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".

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 [SID1234553884]).

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"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.

On January 7, 2019 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported that the ongoing multi-center clinical trial of CK-301 has been expanded to enroll patients in three cohorts intended to support requests for accelerated approval and Biologics License Application (BLA) submissions to the U.S. Food and Drug Administration (FDA) (Press release, Checkpoint Therapeutics, JAN 7, 2019, View Source [SID1234532508]). These cohorts include:

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• Microsatellite instability-high (MSI-H) endometrial cancer that has progressed following one or two prior anti-cancer therapies;

• Microsatellite stable (MSS) endometrial cancer that has progressed following one or two prior anti-cancer therapies; and

• MSI-H or mismatch repair deficient (dMMR) colorectal cancer that has progressed on or after, or been intolerant of, previous treatments, including a fluoropyrimidine-and oxaliplatin-and irinotecan-based chemotherapy.

Each cohort is evaluating a fixed dose of 800 mg CK-301 every two weeks (Q2W). The primary endpoint for each cohort is objective response rate (ORR), and secondary endpoints include duration of response (DOR), progression-free survival (PFS), and overall survival (OS). The ongoing trial is also enrolling cohorts of patients with non-small cell lung cancer (NSCLC) and cutaneous squamous cell carcinoma.

"We are excited to advance our first immuno-oncology drug candidate, CK-301, into these potentially registration-enabling cohorts, representing a significant milestone in the execution of our strategy to obtain multiple accelerated approvals for our anti-PD-L1 antibody," said James F. Oliviero, President and Chief Executive Officer of Checkpoint. "We look forward to presenting interim safety and efficacy data from the ongoing clinical trial in the coming months."

The Phase 1, open-label, multi-center trial is evaluating the safety and tolerability of ascending doses of CK-301 in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers. Following completion of dose escalation in 2018, multiple dose expansion cohorts were initiated. Preliminary data from the ongoing trial suggest that CK-301 is safe and well-tolerated across dose levels ranging from 200 mg to 800 mg administered every two weeks and 1200 mg administered every three weeks, with treatment-related adverse events consistent with marketed anti-PD-1/PD-L1 antibodies.

About CK-301
CK-301 is a fully-human monoclonal antibody of IgG1 subtype that directly binds to Programmed Death Ligand-1 (PD-L1) and blocks the PD-L1 interaction with the Programmed Death Receptor-1 (PD-1) and B7.1 receptors. PD-L1 is an immune-inhibitory checkpoint molecule expressed on epithelial and vascular endothelial cells, as well as by a number of immune cells, and is utilized by tumor cells as an immune escape mechanism. CK-301’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response

On January 7, 2019 Coherus BioSciences, Inc. (Nasdaq: CHRS), a commercial biosimilar company, reported that it has entered into a $75 million senior secured credit facility agreement with Healthcare Royalty Partners (Press release, Coherus Biosciences, JAN 7, 2019, View Source [SID1234532524]).

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"We are pleased to have the renewed support of HealthCare Royalty Partners," said Denny Lanfear, President and CEO of Coherus. "This financing bolsters our cash position and working capital, enabling us to accelerate and enhance the manufacture and sale of UDENYCA (pegfilgrastim-cbqv), which we launched January 3, 2019. We look forward to providing significant value to cancer patients, oncology clinics and hospitals, as well as providing significant savings to payers."

"This investment reflects our continued confidence in the Coherus leadership team, as well as their ability to execute on their commercial plan," said Clarke Futch, Managing Partner and Chairman of the Investment Committee of Healthcare Royalty Partners. "We are honored to help Coherus in its mission to serve patients and deliver savings to the healthcare system. With this second investment in Coherus, we look forward to their continued growth and success."

The senior secured credit facility matures on January 7, 2025 and pays interest quarterly at a rate of 3–month LIBOR plus 7% per annum. Subject to other customary fees, the senior secured credit facility will also be subject to a 4% final payment premium owed on the entire principal amount funded.

On January 7, 2019 Generex Biotechnology Corporation (OTCQB:GNBT) is reported that Joe Moscato, the company’s CEO is attending the annual J.P. Morgan Healthcare Conference from January 7 to 9, 2019 (Press release, Generex, JAN 7, 2019, View Source [SID1234532540]). Mr. Moscato is meeting with leading healthcare investors to present the corporate vision for Generex Biotechnology as an integrated healthcare holding company with a unique strategy to provide end-to-end, patient centric solutions to enhance the doctor patient relationship.

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With 9,000 attendees and representation from over 450 companies, the annual J.P. Morgan Healthcare Conference is the largest and most informative healthcare investment symposium in the industry, bringing together industry leaders, emerging fast-growth companies, innovative technology creators, and members of the investment community.

"We are pleased to unveil the "New" Generex to the biotech and healthcare investment community," stated Joe Moscato, CEO of Generex. "After two-plus years of reorganizing the operations, capital structure, and strategic vision for the company, Generex is poised to deliver on our corporate mission to provide physicians, hospitals, and healthcare providers an end-to-end solution for patient centric care from rapid diagnosis through delivery of personalized therapies, streamlining care processes, minimizing expenses, and delivering transparency for payers. Entering 2019, we are building value in Generex by executing on our strategic plan with our newly acquired MSO and pharmacy network, the advancement of our clinical stage assets in immune-oncology, and through acquisitions in cutting-edge areas like regenerative medicine."