Affinity Biopharma recently announced that it has completed the B1 round of financing reaching hundreds of millions of RMB. This financing round was led by Hongfu Invest, and jointly invested by China Industrial Asset Management, Huaige Capital, and Haiwang Capital. This round of funds will be used to promote the clinical development of several innovative, tumor microenvironment activated drugs, and accelerate the R&D of the company's technology platform and early pipelines to meet huge unmet medical needs in the field of tumor treatment.

Affinity Biopharma is a clinical stage biopharma focused on Tumor MicroEnvironment Activated (TMEA) platform, multispecific therapeutics and first-in-class anti-tumor treatment. With exclusive chemical conjugate linker and validated proprietary platform, its strategy is to selectively unleash the active drug in the tumor by tumor-specific protease cleavage of conjugate linker. It reduces “On target, Off tumor toxicity”, enhancing efficacy at targeted sites and dramatically improving the therapeutic index with global rights. Affinity Biopharma can transform and upgrade traditional drugs into novel precision-guided drugs delivered and activated by the tumor microenvironment.

Affinity Biopharma's unique platform technology brings new opportunities for the development and upgrade of various anti-tumor treatments. The company specialized in Tumor MicroEnvironment Activated (TMEA) Multispecific Therapeutics in Small molecule drug conjugates (SMDC), Antibody drug conjugates (ADC), Antibody-cytokine drug conjugates, Precisely guided cytokine conjugates, antibody conjugates, and bispecific antibody conjugates. With molecular structure change, Affinity Biopharma can greatly enhance the efficacy as well as reduce toxicities of small molecules, cytokines, antibodies, bispecific or multi-specific antibodies, and to form new molecules with global rights. The company has globally proprietary, First-in-Class and Best-in-Class innovative pipelines with a broad commercial potential. Based on the extensive potential of the TMEA platform, Affinity Biopharma is also actively seeking various forms of collaborative partnership, providing global pharmaceutical companies with solutions that enable single-target drugs to be upgraded to precision-guided, multi-specific drugs, and can also provide unique linkers to further improve the cleavage specificity for ADC molecules, and create Best-in-Class innovative drug products.  

At present, the company's small molecule drug conjugate (SMDC) Legubicin is in pivotal trial in soft tissue sarcoma and lung adenocarcinoma. It has achieved superior efficacy compared to the current standard of care, and demonstrated a safety profile completely different from the traditional chemotherapy. Another small molecule drug conjugate (SMDC) Legutaxel is about to complete phase I/II clinical trial, and plans to carry out pivotal trial in multiple cancers including lung cancer, gastric cancer, and ovarian cancer. IMD101 (IL-2 TMEAkine) is a fully masked IL-2 that can be re-activated into a fully active IL-2 molecule in the tumor microenvironment, showing excellent safety and therapeutic effects; IMD101 is designed essentially different from the receptor-selective IL-2, and is planned to launch clinical trials in multiple cancers including bladder cancer, lymphoma, liver cancer, and melanoma. In the future, next generation drugs that are specifically designed to be activated by the tumor microenvironment such as chemotherapy, immunotherapy and ADC drugs could participate in various combined anticancer treatments due to their low toxicity. Affinity biopharma will also actively carry out clinical cooperation with global pharmaceutical companies in combination therapy, to create new combinations for curative cancer treatments, and benefit patients around the whole world.

“This financing round further demonstrates the full recognition and optimism from investors for our tumor microenvironment-specific drug activation and intelligent drug development platform, as well as our existing product pipelines. We aim to transform molecules with potentially effective but highly toxic mechanism of actions, to enhance efficacy, decrease toxicities and address the huge unmet medical needs in the field of tumor treatment, and to open up new opportunities for the clinical application expansion of traditional drugs, the development of new molecular drugs, and the potential for combination therapy. It is worth mentioning that the tumor-specific protease targets we use are pan-tumor, highly and specifically expressed in tumor tissues and therefore can be applied to a variety of drug development for solid tumors. In the next 10 to 20 years, we look forward to revolutionizing cancer treatment through innovative technology platform, turning malignant tumors into chronic and controllable diseases with long-term survival.”  

Yuan Liu, Ph.D., Chief Technology Officer of Affinity Biopharma:

“The Legubicin molecule is non-toxic to cells, therefore becoming a global milestone and First-in-Class drug that enters the era of "non-toxic chemotherapy". There are multiple clinical trials of Legubicin and Legutaxel in China, and Chinese cancer patients use these new chemotherapies earlier than the patients in the United States and Europe. In the Legubicin pivotal trial in soft tissue sarcoma, currently the longest treatment period has been 20 treatment cycles (Q3W, drugs given once every 3 weeks); the tumor in situ and metastases have completely disappeared with a CR evaluation, and the significant reduction of toxic and side effects during treatment also ensures a better quality of life for patients.

Traditional chemotherapies, such as doxorubicin, paclitaxel, platinum, and camptothecin, have been screened in clinical use for nearly 60 years and become broad-spectrum chemotherapy options still in use today, indicating that they have certain superior features compared to other toxicants.  For example, doxorubicin, paclitaxel, and platinum have demonstrated the ability to promote the efficacy of  immunotherapy in clinical practices. We have also observed that Legubicin can boost the T lymphocytes infiltration and the efficacy of PD-1 or CTLA-4 antibodies. Compared with the rapid development of immunotherapy, the chemotherapy discovered in the last century also needs new technology to innovate. Affinity Biopharma focuses on the development of multi-specific, intelligent conjugated drugs, including not only the development of narrow-spectrum ADCs limited by antibody expression, but also the development of new generation chemotherapy to successfully deliver doxorubicin, paclitaxel, and platinum, which cannot be delivered by ADCs, to tumors, and locally produce a higher concentration of active drugs in tumors which traditional chemotherapy cannot achieve, hence overcoming the drug resistance of tumor cells through the bystander effect and high concentration effect, and achieving a complete cure. The clinical success of Legubicin also proves the tumor specificity and blood stability of the linkers in our conjugated drugs. Through similar linker design, we can also deliver macromolecular drugs such as IL-2, CTLA-4, PD-1, CD47, CD3 bispecific antibody, etc. to become new generation of Best-in-Class immunotherapy drugs. In the future, the combination of our new non-toxic chemotherapies together with our new generation of immunotherapies could become a unique broad-spectrum clinical cure for tumors.”