On December 18, 2018 Oncology Venture A/S ("OV" or the Company) reported that the US Food and Drug Administration, FDA has responded positively on questions posed by the company in a Pre-IND/IDE package for the approval pathway for LiPlaCis and its companion diagnostic DRP – Drug Response Predictor – in metastatic breast cancer (Press release, Oncology Venture, DEC 18, 2018, View Source [SID1234532169]).

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The FDA agreed that the 505(b)(2) pathway is an acceptable registration route for LiPlaCis and that no further toxicology studies are needed. Based on current good data the number of patients to be treated is in line with previous guidance in the upcoming pivotal phase 3 trial of LiPlaCis and its DRPÒ for the treatment of patients with advanced breast cancer.
The FDA accepts objective response rate (ORR) as the primary endpoint but asked for further characterization of sub-groups in the breast cancer population aimed for treatment with LiPlaCis.
LiPlaCis is an intelligent, target controlled liposome formulation of one of the world’s most widely used chemotherapies, cisplatin. The specific LiPlaCis formulation allows delivery of LiPlaCis directly at tumor site. The specific LiPlaCis DRP selects the patients whom are expected to benefit from the treatment. LiPlaCis has shown very promising results in an ongoing phase 2 trial, a study that will continue as planned. Recruitment timelines of the pivotal phase 3 study will be updated following the FDA approval of the Investigational New Drug Application (IND) and the Investigational Device Exemption (IDE) expectedly in H1 2019.

"Oncology Venture in-licensed LiPlaCis as a phase 1 project in 2016. The 505(b)(2) strategy allows us to refer to data for a listed drug and will save us important time and resources. Our team has done a remarkable job by moving this project from an early stage to a late stage project in only two years. The discussions with the FDA gave no barrier for proceeding with our pivotal development plans for a fast route to commercialization and we can now increase our partnering activities with pharma," comments Peter Buhl Jensen, M.D., CEO of Oncology Venture.

Data from the ongoing Phase 2 LiPlaCis study in patients with metastatic breast cancer shows a
50% objective response rate (five out of ten patients) in the upper one third of DRP selected patients and a 24% objective response rate (6 out of 25 patients) in the upper two thirds of DRP selected patients. These data should be compared with historical response rates to the established cancer drugs in metastatic breast cancer with a 10-12% objective response rate of eribulin, vinorelbine and gemcitabine and 10% of conventional cisplatin.

If the ongoing phase 2 study will continue to show strong efficacy data, Oncology Venture aims for a Break through designation. This application is planned for filing shortly after the IND and its IDE application for LiPlaCis.

Oncology Venture’s regulatory strategy is to first obtain approval in the US. The aim is then to run randomized pivotal studies in Europe and Asia.

On December 18, 2018 CTI BioPharma Corp. (NASDAQ:CTIC) reported that it has received input from the U.S. Food and Drug Administration (FDA) at a recent Type C meeting on key elements of the design of a new randomized Phase 3 study of pacritinib in adult patients with myelofibrosis (primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis) and who have severe thrombocytopenia (as defined by patients with platelet counts of less than 50,000 per microliter), an indication that has been recognized by the medical community as an important unmet medical need (Press release, CTI BioPharma, DEC 18, 2018, View Source [SID1234532119]).

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The planned Phase 3 study is designed to evaluate the effects of pacritinib as compared to physician’s choice of treatment. The primary efficacy endpoint will be the proportion of patients achieving a greater than or equal to 35% spleen volume reduction (SVR) between baseline and Week 24. Secondary efficacy endpoints of the study include total symptom score reduction and overall survival.

Before commencing the Phase 3 study, CTI plans to meet with the FDA to discuss the final optimal dose analysis from the PAC203 Phase 2 study. To expedite the transition to Phase 3, CTI intends to amend the PAC203 protocol to include a Phase 3 component. The PAC203 Phase 3 component is designed to enroll approximately 200 patients with enrollment expected to commence in the third quarter of 2019. The anticipated cost of the Phase 3 study is approximately $25 million. Taking into account the impact of recently-announced cost saving efforts and the anticipated cost of the new Phase 3 trial, the current CTI financial analysis projects a cash runway that extends into 2020.

On December 18, 2018 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), a clinical-stage biotechnology company specializing in the development of innovative drugs in oncology targeting tumor DNA Damage Response (DDR) to fight resistant cancers, reported having been notified by the European Patent Office (EPO) of its intent to grant the Company a new patent (EP3325623) covering the combination of AsiDNA, Onxeo’s first-in-class agonist of the DNA Damage Response (DDR) , with any PARP inhibitor (PARPi), in all countries of the European Union (EU) (Press release, Onxeo, DEC 18, 2018, View Source [SID1234532120]).

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This new patent protects the intellectual property of Onxeo relating to combined preparations comprising conjugated nucleic acid molecules, including its lead product candidate AsiDNA and a PARP inhibitor, as well as the use of the combined preparations for the treatment of cancer. Under the patent, AsiDNA and the PARP inhibitor may be present in one combined dosage form, or as part of separate dosage forms for sequential administration of the respective drugs. This European patent has a term expiring in mid-2036.

Onxeo has conducted extensive preclinical studies of AsiDNA in combination with various PARPi. These studies show that the combination has a strong synergistic anti-tumor activity in solid tumors, regardless of the genetic mutation status of the tumor. This synergy appears to be a class effect with all PARPi. Combination with AsiDNA could therefore represent an opportunity to expand PARPi indications to HR proficient tumors, which account for approximately 70% of tumors.

"This patent covering the combination of AsiDNA with any PARP inhibitor further reinforces our extensive patent portfolio, which is a key component of the value of AsiDNA. Our strong intellectual property position is an integral part of the Company’s business model, which aims to progress disruptive compounds up to the most valuable clinical inflexion points and then to partner or license them," said Judith Greciet, Chief Executive Officer of Onxeo.

On December 18, 2018 West Pharmaceutical Services, Inc. (NYSE: WST) reported that the Company’s Board of Directors has approved a first-quarter 2019 dividend of $0.15 per share (Press release, West Pharmaceutical Services, DEC 18, 2018, View Source [SID1234532121]). The dividend will be paid on February 6, 2019, to shareholders of record as of January 23, 2019.

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The Company also announced that management will be presenting an overview of the business at the J.P. Morgan Healthcare Conference in San Francisco, California, at 4:30 p.m. PST on Wednesday, January 9, 2019.

A live audio webcast of the presentation, as well as the presentation materials, will be accessible from the Company’s website: investor.westpharma.com.

On December 18, 2018 Erasca, a company dedicated to advancing exceptional scientific approaches to erase cancer, reported that it has completed a $42 million Series A financing round co-led by founding investors City Hill Ventures and Cormorant Asset Management, joined by additional institutional and individual investors (Press release, Erasca, DEC 18, 2018, View Source [SID1234534176]). Proceeds of the financing will support development of a new generation of oncology drugs intended to not just treat, but actually cure cancer.

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"Cancer is a pervasive disease that has impacted nearly everyone I know in some way. Individuals continue to be seriously afflicted and in need of healing beyond what can be provided by available treatments," said Jonathan E. Lim, M.D., Erasca’s executive chairman and co-founder. "Erasca was borne out of a mission to address this significant patient need and, one day, erase cancer. We recognize that this is an ambitious goal, as cancer is a formidable foe. But no mission worth taking is ever easy."

Erasca has multiple discovery programs underway for undisclosed targets that are biological drivers of cancer. The company anticipates it will disclose more about these programs as it moves into human clinical studies. Erasca is also pursuing additional opportunities for pipeline expansion through academic and biopharmaceutical collaborations.

"Founded on exciting new discoveries around key molecular drivers of cancer, and having assembled a team of executives with a legacy of multiple prior successes, Erasca is the company that stands an excellent chance of deftly overcoming multiple obstacles along this exciting, yet long, journey of bringing a breakthrough medicine to patients," said Bihua Chen, Portfolio Manager, Cormorant Asset Management. "Tackling a mission this large requires a combination of passion for the patient and strong business acumen. Jonathan’s background as a physician and biotech company leader who has led multiple successful companies, along with the outstanding team he has assembled, position Erasca well in executing on its mission."

Since 2003, the serial venturepreneur has been a leader and founding investor of four other biotechnology startups that delivered novel therapies for the benefit of patients globally, raised a combined $1 billion in capital and generated more than $4 billion of shareholder value. Dr. Lim’s most recent operational role was as chairman, president, CEO and co-founder of Ignyta, acquired by Roche in February 2018 for $1.7 billion. He has co-founded, funded and led several other successful ventures, including Bonti (acquired by Allergan), Eclipse Therapeutics (acquired by Bionomics) and Halozyme Therapeutics. He also is dedicated to building world-class, mission-driven ventures as managing partner for City Hill Ventures, an impact-minded investment firm he founded in December 2010, and as Venture Partner at ARCH Venture Partners, one of the largest seed and early stage technology venture firms in the U.S. Dr. Lim’s full bio can be accessed here.

Joining Dr. Lim on Erasca’s founding leadership team are business and finance veteran, Gary Yeung, CFA, who serves as the company’s Chief Business Officer, and highly regarded computational biologist, Robert Shoemaker, Ph.D., who is Vice President of Biology.