FibroGen Announces FDA Clearance of Investigational New Drug Application for FG-3165, a Galectin-9 Targeting Monoclonal Antibody, for the Treatment of Patients with Solid Tumors
FibroGen (NASDAQ: FGEN) announced FDA clearance for its Investigational New Drug (IND) application for FG-3165, a monoclonal antibody targeting galectin-9 (Gal9) for treating solid tumors. FG-3165 has shown anti-tumor activity and improved survival in preclinical models and exhibited excellent tolerability in nonclinical safety studies. The company plans to start enrollment for a Phase 1 clinical trial in the second half of 2024 to evaluate the safety and efficacy of FG-3165 in patients with solid tumors characterized by high Gal9 expression. CEO Thane Wettig stated that this marks a significant milestone for FibroGen's oncology pipeline.
- FDA clearance of FG-3165 IND application.
- Preclinical studies showed anti-tumor activity and improved survival rates.
- Nonclinical safety studies demonstrated excellent tolerability.
- Phase 1 clinical trial planned for 2H 2024.
- Current stage is only Phase 1, indicating early development with inherent risks.
- No guaranteed outcomes from the upcoming clinical trial.
- Potential delays in trial enrollment and progression.
Insights
The clearance of FG-3165 by the FDA is an important step for FibroGen, as it allows the company to initiate clinical trials in solid tumors with high Galectin-9 expression. This molecule, FG-3165, is designed to enhance anti-tumor immune responses, making the treatment potentially synergistic with other immune modulatory therapies. From a clinical perspective, targeting Galectin-9 could have significant implications considering that Galectin-9 is involved in multiple pathways that suppress the immune response in tumors. If FG-3165 can effectively counteract this suppression, it may improve outcomes for patients with resistant forms of cancer.
However, being in Phase 1, the focus is primarily on determining the appropriate dosage and ensuring safety. While preclinical results in mouse models are promising, it's important to remember that many drugs that show efficacy in animals do not always translate to humans. Nonetheless, the clearance itself is a positive indicator of the scientific validity and potential safety of FG-3165, which could lead to more advanced trials if early results are favorable.
From a financial standpoint, the FDA clearance is likely to be perceived positively by investors. This milestone not only validates FibroGen’s ongoing research but also paves the way for potential future revenue streams, assuming successful clinical outcomes. Clinical trials, particularly Phase 1, represent substantial investment and risk; however, successful results could significantly enhance the company’s market value and attract partnerships or acquisitions. It’s important to note that while the clearance is a positive indicator, it does not guarantee commercial success.
Investors should also consider the timeline for the trial, with enrollment starting in the second half of 2024. This suggests that any potential market launch, assuming all phases proceed without significant delays, is still several years away. Thus, while the news is promising for long-term growth, short-term financial gains may be limited. Monitoring the trial's progress and initial safety data will be critical to making more informed investment decisions.
This development positions FibroGen within a competitive landscape of oncology therapeutics that are increasingly focusing on immune modulation. The uniqueness of targeting Galectin-9, a relatively less explored target compared to PD-1 or CTLA-4, could provide FibroGen with a competitive edge. The market for immuno-oncology therapies is expanding rapidly and having a differentiated product could prove advantageous in capturing market share.
Nonetheless, investors should be aware that the oncology drug market is highly competitive, with numerous companies developing novel therapies. The eventual success of FG-3165 will depend not only on its clinical efficacy but also on its differentiation from existing therapies in terms of effectiveness, safety and cost. Additionally, investors should keep an eye on partnership deals or collaborations that could bolster FibroGen’s position in the market.
- The safety and efficacy of FG-3165 will be evaluated in a Phase 1 trial in select solid tumors
- Plan to begin enrollment in 2H 2024
SAN FRANCISCO, June 03, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) of FG-3165, a galectin-9 (Gal9) targeted monoclonal antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression.
“The FDA’s IND clearance is an important achievement for us, and we are pleased to advance another product from our promising oncology pipeline into the clinic,” said Thane Wettig, Chief Executive Officer of FibroGen. “To date, FG-3165 has demonstrated anti-tumor activity with improved survival in combination with other immune modulatory therapies in mouse cancer models and has shown excellent tolerability in nonclinical safety studies. We are excited to begin enrollment in a Phase 1 trial in the second half of this year and explore the potential of FG-3165 in enhancing anti-tumor immune responses in the tumor microenvironment.”
The FDA IND clearance enables FibroGen to initiate a Phase 1 clinical trial evaluating the safety and efficacy of FG-3165 in patients with select solid tumors. The trial is anticipated to begin enrollment in the second half of 2024.
About FG-3165
FG-3165 is a galectin-9 (“Gal9”) targeted antibody under development for treatment of solid tumors and potentially hematologic malignancies characterized by high Gal9 levels of expression. Gal9 has been reported to signal through multiple immune checkpoints on lymphocytes, including TIM3, VISTA, and PD-1, suppressing T and natural killer cell activation. FG-3165 selectively binds to Gal9 with high affinity and inhibits its ability to induce lymphocyte cell death, resulting in enhanced tumor cell killing.
Toxicology material as well as GMP material for the upcoming Phase 1 clinical trial was manufactured in partnership with Just-Evotec Biologics.
About FibroGen
FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Pamrevlumab, a fully human anti-CTGF monoclonal antibody, is in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer (LAPC). Roxadustat (爱瑞卓®, EVRENZOTM) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted for review by the China Health Authority. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of an associated CD46-targeted PET biomarker. In addition, FibroGen has expanded its research and development portfolio to include two immuno-oncology product candidates for the treatment of solid tumors. For more information, please visit www.fibrogen.com.
Forward-Looking Statements
This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding its Gal9 clinical program. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential success of FibroGen product candidates, and statements about FibroGen’s plans and objectives and typically are identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. FibroGen’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s most recent quarterly and annual reports on Form 10-Q and Form 10-K, respectively,as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law.
For Investor Inquiries:
David DeLucia, CFA
Vice President, Head of Investor Relations and Corporate FP&A
ir@fibrogen.com
For Media Inquiries:
Simon Miller
Vice President, Marketing and Corporate Communications
media@fibrogen.com
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