Biotech Alert: Searches spiking for these stocks today

These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include: 

• Oncolytics Biotech (ONCY), 89% surge in interest
• Oncosec Medical (ONCS), 59% surge in interest
• Sarepta Therapeutics (SRPT), 42% surge in interest

Pipeline and key clinical candidates for these companies:

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer.

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.

Sarepta Therapeutics engineers precision genetic medicine for rare diseases. The company holds leadership positions in Duchenne muscular dystrophy, or DMD, and limb-girdle muscular dystrophies, or LGMDs, and currently has more than 40 programs in various stages of development. Sarepta’s pipeline is driven by its multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing.

Recent news on these stocks:

June 22

Oncolytics announced pelareorep has been selected for inclusion as a new investigational treatment in Precision Promise, an adaptive Phase 3 clinical trial. The Precision Promise study is designed to evaluate pelareorep in combination with a checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nab-paclitaxel. If successful, the clinical study is expected to support approval of the studied combination as a treatment for first-line metastatic pancreatic ductal adenocarcinoma. Precision Promise has a primary endpoint of overall survival and can include multiple investigational treatments. This design, which was developed with guidance from the FDA, minimizes the number of participants needed to generate licensure-enabling data, thereby accelerating late-stage development by up to two years and reducing costs compared to non-platform trials. Oncolytics expects to open the Precision Promise investigational treatment of pelareorep, checkpoint inhibitor, gemcitabine, and nab-paclitaxel in early 2024.

Sarepta Therapeutics announced FDA accelerated approval of Elevidys, an adeno-associated virus based gene therapy for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy, or DMD, with a confirmed mutation in the DMD gene. This indication is approved under accelerated approval based on expression of Elevidys micro-dystrophin observed in patients treated with Elevidys. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Elevidys is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene. “Consistent with the accelerated approval pathway, the company has committed to the completion of a confirmatory trial. EMBARK, the global, randomized, double-blind, placebo-controlled Phase 3 trial for Elevidys, will serve as the post-marketing confirmatory trial and is fully enrolled with top-line results expected in late 2023,” the company stated. “The approval of Elevidys is a watershed moment for the treatment of Duchenne. Elevidys is the first and only gene therapy approved for Duchenne, and this approval brings us closer to our goal of bringing forward a treatment that provides the potential to alter the trajectory of this degenerative disease. As we prepare to launch Elevidys, we should acknowledge and celebrate the decades of dedication and work from the patient community, families, clinicians, and our Sarepta colleagues that resulted in today’s approval. Our confirmatory trial, EMBARK, should read out in the fourth quarter of this year. If EMBARK confirms the benefits seen in our prior trials, Sarepta will move rapidly to submit a BLA supplement to expand the approved label as broadly as good science permits,” said Doug Ingram, president and CEO of Sarepta. Sarepta is responsible for global development and manufacturing for Elevidys, and distribution within the U.S. will commence immediately. In December 2019, Sarepta partnered with Roche (RHHBY) to accelerate access to Elevidys for patients outside the United States.

June 14

In a regulatory filing, OncoSec disclosed that, after considering strategic alternatives, it filed a voluntary petition for relief under the provisions of Chapter 7 of Title 11 of the United States Code in the United States Bankruptcy Court for the District of New Jersey on June 14. The company’s sole subsidiary, OncoSec Medical Australia Pty, expects to liquidate and wind down operations under Australian law pursuant to a Creditors’ Voluntary Liquidation.

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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.