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ArriVent BioPharma Inc (Nasdaq: AVBP) is a clinical-stage biopharmaceutical company devoted to the discovery, development, and commercialization of innovative medicines to meet the unmet medical needs of cancer patients. The company's primary focus is on advancing its lead candidate, furmonertinib, and developing a diverse pipeline of novel therapeutics, including next-generation antibody-drug conjugates.
Furmonertinib is a highly brain-penetrant, mutation-selective epidermal growth factor receptor (EGFR) inhibitor effective against both classical and uncommon EGFR mutations, such as PACC and exon 20 insertion mutations. In March 2021, furmonertinib received approval in China for first-line treatment of non-small cell lung cancer (NSCLC) with specific EGFR mutations. In October 2023, it was granted Breakthrough Therapy Designation by the U.S. FDA for treating patients with previously untreated, locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations.
ArriVent's development strategy includes multiple clinical trials to maximize the therapeutic potential of furmonertinib. The company is conducting a global Phase 3 trial for first-line NSCLC patients with EGFR exon 20 insertion mutations (FURVENT) and a Phase 1b study for patients with EGFR PACC mutations (FURTHER). Additionally, ArriVent has initiated a Phase 1b combination study of furmonertinib and the SHP2 inhibitor ICP-189 in NSCLC patients with classical EGFR mutations.
With a skilled management team and a strong financial position, ArriVent is well-prepared for the future. The company recently completed its successful IPO in January 2024 and reported a cash runway extending into 2026. Recent achievements include the full enrollment of the NSCLC EGFR PACC mutation Phase 1b cohort in the FURTHER study and promising preclinical data presented at the AACR annual meeting.
ArriVent is committed to delivering transformative therapies to improve the lives of cancer patients globally. The company's deep expertise in drug development and strategic partnerships play a critical role in advancing its mission. For investors and stakeholders, ArriVent BioPharma Inc represents a promising opportunity in the biopharmaceutical industry, driven by scientific innovation and a dedication to addressing significant medical needs.
ArriVent BioPharma (Nasdaq: AVBP) reported Q3 2024 financial results with cash and cash equivalents of $282.9 million, expected to fund operations into 2026. The company reported increased R&D expenses of $58.9 million and G&A expenses of $11.8 million for the nine months ended September 30, 2024. Net loss widened to $59.9 million.
The company's lead drug firmonertinib showed positive results in treating NSCLC patients with EGFR PACC mutations, including those with brain metastases. Top-line data from the Phase 3 FURVENT trial for firmonertinib in NSCLC with EGFR exon 20 insertion mutations is expected in 2025.
ArriVent BioPharma (Nasdaq: AVBP) announced positive interim data from its Phase 1b FURTHER trial for firmonertinib in first-line EGFR PACC mutant non-small cell lung cancer (NSCLC) at the 2024 World Conference on Lung Cancer. Key highlights include:
- 81.8% overall response rate (ORR) and 63.6% confirmed ORR at 240mg dose by blinded independent central review (BICR)
- 46.2% confirmed ORR in CNS metastases
- 90.9% of patients with confirmed responses remained on study
- Generally well-tolerated safety profile
Firmonertinib showed promising dose-dependent activity across EGFR PACC mutations and demonstrated CNS antitumor activity. These results suggest potential as an effective oral, chemotherapy-free treatment for this underserved patient population.
ArriVent BioPharma (Nasdaq: AVBP) reported Q2 2024 financial results and highlighted recent progress. Key points include:
1. Upcoming presentation of clinical proof-of-concept data for firmonertinib in EGFR PACC mutant NSCLC at WCLC 2024.
2. New ADC collaboration agreement with Alphamab, expanding ArriVent's oncology pipeline.
3. Financial position: $298.7 million in cash and cash equivalents, expected to fund operations into 2026.
4. R&D expenses increased to $38.8 million for H1 2024, up from $30.6 million in H1 2023.
5. Net loss of $39.3 million for H1 2024, compared to $33.7 million in H1 2023.
6. Anticipating top-line Phase 3 data for firmonertinib in NSCLC with EGFR exon 20 insertion mutations in 2025.
ArriVent BioPharma (Nasdaq: AVBP) will present interim randomized Phase 1b FURTHER data for first-line firmonertinib monotherapy in patients with non-small cell lung cancer (NSCLC) harboring EGFR PACC mutations at the 2024 World Conference on Lung Cancer (WCLC). The presentation, selected for the Presidential Symposium, marks the first prospectively designed randomized clinical data for a small-molecule EGFR tyrosine kinase inhibitor in this specific patient population. The study, titled 'FURTHER: A Global, Randomized study of Firmonertinib at Two Dose Levels in TKI-Naive, Advanced NSCLC with EGFR PACC Mutations,' will be presented on September 9, 2024. ArriVent will also host a virtual webinar on the firmonertinib program on the same day at 4:30pm ET.
ArriVent BioPharma has entered a collaboration with Jiangsu Alphamab Biopharmaceuticals to develop and commercialize novel antibody drug conjugates (ADCs) for cancer treatment. Under the agreement, ArriVent will utilize Alphamab's ADC research platform, while Alphamab will leverage ArriVent's global development expertise. The agreement includes potential milestone and upfront payments to Alphamab worth up to $615.5 million, excluding Greater China where Alphamab retains development and commercialization rights. Alphamab will also receive tiered sales royalties from ArriVent for each ADC product.
ArriVent BioPharma has appointed Dr. John Hohneker to its Board of Directors.
Dr. Hohneker brings over 30 years of biopharmaceutical leadership and drug development experience, previously holding key roles at Anokion SA, Forma Therapeutics, and Novartis AG.
He currently serves on the Boards of Carisma Therapeutics, Curis, Sonata Therapeutics, and Trishula Therapeutics.
Dr. Hohneker's expertise is expected to aid in advancing ArriVent's pipeline, including its lead candidate firmonertinib, aimed at addressing unmet cancer patient needs.
ArriVent BioPharma reported strong financial results for the first quarter of 2024, with a cash position of $317.4 million, showcasing positive progress in advancing their clinical programs. The company presented preclinical data on firmonertinib at the AACR Annual Meeting, demonstrating its effectiveness across a wide range of mutations in NSCLC. They also dosed the first patient in a Phase 1b combination study with ICP-189 for NSCLC patients with EGFR classical mutations. The company is on track to deliver proof-of-concept data in 2024 and is making strides in selecting a next-generation ADC development candidate.
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