1stOncology™: Cancer Intelligence Service – Page 14368 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

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".

Systems Oncology to Present at eChinaHealth Event During the 37th Annual J.P. Morgan Healthcare Conference

On January 8, 2019 Systems Oncology, an AI-based biopharmaceutical company, reported that Dr. Spyro Mousses, Chief Executive Officer, will present their rapidly growing pipeline of innovative oncology programs discovered with their ExpansiveAI platform, during the 37th annual J.P. Morgan Healthcare Conference in San Francisco, CA (Press release, Systems Oncology, JAN 8, 2019, View Source [SID1234532586]). The presentation is scheduled for Wednesday, January 9th at 10:45AM PST as part of Pitch Day presented by eChinaHealth.

The presentation will give specific examples of new programs and collaborative research opportunities that emerged from Systems Oncology’s unique ability to translate big data into novel insights. Systems Oncology then leverages its unique insights into cancer biology and clinical/regulatory development opportunities to enter into in-licensing and out-licensing deals with organizations around the world to build drug development programs and collaborate with partners to drive these programs forward. Systems Oncology recently closed another two deals: its first deal in China, an in-licensing agreement with a major Chinese university; and its first venture into Japan, an out-licensing collaboration with Toray Industries, a large Japanese corporation, on TRK-880, a novel anti-cancer drug that is projected to be effective across many cancer indications. The presentation at the eChinaHealth event will highlight some of these successful international programs and express Systems Oncology’s interest to continue to collaborate and partner with organizations in Asia as part of its overall global outreach.

ImmunoGen Announces Sale of Residual Kadcyla Royalties

On January 8, 2019 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported the sale of its residual rights to receive royalty payments on commercial sales of Kadcyla (ado-trastuzumab emtansine) to OMERS, the defined benefit pension plan for municipal employees in the Province of Ontario, Canada, for $65 million (Press release, ImmunoGen, JAN 8, 2019, View Source [SID1234532585]).

"ImmunoGen played a key role in the generation and early development of Kadcyla, the first ADC approved for the treatment of HER2-positive breast cancer, and we are pleased to see the continued progress of this important therapy in the market," said Mark Enyedy, President and Chief Executive Officer. "As ImmunoGen evolves into a fully-integrated company with our proprietary portfolio, this transaction further strengthens our balance sheet as we execute on our strategic priorities and work to deliver more good days to people living with cancer."

This transaction entails the sale of the residual interest held by ImmunoGen from a prior transaction with Immunity Royalty Holdings, L.P. (IRH). In 2015, ImmunoGen announced a $200 million non-dilutive royalty transaction through which ImmunoGen sold the right to receive 100% of the royalty revenue on Kadcyla commercial sales to an undisclosed threshold amount, subject to certain conditions. Once the applicable threshold was met, ImmunoGen would receive 85% of the Kadcyla royalty revenue and the original purchaser would receive 15% for the remaining term of the royalty. With this transaction, OMERS now owns 100% of ImmunoGen’s rights to receive Kadcyla royalties.

MTS Health Partners, L.P. acted as exclusive financial advisor to ImmunoGen and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. acted as special transactional counsel to ImmunoGen.

ABOUT KADCYLA ROYALTIES

Genentech, a member of the Roche Group, developed Kadcyla (ado-trastuzumab emtansine) using ADC technology licensed from ImmunoGen under a 2000 agreement established between the companies. This agreement entitles ImmunoGen to receive royalties ranging from 3-5% on Kadcyla sales in countries where ImmunoGen holds valid patents covering Kadcyla, and 2% in countries without relevant ImmunoGen patents. ImmunoGen is entitled to receive royalties on commercial Kadcyla sales in each country for ten years after the launch of Kadcyla in that country. This period extends to twelve years for each country in which ImmunoGen has valid claims in relevant patents on the tenth anniversary of the commercial launch of Kadcyla in that country.

ABOUT OMERS

Founded in 1962, OMERS is one of Canada’s largest defined benefit pension plans, with more than $95 billion in net assets, as at December 31, 2017. It invests and administers pensions for almost half a million members from municipalities, school boards, emergency services, and local agencies across Ontario. OMERS has employees in Toronto and other major cities across North America, the U.K., Europe, Asia, and Australia – originating and managing a diversified portfolio of investments in public markets, private equity, infrastructure, and real estate. For more information, please visit www.omers.com.

Adimab Provides Year-End Update on 2018 Partnership Activities

On January 8, 2019 Adimab, LLC, the global leader in the discovery and optimization of fully human monoclonal and bispecific antibodies, reported that in 2018 it entered into agreements with 10 new companies (Press release, Adimab, JAN 8, 2019, View Source [SID1234532584]). In addition, Adimab announced the expansion of seven of its current partnerships and the achievement of 70 technical and development milestones across numerous collaborations.

In the past ten years, Adimab has partnered with over 60 companies for the discovery of therapeutic IgGs and bispecific antibodies, resulting in more than 260 therapeutic programs derived from the Adimab Platform. In 2018, Adimab and its partners added 56 new therapeutic programs. New alliances for 2018 include collaborations with Biotheus, Boehringer Ingelheim, Cullinan Oncology, Cygnal Therapeutics, Pliant Therapeutics, REGiMMUNE, and Werewolf Therapeutics, among others. In addition, Adimab expanded its collaborations with Boehringer Ingelheim, Innovent Biologics, Mapp Biopharmaceutical, Sanofi, Surface Oncology, and Takeda.

"In 2018, we saw fantastic growth in the number of therapeutic programs coming from our platform," said Guy Van Meter, Senior Vice President of Business Development. "In addition to being the leader for antibody discovery, Adimab has become the go-to provider for bispecifics and protein engineering. Our partners really benefit from our deep domain expertise and get to access all our capabilities."

"In an industry that is used to exaggerated claims, we have proven time and time again that we deliver the highest quality therapeutic leads," added Tillman Gerngross, Chief Executive Officer and Co-Founder of Adimab. "To date more than 80% of our partners have expanded their partnership with Adimab, which is a meaningful indicator of the quality of our work."

Over the past five years, Adimab has worked with an increasing number of smaller companies, backed by leading venture capital firms. Following successful antibody discovery campaigns, many of these companies have gone on to partner their programs with larger pharmaceutical companies. Publicly announced transactions include: Tizona and Abbvie (2019), Dragonfly and Merck (2018), Tusk and Roche (2018), Scholar Rock and Gilead (2018), Alector and Abbvie (2017), Dragonfly and Celgene (2017), Mersana and Takeda (2016), Surface Oncology and Novartis (2016), Potenza and Astellas (2015, 2018), and Innovent and Lilly (2015).

"Roche was very thorough in their diligence, and the quality of the leads and the data from Adimab made the process much smoother," said Luc Dochez, former Chief Executive Officer of Tusk Therapeutics.

"Investors and partners invariably conduct extensive diligence on the structural and pharmacological properties of our drug leads," said Arnon Rosenthal, Co-Founder and Chief Executive Officer of Alector. "Adimab data and the support of the Adimab team were critical elements in developing compelling product candidates."

"Adimab has been a fantastic partner. The Adimab team is comprised of leading scientists, using state of the art technology, who have a sense of urgency towards their collaborators. I cannot praise them highly enough," said Bill Haney, Co-Founder and Chief Executive Officer of Dragonfly Therapeutics.

UroGen Pharma Announces Positive Results of UGN-101 from Pivotal Phase 3 OLYMPUS Trial for the Non-Surgical Treatment of Patients with Low-Grade Upper Tract Urothelial Cancer (LG UTUC)

On January 8, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, reported topline results from the ongoing pivotal Phase 3 OLYMPUS clinical trial of UGN-101 (mitomycin gel) for instillation, an investigational mitomycin formulation for the non-surgical treatment of low-grade upper tract urothelial cancer (UTUC) (Press release, UroGen Pharma, JAN 8, 2019, View Source [SID1234532583]). This analysis showed that on an intent-to-treat basis, 57 percent of patients achieved a complete response (CR) rate at their primary disease evaluation (PDE, or the primary endpoint) which was conducted four to six weeks after completion of UGN-101 treatment. Importantly, all evaluated patients in CR remain disease free at six months.

This international, multi-center trial completed enrollment with 71 patients in December 2018. Of the 71 patients enrolled in the trial, 61 patients have been evaluated for the primary endpoint which was a CR as defined as a negative ureteroscopic evaluation and a negative wash cytology. The remaining 10 patients are awaiting PDE evaluation.

"We are pleased to report that the CR and durability data remain consistent with the Interim Analysis presented in May 2018. These results continue to validate the potential of UGN-101 to shift the surgical treatment paradigm and benefit patients whose only alternative would be repetitive endoscopic surgical intervention or complete loss of a kidney," said Mark P. Schoenberg, M.D., Chief Medical Officer of UroGen. "The durability observed in the OLYMPUS study provides further evidence that the non-surgical treatment of LG UTUC with UGN-101 may result in clinically-meaningful, recurrence free survival. We are grateful to the patients, their families, and clinical investigators who have made this important study possible."

Approximately 45 percent of tumors treated were categorized as unresectable by surgery at baseline. Of the patients who achieved CR, UroGen now has six-month durability on half of these patients. Durability is a key secondary endpoint for the trial.

The safety profile of UGN-101 continues to be acceptable with most treatment-emergent adverse events characterized as mild or moderate and transient and in line with ureteral procedures. These included ureteral narrowing and hydronephrosis, urinary tract infection, flank pain and creatinine elevation.

UroGen intends to seek regulatory approval of UGN-101 in LG UTUC based on data from all 71 patients and initiated its rolling submission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in December 2018. The FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to UGN-101 for the treatment of UTUC. If approved, UGN-101 would be the first drug approved for the non-surgical treatment of LG UTUC.

Seth Paul Lerner, M.D., FACS, Professor of Urology at Baylor College of Medicine in Houston, Texas served as Principal Investigator of the OLYMPUS trial.

About UGN-101

UGN-101 (mitomycin gel) for instillation is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of low-grade upper tract urothelial cancer (LG UTUC). Utilizing the RTGel technology platform, UroGen’s proprietary sustained release, hydrogel-based formulation, UGN-101 is designed to enable longer exposure of mitomycin to urinary tract tissue, thereby enabling the treatment of tumors by non-surgical means. UGN-101 is delivered to patients using standard ureteral catheters.