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MarketScreener Homepage  >  Equities  >  Nasdaq  >  Infinity Pharmaceuticals, Inc.    INFI

INFINITY PHARMACEUTICALS, INC.

(INFI)
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Infinity Pharmaceuticals : 2020 SITC Poster

11/27/2020 | 05:51pm EST

Abstract ID: 434

Background

Melanoma is one of the deadliest cancers and approximately half of all melanoma patients do not benefit from current immunotherapies*

Eganelisib (IPI-549) is a selective PI3K-γ inhibitor that reprograms pro-tumor macrophages to relieve immune suppression and activate anti-tumor T cells

The activation of T cells by eganelisib can be maintained, despite IFN-γ mediated upregulation of PDL1, with checkpoint inhibitors (CPIs) providing

Updated clinical data from the melanoma expansion cohort of an ongoing Ph1/1b Study

of eganelisib (IPI-549) in combination with nivolumab

Michael Postow1, Ryan J. Sullivan2, Ezra EW. Cohen3, Martin Gutierrez4, David S. Hong5, Conor Steuer6, Jerry McCarter7, Nora Zizlsperger7, Jeff Kutok7, Brenda O'Connell7, Jennifer Roberts7, Kara Page7, Halle Zhang7, Bartosz Chmielowski8

Memorial Sloan Kettering Cancer Center1, Massachusetts General Hospital2, University of California San Diego3, Hackensack University Medical Center4, MD Andersen Cancer Center5, Emory University Hospital6, Infinity Pharmaceuticals7, University of California Los Angeles8

synergistic anti-tumor effects

We are currently evaluating safety and anti-tumor activity of eganelisib in combination with CPIs in:

Patients who progressed on immediate prior CPI therapy in the MARIO-1 Phase1/1b clinical trial

CPI naive 2L urothelial cancer patients in MARIO-275

CPI naive 1L TNBC and RCC patients in MARIO-3

*Olbryt, M., Rajczykowski et al International Journal of Molecular Sciences 2020

Eganelisib Mechanism of Action

PI3K-γ Inhibition Reprograms Macrophages to Turn Tumor Microenvironment from Immune Suppressed to Immune Activated

Suppressed T cells

Anti-tumor (M1) Macrophages/Activated Myeloid Cells

PI3K-γ i

M1

M2

Eganelisib

2 Relieves Macrophage Suppression, Expands Activated T cells and

1

Eganelisib Inhibition of PI3K-γ

Generates IFN-γ Mediated Immune Response

Re-programsPro-tumor (M2)

3 Expansion of Activated T Cells Up-

4 Anti-Tumor Activity of Expanded T

Macrophages/ MDSCs to Anti-Tumor

(M1) Function

Regulates PDL1 to Blunt T Cell Response

Cells Maintained with Addition of CPI

IFN-γ -responsive genes

Fold increase

P value

at C2D1

MARIO-1 monotherapy dose escalation study

demonstrated that treatment with eganelisib is

FCGR1B

1.8

1.5 x 10-3

associated with IFN-γ mediated upregulation of PDL1

GBP2

1.5

5.6 x 10-4

in peripheral blood

GBP5

2.3

1.3 x 10-4

GBP1

2.0

1.9 x 10-4

GBP4

1.7

9.4 x 10-4

MARIO-1 Eganelisib Phase 1/1b Trial in Patients with Solid Tumors: Cohort E Design

A key objective of the study is to mount an effective anti-tumor immune response in combination with CPI to generate clinical responses in patients who would not be expected to respond to checkpoint inhibitor therapy alone, including those having progressed on immediate prior CPI therapy

Treatment Start

Eganelisib Benefit

NSCLC

Combination Dose Escalation/Expansion

PD

Clinical Response Summary Based on Investigator Assessment per RECIST 1.1 for Melanoma Cohort

  • More than half (52.6%) of patients who had been refractory to or relapsed following 2 or fewer prior lines of therapy demonstrated a partial response or stable disease
  • 21.1% of patients who had been treated with 2 or fewer prior lines of therapies demonstrated a partial response

All

Patients ≤ 2

Patients ≥ 3

Patients

prior lines

prior lines

N = 40

N = 19

N = 21

Evaluable patients, n

39

20

Best Overall Response

Partial Response (PR), n

4

0

Stable Disease (SD), n

10

4

Progressive Disease (PD), n

24

15

Unknown, n

1

1

Overall Response Rate (ORR) (PR), n (%)

4 (10.3)

0 (0)

Disease Control Rate (DCR) (PR + SD), n (%)

14 (35.9)

4 (20.0)

Progression Free Survival (PFS) in Weeks,

9 (8, 16)

16 (8, 19)

median (95%)

Safety & Tolerability of Melanoma Cohort

Combination treatment with eganelisib and nivolumab is generally well tolerated and associated with a favorable safety profile Most Common TEAEs (All Grade) in >15% of Patients (N=40)

Preferred Term

TEAE

Tx-Related TEAE

Immune-Related

(All)

(All)

Tx-Related TEAE (All)

AST increased

15 (37.5)

13 (32.5)

13 (32.5)

ALT increased

15 (37.5)

13 (32.5)

13 (32.5)

Fatigue

11 (27.5)

8 (20.0)

0

Nausea

11 (27.5)

9 (22.5)

0

Clinical Response: Melanoma Cohort

Eganelisib + Nivolumab Combination Therapy Demonstrates Clinical Benefit in

Patients on 2 or Fewer Prior Therapies Demonstrated Higher Percent Decrease in Target Lesion

Patients Not Expected to Respond to CPI Monotherapy Having Progressed on

Size

Immediate Prior CPI Therapy

Duration on Treatment (Weeks)

60

2 or fewer prior therapies

LesionTargetinChange% Baselinefrom

40

20

0

-20

PR

-40

SD

Best

-60

3 or more prior therapies

PD

On Study

-80

-100

Objective Responses Observed in Melanoma Patients that Progressed on Immediate Prior Treatment with Anti-PD1/PDL1 Therapy

Time (weeks)

Time (weeks)

Time (weeks)

fromChangebaseline

lesionstarget

‐30

0

20

70

120

lesionstarget

‐20

0

20

40

60

80

fromChangebaseline

lesionstarget

‐40

‐20

0

20

40

‐60

fromChangebaseline

‐100

‐100

0

0

0

‐20

‐50

‐50

‐40

%

%

%

Start of MARIO-1 Therapy After

Start of MARIO-1 Therapy After

Start of MARIO-1 Therapy After

Progression on Immediate Prior CPI

Progression on Immediate Prior CPI

Progression on Immediate Prior CPI

Patient A with Stage III melanoma at entry to study

Patient B with Stage IV melanoma at entry to study

Patient C with Stage IV melanoma at entry to study

Refractory to pembrolizumab after 3 months of

Refractory to nivolumab after 5 months of treatment (best

Refractory to pembrolizumab (CR for 1 year; PD after 6

treatment (best response PD)

response PD)

months of therapy)

57% tumor reduction in response to treatment with

79% tumor reduction in response to treatment with

76% tumor reduction in response to treatment with

eganelisib + nivolumab

eganelisib + nivolumab

eganelisib + nivolumab

PFS: > 25 months

PFS: 14 months

PFS: 6 months

Baseline

Treatment with Eganelisib + Nivolumab is Associated with Decreased Immune Suppression and

Eganelisib*+ Nivolumab**

SCCHN

Melanoma

Pyrexia

9 (22.5)

5 (12.5)

0

Decreased appetite

9 (22.5)

6 (15.0)

0

Increased Immune Activation in Melanoma

Decreased MDSCs, T Cell Reinvigoration and Upregulation of Interferon-γ Responsive Factors in Peripheral Blood

*28 day cycles, continuous 40mg QD dosing; **Flat-dose 240 mg Q2W

Baseline Characteristics, Disposition and Exposure of Melanoma Cohort

100% of patients were refractory to or relapsed following anti-PD1/PDL1 therapy, and 87.5% had immediate prior anti-PD1/PDL1 therapy

Anemia

8 (20.0)

2 (5.0)

0

Pruritus

8 (20.0)

7 (17.5)

7 (17.5)

ALP increased

7 (17.5)

6 (15.0)

6 (15.0)

-(cells/mL)

MDSC

change

T Cell Reinvigoration

Interferon-γ Responsive Factors

CXCL9

CXCL10

N=33

N=32

change

N=34

change

N=34

fold

Cycle 7

2

Log

Characteristics

N=40

Age median years, (range)

65.5

(46, 86)

Sex, n (%)

Male

20

(50.0)

Female

20

(50.0)

ECOG, n (%)

Prior therapies, N = 40

n (%)

Prior therapies

1

5 (12.5)

2

6 (15.0)

3

9 (22.5)

4 or more

20 (50.0)

Anti-PD1/PDL1

40 (100)

Vomiting

7 (17.5)

4 (10.0)

0

Rash

7 (17.5)

7 (17.5)

7 (17.5)

Grade 3 and above TEAEs in > 5% of Patients (N=40)

TEAE

Tx-Related TEAE

Immune-Related

Preferred Term

Tx-Related TEAE

(≥ Grade 3)

(≥ Grade 3)

CD14+CD11b+CD33+HLADR

Log2 foldchange

Ki67+of PD1+ mCD8+ (%)

fold

fold

2

2

CXCL10 (pg/mL) Log

C2D1

C1D1

CXCL9 (pg/mL) Log

C1D1

C2D1

C2D1

C1D1

C2D1

C1D1

0

21

(52.5)

1

17

(42.5)

2

1

(2.5)

Best response to prior anti-PD1/PDL1,n (%)

CR

4 (10.0)

PR

3

(7.5)

SD

18

(45.0)

PD

10

(25.0)

Unknown

5 (12.5)

Immediate Prior

35 (87.5)

Anti-CTLA4

28 (70.0)

Investigational immunotherapy

17 (42.5)

MEK/ERK inhibitor

9 (22.5)

BRAF inhibitor

5 (12.5)

Chemotherapy

4 (10.0)

(≥ Grade 3)

AST increased

9 (22.5)

9 (22.5)

9 (22.5)

ALT increased

5 (12.5)

5 (12.5)

5 (12.5)

Disease progression

4 (10.0)

0

0

Rash maculo-papular

3 (7.5)

3 (7.5)

3 (7.5)

Rash

3 (7.5)

3 (7.5)

3 (7.5)

Conclusions

Treatment with a combination of eganelisib + nivolumab:

  • Demonstrates an acceptable safety profile
  • Validates the on-mechanism eganelisib effect of decreased immune suppression (MDSC) and increased immune activation (T Cell reinvigoration, upregulation of IFN-γ responsive factors including CXCL9, CXCL10 and PDL1)
  • Results in clinical activity (ORR of 21.1%, DCR of 52.6%) in melanoma patients with 2 or fewer prior lines of therapy, including those having progressed on immediate prior CPI therapy

Acknowledgements

  • We thank the patients for participating in this clinical trial and their families as well as the investigators and staff at the clinical trial sites.
  • This study is sponsored by Infinity Pharmaceuticals in collaboration with Bristol Myers Squibb.

This is an excerpt of the original content. To continue reading it, access the original document here.

Disclaimer

Infinity Pharmaceuticals Inc. published this content on 09 November 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 27 November 2020 22:50:01 UTC


© Publicnow 2020
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P/E ratio 2020 -6,11x
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