These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
Pipeline and key clinical candidates for these companies:
OncoSec Medical is focused on developing intratumoral immunotherapies to stimulate the patient's immune system to target cancer cells and eradicate disease. OncoSec's lead immunotherapy investigational product candidate – TAVO, tavokinogene telseplasmid – enables the intratumoral delivery of DNA-based interleukin-12, a naturally occurring protein with immune-stimulating functions. OncoSec's clinical pipeline is utilizing TAVO as a potential treatment for multiple cancer indications either as a monotherapy or in combination with checkpoint inhibitors; with the latter potentially enabling OncoSec to address a great unmet medical need in oncology: anti-PD-1 non-responders. Results from completed clinical trials of TAVO have demonstrated a local immune response, and subsequently, a systemic effect as either a monotherapy or combination treatment approach along with a well-tolerated safety profile, warranting further development of TAVO-EP.
Puma Biotechnology is focused on the development and commercialization of products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 -- neratinib, oral; PB272 -- neratinib, intravenous; and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX, neratinib, tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.
Madrigal Pharmaceuticals is pursuing novel therapeutics for nonalcoholic steatohepatitis, or NASH, a liver disease with high unmet medical need. Madrigal’s lead candidate, resmetirom, is a once daily, oral, thyroid hormone receptor-beta selective agonist designed to target key underlying causes of NASH in the liver.
Biotie Therapies, a Finnish biotechnology and pharmaceutics company, was acquired by Acorda Therapeutics (ACOR) in January 2016. Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders.
Autolus is developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. Those include, Obe-cel, a CD19 CAR T cell investigational therapy designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR T cell therapies; AUTO1/22, a novel dual targeting CAR T cell-based therapy candidate based on obe-cel; and AUTO4, a programmed T cell product candidate in clinical development for T cell lymphoma.
Recent news on these stocks:
OncoSec announced early clinical data from an investigator-sponsored trial, or IST, conducted by Ahmad Tarhini at the H. Lee Moffit Cancer Center & Research Institute. This IST is evaluating Tavo, OncoSec's proprietary interleukin 12 encoding plasmid delivered by intratumoral electroporation, in combination with intravenous nivolumab. Interim data were presented as a poster at the 37th Annual Meeting of the Society of Immunotherapy of Cancer, or SITC, in Boston, Massachusetts on November 10. The trial enrolled patients with high-risk operable locoregional advanced stage IIIB-D or stage IVA melanoma. By the time of data cutoff, 10 of 12 patients had completed the neoadjuvant phase of up to three 4-week cycles of TAVO-EP on days 1 and 8 concurrently with 480 mg nivolumab administered every 4 weeks. Following the neoadjuvant treatment period, surgery was performed and adjuvant nivolumab was continued for up to 1 year.
A preoperative overall response rate by RECIST v1.1 was observed in 7 of 10 patients consisting of four patients with complete response and three patients with partial response. Two patients had stable disease and one patient showed progressive disease, or PD. One patient with a RECIST v1.1 PR declined surgery due to significant response after neoadjuvant treatment. At time of surgery, 8 of 9 evaluated patients had a major pathologic response, 6 of 9 patients had a pathological CR. No disease recurrence has been observed at a median follow up of seven months from the date of surgery. Tumor-relevant immune biomarkers, analyzed pre-treatment for six patients, included CD8+ tumor infiltrating lymphocytes, or TILs, PD-L1 expression levels and tumor inflammation signature, or TIS, in the tumor lesions. This analysis identified four patients with low CD8+ TIL, low PD-L1 and low TIS; a biomarker signature that is negative predictive for response to immunotherapy. Of note, all four of these patients achieved pCR. Among the 12 patients with safety data, there were no grade 4/5 treatment-related adverse events; 1 patient experienced a grade three event of hyponatremia. Overall, the combination treatment was well tolerated, and no patient discontinued neoadjuvant treatment due to toxicity. Patients continue to enroll.
BTIG analyst Kaveri Pohlman downgraded OncoSec to Neutral from Buy without a price target. The updated Phase 2 Keynote-695 study results may put the entire platform at risk as melanoma, even PD1-failed melanoma, seems the best case for an improved immunotherapy, Pohlman tells investors in a research note. The updated results of an overall response rate of 18.8% suggest four of 47 patients in the second half of the trial responded, which is "very different from the interim data," the analyst said. Pohlman believes FDA approval "seems a stretch" and uptake is "hard to imagine" following the results.
The company had previously announced data from the Phase 2 KEYNOTE-695 clinical trial evaluating TAVO, OncoSec's proprietary IL-12 encoding plasmid delivered by intratumoral electroporation - TAVO -EP -, in combination with pembrolizumab in patients with unresectable or metastatic melanoma who had progressed on immediate prior anti-PD-1 antibody therapy. The key secondary endpoint of KEYNOTE-695 was met. Investigator assessment showed a confirmed overall response rate - ORR - of 18.8%, which exceeds the pre-specified clinically meaningful ORR of greater than or equal to17%. Three patients achieved a complete response and 16 patients had a partial response. The disease control rate was 40.6%. Median overall survival was 22.7 months after a median follow-up period of 33.4 months. The combination therapy was generally well tolerated with no Grade 4/5 treatment-related adverse events. Grade 3 TRAEs were observed in 4.8% of patients. Top-line results of the primary endpoint of the KEYNOTE-695 trial, ORR are expected to be announced in Q1 2023.
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 15-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.