Oncology

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…

Zymeworks (NYSE:ZYME) and its collaborator BeiGene have announced the dosing of the first patient with zanidatamab (ZW25) in South Korea–based HERIZON-GEA-01 study. The study will focus on patients with advanced or metastatic HER2-positive gastroesophageal adenocarcinomas. As a result of the development, Zymeworks will receive an $8 million development milestone payment from BeiGene. Zymeworks and BeiGene plan to…

Hutchmed (HKG:0013) and AstraZeneca (LON:AZN) have announced the launch of the SACHI Phase 3 study to test the combination of Orpathys (savolitinib) and Tagrissso (osimertinib) as a treatment for locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). Specifically, the study will focus on patients with amplification of the MET…

The life sciences industry has just scratched the surface in terms of chimeric antigen receptor (CAR) T-cell therapy’s potential, according to a session at the Novartis Breakthrough Science media event held on November 10. CAR-T therapy, which has emerged as one of the most promising new treatments for multiple myeloma, certain lymphomas and B-cell acute lymphoblastic leukemia,…

GlaxoSmithKline (NYSE:GSK) will present 11 abstracts on Blenrep (belantamab mafodotin blmf) at the American Society of Hematology (ASH) Annual Meeting and Exposition on December 11–14. Presentations will include new data from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial program and two collaborative studies focused on Blenrep. The drug won FDA approval…

Privately-held ConcertAI has formally integrated with TeraRecon, a provider of advanced visualization services, including 3D and 4D medical imaging post-processing.  Cambridge, Massachusetts–based ConcertAI says the integration will expand its offerings for life science companies, which now can integrate data from electronic medical records, genomic data and medical imaging. As a result, the company can offer…

Johnson & Johnson’s Janssen division (NYSE:JNJ) was among the first drug companies to prioritize oncology research. The company has more than three decades of experience in the domain. Recently, Chimeric antigen receptor (CAR) T therapy has become one of the most exciting areas of research for cancer and other diseases for the company, said Mathai Mammen, global…

AbbVie (NYSE: ABBV) has extended an agreement with the University of Chicago related to collaborative preclinical oncology research. The North Chicago, Illinois–based company and the university are working together on research involving biomarkers and therapeutic applications related to existing AbbVie programs. In the past, the organizations have also explored new drug delivery methods to improve…

The Ivy Brain Tumor Center (Phoenix) and University of California, San Francisco will partner on a Phase 0 clinical trial to test GSK’s (NYSE:GSK) Zejula in patients with newly diagnosed glioblastoma and recurrent glioma (grades II–IV). Zejula (niraparib) is a daily oral poly (ADP-ribose) polymerase (PARP) inhibitor. FDA introduced Phase 0 clinical trials in 2004…

Takeda Pharmaceutical Company Ltd. (TSE:4502/NYSE:TAK) is moving forward with its plan to acquire its collaborator GammaDelta Therapeutics Ltd. (London). The acquisition is subject to customary closing conditions. Takeda projects that the deal will close in the first quarter of its fiscal year, which will end on June 30, 2022. The acquisition would bolster Takeda’s immuno-oncology…

The developer of a cloud-based application for oncology care and research, SimBioSys, has raised $15 million in Series A funding. Genoa Ventures and Northpond Ventures led the funding round, which also involved AV8 Ventures, Heritage Medical Group, and Mayo Clinic. SimBioSys also announced that existing investors and its founders participated in the financing, raising a total of $21 million. The company…

Amgen (NSDQ:AMGN) has acquired privately-held immunotherapy specialist Teneobio (Newark, California). The transaction includes an upfront $900 million upfront payment and future contingent milestone payments worth up to an additional $1.6 billion. Tenebio’s stated mission was to tap human heavy-chain antibodies to “redirect the immune system to safely fight disease.” Earlier this year, it had three drug…

Animal models, long the basis of academic research and preclinical drug discovery, continue to play an important role in advancing our understanding of basic pharmacology and bringing critical therapies to those in need. However, animal models have some natural drawbacks (e.g., not being humans) that hamper their ability to fully predict the interaction of new…