On December 17, 2019 Colorado’s life sciences ecosystem reported that it raised $750 million in 2019, with funds from federal and state grants, successful financing rounds and acquisitions (Press release, Colorado Life Sciences, DEC 17, 2019, View Source [SID1234552444]). The record-breaking acquisition of Boulder-based Array BioPharma by Pfizer for $11.4 billion raises the Colorado financing total to $12.1 billion.

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Major financings contributed to the notable fundraising year for Colorado companies and institutions. Clovis Oncology raised $175 million in clinical trial financing and Inscripta closed $125 million in Series D financing to fund commercialization of its digital genome engineering platform.

Additionally, more than 40 companies and institutions in Colorado received federal grants including funds from the National Institutes of Health (NIH), the U.S. Air Force and Small Business Innovative Research (SBIR) grants from the Small Business Administration. The University of Colorado, National Jewish Health and Colorado State University were the state’s largest recipients of federal grants, all from the National Institutes of Health.

Jennifer Jones Paton, President & CEO of Colorado BioScience Association, says:

"Our ecosystem’s track record of successful financings and acquisitions highlights the global impact made by companies and organizations from Colorado. Life sciences breakthroughs from our state change and save lives around the world. The record-breaking acquisition and successful fundraising demonstrate the strong interest in Colorado’s thriving life sciences ecosystem."

Emily Roberts, Vice President of Colorado BioScience Association, says:

"We are proud of the companies in our ecosystem that landed Advanced Industries Grants from the state of Colorado. These funds are critical for our start-up and mid-stage companies as they seek to prove out concepts and move into commercialization. We are committed to advocating for this important state funding of our innovators and job creators."

The State of Colorado awarded 16 Advanced Industries grants to Colorado life sciences companies in 2019, with grants ranging from $20,000-$250,000. As a designated Advanced Industry in Colorado, the life sciences ecosystem makes a significant contribution to the state’s diverse and fast-growing economy, creating high-paying jobs for more than 89,000 Coloradans.

Colorado BioScience Association works actively on capital and growth initiatives to accelerate investment in our state’s life sciences ecosystem. While robust, Colorado’s percentage of funding per capita lags behind bioscience clusters in California and Massachusetts.

On December 17, 2019 Sengenics, a leading commercial stage precision medicine focused company, reported that Dr Arif Anwar, CEO of Sengenics, has been invited to present at the Biotech Showcase during the upcoming 38th Annual J.P. Morgan Healthcare Conference week in San Francisco (Press release, Sengenics, DEC 17, 2019, View Source [SID1234552443]).

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Dr Arif Anwar will present an overview of the commercialisation strategy of the company, as well as applications of its well-differentiated and patented KREX technology for intra-disease stratification and autoimmune and cancer immunotherapy drug response prediction. The identity of the autoantibody biomarkers discovered from these applications can also guide drug development decision-making for the pharmaceutical industry, allowing for the early elimination of poor drug candidates. For clinical stage candidates, this can result in very significant cost savings as well as acceleration of the best candidates towards faster FDA drug approval. For commercially launched drugs, KREX offers unparalleled opportunities to gain market share by identifying new true responders.

Sengenics currently has partnerships with 9 out of the top 20 pharma to co-develop complementary and companion diagnostic tests for autoimmune and cancer immunotherapy drugs. The company has commenced the process for obtaining FDA 510(k) approval for several of these tests and plans to launch them in 2020. Sengenics’ key value drivers, which are derivatives from enhancing precision medicine, are primarily based on maximising the probability that drugs are prescribed only to patients who have a greater than 90% chance of responding to them. These new Sengenics tests offer a compelling business case for the pharmaceutical industry as well as medical insurance companies, whilst ultimately delivering upon the promise of precision medicine for autoimmune and cancer immunotherapy drugs.

Details of Sengenics’ presentation are as follows:

Event: Biotech Showcase 2020

Date: Tuesday, January 14, 2020

Time: 2:30 PM Pacific Time (5:30 PM Eastern Time)

Title: Realising the Potential of Precision Medicine for Autoimmune and Cancer Drugs using Sengenics’ KREX Technology

Location: Franciscan B (Ballroom Level), Hilton San Francisco Union Square – 333 O’Farrell Street

The presentation document will be available on the Sengenics website in the "Downloads" section on the same day.

On December 17, 2019 Vermillion, Inc. (Nasdaq: VRML), a bioanalytical-based women’s health company focused on gynecologic disease and Einstein Medical Center, the largest independent academic medical center in Philadelphia, reported the first patient enrolled in a study that compares OVA1 to CA125 assay for detection of ovarian cancer risk in African American women (Press release, Vermillion, DEC 17, 2019, View Source [SID1234552442]).

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The study will enroll over 200 prospective African American women with adnexal masses. Ovarian cancer risk will be assessed by both CA125 and OVA1 Plus. The primary objective is to determine the differences in sensitivity and accuracy of cancer risk detection between the testing methodologies. The study is to be expanded to women of varying ethnic backgrounds as well.

"African American women have lower incidence of ovarian cancer than Caucasian women, yet a higher all-cause mortality rate," said Lead Investigator Kate Stampler, D.O., Department of Obstetrics and Gynecology at Einstein Medical Center Philadelphia. "Recent evidence demonstrates that they also have lower levels of CA125 that could lead to underdiagnosis."

Recently published studies demonstrate that OVA1 has greater sensitivity in detecting ovarian cancer across multiple ethnicities and technologies including CA125 and ROMA:

OVA1 in African American women is 2.38-times more sensitive than CA125: 79.2% v 33.3%1
OVA1 in African American women is 1.45-times more sensitive than ROMA: 79.1% v 54.5%2
OVA1 in Caucasian women is more sensitive than CA125: 93.2% v 74.4%1
OVA1 in Caucasian women is more sensitive than ROMA: 93.2% v 82.9%2
"This study should confirm that OVA1 provides more sensitive risk detection in African American women. It may also define differences in sensitivity amongst various ethnicities and races," said Charles Dunton, MD, Global Medical Director, Vermillion. "This study can help address the disparities in diagnosis and outcomes of ovarian cancer in African American women."

OVA1 is an FDA-cleared and ACOG-endorsed blood test offered via ASPiRA Labs. OVA1 proactively assesses the risk of ovarian malignancy from a simple blood test, as a pre-operative biopsy is not medically appropriate. Clinically, OVA1 objectively guides the patient treatment care plan for low-risk and high-risk pelvic mass patients.

On December 17, 2019 Cellestia Biotech AG reported the closing of a CHF 20 million Series B financing round (Press release, Cellestia Biotech, DEC 17, 2019, View Source [SID1234552441]). The new funds will be added to the previous, including CHF 8 million Seed financing, CHF 20 million Series A financing and CHF 1 million non-dilutive research grants, bringing the total capital raised to date by Cellestia to CHF 49 million (USD 50 million).

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"This financing strengthens our balance sheet as we work to achieve important milestones for our clinical candidate CB-103 as well as the follow-up compounds," said Gaudenz von Capeller, CFO of Cellestia Biotech AG.

Cellestia is progressing the ongoing clinical development program of CB-103, a first-in-class small molecule targeted therapy with a novel mode of action. CB-103 is a highly selective protein-protein interaction inhibitor targeting an oncogene transcription factor for the precision medicine treatment of specific cancers. It will also allow Cellestia to advance its innovative R&D pipeline activity.

In June 2019, Guido Guidi (Former Head Europe Novartis Pharma / Head Novartis Oncology Europe) was elected new Chairman of Board of Directors. Robert Karsunky (Head Latin America & Canada at Novartis Pharma) elected new Chairman of the Audit Committee and to the Board of Directors.

Michael Bauer, CEO of Cellestia Biotech AG said, "Guido’s experience and knowledge in development, business and building a successful organisation is a tremendous asset to our company, and we are delighted that he has joined Cellestia as Chairman of our Board. Robert brings long-standing financial expertise to the board and strengthens internal governance in his roles of Chairman of the Audit Committee and Member of the Board. With these additions to the board, we are further adopting the board memberships in line with the company´s growth and development."

"I am excited to be a part of Cellestia’s journey. I find the science to be compelling and look forward to supporting the development of this novel precision oncology solution," said Guido Guidi.

About PPF/SOTIO

PPF Group is an international investment company focusing on multiple market segments such as banking, financial services, telecommunications, insurance, real estate, agriculture and biotechnology. PPF’s reach spans from Europe to Russia, the USA and across Asia. PPF’s assets under management totalled to almost EUR 47 billion (as at 30 June 2019). SOTIO is an international biotechnology company spearheading PPF’s investment and partnering activities in the biotechnology sector. For more information about PPF and Sotio visit www.ppf.eu and www.sotio.com.

About FC Capital

FC Capital is a China-based private equity firm specializing in healthcare investments in the Greater China region, the US and the European countries. FC Capital focuses in cultivating and investing in early and growth stage sector leaders ranging from pharmaceutical companies to technology and data providers that are aligning with secular growth trends or building innovative solutions to emerging challenges. Its parallel RMB and USD funds target high-quality companies looking for a patient and strategic partner to achieve unprecedented cross-border and long-term success.

On December 17, 2019 PharmaMar (MSE:PHM) has reported that it has submitted to the FDA (Food and Drug Administration) in the United States the New Drug Application (NDA) for lurbinectedin for the treatment of patients with SCLC who have progressed after prior platinum-containing therapy, under the accelerated approval regulations (Press release, PharmaMar, DEC 17, 2019, View Source [SID1234552440]).

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This NDA is based on data from the phase II monotherapy basket trial with lurbinectedin for the treatment of SCLC, the results of which were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in June this year. A total of 105 patients from 39 centers in more than 8 Western European countries in addition to the United States were recruited. The trial met its primary endpoint of the Overall Response Rate (ORR) by both investigator and IRC (Independent Review Committee) assessment.

The FDA’s accelerated approval procedure allows for the submission of an NDA for evaluation based on the results of phase II drug investigations for the treatment of serious diseases that cover an unmet medical need. Relapsed SCLC treatment has not changed substantially in more than two decades with the last new chemical entity approved by the FDA in this setting being topotecan, in 1996.

"The application for registration under accelerated approval regulations gives us the possibility that the FDA could approve lurbinectedin in the US for treatment of small cell lung cancer in 2020 and that, if approval is obtained, could begin to be marketed 2 in the second half of 2020 in the United States", explains Luis Mora, General Manager of PharmaMar’s Oncology Business Unit.

Dr. Charles Rudin, Chief of the Thoracic Oncology Service at Memorial Sloan Kettering Cancer Center and principal investigator of the NCI Small Cell Lung Cancer Consortium, said "It is great to finally see some new therapeutic options arriving for small cell lung cancer patients, who represent a major unmet medical need. I have been following the emerging clinical trial data on lurbinectedin, which suggest appealing efficacy and a tolerable safety profile. I believe many treating physicians may welcome lurbinectedin, if approved, as a new standard of care option for their patients with recurrent small cell lung cancer." We would like to extend our sincerest gratitude to the patients, their families and caregivers, as well as the dedicated medical teams who participated in our clinical trials studies and helped bring lurbinectedin to this point.