NewLink Genetics Presents Updated NLG802 Results at the Immuno-Oncology 2019 World Congress
23 May 2019 - 10:30PM
NewLink Genetics Corporation (NASDAQ:NLNK) today announced the
abstract (Poster 61) entitled, “A Phase 1 Clinical Trial of NLG802,
a Prodrug of Indoximod with Enhanced Pharmacokinetic Properties,”
was presented at the Immuno-Oncology 2019 2nd World Congress in
Barcelona, Spain.
The Phase 1 dose-escalation study evaluated the safety, toxicity
and PK of NLG802 to determine the maximum tolerated dose (MTD) or
maximum biologically achievable dose (MBAD). Data from the
study was used to recommend a Phase 2 dose (RP2D) of NLG802.
NLG802 was administered orally at five dose levels up to 1452 mg
BID in 26 patients with recurrent advanced solid tumors. At the
time of analysis for this presentation, five (19%) patients remain
on study, 14 (54%) alive, and four patients withdrew from
follow-up. Six patients achieved a best response of stable disease
per RECIST 1.1 criteria, with 1 patient having durable stable
disease greater than nine months. No subject experienced a
dose-limiting toxicity within the first 28-day cycle. The
most frequently reported adverse events (AE) regardless of
attribution were fatigue (54%), nausea (46%), vomiting (35%),
decreased appetite (31%), and diarrhea (23%).
PK results were also reported from this study. After continuous
twice-daily dosing with NLG802 at all levels, significantly higher
PK exposure was observed. At 1452 mg BID, the highest dose
administered, NLG802 produced a 6-fold increase in Cmax and a
4.7-fold increase in AUC compared with molar equivalent indoximod
dosing.
The treatment regimen was well tolerated with no NLG802-related
serious adverse events (SAE) reported. MTD/MBAD had not been
reached, and recommended Phase 2 dose (RP2D) was established at
1452 mg BID based on achieving preclinical exposure levels required
for pharmacodynamic effects of indoximod.
An interesting response was observed during this study involving
a patient with metastatic pancreatic cancer who had failed three
prior lines of therapy (gemcitabine plus nab-paclitaxel, FOLFIRI,
and irinotecan HCl plus gemcitabine). NLG802 was administered to
this patient as 4th line therapy and was discontinued after five
weeks upon disease progression. The patient was subsequently
re-challenged with gemcitabine plus nab-paclitaxel. Imaging
three months after re-challenge showed a partial response (PR) with
75% reduction in total tumor burden. In addition, the CA19-9
levels dropped 94% from levels prior to this line of therapy. No
objective responses were observed after any earlier rounds of
chemotherapy prior to administration of NLG802. This suggests that
prior treatment with NLG802 may have contributed to the response
ultimately observed in this patient.
“These results corroborate earlier data demonstrating NLG802’s
ability to produce significantly higher exposure levels in patients
compared with molar equivalent dosing of indoximod, while
maintaining tolerability,” said Eugene P. Kennedy, MD, Chief
Medical Officer of NewLink Genetics. “We are encouraged by these
results, which reinforce our belief that NLG802 has the potential
to be an important component of an immuno-oncology treatment
regimen.”
The poster can be accessed through the NewLink
Genetics website at www.NewLinkGenetics.com in the
"Investors & Media" section under "Posters & Presentations"
or by clicking here.
About NLG802
NLG802, an orally-available prodrug of
indoximod, was specifically engineered to increase the
bioavailability of indoximod by leveraging existing mechanisms of
absorption, increasing the exposure of indoximod approximately
5-fold. NewLink Genetics is currently evaluating NLG802 in a Phase
1 dose-escalation clinical trial in cancer patients to assess the
safety and pharmacokinetics of NLG802.
About NewLink Genetics Corporation
NewLink Genetics is a clinical-stage
biopharmaceutical company focusing on developing novel oncology
product candidates to improve the lives of patients with cancer.
NewLink Genetics' IDO pathway inhibitors, indoximod and its prodrug
NLG802, are immuno-oncology drug candidates designed to harness
multiple components of the immune system to combat cancer. The IDO
Pathway is one of the key immuno-oncology targets involved in
regulating the tumor microenvironment and immune escape. NewLink
Genetics’ drug candidate, NLG207 (formerly CRLX101), a nanoparticle
formulation of camptothecin, a topoisomerase 1 inhibitor, is under
development to combat refractory malignancies. For more
information, please visit www.NewLinkGenetics.com and follow us on
Twitter @NLNKGenetics.
Cautionary Note Regarding
Forward-Looking Statements
This press release contains forward-looking
statements of NewLink Genetics that involve substantial risks and
uncertainties. All statements contained in this press release are
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. The words “will be,”
"may," “appear to,” “has potential to,” “look forward to,” “are
designed to,” or the negative of these terms or other similar
expressions, are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. These forward-looking statements include, among
others, statements about results of NewLink’s clinical trials for
product candidates and any other statements other than statements
of historical fact. Actual results or events could differ
materially from the plans, intentions and expectations disclosed in
the forward-looking statements that NewLink Genetics makes due to a
number of important factors, including those risks discussed in
"Risk Factors" and elsewhere in NewLink Genetics' Annual Report on
Form 10-K for the year ended December 31, 2018 and other reports
filed with the U.S. Securities and Exchange Commission (SEC). The
forward-looking statements in this press release represent NewLink
Genetics’ views as of the date of this press release. NewLink
Genetics anticipates that subsequent events and developments will
cause its views to change. However, while it may elect to update
these forward-looking statements at some point in the future, it
specifically disclaims any obligation to do so. You should,
therefore, not rely on these forward-looking statements as
representing NewLink Genetics' views as of any date subsequent to
the date of this press release.
Investor & Media Contact:
Lisa MillerDirector of Investor RelationsNewLink
Genetics515-598-2555lmiller@linkp.com
Source: NewLink Genetics Corporation
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