Selexis Expands Strategic Immuno-Oncology Alliance with Agenus

On January 9, 2019 Selexis SA, a pioneering life sciences company and a global leader in mammalian cell line generation technology, reported that it has signed additional commercial license agreements (CLAs) with Agenus Inc., (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune-modulating antibodies, cancer vaccines, and adoptive cell therapies (Press release, Selexis , JAN 9, 2019, View Source [SID1234532600]).1 Under the new CLAs, Agenus will leverage Selexis’ modular SUREtechnology Platform for the rapid, stable, and cost-effective production of its therapeutic proteins.

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"It’s gratifying to have the opportunity to play a part in Agenus’ mission to redefine cancer treatment by advancing promising new biologics for individuals living with cancer," said Yemi Onakunle, PhD, MBA, Selexis vice president, licensing and business development. "The Selexis team has a notable track record of success in helping our partners overcome protein-expression challenges and advance products rapidly and safely through the clinic to the market where they can be made available to patients in need."

The Selexis SUREtechnology Platform improves the way mammalian cells are used in the discovery, development and manufacturing of recombinant proteins and drugs. The platform provides key significant advantages over traditional approaches, enabling: speed, high-yield, stability and flexibility.

"Our fully integrated capabilities, from early discovery of protein therapeutics to GMP manufacturing, allows us to rapidly produce and clinically test promising new drug candidates thereby delivering innovation with speed. A critical step in this process is the in-house development of commercially viable cell-lines expressing novel and complex proteins," said Alex Duncan, PhD, chief technology officer at Agenus. "We have successfully used the Selexis’ platform to drive our lead anti-CTLA4 (AGEN1884) and anti-PD1 (AGEN2034) programs, and are excited to partner with them to advance our novel single agent and multi-specific antibody programs."

Veracyte to Present at the 21st Annual Needham Growth Conference

On January 9, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported that Bonnie H. Anderson, chairman and chief executive officer, is scheduled to present at the 21st Annual Needham Growth Conference in New York City on Tuesday, January 15, 2019 at 8:40 a.m. EST (5:40 a.m. PST) (Press release, Veracyte, JAN 9, 2019, View Source [SID1234532601]).

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A live audio webcast of the company’s presentation will be available by visiting Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

Halozyme Provides 2019 Pipeline Update And Financial Guidance At 37th Annual JP Morgan Healthcare Conference

On January 9, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported its 2019 financial guidance at the 37th annual JP Morgan Healthcare Conference (Press release, Halozyme, JAN 9, 2019, View Source [SID1234532605]).

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"Looking ahead, our ENHANZE business is gaining momentum with key product development milestones expected this year, including potential FDA approval of a subcutaneous formulation of Herceptin and regulatory submissions for the subcutaneous formulation of Darzalex each representing important near-term catalysts," said Dr. Helen Torley, president and chief executive officer. "In our oncology business, HALO-301 has completed enrollment and topline results are projected in the second half of 2019."

Halozyme provided an update on the 2019 outlook for its ENHANZE franchise. The company expects to make meaningful progress this year toward its projection of the potential for approximately $1 billion in royalty revenue in 2027. During the first quarter, FDA action is expected on the Biologics License Application (BLA) filed by ENHANZE partner Genentech, a member of the Roche Group, for the subcutaneous (SC) formulation of trastuzumab (Herceptin). In the second half of 2019, ENHANZE partner Janssen Biotech, Inc. anticipates filing for approval of the SC formulation of its multiple myeloma drug daratumumab (Darzalex). Also in the second half, Halozyme expects a phase 3 study will be initiated by a partner for an undisclosed target.

By the end of 2019, the company expects three ENHANZE programs to be in phase 3 studies and to have nine active phase 1 programs in addition to its three currently marketed products. This accelerating partner activity supports the projection of the potential for approximately $1 billion in royalty revenue in 2027. Additionally, potential lifetime milestone payments associated with existing ENHANZE partnership programs in development are projected to be $1 billion, with $225 million to $300 million in revenues projected between 2019 and 2021.

The company also provided an update on its late stage targeted oncology asset PEGPH20. Enrollment in HALO-301, the company’s phase 3 study evaluating PEGPH20 in metastatic pancreas cancer, was completed at the end of 2018 with approximately 500 subjects enrolled. The company projects the study will achieve its target of 330 OS (overall survival) events between August and November of 2019. Based on this timeline, the company projects topline results will be available in the second half of 2019.

Halozyme and its partners continue to explore the pan-tumor potential of PEGPH20. This includes ongoing phase 1b studies in pancreas cancer, gastric cancer, gall bladder cancer and cholangiocarcinoma.

2019 Financial Guidance

The company also provided financial guidance for 2019:

Net revenue of $175 million to $185 million, excluding revenue from any new ENHANZE global collaboration and licensing agreements.
Operating expenses of $265 million to $275 million, or $225 million to $235 million excluding an expected increase in cost of goods sold. Excluding the cost of goods sold the modest increase in expenses is driven by ENHANZE partner support, and support of the potential commercialization of PEGPH20.
Operating cash burn of $75 million to $85 million.
Debt repayment of approximately $90 million.
Year-end cash balance of $180 million to $190 million.
Table 1. 2019 Financial Guidance

Guidance Range

Net Revenue

$175 million to $185 million

Operating Expenses

$265 million to $275 million

Operating Expenses (excl. COGS)

$225 million to $235 million

Operating Cash Burn

$75 million to $85 million

Debt Repayment

~$90 million

Year-end Cash Balance

$180 million to $190 million

The company plans to report fourth quarter and full year 2018 financial results on February 21, 2019.

A replay of Dr. Torley’s presentation at the conference today can be accessed for the next 90 days via the "Investors" section of www.halozyme.com. Also, a copy of the presentation made today was filed with the Securities and Exchange Commission as part of a Form 8-K that can also be accessed via the "Investors" section of www.halozyme.com.

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)