1stOncology™: Cancer Intelligence Service

Epigenomics AG: Blood test shows promise in the detection of liver cancer

On April 19, 2018 Epigenomics AG (FSE: ECX, OTCQX: EPGNY) reported promising results from two clinical studies published in EBioMedicine supported by Cell Press and The Lancet, demonstrating high accuracy of Epigenomics’ proprietary epigenetic circulating biomarker mSEPT9 in detecting liver cancer among patients with cirrhosis (Press release, Epigenomics, APR 19, 2018, View Source [SID1234525523]).

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The two independent clinical studies (observational/case-control) included 289 cirrhosis patients with or without liver cancer from France (initial study) and Germany (replication study). Overall, the mSEPT9 test demonstrated high sensitivity of 90.6 percent at a specificity of 87.2 percent (using the "2 out of 3" algorithm). Importantly, a triple-negative mSEPT9 test had the highest negative predictive value for excluding liver cancer (97.2 percent), whereas a triple-positive mSEPT9 test had the highest positive predictive value for retaining a diagnosis of liver cancer (91.5 percent).

The results from the replication study were consistent with those of the initial study with regard to all diagnostic accuracy measures. Furthermore, the mSEPT9 blood test exhibited higher diagnostic accuracy compared to alpha-fetoprotein (AFP), which has been widely used as a diagnostic marker for liver cancer.

"The detection of liver cancer, one of the deadliest cancer types worldwide, still represents a high medical need," said Abderrahim Oussalah MD, PhD, Department of Molecular Medicine at the University Hospital of Nancy (France). "Findings from two independent clinical studies reveal that the mSEPT9 test constitutes a promising opportunity in this respect. As more clinical evidence is needed, we have initiated a further, prospective clinical study with 440 patients in order to confirm the diagnostic accuracy of mSEPT9 in the diagnosis of liver cancer (SEPT9-CROSS study, ClinicalTrials ID: NCT03311152). Future prospective studies should assess the mSEPT9 test in a screening algorithm for patients with cirrhosis to improve risk prediction and the personalized therapeutic management of liver cancer."

According to the World Health Organization, liver cancer is the fifth most common cancer in men and the seventh in women, and ranks second in annual cancer mortality rates worldwide, with liver cancer diagnosed in more than 700,000 people annually. Major risk factors for liver cancer include cirrhosis, infection with hepatitis B or C virus, alcoholic liver disease, and non-alcoholic fatty liver disease.

"We are very excited about the promising clinical results of our mSEPT9 blood test in the diagnosis of liver cancer", said Jorge Garces, President & Chief Scientific Officer of Epigenomics AG. "In the future, an accurate blood test could offer the opportunity to closely monitor patients at high risk for developing liver cancer."

The full-length paper is available here: View Source(18)30116-6/pdf

MorphoSys Resolves a Capital Increase to Implement the Offering of 8,300,000 American Depositary Shares (ADS) in the United States

On April 18, 2018 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported that its Management Board, with the approval of the Supervisory Board, has resolved to increase the share capital of MorphoSys AG by issuing 2,075,000 new ordinary shares from the authorized capital 2017-II, excluding pre-emptive rights of existing shareholders, to implement the initial public offering in the United States of 8,300,000 American Depositary Shares ("ADSs") pursuant to a Registration Statement on Form F-1, as amended, filed with the U.S. Securities and Exchange Commission (Press release, MorphoSys, APR 18, 2018, View Source [SID1234556336]). Furthermore, MorphoSys has granted the underwriters a 30-day option to purchase additional ADSs of up to 15% of the total number of ADSs placed in the offering (i.e. 1,245,000 additional ADSs). Each ADS will represent 1/4 of a MorphoSys ordinary share. The new ordinary shares underlying the ADSs represent 8.1% (including the underwriters’ option to purchase additional ADSs) of the registered share capital of MorphoSys prior to the consummation of the capital increase.

Pricing of the offering is expected to occur on April 18, 2018, following the end of the bookbuilding in the United States.
Within the United States of America, the securities referred to in this release are offered only by means of a prospectus. A copy of the prospectus can be obtained from Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 1-212-902-9316 or by e-mailing [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204; Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by e-mailing [email protected].

A registration statement relating to these securities has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective.

Kymab presents data on two of its immuno-oncology antibodies, providing further evidence of the strength of its franchise

On April 18, 2018 Kymab Group Limited ("Kymab"), a biopharmaceutical company developing fully human monoclonal antibody therapeutics, reported data on KY1044 (a novel anti-ICOS antibody) and KY1055 (a novel ICOS/PD-L1 bispecific antibody), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual meeting held April 14-18, 2018 in Chicago, Illinois, USA (Press release, Kymab, APR 18, 2018, View Source [SID1234537006]).

The AACR (Free AACR Whitepaper) Annual Meeting covers the latest basic, translational, clinical, and prevention-focused research in the field, including important areas such as early detection, cancer interception, and survivorship in all populations.

Notes to Editors
About Kymab’s AACR (Free AACR Whitepaper) Posters
KY1044 poster

Title: The combination of immune checkpoint blockers with the anti-ICOS KY1044 antibody results in a strong tumour response (#2792)

Session Title: Therapeutic Antibodies, Including Engineered Antibodies 2

Session Date and Time: Monday Apr 16, 2018 1:00 PM – 5:00 PM

Link to the Poster (1.4 Mb PDF)

KY1055 poster

Title: KY1055, a novel ICOS/PD-L1 bispecific antibody, efficiently enhances T cell activation and delivers a potent anti-tumour response in vivo. (#LB-153)

Session Title: Late-Breaking Research: Clinical Research 1

Session Date and Time: Monday Apr 16, 2018 1:00 PM – 5:00 PM

Calithera Biosciences Announces FDA Fast Track Designation Granted to CB-839 in Combination with Cabozantinib for Treatment of Patients with Advanced Renal Cell Carcinoma

On April 18, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CB-839 in combination with cabozantinib for the treatment of patients with metastatic renal cell carcinoma who have received one or two prior lines of therapy, including at least one vascular endothelial growth factor tyrosine kinase inhibitor or the combination of nivolumab and ipilimumab (Press release, Calithera Biosciences, APR 18, 2018, View Source [SID1234535241]). CB-839 is a first-in-class, oral, selective, potent inhibitor of glutaminase being evaluated in the CANTATA trial. The trial is a randomized double-blind clinical study of cabozantinib in combination with CB-839 or placebo in 298 patients with clear cell renal cell carcinoma. The primary endpoint is progression free survival and the global study is open for enrollment.

"Despite a number of new therapies for the treatment of renal cell carcinoma, there remains a significant unmet need among advanced patients who have received prior treatment," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "We are pleased that CB-839 has been granted Fast Track designation, demonstrating the FDA’s commitment to facilitate the development and expedite the review of our glutaminase inhibitor as an important new therapy for patients with advanced or metastatic renal cell carcinoma who have failed prior systemic therapy."

The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs and biologics, to treat serious or life threatening conditions, and to fill an unmet medical need. Specifically, Fast Track designation facilitates frequent interactions with the FDA review team, including meetings to discuss all aspects of development to support approval, and also provides the opportunity to submit sections of an NDA on a rolling basis as data become available. About CB-839 Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839’s onco-metabolism activity takes advantage of the unique metabolic requirements of tumor cells and cancer-fighting immune cells such as cytotoxic T-cells. It is currently being evaluated in Phase 2 clinical trials in multiple tumor types, in combination with standard of care agents.

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Epigenomics AG: Blood test shows promise in the detection of liver cancer

MorphoSys Resolves a Capital Increase to Implement the Offering of 8,300,000 American Depositary Shares (ADS) in the United States

Kymab presents data on two of its immuno-oncology antibodies, providing further evidence of the strength of its franchise

Calithera Biosciences Announces FDA Fast Track Designation Granted to CB-839 in Combination with Cabozantinib for Treatment of Patients with Advanced Renal Cell Carcinoma

Some Fun Facts about AACR 2018