Lipocine Trial Results Selected for Presentation at NASH-TAG Conference

Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, announced today that it has been selected to present LPCN 1144 results as part of the 2019 NASH-TAG Conference. The presentation will highlight data from multiple clinical trials of LPCN 1144 in potential non-alcoholic fatty liver disease (“NAFLD”) / non-alcoholic steatohepatitis (“NASH”) patients. The NASH-TAG Conference 2019 is being held January 3rd – 5th in Park City, UT.

Presentation Details
Title:	LPCN 1144 Improves NAFLD/NASH Biomarkers in Subjects At-Risk of NAFLD/NASH
Date:	Saturday, January 5th
Location:	The Chateaux Deer Valley, Park City, UT
Time:	3:50 pm – 4:05 pm

“The observed reduction in serum liver enzymes and lipids highlight the promise of LPCN 1144 as a potential therapy for NASH,” stated Mahesh Patel, Ph.D., Lipocine’s Chairman, President and Chief Executive Officer. “We look forward to sharing the results from our clinical trials with LPCN 1144 as part of the 2019 NASH-TAG Conference,” Dr. Patel further stated.

https://www.streetinsider.com/Corporate+News/Lipocine+%28LPCN%29+Says+LPCN+1144+Clinical+Trial+Results+Selected+for+Presentation+at+NASH-TAG+Conference/14946822.html

Computers turn neural signals into speech

For many people who are paralyzed and unable to speak, signals of what they’d like to say hide in their brains. No one has been able to decipher those signals directly. But three research teams recently made progress in turning data from electrodes surgically placed on the brain into computer-generated speech. These teams haven’t yet managed to re-create speech that people merely imagine. But by monitoring parts of the brain as participants either read aloud, silently mouthed speech, or listened to recordings, the researchers were able to use computational models called neural networks to reconstruct words and sentences that were close enough, in some cases, to be intelligible to human listeners.

Science  04 Jan 2019:
Vol. 363, Issue 6422, pp. 14
DOI: 10.1126/science.363.6422.14

http://science.sciencemag.org/content/363/6422/14

Immunocore’s extended runway

The $100 million upfront payment from Immunocore Ltd.’s most recent deal with Roche’s Genentech Inc. unit gives it enough cash to read out pivotal data from lead program IMCgp100, a catalyst that could help justify its lofty valuation and open up additional financing opportunities.

However, the fact it needed the partnering cash to begin with highlights how high valuations and big raises aren’t guarantees of easy access to future financing.

Immunocore splashed onto the scene in July 2015 with a $320 million series A round backed by Woodford Investment Management, Malin Corp. plc, Baker Brothers, RTW Investments, Eli Lilly and Co. and other undisclosed investors. At the time, it was the largest-ever European venture financing.

What followed was a period of rapid expansion, both in terms of headcount, physical footprint and valuation, which peaked at $1.3 billion, not including potential exercise of share options.

But that expansion cost money. At the end of 2017, Immunocore reported a cash position of £117 million ($158.3 million) and a 12-month operating loss of £67.5 million ($91.3 million) — giving it less than two years’ runway.

The Genentech cash allows Immunocore to stretch its runway beyond 2020, when IMCgp100 (ImmTAC-gp100) could be ready for commercial launch in uveal melanoma.

Since the start of the year, Immunocore has also seen a C-suite exodus, with five departures, headlined by that of CEO Eliot Forster in February.

https://www.biocentury.com/biocentury/product-development/2018-12-14/how-immunocore%E2%80%99s-100m-deal-gives-it-enough-runway-

NantCell Announces New Celgene Investment

Immunotherapy Company Will Present Findings at the JP Morgan Healthcare Conference in San Francisco on January 7th

Second Round Crossover Funding Brings Celgene’s Investment to $105M in NantCell Valued at $4 Billion

Currently Enrolling Patients in Advanced Stage Trials in 15 Indications for Registration Intent

Deep Pipeline of 28 Unique Molecules with 14 First in Human Studies in Over 1,000 Patients to Date

NantCell and it’s founder Dr. Patrick Soon-Shiong announced today that Celgene has completed its crossover investment in NantCell. Dr. Soon-Shiong will be introducing the company at the 37th Annual JP Morgan Healthcare Conference at the Westin St. Francis Hotel, San Francisco on Monday, January 7^th at 8:30am.

NantCell is a privately held immunotherapy company, whose goal is to employ a broad portfolio of biological molecules that will enable it to develop a cancer vaccine to combat multiple tumor types without the use of high-dose chemotherapy. NantCell has one of the most comprehensive late stage clinical pipelines of an integrated platform of immunotherapy technologies addressing both the innate (activated macrophage and natural killer cell) and the adaptive immune system (dendritic, CD4 and CD8 killer T cells). Currently the company is actively enrolling patients for registration trials in 15 indications.

On December 19, 2018, Celgene completed a crossover funding round of $30 million in NantCell at a $4 billion valuation, bringing its overall investment in the company to $105 million with a 2.8% ownership in the company. This follows the May 2015 Celgene initial investment of $75 million in NantCell.

“We have partnered with Dr. Soon-Shiong and his mission to change the course of cancer from the very beginning,” said Mark Alles, Chairman and CEO of Celgene. “From his invention of Abraxane, to acquiring his company in 2010, to launching this protein nanoparticle drug as the backbone of immunotherapy to its current blockbuster status, and now to supporting his vision at NantCell of developing a chemo free cancer vaccine utilizing the body’s own immune system. Celgene invested in NantCell since its inception in 2015 and we are excited to extend this partnership today with the significant clinical progress he has made in developing cytokines and bispecific proteins in the ongoing quest to conquer this disease,” said Alles. Celgene announced on January 3, 2018 that it would be acquired by Bristol-Myers Squibb for $74 billion.

“To our knowledge,” said Soon-Shiong, “there is no other biotech or large pharma company with NantCell’s broad pipeline of bispecific and trispecific fusion cytokine proteins, peptides, mRNA, monoclonal antibodies, neoepitope and tumor associated vaccine delivery and cell therapy products, all in clinical phase of development, across multiple indications, for the treatment of cancer and infectious disease. We are very pleased with Celgene’s continued investment in the company and our shared vision of developing a chemotherapy free cancer vaccine.”

“With the clinical advances of the technology platforms across multiple tumor types at NantCell, the company is now poised to integrate the technologies developed at the two early stage immunotherapy public companies, NantHealth and NantKwest,” said Dr. Soon-Shiong, founder of all three companies. “The adenovirus and yeast vector delivery systems in NantCell compliments the tumor associated antigen and neoepitope discovery engine (GPS Cancer^TM) developed by NantHealth, enabling the subcutaneous delivery of the neoepitopes to enable the recruitment of T cells that target only expressed cancer mutations. The bispecific fusion cytokine proteins of NantCell stimulates the patient’s autologous primary NK and T cells, thereby supplementing the off-the-shelf, cryopreserved haNK cells developed by NantKwest. Collectively the immunotherapy platforms in NantCell, NantHealth and NantKwest serve as a comprehensive path to the development of a cancer vaccine,” said Soon-Shiong.

https://www.businesswire.com/news/home/20190104005541/en/NantCell-Announces-New-Celgene-Investment

Bristol-Celgene Big Winner? Los Angeles Billionaire Patrick Soon-Shiong

While billionaire M.D. Patrick Soon-Shiong’s flashy purchases of the Los Angeles Times newspaper or investments in video-gaming companies have more recently made headlines, it’s his longtime estimated stake in biopharma giant Celgene CELG +5.57% that helped push his net worth up at least $194 million on Thursday on a day when many other billionaires’ fortunes took a dive.

At market close, Celgene shares were up nearly 14% following Bristol-Myers Squibb BMY +3.92%’s Thursday announcement that it would pay $74 billion in cash and stock for the company. Soon-Shiong is now worth an estimated $6.9 billion according to Forbes real-time rankings of the world’s billionaires. As Forbes reported, Bristol will give one of its own shares plus $50 for each share of Celgene, which is about a 54% premium to Celgene’s closing price Wednesday. Earlier in the day, Thursday Celgene’s shares jumped 31% following news of the merger.

Serial entrepreneur Soon-Shiong acquired a stake in Celgene in 2010 after he sold the pharmaceuticals company he founded, Abraxis, to the biotech for $4.5 billion, and he became the largest individual shareholder in the stock. Soon-Shiong had invented cancer drug, Abraxane, which later became one of Celgene’s blockbuster hits after it was shown in a study to extend the lives of patients with pancreatic cancer.

Still despite the Celgene bump, Soon-Shiong’s net worth is down some $900 million from when he appeared on the Forbes 400 in October 2018 at no. 198; his rank is now no. 203. Soon-Shiong’s stakes in the two publicly-traded businesses he’s founded—NantHealth and NantKwest—are down more than 85% and 50%, respectively, in the last six months.

https://www.forbes.com/sites/michelatindera/2019/01/03/bristol-myers-squibb-and-celgenes-big-winner-los-angeles-billionaire-patrick-soon-shiong/#4ea5f23b423c

Aslan Pharmaceuticals announces IND submission for ASLAN003 to FDA

Aslan Pharmaceuticals announced that the FDA has concluded its 30-day review of the Investigational New Drug, or IND, application for ASLAN003. The company plans to evaluate ASLAN003 in the United States as part of an ongoing Phase 2 clinical trial. ASLAN003 is a potential treatment for acute myeloid leukaemia, or AML, for which the FDA has previously granted Orphan Drug Designation. ASLAN plans to enrol patients in the United States as part of a 20-patient expansion cohort for its ongoing trial, to be conducted once an optimum dose of ASLAN003 in AML has been established. In the United States, clinical sites have been selected and we expect the clinical trial to begin in the first half of 2019. Patients will also be enrolled in the expansion cohort in Singapore and Australia, where the Phase 2a clinical trial is ongoing.

https://thefly.com/landingPageNews.php?id=2843570

Avanos downgraded to Underweight from Equal Weight at Barclays

Barclays analyst Kristen Stewart downgraded Avanos Medical (AVNS) to Underweight and lowered her price target for the shares to $36 from $59. Following a review of the pain medicine landscape the analyst has increased concerns regarding the outlook for the company’s ON-Q Pump. Drug shortages are likely to persist into mid-year, Stewart tells investors in a research note. Further, she has longer-term concerns around the potential FDA approval and launch of Heron Therapeutics’ (HRTX) HTX-011.

https://thefly.com/landingPageNews.php?id=2843572