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

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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

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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

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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

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(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.

GenScript Partnership

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On September 26, 2021, GenScript ProBio and AskGene signed a license agreement for GenScript ProBio’s single-domain antibody (sdAb) targeting an immune checkpoint target. GenScript ProBio grants a non-exclusive global license to AskGene to use GenScript ProBio’s sdAb targeting immune checkpoint target for discovery, development and commercialization of its antibody and derivative products. In the future, GenScript ProBio will be the preferred partner for CMC development, clinical and commercial manufacturing of this product.

AskGene, founded in 2012 in Los Angeles, California, is aspired to become the leader in the cytokine prodrug field. The sdAb involved in this license agreement will be paired with AskGene’s proprietary next-generation cytokine therapeutics for cancer immunotherapy and other applications. Compared with traditional antibodies, single-domain antibodies feature lower molecular weight, higher stability, and easier recombinant expression.

Since the establishment of its sdAb discovery platform in 2010, GenScript has accumulated over 11 years of sdAb research and development experience. At present, GenScript ProBio has built up integrated sdAb immune library, sdAb naïve library, sdAb humanization, antibody screening and functional validation platforms. GenScript ProBio has so far reached 6 licensing deals on sdAb products with global biotech and pharma.

“We are very glad to cooperate with AskGene, a team of experienced scientists, and we feel so honored to provide support for the promising next-generation cytokine therapeutic projects,” Dr. Brian Min, CEO of GenScript ProBio said. “I believe the cooperation will further show the technology and platform advantages of both parties. We will keep an eye on the progress of this project and look forward to using GenScript ProBio’s solid CMC development experience to accelerate the project to clinic application and benefit patients.”

AskGene’s Jeff Lu, Ph.D., CEO, said, “GenScript ProBio has profound accumulation and core competitiveness in single domain antibody discovery. We are very pleased to cooperate with this highly professional CDMO company to support us in developing the promising next-generation cytokine therapeutics to benefit patients. We look forward to cooperating with GenScript ProBio to jointly accelerate the transformation of medicine and create a better future.”

AskGene Pharma Signs a Patent Licensing Agreement

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As a subsidiary of Aosaikang Pharm (SZ002755), Askgene Pharma (AskGene) signed a patent licensing agreement (Cross-License Agreement) with Xilio Therapeutics (Xilio), the news was announced on February 19, 2021.

Xilio Therapeutics is a biotechnology company developing potent, tumor-selective immunotherapies for patients with cancer located in Waltham, Massachusetts.

Askgene license Xilio in the development, production and commercialization of a specific product (The product) using its holdings of SmartKine technology (cytokine retrofit technology platform with global intellectual property rights) patents. Xilio pays Askgene a non-refundable down payment of $6 million for the patent license upon authorization, Xilio pays a non-refundable milestone payment to Askgene after the product is approved for listing overseas; and Xilio will also pay Askgene’s non-refundable sales commission from its annual net sales as agreed in the agreement. Askgene has acquired the right to develop, produce and commercialize this product for cancer treatment indications in the Asia Pacific region (except Japan). At the same time, the priority right to access autoimmune disease indications is retained. (Resource: http://www.cs.com.cn/sylm/jsbd/202102/t20210219_6139837.html)

This cooperation will accelerate the company’s research and development pipeline layout in the field of cancer immunity, promote the company’s own research and development platform to achieve product transformation, is conducive to jointly play the advantages of research and development of both sides and promote the company’s internationalization, in line with the company’s innovative drug development.