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: 

• Elevai Labs (ELAB), 24,033% surge in interest
• MorphoSys (MOR), 1,541% surge in interest
• Allakos (ALLK), 1,331% surge in interest
• ProQR Therapeutics (PRQR), 1,177% surge in interest
• Vaxart (VXRT), 231% surge in interest
• Puma Biotechnology (PBYI), 171% surge in interest
• Summit Therapeutics (SMMT), 155% surge in interest
• Genmab (GMAB), 141% surge in interest
• Entera Bio (ENTX), 113% surge in interest

Pipeline and key clinical candidates for these companies:

Elevai Labs is a medical aesthetics company developing cutting-edge physician-dispensed skin care applications. The company solves unmet needs in the medical aesthetics space through a combination of cutting-edge science-driven and next-generation consumer applications. Elevai Labs develops topical aesthetic skin care cosmetic products for the physician-dispensed market, with a focus on leveraging a proprietary stem cell exosome technology.

MorphoSys is a global commercial-stage biopharmaceutical company, focused on developing and delivering innovative medicines, and aspiring to redefine how cancer is treated.

Allakos is a clinical stage biotechnology company developing therapeutics which target immunomodulatory receptors present on immune effector cells involved in allergy, inflammatory and proliferative diseases. Activating these immunomodulatory receptors allows for the direct targeting of cells involved in disease pathogenesis and, in the setting of allergy and inflammation, has the potential to result in broad inhibition of inflammatory cells. The company’s most advanced antibody in ongoing clinical development is AK006. AK006 targets Siglec-6, an inhibitory receptor expressed selectively on mast cells. 

ProQR Therapeutics is dedicated to changing lives through the creation of transformative RNA therapies. ProQR is pioneering a next-generation RNA technology called Axiomer, which uses a cell’s own editing machinery called ADAR to make specific single nucleotide edits in RNA to reverse a mutation or modulate protein expression and could potentially yield a new class of medicines for both rare and prevalent diseases with unmet need.

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart believes that its proprietary pill vaccine delivery platform is “suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications,” the company has stated. Vaxart’s development programs currently include pill vaccines designed to protect against norovirus, coronavirus, seasonal influenza, and respiratory syncytial virus, or RSV, as well as a therapeutic vaccine for human papillomavirus, or HPV, Vaxart’s first immune-oncology indication.

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.

Summit Therapeutics is initiating development activities for SMT112 and will do so first in NSCLC indications. Summit plans to start treating patients in clinical studies by the second quarter of 2023.

Genmab has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies.

Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The company leverages on a disruptive and proprietary technology platform and its pipeline includes five differentiated, first-in-class oral peptide programs, expected to enter into the clinic by 2025. The company’s most advanced product candidate, EB613, is being developed as the first oral, osteoanabolic once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis, with no prior fracture.

Recent news on these stocks:

January 19

ProQR Therapeutics highlighted key updates from its oral presentation at the 5th International Conference on Base Editing, Prime Editing & Related Enzymes in San Diego, California. “We were pleased to present new in vivo data for our proprietary Axiomer RNA editing technology platform at the Deaminet 2024 meeting, demonstrating robust editing of ACTB in the liver of NHP, as well as functional protein data with the liver target ANGPTL3 in mice,” said Gerard Platenburg, Chief Scientific Officer of ProQR. “To date, we have generated robust in vitro and in vivo preclinical platform data across a range of liver and CNS targets. These encouraging data and the progress of our science reinforce the potential of our Axiomer RNA editing oligonucleotides, and we look forward to presenting additional platform data, as well as the first preclinical data for our pipeline programs at upcoming scientific meetings, as we move our technology forward towards trials in humans.” Key updates from the presentation included: Axiomer Editing Oligonucleotides demonstrated high intrinsic editing capability in the liver across models. Presentation of new data highlighting up to 70% editing efficiency of ACTB in liver of mice and NHPs at multiple timepoints. Editing levels confirmed through several reliable RNA analysis methods, including dPCR and RNAseq, showing consistent results. An EON editing ANGPTL3 in mice resulted in a 2-fold increase in lipoprotein lipase activity and a related decrease of LDL cholesterol in plasma of 40% in vivo. Preliminary nonclinical safety assessment showed a similar safety profile compared to other single-stranded RNA oligonucleotides. Ongoing platform advancements anticipated through increased knowledge of ADAR biology, selection of models for prediction of Axiomer potential in human tissue, EON sequence optimization, and investigation of delivery options.

January 16

Elevai Labs announced it has signed an exclusive, worldwide manufacturing and processing technology licensing agreement with INmune Bio (INMB). The licensing agreement grants Elevai a license to use INmune Bio’s proprietary “EMx” technology, developed by INmune Bio, Inc., CMO, Mark Lowdell, PhD, that enables Elevai to manufacture current Good Manufacturing Practice grade, human umbilical cord-derived mesenchymal stromal cells (hucMSCs) at a lower cost to Elevai than purchasing hucMSCs outright. Manufactured hucMSCs can be incorporated into certain licensed topical cosmetic products sold in the medical aesthetics skincare market. Elevai believes incorporating the “EMx” technology into its operations is a step towards the company’s goal of achieving vertical manufacturing integration, while also expanding long-term production capabilities and lowering overall costs. In response to the license agreement, Jordan Plews, PhD, CEO of Elevai Labs, Inc. stated: “partnering with INmune Bio, Inc. aligns perfectly with our mission to pioneer innovative stem cell exosome products. Their understanding of efficient human stem cell isolation and large-scale manufacturing provides us with a remarkable opportunity to expand our manufacturing capabilities, expand our product portfolio, and make a significant impact in the market.”

Morgan Stanley downgraded MorphoSys to Equal Weight from Overweight with a price target of $10.40, up from $9.20. The analyst expects European Union biopharma to offer a “safe haven” from macro and earnings growth concerns. While the firm continues to favor growth and innovation narratives in biopharma over the long term, it expects investors to reward earnings upgrade stories near term.

Allakos announced topline data from its phase 2 clinical trial in patients with atopic dermatitis and from its Phase 2b clinical trial in patients with chronic spontaneous urticaria. “We are disappointed that these trials did not meet their primary endpoint, particularly given the need for new treatment options for patients with these severe diseases. Given that neither trial met its primary endpoint, we have decided to not pursue further clinical development of lirentelimab,” said Craig Paterson, M.D., Chief Medical Officer of Allakos. “We express our gratitude to all of the clinical trial investigators, site coordinators and patients in these trials.” Consistent with previously reported antibody-dependent cellular cytotoxicity activity of lirentelimab on eosinophils, patients treated with lirentelimab showed sustained depletion of blood eosinophil counts. In the ATLAS trial, lirentelimab-treated patients’ blood eosinophils decreased by 96% versus placebo-treated patients’ blood eosinophils which decreased by 15%. In the MAVERICK trial, lirentelimab-treated patients’ blood eosinophils decreased by 95% versus placebo-treated patients’ blood eosinophils which increased by 9%. Safety Results Across both trials safety was similar to previous clinical trials of lirentelimab. The most common adverse events were injection-related reactions. In the ATLAS trial, 18.5% of lirentelimab treated patients experienced IRRs versus 6.2% of placebo treated patients. In the MAVERICK trial, 18.2% of lirentelimab treated patients experienced IRRs versus 8.2% of placebo treated patients. Phase 2 ATLAS Trial Design The 14-week, randomized, double-blind, placebo controlled, multicentered trial evaluated the efficacy, safety and tolerability of lirentelimab versus placebo in adult patients with moderate-to-severe atopic dermatitis inadequately controlled by topical medications. 122 patients were randomized 1:1 to receive 300 mg of subcutaneous lirentelimab or placebo once every two weeks.The primary endpoint was the proportion of patients who achieve at least a 75% reduction from baseline in eczema area and severity index at 14 weeks. Phase 2b MAVERICK Trial Design The 12-week, randomized, double-blind, placebo controlled, multicentered trial evaluated the efficacy, safety and tolerability of lirentelimab versus placebo in adult patients with moderate-to-severe chronic spontaneous urticaria refractory to antihistamines. 123 patients were randomized 1:1 to receive 300 mg of subcutaneous lirentelimab or placebo once every two weeks. The primary endpoint was the absolute change from baseline in Urticaria Activity Control-7 at 12 weeks.

Vaxart announced a change in management. Effective immediately Andrei Floroiu, President and CEO of Vaxart, has announced his resignation from his positions with Vaxart as President, CEO, and Director on Vaxart’s board. Michael Finney, Ph.D., the Chair of Vaxart’s board, has assumed the role of interim CEO to lead the management team through this transition. Vaxart is conducting a CEO search for Floroiu’s successor. Dr. Finney has served as a member of the board since February 2018 and chair of the board since March 2023.

Hear more from InvestingChannel by signing up for The Spill.

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.