|Over a month ago|
Inhibrx reports Phase 1 single agent dose escalation results for INBRX-105 » 09:0703/1203/12/21
The company stated,…
The company stated, "INBRX-105 is a precisely engineered multi-specific therapeutic candidate based on our single domain antibody platform that is designed to agonize 4-1BB selectively in the presence of programmed death ligand 1, a protein that is typically found in the tumor microenvironment and lymphoid tissues. The study is a first-in-human, multicenter, open-label, non-randomized, Phase 1 trial in patients with locally advanced or metastatic solid tumors. The trial is designed to determine the safety profile and identify the maximum tolerated dose and/or recommended Phase 2 dose of INBRX-105 administered as a single agent or in combination with Keytruda, a programmed death receptor-1 checkpoint inhibitor. Single agent dose escalation was completed with a total of 32 patients enrolled. We observed dose-limiting toxicities, which were consistent with immune related adverse events (for example, hepatitis, arthritis and myalgia/hyperthyroidism) at several dose levels and determined the 1 mg/kg dose level as the MTD of INBRX-105. Patients were not pre-screened for PD-L1 expression. Eight out of 18 evaluable patients (44%) receiving INBRX-105 at dose levels equal to or greater than 0.1 mg/kg achieved stable disease, with the greatest reduction in tumor volume observed to be 20% by RECISTv1.1. The longest duration on treatment with INBRX-105 was 41 weeks, or approximately nine and a half months. Notably, seven patients with stable disease tested positive for PD-L1 expression, with a minimum of 1% positivity as determined by immunohistochemistry (Range 1 to 95%), and the results of one patient are pending. Four of these eight patients were refractory to or progressed on prior PD-1 checkpoint inhibitors. We expect to achieve the maximal therapeutic benefit of INBRX-105 in combination with PD-1 checkpoint blockade. In our preclinical studies we observed that acute exposure to PD-L1 dependent 4-1BB agonism was sufficient to derive maximal anti-tumor activity when co-dosed with another PD-1 blocking agent at a target saturating dose. As such, a dose escalation cohort of INBRX-105 in combination with Keytruda is targeted to initiate enrollment during the second quarter of 2021 and we expect to announce initial data during the fourth quarter of 2021."
Inhibrx reports Q4 EPS (47c), consensus (54c) » 09:0303/1203/12/21
Reports Q4 revenue…
Reports Q4 revenue $2.78M, consensus $990,000.
Inhibrx management to meet virtually with Jefferies » 10:0003/0803/08/21
Virtual Meeting to be…
Virtual Meeting to be held on March 8 hosted by Jefferies.
Inhibrx price target raised to $44 from $28 at Credit Suisse » 08:2902/0302/03/21
Credit Suisse analyst…
Credit Suisse analyst Martin Auster raised the firm's price target on Inhibrx to $44 from $28 and keeps an Outperform rating on the shares. After conducting a deep-dive on alpha-1 antitrypsin deficiency and INBRX-101, the analyst sees potential for significant program derisking if INBRX-101 can maintain plasma AAT levels within the normal range with evidence the drug effectively accesses the lung. Depending on the magnitude of de-risking observed and expectations of product positioning, Auster could see NPV upside of up to $20-$40/share.
Inhibrx Inc trading resumes 09:3701/2801/28/21
Inhibrx Inc trading halted, volatility trading pause 09:3201/2801/28/21
|Over a quarter ago|
Inhibrx granted FDA Fast Track designation for INBRX-109 » 09:0101/1301/13/21
Inhibrx announced the…
Inhibrx announced the U.S. FDA granted Fast Track designation to INBRX-109 for the treatment of patients with unresectable or metastatic conventional chondrosarcoma. INBRX-109 is a precisely engineered tetravalent single domain antibody-based therapeutic candidate that agonizes death receptor 5 to induce tumor selective programmed cell death. A potential registration-enabling Phase 2 study of INBRX-109 has been discussed with the FDA and will be designed as a randomized, blinded, placebo-controlled study in unresectable or metastatic conventional chondrosarcoma with progression-free survival as the primary endpoint. Inhibrx expects to start dosing patients in this potentially registration-enabling study in the second or third quarter of this year.
Inhibrx reports Q3 EPS (77c), consensus (60c) » 16:1611/1311/13/20
Reports Q3 revenue $5.9M,…
Reports Q3 revenue $5.9M, consensus $1M. Mark Lappe, Inhibrx's CEO commented, "Over the course of the next two years, we expect multiple data read-outs from our four clinical programs in the oncology and orphan disease space and to initiate new clinical programs. This additional debt line from Oxford extends our IPO proceeds and provides us greater optionality and the ability to complete these expected clinical milestones with appropriate runway cushion. We appreciate the strong support and our longstanding partnership from Oxford."
Inhibrx's chondrosarcoma candidate shows positive Phase 1 results » 16:1911/1111/11/20
Inhibrx announced updated…
Inhibrx announced updated interim results today from a Phase 1 clinical trial evaluating the efficacy and safety of INBRX-109 in patients with chondrosarcoma. Chondrosarcoma is an orphan disease and bone cancer with approximately 2,800 new patients diagnosed annually in the U.S.and the EU. There are currently no therapeutics approved for the treatment of chondrosarcoma. Inhibrx's most advanced program, INBRX-109, is a precision-engineered, tetravalent DR5 agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation. Of the 12 patients evaluable for efficacy within the ongoing chondrosarcoma expansion cohort to date, disease control was observed in 11 of 12 patients - 92% - and 8 of 12 patients - 67% - had a decrease in their tumor burden. Two of the patients achieved partial responses with reductions in tumor size of 60% and 32% as of October 2020. Based on these preliminary results, the observed disease control rate at the four-month follow-up was 8 of 12 subjects - 67% - with 7 of 12 patients continuing on study. The longest disease control duration observed to date for a patient in this cohort was 33 weeks, or approximately eight months. The safety and tolerability profile continued to be favorable with most patients, approximately 90%, experiencing no signs of hepatotoxicity. There have been no new serious or severe adverse events since Inhibrx's last safety update in July. The trial is ongoing and an additional 10 patient slots were added, per investigator requests, to the chondrosarcoma cohort.
Fly Intel: Top five analyst initiations » 10:1509/1409/14/20
ARNC, CZR, OSTK, INBX, GNRC
Catch up on today's…
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Arconic (ARNC) initiated with a Buy at Deutsche Bank. 2. Caesars (CZR) initiated with a Neutral at Goldman Sachs. 3. Overstock.com (OSTK) initiated with a Buy at Needham. 4. Inhibrx (INBX) initiated with a Buy at Jefferies as well as an Outperform at Evercore ISI and Credit Suisse. 5. Generac (GNRC) initiated with a Buy at Argus. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.