On January 2, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported that it entered an amended agreement providing ApolloBio Corporation (NEEQ:430187) with the exclusive right to develop and commercialize VGX-3100, Inovio’s DNA immunotherapy product designed to treat pre-cancers caused by human papillomavirus (HPV), within Greater China (China, Hong Kong, Macao, Taiwan) (Press release, Inovio, JAN 2, 2018, View Source [SID1234522799]).

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Based on new agreement, ApolloBio will make an upfront payment of $23 million (an increase from the previously announced amount of $15 million), as well as potential future payments up to $20 million upon meeting certain milestones. In addition, Inovio is entitled to receive double-digit tiered royalty payments on sales. As part of the new terms which replace the previous amendments to this agreement that were announced on November 2, 2017, the parties have agreed to terminate ApolloBio’s right to purchase Inovio stock. This collaboration of VGX-3100 encompasses the treatment and/or prevention of pre-cancerous HPV infections and HPV-driven dysplasias (including cervical, vulvar and anal pre-cancers) and excludes HPV-driven cancers and all combinations of VGX-3100 with other immunostimulants. The agreement also provides for potential inclusion of the Republic of Korea during the next three years.

Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, "ApolloBio is an excellent partner that brings significant capabilities and expertise relating to product development, the Chinese regulatory landscape, and the healthcare marketplace in China. We are pleased to move forward with an agreement that preserves the best interest for our shareholders by obtaining a greater upfront non-dilutive cash license fee of $23 million and removing the equity provisions. In addition, this collaborative agreement with ApolloBio could potentially accelerate our overall global VGX-3100 efforts by accessing clinical study patients in China. We expect this deal to close in the first quarter of 2018."

Dr. Weiping Yang, Chief Executive Officer of ApolloBio, said, "This license and collaboration agreement marks our determination to introduce late stage innovative new drugs to meet severely unmet medical needs within the Greater China region. We are excited at the potential for VGX-3100 to address multiple indications within HPV-associated pre-cancer, and we very pleased to be launching this strategic collaboration with Inovio, an innovative global biotechnology partner."

About VGX-3100

VGX-3100 is an HPV-specific immunotherapy that is being developed as a non-surgical treatment for high-grade cervical dysplasia and related underlying persistent HPV infection. VGX-3100 works in vivo to activate functional, antigen-specific, CD-8 T-cells to clear persistent HPV 16/18 infection and cause regression of pre-cancerous cervical dysplasia. In a phase 2b trial, VGX-3100 demonstrated clinical efficacy and was generally well tolerated, without the side effects and obstetric risks associated with surgical excision. VGX-3100 is a first-in-class HPV-specific immunotherapy that targets the underlying cause of cervical dysplasia, providing an opportunity for women to reduce their risk of cervical cancer without undergoing an invasive surgical procedure.

About HPV and Cervical Dysplasia

HPV is the most common sexually transmitted infection and is the main cause of cervical cancer, which kills more than 250,000 women every year worldwide. Among the 300 million women currently infected with HPV, 500,000 will be diagnosed with cervical cancer each year. Two types of HPV (HPV 16 and HPV 18) cause 70% of cervical cancer cases. High-grade cervical dysplasia is also caused by persistent HPV infection and is a pre-cancerous condition that can progress to cervical cancer if left untreated. Globally the number of high-grade cervical dysplasia cases is estimated to be in the range of 10 million.

Currently there are no approved medical treatments for persistent HPV infection or cervical dysplasia. The primary treatment for high-grade cervical dysplasia is surgical excision of the pre-cancerous lesion and a margin of healthy cervical tissue. Because surgical excision does not treat the underlying HPV infection that causes cervical dysplasia, there is a 10-16% risk of disease recurrence. Women with persistent HPV infection after surgical excision remain at high risk for cervical cancer. In addition, surgical treatment is associated with pain and cramping, and a risk for post-surgical bleeding, infection, and pre-term delivery and miscarriages during future pregnancies.

On January 2, 2018 AgeX Therapeutics, Inc. (AgeX), a subsidiary of BioTime, Inc. (NYSE American: BTX), reported a newly-published peer-reviewed study that reveals genes implicated in tissue regeneration, cancer, and aging (Press release, BioTime, JAN 2, 2018, View Source;p=RssLanding&cat=news&id=2324347 [SID1234522796]). The study, by scientists at AgeX and BioTime, in collaboration with Insilico Medicine, utilized artificial intelligence (AI) technology to parse millions of gene expression data points to decipher the complex mechanisms controlling natural tissue regeneration. The results, published in the peer-reviewed scientific journal Oncotarget, showed that the candidate genes are expressed differently in tissues early in development when they are capable of regeneration compared to later in life when regeneration can no longer take place. Surprisingly, some of the genes, including one highlighted in the study, COX7A1, displayed a rare profile of being nearly universally dysregulated in diverse types of cancer. The discoveries may lead to novel strategies to induce Tissue Regeneration (iTRTM) in the context of trauma or age-related degenerative disease, as well as treat and diagnose cancer.

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"It is rare to find genes implicated in tissue regeneration, let alone with abnormal expression in so many diverse cancer types such as those of the breast, lung, kidney, bone, and muscle," said Michael D. West, PhD, CEO of AgeX and co-CEO of BioTime. "AgeX has certain rights to use the associated patent applications and to commercialize related therapeutic and diagnostic applications. Since we believe unlocking the natural ability of the human body to regenerate tissues afflicted with degenerative disease is a very large market opportunity, we are aggressively developing products using the technology."

A short video is available online describing the discovery and its implication for product development at AgeX. Included in the video is a discussion of an iTR product designated RenelonTM, which, in its first generation form, utilizes a repurposed drug and may therefore have a relatively short development timeline.

"The embryonic-to-fetal transition (EFT) deciphered in this study is emerging as a wonderful new arena in which to explore the enhancement of regenerative capacity in old age, which is the core of AgeX’s mission," said Aubrey de Grey, PhD, VP of New Technology Discovery at AgeX. "The discovery of a subunit of the respiratory chain as a key EFT marker dovetails this research fascinatingly with age-related changes in mitochondrial function, which have long been a priority in the anti-aging field and in my own work."

"BioTime and AgeX Therapeutics are at the forefront of regenerative medicine," commented Alex Zhavoronkov, PhD, CEO of Insilico Medicine. "By utilizing their heavy investment in large-scale, highly-controlled experiments and their unique expertise in regenerative medicine we managed to develop the AI-powered system for cell and tissue sample profiling. We utilized this system to identify the important genes implicated in the EFT, and possibly in aging. This collaboration started in 2015 when deep leaning methods were in their infancy and required two years to diligently validate the outcomes. We learned that domain expertise is just as important as expertise in AI."

Background on Induced Tissue Regeneration

The leading unsolved problem in medicine as the year 2018 arrives remains the inability of the adult human body to regenerate tissues affected by injury or disease. It is estimated that approximately 80% of the nearly $3 trillion annual health care expenditures in the United States can be attributed to chronic disease. The chronic degenerative diseases of aging are also on the rise due to the aging of the 76 million post-WWII baby boom population. AgeX is focused on developing breakthrough technology platforms to directly address some of the largest markets associated with this demographic. One such platform is induced Tissue Regeneration (iTR), the subject of today’s scientific publication.

Adult humans, like most mammals, have only a limited capacity to repair tissues in the body resulting from trauma or degenerative disease. However, in some species, such as the Mexican salamander, there exists a profound capacity to regenerate injured tissues, even amputated limbs. Recent studies suggest that this power reflects a capacity present early in life and largely lost by the time we are born.

Using the Company’s proprietary pluripotent stem cell-based platform, AgeX and BioTime scientists compared cells with the potential to regenerate tissue in humans, similar to that occurring in naturally regenerating animals, with adult cells lacking the capacity. The transition from an embryonic capacity to regenerate tissue to the subsequent loss in adults (replaced by scarring rather than regenerating) is one of the most complex processes studied in biology today. Therefore, AgeX scientists collaborated with Insilico Medicine to apply machine intelligence to better understand the process. A computer-based analytical tool designated "Embryonic.AI" resulting from this AI research is available online at AgeX database LifeMap Discovery.

The study resulted in the identification of genes differently expressed during the time tissues can regenerate compared to later in life when that capacity is impaired. One gene highlighted in the study is designated COX7A1 which is thought to play a role in energy metabolism along with other critical functions in the cell. Consistent with a role of COX7A1 in regeneration and cancer, the gene appeared to be profoundly dysregulated in a broad array of cancer cell types, suggesting cancer may be thought of as "regeneration out of control." As a result, the discoveries reported in today’s publication may have the potential to lead to the ability to induce scarless tissue regeneration in humans, as well as point to new strategies for the diagnosis and treatment of cancer.

The publication titled "Use of deep neural network ensembles to identify embryonic-fetal transition markers: repression of COX7A1 in embryonic and cancer cells" (Oncotarget, December 2017, in press, View Source included Michael D. West, Ivan Labat, Hal Sternberg, and Dana Larocca of AgeX; Igor Nasonkin and Ratnesh Singh of BioTime; Karen B. Chapman and Evgeny Izumchenko of Johns Hopkins University; Karen Copeland of Boulder Statistics; and Eugene Makarev, Alex Aliper, Andrey Kazennov, Andrey Alekseenko, Nikolai Shuvalov, Evgenia Cheskidova, Aleksandr Alekseev, Artem Artemov, Evgeny Putin, Polina Mamoshina, Nikita Pryanichnikov, Ksenia Lezhnina, Mikhail Korzinkin, and Alex Zhavoronkov of Insilico Medicine.

On January 2, 2018 Heron Therapeutics, Inc. (NASDAQ: HRTX), a commercial-stage biotechnology company focused on developing novel, best-in-class treatments to address some of the most important unmet patient needs, reported that Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics, will present at the 36th Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2018, at 5:00 p.m. PST at the Westin St. Francis hotel in San Francisco, CA (Press release, Heron Therapeutics, JAN 2, 2018, View Source [SID1234522824]).

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A live webcast of this presentation will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the presentation will be archived on the site for 60 days.

On January 2, 2018 Alexion Pharmaceuticals (Nasdaq: ALXN) reported that management will present at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 8, 2018 at 9:00 a.m., PT (12:00 p.m., ET) (Press release, Alexion, JAN 2, 2018, View Source [SID1234522810]). The Q&A breakout session will immediately follow the presentation at 9:30 a.m., PT (12:30 p.m., ET).

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An audio webcast of the presentation and breakout session will be available live. You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

On January 2, 2018 Alkermes plc (NASDAQ: ALKS) reported that its corporate presentation will be webcast live at the 36th Annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 9, 2018 at 10:30 a.m. PT (1:30 p.m. ET/6:30 p.m. GMT) from the Westin St. Francis Hotel in San Francisco (Press release, Alkermes, JAN 2, 2018, View Source;p=RssLanding&cat=news&id=2324467 [SID1234522811]). The presentation will be followed by a question and answer session that will begin at 11:00 a.m. PT (2:00 p.m. ET/7:00 p.m. GMT). A webcast of both the presentation and question and answer session may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.