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BioWorld - Thursday, January 1, 2026
Home » Topics » Cancer, BioWorld

Cancer, BioWorld
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FDA website and logo

Drug companies, US FDA burying the lede on accelerated approval

March 23, 2022
By Mari Serebrov
As congressional scrutiny of the U.S. FDA’s accelerated approval path continues, the agency is focusing research efforts into appropriate disclosure on direct-to-consumer websites about a drug’s accelerated approval and the status of confirmatory trials. Previous research by the FDA’s Office of Prescription Drug Promotion (OPDP) found that 27% of DTC websites providing information about a drug with accelerated approval don’t disclose that the products are on the market through accelerated approval.
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Pancreatic tumor metastasis In a mouse

‘Trojan horse’ approach redirects tetanus immune response to tumors

March 23, 2022
By Anette Breindl
Researchers at the Albert Einstein College of Medicine have turned pancreatic cancer’s immunosuppressive properties, and mechanisms, against itself. The team have used the bacterium Listeria monocytogenes as a delivery vehicle for tetanus toxoid protein, a highly immunogenic antigen that is used in childhood tetanus vaccinations. In mouse models of pancreatic cancer, treatment reduced both primary tumors and metastases, and extended survival.
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Gold dollar sign inside gold cog

Affini-T raises $175M with help from Bayer to develop T-cell treatments

March 22, 2022
By Lee Landenberger
In its drive to rewrite the rules of the tumor microenvironment so it can capture of the holy grail of successfully battling solid tumors by using T cells, Affini-T Therapeutics Inc. has completed an oversubscribed $175 million. The focus is to develop multiple oncogene driver programs for treating solid tumors such as those with mutated KRAS variants into the clinic, pursue complementary technology licenses to strengthen its cell therapy platform and to optimize its discovery engine.
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Health, medical icons

Crop failure: Oric, Aligos, Neurana bids go dry in tough clinical season

March 22, 2022
By Randy Osborne
Oric Pharmaceuticals Inc. is quitting development of ORIC-101 after interim analyses of two phase Ib studies concluded that the clinical activity does not justify going forward with the compound. The company was testing ORIC-101, a glucocorticoid receptor antagonist, combined with Abraxane in various solid tumors and paired with Xtandi in metastatic prostate cancer.
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Spotlight raises $36.5M to advance non-viral gene editing tech, lead I-O program

March 22, 2022
By Michael Fitzhugh
Spotlight Therapeutics Inc., a company developing cell-targeted in vivo CRISPR gene editing biologics, has raised $36.5 million in series B financing to support advancement of its first-in-class immuno-oncology program and further applications of its in-house technology platform. The financing round was co-led by new investors GordonMD Global Investments and Epiq Capital Group, with participation from Magnetic Ventures, as well as existing investors GV, Emerson Collective and others.
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Ovarian cancer illustration

Researchers discover genetic targets linking endometriosis, ovarian cancer subtypes

March 22, 2022
By Tamra Sami
Researchers at the University of Queensland have found a genetic link between endometriosis and ovarian cancer subtypes, enabling them to identify potential drug targets for therapy and increasing the understanding of both diseases.
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Street serves mirv curve as Immunogen sinks on ‘positive’ phase III ovarian cancer trial readout

March 21, 2022
By Randy Osborne
Wall Street was not as pleased as some might have expected by Immunogen Inc.’s full results from the pivotal study called Soraya testing mirvetuximab soravtansine (mirv) monotherapy in patients with folate receptor (FR) alpha-high, platinum-resistant ovarian cancer (PROC) who have been previously treated with Avastin (bevacizumab, Roche Holding AG). Analysts hailed the results as positive but shares (NASDAQ:IMGN) closed at $4.30, down 96 cents, or 18.25%.
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Opdualag

This is just the beginning, says LAG-3 discoverer as BMS grabs first-in-class approval

March 21, 2022
By Jennifer Boggs and Richard Staines
Bristol Myers Squibb Co.’s relatlimab will hit the market as the first U.S. FDA-approved LAG-3 inhibitor, cleared by the agency for use in a fixed-dose combination with Opdivo (nivolumab) to treat adult and pediatric patients with unresectable or metastatic melanoma. The approval, a day ahead of the March 19 FDA target date, adds another type of immune checkpoint inhibitor to the oncology arsenal, which already includes drugs targeting PD-1/PD-L1 and CTLA4.
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3D illustration of chromosomes

Wages of CIN could total $1B-plus for Volastra in synthetic-lethality BMS deal

March 21, 2022
By Randy Osborne
Volastra Therapeutics Inc., dedicated to taking aim at chromosomal instability (CIN) to design cancer drugs by way of its CINtech platform,, scored a potential $1 billion-plus agreement with Bristol Myers Squibb Co. (BMS) to find synthetic lethal targets as drug candidates.
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Junshi, Coherus roll out final phase III data on PD-1 and chemotherapy combo for NSCLC

March 16, 2022
By Doris Yu
Shanghai Junshi Biosciences Co. Ltd. and Coherus Biosciences Inc. have disclosed positive data from a phase III trial of the anti-PD-1 antibody toripalimab in combination with chemotherapy in China. Though already approved for several indications, they’re seeking to position it as a first-line treatment of advanced squamous or non-squamous non-small-cell lung cancer (NSCLC). The final data largely confirmed interim findings from the study, first reported in August 2021.
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