Oncology

On the heels of announcing a restructuring plan that reduces its workforce by 30%, Black Diamond Therapeutics (Nasdaq:BDTX) has announced that its discovery engine was featured in the peer-reviewed Cancer Research journal. The journal is published by American Association for Cancer Research (AACR). A paper highlighted in the journal explained how the company’s Mutation-Allostery-Pharmacology (MAP) discovery…

AstraZeneca (LON:AZN) has announced that its supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has received Priority Review from FDA when used with chemotherapy in patients with locally advanced or metastatic biliary tract cancer (BTC). The company had submitted data from the TOPAZ-1 Phase 3 study indicating an improvement in overall survival compared to standard-of-care chemotherapy.…

The Swiss Big Pharma Novartis (NYSE:NVS) announced that the anti-PD-1 immune checkpoint inhibitor tislelizumab with chemotherapy improved overall survival in patients with advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in a Phase 3 study. The RATIONALE 306 trial of tislelizumab and chemotherapy met its primary endpoint at interim analysis. The study pitted the…

The HER2-directed antibody-drug conjugate Enertu (trastuzumab deruxtecan) has won its fifth breakthrough therapy designation from the FDA. Enhertu was developed jointly by AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS: DSNKY). The latest designation relates to treating adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer. Of the five breakthrough therapy designations for the drug,…

Precision oncology firm Black Diamond Therapeutics (Nasdaq:BDTX) has announced a restructuring plan to free up cash to prioritize the development of BDTX-1535 and BDTX-4933. The company plans on trimming nearly one-third of its workforce. BDTX shares ticked up about 1% to $2.75 after announcing the news yesterday but fell 4% today to $2.64. According to…

Black Diamond Therapeutics (Nasdaq: BDTX) has announced that it has dosed the first patient in the Phase 1 study focused on BDTX-1535. BDTX-1535 is a MasterKey inhibitor of epidermal growth factor receptor (EGFR) to potentially treat non-small cell lung cancer (NSCLC) and glioblastoma (GBM). Cambridge, Massachusetts–based Black Diamond believes BDTX-1535 holds significant potential for EGFR-mutant…

The FDA today issued a new draft guidance outlining plans for increased diversity in clinical trials in the U.S. Expanding upon previous guidances for improving clinical trial diversity, this latest draft guidance — “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials” — recommends that sponsors of medical…

The cell and gene therapy company Mustang Bio (Nasdaq:MBIO) will initiate a Phase 1 clinical trial combining CAR T cells and oncolytic virus as a potential therapy for recurrent glioblastoma. The prognosis for glioblastoma is generally poor with approximately 40% survival in the first year following diagnosis, according to the American Association of Neurological Surgeons. The…

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.