These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
- iBio (IBIO), 98% surge in interest
- Marker Therapeutics (MRKR), 50% surge in interest
- Ocular Therapeutix (OCUL), 45% surge in interest
Pipeline and key clinical candidates for these companies:
iBio develops next-generation biopharmaceuticals using computational biology and 3D-modeling of subdominant and conformational epitopes, prospectively enabling the discovery of new antibody treatments for hard-to-target cancers and other diseases. iBio’s mission is to "decrease drug failures, shorten drug development timelines, and open up new frontiers against the most promising targets," the company says.
Marker Therapeutics is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. "Because Marker does not genetically engineer its T cell therapies, we believe that our product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies," the company says.
Ocular Therapeutix is focused on the formulation, development, and commercialization of therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix’s first commercial drug product, Dextenza, is an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. Ocular Therapeutix’s earlier stage development assets include: OTX-TKI, currently in Phase 1 clinical trials for the treatment of wet AMD and diabetic retinopathy; OTX-TIC, currently in a Phase 2 clinical trial for the treatment of primary open-angle glaucoma or ocular hypertension; and OTX-CSI for the chronic treatment of dry eye disease and OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, both of which have completed Phase 2 clinical trials.
Recent news on these stocks:
June 12
Marker Therapeutics announced that the first patient has been treated in the company sponsored Phase 1 multicenter APOLLO trial investigating MT-601, a multi-tumor-associated antigen-specific T cell product targeting six antigens, for the treatment of patients with lymphoma who have failed or are ineligible to receive anti-CD19 CAR T cell treatment. Marker is developing MT-601, an autologous T cell product that is directed against six tumor associated antigens for the treatment of patients with relapsed/refractory lymphoma who are either ineligible to receive or have failed anti-CD19 CAR T cell therapy. Given the positive TACTAL trial results, which targeted five tumor associated antigens, Marker believes broadening its multiTAA-specific T cell product to target six antigens could result in better and more durable responses due to its ability to overcome antigen loss by targeting more than one antigen. The recent press release issued by Marker on May 31, 2023, referenced in vitro nonclinical data indicating that MT-601 prevented growth of lymphoma cells regardless of CD19 expression and prevented growth of CD19 expressing lymphoma cells that had become resistant to CAR T infusion. These data demonstrate the therapeutic potential of MT-601. The APOLLO trial sponsored by Marker is assessing MT-601 in patients with lymphoma who have either relapsed after anti-CD19 CAR T cell therapy or were ineligible to receive it. The primary objective of this exploratory Phase 1 clinical trial is to evaluate the optimum dose, safety, and preliminary efficacy of MT-601 in patients with various lymphoma subtypes. Data from the APOLLO trial will guide Marker Therapeutics on the future development of MT-601. The first patient in the APOLLO trial recently received MT-601 at the 200 million cell dose level. This patient was monitored for 18 days after being dosed and showed no treatment-related adverse events, indicating that the therapy was well tolerated. This observation is consistent with the favorable safety profile and tolerability previously reported for lymphoma patients in the TACTAL study. Under the APOLLO trial, eight clinical sites across the United States will cumulatively enroll up to 30 patients during the dose escalation phase.
June 11
Ocular Therapeutix announced 12-month data from its Phase 1 U.S. clinical trial evaluating OTX-TKI, the company’s axitinib intravitreal hydrogel implant, for the treatment of wet age-related macular degeneration, or wet AMD. OTX-TKI is also being developed for the treatment of diabetic retinopathy and other retinal diseases. The 12-month data demonstrated maintenance of controlled wet AMD subjects comparable to aflibercept injections every eight weeks with a single administration of OTX-TKI. Four subjects received rescue therapy for the first time at Month 12, indicating the waning of OTX-TKI’s therapeutic effect and potential disease reactivation, which helps establish a re-dosing timeline for patients. No serious drug-related ocular or systemic adverse events have been observed in the trial. The clinical trial enrolled a total of 21 subjects at six clinical sites in the United States, who were randomized 3:1 to an arm receiving a single OTX-TKI implant, with a 2 mg aflibercept injection four weeks after implant injection, and an arm receiving aflibercept injections every 8 weeks. One subject in the OTX-TKI arm was not treated per protocol and has been removed from the efficacy analysis, as the subject incorrectly received aflibercept instead of a sham injection at Month 3 and 5 visits. As of the data cutoff of April 14, 2023, there were no drug-related ocular or systemic serious adverse events observed in the OTX-TKI arm. As the company previously announced at the 10-month data readout, one SAE of endophthalmitis was observed in the OTK-TKI arm, which occurred following the mandated aflibercept injection at Month 1 and was assessed by the investigator as related to the injection procedure. There were no retinal detachment, retinal vasculitis, or implant migration into the anterior chamber adverse events observed in the OTX-TKI arm, and no subjects had dropped out of either arm as of the data cutoff. The results showed subjects treated with a single OTX-TKI implant continued to demonstrate sustained BCVA in the OTX-TKI arm at 12 months, which was comparable with the aflibercept arm. 60% of OTX-TKI subjects were rescue-free up to Month 12. At the Month 12 visit, an additional four of the subjects were rescued. Overall, an 89% reduction in treatment burden was observed in OTX-TKI treated subjects at 12 months. The company is prepared to initiate a pivotal trial in wet AMD as early as the third quarter of 2023, subject to obtaining the necessary financing, which could be provided through a strategic alliance. OTX-TKI is also being evaluated in other retinal diseases. The company recently completed enrollment of the Phase 1 HELIOS clinical trial to evaluate OTX-TKI for the treatment of diabetic retinopathy and 6-month interim results are expected in Q1 of 2024.
June 6
iBio announced the expansion of its AI-powered technology stack with the launch of EngageTx, a proprietary T-cell engager antibody panel designed for developing bispecific antibodies for immuno-oncology applications. Through comprehensive screening and optimization techniques, iBio has identified highly potent, fully human TROP-2 monoclonal antibodies, which have been formatted into bispecific TROP-2 x CD3 molecules using EngageTx.
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About “Biotech Alert”
The Fly will report on a selection of biotech stocks seeing a surge in interest from retail and financial professional investors, based on data from InvestingChannel.
This Fly exclusive recap reveals the biotech stocks that are seeing a spike in searches among the 20-plus million retail and financial professional investors through InvestingChannel’s online financial news media ecosystem.
This increased attention from the investors may be in response to, or advance of, outsized moves for stocks in the biotech sector, which tend to be volatile and prone to sharp swings in share price around binary events such as clinical study results and FDA approvals.
Published first on TheFly
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