Compared to the Dow Jones Industrial Average which has gained an impressive 10.6% through Q3 2021, and the S&P 500 and Nasdaq doing even better with 14.7% and 12.1% gains respectively, the biotech sector has been lagging behind . The Nasdaq Healthcare Index has only gained 4.2%, while the XBI biotech index has fallen 10.7%, despite continued strong fundamentals. However, amid the sector’s challenges, several new developments have emerged, giving well needed fuel to several biotech stocks who have been delievering all types of optimistic results, including those from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Sesen Bio Inc. (NASDAQ:SESN), Clarus Therapeutics Holdings, Inc. (NASDAQ:CRXT), OrphazymeA/S (NASDAQ:ORPH), and Johnson & Johnson (NYSE:JNJ).
Most recently, Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), developers of the promising immunotherapeutic agent pelareorep announced that its global clinical-stage biopharmaceutical partners Adlai Nortye had initiated dosing in a bridging clinical trial for patients with advanced or metastatic breast cancer using a therapy of pelareorep combined with paclitaxel—this time for patients in China.
For women in America, breast cancer is known as the second leading cause of death from cancer, with an estimated 42,000 deaths in the US in 2020. However, in China, breast cancer is now estimated to be the largest subtype of cancer among women, with over 416,000 cases and over 117,000 deaths in 2020.
Oncolytics had already conducted randomized phase 2 trials in North America, the first of which, IND-213, showed that treatment with pelareorep and paclitaxel led to a statistically significant increase in overall survival compared to treatment with paclitaxel alone.
Oncolytics' second randomized phase 2 trial, BRACELET-1, is ongoing and evaluates pelareorep-paclitaxel combination therapy both with and without a checkpoint inhibitor.
Results from this newly initiated bridging trial should allow Adlai Nortye to include data from Oncolytics' North American metastatic breast cancer trials in a future submission to Chinese regulators.
"Adlai's bridging trial is an important step forward for pelareorep's clinical development path in China, which has a rapidly growing pharmaceutical market that is currently the second-largest in the world," said Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development. "We are very pleased that dosing in the trial has commenced and congratulate our partner on this notable achievement. Looking ahead, we are eager to continue our partnership with Adlai as we work to advance pelareoreptowards registration in major global markets."
Shareholders of Sesen Bio Inc. (NASDAQ:SESN) aren’t expected to receive the company’s next earnings report until November 7. In the meantime, the late-stage clinical company continues to develop its lead program, Vicineum™, also known as oportuzumab monatox, which is currently in the follow-up stage of a Phase 3 registration trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
Most recently, Sesen Bio expanded its chemistry, manufacturing, and control (CMC) and clinical development teams, hiring two new members. The hirings came as Sesen Bioprepares for CMC and clinical Type A meetings with the US Food and Drug Administration (FDA) for Vicineum™.
The company already submitted a request for the CMC Type A meeting, which is anticipated to occur at the end of October, andexpects the clinical Type A meeting to occur later in the fourth quarter of 2021.
After falling from a price of $4.91 in mid-August down to a low of $0.728 on October 6th, 2021, Sesen appears to have begun a recovery, having gained 44% within a week, hitting $1.05 as of October 13th.
Another biotech player that has seen upward movement in recent days has been Clarus Therapeutics Holdings, Inc. (NASDAQ:CRXT), which since October 7th moved up over 72% from $3.51 to as much as $6.04 on October 13th.
Back in September, Clarus and McGill University announced an exclusive worldwide licensing agreement to develop and commercialize technology to treat rare conditions associated with Coenzyme-Q10 (CoQ10 or Ubiquinone) deficiencies.
The agreement enables Clarus to develop and commercialize McGill’s proprietary technology designed to treat conditions associated with CoQ10 deficiencies in humans.
Though rare, an estimated 1 in 5,000 adults worldwide has what’s known as mitochondrial disease. Together, Clarus and McGill are accelerating development of potential treatments for rare, endocrine, metabolic, and nuerological conditions associated with primary and secondary ubiquinone deficiencies that belong to the wider class of these mitochondrial diseases.
Oral CoQ10 supplements already on the market are largely ineffective because they don’t result in intracellular uptake of CoQ10. McGill has identified a method to substantially increase such uptake, thereby forming the basis for a new, and potentially profound, method of addressing deficiencies of CoQ10.
“This collaboration with world-renowned McGill University expands our focus beyond androgen-based medicines to a metabolic therapy for CoQ10 deficiencies that have very limited treatment options,” said Dr. Robert Dudley, Clarus’s Founder, President and Chief Executive Officer. “Knowing the role McGill’s discovery may have to address this important, unmet medical need is a terrific opportunity, and we are excited to get started.”
Shares in Orphazyme A/S (NASDAQ:ORPH) also took off recently, having risen over 30% from $3.815 on October 6th to as high as $4.98 on October 13th. Orphazyme is a late-stage biopharmaceutical company developing arimoclomol, for which it is seeking marketing authorization in both Europe and the United States for the treatment of Niemann-Pick disease Type C (NPC).
In Europe, the review process under the centralized procedure is already underway . Following dialogue with regulators and the anticipated timeline to respond to the Day 180 List of Outstanding Issues, Orphazyme now anticipates a CHMP opinion in Q1 2022 compared to previous Q4 2021.
In the US, Orphazyme has also requested and was granted a Post-Action Type A meeting with the FDA, which is scheduled for mid-October.
Meanwhile, pharma giant Johnson & Johnson (NYSE:JNJ)continues its pioneering work in the battle against HIV/AIDS. As well, in November, JNJ is set to hold a Business Review for the investment community, where company leaders will share a detailed review of the company’s Pharmaceuticals business, differentiated strategy and robust pipeline, and long-term growth outlook.
However, according to Bloomberg , Johnson & Johnson didn’t receive a recommendation from US regulators for recipients of the company’s Covid-19 vaccine to receive a booster. However, the FDA is set to later convene on JNJ’s request for emergency-use authorization of a second shot.
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