【Company Research】I-Mab BioPharma (IMAB US) – Promising Phase 1 data of anti-CD47 antibody at the 2020 SITC Annual Meeting

• Phase 1 results demonstrate differentiated safety and PK profile and efficacy signal of lemzoparlimab (TJC4). Lemzoparlimab is a highly differentiated CD47 antibody designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity. I-Mab released in a poster at the 2020 SITC Annual Meeting, demonstrating the initial results of its US phase 1 clinical trial (NCT03934814) evaluating lemzoparlimab for the treatment of relapsed or refractory solid tumors and lymphoma. Lemzoparlimab is well tolerated as a single agent at a dose range of up to 30 mg/kg without introducing any priming dosing strategy. In all DLT-evaluable patients, no dose-limiting toxicities or severe hematologic adverse events were observed. Lemzoparlimab PK appears to be linear at mid to high dose levels following a single dose with no significant "sink effect". One confirmed partial response (PR) was observed in a melanoma patient in the 30 mg/kg monotherapy cohort (N=3), who had failed prior treatments with checkpoint inhibitors.

 

• Multiple ongoing trials in the US and China. The above mentioned US phase I study (NCT03934814) includes in two parts. The first part is comprised of a single agent dose escalation followed by two separate combination regimens in an escalating dose range (Part 1b with pembrolizumab; Part 1c with rituximab). The second part is a dose expansion study in the combination therapies. The data released at SITC 2020 is the single agent dose escalation in first part. Recruitment of patients for the dose escalation study of lemzoparlimab in combination with pembrolizumab or rituximab is ongoing. In China, I-Mab is conducting a phase I trial of lemzoparlimab for hematologic tumors which has finished 20mg/kg in dose escalation and was expected to be finished by 1Q21.

 

• Significant synergies from the global strategic partnership with AbbVie. I-Mab reached a broad, global collaboration agreement with AbbVie for the development and commercialization of lemzoparlimab. I-Mab retains all rights to develop and to commercialize lemzoparlimab in mainland China, Macau and Hong Kong. Going forward, I-Mab will work closely with AbbVie to facilitate clinical development of lemzoparlimab both globally and in China. We expect the two partners to expand the collaboration to additional transformative therapies. We see potential significant clinical synergies between I-Mab's lemzoparlimab and AbbVie's Venclexta (Venetoclax, a Bcl-2 inhibitor) in treating AML and MDS.

 

• Maintain BUY. We maintain our DCF-based TP unchanged at US$52.57 (WACC: 10.6%, terminal growth rate: 3.0%).