AimMax Bio Achieves Six IND Approvals in Six Months for First-in-Class Therapies Targeting Solid Tumors and Immune Disorders

2021 was an unusual year for Aimeifei Biopharma,The company obtained IND approvals for six clinical indications in the United States and China in August and December 2021, respectively., marking the company's first clinical milestone since its inception.

Among these six IND approvals, five are derived from IPG1094, a pipeline independently developed by Nanjing aimeifei Biomedical Technology Co., Ltd. This isThe World’s First Small-Molecule Inhibitor Targeting Macrophage Migration Inhibitory Factor (MIF), the company is conducting clinical trials in Australia, the United States, and China for five indications: multiple myeloma, solid tumors, multiple sclerosis, systemic lupus erythematosus, and psoriasis.

Among the first-tier drugs with the fastest clinical progress at Nanjing aimeifei Biomedical Technology Co., Ltd, in addition to IPG1094, another one is IPG7236, which isChina's First CCR8 Antagonist to Enter Clinical Trials, indicated for the treatment of various solid tumors, has currently received Investigational New Drug (IND) approval from the U.S. FDA and China’s CDE, with clinical trials underway in both China and the United States.

In addition to its first-tier candidates IPG1094 and IPG7236, Aimeifei Biologics has more than ten additional drug candidates in its clinical pipeline across second-, third-, fourth-, and fifth-tier categories, all of which are independently developed First-in-Class innovative drugs. VCBeat conducted an exclusive interview with Dr. Fan Guohuang, founder of Aimeifei Biologics, to gain insights into the company’s development history, core products, competitive advantages, and future plans.

Aimifei Biologics, also known as Nanjing Aimifei Biomedical Technology Co., Ltd., was established in 2016. It is a biopharmaceutical company dedicated to the research and development of innovative drugs targeting globally leading candidates for the treatment of malignant tumors, autoimmune diseases, and neurodegenerative disorders. Focusing on immune modulation and other key mechanisms, the company has built a pipeline of 15 novel drug candidates, a scale that is rare among domestic enterprises.

Dr. Fan Guohuang, Founder of Aimeifei BiologicsWith 28 years of experience in pharmacological research on major diseases such as malignant tumors and neurodegenerative disorders, Dr. Fan Guohuang managed a new drug R&D team at the GlaxoSmithKline (GSK) China R&D Center for six years, leading preclinical studies and clinical trials for multiple novel therapeutics in critical disease areas. Prior to joining GSK, Dr. Fan was a tenured professor at a prestigious U.S. university. He has published more than 60 research papers in prominent international journals, holds over 20 invention patents, and has received numerous honors, including the National Natural Science Award.

Dr. Wang Jianfei, Chief Scientific Officer (CSO) of the CompanyHe previously held a position at GSK, serving as the Director of the Integrated Biotechnology Research Department’s major platform at the GSK China R&D Center. He established a comprehensive preclinical R&D platform, providing target validation, lead compound optimization, and pharmacodynamic and pharmacokinetic technical support for dozens of the company’s projects. His contributions earned him multiple awards from the GSK China R&D Center, including the Gold Award. As the Global Lead of GSK’s Integrated Biotechnology Platform, Dr. Wang Jianfei successfully advanced multiple new drug development projects through clinical trial applications and into clinical trials. He was recognized as a Senior GSK Fellow, the highest scientific rank within the company.

Dr. Wang Jianfei has over 28 years of experience in translational medicine research, has published more than 70 papers in world-renowned international journals, and holds multiple patents.

In addition to the company’s founder and Chief Scientific Officer, Nanjing Aimeifei Biomedical Technology Co., Ltd. has assembled a distinguished team of experts in medicine, pharmacology, medicinal chemistry, biology, and related fields. Team members hail from core R&D management and operational roles at major multinational pharmaceutical companies such as GSK and Pfizer, as well as from renowned academic and research institutions both in China and abroad. Collectively, they have contributed to dozens of novel drug projects in preclinical and clinical development stages.

Macrophage Migration Inhibitory Factor (MIF)It is the only cytokine with enzymatic activity, promoting tumor cell proliferation by acting on the tumor suppressor gene p53, and facilitating the formation of myeloid-derived suppressor cells (MDSCs) through tumor exosomes, thereby inhibiting the proliferation and antitumor function of CD8+ T cells.

Due to its anti-tumor properties, MIF has attracted numerous companies to develop antibody-based drugs targeting it; however, most clinical trials have failed at Phase II. Dr. Fan Guohuang, founder of Nanjing Aimeifei Biomedical Technology Co., Ltd., explained the possible reasons: “Unlike other cytokines, MIF is located within exosome structures, lacks a signal peptide, and remains permanently encapsulated within cellular membrane structures. Therefore, it is difficult for antibody drugs to access targets on the cell membrane.”

Aimeifei Biopharma’s new drug development strategy focuses on developing a cell-permeable small-molecule inhibitor of MIF targeting its tautomerase activity,Currently, no small-molecule inhibitors targeting MIF have been marketed worldwide.. MIF inhibitors not only directly inhibit tumor cell growth but also reverse the immunosuppressive tumor microenvironment by suppressing MDSC generation, thereby exhibiting dual antitumor functions.

Furthermore, during the progression of autoimmune diseases, abnormally overexpressed MIF promotes sustained polarization of macrophages toward the M1 phenotype by inhibiting pathways such as p53, leading to amplified inflammation and tissue organ damage. MIF inhibitors facilitate the transition of M1 macrophages (pro-inflammatory) to M2 macrophages (anti-inflammatory), thereby restoring immune balance and treating the disease at its root.

According to preclinical studies by Nanjing aimeifei Biomedical Technology Co., Ltd., IPG1094 demonstratedExceptional safety profile, with a safety margin exceeding 40-fold, rare with no significant toxic side effects。

CCR8CCR8 is a chemokine receptor that is expressed in most solid tumors and highly expressed on tumor-associated regulatory T cells (Tregs), while exhibiting very low or no expression on non-tumor-associated Tregs. Previously, biopharmaceutical companies had developed CCR8 antibody drugs; however, because CCR8 is also expressed on memory CD4+ T lymphocytes, natural killer (NK) cells, bladder epithelial cells, and other cell types, relying on the antibody-dependent cellular cytotoxicity (ADCC) effect mediated by the Fc region for anticancer activity would result in nonspecific killing of these normal cells, leading to severe immune-related toxic side effects.

Regarding CCR8, Aimeifei Biologics has also adopted an antagonist strategy. Dr. Fan Guohuang, founder of Aimeifei Biologics, introduced that IPG7236 inhibits the infiltration and expansion of regulatory T cells (Tregs) within tumors, as well as their immunosuppressive effects on effector T cells, by blocking CCR8-mediated signaling. Since this mechanism does not kill CCR8-expressing tumor cells via antibody-dependent cellular cytotoxicity (ADCC), but rather blocks the CCR8-mediated signaling pathway, it ultimately suppresses the migration, proliferation, and immunosuppressive activity of tumor-associated Tregs with high CCR8 expression, thereby enablingEffectively Avoid Toxic Side Effects Caused by ADCC。

Recently, Nanjing aimeifei Biomedical Technology Co., Ltd.'sCCR8 Antagonist IPG7236 Completes First-in-Human Dosing in the United States, with No Drug-Related Adverse Events Observed。

It is reported that Aimeifei Biopharma has four additional drug development pipelines in the second tier, which are currently submitting Investigational New Drug (IND) applications; three third-tier pipelines are in the process of screening candidate molecules; drug screening has been initiated for fourth-tier candidates; and target research and validation are underway for fifth-tier drugs. The companyThe company is also set to complete its Series B1 financing round in the near future., the funds raised will support the establishment of the company's overseas branches and advance its clinical pipeline into Phase II.