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Vermillion, Inc. and Einstein Medical Center Philadelphia Announce the First Patient Enrolled in Prospective National Clinical Study of Ovarian Cancer Risk Detection Methods in African American Women

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.

Cellestia Biotech AG successfully closes Series B financing round, raising a total of CHF 20 million

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).

"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.

PharmaMar has filed New Drug Application for lurbinectedin with the FDA for the treatment of relapsed small cell lung cancer

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]).

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.

Onconova Therapeutics and Pint Pharma Announce Brazilian Health Authority Approval for Initiating INSPIRE Trial with Intravenous Rigosertib in Higher-Risk Myelodysplastic Syndromes in Brazil

On December 17, 2019 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), and Pint Pharma, a European-based pharmaceutical company focused on the development, registration and commercialization of specialty-based treatments for the Latin American market, reported the receipt of approval from the Brazilian Health authority to initiate the INSPIRE Trial in Brazil with intravenous rigosertib in Higher-Risk MDS (HR-MDS) (Press release, Onconova, DEC 17, 2019, View Source [SID1234552438]). In November 2019 enrollment in the INSPIRE Trial surpassed 90% percent of the required enrollment, and the Company continues to anticipate reporting topline data in the first half of 2020, following full enrollment and reaching the number of required survival events.

"As we enter the final stage of enrollment of the INSPIRE Trial, we thank our corporate partner Pint Pharma for their collaboration in opening the study in Brazil," said Dr. Steven Fruchtman, President and CEO of Onconova Therapeutics, Inc. "The INSPIRE Trial surpassed 90% percent of the required enrollment in November 2019 and we expect the addition of up to 16 clinical trial sites in Brazil will provide further momentum to our anticipated reporting of topline data in the first half of 2020, following full enrollment and reaching the number of required survival events."

"We are excited to collaborate with Onconova in opening new clinical sites and look forward to the recruitment of eligible patients for the INSPIRE Trial in Brazil," said David Munoz, Chief Executive Officer of Pint Pharma. He added, "We are also pleased that local physicians will gain invaluable experience with rigosertib by their participation on the INSPIRE Trial."

Dr. Ric Woodman, Chief Medical Officer of Onconova, is working closely with Dr. Valnei Canutti, Chief Scientific Officer of Pint. Dr. Woodman commented, "There is a great unmet medical need and interest to conduct studies in patients with HR-MDS in this geographical region. I look forward to a productive collaboration with Pint Pharma and working with Dr. Canutti, an expert in conducting trials in Brazil as well as an expert in MDS."

Dr. Canutti added, "We anticipate meaningful contributions from Brazil to accrual to the INSPIRE Trial and are excited about receiving health authority approval to initiate INSPIRE in Brazil. There are significant numbers of patients with HR-MDS in Brazil with no approved approach following failure of the standard of care azacitidine. We at Pint, in collaboration with our partner Onconova, look forward to Brazil’s contributions to complete accrual to this important pivotal global trial."

About Pint Pharma

Pint Pharma is devoted to the development, registration, and commercialization of specialty-based treatments. Pint Pharma benefits from leaders with extensive experience in the pharmaceutical sector and who are based strategically throughout Latin America and Europe. Pint Pharma has a long track record of developing strong relationships with global pharmaceutical and healthcare companies. Pint Pharma strives to be the first Pan-Latin American provider of innovative and high value-added treatments within Rare Diseases, Specialty Care, and Oncology.

Nimbus Therapeutics Appoints Chief Medical Officer Annie C. Chen, M.D., MPH, to President of the Company’s Tyk2 Subsidiary

On December 17, 2019 Nimbus Therapeutics, a biotechnology company coupling targets selected based on causal human biology with structure-based drug discovery and development, reported the promotion of Chief Medical Officer, Annie C. Chen, M.D., MPH, to President of the company’s Tyk2 subsidiary, Nimbus Lakshmi, Inc (Press release, Nimbus Therapeutics, DEC 17, 2019, View Source [SID1234552437]). In this role, Dr. Chen will provide executive leadership for financial, business, and development activities associated with the company’s tyrosine kinase 2 (Tyk2) program, in addition to continuing her role as Chief Medical Officer for Nimbus Therapeutics.

"We’re at a very exciting juncture as Nimbus gears up to once again become a clinical-stage company, and there is no better person to helm that effort than Annie," said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. "Annie’s extensive background in immunology, her experience leading clinical strategy to bring multiple therapies forward to regulatory approval, and her passionate dedication as a clinician to the well-being of her patients will be of enormous value to our Tyk2 program as it advances into the clinic."

"Tyk2 is a genetically validated target for the treatment of many autoimmune and inflammatory disorders, and through Nimbus’ structure-based drug discovery efforts, we have developed promising allosteric modulators that effectively inhibit this target," said Dr. Chen. "I’m honored to lead these multidisciplinary efforts for Nimbus as we initiate clinical studies and chart the program’s future path."

Dr. Chen, who received her medical training as an adult rheumatologist, has served as Chief Medical Officer of Nimbus since 2015. She provided oversight for the company’s acetyl CoA carboxylase clinical program for NASH and supported business development and financing efforts, before its acquisition by Gilead. Prior to joining Nimbus, Dr. Chen was Executive Director of Clinical Research, Section Head of Vaccines at Merck and Co., where she oversaw clinical research activities for a broad portfolio of vaccines, from discovery through registration and life cycle management. Dr. Chen also held the role of Section Head of Immunology, where she oversaw clinical research for small molecule and protein therapeutics. Prior to Merck, Dr. Chen held roles of increasing responsibility at Genentech, and began her career at Celera Genomics.