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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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 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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

On October 10, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will webcast its Quarterly Update Conference Call for the third quarter 2018 on Tues., Nov. 6 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call (Press release, Halozyme, OCT 10, 2018, View Source [SID1234529865]). On the same date, Halozyme will release financial results for the third quarter ended September 30, 2018 following the close of trading.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The call will be webcast live through the "Investors" section of Halozyme’s corporate website and a replay will be available following the close of the call. The live call may be accessed by dialing (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 387156. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 55575898.

On October 10, 2018 AUM LifeTech, Inc., a Philadelphia-based biotech company, reported that it has partnered with the Children’s Hospital of Philadelphia (CHOP) and the Perelman School of Medicine at the University of Pennsylvania to employ next-generation RNA silencing FANA technology as a new approach to cancer immunotherapy designed to treat lung cancer (Press release, AUM Lifetech, OCT 10, 2018, View Source [SID1234529849]). The preclinical results were presented at the 2018 Annual Meeting of the Oligonucleotide Therapeutics Society (OTS) in Seattle, WA.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study demonstrated that by reducing levels of a key protein called Foxp3 in immune cells using FANA antisense oligonucleotides (FANA ASOs), a next-generation gene silencing technology, lung cancer survival could be improved. Foxp3 is found in a subset of immune cells called T-regulatory (Treg) cells that constitute 5-10% of T cells (a type of white blood cell). Typically, Tregs suppress inappropriate immune activity and autoimmune diseases, however, their presence in tumors can prove deleterious and promote progression of many types of human cancers. In such cases, Tregs prevent anti-tumor responses by stopping the body’s conventional immune cells from attacking the cancerous cells. Without Foxp3, Treg cells are unable to perform their immune suppressing function. The team showed that FANA ASO therapy effectively reduced the levels of Foxp3 protein in Tregs by silencing Foxp3 gene (messenger RNA or mRNA), thus mitigating Treg-induced immune suppression and allowing the body to mount a full attack on the tumor. "Lung cancer is the biggest killer amongst all cancers. Our preclinical data in a lung cancer animal model is very encouraging and showed complete tumor rejection in a statistically significant animal population that were dosed with FANA antisense oligonucleotide therapy. We are now pursuing the next set of preclinical studies as we move towards filing of an Investigational New Drug (IND) application. I am very thankful to our collaborators and proud of my entire team as we embark on this extraordinary and very important journey to fight cancer," said Veenu Aishwarya, co-founder and Chief Executive Officer of AUM LifeTech, Inc.

This research was co-led by Dr. Wayne Hancock, Chief of the Division of Transplantation Immunology at the Children’s Hospital of Philadelphia. Dr. Hancock, a globally recognized immunologist, is also a Professor of Pathology and Laboratory Medicine at the University of Pennsylvania School of Medicine and has been working in the immune oncology and cancer immunotherapy space for over three decades. "We are very excited about our preclinical data. Tregs are known to suppress anti-tumor responses by host CD8 and CD4 T cells, B cells, NK cells, macrophages and dendritic cells. The ability of FANA ASOs to silence Foxp3 in Tregs makes them very attractive candidates for cancer immunotherapy for lung cancer, especially because currently there are no effective ways to target Tregs. The biggest advantage of FANA ASO therapy is its ability to self-deliver without the need of any formulations," said Dr. Hancock. "There is a lot of enthusiasm in the field of immuno-oncology. Last week’s announcement of the Nobel Prize in Medicine to Dr. James Allison (for CTLA-4) and Dr. Tasuku Honjo (for PD-1) further demonstrates the importance of this field. We plan to use FANA antisense therapy to further advance cancer immunotherapy."

FANA therapy can add significant unprecedented advantages to conventional therapeutic modalities and also target undruggable targets. This is especially beneficial for very aggressive forms of cancer, several of which are difficult to diagnose at early stages. "Existing strategies to treat some forms of cancer include the use of checkpoint inhibitors (monoclonal antibodies) to target immune checkpoints like PD-1 or CTLA-4, which are cell surface proteins involved in regulating the immune system. In other cases, they block the interaction between PD-1 and its ligand PD-L1. Some recent promising strategies include the use of chimeric antigen receptor (CAR) T-cell therapy to treat cancer. Checkpoint inhibitors and CAR T-cell therapy intercept their target at the protein or cellular level respectively. Using FANA ASO therapy, AUM LifeTech has joined the fight against cancer, and is advancing cancer immunotherapy, at the genetic level by directly targeting key genes to achieve anti-tumor immunity," added Aishwarya.

This study used RNA silencing FANA technology which has some key advantages over conventional gene silencing approaches. "I am very happy to see multiple applications of our FANA technology especially in the field of cancer. FANA provides high sequence specificity, stability and efficacy. It has been a long journey for AUM and I am delighted to see that their work is getting ready for clinical applications," said Dr. Masad J. Damha who is Distinguished James McGill Professor at McGill University in Canada. Dr. Damha, an internationally known nucleic acid researcher, serves on the Scientific Advisory Board of AUM LifeTech.

AUM LifeTech has leveraged the space, resources and support of the University City Science Center in Philadelphia since 2013. "The Science Center is delighted to provide the resources and support that allows companies like AUM LifeTech to grow and thrive," said Steve Zarrilli, President & CEO of the University City Science Center. "This promising research and exciting partnership are a reminder of the robust community of innovators that is driving research forward and advancing healthcare in Philadelphia and beyond."

On October 10, 2018 Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development and commercialization of female-specific oncology products, reported the launch of a Phase 2 trial for the treatment of metastatic breast cancer (Press release, Sermonix Pharmaceuticals, OCT 10, 2018, View Source [SID1234532258]). The program is an open-label, randomized, multi-center study evaluating the activity of its lead investigational drug, oral lasofoxifene, versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Clinical data have shown a significant reduction in the incidence of ER+ breast cancer in postmenopausal women with osteoporosis who were treated with lasofoxifene," said Paul Plourde, MD, Sermonix vice president of clinical development. "Additional non-clinical and clinical study results provide further impetus for undertaking a Phase 2 trial in a targeted way that compares lasofoxifene to fulvestrant, a current, widely used injectable medication for advanced metastatic breast cancer."

Linical Accelovance Group, a mid-size global contract research organization, will serve as Sermonix’s research partner for the study, enrolling 100 patients in 27 sites across the U.S.

"Sermonix selected Linical Accelovance to be our clinical research development partner for this program because we are impressed with the organization’s integrated clinical trial services, as well as its operational capabilities in the development of oncology drugs," said Sermonix Chief Operating Officer Dr. Miriam Portman.

The trial will utilize oral lasofoxifene for advanced breast cancer patients with ESR1 gene mutations. The primary clinical endpoint will be progression-free survival (PFS).

"Sermonix is developing lasofoxifene as a personalized medicine treatment for patients with ER+ metastatic breast cancer that have progressed after endocrine and other therapies," said Sermonix Chief Executive Officer Dr. David Portman. "We look forward to seeing how it performs in the Phase 2 trial versus fulvestrant."

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. (NASDAQ: LGND). Lasofoxifene has been studied in comprehensive non-oncology clinical trials recruiting more than 15,000 women worldwide and has demonstrated efficacy for treating vulvovaginal atrophy (VVA), and postmenopausal osteoporosis.

Oral Lasofoxifene’s binding affinity and activity in mutations of the estrogen receptor may hold promise for patients who have acquired resistance and mutations of the estrogen receptor, a common mutation in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations has recently been discovered and Sermonix has exclusive rights to develop and commercialize oral lasofoxifene in this area. Oral Lasofoxifene, a potent, well-tolerated and bioavailable SERM, if approved could play a critical role in the personalized treatment of advanced ER+ breast cancer.