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Inhibrx Biosciences, Inc. reports clinical and corporate updates for a pipeline of biologic therapeutic candidates developed with protein engineering platforms. The company’s programs include ozekibart (INBRX-109), a tetravalent death receptor 5 agonist antibody studied in oncology indications including chondrosarcoma, colorectal cancer and Ewing sarcoma, and INBRX-106, a hexavalent OX40 agonist evaluated in immuno-oncology settings such as head and neck squamous cell carcinoma.
Company developments commonly cover clinical trial data, regulatory submissions and designations, scientific conference presentations, quarterly and annual financial results, and capital resources. Inhibrx Biosciences also carries a completed corporate history tied to its 2024 separation from Inhibrx, Inc. following the sale of the INBRX-101 program.
Inhibrx, Inc. (Nasdaq: INBX) announced potential for accelerated approval from the FDA for INBRX-101, a recombinant human AAT-Fc fusion protein, aimed at treating emphysema due to alpha-1 antitrypsin deficiency (AATD). The FDA supports the use of functional AAT serum levels as a surrogate endpoint. All patients tested in the Phase 1 study showed detectable INBRX-101 in bronchoalveolar lavage fluid. Inhibrx plans to begin a registration-enabling trial in Q1 2023, with a recent amendment to its loan agreement enabling $30 million funding upon announcing this regulatory path.
Inhibrx, a clinical-stage biopharmaceutical company, will host a live webcast on October 4, 2022, at 5:30 a.m. PT, to discuss the regulatory pathway for INBRX-101. This treatment targets alpha-1 antitrypsin deficiency (AATD), a rare disease affecting about 100,000 patients in the U.S. INBRX-101 is designed for less frequent dosing compared to current therapies. The Phase 1 study demonstrated safety and efficacy, with no severe adverse events reported. The FDA granted INBRX-101 orphan-drug designation in March 2022.
Inhibrx, Inc. (Nasdaq: INBX) announced that the European Commission has granted orphan medicinal product designation to INBRX-109 for treating chondrosarcoma, building on a positive EMA opinion. This designation can lead to benefits like reduced fees and market exclusivity. Chondrosarcoma affects about 2,800 new patients annually in the US and EU, with no approved therapies currently available. INBRX-109 is a DR5 agonist antibody, and the company has initiated a Phase 2 trial, showing promising preliminary results in prior trials.
Inhibrx, Inc. (Nasdaq: INBX) reported its Q2 2022 financial results with a net loss of $37.7 million ($0.97 per share), up from $20.7 million ($0.55 per share) in Q2 2021. The company had $176.4 million in cash and equivalents as of June 30, 2022. Key highlights include a successful Phase 1 trial of INBRX-101 for AAT deficiency and the completion of Phase 1 dose escalation for INBRX-105. The company secured $60 million from Oxford Finance through a loan agreement.
On June 30, 2022, Inhibrx, Inc. (Nasdaq: INBX) announced the completion of Phase 1 dose escalation for its novel targeted 4-1BB agonist, INBRX-105, in combination with Keytruda®. The trial, involving 30 patients, indicated a favorable safety profile and durable responses. Additionally, the company secured $60 million in funding through its Loan Agreement with Oxford Finance, adjusting its cash balance to approximately $176 million. The next phase of trials is set to include around 90 patients, with initial results expected in early 2023.
Inhibrx, Inc. (Nasdaq: INBX) will present details on its INBRX-109 Phase 2 trial for conventional chondrosarcoma at the 2022 ASCO Annual Meeting from June 3-7, 2022. The trial aims to establish a placebo-controlled methodology for evaluating INBRX-109, a DR5 agonist antibody. Preliminary Phase 1 results showed efficacy in 89% of patients, with a median progression-free survival of 7.4 months. The presentation, led by Dr. Sant P. Chawla, will take place on June 5, 2022, from 9 a.m. to 11 a.m. CST, and the poster will be available online.
Inhibrx Inc. announces favorable topline results from a Phase 1 clinical trial of INBRX-101, a recombinant human AAT-Fc fusion protein for treating alpha-1 antitrypsin deficiency (AATD). The study involved 31 patients and showed no severe drug-related adverse events, with mild and reversible issues reported. The drug achieved an average functional alpha-1 antitrypsin (AAT) level of 40.4 µM after the third dose, surpassing the current standard of care's 17.8 µM. Inhibrx believes INBRX-101 could reduce infusion frequency significantly, offering a more convenient treatment option.
Inhibrx, Inc. (Nasdaq: INBX) reported its Q1 2022 financial results and corporate updates on May 9, 2022. The company reported cash and equivalents of $143.5 million, an increase from $131.3 million at year-end 2021. R&D expenses rose to $24.9 million, compared to $16.4 million in Q1 2021. General and administrative expenses also increased to $5.1 million. The net loss for Q1 2022 was $31.3 million ($0.80 per share), up from $19.3 million ($0.51 per share) in Q1 2021. Recent highlights include FDA orphan-drug designation for INBRX-101 and a $130 million loan agreement amendment.
Inhibrx, Inc. (Nasdaq: INBX) announced the establishment of a Scientific Advisory Board (SAB) for its clinical program INBRX-101, aimed at treating alpha-1 antitrypsin deficiency (AATD). The board consists of leading experts in AATD, who will collaborate with Inhibrx's management to advance INBRX-101 towards regulatory approval. The drug has shown promise as a potentially best-in-class treatment, addressing a significant unmet need in AATD, which affects about 100,000 patients in the U.S. Current standard treatments require inconvenient weekly dosing, while INBRX-101 may allow for monthly administration.
Inhibrx (Nasdaq: INBX) announced that late-breaking data on INBRX-101 will be presented at the American Thoracic Society (ATS) 2022 Conference from May 13-18, 2022, in San Francisco, CA. The oral presentation, led by Mark Brantly, focuses on a novel recombinant AAT-Fc fusion protein for patients with Alpha-1 Antitrypsin Deficiency (AATD). It will occur on May 16, while a related poster presentation will take place on May 17. AATD affects about 100,000 individuals in the US, leading to serious lung issues. INBRX-101 has shown promising early results in an ongoing Phase 1 trial.