On January 7, 2020 Exelixis, Inc. (Nasdaq: EXEL) reported that Michael M. Morrissey, Ph.D., the company’s President and Chief Executive Officer, will provide a corporate overview at the 38th Annual J.P. Morgan Healthcare Conference being held next week in San Francisco (Press release, Exelixis, JAN 7, 2020, View Source [SID1234552808]). Exelixis’ presentation has been scheduled for Tuesday, January 14, 2020 at 7:30 PM EST / 4:30 PM PST.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 14 days.

On January 7, 2020 Revolution Medicines, Inc., a clinical-stage oncology company focused on developing targeted therapies to inhibit elusive frontier targets within notorious cancer pathways, reported that preliminary data from the company’s Phase 1 clinical trial (RMC-4630-01) of RMC-4630 will be presented at the 6th AACR (Free AACR Whitepaper)-IASLC International Joint Conference: Lung Cancer Translational Science from the Bench to the Clinic being held January 11-14, 2020 in San Diego, CA (Press release, Revolution Medicines, JAN 7, 2020, https://www.prnewswire.com/news-releases/revolution-medicines-to-present-preliminary-data-from-phase-1-clinical-trial-of-rmc-4630-at-6th-aacr-iaslc-international-joint-conference-300982012.html [SID1234552825]).

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RMC-4630, the company’s investigational SHP2 inhibitor, is a potent and orally bioavailable small molecule that is designed to selectively inhibit the activity of SHP2, an upstream cellular protein that plays a key role in modulating cell growth by transmitting signals from receptor tyrosine kinases to RAS. The ongoing Phase 1 monotherapy study is evaluating RMC-4630 for a range of tumor types featuring specific, molecularly-defined oncogenic mutations.

Data from the study will be reported in podium and poster presentations entitled, "The SHP2 inhibitor RMC-4630 in patients with KRAS-mutant non-small cell lung cancer: Preliminary evaluation of a first-in-man phase 1 clinical trial."

Details of the presentations are as follows:

Podium Presentation:

Session: Plenary Session 1: Therapeutic Targeting and Vulnerabilities of Ras-Driven Lung Cancer
Presenting Author: Sai-Hong Ignatius Ou, M.D., Ph.D., Chao Family Comprehensive Cancer Center, University of California, Irvine
Session Date/Time: Saturday, January 11, 2020, 4:30 – 6:15 p.m. Pacific
Poster Presentation:

Poster Number: A12
Session: Poster Session A
Presenting Author: Sai-Hong Ignatius Ou, M.D., Ph.D., Chao Family Comprehensive Cancer Center, University of California, Irvine
Session Date/Time: Sunday, January 12, 2020, 12:00 – 2:00 p.m. Pacific
In addition to the presentations on RMC-4630, Revolution Medicines will also report preclinical data on its mutant RAS(ON) inhibitors in a poster presentation at the conference. Details of that presentation are as follows:

Poster Presentation:

Poster Number: A06
Title: Tri-complex inhibitors of the oncogenic, GTP-bound form of KRASG12C overcome RTK-mediated escape mechanisms and drive tumor regressions in preclinical models of NSCLC
Session: Poster Session A
Presenting Author: Robert Nichols, Ph.D., associate director, systems biology at Revolution Medicines
Session Date/Time: Sunday, January 12, 2020, 12:00 – 2:00 p.m. Pacific
About RMC-4630 and Sanofi Collaboration

The RMC-4630 program is the focus of an exclusive global research, development and commercialization agreement with Sanofi, under which Revolution Medicines received a $50 million upfront payment, and Sanofi agreed to reimburse Revolution Medicines for substantially all research and all development costs for the joint SHP2 program. Sanofi received an exclusive worldwide license for global commercialization of any approved products targeting SHP2, subject to a U.S. co-promote right for Revolution Medicines. The companies have agreed to enter into a 50/50 profit and loss share arrangement in the U.S., and Revolution Medicines is entitled to receive tiered royalties on annual net sales ranging from high single digit to mid-teen percentages on sales in other markets. Revolution Medicines could also receive more than $500 million in development and regulatory milestone payments.

On January 7, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that it has entered into an option and license agreement to acquire exclusive, worldwide rights from ImmuNext Inc. (ImmuNext) to develop and commercialize anti-VISTA antibodies for the treatment of cancer, including ImmuNext’s lead compound, CI-8993 (formerly JNJ-61610588) (Press release, Curis, JAN 7, 2020, View Source [SID1234552775]). CI-8993 is a clinical-stage monoclonal antibody designed to antagonize the V-domain Ig suppressor of T cell activation (VISTA) signaling pathway.

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"This agreement aligns with our mission to develop the next generation of targeted cancer therapies and extends our leadership in developing anti-VISTA therapeutics," said James Dentzer, President and Chief Executive Officer of Curis. "The ImmuNext team and Dr. Randolph Noelle, whose lab in the Geisel School of Medicine at Dartmouth College co-developed the original characterization of VISTA biology, bring world-class expertise that will be invaluable to our collaboration as we seek to optimize the clinical development of CI-8993."

"VISTA is an important negative checkpoint regulator that plays a key role in the immune suppression induced by cancer," said Dr. Robert Martell, Head of R&D at Curis. "Recent studies also suggest VISTA is strongly upregulated in response to treatment with other cancer immunotherapy agents. We believe, a therapeutic antibody that can target and suppress VISTA represents a compelling single-agent strategy to potentially reverse tumor immune suppression and prevent resistance to other checkpoint inhibitors. In 2019, Curis led the clinical development of the first anti-VISTA program with a small molecule, CA-170. We look forward to leveraging that experience in 2020, this time with an antibody."

CI-8993 was originally developed as part of a license and collaboration agreement between ImmuNext and Janssen Biotech, Inc (Janssen). In 2016, Janssen initiated clinical development of CI-8993 in a Phase 1 study evaluating safety, pharmacokinetics and pharmacodynamics of ascending doses of CI-8993 in patients with advanced solid tumors. The study enrolled 12 patients, in which one patient experienced dose-limiting side effects related to cytokine release syndrome. Janssen opted to close the study and ImmuNext regained control of the asset.

"In the years since the original CI-8993 study, the advent of CAR-T therapy and broad expansion of immunotherapy have led to an evolution within the oncology community toward the safe management of "on-target" side effects such as cytokine release and immune-mediated toxicity. For example, in 2018, the National Comprehensive Cancer Network (NCCN) developed its Guidelines for Management of Immunotherapy-Related Toxicities. We believe the time is right to re-introduce CI-8993 into the clinic as a potentially transformative new therapy for patients," said Dr. Martell.

Under the terms of the agreement with ImmuNext, Curis will make an upfront payment to ImmuNext in exchange for an option to obtain an exclusive, worldwide license to develop and commercialize ImmuNext’s anti-VISTA compounds and products containing these compounds in the field of oncology. This option is exercisable upon the earlier of: (i) four years from signing of the agreement; and (ii) 90 days after database lock for the first Phase 1a/1b trial in which the clinical endpoints are satisfied. Upon option exercise, Curis will pay ImmuNext an option exercise fee. ImmuNext is also eligible to receive future potential development, regulatory, and commercial milestone payments, as well as royalties on product sales.

For more information regarding the financial and other terms of the agreement, please refer to the Current Report on Form 8-K filed by Curis with the U.S. Securities & Exchange Commission on January 7, 2020.

About VISTA

VISTA is a novel negative checkpoint ligand that is homologous to PD-1/PD-L1 and suppresses T cell activation. VISTA relieves negative regulation by hematopoietic cells and enhances protective anti-tumor immunity, and is highly expressed on myeloid cells and T cells. Preclinically, VISTA monoclonal antibody treatment increased the number of tumor-specific T cells in the periphery, and enhanced the infiltration, proliferation and effector function of tumor-reactive T cells within the tumor microenvironment (TME). VISTA blockade alters the suppressive feature of the TME by decreasing the presence of monocytic myeloid-derived suppressor cells and increasing the presence of activated dendritic cells (DCs) within the TME leading to enhanced T cell mediated immunity. VISTA monoclonal antibody administration as a monotherapy has been shown to suppress the growth of both transplantable and inducible melanoma in preclinical models. Previous studies have demonstrated that VISTA blockade may be synergistic with peptide-based cancer vaccines to impair the growth of established tumors.

Clinically, VISTA is strongly expressed in several tumor types including pancreatic cancer, mesothelioma, and prostate cancer. VISTA creates an immune blocking signal that is independent of, and complementary to, PD-1 and CTLA-4. VISTA expression in patient samples increases as a compensatory reaction to treatment with PD-1 and CTLA-4 directed therapy.

On January 7, 2020 Incyte (Nasdaq:INCY) reported the validation of the Company’s Marketing Authorization Application (MAA) for pemigatinib for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that is relapsed or refractory after at least one line of systemic therapy (Press release, Incyte, JAN 7, 2020, View Source [SID1234552792]). The European Medicines Agency’s (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process.

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"The EMA’s validation of Incyte’s Marketing Authorization Application opens the review process as we seek to bring the first targeted therapy to Europe for patients with cholangiocarcinoma," said Peter Langmuir, M.D., Group Vice President, Targeted Therapeutics, Incyte. "The need for new therapies for cholangiocarcinoma was also recently recognized by the U.S. Food and Drug Administration’s acceptance, for Priority Review, of our New Drug Application for pemigatinib this past November. We are looking forward to continuing to work with regulatory authorities to bring this novel targeted therapy to eligible patients around the world."

The MAA application is based on data from the FIGHT-202 study evaluating pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma.1

Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its origin: intrahepatic cholangiocarcinoma (iCCA) occurs in the bile duct inside the liver and extrahepatic cholangiocarcinoma occurs in the bile duct outside the liver. Patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor.2,3 The incidence of cholangiocarcinoma varies regionally, but ranges between 0.4 – 1.8 per 100,000 in Europe.4 FGFR2 fusions or rearrangements occur almost exclusively in iCCA, where they are observed in 10-16 percent of patients.5-7

About FIGHT-202

The FIGHT-202 Phase 2, open-label, multicenter study (NCT02924376) is evaluating the safety and efficacy of pemigatinib – a selective fibroblast growth factor receptor (FGFR) inhibitor – in adult (age ≥ 18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status.

Patients were enrolled into one of three cohorts – Cohort A (FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genetic alterations) or Cohort C (no FGF/FGFR genetic alterations). All patients received 13.5 mg pemigatinib orally once daily (QD) on a 21-day cycle (two weeks on/one week off) until radiological disease progression or unacceptable toxicity.

The primary endpoint of FIGHT-202 is overall response rate (ORR) in Cohort A, assessed by independent review per RECIST v1.1. Secondary endpoints include ORR in Cohorts B, A plus B, and C; progression free survival (PFS), overall survival (OS), duration of response (DOR), disease control rate (DCR) and safety in all cohorts.

For more information about FIGHT-202, visit View Source

About FIGHT

The FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program includes ongoing Phase 2 and 3 studies investigating safety and efficacy of pemigatinib therapy across several FGFR-driven malignancies. Phase 2 monotherapy studies include FIGHT-202, as well as FIGHT-201 investigating pemigatinib in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 mutations or fusions/rearrangements; FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 fusions/rearrangements; FIGHT-207 in patients with previously treated, locally-advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or fusions/rearrangements, irrespective of tumor type. FIGHT-205 is a Phase 2 study investigating pemigatinib plus pembrolizumab combination therapy and pemigatinib monotherapy in patients with previously untreated, metastatic or unresectable bladder cancer harboring FGFR3 mutations or fusions/rearrangements who are not eligible to receive cisplatin. FIGHT-302 is a recently initiated Phase 3 study investigating pemigatinib as a first-line treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.

About FGFR and Pemigatinib

Fibroblast growth factor receptors (FGFRs) play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating fusions, rearrangements, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers.

Pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.

On January 7, 2020 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 12:00 p.m. PST on Wednesday, January 15, at the 38th Annual J.P. Morgan Healthcare Conference (Press release, Puma Biotechnology, JAN 7, 2020, View Source [SID1234552809]). The conference will be held at the Westin St. Francis Hotel in San Francisco.

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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

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A live webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com. The presentation will be archived on the website and available for 30 days.