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Exelixis to Release Third Quarter 2018 Financial Results on Thursday, November 1, 2018

On October 18, 2018 Exelixis, Inc. (NASDAQ: EXEL) reported that its third quarter 2018 financial results will be released on Thursday, November 1, 2018 after the markets close (Press release, Exelixis, OCT 18, 2018, View Source [SID1234529963]). At 5:00 p.m. EDT / 2:00 p.m. PDT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

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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 conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 1043999 to join by phone.

A telephone replay will be available until 8:00 p.m. EDT on November 3, 2018. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 1043999. A webcast replay will also be archived on www.exelixis.com for one year.

Castle Biosciences Announces Medicare Coverage for the DecisionDx-Melanoma Test in Cutaneous Melanoma

On October 18, 2018 Castle Biosciences, Inc., the skin cancer diagnostics company providing molecular diagnostics to improve cancer management decisions, reported Medicare coverage for the DecisionDx-Melanoma test that predicts risk of metastatic disease and helps to guide use of sentinel lymph node biopsy (SLNB) in patients with cutaneous melanoma (Press release, Castle Biosciences, OCT 18, 2018, View Source [SID1234529962]).

"Improved access to the DecisionDx-Melanoma test for the 59 million Medicare recipients can drive better-informed management decisions for melanoma patients and help to safely avoid costly surgical procedures," said Derek Maetzold, President and CEO of Castle Biosciences. "Using the DecisionDx-Melanoma test to identify low-risk tumor biology and inform the discussion of SLNB options provides an important advance in the management of early stage melanoma patients."

Palmetto GBA, a Medicare Administrative Contractor (MAC), the administrator of the Medicare MolDX program that assesses molecular diagnostic technologies, issued a final local coverage determination (LCD) for the DecisionDx-Melanoma test effective December 3, 2018. Medicare beneficiaries will now have improved access to the test to help guide use of SLNB in the context of patient-specific management plans. The LCD provides for coverage of the DecisionDx-Melanoma test for SLNB eligible patients with T1 and T2 cutaneous melanoma tumors (2.0 mm in thickness or less, as defined in AJCC Staging Manual v8, 2017) and clinically negative sentinel node basins who are being considered for SLNB to determine eligibility for adjuvant therapy.

Approximately 12,000 patients had the DecisionDx-Melanoma test ordered in the last 12 months to better inform patient management decisions and help guide their melanoma care. This is an important milestone for the test, which is supported by more than 15 peer-reviewed publications including analytic and clinical validation, performance studies, and clinical utility in prospective and retrospective studies.

The final LCD is posted to the Medicare Coverage Database on the Centers for Medicare and Medicaid Services (CMS) website.

The DecisionDx-Melanoma test is a 31-gene expression profile (GEP) that determines a cutaneous melanoma patient’s risk for metastatic disease. The test classifies patients as having a tumor with low (Class 1) or high (Class 2) risk for developing metastasis within 5 years of diagnosis. Patients with a Class 1 tumor profile also have a low likelihood of being SLN positive. Thus, the individualized risk profile result of this test can be used to guide use of SLNB in the context of patient-specific management plans.

The use of the DecisionDx-Melanoma test to inform SLNB decision-making was validated in two multicenter, prospective cohorts totaling 1,421 patients which showed that a Class 1A test result can identify a population with a >95% likelihood of a negative SLNB (>95% negative predictive value [NPV]). For the Medicare-eligible population (65 years old and over), patients with a T1 or T2 tumor and a DecisionDx-Melanoma Class 1A result have an NPV of 98.4%. Data from retrospective studies has shown that patients with a Class 1A result have a 99.6% melanoma-specific survival rate at 5 years. Thus, the DecisionDx-Melanoma test can inform SLNB decision-making by identifying a group of patients with low-risk tumor biology who are less than 5% likely to be SLN positive. These patients have a very low likelihood for metastatic disease, and thus can safely avoid this surgical procedure, potentially reducing the SLNB rate by up to 52% in the Medicare population.

Sentinel Lymph Node Biopsy Background

SLNB is a surgical procedure generally recommended to assess prognosis of cutaneous melanoma patients. The procedure provides prognostic information and can determine eligibility for adjuvant therapies, but can be associated with complications, adding a significant economic burden to the healthcare system. Elderly patients account for a substantial proportion of patients with melanoma, and 60% of melanoma-related deaths occur in patients 65 years of age or older. However, while older age is associated with a poor prognosis, fewer elderly patients are found to be SLN positive, which indicates that the prognostic value of SLNB is limited in this population.

Current guidelines recommend that clinicians discuss and/or offer the SLNB procedure with patients who have a greater than 5% likelihood of SLN positivity, and do not recommend the procedure if a patient has a less than 5% likelihood of a positive SLN. For patients who are SLNB eligible, the DecisionDx-Melanoma test can inform SLNB decision-making by identifying a group of patients with low-risk tumor biology who are less than 5% likely to be SLN positive, and thus can safely avoid the procedure.

About DecisionDx-Melanoma

The DecisionDx-Melanoma test uses tumor biology to predict individual risk of melanoma recurrence and sentinel lymph node positivity independent of traditional factors. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multi-center studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in four prospective studies including 702 patients. The consistent high performance and accuracy demonstrated in these studies, which combined have included over 1,300 patients, provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included over 1,400 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in multi-center and single-center studies. More information about the test and disease can be found at www.SkinMelanoma.com.

Onxeo to Present Overview of AsiDNA™ for Treatment of Solid Tumors at DNA Damage Response Therapeutics Summit 2019

On October 18, 2018 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO FR0010095596), a clinical-stage biotechnology company specializing in the development of innovative drugs in oncology, targeting tumor DNA Damage Response (DDR) to fight resistant cancers, reported that the Company was invited to present an overview of AsiDNA for the treatment of solid tumors at the 2nd DNA Damage Response Therapeutics Summit (DDRTS) to be held January 29-31, 2019, in Boston, MA (Press release, Onxeo, OCT 18, 2018, View Source [SID1234529961]).

This leading industry summit provides the opportunity to gain exclusive insights on the latest innovations in the field of tumor DNA Damage Response. The presence of prominent pharmaceutical groups and research institutions testifies to the attractiveness of this rapidly growing field.

Onxeo will present an overview of AsiDNA, the Company’s first-in-class compound targeting tumor DNA break repair pathways, during a session entitled, "New Developments in PARP Inhibitors & Novel DDR Pathway Targets."

Françoise Bono, Chief Scientific Officer of Onxeo, said: "AsiDNA has shown unique properties in translational research, notably its ability to prevent resistance to PARP inhibitors and to potentiate their activity in cancer cells, regardless of genetic mutation status. Its strong synergy with DNA-damaging agents, such as chemotherapies and PARP inhibitors, could also open new therapeutic options in difficult-to-treat cancers. We are pleased to have been selected to present at this benchmark event among the world’s most recognized stakeholders in DNA Damage Response. This is the ideal forum to update the industry, scientific and clinical experts on the recent clinical development progress achieved with AsiDNA, a highly-differentiated molecule acting upstream of multiple DNA damage response pathways."

Session: New Developments in PARP Inhibitors & Novel DDR Pathway Targets
Date: Wednesday, January 30, 2019
Time: 2:00 pm
Location: Revere Hotel Boston Common, 200 Stuart St., Boston, MA 02116
Onxeo’s presentation: AsiDNA, A First-in-Class Decoy Oligonucleotide Targeting DNA Repair to Kill Tumor Cells

AsiDNA is an innovative global DNA damage response inhibitor preventing recruitment of enzymes involved in DSB and SSB repair at the damage site
AsiDNA is synergistic with PARP inhibitors, prevents and reverses PARPi-acquired resistance
Recent outcomes from the phase 1 clinical study of AsiDNA
For further information, please visit the DNA Damage Response Therapeutics Summit website.

ENDOCYTE ENTERS INTO AGREEMENT TO BE ACQUIRED BY NOVARTIS AG FOR $2.1 BILLION

On October 18, 2018 Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for cancer treatment, reported that it has entered into an agreement and plan of merger with Novartis AG ("Novartis") pursuant to which Novartis will acquire Endocyte for $24 per share, or a total equity value of approximately $2.1 billion, in cash (Press release, Endocyte, OCT 18, 2018, View Source [SID1234529960]). This offer represents a premium of 54% percent to Endocyte’s closing price of $15.56 on October 17, 2018. The transaction was unanimously approved by the board of directors of Endocyte.

"Since acquiring exclusive worldwide rights to develop and commercialize PSMA-617 agents in 2017, the entire Endocyte team, along with our partners, have worked tirelessly to build a leading radioligand (RLT) portfolio and create value for patients and shareholders alike. We are thrilled that Novartis recognizes the potential for 177Lu-PSMA-617 to change the treatment landscape for men with metastatic castration-resistant prostate cancer (mCRPC), as well as the broader role that RLTs may potentially play in the treatment of cancer," said Mike Sherman, president and CEO of Endocyte. "The global reach and expertise of Novartis in developing and commercializing RLT therapies will be critical in efforts for patients to benefit from these therapies as quickly as possible."

Completion of the transaction is expected in the first half of 2019, subject to approval by Endocyte stockholders, antitrust and regulatory approvals and other customary closing conditions. Until that time, Endocyte will continue to operate as a separate and independent company.

Centerview Partners LLC is acting as lead financial advisor to Endocyte. Jefferies LLC is also acting as financial advisor to Endocyte. Faegre Baker Daniels LLP is acting as legal counsel to Endocyte.

Website Information

Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document.

PharmaMar will present at ESMO results of the phase III CORAIL study with lurbinectedin in platinum-resistant Ovarian Cancer

On October 18, 2018 During the congress of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper), that will be held from the 19th to the 23rd of October in Munich, Germany, PharmaMar’s (MSE:PHM) Zepsyre (lurbinectedin) abstract #9320 entitled "Phase III trial of Lurbinectedin versus PLD or Topotecan in platinum-resistant ovarian cancer patients: Results of CORAIL trial" will be presented orally on the 19th of October (Press release, PharmaMar, OCT 18, 2018, View Source [SID1234529959]).

Dr. Ali Zeaiter, Director of Clinical Development of the Oncology Business Unit at PharmaMar explains: "While we are disappointed that the CORAIL trial didn´t meet its primary endpoint of PFS, the data obtained support that lurbinectedin has activity in platinum-resistant Ovarian Cancer."

Data obtained from other PharmaMar compounds of marine origin, lurbinectedin and Yondelis (trabectedin) will also be presented. These include four other posters with the latest advances in the clinical development of trabectedin, including the results of the randomized phase III (TSAR) study evaluating the quality of life of patients with Advanced Soft Tissue Sarcoma (ASTS).

The studies that will be presented during the ESMO (Free ESMO Whitepaper) 2018 Congress are available at: View Source

Lurbinectedin

Phase III trial of Lurbinectedin versus PLD or Topotecan in platinum-resistant ovarian cancer patients: Results of CORAIL trial (#932O)
Oral presentation – 19.10.2018, 14:00 – 15:15, in Hall A1 – Room 15.
Principal Author: S. Gaillard, Baltimore, US.

SAKK 17/16 – Lurbinectedin monotherapy in patients with progressive malignant pleural mesothelioma: A multicenter, single-arm phase II trial (#1817TiP)
Poster – 20.10.2018, 13:30 Hall A3 – Poster Area – Networking Hub
Principal Author: Y. Metaxas. Chur, Switzerland.

Yondelis (trabectedin)

Health-related quality of life in patients with advanced soft tissue sarcoma (ASTS): Results from the TSAR randomized phase III trial of the French Sarcoma Group (#1604PD)
Poster Discussion – Sarcoma. 22.10.2018, 11:00 – 12:15, in Hall B3 – Room 23
Principal Author: Axel Le Cesne, Villejuif, France.

Quality of Life in patients with soft tissue sarcoma undergoing palliative treatment – A multicenter, cluster-randomized trial within the German Interdisciplinary Sarcoma Group, GISG-12 (#1606PD)
Poster Discussion – Sarcoma. 22.10.2018, 11:00 – 12:15, in Hall B3 – Room 23
Principal Author: Leopold Hentschel, Dresden, Germany.

Trabectedin and radiotherapy in advanced sarcoma: experience of a Reference Center (#1626P)
Poster – 22.10.2018, 12:45 – 13:45, in Hall A3 – Poster Area Networking Hub
Principal Author: Javier Martín-Broto, Seville, Spain.

Trabectedin plus pegylated liposomal doxorubicin (PLD) in patients with platinum-sensitive recurrent ovarian cancer (PSROC) regardless of prior use of antiangiogenics: First results of an observational, prospective study (#987P)
Poster – 20.10.2018, 12:30 – 13:30, in Hall A3 – Poster Area Networking Hub
Principal Author: Sandro Pignata, Naples, Italy.

Legal warning
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

About PharmaMar
Headquartered in Madrid, PharmaMar is a biopharmaceutical company, focused on oncology and committed to research and development which takes its inspiration from the sea to discover molecules with antitumor activity. It is a company that seeks innovative products to provide healthcare professionals with new tools to treat cancer. Its commitment to patients and to research has made it one of the world leaders in the discovery of antitumor drugs of marine origin.
PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes Yondelis in Europe and has other clinical-stage programs under development for several types of solid cancers: lurbinectedin (PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and a chemical enterprise, Zelnova Zeltia. To learn more about PharmaMar, please visit us at www.pharmamar.com.

About YONDELIS (trabectedin)
YONDELIS (trabectedin) is a multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The drug exerts its activity by targeting the transcriptional machinery and impairing DNA repair. It is approved in close to 80 countries in North America, Europe, South America and Asia for the treatment of advanced soft tissue sarcomas as a single-agent and for relapsed ovarian cancer in combination with DOXIL/CAELYX (doxorubicin HCl liposome injection) in the European Union. Under a licensing agreement with PharmaMar, Janssen Products, L.P. has the rights to develop and sell YONDELIS globally except in Europe, where PharmaMar holds the rights, and in Japan, where PharmaMar has granted a license to Taiho Pharmaceuticals.

About lurbinectedin
Lurbinectedin (PM1183) is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction.