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MorphoSys and Immatics Biotechnologies Enter Strategic Alliance in Immuno-oncology

On August 25, 2015 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX, OTC: MPSYY) and Immatics Biotechnologies GmbH reported a strategic alliance to generate novel antibody-based therapeutics against multiple proprietary cancer antigens recognized by T cells (Press release, MorphoSys, AUG 25, 2015, View Source [SID:1234507332]).

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The collaboration agreement provides MorphoSys with access to several proprietary tumor-associated peptides (TUMAPs) discovered using Immatics’ XPRESIDENT platform to develop novel antibody-based therapeutics against these targets in a number of solid and hematological cancers. XPRESIDENT enables access to novel antibody targets associated with proteins that are present inside cancer cells. In return, Immatics will be provided with MorphoSys’ Ylanthia antibodies against a number of its TUMAPs, with proprietary development rights. The companies will pay each other milestones based on their respective development progress as well as royalties on marketed products. Financial details of the agreement were not disclosed.

Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG, commented: "We are delighted to join forces with Immatics, a world leader in discovering truly novel cancer targets that would be otherwise inaccessible for antibody-based therapies. This alliance opens up the intracellular target space for us and thus complements the therapeutic approaches we use in other oncology programs. We believe this collaboration will create several unique product opportunities for us based on truly differentiated compounds."

Dr. Harpreet Singh, Chief Scientific Officer of Immatics Biotechnologies GmbH, added: "The alliance with MorphoSys marks an important strategic milestone for Immatics. We are now entering the field of antibody-based therapeutics complementing our existing cancer immunotherapy pipeline. The combination of MorphoSys’ outstanding capabilities to create antibodies and the unique access to intracellular targets through our XPRESIDENT discovery engine provides both partners the opportunity to jointly deliver the next generation of transforming antibody drugs for cancer patients with high unmet medical need."

Tumor cells differ from healthy cells in the expression of tumor-associated proteins. These proteins are degraded inside living cells into shorter fragments, called peptides, which are then shuttled to the cell surface. Specialized receptors on the cell surfaces, so-called major histocompatibility complex (MHC) receptors, display these peptides to the external environment thereby providing a snapshot of the cell’s interior. The therapeutic programs now being pursued by Immatics and MorphoSys aim to discover Ylanthia antibodies against these MHC-bound peptide targets in order to kill the tumor cells. Immatics’ XPRESIDENT discovery platform is the only known high-throughput research technology to directly identify, quantify, and prioritize these cancer-related peptides.

10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, Nuvilex, AUG 24, 2015, View Source [SID:1234507333])

8-K – Current report

On August 24, 2015 Laboratory Corporation of America Holdings (LabCorp) (NYSE: LH) reported the nationwide availability of its VistaSeq Hereditary Cancer Panel, a novel, 27-gene panel designed to identify patients with increased risk of breast, ovarian, melanoma, pancreatic, colorectal, endometrial, gastric, prostate, and other cancers (Filing, 8-K, LabCorp, AUG 24, 2015, View Source [SID:1234507327]). These cancers are projected to result in approximately 900,000 new diagnoses of cancer, and almost 200,000 deaths, annually in the U.S.

"This innovative new offering enhances our industry-leading portfolio of genetic and genomic testing, which we seamlessly integrate with the largest cohort of board-certified genetic counselors in the industry," said David P. King, Chairman and Chief Executive Officer. "VistaSeq is an important advancement in precision medicine, and represents the latest example of our strategic focus on delivering world-class diagnostics and using the resulting information to change the way care is provided."

The VistaSeq Hereditary Cancer Panel provides an assessment of genetic mutations within a panel of 27 genes known to be associated with hereditary cancer syndromes. The information provided is used to determine an increased cancer risk in patients with an associated personal or family history. Mutations in different genes may cause the same type of cancer; conversely, one gene may be associated with multiple hereditary cancer syndromes. VistaSeq will give healthcare providers and patients additional information to assist in understanding further monitoring and appropriate medical management options.

NCCN Guidelines and The Society of Gynecologic Oncology (SGO) note that hereditary multi-gene panels may be an efficient and cost-effective approach to genetic cancer testing when used in appropriate clinical settings.

"LabCorp’s VistaSeq testing capabilities and services provide physicians and patients with powerful tools for the assessment of hereditary cancers," stated Dr. Marcia Eisenberg, LabCorp Diagnostics’ Chief Scientific Officer. "VistaSeq was developed based on our strong in-house expertise in genomics and the latest advancements in science. LabCorp is a leader in genetic testing and counseling services, and we continue to expand our innovative menu of focused genetic tests."

The VistaSeq test is available nationwide through any LabCorp account, and will be performed by Integrated Genetics, a member of LabCorp’s Specialty Testing Group. In addition, LabCorp offers a complete range of complementary services to the testing for patients and physicians, including insurance pre-authorization support and access to genetic counselors, who are professionally trained to analyze, assess, and interpret genetic test results.

Five Prime Therapeutics Announces Oral Presentation of Initial Data From Ongoing Phase 1b Trial of FP-1039/GSK3052230 in Squamous Non Small Cell Lung Cancer and Mesothelioma at World Conference on Lung Cancer

On August 24, 2015 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, reported that initial data from GlaxoSmithKline (GSK)’s ongoing Phase 1b trial of FP-1039/GSK3052230, an FGF ligand trap, in patients with squamous non small cell lung cancer (sqNSCLC) and mesothelioma will be featured in an oral presentation by study investigators during the upcoming World Conference on Lung Cancer 2015 in Denver (September 6-9, 2015) (Press release, Five Prime Therapeutics, AUG 24, 2015, View Source [SID:1234507326]).

Abstract #2879 entitled, "FP1039/GSK3052230 with Chemotherapy in Patients with Fibroblast Growth Factor (FGF) pathway deregulated squamous NSCLC or MPM," published today at View Source and includes data through the time of submission in April 2015. The oral presentation is scheduled on Wednesday, September 9, 2015 in the "Mini 38: Biology and Prognosis" session [6:30-8:00 pm] and is expected to include study data up to August 2015, which will be detailed in a press release at that time.

The Phase 1B trial being conducted by GSK is evaluating the safety and efficacy of FP-1039/GSK3052230 weekly infusion in combination with paclitaxel + carboplatin in previously untreated FGFR1 gene amplified metastatic squamous NSCLC (Arm A), in combination with docetaxel in FGFR1 gene amplified metastatic squamous NSCLC that has progressed after at least 1 line of chemotherapy (Arm B), or in combination with pemetrexed + cisplatin in patients with untreated and unresectable malignant pleural mesothelioma (Arm C). GSK continues to enroll patients in the study. Arm A and Arm C have advanced into the expansion phase and dose escalation is ongoing for Arm B.

Five Prime licensed development and commercialization rights for FP-1039/GSK3052230 in the U.S., Europe and Canada to GSK, which funds clinical development. Five Prime retains rights outside of these regions as well as an option to co-promote FP-1039/GSK3052230 in the U.S.

About FP-1039/GSK3052230

FP-1039/GSK3052230 is a protein drug designed to intervene in FGF signaling. As a ligand trap, FP-1039/GSK3052230 binds to FGF ligands circulating in the extracellular space, preventing these signaling proteins from reaching FGFR1 on the surface of tumor cells where they would otherwise stimulate cancer cell division and/or angiogenesis. However, FP-1039/GSK3052230 does not bind to certain "hormonal" FGFs, including FGF23, which regulates phosphate levels in the blood. As a result, treatment with FP-1039/GSK3052230 treatment has not been shown to cause hyperphosphatemia, a side effect seen with small molecule inhibitors of FGF receptors, which block the activity of both cancer-associated FGFs and FGF23.

Five Prime licensed development and commercialization rights for FP-1039/GSK3052230 in the U.S., Europe, and Canada to GSK, which funds clinical development. The Phase 1B clinical trial is investigating treatment with FP-1039/GSK3052230 combined with standard doses of chemotherapy in patients with newly-diagnosed or recurrent FGFR1 amplified metastatic squamous non-small cell lung cancer as well as patients with malignant pleural mesothelioma, a tumor in which the FGF2 ligand is overexpressed.

Data From METEOR Pivotal Trial of Cabozantinib in Advanced Renal Cell Carcinoma Accepted as Late-Breaker Presentation in Presidential Session at European Cancer Congress 2015

On August 24, 2015 Exelixis, Inc. (NASDAQ:EXEL) reported that data from clinical trials of cabozantinib and cobimetinib will be the subject of three presentations at the European Cancer Congress (ECC) 2015, which will be held September 25-29, 2015, in Vienna, Austria (Press release, Exelixis, AUG 24, 2015, View Source;p=RssLanding&cat=news&id=2081424 [SID:1234507323]).

METEOR Data Accepted for Oral Presentation in Presidential Session

Detailed data from METEOR, the phase 3 pivotal trial of cabozantinib in advanced renal cell carcinoma, will be presented at the ECC as a late-breaking abstract in the Presidential Session I on Saturday, September 26, 2015. In July 2015, Exelixis announced that the trial met its primary endpoint, demonstrating a statistically significant increase in progression-free survival for cabozantinib versus an active comparator, everolimus, in a population of patients who experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor.

The details of the presentation are as follows:

Abstract 4LBA: Late-Breaking Abstract: Cabozantinib versus Everolimus in Patients with Advanced Renal Cell Carcinoma: Results of the Randomized Phase 3 METEOR Trial

Toni K. Choueiri, M.D.
Presidential Session I
Saturday, September 26, 2015
Session from 14:30-16:40 CEST (8:30-10:40 a.m. EDT); presentation expected to begin at 16:20 CEST (10:20 a.m. EDT)

Cobimetinib Data Accepted for Proffered Paper and Poster Sessions

Also at the meeting, Exelixis’ collaborator Genentech, a member of the Roche Group, will present data on cobimetinib, an Exelixis-discovered compound, in combination with vemurafenib in previously untreated patients with advanced malignant melanoma harboring the BRAF V600 mutation.

The details of the cobimetinib presentations are as follows:

Abstract 25LBA: Late-Breaking Abstract: Impact of Baseline Genetic Heterogeneities on Progression-Free Survival (PFS) in Patients (pts) with Advanced BRAFV600-mutated Melanoma Treated with Cobimetinib (COBI) + Vemurafenib (VEM) in the phase 3 coBRIM Study

Professor Grant McArthur
Proffered Paper Session: Melanoma and Skin Cancer I
Sunday, September 27, 2015
Session from 11:30-12:30 CEST (5:30-6:30 a.m. EDT); presentation expected to begin at 12:10 CEST (6:10 a.m. EDT)
Hall A2

Abstract 3340: Treatment beyond Progression in Advanced BRAF-mutated Melanoma with Vemurafenib and Cobimetinib: Results from the BRIM7 Trial

Karl Lewis, M.D.
Poster Session: Melanoma and Skin Cancer
Sunday, September 27, 2015
Session from 16:45-18:45 CEST (10:45 a.m. – 12:45 p.m. EDT)
Hall C, Poster 217

About Cabozantinib

Cabozantinib inhibits the activity of tyrosine kinases including MET, VEGF receptors, AXL, and RET. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment.

COMETRIQ (cabozantinib) is currently approved by the U.S. Food and Drug Administration for the treatment of progressive, metastatic medullary thyroid cancer (MTC).

The European Commission granted COMETRIQ conditional approval for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC. Similar to another drug approved in this setting, the approved indication states that for patients in whom Rearranged during Transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decisions.

Important Safety Information, including Boxed WARNINGS

WARNING: PERFORATIONS AND FISTULAS, and HEMORRHAGE

Serious and sometimes fatal gastrointestinal perforations and fistulas occur in COMETRIQ-treated patients.

Severe and sometimes fatal hemorrhage occurs in COMETRIQ-treated patients.

COMETRIQ treatment results in an increase in thrombotic events, such as heart attacks.

Wound complications have been reported with COMETRIQ.

COMETRIQ treatment results in an increase in hypertension.

Osteonecrosis of the jaw has been observed in COMETRIQ-treated patients.

Palmar-Plantar Erythrodysesthesia Syndrome (PPES) occurs in patients treated with COMETRIQ.

The kidneys can be adversely affected by COMETRIQ. Proteinuria and nephrotic syndrome have been reported in patients receiving COMETRIQ.

Reversible Posterior Leukoencephalopathy Syndrome has been observed with COMETRIQ.
Avoid administration of COMETRIQ with agents that are strong CYP3A4 inducers or inhibitors.
COMETRIQ is not recommended for use in patients with moderate or severe hepatic impairment.
COMETRIQ can cause fetal harm when administered to a pregnant woman.

Adverse Reactions – The most commonly reported adverse drug reactions (≥25%) are diarrhea, stomatitis, palmar-plantar erythrodysesthesia syndrome (PPES), decreased weight, decreased appetite, nausea, fatigue, oral pain, hair color changes, dysgeusia, hypertension, abdominal pain, and constipation. The most common laboratory abnormalities (≥25%) are increased AST, increased ALT, lymphopenia, increased alkaline phosphatase, hypocalcemia, neutropenia, thrombocytopenia, hypophosphatemia, and hyperbilirubinemia.

Please see full U.S. prescribing information, including Boxed WARNINGS, at www.COMETRIQ.com/downloads/Cometriq_Full_Prescribing_Information.pdf

Please refer to the full European Summary of Product Characteristics for full European Union prescribing information, including contraindication, special warnings and precautions for use at www.sobi.com once posted.

About the Cobimetinib Development Collaboration

Exelixis discovered cobimetinib internally and advanced the compound to investigational new drug (IND) status. In late 2006, Exelixis entered into a collaboration agreement with Genentech, under which Exelixis received initial upfront and milestone payments in connection with signing the agreement and submitting the IND. Exelixis was responsible for development of cobimetinib through the determination of the maximum tolerated dose in phase 1, at which point Genentech exercised its option to further develop the compound.

In November 2013, Exelixis exercised its option to co-promote cobimetinib, if approved, in the United States. Exelixis is entitled to an initial equal share of U.S. profits and losses, which will decrease as sales increase, and will share in the U.S. marketing and commercialization costs. Exelixis is eligible to receive royalties on any sales of the product outside the United States.