Yiming Angko-B (01541): Next-generation MCE molecule, major phase IB/IIa clinical data disclosure, once again confirming the differentiated innovation advantages of IMM0306

After receiving IND approval from the US FDA for systemic lupus erythematosus indications on August 21 this year, amurefup α (IMM0306), a bispecific molecule independently developed by Yiming Angko-B (01541) targeting CD47 and CD20, once again ushered in a milestone.

On September 23, Yiming Angke issued an announcement announcing the latest results of the Phase IB/IIa clinical study (NCT05771883) with amulirafusp alpha (IMM0306) combined with lenalidomide (Lenalidomide) for the treatment of relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma.

According to the latest data, IMM0306's ORR reached 92.3% and CRR reached 53.8% in marginal zone lymphoma (MZL); in follicular lymphoma (FL), IMM0306's ORR reached 88.6% and CR rate 70.5%. More importantly, this joint program showed an extremely low discontinuation rate among the entire MZL/FL population, and there were no CRS-related toxicity or treatment-related deaths, establishing an “efficient and low toxicity” treatment window.

As the two most common indolent lymphomas, the main characteristics of FL and MZL indications are repeated recurrence, need repeated treatment, and limited treatment options after first-line treatment fails.

As far as the incidence rate is concerned, statistics show that there are about 122,000 FL cases diagnosed worldwide each year, and the incidence is high among middle-aged and elderly people; while MZL is the most common indolent lymphoma other than FL, accounting for about 7%-15% of all non-Hodgkin lymphoma (NHL) cases. Since patients with both indications have a long average survival time and face a lifelong relapse-treatment cycle, there is a huge unmet need for innovative treatments with high efficiency and low toxicity.

In this market context, the emergence of Yiming Angke's IMM0306 has undoubtedly brought better treatment options to patients around the world as an innovative therapy with more outstanding efficacy and a safety spectrum more suitable for long-term medication use.

It is worth mentioning that for the above two types of inert lymphoma, the treatment goal is not only significant objective remission, but also pursues a depth of complete remission (CR) to reduce the risk of subsequent recurrence and improve long-term survival.

Judging from the latest research data disclosed by Yiming Angke, there is a horizontal comparison of other existing R/R FL immunotherapy plans,

IMM0306 combined with lenalidomide showed an unprecedented high remission rate, deep and long-lasting relief, and an excellent safety spectrum in R/R MZL and R/R FL patients.

In terms of R/R FL indications, IMM0306 combined with lenalidomide achieved 88.6% and 70.5% of ORR and CR rates, respectively. The CR rate was significantly higher than 38.0% of the historical data of the “otuzumab+lenalidomide” regimen, showing a stronger ability to clear tumors; it also achieved a two-fold increase in CR (70.5% vs. 34.7%) compared to the historical data of the “rituximab+lenalidomide” chemotherapy R2 regimen; furthermore, even in the face of the “Tafasitamab+R2” three-drug combination regimen, it can still maintain higher ORR and CR advantages.

In terms of MZL indications, IMM0306 combined with lenalidomide achieved 92.3% and 52.8% of ORR and CR rates, respectively. Compared with the 57.8% ORR and 12% CRR of BTK inhibitors already on the market, the IMM0306 combined lenalidomide regimen is expected to provide a more efficient treatment option for MZL patients.

Furthermore, as a CD47XCD20 myeloid cell adapter (MCE), IMM0306 can mediate ADCP/ADCC kill B-cell lymphoma through macrophages/NK cells, mechanically avoiding CRS and ICANS risks common with T-cell conjugators (such as CD20×CD3 double antibodies).

This mechanistic advantage was once again strongly verified in the safety data released this time: while IMM0306 maintained low toxicity and efficiency, no serious toxic side effects or neurotoxicity associated with cytokine storms were observed in this study. This is particularly important for indolent lymphoma groups requiring long-term management. It is also expected to greatly reduce the complexity of clinical management and improve patients' adherence to treatment and quality of life.

epilogue

With the disclosure of IMM0306's major data on the two indications, Yiming Angke's certainty in differentiating original research and innovation has been further confirmed. Currently, the drug has been approved for clinical trials by the US FDA. In addition to FL and MZL indications, the drug is also efficiently promoting clinical development in various fields including FL, SLE, IgG4-RD, NMOSD, membranous nephropathy, and PSS.

In the future, when this potential FIC/BIC product is successfully approved for listing, it is expected that it will become a key part of Yiming Enke's continuous increase in the company's profits, further opening up more room for the company's valuation imagination.