objective response rate (ORR) was 75% (18 PR patients), and the disease control rate (DCR) was 100%.

In summary, ASKB589 was well-tolerated with manageable safety and good tolerability both as monotherapy and in combination with chemotherapy.  ASKB589 combined with CAPOX regimen as first-line treatment for patients with CLDN 18.2-positive gastric or gastroesophageal junction cancer showed deep and durable antitumor activity at dose levels ≥ 6 mg/kg.

Barbara Hickingbottom, J.D., M.D., Chief Medical Officer of AskGene, commented: “Claudin 18.2 has recently been validated as the first new molecular target that demonstrates the potential for clinical benefit for patients with gastric and gastroesophageal cancer in quite some time.  This clinical trial shows that ASKB589, particularly in combination with chemotherapy, can be administered safely in patients with these types of cancer and results in a high rate of deep and durable responses, as well as a remarkable disease control rate.  We are planning to initiate a registrational trial in claudin 18.2 selected G/GEJ patients in 2023. ”

Presentation Details

  • Title: Safety and Anti-Tumor Activity of a Phase I/II Study of ASKB589, an Anti-Claudin 18.2 (CLDN18.2) Monoclonal Antibody as a Monotherapy and in Combination with Chemotherapy in Patients with Solid Tumors
  • First Author: Miao Zhang, Peking University Cancer Hospital
  • Presenter: Barbara Hickingbottom, AskGene
  • Abstract #: 397
  • Poster #: G19

About NCT04632108

The NCT04632108 study is a first-in-human study evaluating the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of ASKB589 monotherapy and combination chemotherapy in patients with advanced solid tumors.  The study includes ASKB589 monotherapy dose escalation and expansion study (Part A) and dose escalation and expansion study of ASKB589 combined with chemotherapy (Part B). The patients in the dose escalation studies were enrolled regardless of the expression of CLDN18.2, while only the patients who test positive for CLDN18.2 by the central lab have been enrolled in the dose expansion study.

About ASKB589

ASKB589 is an innovative biological drug discovered and developed by AskGene.  It is a recombinant humanized monoclonal antibody targeting claudin 18.2.  The drug mediates antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) through high-affinity binding to cancer cells.  ASKB589 is intended for use in gastric and gastroesophageal junction cancers and pancreatic cancers.  The multi-center Phase I/II clinical trial in China is led by Professor Shen Lin from Peking University Cancer Hospital.

About AskGene Pharma

AskGene Pharma, founded in 2012 in Los Angeles, California, is dedicated to the discovery and development of novel antibody and fusion protein therapeutics.  It has established the proprietary SmartKine® cytokine prodrug platform, which significantly improves the developability of cytokines for oncology and inflammation indications.  AskGene has multiple programs in clinical and preclinical developments.  In addition to the cytokine programs, AskGene is also developing ASKB589, an anti-CLDN18.2 antibody currently in phase 2 development for gastric cancer; and ASKG712, a bifunctional molecule targeting both VGEF and ANG-2 pathways currently in phase 1 development for ophthalmology indications.

AskGene Announces Completion of First Human Dosing of ASKG315, The First IL-15 Prodrug in Clinical Development

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Camarillo, California, December 30th, 2022 – AskGene Pharma Inc. is pleased to announce that the first patient completed their first dose (Cycle 1, Day 1) in the phase I clinical trial of ASKG315 in Shanghai, China.  The study is an open label, multicenter phase I clinical trial evaluating the safety, tolerability, and pharmacokinetics of ASKG315 for injection in patients with locally advanced or metastatic solid tumors.  ASKG315 is the first IL-15 prodrug in clinical development in the world.

Jian-Feng (Jeff) Lu, Ph.D., CEO of AskGene commented: “ASKG315 is the second cytokine prodrug incubated from our propriety SmartKine® cytokine prodrug platform technology.  Preclinical data showed that ASKG315 selectively stimulated NK cells and CD8+ T cells.  We are looking forward to achieving initial clinical proof of concept of the molecule as well as the platform.  With multiple clinical programs, AskGene is establishing its global leading position in the field of cytokine prodrug.”

Barbara Hickingbottom, J.D., M.D., Chief Medical Officer of AskGene commented: “Cytokines are natural immune stimulants, which cannot be used widely due to their short half-lives and narrow therapeutic windows.  AskGene expects to use its proprietary technology to overcome these challenges.  With the recent clearance of the ASKG915 IND by FDA, and an IL-2 prodrug in clinical development through a partnership, AskGene now has three cytokine prodrug programs in clinical development.  We are very excited about the progress made in 2022 and look forward to the upcoming POC data from our clinical studies in 2023”.

About ASKG315

ASKG315 is a novel and proprietary IL-15 prodrug discovered and developed by AskGene.  It is the world’s first IL-15 prodrug moved into clinical development.  Preclinical data of ASKG315 showed that this molecule selectively stimulated NK cells and CD8+ T cells in cynomolgus monkeys. Compared to previous generations of cytokine drugs, the prodrug design significantly extended the half-life, effectively improved the safety window, and reduced toxicity.  ASKG315 has the longest half-life in cynomolgus monkeys among similar cytokine drugs in development.

About AskGene Pharma

AskGene, founded in 2012 in Los Angeles, California, is dedicated to the discovery and development of novel antibody and fusion protein therapeutics. It has established the proprietary SmartKine® cytokine platform, which significantly improves the developability of cytokines for oncology and inflammation indications. AskGene has multiple programs in clinical and preclinical developments.  In addition to the cytokine programs, AskGene is also developing ASKB589, an anti-CLDN18.2 antibody currently in phase 2 development for gastric cancer; and ASKG712, a bifunctional molecule targeting both VGEF and ANG-2 pathways currently in phase 1 development for ophthalmology indications.

AskGene Announces Clearance of IND Application by US FDA for ASKG915, A First-in-Class Anti-PD-1-IL-15 Prodrug Fusion Molecule for the Treatment of Patients with Solid Tumors

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Camarillo, California, December 30th, 2022 – AskGene Pharma Inc. is pleased to announce that the United States Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the clinical development of ASKG915, a novel and proprietary anti-PD-1-IL-15 prodrug fusion molecule for the treatment of cancer.  Under this IND, AskGene will soon initiate a phase 1 study in the United States to investigate the safety, tolerability, pharmacokinetics, and efficacy of ASKG915 in patients with advanced solid tumors.  ASKG915 will be the first anti-PD-1-IL-15 prodrug fusion molecule moving into clinical development in the world.

Jian-Feng (Jeff) Lu, Ph.D., CEO of AskGene commented: “We are pleased that we received IND clearance for ASKG915, which is our third cytokine prodrug program entering clinical development. This important milestone brings us closer to delivering a truly bifunctional molecule with synergistic effect of an IL-15 agonist and PD-1 blockage to treat oncology patients. ASKG915 is expected to benefit patients who do not respond to current immunotherapies.”

About ASKG915

ASKG915 is the world’s first PD-1 antibody-IL-15 prodrug fusion molecule to enter clinical development.  The molecule can achieve tumor targeting through the anti-PD-1 antibody and be locally activated at the tumor site.  It is also designed to allow high enough of a dosage so that the anti-PD-1 antibody has full PD-1 blockage functionality.  Preclinical data showed that ASKG915 has extended PK, significantly better efficacy than an anti-PD-1 antibody monotherapy, and an expanded therapeutic window.  ASKG915 is expected to benefit patients who are not responding to existing anti-PD-1 antibody therapies.  A Phase I clinical trial is expected to start in the first half of 2023.

About AskGene Pharma

AskGene, founded in 2012 in Los Angeles, California, is dedicated to the discovery and development of novel antibody and fusion protein therapeutics. It has established the proprietary SmartKine® cytokine platform, which significantly improves the developability of cytokines for oncology and inflammation indications. AskGene has multiple programs in clinical and preclinical developments.  In addition to the cytokine programs, AskGene is also developing ASKB589, an anti-CLDN18.2 antibody currently in phase 2 development for gastric cancer; and ASKG712, a bifunctional molecule targeting both VGEF and ANG-2 pathways currently in phase 1 development for ophthalmology indications.

AskGene Announces Submission of IND to FDA for ASKG915

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Camarillo, California, November 21st, 2022 – AskGene Pharma Inc. is pleased to announce the submission of an Investigational New Drug (IND) application for ASKG915 to the United States Food and Drug Administration (FDA).  ASKG915 is a recombinant human anti-PD-1 monoclonal antibody and IL-15 prodrug fusion protein for oncology indications.

Jian-Feng (Jeff) Lu, Ph.D., CEO of AskGene commented: “ASKG915 is our third cytokine prodrug entering clinical development, which was discovered and developed using our propriety SmartKine® cytokine platform technology.  Based on the projected dose, it will have full bifunction activities encompassing the combined therapeutic potencies of IL-15 super-agonist and Anti-PD1.  ASKG915 is the first anti-PD-1-IL-15 prodrug fusion molecule moving into clinical development.  It represents the next generation of immunotherapy and is expected to achieve better safety, efficacy, and overall benefit for patients, especially those who may not respond to current immunotherapies.”

About AskGene Pharma

AskGene (California, USA), founded in 2012 in Los Angeles, California, is dedicated to the discovery and development of novel antibody and fusion protein therapeutics.  AskGene is a pioneer in the discovery and development of next generation cytokine therapeutics.  It has established the cutting edge SmartKine® cytokine platform.  The SmartKine® platform significantly improves the developability of cytokines for oncology and inflammation indications.  AskGene is actively moving multiple projects into clinical and preclinical developments.

About ASKG915

ASKG915 is the world’s first PD-1 antibody-IL-15 prodrug fusion molecule to enter clinical development.  The molecule can achieve tumor targeting through the anti-PD-1 moiety and be locally activated at the tumor site.  It is also designed to allow high enough doses for the anti-PD-1 moiety to have full receptor blocking functionality.  Preclinical data showed that ASKG915 has extended PK, significantly better efficacy than anti-PD-1 antibody monotherapy, and an expanded therapeutic window.  ASKG915 is therefore expected to offer greater benefit to patients than existing anti-PD-1 antibody monotherapies.  The IND application for ASKG915 to the US FDA will be followed by an application to the Chinese authorities in the fourth quarter of 2022.  A Phase I clinical trial is expected to start in 2023.