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Genexine and NeoImmuneTech Announce Data Release for their Phase 1/2 Study of GX-I7/NT-I7 (efineptakin alfa) and KEYTRUDA® (pembrolizumab) in patients with Triple-Negative Breast Cancer
2020.11.09
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ROCKVILLE,
Md – November 9th, 2020 – Genexine, Inc. and NeoImmuneTech,
Inc. today announced the release of data for the dose escalation
(DE) phase of their Phase 1b/2a study of GX-I7/NT-I7 (efineptakin alfa), a
novel T cell amplifier, in combination with KEYTRUDA® (pembrolizumab), a
leading checkpoint inhibitor (CPI), for the treatment of heavily pretreated
patients with relapsed or refractory triple-negative breast cancer (TNBC).
These data were shared in a poster presentation at the Society for
Immunotherapy of Cancer (SITC) conference on November 9th, 2020. The primary objectives of
the DE phase of this study are to evaluate safety and tolerability of
GX-I7/NT-I7 in combination with pembrolizumab and to determine the recommended
phase 2 dose (RP2D). Two combination schedules of GX-I7/NT-I7 and pembrolizumab
were evaluated: 1. Sequential administration of pembrolizumab + GX-I7/NT-I7, after
cyclophosphamide (CPA) chemotherapy pre-treatment, and 2. Concurrent administration
of pembrolizumab + GX-I7/NT-I7, without CPA chemotherapy pre-treatment. Total of 60
patients have been enrolled and treated in the DE phase of the study. Based on
the encouraging efficacy and safety data, the standard dose of pembrolizumab
plus 1,200 ug/kg GX-I7/NT-I7 concurrent administration without CPA chemotherapy
pre-treatment has been selected as the RP2D. At this level, an objective
response rate (ORR) of 28% has been observed. Both combination schedules
were well tolerated, and the most common treatment-related AEs were injection
site reaction (n=44, 73.4%), rash (n=26, 43.4%), pyrexia (n=21, 35.0%), ALT/AST
increase (n=19, 31.7%), GGT increase (n=12, 20.0%), myalgia (n=12, 20.0%) and
nausea (n=11, 18.4%). GX-I7/NT-I7 was dosed up to 1,440ug/kg, however this
level was not selected due to one dose-limiting toxicity observed with no
additional clinical benefit noted. “In addition to a well
tolerated safety profile, we are pleased to see promising initial efficacy data
at the RP2D in the dose escalation phase of this combination study,” said Jung
Won Woo, Ph.D., Chief Development and Business Officer at Genexine. “We look
forward to completing the phase 2 portion of the study and confirming the
promising efficacy in a large dataset.” NgocDiep Le, M.D., Ph.D.,
Executive Vice President and Chief Medical Officer of NeoImmuneTech, added: “Metastatic
triple-negative breast cancer is an area of signficant unmet need, making up
15-20% of breast cancers, and yielding progressively lower response rates and shorter
survival after each subsequent relapse. These early efficacy signals in the
dose escalation phase of our trial are encouraging and suggest that we may be
able to provide a much needed chemo-free treatment option for these patients in
dire need.” Additional information on the trial can be found on www.clinicaltrials.gov using the identifier NCT03752723. KEYTRUDA® is a registered
trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,
Inc., Kenilworth, N.J., USA.
GX-I7
(Genexine Code Name) / NT-I7 (NIT Code Name) is the only clinical-stage
long-acting human IL-7, and is being developed in oncologic and
immunologic indications, where T cell amplification and increased functionality
may provide clinical benefit. IL-7
is a fundamental cytokine for naïve and memory T cell development and for
sustaining immune response to chronic antigens (as in cancer) or
foreign antigens (as in infectious diseases). GX-I7/NT-I7 exhibits favorable PK/PD
and safety profiles, making it an ideal combination partner. GX-I7/NT-I7 is
being studied in multiple clinical trials in solid tumors and
as vaccine adjuvant. Studies are
being planned for testing in hematologic malignancies, additional solid tumors
and other immunology-focused indications.
About NeoImmuneTech NeoImmuneTech,
Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company,
dedicated to expanding the horizon of immuno-oncology and enhancing immunity to
infectious diseases. NIT is led by the scientific founder and inventor of NT-I7
(efineptakin alfa) and complemented by a strong executive team with rich
industry experience at companies such as Novartis, BMS, GSK, Pfizer, Amgen, Eli
Lilly, MedImmune/AstraZeneca and PwC. NIT is expanding rapidly in personnel and
operations, as well as partnering with industry and academic leaders to
investigate NT-I7 as monotherapy and in combination with various immunotherapeutics.
For more information, please visit www.neoimmunetech.com.
About Genexine Genexine, Inc., listed on KOSDAQ (095700) since 2009, is a leading
biotherapeutics company focused on immuno-oncology and orphan disease. Genexine
has a robust pipeline of products in the clinical stage, e.g. Hyleukin-7TM,
HyTropin (GX-H9), Papitrol (GX-188E), etc. based on long-acting Fc fusion
technology and therapeutic DNA vaccine technology. Genexine has completed
multinational phase II trials and is preparing to apply IND of US Phase III
trial for HyTropin (long-acting human growth hormone, hGH-hyFc). Papitrol, a
therapeutic DNA vaccine for HPV-associated diseases, is under Phase II in
Europe and Korea for Cervical Intraepithelial Neoplasia (CIN) II/III. Founded
in 1999, Genexine has over 140 employees, and half of them are scientists with
MSc, or Ph.D. Genexine is located in Pangyo Techno Valley near Seoul, Korea
with a branch office in New York.
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