On March 18, 2016 Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, reported publication of abstracts on neratinib for the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016 (Press release, Puma Biotechnology, MAR 18, 2016, View Source [SID:1234510445]). The AACR (Free AACR Whitepaper) Annual Meeting will be held at the Ernest N. Morial Convention Center in New Orleans from April 16 to April 20.

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Sun, Apr 17, 1:00 – 5:00 p.m. CDT – Abstract 298, Section 16, Poster Board 9: Amplification of mutant ERBB2 drives resistance to the irreversible kinase inhibitor neratinib in ERBB2-mutated breast cancer patients.
FJ Carmona, D Hyman, G Ulaner, J Erinjeri, N Bouvier, H Won, R Cutler, A Alani, M Berger, J Baselga, M Scaltriti.

Tue, Apr 19, 8:00 a.m. – 12:00 p.m. CDT – Abstract 3140, Section 22, Poster Board 7: Differential clonal selection in tumor tissue and cell-free DNA from a neratinib-treated refractory breast cancer patient harboring an activating ERBB2 (HER2) mutation.
L Joenson, CW Yde, O Østrup, M Mau-Sørensen, FC Nielsen, U Lassen

Wed, Apr 20, 8:00 a.m. – 12:00 p.m. CDT – Abstract 4760, Poster Board 11: Efficacy of EGFR/HER2 duel-kinase inhibitors in PDX models harboring known and novel HER2-mutations.
MJ Wick, M Farley, T Vaught, J Meade, M Glassman, A Moriarty, AW Tolcher, D Rasco, A Patnaik, KP Papadopoulos

The abstracts are available online at: View Source;DetailItemID=363#.Vusrr-IrKUk.

(Filing, Annual, GlaxoSmithKline, 2015, MAR 18, 2016, View Source [SID:1234509645])

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On March 18, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported it will present two important new studies at the 2016 Society for Gynecologic Oncology annual meeting in San Diego, Calif (Press release, Myriad Genetics, MAR 18, 2016, View Source [SID:1234509630]).

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The data demonstrate the ability of the myRisk Hereditary Cancer test to identify deleterious mutations in patients with endometrial cancer. Additionally, a different study showed the superior ability of the combined three biomarker myChoice HRD test to predict survival in patients with platinum treated ovarian cancer.

"Endometrial cancer is the most frequent gynecologic cancer and a significant number of these cases are due to mutations in hereditary cancer genes," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. "Our new data show that gene panel testing can identify many more patients with harmful mutations than testing Lynch Syndrome genes alone. The additional information provided by the myRisk Hereditary Cancer test will help physicians optimize care for their patients."

Details about the featured Myriad presentations at SGO are below. Follow Myriad on Twitter via @MyriadGenetics and stay up-to-date with the meeting by using the hashtag #SGOMtg.

myRisk Hereditary Cancer Presentation — Endometrial Cancer

Title: Hereditary cancer panel testing in an unselected endometrial carcinoma cohort.
Date: Saturday, March 19, 2016: 7:50 to 9:55 a.m. PT.
Location: Podium — Abstract 6261.
Presenter: Kari Ring, MD Anderson Cancer Center.

This study evaluated the prevalence of cancer predisposition gene mutations in 381 endometrial cancer patients who had previously undergone tumor testing to screen for Lynch Syndrome. Patients were tested for mutations in 25 cancer genes using the myRisk Hereditary Cancer test. The results showed that 9.2 percent of endometrial cancer patients had a deleterious mutation, including 5.8 percent with a mutation in a Lynch Syndrome gene and 3.4 percent in 10 non-Lynch genes. Multi-gene panel testing with myRisk demonstrated the ability to identify 60 percent more mutations, several of which are associated with ovarian and uterine cancers. These findings support gene panel testing to identify patients who may be missed by current Lynch Syndrome testing alone.

myChoice HRD Presentation

Title: Homologous recombination deficiency (HRD) score shows superior association with outcome compared to its individual score components (LOH, TAI and LST) in platinum treated serous ovarian cancer.
Date: Saturday, March 19, 2016: 7:50 to 9:55 a.m. PT.
Location: Podium — Abstract 6286.
Presenter: Gordon B. Mills, M.D., Ph.D., MD Anderson Cancer Center.

This study compared the predictive ability of the combined three biomarker myChoice HRD score to the three independent measures of homologous recombination deficiency that comprise the assay including: loss of heterozygosity (LOH) score, telomeric-allelic imbalance (TAI) score, and large-scale state transitions (LST) score. The results showed that the combined myChoice HRD score predicted progression-free survival (p=2.2×10-6) and overall survival (p=1.0×10-8) in patients with platinum-treated ovarian cancer. In a bivariate analysis none of the individual biomarkers (LOH, TAI and LST) reached statistical significance for either progression free survival or overall survival. In this study, myChoice HRD was shown to be a superior predictor of clinical outcomes to any of the individual score components including LOH, TAI and LST.

About Myriad myRisk Hereditary Cancer Testing
The Myriad myRisk Hereditary Cancer test uses next-generation sequencing technology to evaluate 25 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. For more information visit: myriad.com.

About myChoice HRD
Myriad’s myChoice HRD is the first homologous recombination deficiency test that can detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. High myChoice HRD scores reflective of DNA repair deficiencies are prevalent in all breast cancer subtypes, ovarian and most other major cancers. In previously published data, Myriad showed that the myChoice HRD test predicted drug response to platinum therapy in certain patients with triple-negative breast and ovarian cancers. It is estimated that 1.8 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents. For more information visit: myriad.com.

On March 17, 2019 Kymab reported that Dr David Chiswell OBE has been appointed as Chief Executive Officer with effect from April 2016 (Press release, Kymab, MAR 17, 2016, View Source [SID1234537012]). Dr Chiswell has acted as interim CEO since early 2015, having been appointed Chairman in September 2013. Dr Tim Rink will take the role of Lead Director with effect from April.

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Dr Chiswell has an enviable record in the industry, having worked at Amersham, founded Cambridge Antibody Technology in 1990, been Chair of the UK’s BioIndustry Association, and served seven other biotech companies as Chairman or Director.

"I am delighted with Dave’s appointment as CEO; Dave has an outstanding track record and experience in antibody development and building Biotech companies," said Dr Rink. "He was instrumental in the development of the world’s best selling antibody, Abbvie’s HUMIRA (Adalimumab), which was launched in 2003 and has annual sales in excess of $14 billion."

"I have spent one of the most satisfying years of my career as interim CEO working closely with the excellent team at Kymab," said Dr Chiswell. "I believe Kymab has all the tools needed to enable it to become a truly successful major Biotech company. Our Kymouse platform has already generated an enviable product pipeline of human monoclonal antibodies which we will continue to expand.

"We attracted high quality investors Woodford and Malin alongside the Wellcome Trust and the Bill & Melinda Gates Foundation in our US$90 million Series B fund raise, one of the largest pre-clinical rounds in UK biotech. We have established major partnerships such as Novo Nordisk and the US cancer hospital MD Anderson.

"I am very pleased to be taking the helm on a permanent basis at a time when we are commencing our clinical trial programmes."

Dr Chiswell has over 30 years’ experience in the biotechnology industry having co-founded Cambridge Antibody Technology (CAT) in 1990, serving as CEO from 1996 to 2002. CAT listed on the London Stock exchange in April 1997 and Nasdaq in June 2001, and was subsequently sold to AstraZenca where it forms an important part of their biopharmaceutical franchise.

Since leaving CAT in 2002, he has focused on the development of early-stage biotechnology companies, having previously served as a director of Arakis, non-executive chairman of Sosei, Arrow Therapeutics and Daniolabs, and as CEO of Nabriva Therapeutics (2009 to 2012). Dr Chiswell currently serves as chairman of Albireo Pharma and is a director of Nabriva Therapeutics.

He is a past chairman of the UK BioIndustry association (BIA) and in 2006 he was awarded the Most Excellent Order of the British Empire (OBE) by Her Majesty the Queen for services to the biotechnology industry.

On March 17, 2016 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, reported that preclinical data from a combination study of Affimed’s lead candidate AFM13 and checkpoint modulators, including checkpoint inhibitor PD-1, as well as data on Affimed’s preclinical programs AFM21/22 and AFM24 will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2016 Annual Meeting being held April 16 – 20, 2016 in New Orleans, LA (Press release, Affimed Therapeutics, MAR 17, 2016, View Source [SID:1234512470]).

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AFM13

On Monday, April 18, "Immune checkpoint inhibition by anti-PD-1 or CD137 co-stimulation enhances cytotoxicity towards CD30+ tumors mediated by the bispecific tetravalent CD30/CD16A TandAb AFM13" (Abstract #2323) will be available in a poster session. The results of this preclinical study, conducted in collaboration with Stanford University, confirm earlier evidence of the synergy of our lead candidate, the CD30/CD16A-specific NK-cell engager AFM13, in combination with PD-1 inhibitors in in vivo PDX models with human CD30+ Hodgkin lymphoma (HL) tumors. Our data demonstrate that this synergy is mediated by tumor-infiltrating lymphocytes, macrophages and dendritic cells, and provide strong evidence for cross-talk between innate and adaptive immunity induced by AFM13-recruited human NK-cells. Together with AFM13’s adequate safety profile in patients, these results further justify the Phase 1b combination study investigating AFM13 in combination with pembrolizumab in relapsed/refractory HL patients which we expect to be initiated in the first half of this year.

AFM21/22

On Sunday, April 17, "Anti-EGFRvIII TandAbs recruiting either T or NK cells are highly specific and potent therapeutic antibody candidates for the treatment of EGFRvIII+ tumors" (Abstract #580) will be available in a poster session. In this preclinical study we report development of tetravalent, bi-specific TandAbs (tandem antibodies) that recognize EGFRvIII, the most prevalent tumor-specific variant of the epidermal growth factor receptor, EGFR. Our TandAbs recruit either T-cells or NK-cells, both of which are highly potent and efficacious immune effector cells, by binding to their activating receptors CD3 (AFM21) and CD16A (AFM22), respectively. This allows for the selective destruction of EGFRvIII-positive tumor cells, while sparing healthy, EGFRvIII-negative cells. The AFM21/22 program further validates the robustness of our proprietary TandAb technology platform, allowing for rapid identification of candidate molecules which are stable, highly expressed, and display significant in vitro and in vivo cytotoxicity to cancer cells.

AFM24

On Sunday, April 17, "Highly cytotoxic EGFR/CD16A TandAbs specifically recruit NK cells to potently kill various types of solid tumors" (Abstract #593) will be available in a poster session. In this preclinical study we describe the development of our novel bispecific, tetravalent EGFR/CD16A-specific NK-cell TandAbs and provide evidence for their therapeutic potential. When constitutively activated through amplification or dysregulation, the EGFR wild type (EGFRwt) plays an important role in the pathophysiology of numerous solid cancers. Specifically utilizing the cytotoxic potential of NK-cells for the elimination of EGFR-overexpressing cancer cells, we engineered a set of EGFR/CD16A TandAbs and selected ideal candidates based on their binding, thermostability and cytotoxic properties. Our data suggest that EGFR/CD16A TandAbs are novel, highly potent drug candidates suitable for the treatment of EGFR-overexpressing malignancies and suited to overcome the intrinsic or acquired resistance to other EGFR-targeting treatments such as tyrosine kinase inhibitors or monoclonal antibodies, which has been observed in a large number of patients.

Full abstracts of the presentations can be accessed on the AACR (Free AACR Whitepaper) website at www.aacr.org.