LineaRx to Collaborate with Italy’s Takis and Evvivax on Cancer Vaccines

LineaRx, a subsidiary of Applied DNA Sciences, has entered into a Joint Development Agreement with Takis SRL and Evvivax SLR. They will focus on developing anti-cancer vaccines.

Under the terms of the deal, LineaRx and Takis and Evvivax will work together to develop linear DNA expression vectors of two of Takis/Evvivax’s anti-cancer vaccine candidates. They will use LineaRx’s linear DNA technology.

The companies have a previous collaboration in place, launched in November 2017, which they say has shown promise in mouse models. Takis SRL is based in Rome, Italy. Its focus is on developing therapeutic cancer vaccines. EvviVax is also based in Rome, and focuses on engineered veterinary vectored immunotherapy and vaccines. It is a spin-off of Takis.

“We are excited to co-develop linear DNA expression vectors for our DNA vaccine candidates with LineaRx,” stated Luigi Aurisicchio, chief executive officer of Takis/Evvivax. “The advantages of linear DNA over plasmids would provide a clear market edge over plasmid-based DNA sources. We look forward to a mutually beneficial collaboration.”

LineaRx was only formed on September 18. Applied DNA Sciences is a leader in large-scale PCR-based DNA manufacturing. LineaRx was formed to commercialize Applied DNA Sciences’ “experience in the design, manufacture and chemical modification of DNA by large-scale polymerase chain reaction in the field of biotherapeutics.”

Linear DNA is what comes out of PCR, which is distinct from plasmids grown in bacteria—plasmids are circular. LinearRx will focus on gene therapy, immuno-oncology and DNA vaccines. Most gene therapies are based on plasmids, but they are also associated with the genes for antibiotic resistance, which can cause problems in gene therapy.

“We believe the launch of LineaRx will unlock significant value to the benefit of Applied DNA shareholders and to the world of healthcare,” said James Hayward, president and chief executive officer of Applied DNA, in a statement. “Our proprietary and patented approach to linear DNA manufacturing holds the promise to deliver more efficient, affordable and safer genetic therapeutics to a broad patient population.”

In explaining how LineaRx and Applied DNA differs, and why they split off LineaRx, Hayward said, “Unlike Applied DNA’s taggant business, in which the DNA is short and nonfunctional by design, LineaRx DNA sequences are long (gene-sized) and contain the control elements that allow their expression in cells after specialized delivery to the cells. The segregation between the divisions enables the companies to differentiate their product portfolios, business units, operations and regulatory affairs.”

Applied DNA is licensing multiple patents related to therapeutic applications to LineaRx. They include the rights to manufacture DNA via PCR using Applied DNA’s patented systems under cGMP conditions and the capacity for remote control. This potentially can allow for rapid manufacturing in a distributed network on the battlefield or in hospitals that use gene therapies like CRISPR or cellular therapies like CAR-T.

As part of the spinoff, LineaRx takes on Applied DNA’s Contract Research Organization (CRO) and Contract Manufacturing Organization (CMO) activities to the biotherapeutics market. “By segregating our markets, and differentiating our sales teams, we expect to be able to better focus our selling efforts,” Hayward stated. “LineaRx will provide prospective customers and development partners access to a unique portfolio of patented and proprietary linear DNA technologies designed to effectively optimize delivery, improve targeting, and extend expression of gene therapy products.”

https://www.biospace.com/article/am6a-linearx-to-collaborate-with-italian-companies-takis-and-evvivax-on-cancer-vaccines/

China’s Hillhouse Capital’s New Fund Has $10.6 Billion to Invest

China’s Hillhouse Capital Group, an equity investment firm, has a new fund, Hillhouse Fund IV, with $10.6 billion ready to invest. The close of this new fund makes it the biggest capital raise by a private-equity company in Asia.

Hillhouse plans to invest in companies focused on healthcare, consumer, technology and services sectors globally, although mostly in Asia. It has made investment in well-known companies like search engine Baidu, AirBnB and Uber Technologies.

In the biopharma arena, it co-led a series C financing round in biotech company Jacobio Pharmaceuticals in August worth $55 million and led a $35 million series B+ round in Hangzhou Just Biotherapeutics in June.

It was also part of a group of investors that in 2015 delisted China’s biotechnology company WuXi AppTec from the New York Stock Exchange with its founder Li Ge and took the company private in a $3.3 billion deal. WuXi AppTec has recently applied for an initial public offering (IPO) in Hong Kong. WuXi AppTec began trading on the Shanghai Stock Exchange in May.

WuXi AppTec was founded in 2000 in Shanghai. Since it began trading on the Shanghai Stock Exchange, its shares have almost quadrupled, giving it a market value of $13 billion.

Hillhouse Capital Group was founded in 2005 by Zhang Lei, a Chinese investor and entrepreneur. He also acts as its chief executive officer. Zhang holds master’s degrees from Yale University, where he also performed an internship with the college’s endowment. The endowment later granted him $20 million in seed funding.

In a June 2017 speech Zhang gave at his undergraduate alma mater, Renmin University of China in Beijing, Hillhouse manages around $30 billion in assets.

“We are deeply grateful for the ongoing trust of our partners,” Zhang said in a statement, regarding the new fund. “We look forward to working with innovation-minded, world-class businesses and management teams seeking to deploy technology-driven solutions to create value for all stakeholders.”

Reuters reports, “The Hillhouse fund adds to a massive industry-wide pool of money for Asian acquisitions and investments, with investors attracted by rapid economic growth and a growing number of technology companies compared to other major markets.”

For example, in June, Blackstone Group raised about $9.4 billion for two new funds.

Previously, in June 2017, the largest fundraising by a private equity firm in Asia was KKR & Co’sAsia-focused buyout fund, which closed on $9.3 billion.

Earlier this year, Hillhouse led a group of investors in an attempt to acquire Yum China Holdings in an all-cash deal worth more than $17 billion. Yum China is the country’s largest restaurant operator, holding licensed to KFC, Pizza Hut and Taco Bell in the country. However, Yum China’s board rejected the bid.

Per an August Financial Times report, since 2012, research and development cooperation between U.S. companies and China are up 70 percent. The Chinese biopharma industry is booming. Examples include China’s BeiGene partnering with SpringWorks Therapeutics to focus on solid tumors. And in August, WuXi’s subsidiary, Shanghai Syntel Pharmaceutical Co., Ltd., a opened a site in San Diego to provide process research and development in addition to API manufacturing services for early phase clinical studies. WuXi also has partnerships with several U.S. companies, including Unity Biotechnology, IDEAYA Biosciences, and Juno Therapeutics.

https://www.biospace.com/article/not-just-pocket-change-china-s-hillhouse-capital-s-new-fund-has-10-6-billion-to-invest-ip3o-/

Amicus Therapeutics Buys Celenex for $100 Million up Front

Amicus Therapeutics, headquartered in Cranbury, New Jersey, inked a definitive agreement for 10 gene therapy programs licensed from Nationwide Children’s Hospital through the acquisition of Celenex. The programs were developed at The Center for Gene Therapy at The Research Institute at Nationwide Children’s Hospital and The Ohio State University. Celenex was a spinout of Nationwide Children’s Hospital.

Under the terms of the deal, Amicus will pay $100 million up front in cash. Celenex shareholders are eligible for up to $15 million in development milestones and $262 million in regulatory submission and approval milestones. Amicus indicates it doesn’t expect to pay more than $75 million over the next four years in milestones payments.

All of the programs are in neurologic lysosomal storage disorders. The three lead programs are CLN6, CLN3 and CLN8 for Batten disease. Batten disease is also called Neuronal Ceroid Lipofuscinosis (NCL), a rare and life-threatening group of disorders.

“The in-licensing and acquisition of these gene therapy programs provides an extraordinary opportunity to transform the lives of thousands of children living with some of the most devastating forms of lysosomal storage disorders, for which there are virtually no treatment options today,” said John F. Crowley, Amicus’ chairman and chief executive officer, in a statement. “The groundbreaking work of Drs. Brian Kaspar and Kathrin Meyer at Nationwide Children’s Hospital, along with collaborator, Arthur Burghes, PhD, professor at The Ohio State University, on these programs has led to remarkably strong and consistent pre-clinical results and now, in CLN6 Batten disease, encouraging early results in children.”

Two of the 10 programs have already entered human clinical trials. Amicus markets Galafold to treat Fabry disease and is currently developing a second therapeutic to treat Pompe disease. This acquisition expands the company’s pipeline significantly, shifting the focus from drugs that stabilize but don’t cure lysosomal storage disorders to potential cures.

STAT writes, “One of those newly acquired gene therapies targets the CLN6 mutation form of Batten disease. Gordon Gray, a Hollywood film producer, and his wife Kristen have two daughters born with this form of Batten. The Grays formed a scientific foundation and later co-founded Celenex as a way to find a treatment for their daughters and others with the disease.”

“Gordon and Kristen Gray moved heaven and earth to partner with these researchers to advance these potentially life-saving medicines for their daughters and now for many thousands more,” stated Crowley. “I am honored that they and their research team have chosen to entrust these 10 programs to the passionate team of scientists and entrepreneurs at Amicus. I cannot think of a better foundation for Amicus’ entry into gene therapies.”

Gordon Gray is best known for his work on the films The Rookie, Secretariat and Invincible.

BioMarin Pharmaceutical offers Brineura, a drug to treat the CLN2 type of Batten disease in children. Abeona Therapeutics is developing a gene therapy for the CLN1 type of Batten.

All 10 programs acquired in the deal leverage intrathecal delivery. This approach utilizes AAV vector technology that has been successful in other rare CNS indications, such as spinal muscular atrophy (SMA).

“The preclinical proof-of-concept we have seen to date in CLN6, CLN3, and CLN8 further support the applicability of the AAV vector we developed at Nationwide Children’s in genetic disease of the CNS,” said Kathrin Meyer, in a statement. “I firmly believe that Amicus is the optimal scientific and clinical partner to advance these programs and look forward to actively collaborating with the Amicus team on the development of these important potential therapies and getting them to as many children as quickly as possible. They truly have the potential to transform lives.”

https://www.biospace.com/article/am6a-amicus-therapeutics-buys-celenex-for-100-million-up-front/

Y-mAbs Therapeutics Looks at an $80 Million IPO

New York-based Y-mAbs Therapeutics is looking to raise $80 million with an initial public offering on Friday. The company will issue 5.3 million shares of common stock at a price of $14 to $16 per share, according to reports.

The news comes about one month after Y-mAbs filed a preliminary prospectus for a $92 million initial public offering. Since the preliminary prospectus was filed, Y-mAbs seems to have adjusted its IPO expectations.

Y-mAbs is developing antibody-based therapeutics products for the treatment of cancer. Last month the company’s lead neuroblastoma treatment naxitamab in combination with GM-CSF, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). The company is studying the combination therapy for treatment of high-risk neuroblastoma refractory to initial therapy or with incomplete response to salvage therapy in patients older than 12 months of age with persistent, refractory disease limited to bone marrow with or without evidence of concurrent bone involvement. Naxitamab is currently in Phase II development. Neuroblastoma is a rare and almost exclusively pediatric cancer that develops in the sympathetic nervous system.

“We believe that Naxitamab provides a new opportunity for pediatric patients otherwise faced with little or no options. This is an important milestone achievement for Y-mAbs, and we continue to work with the regulatory authorities to advance naxitamab to patients suffering from high-risk neuroblastoma as quickly as possible,” Thomas Gad, president and head of business development and strategy at Y-mAbs, said in a statement.

In addition to naxitamab, Y-mAbs is also developing radioiodinated omburtamab, which targets an immune checkpoint molecule called B7-H3, for the treatment of central nervous system leptomeningeal metastases (CNS/LM) from neuroblastoma. CNS/LM is a rare and usually fatal complication of NB in which the disease spreads to the membranes, or meninges, surrounding the brain and spinal cord in the CNS, the company said. In April

Y-mAbs Therapeutics is joining a rush of companies filing for IPOs this year. As BioSpace reported earlier this month, so far there have been 58 biotech IPOs in 2018. The craze began with Menlo Therapeutics in January and the most recent was Elanco Animal Health, a division of Eli Lilly.

For Y-mAbs, BofA Merrill Lynch, Cowen and Canaccord Genuity acted as the underwriters for the IPO and BTIG was co-manager, according to the Fairfield Current.

A year ago, Y-mAbs Therapeutics closed out a $30 million private equity placement that included the addition of Sofinnova Ventures and Scopia Capital Management to the ranks of the company’s shareholders. Y-mAbs Therapeutics was founded in 2015 and has 29 employees.

https://www.biospace.com/article/ip3o-y-mabs-therapeutics-looks-at-an-80-million-ipo-/

Molecular Templates, Takeda in Multiple Myeloma in Deal Worth up to $632M

Shares of Molecular Templates are up more than 52 percent in premarket trading after the company announced it has struck a deal with pharma giant Takeda Pharmaceuticals that could be worth up to $632 million to develop CD38-targeted engineered toxin bodies (ETBs).

This morning Austin, Texas-based Molecular Template said the companies will jointly develop the lead CD38-targeted engineered toxin body to target multiple myeloma. The two companies initially plan to collaborate on a CD38-targeted ETB that resulted from a previous discovery collaboration between the two companies. In an announcement late Wednesday, the two companies said they developed preclinical stage ETBs targeting CD38 under the prior discovery collaboration.

Eric Poma, chief executive and chief scientific officer at Molecular Template, said the two companies have worked closely since 2016 to develop CD38-targeted ETBs. During that time, Poma said they have made substantial improvements over its own internal program, MT-4019, a CD38 targeted ETB for multiple myeloma. Earlier this year the company said it intended to take MT-4019 into Phase I development by the end of the third quarter.

Multiple myeloma is an incurable cancer found in bone marrow. There are more than 118,000 people living with, or in remission from, multiple myeloma in the United States. Approximately 30,280 Americans are diagnosed with multiple myeloma each year and 12,590 patient deaths are reported on an annual basis, according to the American Cancer Society.

Multiple myeloma cells widely express the CD38 protein, making it an increasingly important target in the development of therapeutics for multiple myeloma. There are already some CD38-targeted treatments for multiple myeloma on the market, including Janssen’s Darzalex.

By targeting the CD38 protein with ETBs, they can deliver a modified bacterial toxin to the myeloma cells. That toxin destroys the cancer cells through the enzymatic and irreversible destruction of ribosomes, the companies said. Unlike other CD38-targeted therapies, ETBs are not reliant on the body’s own immune system for effectiveness, offering the potential of broader and deeper responses, Takeda and Molecular Templates said in a statement.

“Takeda’s expertise in multiple myeloma and strong antibody capabilities allowed us to develop CD38-targeted ETBs that, of the ones tested to date, are the most potent ETBs we have created with our platform.  We look forward to moving this program into the clinic,” Poma said in a statement.

Philip Rowlands, Takeda’s head of the Oncology Therapeutic Area Unit, pointed to Takeda’s long commitment to developing blood cancer treatments. As Takeda has worked with Molecular Templates over the past two years, Rowlands said they have “seen the promise” of Molecular’s ETB platform.

“As we expand our relationship and continue to explore next-generation modalities, our hope is to bring forth new and important treatment options for patients,” Rowland said in a statement.

Under terms of the agreement, Molecular Templates will receive $30 million from Takeda as part of an upfront payment. Molecular Templates is eligible to receive development, regulatory and commercial milestone payments of up to $632.5 million if Molecular Templates exercises its co-development option or $337.5 million if Molecular Templates does not exercise or opts out of its co-development option. Takeda has also agreed to pay royalties on sales of the commercial product developed through the collaboration. Molecular Templates and Takeda will share equally in the development costs.

https://www.biospace.com/article/am6a-molecular-templates-and-takeda-to-take-on-multiple-myeloma-in-deal-worth-up-to-632-million/

Lilly has been ‘very clear’ on plans to exit Elanco stake in 2019, Simmons says

Elanco (ELAN) CEO Jeff Simmons is being interviewed on CNBC. Eli Lilly (LLY) is spinning off Elanco via an IPO this morning.
https://thefly.com/landingPageNews.php?id=2793275

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New Age Beverages to Debut CBD Product Portfolio at Convenience Store Confab

NEW AGE BEVERAGES CORPORATION (NASDAQ: NBEV), the Colorado-based organic and natural healthy functional beverage company intending to become the world’s leading healthy beverage company, today announced that it intends to debut its portfolio of CBD infused beverages at the upcoming North American Convenience Store show (NACS) to be held at the Las Vegas Convention Center on October 7-10, 2018.

Given the growing awareness of the potential health benefits of CBD, the New Age Health Sciences Division evaluated the data and science supporting the emerging segment. As a result of that assessment, New Age began testing a CBD-infused beverage earlier this year in its home market in Colorado. Based on the learnings gained in the test market and the increased consumer acceptance of the segment, New Age has decided to expand its presence in the category. The Company has taken the learnings it gained in product formulation and taste, efficacy and dosage, and consumer communication and has developed a portfolio of CBD-infused beverages. Now, coupled with the increased interest from major retailers in North America, New Age intends to unveil its portfolio and category insights with select retail partners at the NACS show on October 8th.

According to the Brightfield Group, the Global market for CBD will top $22 Billion with the next 4 years. Non-psychotropic CBD is one of the most medicinal compounds in the cannabis plant, reportedly helping with everything from arthritis to epilepsy and cancer, and is seen by many as a natural remedy instead of a pharmaceutical or narcotic drug. The 2018 Farm Bill, which was recently passed by both the House and Senate, would likely legalize CBD for farmers across the country and allow it for sale nationally in all channels.

New Age will be meeting with some of the major retailers in the country at NACS on October 8-10th and taking orders on a first come, first serve basis, given anticipated demand. New Age’s Health Sciences Division is overseeing and carefully controlling production, quality, and its supply chain and sales channel partners given the importance of efficacy and quality control in the end product.

Zach Ross, Marley Marketing Manager at New Age commented, “We believe we have developed unique consumer insights and accessed superior technology in CBD-infused beverages over the past year, and we are excited to share those insights with key retail partners. We believe we are in a position to bring national leadership to this emerging growth segment, and intend to launch the most efficacious and safe CBD-infused products for consumers, with the most responsible marketing and education to a segment that has potential to be transformative to healthy functional beverages.”

https://finance.yahoo.com/news/age-beverages-corporation-set-debut-142000473.html