Oncology

GlaxoSmithKline plc (LSE/NYSE:GSK) has reached a deal to acquire Sierra Oncology (Nasdaq:SRRA) to bolster its oncology pipeline. Under the terms of the proposed deal, GSK would pay $44 per share for a total value of approximately $1.9 billion. GSK shares were mostly flat in mid-day trading, dipping 0.032% to $46.52. SRRA shares surged 38.31% to…

AbbVie (NYSE:ABBV) has announced new data from a Phase 2 study of navitoclax with ruxolitinib in patients with myelofibrosis, a rare bone marrow cancer. The data indicate that the combination therapy induces cell death, potentially leading to the reversal of bone marrow fibrosis and improving survival for patients who respond to the therapy. The study…

Spatial biology specialist Lunaphore (Tolochenaz, Switzerland) recently announced a collaboration with the pathology department at Massachusetts General Hospital to develop an in vitro diagnostic (IVD) that assesses the sensitivity of solid tumors to poly-ADP ribose polymerase (PARP) inhibitors. “Lunaphore is based on a technology that I developed for my Ph.D. at the Swiss Federal Institute…

Lynparza (olaparib) significantly reduced death risk when treating germline BRCA-mutated high-risk early breast cancer in the Phase 3 OlympiA study, according to AstraZeneca (LON: AZN). Lynparza recently became the first FDA-approved medicine targeting BRCA mutations in the same type of cancer. The drug is the first poly(ADP-ribose) polymerase (PARP) inhibitor to show an overall survival…

Amcenestrant, a once-promising investigational optimized oral selective estrogen receptor degrader (SERD) from Sanofi (Nasdaq: SNY), did not meet the primary endpoint in a recent Phase 2 trial focused on advanced or metastatic breast cancer. Sanofi had previously referred to amcenestrant as a “potentially transformative” product. Investigators did not identify any new safety signals for the…

The poly(ADP-ribose) polymerase inhibitor Lynparza (olaparib) has become the first FDA-approved medicine targeting BRCA mutations in early breast cancer. The drug was developed by AstraZeneca (NSDQ:AZN) and Merck & Co. (NYSE:MRK), which is known as MSD outside of the U.S. Lynparza is already approved for a number of other indications. FDA approved the drug to…

Novartis (NYSE:NVS) has inked a deal with the biopharma Carisma Therapeutics focused on the production of human epidermal growth factor receptor 2 (HER2)-targeted chimeric antigen receptor macrophages (CAR-M) to potentially treat solid tumors. Carisma is headquartered in Philadelphia. As part of the deal, Carisma will shift manufacturing to a Novartis cell therapy site in Morris…

Johnson & Johnson‘s Janssen unit (NYSE:JNJ) has filed a submission of a Type II variation application to the European Medicines Agency (EMA) for the potential approval of Imbruvica (ibrutinib) with bendamustine and rituximab (BR) to treat adults with previously untreated mantle cell lymphoma (MCL). The indication would cover patients who are not suitable for autologous…

Life sciences company Lunaphore (Lausanne, Switzerland) will collaborate with the Pathology Department at Massachusetts General Hospital to create an in vitro diagnostic (IVD) to evaluate the sensitivity of solid tumors to poly-ADP ribose polymerase (PARP) inhibitors. Lunaphore’s chip technology can extract spatial proteomic and genomic data from tumors. The project will first focus on ovarian,…

In 2016, then-Vice President Joe Biden announced a Cancer Moonshot initiative to speed the development of new therapies to treat cancer. Biden is now launching a new initiative committed to improving the cancer survival rate by at least 50% by 2047. The plan also aims to improve the quality of life for patients with cancer.…

Janssen (NYSE:JNJ) has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for approval of a T-cell redirecting, bispecific antibody to treat relapsed or refractory multiple myeloma (RRMM). Known as teclistamab (JNJ-64007957), the bispecific antibody targets the B-cell maturation antigen (BCMA) and CD3.1. In December 2021, Janssen submitted a Biologics License Application…

Regeneron Pharmaceuticals (NSDQ:REGN) and Sanofi (NSDQ:SNY) have voluntarily withdrawn the supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for advanced cervical cancer. A press release noted that the agency and the sponsors were unable to “align on certain post-marketing studies” that would have been required to greelight the sBLA. FDA first…

Soon after taking the reins of Zymeworks (NYSE:ZYME), new Chair and CEO Kenneth Galbraith has decided to sharpen the company’s focus and reduce the firm’s headcount. To free up cash, the company plans to lay off at least one-quarter of its staff, including 10 members (50%) of its senior management team. The Vancouver–headquartered company also intends to…

Sorrento Therapeutics (NSDQ:SRNE) has received the go-ahead from the Brazilian Health Regulatory Agency (ANVISA) for a Phase 2a study involving its COVI-MSC allogeneic adipose-derived mesenchymal stromal cells. The company hopes the experimental treatment will benefit patients with so-called “long COVID,” a syndrome linked with a variety of symptoms ranging from fatigue to pulmonary compromise. The…

FDA has accepted the supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan), a HER2-directed antibody and DNA topoisomerase I inhibitor conjugate from AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS:DSNKY). The sBLA pertains to treating adults with unresectable or metastatic HER2-positive breast cancer previously treated with an anti-HER2-based regimen. FDA also granted priority review to the…

NeuroMetrix (NSDQ:NURO) announced today that it received FDA breakthrough device designation for its Quell technology. Woburn, Massachusetts-based NeuroMetrix’s Quell garnered the breakthrough nod for reducing moderate-to-severe symptoms of chemotherapy-induced peripheral neuropathy (CIPN) that have persisted for at least six months following the end of chemotherapy. Get the full story at our sister site, MassDevice.

Freenome said today that it has raised $290 million from Roche to advance its cancer early detection platform, which uses a routine blood draw. The South San Francisco, California–based company has raised more than $1.1 billion since its founding in 2014. Get the full story on our sister site MassDevice. 

Scientists have experimented with mRNA for decades, but the pandemic foisted the platform into the limelight. The Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) COVID-19 vaccines have since emerged as two of the best-selling pharmaceutical products in recent memory. Researchers are now exploring dozens of new possibilities for the mRNA platform. Here, we summarize several areas where…

Zymeworks (NYSE:ZYME) will install Ken Galbraith as chairman and CEO, replacing the company’s outgoing leader Ali Tehrani on or before February 1.  Galbraith has more than 30 years of experience working in life sciences, venture capital and global commercialization.  “Ken Galbraith is an outstanding global leader who brings more than 30 years of life science…

Genome editing company Intellia Therapeutics (NSDQ:NTLA) and cell therapy firm Kyverna Therapeutics have entered into a licensing and collaboration agreement to develop an allogeneic CD19 chimeric antigen receptor (CAR) T-cell therapy for various B cell-mediated autoimmune diseases. Under the terms of the agreement, Intellia (Cambridge, Massachusetts) will get an equity stake in Kyverna (Emeryville, California)…

NaNotics LLC (Mill Valley, California) has announced that it will work with the Mayo Clinic to develop a cancer treatment known as NaNots that works by depleting targeted pathogenic molecules from the blood. The NaNot would target a soluble form of programmed death-ligand 1 (PD-L1), a tumor-generated immune inhibitor, while ignoring membrane forms of PD-L1.…

Immix Biopharma (NSDQ:IMMX) has announced that the FDA has granted a rare pediatric disease designation related to the potential use of IMX-110 for rhabdomyosarcoma, a rare cancer affecting skeletal muscle. Roughly 400 to 500 cases of rhabdomyosarcoma occur each year in the U.S., according to cancer.org.  IMMX shares jumped 62.36% to $5.78 after the announcement. Immix…

Candel Therapeutics (NSDQ:CADL) recently announced that it had entered a strategic collaboration with microrobotics startup Bionaut Labs (Los Angeles) to explore precision-targeted delivery of oncolytic viral immunotherapies. To learn more about the company, we reached out to Candel’s  Dr. Paul Peter Tak, president and CEO of the company. Candel Therapeutics has two viral immunotherapy platforms,…

Singapore-based Tessa Therapeutics has shared clinical data from the pilot stage of an ongoing Phase 2 study of TT11, an autologous CD30 chimeric antigen receptor T-cell (CAR-T) therapy. The data found that the CAR-T therapy had a favorable safety profile and promising efficacy in relapsed or refractory CD30-positive classical Hodgkin lymphoma (cHL) patients. Recipients of…

Janssen (NYSE:JNJ) has received European authorisation for Rybrevant (amivantamab-vmjw) to treat adults with non-small cell lung cancer (NSCL) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Rybrevant is a fully-human EGFR-MET bispecific antibody. NSCL is responsible for the majority of lung cancers. The Conditional Marketing Authorisation (CMA) covers patients who have failed…