Cambridge Epigenetix announces programme for routine screening and detection of colorectal cancer and other common tumours

On January 8, 2019 Cambridge Epigenetix Ltd, a pioneer in the development and application of epigenetic technologies, reported its discovery and development programme for a test to detect colorectal and other cancers (Press release, Cambridge Epigenetix, JAN 8, 2019, View Source [SID1234532587]). This follows completion of a c. $30 million funding round, as well as the acquisition of exclusive patent rights for its epigenetic sequencing platform.

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Epigenetic changes act as a control layer for the genome and can alter gene expression, but not the genetic code itself. These alterations may involve the presence of small chemical groups on the building blocks, or nucleotide bases, which make up DNA. DNA from cancer cells has a distinct epigenetic signature, and this is the basis for the use of epigenetic tests in cancer testing.

"The global burden of colorectal cancer (CRC) is expected to increase by 60% to more than 2.2 million new cases and 1.1 million deaths by 2030,"1 stated Dr David Johnson MD, MACG, FASGE, MACP, Professor of Medicine and Chief of Gastroenterology at Eastern Virginia Medical School, Norfolk, VA, who serves as a member of the company’s clinical advisory board. "Detection of CRC remains a challenge, and the availability of a non-invasive, easy-to-administer and affordable screening test as our first initiative could transform the diagnosis, detection and treatment of pre-cancerous lesions and CRC." Dr Johnson has previously been President of the American College of Gastroenterology and has played a pivotal role in shaping the dialogue around colon cancer screening and early detection. He was instrumental in putting through the historic first legislation to mandate colon cancer screening using colonoscopy as the preferred standard in the state of Virginia, USA.

In support of its mission, the company has been granted broad and exclusive patent rights (US Patent number 10,041,938) for the use of epigenetic modification 5-hydroxymethylcytosine (5hmC) as a diagnostic biomarker for cancer. Cambridge Epigenetix is using proprietary technology for analysing 5hmC in circulating free DNA (cfDNA) to develop a test for detection of CRC. The company is currently conducting a large discovery study with over 2,000 patient samples, including healthy volunteers, and individuals with adenomas and all stages of CRC. This study follows encouraging preliminary results from profiling 5hmC in over 200 CRC and healthy volunteer cfDNA samples.2 Several independent studies have indicated that measuring 5hmC in plasma circulating cfDNA is effective for non-invasive cancer detection. 3,4

Sir Shankar Balasubramanian, co-founder of Cambridge Epigenetix, FRS, FMedSci, Herchel Smith Professor of Medicinal Chemistry in the Department of Chemistry at the University of Cambridge, said: "Cambridge Epigenetix’s 5hmC platform analyses some of the earliest markers of cancer development in patients’ blood samples to detect disease. Ultimately, our aim is to develop a diagnostic test that can detect multiple cancers from one standard blood draw."

The latest round of secured funding will advance the company’s proprietary technology platform, which enables the sensitive and specific detection of epigenetic biomarkers for cancer in blood and other liquid biopsy samples. Ahren Innovation Capital (UK) led the funding round with current US-based supporters GV, New Sciences Ventures and Sequoia Capital. Additionally, new investors – including DNA Capital (Brazil) – also participated, bringing the total amount raised by the company since founding to $56.5 million.

Alice Newcombe-Ellis, Founder & Managing Partner, Ahren Innovation Capital, said: "Cancer detection through liquid biopsy has the possibility of transforming human health. Our investment will help Cambridge Epigenetix build on its strong intellectual property foundation, based on the research conducted by Sir Shankar Balasubramanian and Professor Anjana Rao."

Cambridge Epigenetix also announces the appointment of Dr Suman Shirodkar, MBBS, PhD as the CEO of the company. Dr Shirodkar has extensive leadership experience in the industry and will lead the next phase of development of the diagnostic test. Prior to joining Cambridge Epigenetix, Dr Shirodkar led product teams in oncology, HIV, and cardiovascular medicine at Pfizer and Novartis.

"It is a very exciting time to be leading Cambridge Epigenetix" commented Dr Suman Shirodkar. "Our ability to detect 5hmC in circulating, cell-free DNA, and the discovery and development of a liquid biopsy signature for tumours, could revolutionise cancer care and decrease cancer mortality through widespread screening, early detection and timely intervention. I am excited to lead the talented team at Cambridge Epigenetix for the development and launch of the first of many tests to detect cancer".

Cellular Biomedicine Group Initiates Patient Recruitment for Clinical Trial in B Cell Maturation Antigen (Anti-BCMA) Chimeric Antigen Receptor T-Cell (CAR-T) Therapy Targeting Multiple Myeloma (MM)

On January 8, 2019 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm engaged in the development of immunotherapies for cancer and stem cell therapies for degenerative diseases, reported the initiation of patient recruitment to support the study of anti-BCMA CAR-T therapy targeting relapsed and refractory Multiple Myeloma in China (Press release, Cellular Biomedicine Group, JAN 8, 2019, View Source [SID1234532588]).

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"China has seen a substantial increase in the incidence of Multiple Myeloma. As a drug development company, BCMA is the first of multiple assets that CBMG is advancing amongst our oncology pipeline beyond our collaboration with a global leader in cell therapy," commented Tony (Bizuo) Liu, Chief Executive Officer of the Company. "We plan to provide updates in the near future on the progress of our other proprietary technologies, including anti-CD22 and anti-CD20 CAR-T targeting relapsed Acute Lymphoblastic Leukemia (ALL) and Diffuse Large B-cell Lymphoma (DLBCL) patients post anti-CD19 CAR-T treatment, Alpha Fetoprotein T-cell Receptor (AFP-TCR-T) for Hepatocellular Carcinoma, and next generation Tumor Infiltrating Lymphocytes (TIL) for the treatment of non-small cell lung cancer (NSCLC) and other solid tumor indications. We hope to be able to provide expeditious, safe and effective therapies to cancer patients who currently have limited treatment options."

About the Study
This Phase I clinical study will enroll 22 patients to evaluate the safety and efficacy of C-CAR088 (anti-BCMA Chimeric Antigen Receptor T-Cell therapy) in patients with relapsed and/or refractory Multiple Myeloma.

About Multiple Myeloma in China
It is estimated that there are 27,800 new cases of Multiple Myeloma, a cancer derived from plasma cells, diagnosed in China each year. With the acceleration of the aging process in China, it is predicted that Multiple Myeloma, with a rapid growth in incidence, will become one of the more significant diseases that affect people’s health in the country. (Source: Blood Cancer J. 2014 Aug 15;4:e239. doi: 10.1038/bcj.2014.55)

OBI Pharma, Inc. to Present at the J.P. Morgan Healthcare Conference

On January 8, 2019 OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), reported that Amy Huang, General Manager, will present a company overview at the 37th Annual J.P. Morgan Healthcare Conference on Wednesday, January 9, 2019 at 9:00 a.m. PST/12 noon EST, in San Francisco, CA (Press release, OBI Pharma, JAN 8, 2019, View Source [SID1234532589]).

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BerGenBio to present company overview at Biotech Showcase 2019 during annual J.P. Morgan Conference in San Francisco

On January 8, 2019 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class AXL kinase inhibitors to treat multiple cancer indications, reported that the Company will be presenting a corporate overview at the Biotech Showcase 2019 in San Francisco today at 10:00 am PST (Press release, BerGenBio, JAN 8, 2019, https://www.bergenbio.com/bergenbio-to-present-company-overview-at-biotech-showcase-2019-during-annual-j-p-morgan-conference-in-san-francisco/ [SID1234532590]).

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The presentation will webcast live and the presentation is available for download at the Company’s website: www.bergenbio.com/investors/presentations/

Details for the presentation are as follows:

Biotech Showcase
Date: Tuesday, January 8, 2019
Time: 10:00 am PST
Room: Franciscan A (Ballroom Level)
Venue: Hilton San Francisco Union Square Hotel, 333 O’Farrell Street

END

Contact
Richard Godfrey, CEO, BerGenBio ASA
+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA
[email protected]
+47 917 86 513

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

ONO Receives Manufacturing and Marketing Approval in Japan for Demser® Capsule, a Tyrosine Hydroxylase Inhibitor, for Improvement of Status of Catecholamine Excess Secretion in Patients with Pheochromocytoma

On January 8, 2019 Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President, Representative Director, Gyo Sagara; "ONO") reported that it received a manufacturing and marketing approval of Demser (metyrosine) Capsule 250 mg ("Demser"), a tyrosine hydroxylase inhibitor, in Japan for the improvement of status of catecholamine excess secretion in patients with pheochromocytoma (Press release, Ono, JAN 8, 2019, View Source [SID1234605553]). Pheochromocytoma (PC) is a neuroendocrine tumor deriving from the adrenal medulla or the extraadrenal gland ganglion with 2,920 patients estimated in Japan*. Catecholamine excessively secreted from PC causes various symptoms, such as tachycardia, headache, palpitation, sweating, constipation, including hypertension. Sympatholytic drugs, α-blocker and β-blocker, for control of blood pressure and heart rate have been usually used to improve these symptoms. As there are many cases where surgical removal of tumors is not applicable in patients with locally invasive or metastatic malignant PC, a long-term therapy, such as radiotherapy and chemotherapy is required. The chronic continuation of catecholamine excess secretion may increase a risk of causing cardiovascular-related adverse events such as heart failure or fatal arrhythmia. Demser inhibits tyrosine hydroxylase related to the production of catecholamine, reduces catecholamine extremely secreted from PC, and alleviates symptoms due to catecholamine excess secretion. Demser is a promising drug with an efficacy in the improvement of the symptoms in patients who are not able to sufficiently control the symptoms with sympatholytic drugs. Demser is a product for which development companies were recruited in Japan at the "Review Committee on Unapproved or Off-label Drugs with High Medical Needs", established by the Ministry of Health, Labour and Welfare (MHLW), and ONO has been developing this product. In May 2015, the product was designated for the orphan drug by the MHLW. ONO obtained exclusive rights to develop and commercialize metyrosine in Japan for the treatment of PC (and conditions and symptoms related thereto), in accordance with the license agreement concluded in October 2013 with Valeant Pharmaceuticals North America LLC, an affiliate of Valeant Pharmaceuticals International, Inc. (In July 2018, the company name was changed to Bausch Health Companies Inc., "Bausch Health"). In the US, Bausch Health markets the product under the tradename of "Demser" in the indication of PC. *: "Actual condition survey and preparation of medical guideline of pheochromocytoma" Research Report 2009, Research Project on Overcoming Intractable Diseases Project being conducted by the Ministry of Health, Labour and Welfare Overview of Demser Capsule 250 mg Product Name Demser Capsule 250 mg Generic name (JAN) Metyrosine Indication Improvement of status of catecholamine excess secretion in patients with pheochromocytoma Dosage and administration Usually, for adults and children 12 years of age and older, start to administer 500 mg of metyrosine orally daily. When the effect is insufficient, titrate the dose by 250 mg or 500 mg daily at intervals of 3 days or more by monitoring the clinical course closely, and dosage should be adjusted under adequate observation of urinary catecholamine amount and symptoms of the patient. However, the maximum daily dose is 4,000 mg with the highest dose of 1,000 mg per dose at intervals of 4 hours or longer. The daily dose of 500 mg is divided twice a day, 750 mg three times a day and 1,000 mg four times a day. Manufacturer/distributor Ono Pharmaceutical Co., Ltd. Approval date January 8, 2019 Conditions for approval 1. Risk Management Plan should be designed appropriately implemented. 2. Because of the very limited number of patients treated with the product in Japanese clinical trials, a post-marketing use-results survey covering all cases should be performed until data on a certain minimum number of patients have been accumulated. Through these activities, actions necessary to ensure the proper use of the product should be taken by identifying the characteristics of patients to be treated with the product and collecting safety and efficacy data as soon as possible.

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