SHANGHAI and WARREN,
N.J., May 23, 2024 /PRNewswire/ -- Laekna,
Inc. (2105.HK), a science-driven, clinical-stage biotechnology
company, announced that the company has received approval from
the U.S. Food and Drugs Administration for the protocol of the
phase III clinical trial of LAE002 (afuresertib, an AKT inhibitor)
plus LAE001 (CYP17A1/CYP11B2 dual inhibitor) ("LAE201")in patients
with metastatic castration-resistant prostate cancer (mCRPC)
following standard of care (SOC) treatment.
Laekna initiated a Phase II clinical trial of the multi-region
clinical trial of the study of LAE201 in the U.S. in June 2021, and South
Korea in September 2022. The
trial is an open-label, dose-escalation and dose expansion study to
assess the efficacy and safety of the combination candidate.
The study demonstrated promising treatment benefit for mCRPC
patients. As of Nov 21, 2023, 40
patients who progressed on 1–3 lines of standard treatments,
including at least 1 line of abiraterone, or the second generation
of AR antagonists, had been enrolled in the recommended phase II
dose group. The median rPFS was 8.1 months. This is a significant
improvement compared to the median rPFS of 2 to 4 months of mCRPC
patients under the standard treatments historically[1].
The combination therapy was generally tolerable with manageable
treatment emergent adverse events and recoverable after routine
treatments.
"Since the Phase II data of the combination therapy of LAE002
(afuresertib) plus LAE001 demonstrated encouraging anti-tumor
activity and safety profile in patients with mCRPC, a following
Phase III pivotal trial design has been discussed with the U.S. FDA
and the approval for the protocol has been received this month,"
said Dr. Yong Yue, Chief Medical
Officer of Laekna. "The approval marks a significant milestone for
Laekna. The mCRPC post 1-3 lines of SOC are difficult-to-treat late
stage cancer with poor outcomes. It is an unmet medical need
worldwide.We look forward to bringing this precision therapy to
mCRPC patients who are in need of novel treatment options."
[1] R. de Wit, et al., 2019;Rhian Sian Davies et al., 2016
About afuresertib
Afuresertib(LAE002) is one of the only two AKT inhibitors in or
completed the pivotal-stage clinical development for anti-cancer
treatment globally.
Afuresertib is a potent AKT inhibitor that inhibits all three
AKT isoforms (AKT1, AKT2 and AKT3). Afuresertib has demonstrated
several advantages compared to other AKT inhibitors, including
higher efficacy, better potency, more significant tumor inhibition
exposure and a better safety profile, based on public data.
Capivasertib is the first approved AKT inhibitor from AstraZeneca,
which FDA approved for HR+/HER2- breast cancer in November 2023.
With the promising efficacy data from our afuresertib Phase Ib
study for HR+/HER2- breast cancer, which was presented in SABCS
2023, Laekna has initiated the Phase III pivotal study. We also
continue to develop our clinical trials for the treatment of breast
cancer, prostate cancer, ovarian cancer and PD-1/PD-L1
drug-resistant solid tumors to address the unmet medical needs. In
several clinical trials, the combination of afuresertib with other
therapeutics exhibits favorable efficacy results.
About LAE001
LAE001 is an androgen synthesis inhibitor that inhibits both
CYP17A1 and CYP11B2. Laekna in-licensed LAE001 from Novartis in
2017. According to Frost & Sullivan, LAE001 is the only dual
CYP17A1/CYP11B2 inhibitor in clinical trials for the treatment of
prostate cancer globally.
As a dual CYP17A1/CYP11B2 inhibitor, LAE001 can block both
androgen and aldosterone synthesis and potentially be administrated
without prednisone, the short-term high dose or long-term exposure
of which can lead to a variety of adverse events.
About Laekna
Stock Code: 2105.HK
Founded in 2016, Laekna is a science-driven, clinical-stage
biotechnology company committed to bringing novel therapies to
cancer, metabolic diseases and liver fibrosis patients
worldwide.
As of December 31, 2023, we have
initiated six clinical trials for afuresertib (LAE002), LAE001 and
LAE005 for the treatment of breast cancer, prostate cancer, ovarian
cancer and PD-1/ PD-L1 drug-resistant solid tumors to address the
unmet medical needs. Among these six clinical trials, three are
multi-regional clinical trials (MRCTs). Afuresertib is a potent AKT
inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and
AKT3) as well as one of the only two AKT inhibitors in or completed
the pivotal-stage clinical development for anti-cancer treatment
globally.
Laekna's internal drug discovery platform has discovered 14 drug
candidates. LAE102 is our internally discovered antibody against
ActRIIA. We've obtained IND approvals from the FDA and the
CDE in relation to obesity. Blocking Activin-ActRII pathway
could promote muscle regeneration and decrease fat mass. Laekna
team has accumulated tremendous experience and deep know-how in
this specific field and is developing more drug candidates
(LAE103 and LAE123) to maximize the value of targeting ActRII
receptors.
Laekna, Inc. was listed on the Main Board of The Stock Exchange
of Hong Kong Limited (the "Hong Kong Stock Exchange") on
June 29, 2023, with the
stock code 2105.HK.
For more information, please visit: https://www.laekna.com/
or https://www.linkedin.com/company/74110713/
Forward-Looking Statements
This press release may contain certain "forward-looking
statements" which are not historical facts, but instead are
predictions about future events based on Laekna's current beliefs,
assumptions and expectations, commonly identified by words such as
"would", "may", "expects", "believes", "plans", "intends",
"projects" and other terms with similar meaning. Although we
believe that our predictions are reasonable, future events are
inherently uncertain and our actual future results or performance
may be materially different from what we expect. Accordingly, you
are strongly cautioned that reliance on any forward-looking
statements is subject to significant known and unknown risks and
uncertainties. All forward-looking statements contained herein are
qualified by reference to the cautionary statements set forth in
this section. All information provided in this press release is as
of the date of this press release and are based on assumptions that
we believe to be reasonable as of this date, and we do not
undertake any obligation to update any forward-looking statement,
except as required under applicable law.
View original
content:https://www.prnewswire.com/news-releases/laekna-announces-fda-approval-for-the-phase-iii-clinical-trial-protocol-of-lae002-afuresertib-plus-lae001-for-the-treatment-of-prostate-cancer-302154036.html
SOURCE Laekna