Results of Phase 1443-0001 Monotherapy Trial

Phase I safety data

• BI 765063 was well-tolerated with no reported DLTs up to the highest dose tested. MTD was not reached

- No treatment-related thrombocytopenia and only one case

  of anemia (grade 2) was observed¹

- Most treatment-related IRRs were low grade and reversible^1,2

• The most frequent TRAEs were IRR (28%), fatigue (28%), arthralgia, maculo-papular rash (22%), and pruritus (17%)¹

• All treatment-related AEs were mild to moderate, except for one case of grade 3 maculopapular rash¹

• BI 765063 showed dose-proportional systemic exposure and full RO saturation in Cycle 1 at the 18 and 24 mg/kg dose levels¹

• (1443-0002) is being conducted with BI 765063 (SIRP-alpha) 1st GEN. All future studies will be with BI 770371 (SIRP-alpha) 2nd GEN.

Phase I efficacy data

• BI 765063 showed preliminary antitumor activity in the Phase I study in patients with advanced solid tumors

  - A combination of PR and SD responses were observed

    in 21 of 47 (45%) evaluable patients (data as of June 2021)²

  - One patient with HCC with liver and lung metastases and

    seven prior lines of therapy showed a durable PR 

    maintained for >18 months 

   (treatment is still ongoing as of April 2022)³

• Analysis of paired tumor biopsies in other patients is ongoing

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Phase I safety data

• BI 765063 in combination with the PD-1 inhibitor ezabenlimab was well tolerated with no DLTs. MTD was not reached

  - No treatment-related thrombocytopenia 

    and only one case of anemia (grade 2) were observed

• All BI 765063 TRAEs were grade 1 or 2, except grade 3 rash maculopapular in 1 patient; no grade 4/5 TRAEs were reported

• The RP2D of BI 765063 was determined as 24 mg/kg Q3W with full RO saturation

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Phase I efficacy data

• BI 765063 in combination with PD-1 inhibitor ezabenlimab showed preliminary antitumor activity in the Phase 1 study in patients with advanced solid tumors¹ 

  - Two patients with endometrial cancer experienced

    confirmed PRs and an additional patient with CRC had an iPR

• Treatment with BI 765063 at 18 and 24 mg/kg, as monotherapy or in combination with ezabenlimab, leads to an apparent transient increase in the percentage of activated CD80+/CD14+ monocytes in V1/V1 (SIRPα homozygous) and V1/V2 (SIRPα heterozygous) patients at Cycle 1 Day 2, in line with the expected MoA