Syndax Pharmaceuticals, Inc. · NASDAQ:SNDX
Syndax Pharmaceuticals — Corporate Update (July 2023)
16 slides from Syndax Pharmaceuticals's corporate update, July 2023
Slide 1: Axatilimab AGAVE-201 Positive Top-Line Data Call / July 2023
Axatilimab AGAVE-201 Positive Top-Line Data Call / July 2023
Slide 2: Forward-looking statements disclosure
Forward-looking statements disclosure This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referenci
Slide 3: AGAVE-201 provides compelling evidence of benefit in refractory cGVHD
AGAVE-201 provides compelling evidence of the benefit axatilimab could offer patients with refractory cGVHD All cohorts in AGAVE-201 met the primary endpoint Durable responses accompanied by a reduction in symptom burden Axatilimab well tolerated; most common AE events were consistent with on target
Slide 4: Axatilimab is the first cGVHD treatment to target the disease-modifying macrophage
Axatilimab is the first cGVHD treatment to target the disease-modifying macrophage • Axatilimab may offer a CSF-1R mediates pro-inflammatory and pro-fibrotic differentiated, practice-changing monocyte/macrophage differentiation and activation 1 intervention in cGVHD Blood vessel CSF-1 Circulating CS
Slide 5: AGAVE-201, a global pivotal trial designed to identify an optimal dose
AGAVE-201, a global pivotal trial designed to identify an optimal dose in chronic GHVD patients * Patients had the option to switch to 0.3 mg/kg Q2W* cohort specific Q4W dose after 6 Randomization months on trial R/R cGVHD 1:1:1 1 mg/kg Q2W* Primary Endpt: ORR2 by Cycle 7 Day 1 n=241 • Statistical s
Slide 6: AGAVE-201 enrolled refractory, late-line cGVHD patients
AGAVE-201 enrolled refractory, late-line cGVHD patients, > 70% had prior treatment with ruxolitinib Total Population (ITT) N=241 Age median (min, max), years 53 (7, 81) Male 63% Race – white 83% Median time since cGVHD diagnosis 48 months Patient ≥ 4 organs involved 54% characteristics were % Patien
Slide 7: All 3 cohorts in AGAVE-201 met the primary endpoint of ORR
All 3 cohorts in AGAVE-201 met the primary endpoint of ORR 80% 74% 75% 72% 67% ORR by C7D1 (primary endpoint) 60% Best OR on trial 50% 50% 40% Threshold for success: Statistical significance 20% achieved if lower bound of the 95% CI 95% CI 95% CI 95% CI 95% CI 95% CI 95% CI of ORR exceeds 30% (63, 8
Slide 8: At 0.3 mg/kg every 2 weeks, responses were durable with reduced symptom burden
At 0.3 mg/kg every 2 weeks, responses were durable and accompanied by a reduction in symptom burden 60% 55% of responders of patients showed maintained a a >7 pt decrease in response at 12 mLSS months1 Responses were observed across patients with prior exposure to approved agents including ibrutinib
Slide 9: Axatilimab was generally well tolerated
Axatilimab was generally well tolerated Parameter, n (%) 0.3 mg/kg Q2W N=79 ≥ Grade 3 treatment-related AE 14 (17.7) Discontinued treatment for AE 5 (6.3) Most common adverse events were Most frequent adverse events of any grade consistent with on target effects of Parameter, n (%) 0.3 mg/kg Q2W CSF
Slide 10: Higher frequency of adverse events observed at doses above 0.3 mg/kg Q2W
Higher frequency of adverse events were observed at doses above 0.3 mg/kg Q2W Parameter, n (%) 0.3 mg/kg Q2W 1.0 mg/kg Q2W 3.0 mg/kg Q4W Total N=79 N=81 N=79 N=239 ≥ Grade 3 treatment-related AE 14 (17.7) 28 (34.6) 37 (46.8) 79 (33.1) Discontinued treatment for AE 5 (6.3) 18 (22.2) 14 (17.7) 37 (15.
Slide 11: The growing cGVHD market presents an attractive opportunity
The growing cGVHD market presents an attractive opportunity The estimated global chronic GVHD market in 2022 was $2 - 2.5B and is expected to expand due 14,000 50% to2: patients living of patients require • Rising prevalence of blood with cGVHD treatment beyond cancers boosted by an in the US1 syste
Slide 12: Significant unmet need remains across all lines of therapy
Significant unmet need remains across all lines of therapy Current Standard of Care1 If approved, axatilimab 1st Corticosteroids will provide a Line differentiated mechanism from currently approved 2nd JAKAFI® agents for patients with Line IMBRUVICA® refractory cGVHD despite at least 2 prior therapi
Slide 13: Axatilimab has the potential to be a differentiated treatment option for cGVHD
Axatilimab has the potential to be a differentiated treatment option for cGHVD Unique MOA for cGVHD High and durable ORR • First agent to target disease • 74% ORR at 0.3 mg/kg causing macrophages to impact • 60% of patients treated at 0.3 fibrosis & inflammation mg/kg remained in response at • Poten
Slide 14: 2024 & Beyond
Axatilimab has the potential to expand into additional high value indications and new geographies Expansion into fibrotic indications: ~215,000 US IPF POC* init YE23 ~335,000 WW2 2024 & Beyond Expansion into EU, Japan, ROW >35,000 WW1 Expansion into 1st L cGVHD: ~14,000 US1 Jakafi® combo trial init
Slide 15: Upcoming milestones for axatilimab
Upcoming milestones for axatilimab Present full AGAVE-201 results at a medical meeting Potential BLA submission by year-end 2023 (led by Incyte) Initiate a combination trial with Jakafi® by year-end 2023 (led by Incyte) Initiate a Phase 2 trial in IPF by year-end 2023 (led by Syndax) Commercial read
Slide 16: Determined to realize a future in which people with cancer live longer and better
Determined to realize a future in which people with cancer live longer and better than ever before. 16
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