Oncology

While the COVID-19 pandemic has highlighted the prowess of the pharmaceutical industry, it should also “serve as a major wake-up call,” said Dr. George Yancopoulos, co-founder, president and CSO of Regeneron (NSDQ:REGN), at a panel at the virtual USA India Chamber of Commerce meeting. COVID-19 has underscored the importance of preparing for infectious pandemics and…

RedHill Biopharma Ltd. (Nasdaq: RDHL) announced positive results from a Phase 2 U.S. study involving its opaganib in hospitalized COVID-19 patients with pneumonia.  The study indicated that opaganib reduced the need for supplemental oxygen therapy and an earlier hospital discharge. RedHill also concluded that the drug was well-tolerated based on the placebo-controlled Phase 2 study,…

Community-based clinical trials are growing more common in oncology for several reasons. First, drug developers are looking to boost recruitment efforts and address traditional ethnic and economic health disparities in such studies. Second, community hospitals are growing better equipped to participate in such trials. And finally, drug developers are working on expanding the pool of…

Valemetostat, a potential first-in-class drug from Daiichi Sankyo, led to durable tumor response in patients with peripheral T-cell lymphoma (PTCL) and adult T-cell leukemia/lymphoma (ATL) in a Phase 1 study.  The company presented highlights from the trial at the European Hematology Association (EHA) 2021 Virtual Congress today.   In the study, the objective response rate was…

Dr. Michael Gross, an activist shareholder of immunotherapy specialist IMV (NSDQ:IMV), has launched an offensive intended to cause a leadership shakeup at the company. Gross released a press release on June 1 announcing his plans to oust the company’s board chair Andy Sheldon and the chair of the board’s compensation committee, Julia Gregory. The director…

AstraZeneca (LON: AZN) announced that its oncology drug olaparib (Lynparza) led to clinically meaningful improvements in a Phase 3 study. The study focused on patients with germline BRCA-mutated high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. Some 5% of breast cancer patients have BRCA1 and BRCA2 mutations. Clinical trial investigators have repeatedly…

Corbus Pharmaceuticals (NSDQ:CRBP) is expanding its pipeline in immuno-oncology and fibrotic disease with licensing deals for two monoclonal antibodies (mAbs), which it has named CRB-601 and CRB-602. Both mAbs target integrins that inhibit activation of transforming growth factor-beta (TGF-β), a cytokine linked to inflammation, fibrosis and cancer. “TGF beta needs to be activated from its…

Rybrevant, a novel fully-human bispecific antibody from the Janssen division of Johnson & Johnson, became the first treatment for people with non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. In particular, the indication covers such cancer that has progressed on or after platinum-based chemotherapy. The agency also approved the…

Bristol Myers Squibb (NYSE:BMY) has announced results from a Phase 2/3 study that found a fixed dose of relatlimab and Opdivo (nivolumab) led to significant progression-free survival (PFS) rates when used as first-line therapy for metastatic or unresectable melanoma. The RELATIVITY-047 trial found that the median progression-free survival rates were 10.12 months for those receiving…

The pandemic has heightened interest in COVID-19 therapies, sometimes stealing attention from other pharmaceutical breakthroughs. But the pandemic has also served as a reminder that investment in new drugs can pay dividends while leading to a greater societal appreciation for the industry. A 2019 study published in International Health concluded that pharmaceuticals that have launched…

Endevica Bio (formerly TCI Peptide Therapeutics) started in 2009, focusing on peptides that affect the melanocortin system, which mammals use to regulate food intake and energy homeostasis. The company’s core focus is on a drug candidate known as TCMCB07, a potential treatment for cachexia in cancer patients. Cachexia, a wasting disorder that can result in…

COVID-19 vaccines launched BioNTech and Moderna into the limelight, making these once little-known companies prominent companies. But neither wants to be pigeonholed as a COVID-19 vaccine company. BioNTech cofounder Özlem Türeci stressed in a recent interview with AP that the mRNA vaccine technology that is its focus could be a powerful weapon against cancer. “We have several different…

The precision oncology company 4D Path has committed to partnering with the U.K.-based University of Leeds at least until 2027. The two entities are already collaborators, having worked together on three completed breast cancer clinical trials. In particular, researchers at the University of Leeds have used 4D Path’s Q-plasia OncoReader Breast software to analyze data from more…

The biopharmaceutical company IMV (NSDQ:IMV) has recently revealed promising data related to its lead immunotherapy as a potential ovarian cancer treatment. In the Phase 2 DeCidE1 trial, the immunotherapy DPX-Survivac with intermittent low-dose cyclophosphamide showed durable anti-tumor activity in patients with recurrent, advanced ovarian cancer. A recent analysis from three different clinical trials published in published…

Dialectic Therapeutics issued an SEC Form D to confirm the sale of nearly $6.4 million in debt, options, warrants and/or other rights to purchase securities. According to the filing, the Dallas-based cancer treatment technology developer made the first sale in its offering of $6.35 million on Dec. 15, 2020. The $6.35 million already sold is…

What do cupcakes have to do with oncology, and more specifically, predictive diagnostics? Before I explain, I’ll provide some context. I recently came across an image that illustrated the difference between how Doppler radar detects conditions for a Tornado Watch versus a Tornado Warning using cupcakes.1 One side of the graphic shows each of the…

In July 2020, the clinical-stage biotech Tevogen Bio (Metuchen, N.J.) announced its plans to use its proprietary T-cell therapy to treat COVID-19. Now, the company has announced that it has received funding from HMP Partners, a team of physician-investors, to advance what it terms an “investigational curative” therapy. Tevogen will use the funding to support…

OncoSec (NASDAQ: ONCS), a cancer immunotherapy company currently focused on R&D, is planning U.S. promotion of its tavokinogene telseplasmid (TAVO) drug for a type of metastatic melanoma — and eventually other cancers. “We don’t currently have a sales force. If successful, we’re going to need to have a sales and marketing team embedded in the…

The FDA has OK’d human clinical trials for Anixa Biosciences (NASDAQ: ANIX) and Cleveland Clinic’s novel breast cancer vaccine that immunizes against the alpha-lactalbumin protein.  Within the mammary gland, the alpha-lactalbumin protein is involved in lactose synthase production, which, in turn, is required to make lactose and milk. Typically expressed later in pregnancy and during lactation,…

The FDA has approved Gallium 68 PSMA-11 for patients suspected of having prostate cancer metastasis who are potentially treatable with surgery or radiation therapy. The approval also covers patients with suspected prostate cancer recurrence, given their abnormal prostate-specific antigen (PSA) levels. An intravenous radioactive diagnostic agent, the drug is the first compound supporting positron emission…

Biotechnology traces its roots to the Neolithic era when early civilizations discovered how to ferment grains to prepare alcoholic brews and bread. It wasn’t until genetic engineering became mainstream in the mid-1970s, however, that biotechnology, as we know it today, was launched. The field continues to evolve today. The advent of new technology has revolutionized the market…

Oxford Gene Technology (OGT) has expanded its SureSeq line of next-generation sequencing (NGS) panels to detect genetic variants associated with breast and ovarian cancer and myeloid disorders. One of the offerings is a myeloid panel that can detect abnormalities in 70 genes associated with a range of diseases, including acute myeloid leukemia, myelodysplastic syndrome and…

For the past 18 years, the Cleveland Clinic has predicted what the top 10 medical disruptors will be for the following year. The list of technologies, cultivated by a panel of physicians and scientists at the clinic, was led by Dr. Will Morris, executive medical director of Cleveland Clinic Innovations, and Dr. Akhil Saklecha, managing…

Mission Bio has secured $70 million in Series C financing to scale its single-cell multi-omics technology, according to the company. Novo Growth, the growth equity of Novo Holdings, led the round that included new investor Soleus Capital. Previous investors Mayfield, Cota, and Agilent also participated in the financing, which brings the company’s total funding to…

The Galien Foundation recently announced nominees for most innovative pharmaceutical agents for its 14th Annual Prix Galien USA Awards. The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical, pharmaceutical drugs and medical technology products that are designed to improve the human condition. “As we celebrate 50 years of the Prix Galien…