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:
Prothena’s wholly owned programs include birtamimab for the potential treatment of AL amyloidosis and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ, or amyloid beta, and the company’s dual Aβ-tau vaccine. Prothena’s collaborations include prasinezumab, which targets alpha-synuclein, with Roche for the potential treatment of Parkinson’s disease, PRX004 for the potential treatment of ATTR amyloidosis with Novo Nordisk (NVO), and programs that target tau such as PRX005, TDP-43 and an undisclosed target with Bristol-Myers Squibb (BMY) for the potential treatment of neurodegenerative diseases.
MorphoSys uses groundbreaking science and technologies to discover, develop, and deliver innovative cancer medicines to patients. Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity and Antibody-Dependent Cellular Phagocytosis.
Quanterix is a company that’s digitizing biomarker analysis with the goal of advancing the science of precision health. The company’s digital health solution, Simoa, "has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the continuum from health to disease," the company says. Quanterix’ technology is currently being used for research applications in several therapeutic areas, including oncology, neurology, cardiology, inflammation and infectious disease.
Denali Therapeutics is developing a portfolio of product candidates engineered to cross the blood-brain barrier for neurodegenerative diseases. DNL151 is a selective, central nervous system-penetrant small molecule inhibitor of LRRK2 that is hypothesized to improve lysosomal dysfunction. DNL151 is an investigational drug that is not approved by any regulatory authority, and its safety and efficacy have not been established.
Tcr2 Therapeutics is developing a range of cell therapies for solid tumors as well as blood cancers by targeting a number of different surface antigens on cancer cells that have beneficial expression characteristics. The company is also supplementing its basic TRuC-T cell format with enhancements to combat the hostile tumor microenvironment in case certain cancer indications prove more resistant. Its most advanced program, gavo-cel, targets tumors that express the protein mesothelin, including ovarian cancer, non-small cell lung cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. Tcr2 has also developed an allogeneic, or off-the-shelf, TRuC-T cell.
Recent news on these stocks:
Biogen (BIIB) and Denali Therapeutics announced that dosing has commenced in the global Phase 3 LIGHTHOUSE study to evaluate the efficacy and safety profile of BIIB122, DNL151, as compared to placebo in approximately 400 participants with Parkinson's disease and a confirmed pathogenic mutation in the leucine-rich repeat kinase 2 gene. The primary endpoint of the LIGHTHOUSE study is time to confirmed worsening, as assessed using the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) over the treatment period, up to 180 weeks. Participants will be randomized to receive oral BIIB122 or placebo once daily. "In collaboration with Biogen, we are excited to be pursuing the potential of LRRK2 inhibition as an effective treatment for Parkinson's disease," said Carole Ho, M.D., Chief Medical Officer of Denali. "The initiation of the Phase 3 LIGHTHOUSE study marks an important milestone in the BIIB122 development program. Together with the recent initiation of the Phase 2b LUMA study in early-stage Parkinson's disease, we hope to have the opportunity to bring a novel therapeutic option to people living with Parkinson's disease."
BofA analyst Tazeen Ahmad upgraded Prothena to Buy from Neutral with a price target of $65, up from $45, following the positive data reported from Biogen and Eisai's (ESALY) Phase 3 Alzheimer's trial for lecanemab. While admitting "there is still debate about the meaningfulness of the data and addressable market," the trial result is "a big milestone in the treatment of AD" and reads through positive to Prothena given how it strengthens the amyloid thesis, Ahmad tells investors. Given the positive lecanemab data, Ahmad adjusted assumptions for PRX012 and increased the view on the odds of success for PRX012 to 35% from 25% while also seeing a higher likelihood of success for PRX123.
MorphoSys U.S. announced data from the ongoing L-MIND study showing that Monjuvi, tafasitamab-cxix plus lenalidomide, followed by Monjuvi monotherapy provided long-term efficacy in patients with relapsed or refractory diffuse large B-cell lymphoma treated for at least 2 years, including six patients on treatment for 5 years or more. Additionally, the frequency of adverse events declined after patients transitioned from combination therapy to monotherapy. The data will be presented during a poster session at the Tenth Annual Meeting of the Society of Hematologic Oncology in Houston, Texas. A complete response was observed in 23 of the 27 patients, including four who were refractory to their primary therapy. A partial response was seen in four patients, two of whom were still on treatment at data cutoff. The majority of adverse events were grade 1 or 2 during both combination and monotherapy treatment. Patients experienced a lower frequency of all-grade and grade 3 or higher adverse events during monotherapy. The most common adverse events with combination therapy were neutropenia and diarrhea, which declined after patients switched to monotherapy. Neutropenia and diarrhea remained the most common adverse events in the first two years of monotherapy.
TCR2 Therapeutics announced positive topline results from the Phase 1 portion of the gavo-cel Phase 1/2 clinical trial for mesothelin-expressing solid tumors, with some patients still being monitored for clinical response or stable disease. As of the September 9 data cutoff, 32 patients had received a single gavo-cel infusion in the Phase 1 portion. gavo-cel demonstrated a disease control rate of 77%. 28 of the 30 - 93% - patients evaluable for efficacy experienced tumor regression of their target lesions. Eight patients experienced target lesion regression greater than 30%. gavo-cel has induced responses in every tumor type tested to date. The overall response rate among patients who received gavo-cel following lymphodepletion chemotherapy was 22% by BICR and 26% by investigator assessment. By BICR, the ORR was 21% among patients with malignant pleural/peritoneal mesothelioma and 29% among those with ovarian cancer. The median overall survival for patients with MPM was 11.2 months, whereas the median progression-free survival for patients with MPM was 5.6 months. gavo-cel was generally well tolerated with a manageable adverse event profile up to DL5. The Phase 2 portion of the trial underway implementing multiple approaches to further improve clinical outcomes.
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.