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

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

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

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

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.

AskGene Presents Latest Results on ASKG315 and ASKG915 at SITC 2022

Camarillo, California, November 15th, 2022 – AskGene presented the pre-clinical results of ASKG315 (IL-15 prodrug) and ASKG915 (PD-1/IL-15 prodrug) at the Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting in Boston on November 8 – 12, 2022.  For ASKG315 phase I clinical study design was also presented.  The two posters were:

  • #1101, Chunxiao Yu et al., ASKG315 – An IL-15 Prodrug with Antibody-like PK, Enhanced Safety and Expanded Therapeutic Window
  • #1183, Kurt Shanebeck et al., ASKG915 – An Anti-PD-1 Antibody-IL-15 Prodrug Fusion Molecule with Enhanced Therapeutic Potential

About ASKG315

ASKG315 is the first prodrug molecule derived from the SmartKine® platform, which is AskGene’s proprietary cytokine prodrug technology platform. It is projected to be the world’s first IL-15 prodrug to enter clinical development.  Preclinical data of ASKG315 showed that this molecule can selectively activate NK cells and CD8+ cells.  Compared to previous generations of cytokine drugs, the prodrug design effectively improved the safety window, significantly extended the half-life, and reduced toxicity.  ASKG315 has been approved for clinical trials in Australia and China, and phase I trials will be initiated in both countries in the near future.

About ASKG915

ASKG915 is projected to be the world’s first PD-1 antibody-IL-15 prodrug fusion molecule to enter clinical development.  The molecule can achieve tumor targeting through PD-1 and be locally activated at the tumor site.  At the same time, the molecule can achieve high dosage, so the PD-1 antibody has full PD-1 blockage functionality.  Preclinical data showed that ASKG915 has extended PK, significantly better efficacy than PD-1 antibody monotherapy, and expanded therapeutic window.  ASKG915 is expected to benefit more patients than existing PD-1 antibody monotherapies.  IND applications for ASKG915 will be submitted in US and China in the fourth quarter of 2022.  Phase I clinical trials are expected in 2023.

AskGene Announces Appointment of Chief Medical Officer and VP of Preclinical & Clinical Pharmacology


Camarillo, California, August 19, 2022AskGene Pharma Inc. (AskGene) today announced the appointment of Barbara Hickingbottom, J.D., M.D. as Chief Medical Officer and Matt Hsu, Ph.D. as VP of Preclinical and Clinical Pharmacology.  Dr. Hickingbottom will be responsible for leading the global clinical development of AskGene, including pipeline strategy, clinical development plans and operations, product registration, and guiding the global clinical collaborations with existing and potential partners.  Dr. Hsu will be responsible for leading global preclinical and clinical pharmacology activities.

Jian-Feng (Jeff) Lu, Ph.D., CEO of AskGene commented: “We are pleased to welcome Dr. Hickingbottom and Dr. Hsu to our management team earlier this year.  They will each bring us over two decades of global industry experience, which will help AskGene to continue to optimize our clinical development and global registration strategies for our lead biological products and to progress our promising pipeline of novel drugs positioned to address major areas of unmet clinical needs.  We believe the appointment will bring strong energy and leadership to AskGene for our global clinical development and facilitate regulatory approval of lead innovative cytokine projects and other innovative molecules.”

Barbara Hickingbottom J.D., M.D., CMO of AskGene commented: “I am profoundly excited to bring my experience to AskGene pipeline and join AskGene at this important time as ASKG315 is entering into the clinical stage in Australia.  The early preclinical data for ASKG315 and ASKG915 are very promising, and I look forward to working alongside AskGene’s highly skilled scientific teams to bring the whole AskGene portfolio to patients globally.”

Dr. Matt Hsu, VP of Preclinical and Clinical Pharmacology commented:  “AskGene’s innovative SmartKine® platform with a prodrug approach for cytokine therapies has demonstrated promising anti-tumor activities in preclinical species.  With strong efficacy and reduced toxicity, this technology has a potential to overcome the limitation of cytokine use clinically and revolutionize immunotherapies.  Therefore, I am looking forward to working with the company’s leadership team to advance novel and highly innovative clinical projects and candidates in the areas of oncology and immunological diseases, and to build a robust pipeline that has the opportunity to transform care for many more patients in need around the world.”

Before joining AskGene, Dr. Hickingbottom served as the Head of Clinical Development at Xencor, Inc. (Xencor).  During her time at Xencor, she was deeply involved in the clinical development of 12 anti-tumor biological innovative drugs in Xencor’s pipeline and responsible for all of the company’s clinical-stage products.  Prior to Xencor, Dr. Hickingbottom worked as both a consultant and a scientist in many biopharmaceutical companies, including BioMarin, Mannkind, Novartis, Xoma, Novacea, and CTL Immunotherapies.  Dr. Hickingbottom is an accomplished clinical pathologist with over 25 years of life sciences experience in clinical development, medical affairs, and registration strategy.  She received her Medicine Doctor degree from the Tufts University School of Medicine and completed her internship and residency in pathology at Stanford.  She also received a Juris Doctor degree from the Harvard Law School.

Dr. Hsu has more than two decades of experiences in drug development, ranging from proof of concept to approval.  Previously, Dr. Hsu was Senior Principal Scientist in the Clinical Pharmacology Modeling & Simulation group at Amgen, where he led the Technical and Professional Unit for clinical study data and report preparation, conducted clinical pharmacology studies in translational sciences, applied PK/PD knowledge for dose selection at IND and End-of-Phase 2 stages, and prepared NDA/BLA submission for drug approvals.  Prior to Amgen, Dr. Hsu worked in Preclinical Development at Johnson & Johnson in New Jersey and received his Ph.D. in Pharmaceutical Sciences from the University of Michigan.  He has published more than 35 peer-reviewed papers.

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 prodrug platform. The SmartKine® platform significantly improves the developability of cytokines for oncology and inflammation indications. AskGene is actively moving multiple projects into preclinical and clinical developments.

AskGene Pharma Announces First Development Milestone in License Agreement with AffaMed for the Development of ASKG712 in Retinal Disease

Camarillo, California, June 20, 2022 – AskGene Pharma Inc., an innovative clinical-stage biotech company, announces that its partner AffaMed has dosed the first patient in its US Phase 1 study of ASKG712 (AM712), a novel proprietary bispecific biologic molecule blocking both vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) for the treatment of retinal diseases. The study will investigate the safety, tolerability, pharmacokinetics, and efficacy of AMSKG712 in subjects with neovascular age-related macular degeneration (nAMD).  As a result, AskGene will receive the first development milestone payment from AffaMed.

Jian-Feng (Jeff) Lu, Ph.D., CEO of AskGene commented: “Dosing the first patient with ASKG712 is a major milestone for this program. AskGene wants to congratulate its partner AffaMed for this achievement, and looks forward to working together with AffaMed and advancing ASKG712 as an innovative and differentiated therapy for the patient population with nAMD and other retinal diseases.”

Age-related macular degeneration (AMD) is an acquired degeneration of the retina that results in significant central vision loss due to neovascular (choroidal neovascular membrane formation) and non-neovascular (drusen and retinal pigment epithelium abnormalities) damages.  Neovascular AMD is an advanced form of macular degeneration that has historically been the leading cause of AMD-related vision loss. Simultaneous neutralization of VEGF and Ang-2 represents a novel therapeutic approach to treat nAMD with better efficacy.

In late 2021, AskGene licensed to AffaMed the exclusive rights to develop, manufacture, and commercialize ASKG712 globally in ex-Asia plus Japan territories.  AskGene retains the rights for develop, manufacture, and commercialize ASKG712 in Asia territories except Japan.

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 prodrug 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 AM712 (ASKG712)

AM712 is a novel bispecific biologic molecule specifically designed for ocular use. It provides dual inhibition of two important disease-relevant pathways in retinal diseases, VEGF and Ang-2. In pre-clinical studies, AM712 demonstrated robust efficacy, good ocular pharmacokinetics, and the desired safety profile supporting clinical exploration. AskGene received China CTA clearance for AM712 from NMPA in January 2022.  the Investigational New Drug (IND) applications filed by AffaMed for the clinical development of ASKG712 was cleared by the United States Food and Drug Administration (FDA) in January 2022.

ASKB589 Achieved Partial Response in Phase I/II Clinical Trial

News, 2022-04-29

AskGene is pleased to announce that its lead program ASKB589 has recently achieved single agent efficacy in its on-going Phase I/II clinical trial. Two gastric cancer patients have achieved partial response (PR) after receiving ASKB589 monotherapy for 6 weeks.

ASKB589 is an innovative biological drug discovered and developed by AskGene. It is a recombinant humanized monoclonal antibody targeting claudin18.2. 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 cancer. The multi-center Phase I/II clinical trial in China is led by Professor Shen Lin from Peking University Cancer Hospital.

In the on-going Phase I/II single-agent dose escalation and expansion study, two patients with advanced gastric cancer have achieved PR according to RECIST 1.1 after 6 weeks of treatment with ASKG589 monotherapy. The target lesions were significantly reduced, some non-target lesions disappeared, and tumor markers were significantly reduced. The two patients were among the 10 mg/kg and 20 mg/kg group, respectively, and were relapsed/refractory after multiple lines of chemotherapy and anti-PD-1 antibody therapy. In addition, in the dose escalation study of ASKB589 in combination with CAPOX chemotherapy for the first-line treatment of gastric cancer, three patients in the 3 mg/kg and 6 mg/kg dose groups achieved PR according to RECIST 1.1, after 6 weeks or 12 weeks of treatment.

Professor Shen Lin, Vice President of Peking University Cancer Hospital and Director of the Division of Gastrointestinal Oncology, said: “Claudin18.2 has become an exciting target in the field of gastric cancer treatment. Currently, many companies are developing drugs targeting CLDN18.2. ASKB589 is the third (among the first wave) in China to obtain a CDE clinical trial license. The clinical trial is progressing smoothly, and patients in both high-dose single-agent and combination therapy have shown good tolerance. In terms of efficacy, ASKB589 has also shown efficacy in the single-agent group. The dose-escalation study of combination therapy is also progressing smoothly.”

Dr. Jianfeng (Jeff) Lu, Chief Executive Officer of AskGene, said: “Gastric cancer is one of the malignant tumors with high morbidity and mortality in China. The development of innovative drugs for gastric cancer has not been the focus of international companies. We hope to bring safe and efficacious innovative drugs to gastric cancer patients. Claudin18.2 is a very promising target for gastric cancer treatment. The significant anti-tumor activity observed in single-agent therapy is a very gratifying start. The company will accelerate clinical development, hoping to benefit more patients as soon as possible.”

AM712 (ASKG712) IND Filing in USA

AffaMed Therapeutics (“AffaMed”), in collaboration with Askgene, announces that the United States Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the clinical development of AM712 (ASKG712) for the treatment of retinal vascular diseases.

Below is the press release from Affamed (https://www.affamed.com/press-releases-33): AffaMed Therapeutics (“AffaMed”), a global clinical stage biotechnology company dedicated to developing and commercializing transformative pharmaceutical, digital and surgical products, today announced that the United States Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the clinical development of AM712 (ASKG712), a novel proprietary bispecific biologic molecule blocking both vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) for the treatment of retinal vascular diseases.

Under this IND, AffaMed will soon initiate a Phase 1 study in the United States to investigate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in subjects with neovascular AMD.

AffaMed Therapeutics recently entered into a licensing agreement with AskGene Pharma Inc. (“AskGene”) for the exclusive rights to develop, manufacture and commercialize AM712 in ex-Asia plus Japan territories globally.

“We are excited to partner with AskGene and receive our first IND clearance from the FDA.” Dr. Dayao Zhao, CEO of AffaMed commented: “As part of our China-for-Global innovation strategy to leverage AffaMed’s strong presence in China and the US to advance differentiated therapeutics for the world markets, this license agreement further strengthens our global ophthalmology pipeline. I am very pleased to witness our rapid execution of this strategy from licensing to US IND clearance and look forward to our close cooperation with AskGene.”

“AskGene is committed to rapidly bringing safe and effective medicines to patients through the use of innovative technologies. We are very pleased to cooperate with AffaMed to develop the promising anti-VEGF/ANG2 bispecific molecule AM712(ASKG712) to benefit patients” said AskGene’s CEO Dr. Jeff Lu: “The exceptional global expertise by the AffaMed team in the ophthalmology area was an important consideration for our collaboration. Working together, we can accelerate the development of ASKG712 globally.”

Dr Ji Li, President of AffaMed commented: “We believe AM712 has the potential to be a best-in-class anti-VEGF/Ang-2 bispecific biologic molecule to address the high unmet medical needs among patients with retinal vascular diseases. We are thrilled to demonstrate our strong execution capabilities in receiving the US IND clearance within 2 months after completing our licensing agreement with AskGene.”

About AM712 (ASKG712)
AM712 is a novel bispecific biologic molecule specifically designed for ocular use. It provides dual inhibition of two important disease-relevant pathways in retinal diseases, VEGF and Ang-2. In pre-clinical studies, AM712 demonstrated robust efficacy, adequate ocular pharmacokinetics, and the desired safety profile supporting clinical exploration. AskGene has recently received China CTA clearance for AM712(ASKG712) in January 2022.

ASKG712 IND Filing in China

(Camarillo, California and Nanjing, Jiangsu Province, China) Askgene announces the acceptance of IND to initiate a clinical trial of ASKG712 to treat nAMD (neovascular age related macular degeneration) from NMPA (National Medical Products Administration) in China.

AMD is a disease with a progressive loss of central vision involving the retina of the macular region, which can lead to irreversible vision loss in patients. It is one of the leading causes of blindness in adults over 50 years old. Data shows that there are currently over 21.4 million AMD patients in China. With the aging of the population, the incidence rate will increase further. The current standard care treatment utilizes single-target anti-VEGF drugs, which require frequent (monthly) intravitreal injections resulting in poor patient compliance and heavy economic burden.

ASKG712 is an innovative bispecific antibody developed by Askgene that targets both VEGF and ANG-2. ASKG712 inhibits the VEGF/VEGFR signaling pathway and controls the formation of new blood vessels. It can also effectively inhibit ANG-2 signaling to improve vascular stability and reduce retinal inflammation. Faricimab, the world’s first bispecific with the same targets as ASKG712 developed by Roche, has achieved all primary endpoints for its four phase III clinical trials in 2021. About half of the patients can reach dosing once every four months. The preclinical results of ASKG712 show that it is safe and has a stronger binding affinity to VEGF and ANG2, which is expected to achieve better clinical efficacy and reduce the number of intravitreal injections.

With the acceptance of the IND, Askgene will carry out clinical trials of ASKG712 in China in the near future.