Innate Pharma Reports First Quarter 2024 Business Update and Financial Results
-- First preclinical data set for IPH45, a pre-IND anti-Nectin-4 Antibody
Drug Conjugate, presented as an oral presentation at AACR 2024
-- Progression of Sanofi-developed NK Cell Engager SAR443579/IPH6101 to
Phase 2 in blood cancers
-- Five ASCO Annual Meeting 2024 abstracts:
-- Final TELLOMAK Phase 2 data for lacutamab in Mycosis Fungoides
-- Two posters on IPH6501, Innate's second generation ANKET$(R)$ in
B--cell Non-Hodgkin's Lymphoma
-- AstraZeneca to present poster on updated results for monalizumab
from Phase 2 stage III unresectable NSCLC trial
-- Monalizumab SCLC Phase 2 MOZART trial poster
-- Cash position of EUR113.9 million1 as of March 31, 2024 (not including
the EUR4.0 million payment to be received from Sanofi), anticipated cash
runway into end 2025
-- Conference call to be held today at 2:00 p.m. CEST / 8:00 a.m. EDT
MARSEILLE, France--(BUSINESS WIRE)--May 14, 2024--
Regulatory News:
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") today reported its consolidated financial results for the quarter ending March 31, 2024.
"We are executing our strategy of building on our partnered drug candidates while advancing our next generation of proprietary medicines, " said Hervé Brailly, Chief Executive Officer ad interim of Innate Pharma. "Our second generation ANKET(R) , IPH6501 began clinical development for NHL. We presented preclinical data for IPH45, our Nectin-4 ADC, at the recently held AACR Annual Meeting. Our partner Sanofi also advanced SAR443579, a tri-functional NK Cell Engager targeting CD123, to Phase 2 in blood cancer. We expect to have several data presentations at ASCO, including data from the TELLOMAK Phase 2 trial with lacutamab in mycosis fungoides, as we prepare to submit an IND for IPH45 later this year."
Webcast and conference call will be held today at 2:00pm CEST (8:00am EDT) The
live webcast will be available at the following link:
https://events.q4inc.com/attendee/244650312 Participants may also join via
telephone using the following registration link:
https://registrations.events/direct/Q4I9730892 This information can also be
found on the Investors section of the Innate Pharma website,
www.innate-pharma.com. A replay of the webcast will be available on the
Company website for 90 days following the event.
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(1) Including short term investments (EUR21.3 million) and non-current
financial instruments (EUR10.1 million).
Pipeline highlights:
Lacutamab (anti-KIR3DL2 antibody):
Cutaneous T Cell lymphoma
TELLOMAK is a global, open-label, multi-cohort Phase 2 clinical trial evaluating lacutamab in patients with Sézary syndrome and mycosis fungoides $(MF)$.
-- Top-line results in MF patients will be presented at the ASCO Annual
Meeting 2024 being held May 31 -- June 4 in Chicago. Title of the
abstract is: Lacutamab in patients with relapsed and/or refractory
mycosis fungoides: results from the TELLOMAK Phase 2 trial. The full
abstract will be released at 5:00 PM ET on Thursday, May 23, 2024 on the
ASCO Annual Meeting website.
-- In January 2024, Innate announced that the US Food and Drug
Administration (FDA) has lifted the partial clinical hold previously
placed on the lacutamab IND on October 2023 following a patient death in
the TELLOMAK study. The FDA decision to lift the partial clinical hold is
based on the FDA review of the fatal case which Innate, together with a
steering committee of independent experts, determined to be related to
aggressive disease progression and lacutamab unrelated.
Peripheral T Cell lymphoma (PTCL)
-- The Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial, an
investigator-sponsored, randomized controlled trial led by the Lymphoma
Study Association (LYSA) to evaluate lacutamab in combination with
chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus
GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL
is ongoing and continues to recruit patients.
ANKET(R) (Antibody-based NK cell Engager Therapeutics):
ANKET(R) is Innate's proprietary platform for developing next-generation, multi-specific NK cell engagers to treat certain types of cancer. Innate's pipeline includes five public drug candidates born from the ANKET(R) platform: SAR443579 (SAR'579/IPH6101) (CD123-targeted), SAR445514 (SAR'514/IPH6401) (BCMA-targeted), IPH62 (B7-H3-targeted), IPH67 (target undisclosed, solid tumors) and tetra-specific IPH6501 (CD20-targeted with IL--2v). Several other undisclosed proprietary preclinical targets are being explored.
IPH6501 (proprietary)
IPH6501 is Innate's proprietary CD20-targeted IL-2v bearing second-generation ANKET(R) .
-- Innate will present 2 posters on IPH6501 at the upcoming ASCO Annual
Meeting 2024, being held from May 31 to June 4 in Chicago. Titles of the
abstract are:
-- A Phase 1/2, Open-Label, Multicenter Trial Investigating the
Safety, Tolerability, and Preliminary Antineoplastic Activity of
IPH6501 in Patients With Relapsed and/or Refractory
CD20-expressing Non-Hodgkin Lymphoma
-- Preclinical assessment of IPH6501, a first-in-class IL2v-armed
tetraspecific NK Cell Engager directed against CD20 for R/R B-NHL,
in comparison to a CD20-targeting T Cell Engager
-- The full abstracts will be released at 5:00 PM ET on Thursday, May 23,
2024 on the ASCO Annual Meeting website.
-- In March 2024 the first patient was dosed in the Phase 1/2 clinical
trial evaluating IPH6501 in B cell Non-Hodgkin's lymphoma (B-NHL). The
study is planned to enroll up to 184 patients.
SAR443579, SAR445514, IPH62 and IPH67 (under development by Sanofi)
SAR443579/IPH6101
The Phase 1/2 clinical trial, currently under development, by Sanofi is progressing well, evaluating SAR443579 / IPH6101, a trifunctional anti-CD123 NKp46×CD16 NK cell engager and ANKET(R) platform lead asset, in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high-risk myelodysplastic syndrome (HR-MDS).
-- In April 2024, Sanofi advanced SAR443579 / IPH6101, to the Phase 2 dose
expansion of the trial. Under the terms of the 2016 research
collaboration with Sanofi, the progression to the dose expansion part of
the trial has triggered a milestone payment from Sanofi to Innate of
EUR4m (which has been booked as revenue in the first quarter but had not
been received from Sanofi in the quarter, and has therefore not been
included in the cash position).
SAR445514/IPH6401
The Sanofi led Phase 1/2 clinical trial with SAR'514 / IPH6401, a trifunctional anti-BCMA Nkp46xCD16 NK cell engager, in patients with Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Light-chain Amyloidosis is ongoing.
IPH62
IPH62 is a NK cell engager program targeting B7-H3 from Innate's ANKET(R) platform under development. Upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization.
IPH67
IPH67 is a NK cell engager program in solid tumors from Innate's ANKET(R) platform under development. Following a research collaboration period, Sanofi will be responsible for all development, manufacturing and commercialization.
Sanofi still retains the option of one additional ANKET(R) target under the terms of the 2022 research collaboration and license agreement.
Antibody Drug Conjugates:
Innate develops different approaches for the treatment of cancer utilizing its antibody engineering capabilities to deliver novel assets, with its innovative ANKET(R) platform and is also exploring Antibody Drug Conjugates $(ADC)$ formats.
Beyond its proprietary programs, Innate has an ongoing agreement with Takeda on ADCs.
IPH45 (Nectin-4 ADC):
IPH45 is Innate's proprietary and differentiated exatecan-Antibody Drug Conjugate $(ADC.AU)$ targeting Nectin-4.
-- First preclinical data were presented in an oral presentation at the
American Association for Cancer Research (AACR) Annual Meeting 2024. In
preclinical studies, IPH45 shows anti-tumor efficacy in vivo, in Nectin-4
expressing tumors including in Enfortumab Vedotin $(EV)$ refractory models.
Importantly, IPH45 shows stronger activity than EV, in multiple
urothelial carcinoma patient-derived xenografted $(PDX)$ mice models,
across Nectin-4 high and Nectin-4 low expression levels. In addition,
IPH45 has anti-tumor activity in combination with anti-PD1 treatment in
PD-1 resistant model in vivo and has a favorable safety profile in
relevant animal toxicology models.
-- IPH45 continues towards IND filing in 2024.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:
The Phase 3 PACIFIC-9 trial run by AstraZeneca evaluating durvalumab (anti-PD-L1) in combination with monalizumab or AstraZeneca's oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy $(CRT)$ is ongoing.
AstraZeneca will present a poster at ASCO titled: "Updated results from COAST, a phase 2 study of durvalumab $(D)$ +/- oleclumab $(O)$ or monalizumab $(M)$ in patients (pts) with stage III unresectable non-small cell lung cancer (uNSCLC)."
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