On October 10, 2018 Helix BioPharma Corp. (TSX: HBP), (FSE: HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that it has extended its collaboration agreement with Moffitt Cancer Center for an additional year (Press release, Helix BioPharma, OCT 10, 2018, View Source [SID1234530409]).

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During the first year of the collaboration, a new pancreatic adenocarcinoma mouse model suitable for testing L-DOS47 in combination with immunotherapy was developed. Preliminary studies in this model showed that L-DOS47 may increase the activity of a PD-1/PD-L1 inhibitor in treating pancreatic cancer. In addition, work was initiated to demonstrate that certain imaging techniques may be useful in directly measuring tumor acidity. Helix is hoping to use this non-invasive technique in the clinic soon.

In year two of the project, work will include not only the study of L-DOS47 in combination with PD-1/PDL1 inhibitors, but also in combination with other drugs in the pancreatic model. Analysis of the immune response that is occurring in the tumor upon L-DOS47 combination treatment will also be characterised. Results from these studies will add to the current understanding of how tumor acidity affects the tumor immune response. Data from these studies will also support Helix’s plan to increase the clinical application of L-DOS47 with various combination treatments, including immunotherapies with checkpoint inhibitors.

"We are strongly encouraged by our preliminary data that this may be an effective approach to improving outcomes to a variety of therapies" said Dr. Robert Gillies, Martin Silbiger Endowed Chair, Moffitt Cancer Center. "We know that tumor acidity is an important contributor to therapy resistance, and thus neutralizing acidity with L-DOS47 should have a positive effect in combination with chemotherapies and immune checkpoint blockade".

"This years’ Nobel prize in Physiology or Medicine was awarded for the discovery of cancer therapy by inhibition of negative immune regulation." said Heman Chao, Ph.D., Chief Executive & Scientific Officer of Helix. "We are very excited to work with the Moffitt team in applying L-DOS47 in immunotherapy and we look forward to using L-DOS47 with PD-1/PD-L1 inhibitors in the clinic which could result in significant benefits to patients."

On October 10, 2018 Incyte (Nasdaq: INCY) has reported that the Phase 2 intermediate data of its selective inhibitor of FGFR1 / 2/3 in the clinical research phase, pemigatinib (INCB54828), will be will present at the next European Congress of Oncology (ESMO) (Free ESMO Whitepaper) 2018 that will take place in Munich, Germany, from October 19 to 23, 2018 (Press release, Incyte, OCT 10, 2018, View Source [SID1234529846]).

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The information that will be announced in ESMO (Free ESMO Whitepaper) 2018 includes poster presentations on the FIGHT-202 study of pemigatinib in patients with advanced cholangiocarcinoma (cancer of the bile duct) and previously treated / metastatic or surgically unresectable with a genetic alteration of the factor of fibroblastic growth (FGF) / FGFR, as well as the FIGHT-201 study of pemigatinib in patients with metastatic or surgically unresectable urothelial carcinoma (cancer of the bladder) carrying an alteration of the FGF / FGFR gene.

"We are pleased that pemigatinib data – part of our portfolio of targeted treatments – have been selected for presentation at this year’s ESMO (Free ESMO Whitepaper) conference," said Steven Stein, MD, medical director, Incyte. "We are keen to share the latest intermediate data from the ongoing FIGHT-202 trial for pemigatinib in patients with cholangiocarcinoma, who continue to support our project to submit the new drug registration request in 2019 for this indication, as well as updated data from the FIGHT-201 study of pemigatinib in patients with urothelial carcinoma, which supports the recruitment for the continuous administration cohort of this trial ».

The summaries were made public today on the ESMO (Free ESMO Whitepaper) congress website, at View Source .

Poster details:

Intermediate results of FIGHT-202, an open and multicenter Phase 2 study of INCB054828 in patients (pts) with advanced and previously treated / metastatic or surgically unresectable cholangiocarcinoma (CCA) with / without alterations of the fibroblast growth factor (FGF) gene / FGF receptor (FGFR) (summary No. 756P, poster presentation session)

Sunday, October 21, 2018 from 12:45 pm Spanish Peninsular Time until 1:45 pm Spanish Peninsular Time (6:45 am East Coast Time at 7:45 am Eastern Time) in the Pavilion A3 – Poster Area Networking Hub
Intermediate results of FIGHT-202, an open-label multicentre study in Phase 2 of INCB054828 in patients (pts) with metastatic or surgically unresectable urothelial carcinoma (UC) carrying the genetic alterations (GA) of fibroblast growth factor (FGF) / FGF receptor (FGFR) (summary No. 900P, poster presentation session)

Monday, October 22, 2018 from 12:45 pm Spanish Peninsular Time at 1:45 pm Spanish Peninsular Time (6:45 am East Coast Time at 7:45 am Eastern Time) in Hall A3 – Poster Area Networking Hub
The details of the full session and the data submission lists for ESMO (Free ESMO Whitepaper) 2018 can be found at:

View Source .

About the FGFR and Pemigatinib (INCB54828)

Fibroblast growth factor receptors (FGFR) play an important role in the proliferation of tumor cells and in survival, migration and angiogenesis (formation of new blood vessels). The mutations, translocations and activating gene amplifications of the FGFRs are closely correlated with the development of various types of cancer.

Pemigatinib is a potent selective inhibitor of isoforms 1, 2 and 3 of FGFR that, in preclinical studies, has shown a selective pharmacological activity against cancer cells with alterations in FGFR. Phase 2 studies investigating the safety and efficacy of pemigatinib monotherapy for various neoplasms due to FGFR are underway. The FIGHT clinical trial program (FIbroblast Growth factor receptor in oncology and Hematology Trials) currently comprises the FIGHT-201 study in patients with metastatic or surgically unresectable bladder cancer, including activating alterations of FGFR3; the FIGHT-202 study in patients with metastatic or surgically unresectable cholangiocarcinoma who did not respond to previous treatment, including activating translocations of FGFR2; and the FIGHT-203 study in patients with myeloproliferative neoplasms with activating translocations of FGFR1.

On October 10, 2018 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that its acquisition of Vernalis plc has successfully closed and Vernalis will now operate as a subsidiary of Ligand (Press release, Ligand, OCT 10, 2018, View Source [SID1234529847]). Vernalis is a structure-based drug discovery biotechnology company with a broad pipeline of partnered programs and ongoing collaborations. In conjunction with this event, Ligand announced that its portfolio now contains more than 178 shots on goal.

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"We welcome the Vernalis team into the Ligand family and are pleased to add its expertise in structure-based drug discovery to our discovery technology platforms that we offer partners. The Vernalis team has proven its ability to generate novel drug candidates for its partners, including the leading partnerships with Verona and Corvus for COPD and oncology," said John Higgins, Chief Executive Officer of Ligand. "As we advance the Ligand business model, we will continue to evaluate a variety of business, royalty and technology acquisitions, all with the objective of adding shots on goal to our portfolio and creating potential for long-term, diversified and sustainable cash flows for our investors."

Under the terms of the acquisition, Ligand paid Vernalis shareholders approximately $42.3 million, offset by approximately $32 million of net cash on hand at Vernalis, after deal costs.

As previously announced, the acquisition of Vernalis provides Ligand with the following:

A portfolio of more than 8 fully-funded partnered programs, or shots on goal, including:
RPL554, a Phase 2, novel treatment for COPD, which is partnered with Verona Pharma;
CPI-444, a Phase 1, adenosine A2A receptor antagonist for treatment of solid tumors, which is partnered with Corvus Pharmaceuticals.
A 70-person R&D team based in Cambridge, England focused on fragment- and structure-based drug discovery and partnering, with an active portfolio of collaboration agreements generating over $8 million per year of service revenue matched by a comparable level of costs, and partnerships that have the potential to generate additional near-term shots on goal. Ongoing collaboration partners include Servier, Daiichi Sankyo, Asahi Kasei and others.
An established compound library and additional early-stage, unpartnered programs in oncology, CNS and other areas that will provide business development out-licensing and corporate formation opportunities.
England-based operations that provide a platform to more efficiently pursue investment and acquisition opportunities in Europe and the United Kingdom.
Ligand 2018 Financial Outlook

As previously announced, revenue and operating expense impact from Vernalis in 2018 is currently expected to be small and mostly offset each other. Beyond 2018, research business revenue is expected to approximate expenses with longer-term milestones and royalties being accretive to future Ligand earnings.

Advisors

MTS Securities, LLC and finnCap Ltd. served as financial advisors and Latham Watkins LLP served as legal advisor to Ligand in this transaction.

On October 10, 2018 Gotham Therapeutics, a biotechnology company developing a novel drug class targeting RNA-modifying proteins, reported with a $54 million Series A financing co-led by founding investor Versant Ventures, Forbion and S.R. One (Press release, Gotham Therapeutics, OCT 10, 2018, View Source [SID1234550889]). The syndicate also included Celgene Corporation and Alexandria Venture Investments. Gotham is part of New York’s rapidly growing biopharma community with a subsidiary at one of Europe’s leading life science clusters near Munich, Germany.

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Versant created and seeded Gotham based upon the seminal discoveries of co-founder Samie Jaffrey, M.D. Ph.D., a pioneer in an exciting new field within RNA metabolism called epitranscriptomics. Dr. Jaffrey is a professor of pharmacology at Weill Cornell Medicine and a member of the Scientific Advisory Board for Gotham Therapeutics. His work has shed light on the role of post-transcriptional mRNA modifications in health and disease. These modifications and their biological effects are driven by protein complexes commonly described and categorized as writers, erasers and readers of the epitranscriptomic code.

With its seed funding, Gotham built a platform to assess the impact of RNA-modifying proteins on disease biology and developed small molecules against priority targets. The Series A proceeds will allow Gotham to establish clinical proof of concept and to invest broadly in a pipeline of preclinical candidates that have potential to treat diseases intractable to classical approaches.

"As we pursue several important targets, the information we glean will help us further validate and build our platform for increasingly broad applications. Our goal is to become the leader in drugging key proteins that modulate mRNA functionality, thereby impacting disease onset and progression," said Lee Babiss, Ph.D., CEO of Gotham.

"While academic research and the pharmaceutical industry focused initially on modifications of DNA, a growing body of evidence indicates that mRNA modifications help determine to which degree genes are translated into proteins. RNA modifications and their associated protein complexes therefore represent an untapped frontier that could yield new therapeutic approaches," added Dr. Jaffrey.

Gotham has assembled an experienced founding team led by Dr. Babiss, former President of Pharma Research at Roche. Dr. Babiss is an early adopter of RNA drug discovery approaches who has a track record of translating discoveries into therapeutic candidates. He also has served as CSO of PPD, and as Head of Human Genetics and Personalized Healthcare at Glaxo Wellcome.

"After following the developments in the RNA drug discovery field for a number of years, we felt this was the right time to build a company that could capitalize on translating the scientific discoveries into a whole new class of drug candidates," said Carlo Rizzuto, Ph.D., Partner at Versant. "With our initial investment, the Gotham team constructed a platform able to validate critical links between specific types of RNA modifications and disease biology. We look forward to advancing a number of drug candidates with this new round of financing."

"We are excited to invest in Gotham, one of the pioneers in the fast-emerging field of RNA metabolism, which could create a paradigm shift in both cancer therapy and other major diseases," commented Holger Reithinger, Ph.D., General Partner at Forbion. "Gotham represents the first investment by our recently announced Forbion IV fund. Our new fund aims to help build leading companies around exciting new science, proven teams or in-licensed assets."

Dr. Reithinger will join Dr. Babiss, Dr. Rizzuto and Jill Carroll, Principal, SR One, on Gotham’s Board of Directors. Jorge DiMartino M.D., Ph.D., Vice President, Translational Development Oncology at Celgene and Head of Celgene’s Epigenetics Thematic Center of Excellence, has joined the board in an observer role.

On October 10, 2018 Janssen Pharmaceuticals of Johnson & Johnson reported tha it will present new data from the entire cancer portfolio at the 2018 annual European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress, which will be held from 19 to 23 October in Munich, Germany (Press release, Johnson & Johnson, OCT 10, 2018, View Source [SID1234529848]).

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The original text of this announcement, written in the source language, is the official version that is authentic. Translations are offered solely for the convenience of the reader and must refer to the original text, which is the only legally valid one.