On June 12, 2019 Prelude Therapeutics, a privately held, clinical-stage biopharmaceutical company focused on the discovery and development of small molecule drugs that target key drivers of cancer cell growth, survival and resistance, reported that secured $60 million in Series B financing; taking its total investments to date to $95 million (Press release, Prelude Therapeutics, JUN 12, 2019, View Source [SID1234539637]). The financing was co-led by Prelude’s two existing institutional investors, including OrbiMed Advisors LLC.

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Since its launch in July 2016, Prelude has made rapid progress in its first discovery program targeting Protein Arginine Methyltransferase 5 (PRMT5), a member of the arginine methyltransferase family. PRMT5 plays an important role in several cellular processes that drive cancer cell proliferation, cell cycle progression and resistance to apoptosis in hematological malignancies and solid tumors.

Proceeds from the Series B financing will be used to advance Prelude’s proprietary PRMT5 inhibitor, PRT543, through proof of concept clinical studies. PRT543 is in a parallel dose escalation Phase 1 clinical trial for solid tumors, myeloid malignancies and lymphomas.

Series B funding will also be used to advance additional differentiated compounds from the PRMT5 program and strengthen Prelude’s discovery, preclinical and clinical development infrastructure to support a rapidly advancing pipeline beyond PRMT5. Prelude has established several drug discovery programs and compounds from these early-stage programs are also expected to enter preclinical development in the second half of 2019 with a potential IND-filing in 2020.

"We are very appreciative of the continued support of our current investors, who have been integral to the founding of Prelude and the creation of our growing pipeline," said Kris Vaddi, PhD, Founder and CEO of Prelude Therapeutics. "We believe PRMT5 inhibitors represent a promising new class of drugs to treat cancers, including ones that have developed resistance to existing targeted therapies. We are also pleased to have assembled such a talented, experienced and proven leadership team to address some of the most pressing gaps in cancer treatment."

Prelude Management Team

Dr. Vaddi founded Prelude in July 2016 and serves as CEO and a member of the Board of Directors. Prior to Prelude, Dr. Vaddi was a member of the founding team of Incyte Corporation in 2002 and most recently served as a group vice president. He initiated and championed JAK research programs at Incyte that led to the discovery, development and approval of Jakafi (ruxolotinib) for Myelofibrosis and Polycythemia Vera and Olumiant (Baricitinib) for rheumatoid arthritis. Dr. Vaddi received his Doctorate in Veterinary Medicine from APAU in India and his PhD from the University of Florida.

On May 1, 2019, David Mauro, MD, PhD, was named Chief Medical Officer. Dr. Mauro comes to Prelude with strong drug development experience in positions of increasing responsibility at Bristol-Myers Squibb, Merck and most recently Checkmate Pharmaceuticals as its Chief Medical Officer. Dr. Mauro earned his MD and PhD from Temple University School of Medicine.

Beginning July 1, 2019, Brian Piper, MBA will join Prelude as Chief Financial Officer. Mr. Piper most recently served as Chief Financial Officer at Aevi Genomic Medicine, where he was responsible for leadership and management of corporate financing and reporting, corporate fundraising efforts and investor relations. Prior to that, Mr. Piper held roles of increasing responsibility in finance, program and alliance management and investor relations at Shire Pharmaceuticals.

On June 12, 2019 Starpharma (ASX: SPL, OTCQX: SPHRY) reported the first patent for DEP Bcl2/xL inhibitor conjugates, developed in collaboration with AstraZeneca, has been granted by the US Patent and Trademark Office (Press release, Starpharma, JUN 12, 2019, View Source [SID1234537239]). These patented DEP Bcl2/xL inhibitor conjugates combine Starpharma’s innovative DEP delivery technology with AstraZeneca’s novel Bcl2/xL inhibitors, which are being investigated for treating various cancers, including leukemias.

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This is the first patent to be granted for DEP conjugates developed under the multiproduct DEP licence between Starpharma and AstraZeneca. The granted patent shows promising data on DEP Bcl2/xL inhibitor conjugates in various preclinical human tumour models, both alone and in combination with other leading current anti-cancer treatments. This data was previously announced to the ASX on 31 August 2018.

AZD0466 is a developmental DEP Bcl2/xL inhibitor conjugate, with broad combination potential being evaluated in both solid and haematological tumours (blood cancers), due to its potential to target both Bcl2 and Bcl/xL. AZD0466 is in the final stages of preclinical development with a US FDA investigational new drug application (IND) planned in the near future.

Starpharma CEO, Dr Jackie Fairley commented: "The grant of this US patent is an important milestone for Starpharma’s partnered DEP programs, and further highlights the benefits that the DEP platform provides in the development of novel oncology agents. The DEP Bcl2/xL inhibitor conjugates are a great illustration of the commercial value that can be created using Starpharma’s DEP platform".

Under the AstraZeneca multiproduct DEP licence, Starpharma is eligible to receive potential development, launch and sales milestones of US$124 million for the first DEP product, and US$93.3 million for each subsequent qualifying product. Starpharma will also receive tiered royalties on net sales, and AstraZeneca funds development costs of DEP AstraZeneca products, including the DEP Bcl2/xL inhibitor conjugates which are the subject of this patent.

On June 12, 2019 Xynomic Pharmaceuticals Holdings, Inc. ("Xynomic", Nasdaq: XYN), a clinical stage US-China oncology drug development company, reported that it recently held a pre-IND meeting with the U.S. Food and Drug Administration (FDA) for its pan-PAF inhibitor XP-102 (BI 882370) for the treatment of cancers (Press release, Xynomic Pharmaceuticals, JUN 12, 2019, http://xynomicpharma.com/en/xynomic-completes-pre-ind-meeting-with-us-fda-for-xp-102-a-novel-pan-raf-inhibitor-against-colorectal-cancer-and-lung-cancer/ [SID1234537089]). The FDA addressed Xynomic’ questions related to CMC, nonclinical and clinical protocol, and provided valuable advice on overall clinical development plan to advance this drug candidate. Xynomic is on track to file this Investigational New Drug ("IND") application in the second half of 2019.

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XP-102 is a second generation potent and selective pan-RAF inhibitor uniquely binding to the DFG-out conformation, whereas marketed BRAF inhibitors occupy the DFG-in conformation. In the colorectal cancer (CRC) animal models, XP-102 showed superior anti-tumor activity to vemurafenib, a marketed BRAF inhibitor in both the Colo-205V600V/Emodel and HT-29V600V/E model. XP-102 in combination with cetuximab induced tumor regressions in the less sensitive HT-29 model.

"Our meeting with the FDA was a major step forward and the feedbacks provided by the agency was valuable in our development of clinical and regulatory strategies that will support our goal of advancing XP-102 through clinical development," said Y. Mark Xu, Xynomic’ Chairman and CEO. "We believe that XP-102 holds potential as an innovative therapy against B-RAF V600 mutated solid tumors including CRC and non-small cell lung cancer and hairy cell leukemia."

On June 12, 2019 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that Geoffrey O’Brien, JD/MBA, Vice President and Executive Officer, will present a corporate overview at the JMP Securities Life Sciences Conference on Wednesday, June 19, 2019 at 11:30 am at the St. Regis New York Hotel in New York City (Press release, MediciNova, JUN 12, 2019, View Source [SID1234537066]). MediciNova will be available for one-on-one meetings at this conference and investors may request a one-on-one meeting through JMP Securities.

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On June 12, 2019 NuCana plc (NASDAQ: NCNA) reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the Company’s investigational drug, Acelarin (NUC-1031), for the treatment of biliary tract cancer (Press release, Nucana BioPharmaceuticals, JUN 12, 2019, View Source [SID1234537054]). Acelarin is a new chemical entity and is NuCana’s ProTide transformation of gemcitabine.

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"We are pleased to have received orphan drug designation from the FDA for Acelarin in biliary tract cancer," said Hugh Griffith, NuCana’s Founder and Chief Executive Officer. "There is a high unmet need for patients suffering from this cancer type. Our Phase Ib study of Acelarin combined with cisplatin showed an approximate doubling of the response rate expected with the standard of care, gemcitabine plus cisplatin, with several patients achieving significant reductions in their tumor volume as well as further tumor shrinkage over time. We believe Acelarin represents a potential significant advance in biliary tract cancer and we remain on track to open our global Phase III study in combination with cisplatin as a front-line treatment for patients with advanced biliary tract cancer in 2019."

Orphan drug designation is granted by the FDA to drugs that are defined as those intended for the treatment, prevention or diagnosis of rare diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug designation provides certain benefits and incentives that may include tax credits towards the cost of clinical trials and prescription drug user fee waivers.

About Biliary Tract Cancer

Biliary tract cancer is a form of cancer that develops in the bile duct system, which connects the liver, gallbladder, and small intestine, moving bile – a fluid that helps digest fats – to the small intestine. Approximately 178,000 new cases of biliary tract cancer are diagnosed each year worldwide, with more than 12,000 of those diagnoses in the United States.