On November 12, 2019 Skyhawk Therapeutics, Inc. (Skyhawk) reported that it has entered into a second global strategic collaboration with an affiliate of Celgene Corporation (NASDAQ: CELG) (Press release, Skyhawk Therapeutics, NOV 12, 2019, https://www.prnewswire.com/news-releases/skyhawk-therapeutics-announces-a-second-multi-target-collaboration-agreement-with-celgene-to-discover-and-develop-novel-small-molecules-that-modulate-rna-splicing-300956283.html [SID1234551025]). This new agreement follows the June 2018 collaboration between the two companies and focuses on targets relevant to the field of autoimmune disorders, oncology, and immuno-oncology, providing further validation of Skyhawk’s proprietary SkySTARTM technology platform. The scope of the collaboration allows the parties to systematically interrogate a range of targets that have been clinically validated or are highly associated with the genetic basis of disease but have been considered undruggable using conventional small molecule therapies.

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Under the collaboration agreement, Skyhawk grants Celgene options to exclusively license worldwide intellectual property rights to candidates discovered and developed under the collaboration that are directed to program targets. Following Celgene’s exercise of its option, Celgene will be responsible for further development and commercialization.

"Our impressive progress to date on targets that are part of our 2018 collaboration has led Celgene to enter into this new agreement focused on challenging targets beyond neurology," said Bill Haney, co-founder and CEO of Skyhawk Therapeutics. "This provides further evidence of the ability of our SkySTARTM technology platform to rapidly identify druggable sites and unique chemical matter to correct mRNA mis-splicing that may result in new treatment options for patients. We look forward to the advancement of programs under this new collaboration and the potential to bring new treatment options to patients with unmet medical needs."

"The Skyhawk team’s rapid and substantive progress demonstrates to us the unique advantages of the SkySTARTM platform and led us to expand our relationship. We see Skyhawk’s platform as a key disruptive technology that will support the autoimmune, oncology and immuno-oncology pipelines of the company we are today, and the company we are planning to be," said Rupert Vessey, M.A., B.M., B.Ch., F.R.C.P., D.Phil., President, Research & Early Development, Celgene Corporation."

On November 12, 2019 Dragonfly Therapeutics, Inc. ("Dragonfly"), a biotechnology company developing novel immunotherapies that use the innate immune system to treat disease, reported that the first patient in a Phase I / II study of DF1001 at the MD Anderson Cancer Center at the University of Texas, Houston , USA , and the study by Dragonfly on DF1001 is currently recruiting patients with several types of advanced solid tumors, the human epidermal growth factor Receptor 2 (HER2) (Press release, Dragonfly Therapeutics, NOV 12, 2019, View Source [SID1234551024]).

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"DF1001 is the first candidate in our TriNKET platform to reach the clinic, marking our transition to becoming a clinical development company," said Bill Haney , co-founder and CEO of Dragonfly Therapeutics, "We are very excited about working with the MD Anderson’s immunotherapy experts as part of our study of the differential safety profile that our NK cell engages can offer against existing immuno-oncology options, and we also look forward to improving other assets in our portfolio with the same purposefulness that made us possible To further develop DF1001 for patients. "

"Clinical candidates coming from Dragonfly’s TriNKET platform have the potential for exceptional therapeutic performance," said Jean-Marie Cuillerot, Chief Medical Officer of Dragonfly Therapeutics. "We look forward to working with our MD Anderson collaboration partners on DF1001 continue to evolve for a variety of patients who are not receiving adequate treatment from currently available therapies. "

"Today is a big day for Dragonfly, founded less than four years ago. It is very exciting that the first clinical candidate of our TriNKETs pipeline has now reached the clinic, "said Tyler Jacks , director of the Koch Institute at MITand co-founder of the company. "In addition to our DF1001 program and our extensive development of drug candidates for Celgene and Merck, Dragonfly has an extensive pipeline of other internal programs that are rapidly approaching the clinic, including an internal program planned for the second quarter of 2020 for our second new program investigational. This remarkable progress and speed underline the urgency with which Dragonfly has pursued its goal of providing potential new treatment options for cancer patients. "

Dragonfly Therapeutics received an Investigational New Drug approval for its immunotherapy drug DF1001 earlier this year from the US Food and Drug Administration (FDA). The Company’s Phase I / II clinical trial is a sophisticated, open-label, non-randomized, first-in-man, multiple-dose multiple-dose study to evaluate the safety, tolerability, pharmacokinetics, and biological and clinical activity of DF1001 in patients with locally advanced or advanced disease metastatic solid tumors with HER2, with subsequent extension to selected indications.

Further study information, including eligibility criteria, is available at the following link: View Source (ClinicalTrials.gov identifier: NCT04143711).

About DF1001
DF1001 is a novel investigational drug candidate being studied in adult patients for the treatment of advanced solid HER2-positive tumors. DF1001 was discovered and developed by Dragonfly’s TriNKET platform. DF1001 has the potential to stimulate effective anti-tumor immunity in patients who are not suited for or respond to current therapies. DF1001 is the most advanced in the pipeline of TriNKET , which Dragonfly is developing to meet the unmet medical needs of patients with a variety of cancers.

About Dragonfly’s
TriNKET Platform Dragonfly’s TriNKET platform is the foundation of a portfolio of novel therapeutics that are trispecific natural killer cell activation therapies designed to enhance the natural and killer cells (NK) of the innate and adaptive Activate and redirect the immune system so that the cancer is eliminated.

On November 12, 2019 St. Elizabeth Healthcare reported that has just performed its 10,000th lung screening, a significant and rare milestone only held by a handful of other systems in the country (Press release, St Elizabeth Healthcare, NOV 12, 2019, View Source [SID1234551023]). The system’s estimated rolling 12-month completion rate for eligible patients is over 25%, exceeding the national average of less than 5%, based on 2016 data presented at the 2018 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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Kentucky ranks worst in the country for lung cancer diagnosis and death rates, according to 2018 data from the North American Association of Central Cancer Registries reported by the American Cancer Society. Based on the most recent rates published for the current American Joint Committee on Cancer (AJCC) staging system, when lung cancer is diagnosed and treated early (Stage I), the five-year survival rate can exceed 90%. This is all the more important since Kentucky is consistently one of the top two states in smoking rates, according to 2018 CDC data.

"That’s why we have stepped up to solve a problem that’s right here," shared Dr. Doug Flora, executive medical director of oncology services at St. Elizabeth. "We want our patients, their families and the community to do more than recognize Lung Cancer Awareness Month in November—let’s get more area residents screened and save lives."

The lung screening is a low-dose CT scan that has now identified about 100 lung cancers under Stage III. Early detection offers more options, namely allowing St. Elizabeth surgeons and their teams to remove the tumors and often spare lung cancer patients the need for chemotherapy. For patients who are not surgical candidates, the St. Elizabeth radiation oncology team also has excellent means to eradicate the cancer.

"By finding these tumors at an earlier Stage I or II, we are seeing a ‘stage migration’ shift. Pinpointing tumors at lower stages significantly increases chances of survival," said Dr. Michael Gieske, medical director of lung cancer screening at St. Elizabeth. "The screenings are already extending and saving lives."

St. Elizabeth has recruited and developed a large multidisciplinary team to combat lung cancer, led by highly qualified lung cancer surgeons, radiologists, pulmonologists, primary care physicians, nurse navigators and medical and radiation oncologists. Under their direction, a comprehensive lung cancer screening program was built that is among the country’s most robust and successful. Early on St. Elizabeth obtained and continues to maintain certifications as a Screening Center of Excellence and a Diagnostic Imaging Center of Excellence.

Approximately 350 at-risk patients are screened per month at St. Elizabeth, detecting a new lung cancer in about one in every 62 scans. When Dr. Gary Schmitt, radiologist with Radiology Associates of NKY, and Dr. Glen Turner, now retired St. Elizabeth pulmonologist, began the program in late 2013, staff completed seven lung cancer screens total for the year.

"Since the program’s inception, progress and impact are both significant," said Dr. Royce Calhoun, medical director of thoracic surgery at St. Elizabeth. "The screenings give patients and their physicians important information, creating opportunity for early tumor removal when time is of the essence."

St. Elizabeth is investing heavily in building programs and focusing resources on aggressive lung cancer screening and early detection. The St. Elizabeth lung screening program is just one example of being "right here" for the Northern Kentucky community. To learn if you are a candidate for a screening, visit stelizabeth.com/lung.

On November 12, 2019 Veloxis Pharmaceuticals A/S (OMX: VELO) reported its Interim Report for the first nine months of 2019 (Press release, Veloxis Pharmaceuticals, NOV 12, 2019, View Source [SID1234551022]). This Company Release should be read in conjunction with Veloxis’s full Interim Report for the first nine months of 2019, which is attached to this release and also available on Veloxis’s website at: View Source

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Highlights

Product revenue for the first nine months of 2019 was USD 54.5 million, an increase of 97% compared to the same period last year.
US revenue increased 98% to USD 47.3 million
EU revenue increased 80% to USD 7.0 million
Over 96% of US transplant centers have used Envarsus since its launch.
Cash balance, USD 35.9 million on September 30, 2019.
Veloxis reported a net income of USD 7.7 million for the first nine months of 2019 compared with a net loss of USD 4.1 million for the same period in 2018.
Outlook for 2019

On 31 October 2019, Veloxis revised its 2019 Outlook of revenues to be in the range of USD 75–82 million and operating income before accounting for stock compensation to be in the range of USD 15–22 million. Veloxis previously reported its 2019 Outlook to be USD 69–77 million for revenues and operating income before accounting for stock compensation to be in the range of USD 10–15 million.

Conference Call

A conference call will be held tomorrow, November 13, 2019 at 4:00 p.m. CET (Denmark); 3:00 p.m. GST (London); and 10:00 a.m. EST (New York).

To access the live conference call, please dial one of the following numbers:

DK: +45 32 72 75 18

UK: +44 (0) 203 009 5710

US: +1 917 720 0178

Confirmation Code: 1177055

Following the conference call, a recording will be available on the Company’s website: View Source

About Envarsus

Envarsus is a novel formulation of tacrolimus designed using advance technology which allows for increased bioavailability and controlled, smooth delivery, resulting in in once daily dosing, a lower total daily dose requirement, and lower peak concentrations with less fluctuation.

In addition to the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus, Envarsus is now FDA-approved for use in de novo kidney transplant patients as of December 2018. That means more patients, including hard-to-treat patients such as rapid metabolizers, can benefit from once-daily controlled-release Envarsus. Envarsus is marketed as Envarsus XR in the Unites States.

On November 12, 2019 ThermoGenesis Holdings, Inc. (Nasdaq: THMO), formerly known as Cesca Therapeutics Inc., a market leader in automated cell processing tools and services in the cell and gene therapy field, reported it will delay its third quarter ended September 30, 2019 earnings release and conference call, previously scheduled for , Tuesday, November 12, 2019 (Press release, Thermogenesis, NOV 12, 2019, View Source [SID1234551021]). The company now intends to report its third quarter 2019 results on Thursday, November 14, 2019, after the close of trading. A conference call and webcast will follow at 1:30 p.m. PT/ 4:30 p.m. ET.

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To participate in the conference call, please dial 1-844-889-4331 (domestic), 1-412-380-7406 (international) or 1-866-605-3852 (Canada). To access a live webcast of the call, please visit: View Source

A replay of the call will be available until December 5 and can be accessed by dialing 1-877-344-7529 (domestic), 1-412-317-0088 (international) or 1-855-669-9658 (Canada) and referencing access code 10136101. The webcast will be available for three months.