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Five Prime Therapeutics Provides Update on Phase 2 Trial of Cabiralizumab Combined with Opdivo® in Pancreatic Cancer

On February 18, 2020 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, reported that Bristol-Myers Squibb informed the company that the randomized Phase 2 trial testing the combination of cabiralizumab with Opdivo (nivolumab) with and without chemotherapy in patients with advanced pancreatic cancer did not meet its primary endpoint (Press release, Five Prime Therapeutics, FEB 18, 2020, View Source [SID1234554429]). While Bristol-Myers Squibb has no near term plans for additional sponsored development of cabiralizumab, Bristol-Myers Squibb will continue to support the evaluation of cabiralizumab in select, ongoing investigator-sponsored trials and may continue to assess future development opportunities for the investigational asset. Bristol-Myers Squibb also informed the company that no new safety signals were observed in the Phase 2 trial.

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"Pancreatic cancer is a difficult disease to treat, and unfortunately the combination of cabiralizumab and Opdivo with and without chemotherapy did not show any meaningful benefit over standard of care chemotherapy in this randomized, controlled Phase 2 trial," said Helen Collins, M.D., Executive Vice President and Chief Medical Officer of Five Prime Therapeutics. "We are disappointed by this outcome and appreciate the participation of the investigators, staff, patients, caregivers, and our development partner who all contributed to the conduct and completion of this Phase 2 clinical trial."

The multi-arm, randomized, controlled Phase 2 clinical trial (NCT03336216) enrolled approximately 160 patients with locally advanced or metastatic pancreatic cancer that has progressed during or after one line of chemotherapy.

Dynavax to Present at the Cowen 40th Annual Health Care Conference

On February 18, 2020 Dynavax Technologies Corporation (NASDAQ: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported that Ryan Spencer, Chief Executive Officer, will present at the Cowen 40th Annual Health Care Conference on Monday, March 2, at 1:30 p.m. E.T (Press release, Dynavax Technologies, FEB 18, 2020, http://investors.dynavax.com/news-releases/news-release-details/dynavax-present-cowen-40th-annual-health-care-conference [SID1234554426]).

The presentation will be webcast and may be accessed through the "Events & Presentations" page on the "investors" section of the Company’s website at View Source

CANBRIDGE PHARMACEUTICALS COMPLETES US$98 MILLION SERIES D FINANCING

On February 18, 2020 CANbridge Pharmaceuticals Inc., a biopharmaceutical company developing innovative drug candidates to treat underserved medical conditions in China and other markets, reported the completion of a US$98 million Series D financing (Press release, CANbridge Life Sciences, FEB 18, 2020, View Source [SID1234554425]). The round was led by General Atlantic, a leading global growth equity firm, and WuXi AppTec. Each firm also has the option to invest up to an additional $10 million, upon the satisfaction of certain conditions by CANbridge. Additional participating investors in this round include RA Capital Management, Hudson Bay Capital Management, YuanMing Prudence Fund and Tigermed. The proceeds, the majority of which come from global investors, will be used to accelerate and expand the CANbridge rare disease pipeline through internal development and external partnerships, further build CANbridge’s commercial infrastructure and capabilities in China and supplement working capital.

CANbridge has a deep rare disease pipeline, including Hunterase, for which it filed a New Drug Application (NDA) in China and has plans to commercialize the drug this year. In addition, CANbridge recently entered into the commercial stage with two approved oncology products, Caphosol, in mainland China, and NERLYNX (neratinib), in Hong Kong.

"That most of this capital raise comes from global life science investors, indicates the level of enthusiasm CANbridge is generating on the world stage as an industry leader in rare disease in China," said James Xue, PhD, Founder, Chairman and CEO, CANbridge Pharmaceuticals. "We look to the future, as CANbridge continues to advance as a commercial-stage company with the powerful backing and endorsement of such investors."

"CANbridge is an early mover and a leader in China’s rare disease market," said Lefei Sun, Managing Director and Head of Healthcare for China at General Atlantic. "The company has built a rich pipeline of candidates, and we believe that CANbridge is well-positioned to capture the substantial market opportunity in the Chinese biotechnology space. We are excited to partner with the CANbridge team to support the company’s vision to bring innovative therapeutics to patients across China."

"CANbridge is developing a compelling and deep pipeline of assets, focused around directly addressing the unmet needs of patients with rare genetic diseases in China and around the world," said Derek DiRocco, PhD, Principal, RA Capital Management. "The leadership team at CANbridge is equipped with an impressive background, anchored in the development of rare disease therapeutics, and is poised to build the regulatory and commercial infrastructure necessary to significantly advance the rare disease segment of China’s biotech industry. RA Capital is excited to partner with CANbridge, and shares in leadership’s vision of building an innovative biotech company that aims to deliver effective therapeutics to patients in need."

Cellectis and Servier Expand Collaboration on UCART19 Products

On February 18, 2020 Cellectis (Euronext Growth: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), and Servier, an international pharmaceutical company, reported the execution of a binding term sheet to enter into an amendment to the agreement initially signed between the two companies in 2014 (Press release, Cellectis, FEB 18, 2020, View Source [SID1234554424]).

Under the term sheet, Cellectis shall grant to Servier, through an amendment to the agreement, an expanded exclusive worldwide license to develop and commercialize all next generation gene-edited allogeneic CAR T-cell products targeting CD19, including rights to ALLO-501A, an anti-CD19 candidate in which the rituximab recognition domains have been removed, either directly or through its US sublicensee Allogene Therapeutics.

In this amendment, financial terms will be improved to include an additional USD 27.6 million (EUR 25 million) upfront payment, as well as up to USD 410 million (EUR 370 million) in clinical and commercial milestones. The royalty rate will be increased from tiered high single-digit royalties to flat low double-digit royalties based on net sales of products.

In addition, pursuant to the amendment, Cellectis shall regain exclusive control over the five undisclosed allogeneic CAR T-cell targets previously covered by the initial agreement.

The amendment will be effective upon its execution.

"This amendment to our license agreement with Servier provides to Cellectis an attractive economic upside to product candidates targeting CD19 and enriches our proprietary portfolio of targets," said Dr. André Choulika, Chairman and CEO, Cellectis. "We are committed to positioning Servier and Allogene for streamlined success, so the CD19-directed products have the potential to reach patients faster, while also providing Cellectis the means to expand our proprietary product pipeline."

About UCART19/ALLO-501 and ALLO-501A

UCART19/ALLO-501 and ALLO-501A are two anti-CD19 allogeneic CAR-T product candidates being jointly developed under a clinical development collaboration between Servier and Allogene Therapeutics based on an exclusive license granted by Cellectis to Servier.

Such products utilize Cellectis’ technologies, including TALEN gene editing technology pioneered and controlled by Cellectis. Servier grants to Allogene exclusive rights to UCART19 in the US while Servier retains exclusive rights for all other countries.

Research suggests statins could lower ovarian cancer risk

On February 18, 2020 Cancer Research UK reported that a genetic study has found evidence to suggest that women who take statins in the long term could be less likely to develop ovarian cancer (Press release, Cancer Research UK, FEB 18, 2020, View Source [SID1234554423]).

"Our findings open up the possibility of repurposing a cheap drug to help prevent ovarian cancer – especially in women who are at a higher risk." – Professor Richard Martin
The same result was also found in women who carry the BRCA1/2 gene fault. Having the BRCA1/2 fault puts women at a higher risk of ovarian cancer than the general population*.

The research published in JAMA studied genes and the extent to which they inhibit the enzyme HMG-CoA reductase – which is responsible for regulating cholesterol in the body – and is the exact enzyme targeted by statin drugs to reduce cholesterol.

While the study suggests that statins could lower ovarian cancer risk, more research needs to be done specifically looking at their use and impact on women’s risk of developing the disease.

The researchers based at the University of Bristol looked at 63,347 women between the ages of 20 and 100 years old, of whom 22,406 had ovarian cancer. They also looked at an additional 31,448 women who carried the BRCA1/2 fault, of whom 3,887 had ovarian cancer. The study used an approach called Mendelian randomization, which involves analysing the genetic data from thousands of people.

Statins may protect against the development of ovarian cancer because they’ve been shown to induce apoptosis – one of the body’s ways of getting rid of old, faulty or infected cells – and to stop tumours from growing in laboratory studies. Another line of thought is that statins lower circulating cholesterol, which helps regulate cell growth, though this research suggests that lower circulating cholesterol was not the method by which statins may reduce ovarian cancer risk.

The findings suggest that long-term statin use could be associated with an estimated 40% reduction in ovarian cancer risk in the general population, although the estimate comes from looking at gene variation rather than statins themselves, and the exact mechanism by which these genes are associated with lower ovarian cancer risk is unclear.

Ovarian cancer is the 6th most common cancer in women in the UK. There are around 7,400 cases each year**, and out of those with a known stage at diagnosis, almost 6 in 10 are diagnosed at a late stage***. Around 4,100 women die from the disease every year in the UK.

There is no test that reliably picks up ovarian cancer at an early stage, so chemoprevention could be an important approach to saving lives.

Professor Richard Martin, from the University of Bristol, said: "Our findings open up the possibility of repurposing a cheap drug to help prevent ovarian cancer – especially in women who are at a higher risk. It’s incredibly interesting that women whose bodies naturally inhibit the enzyme targeted by statins have a lower risk of ovarian cancer, but we don’t recommend anyone rushes to take statins specifically to reduce ovarian cancer risk because of this study.

"It’s a promising result and I hope it sparks more research and trials into statins to demonstrate conclusively whether or not there’s a benefit."

Dr Rachel Orritt, Cancer Research UK’s health information manager, said: "This study is a great first step to finding out if statins could play a role in lowering ovarian cancer risk, and justifies future research into this area.

"But there’s not yet enough evidence to know if statins themselves could reduce the risk of developing ovarian cancer safely. And it’s important to remember that the risk of developing ovarian cancer depends on many things including age, genetics and environmental factors. Speak to your doctor first if you have any concerns about your risk."