FDA Approves IND Submission Allowing ABVC BioPharma to Proceed With Clinical Study of ABV-1519 for Treatment of Non-Small Cell Lung Cancer
06 January 2023 - 12:30AM
via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical
stage biopharmaceutical company developing therapeutic solutions in
oncology/hematology, CNS, and ophthalmology today announced that
the US Food & Drug Administration notified the company that the
IND application for the proposed clinical investigation of BLEX
404, the primary active ingredient in ABV-1519, for advanced
inoperable or metastatic EGFR-mutated non-small cell lung cancer
has been approved and the study can proceed. The treatment, which
is being co-developed by BioKey, Inc., a wholly owned subsidiary of
ABVC based in Fremont, California and by the Rgene Corporation was
submitted to the FDA by Rgene on November 30, 2022.
The application, designated IND 161602, was approved on December
30, 2022. It contained the clinical protocol for ABV-1519 and was
entitled “A Phase I/II, Open Label Study to Evaluate the Safety and
Efficacy of BLEX 404 Oral Liquid Combined with Pemetrexed +
Carboplatin Therapy in Patients with Advanced Inoperable or
Metastatic EGFR-Mutated Non-Small Cell Lung Cancer Patients.”
BLEX 404, the primary active ingredient, is extracted from the
Maitake mushroom (Grifola frondosa), an edible mushroom, whose
immunological effects and safety have been demonstrated in two
Phase I/II clinical studies performed at Memorial Sloan Kettering
Cancer Center (MSKCC) with breast cancer and myelodysplastic
syndromes (MDS) patients.
“We are pleased the US FDA approved IND 161602 within the 30-day
review period. As a result of that approval, our BioKey subsidiary
has earned a milestone payment of $600,000 from Rgene, our
development partner,” said Dr. Howard Doong, Chief Executive
Officer of the Company; “RGC-1501 is the first of three
co-development projects with Rgene and will initially be conducted
at Taipei Veterans General Hospital in Taiwan.”
The global Non-Small Cell Lung Cancer (NSCLC) market size is
expected to reach USD13.68 Billion in 2030 and register a revenue
CAGR of 6.5% over the forecast period, according to latest report
by Reports and Data
(https://www.biospace.com/article/non-small-cell-lung-cancer-nsclc-market-analysis-2022-2030-increasing-incidence-of-lung-cancer
).
About ABVC BioPharmaABVC BioPharma is a clinical-stage
biopharmaceutical company with an active pipeline of six drugs and
one medical device (ABV-1701/Vitargus®) under development. For its
drug products, it is focused on utilizing its licensed technology
to conduct proof-of-concept trials through Phase II of the clinical
development process at world-famous research institutions (such as
Stanford University, University of California at San Francisco, and
Cedars-Sinai Medical Center). For Vitargus®, the company intends to
conduct the clinical trials through Phase III at various locations
throughout the globe.
Forward-Looking StatementsThis press release contains
“forward-looking statements.” Such statements may be preceded by
the words “intends,” “may,” “will,” “plans,” “expects,”
“anticipates,” “projects,” “predicts,” “estimates,” “aims,”
“believes,” “hopes,” “potential,” or similar words. Forward-looking
statements are not guarantees of future performance, are based on
certain assumptions, and are subject to various known and unknown
risks and uncertainties, many of which are beyond the Company’s
control, and cannot be predicted or quantified, and, consequently,
actual results may differ materially from those expressed or
implied by such forward-looking statements. Such risks and
uncertainties include, without limitation, risks and uncertainties
associated with (i) our inability to manufacture our product
candidates on a commercial scale on our own, or in collaboration
with third parties; (ii) difficulties in obtaining financing on
commercially reasonable terms; (iii) changes in the size and nature
of our competition; (iv) loss of one or more key executives or
scientists; and (v) difficulties in securing regulatory approval to
proceed to the next level of the clinical trials or to market our
product candidates. More detailed information about the Company and
the risk factors that may affect the realization of forward-looking
statements is set forth in the Company’s filings with the
Securities and Exchange Commission (SEC), including the Company’s
Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q.
Investors are urged to read these documents free of charge on the
SEC’s website at http://www.sec.gov. The Company assumes no
obligation to publicly update or revise its forward-looking
statements as a result of new information, future events or
otherwise.
Contact:Leeds Chow, CFOEmail: leedschow@ambrivis.com
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