Onco Actu du 26 septembre 2019

	1.1 BIOLOGIE - GÉNOME
Cancer: the origin of genetic mutations [Université de Genève] By linking DNA replication failures in cancer cells to their genetic instability, researchers at UNIGE unveil a mutation mechanism that is essential for cancer development.
	3.1.1 PRÉVENTION - TABAC - E-CIGS
Juul, e-cigarette maker, to drop ads, won’t lobby against proposed ban on flavored products [STAT] “I have long believed in a future where adult smokers overwhelmingly choose alternative products like JUUL,” said K.C. Crosthwaite, the incoming CEO, in a statement. “Unfortunately, today that future is at risk due to unacceptable levels of youth usage and eroding public confidence in our industry.”
Remarks prepared for testimony before a U.S. House Energy and Commerce Subcommittee on FDA Regulation of Electronic Nicotine Delivery Systems and Investigation of Vaping Illnesses [FDA] In short: the data indicate that FDA must do more.
Early Signs of Vaping Health Risks Were Missed or Ignored [Bloomberg] Doctors and researchers scattered around the globe saw problems, but ‘nobody put two and two together.
FDA ‘should have acted sooner’ on e-cigarettes, agency head tells Congress [STAT] Sharpless said the agency is expected to finalize draft guidance in the coming weeks that will “dramatically impact” the market of flavored e-cigarettes, which are widely seen as fueling the popularity of vaping among young people. But Sharpless faced tough questions about why the agency hadn’t acted sooner — or done more — to grapple with the growing e-cigarette industry.
Factbox: U.S. lawsuits take aim at vaping [Reuters] Lawsuits on behalf of young consumers have been filed against e-cigarette maker Juul Labs Inc and others are expected amid increasing scrutiny.
Juul Replaces Its C.E.O. With a Tobacco Executive [NY Times] The surprise announcement was the latest sign of crisis at a company under scrutiny over its vaping products that have been highly popular among teenagers.
Juul boss exits in vaping crisis as Philip Morris, Altria axe merger talks [Reuters] Marlboro makers Philip Morris International Inc and Altria, announcing the end of their $187 billion merger talks, said they would instead focus on the joint launch of tobacco-heating product iQOS in the United States.
	3.3 PRÉVENTION - VACCINS
Most American Adults Are Unaware of HPV-Related Cancers, Indicating Need for Heightened Awareness [AJMC] In a study published this week in the journal JAMA Pediatrics, researchers from The University of Texas Health Center Science Center at Houston (UTHealth) School of Public Health reported that more than 70% of US adults across 3 age groups were unaware that HPV causes anal, penile, and oral cancers.
	5.1 TRAITEMENTS - PRÉ-CLINIQUE
Discovery of how colorectal cancer drug works will help more patients [Salk Institute] To understand why KRAS G13D tumors responded to cetuximab, the researchers first used computational models to simulate complex reactions and tease out biochemical differences between healthy and mutant genes based on the biochemical understanding of each process and previous clinical trial data.
	5.12 IMMUNOTHÉRAPIES
FDA warning slowed immunotherapy use in bladder cancer [Biopharma Dive] Doctors treating patients with bladder cancer prescribed immunotherapies less often, and chemotherapy more, following the Food and Drug Administration's decision to restrict the approvals of Keytruda and Tecentriq in the tumor type, new research published Tuesday in JAMA found.
CICON19 Day 1 Update: Cancer Prevention and Combination Immunotherapy Strategies [Cancer research Institute] Schumacher, who received the 2016 William B. Coley Award, posed three questions that he sought to answer during his talk. First, do early immunological responses predict clinical responses to PD-1 checkpoint immunotherapy? Second, are there baseline parameters that predict immunological responsiveness? And third, are there distinct subtypes of immunologically non-responsive tumors?
	5.12.2 IMMUNOTHÉRAPIES - CAR-T, THÉRAPIES CELLULAIRES
First chimeric antigen receptor (CAR) T cell therapy targeting B cell-activating factor receptor (BAFF-R) eradicates blood cancers that relapsed after CD19 CAR T therapies [City of Hope] When the BAFF-R CAR T trial opens, City of Hope will manufacture the CAR T cells using in its own facility, the Cellular Therapy Production Center.
Researchers Say Second-Generation CAR T-Cell Therapy Proves Successful in Early Studies, Human Trial Planned [AJMC] Trials in human participants are expected to begin within 6 months, according to one of the researchers involved in the study, which was published in Science Translational Medicine.
	5.12.4 IMMUNOTHÉRAPIES - ESSAIS
Investigational drug with immunotherapy may provide new therapeutic opportunity for patients previously treated for kidney and lung cancer [MD Anderson Cancer Center] Pegilodecakin with pembrolizumab and nivolumab shown to be safe in Phase IB study.
	5.12.5 IMMUNOTHÉRAPIES - PHARMA
BioNTech guns for $250M raise at $4.5B valuation in IPO plan [Fierce Biotech] BioNTech has allocated $35 million to take CAR-Ts, T-cell receptors and mRNA-encoded antibodies and cytokines through phase 1 and set aside $20 million for preclinical work on other programs.
Amgen Announces Positive Results From Two Phase 3 BLINCYTO® (blinatumomab) Studies In Pediatric Patients With Relapsed Acute Lymphoblastic Leukemia [Amgen] Phase 3 '215 and Children's Oncology Group (COG) Studies Both Stopped Early Due to Treatment Benefit of BLINCYTO Over Chemotherapy.
	5.2 PHARMA
Health Canada says four more companies recalling versions of Zantac [Reuters] Health Canada said the lots of the medicines being recalled may have been made using an active ingredient containing the impurity, N-nitrosodimethylamine (NDMA), above accepted levels.
	5.2.1 PHARMA - PARTENARIATS
Pfizer and Flatiron Health Announce Expanded Strategic Collaboration to Unlock Power of Real-World Evidence in Oncology [Flatiron] Pfizer will draw on de-identified, real-world datasets and analytical expertise from Flatiron Health to inform development strategies and activities for a number of clinical development projects across major tumor types, as well as jointly explore other innovative ways to drive clinical development innovation with real-world data.
Boehringer Ingelheim backs Max Planck spinout in taking a shot at tough class of cancer targets [EndPoints] Scientists have long known about tumor-associated carbohydrate antigens — those abnormal saccharides that are abundant on cancer cell surfaces and feed them on — but their ability to hide from the immune systems means they have proved to be evasive targets in immuno-oncology.
	5.2.3 PHARMA - ÉCONOMIE
GSK invests $120M in biopharma plant as renewed oncology bets grow [Fierce Pharma] Soon after Walmsley become CEO in 2017, she reworked the company’s R&D and rolled out a plan that includes a refocus on oncology just two years after the company swapped away its marketed cancer drugs to Novartis.
	5.3.4 TRAITEMENTS - AMM (FDA, EMA,...)
EMA Recommends Granting a Marketing Authorisation for Generic Bortezomib [ESMO] Bortezomib Fresenius Kabi is intended for the treatment of multiple myeloma and mantle cell lymphoma.
	6.1 OBSERVATION
Assisted reproduction and risk of prostate cancer for men [BMJ] Applying a more long term view, and seeing infertility as an early symptom of general disease, opens up the possibility of offering preventive health measures to a significant proportion of the male population, specifically to those with higher risks for a wide range of disease.
Men with fertility struggles far more likely to develop prostate cancer [The Telegraph] “It is important to be clear that this is not because the techniques of assisted reproduction go on to cause prostate cancer, but probably because the two have a common cause in some way."
Male infertility linked to prostate cancer risk [BBC News] Among the natural conception group, 3,244 (0.28%) were diagnosed with prostate cancer, compared with 77 (0.37%) in the IVF group and 63 (0.42%) among those who had ICSI.
	6.10 POLITIQUES
U.K.’s Labour Party wants government to build its own manufacturing to lower drug prices [Fierce Pharma] The paper, among many other suggestions, says publicly funded production facilities could produce both generics and new chemical entities where prices have been jacked up because of price hikes “due to market consolidation or other reductions in manufacturing capacity (following the Civica Rx example above).”
	6.10.1 POLITIQUES (USA)
Trump’s trade war is hurting companies like mine — and the biotechnology industry [STAT] My company, PepVax Inc., began developing a novel DNA-based treatment for an aggressive form of breast cancer called triple-negative breast cancer in 2013. Last year we worked for almost six months to secure funding from a group of Chinese investors to move our lead candidate therapy into late-stage animal studies and then into human trials.
	6.3 ASSOCIATIONS/FONDATIONS
Different challenges, same determination: how we’re tackling children’s and young people’s cancers. [Cancer Research UK] Survival rates for some children’s cancers haven’t improved much since the 1970s. And of the children and young people who do survive their cancer, some experience serious, long-term side effects from their treatment, which can affect them for the rest of their lives. We want to change this.