American Society of Clinical Oncology

Alexandria, VA, United States

American Society of Clinical Oncology

Alexandria, VA, United States
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News Article | May 11, 2017
Site: www.businesswire.com

TOKYO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that the results of the Japanese phase III study (J-ALEX) of Alecensa®, in patients with ALK fusion gene positive non-small cell lung cancer (NSCLC), were published in the electronic version of “The Lancet” on May 10, 2017. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30565-2/fulltext The initial results of the J-ALEX study were presented at a session of the American Society of Clinical Oncology (ASCO) meeting held in Chicago, on June 6, 2016. “The publication of the J-ALEX study results in 'The Lancet' assures the firm position of Alecensa in the first line therapy of patient with ALK fusion gene positive NSCLC,” said Dr. Yasushi Ito, Senior Vice President, Head of Project & Lifecycle Management Unit. “We believe that Alecensa will also contribute to improving the outcomes for patients in first line therapy, as well as second line therapy in the future.” The J-ALEX study was an open-label, randomized phase III study that compares the efficacy and safety between Alecensa and crizotinib. The J-ALEX study enrolled 207 ALK-inhibitor naïve patients with ALK fusion gene positive advanced or recurrent NSCLC, who either had not undergone chemotherapy or had undergone one chemotherapy regimen. The primary endpoint of the J-ALEX study was progression free survival (PFS) as assessed by an independent review board. The secondary endpoints included overall survival, objective response rate, safety, and other endpoints. The PFS hazard ratio of the Alecensa arm to the crizotinib arm was 0.34 (99.7% CI: 0.17-0.71, stratified log-rank p<0.0001) and Alecensa demonstrated significantly prolonged PFS. Median PFS was not reached (95% CI: 20.3-Not Estimated) in the Alecensa arm while it was 10.2 months (95%CI: 8.2-12.0) in the crizotinib arm. In the Alecensa arm, constipation (35%) was an adverse event (AE) with >30% frequency, while in the crizotinib arm nausea (74%), diarrhea (73%), vomiting (58%), visual disturbance (55%), dysgeusia (52%), constipation (44%), ALT elevation (32%), and AST elevation (31%) were each seen in >30% patients. Grade 3-4 AEs occurred in 26% of the Alecensa arm and in 52% of the crizotinib arm, there were no treatment-related deaths in either arm. In February 2016, Chugai carried out a prospectively-defined interim analysis and had an independent data monitoring committee examine the results. Since the results showed that the Alecensa arm significantly prolonged the PFS, the committee decided to recommend an early discontinuation of the J-ALEX study. Based on the results of the J-ALEX study, Alecensa was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in September 2016 for first line therapy of patients with ALK-positive non-small cell lung cancer. Chugai Pharmaceutical is one of Japan’s leading research-based pharmaceutical companies with strengths in biotechnology products. Chugai, based in Tokyo, specializes in prescription pharmaceuticals and is listed on the 1st section of the Tokyo Stock Exchange. As an important member of the Roche Group, Chugai is actively involved in R&D activities in Japan and abroad. Specifically, Chugai is working to develop innovative products which may satisfy the unmet medical needs, mainly focusing on the oncology area. In Japan, Chugai’s research facilities in Gotemba and Kamakura are collaborating to develop new pharmaceuticals and laboratories in Ukima are conducting research for technology development for industrial production. Overseas, Chugai Pharmabody Research based in Singapore is engaged in research focusing on the generation of novel antibody drugs by utilizing Chugai’s proprietary innovative antibody engineering technologies. Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical development activities in the United States and Europe. The consolidated revenue in 2016 of Chugai totalled 491.8 billion yen and the operating income was 80.6 billion yen (IFRS Core basis). Additional information is available on the internet at https://www.chugai-pharm.co.jp/english.


LAWRENCEVILLE, N.J., May 12, 2017 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, today announced financial results for the quarter ended March 31, 2017 and provided an update on its development programs for ThermoDox®, its proprietary heat-activated liposomal encapsulation of doxorubicin and GEN-1, an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein.  The Company's lead program is ThermoDox® which is currently in Phase III development for the treatment of primary liver cancer and in Phase II development for the treatment of recurrent chest wall breast cancer.  The Company's immunotherapy program consists of GEN-1 and is currently in Phase I development for the localized treatment of ovarian cancer. "Celsion continues to make major progress with respect to our ongoing global, pivotal Phase III OPTIMA Study in primary liver cancer.  This ground-breaking study continues to attract interest and support from the medical community, international regulatory agencies, and research organizations like the National Institutes of Health," said Michael H. Tardugno, Celsion's chairman, president and CEO.  "Our product development efforts in immuno-oncology are equally important. We have demonstrated the potential of our GEN-1 IL-12 immunotherapy program to be an effective adjuvant, in both first and second-line ovarian cancer. Recruiting the immune system to work in combination with the standard of care in this patient population has been the goal of medical researchers worldwide.  With GEN-1, we believe there is the potential for a break-through and we look forward to reporting comprehensive clinical results and translational research data from our Phase 1B OVATION Study at the ASCO Annual Meeting in June 2017." Announced the Publication of Preclinical Results of ThermoDox® for the Treatment of Bladder Cancer in the International Journal of Hyperthermia.  The Company reported results from porcine in vivo studies to evaluate ThermoDox® in combination with loco-regional mild hyperthermia for targeted drug delivery to the bladder wall as a potential treatment for bladder cancer.  Doxorubicin accumulation and distribution within the bladder wall with ThermoDox® plus mild bladder hyperthermia was achieved at concentrations nearly ten times higher than with free intravenous doxorubicin combined with mild bladder hyperthermia. The study was conducted under a Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health (NIH) to evaluate whether ThermoDox® combined with mild heating of the bladder can target drug delivery in the bladder. Announced Support for the OPTIMA Study from the China FDA and Vietnam Ministry of Health.  The Company discussed ThermoDox® and the OPTIMA Study with regulatory agencies in two key markets, China and Vietnam.  The Company met with the China Food and Drug Administration (CFDA) to review the ongoing Phase III OPTIMA Study and regulatory pathway for ThermoDox® in China. CFDA was presented with the final overall survival data from the Chinese patient cohort of the HEAT study, which demonstrated a survival benefit in patients treated with ThermoDox® plus optimized RFA versus optimized RFA alone. The CFDA informed the Company that if the ongoing Phase III OPTIMA Study is successful, the trial could serve as the basis for a direct regulatory filing in China without the need to file for prior approval in the U.S. or European Union which is currently required for foreign company application. This would allow the Company to accelerate its plans for a regulatory filing in China and, if approved, provide for a significantly earlier launch date in China than originally expected. The Company's management team also met with the Ministry of Health in Vietnam and based on that meeting, it will move forward with launching additional trial sites for the OPTIMA Study in that country. The Company plans to activate 5 additional clinical trial sites in Vietnam by the second quarter of 2017. Vietnam represents a significant market for ThermoDox® where HCC incidence rates are among the highest in the world. Announced the Issuance of Two New Patents for ThermoDox.  In January 2017, the Company announced the issuance of two patents which are directly applicable to the method of treating cancer using our current ThermoDox® formulation.  These new patents further strengthen the Company’s global patent portfolio around novel heat-sensitive liposome engineered to address a broad range of difficult-to-treat cancers. Announced Continuing Positive Data from the OVATION Study in Newly Diagnosed Advanced Ovarian Cancer Patients.  In January 2017, the Company announced data from the first four cohorts of patients in its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1 with the standard of care for the treatment of newly-diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery.  In the first twelve patients dosed in the OVATION Study, GEN-1 plus standard chemotherapy produced impressive results, with no dose limiting toxicities and highly promising efficacy signals in this difficult to treat cancer. The efficacy data included highly encouraging tumor response rates - 100% disease control rate (DCR) and 75% objective response rate (ORR), successful surgical resections of the eligible patients’ tumors, impressive pathological responses and dramatic, clinically meaningful drops in CA-125 protein levels.  In February 2017, the Company presented two posters at the American Society of Clinical Oncology (ASCO) - Society for Immunotherapy of Cancer (SITC) Clinical Immuno-Oncology Symposium held from February 23 - 25, 2017 in Orlando, FL.  The ASCO-SITC Clinical Immuno-Oncology Symposium focused on the latest clinical and translational research in immuno-oncology and the implications for clinical care. Raised $6.8 Million Through Two Equity Offerings in December 2016 and February 2017.  The Company completed two equity offerings of shares of common stock, or pre-funded warrants in lieu thereof, to purchase common stock with institutional healthcare and retail investors totaling $6.8 million in gross proceeds. For the quarter ended March 31, 2017, Celsion reported a net loss of $5.2 million, or $0.12 per share, compared to a net loss of $5.7 million, or $0.24 per share, in the same period of 2016. Operating expenses were $4.9 million in the first quarter of 2017 compared to $5.3 million in the same period of 2016.  This decrease was primarily due to lower general and administrative expenses. Research and development (R&D) costs were relatively constant at $3.5 million and $3.4 million in the first quarters of 2017 and 2016, respectively.  Clinical development costs for the Phase III OPTIMA Study were $1.6 million in the first quarter of 2017 compared to $1.0 million in the same period of 2016 due to higher patient enrollment and investigator grant expenses in the trial.  R&D costs for other development programs were lower as a result of the Company’s tighter clinical development focus around the pivotal Phase III OPTIMA Study for the treatment of primary liver cancer and the clinical development program for GEN-1 IL-12 immunotherapy for the localized treatment of ovarian cancer coupled with lower costs in the first quarter of 2017 associated with the production of ThermoDox® clinical supplies to support the OPTIMA Study.  General and administrative expenses decreased $0.4 million, from $1.9 million in the first quarter of 2016 to $1.5 million in the first quarter of 2017.  This 21% decrease in general and administrative expenses in 2017 is primarily the result of reduction in personnel costs and lower professional fees. Net cash used in operations was $3.1 million in the first quarter of 2017 compared to $4.7 million in the same period of 2016.  The Company ended the first quarter of 2017 with $4.5 million of total cash and cash equivalents.  In February 2017, the Company raised $5 million in gross proceeds under a secondary public offering with various institutional and retail investors. The Company is hosting a conference call to provide a business update and discuss year-end 2016 financial results at 11:00 a.m. ET on Friday, May 12, 2017. To participate in the call, interested parties may dial 1-888-282-4591 (Toll-Free/North America) or 1–719-457-2605 (International/Toll) and ask for the Celsion Corporation First Quarter 2017 Earnings Call (Conference Code: 4060768) to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at www.celsion.com. The call will be archived for replay on Friday, May 12, 2017 and will remain available until May 26, 2017.  The replay can be accessed at 1-888-203-1112 (Toll-Free/North America) or 1-719-457-0820 (International/Toll) using Conference ID: 4060768.  An audio replay of the call will also be available on the Company's website, www.celsion.com, for 90 days after 2:00 p.m. ET Friday, May 12, 2017. Celsion is a fully-integrated oncology company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies. The Company's lead program is ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in Phase III development for the treatment of primary liver cancer and in Phase II development for the treatment of recurrent chest wall breast cancer.  The pipeline also includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian and brain cancers.  Celsion has two platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies.  For more information on Celsion, visit our website: http://www.celsion.com (CLSN-FIN). Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995.  Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the significant expense, time, and risk of failure of conducting clinical trials; the need for Celsion to evaluate its future development plans; possible acquisitions or licenses of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Celsion's periodic reports and prospectuses filed with the Securities and Exchange Commission.  Celsion assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.


News Article | May 11, 2017
Site: globenewswire.com

Dublin, May 11, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Cancer Immunotherapy: Building on Initial Successes to Improve Clinical Outcomes" report to their offering. This new report includes an updated discussion of approved and clinical stage agents in immuno-oncology, including recently-approved agents. It also addresses the means by which researchers and companies are attempting to build on prior achievements in immuno-oncology to improve outcomes for more patients. Some researchers and companies refer to this approach as immuno-oncology 2.0. The American Society of Clinical Oncology (ASCO), in its 12th Annual Report on Progress Against Cancer (2017), named Immunotherapy 2.0 as its Advance of the Year. Nevertheless, metastatic melanoma remains incurable. Furthermore, in many studies in advanced melanoma and other cancers, only a minority of patients have benefited from immunotherapy treatments. Researchers and companies are therefore looking for ways to build on the initial successes of the immuno-oncology field to improve outcomes for more patients, hence the need for an immuno-oncology 2.0. Agents that are intended to improve the results of treatment with agents like checkpoint inhibitors may also be referred to as second-wave immuno-oncology agents. As discussed in this report, researchers have found that checkpoint inhibitors produce tumor responses by reactivating TILs (tumor infiltrating lymphocytes)-especially CD8+ cytotoxic T cells. This key observation is perhaps the most important factor driving development of second-wave immuno-oncology strategies. As a result, researchers have been developing biomarkers that distinguish inflamed (i.e., TIL-containing) tumors-which are susceptible to checkpoint inhibitor therapy-from cold tumors, which are not. They have also been working to develop means to render cold tumors inflamed, via treatment with various conventional therapies and/or development of novel agents. These studies are the major theme of second-wave immuno-oncology, or immuno-oncology 2.0. Highlights of this Report Include: - Approvals of checkpoint inhibitors - Biomarkers for checkpoint inhibitor treatments - Approved and clinical-stage immunotherapy biologics other than checkpoint inhibitors - Immunotherapy with TIL cells - Commercialization of TIL therapy - Adoptive immunotherapy with genetically engineered T cells bearing chimeric antigen receptors (CARs) - Manufacturing issues with CAR T-cell therapies - General conclusions on the progress of cellular immunotherapy - Outlook for cancer immunotherapy Key Topics Covered: 1: Introduction - The early history of cancer immunotherapy - Coley's toxins - Cytokines as immunomodulatory drugs - Interleukin-2 - Alpha-interferons - Interleukin-12 - Interleukin-12 as a bridge between innate and adaptive immunity - Investigation of interleukin-12 as an anticancer therapeutic - Interleukin-10 - Interleukin-15 - Admune/Novartis' heterodimeric IL-15:IL-15Ra (hetIL-15) - Altor's ALT-803 - Conclusions: Cytokine-based immunotherapies for cancer 2: What are immune checkpoints? - CTLA-4 blocking agents - Ipilimumab - Tremelimumab - PD-1 blocking agents - Nivolumab - Combination therapy of nivolumab plus ipilimumab in melanoma - Pembrolizumab - Pembrolizumab as a first-line treatment for advanced NSCLC - Pembrolizumab in colorectal carcinoma with mismatch-repair deficiency - Studies of pembrolizumab in combination immunotherapies - PDR001 - PD-L1 blocking agents - Atezolizumab - Atezolizumab in treatment of urothelial carcinoma - Atezolizumab for the treatment of NSCLC - Atezolizumab in treatment of other solid tumors - Other anti-PD-L1 mAb agents - Durvalumab - Avelumab - Anti-LAG-3 agents - anti-TIM-3 - NewLink Genetics' small-molecule IDO pathway inhibitors and checkpoint inhibition - Infinity's PI3K? inhibitor IPI-549 for modulation of immune suppression in tumors - Biomarkers for checkpoint inhibitor treatments - Target biomarkers - Genetic biomarkers - Immunological biomarkers - Use of biomarker tests in treatment with checkpoint inhibitors - Checkpoint inhibitors plus radiation therapy - Checkpoint inhibitors plus targeted therapies - Checkpoint inhibitors with cytotoxic chemotherapies - Discussion 3: Immune Agonists - Celldex Therapeutics' Varlilumab (CDX-1127) - OX40 agonists - MedImmune/AZ's OX40 agonist program - Roche/Genentech's OX40 agonist program - Nektar Therapeutics/BMS's NKTR-214, a CD122 agonist - Glucocorticoid-induced TNFR-related (GITR) protein agonist (Leap Therapeutics' TRX518) - Conclusions 4: Bispecific antibodies - Marketed bispecific antibody agents - Catumaxomab - Blinatumomab - Bispecific antibodies as an alternative to CAR-T cells - Xencor's cross-linking monoclonal antibody (XmAb) bispecific platform technology - Regeneron's native human immunoglobulin-format bsAb, REGN1979 - Roche/Genentech's full-length bsAbs: Generated using CrossmAb technology - MacroGenics' MGD007: Generated using dual-affinity re-targeting (DART) technology - Conclusions 5: Therapeutic Anticancer Vaccines and Oncolytic viruses - Introduction - Cancer vaccines-a field rife with clinical failures - Why has the cancer vaccine field been so prone to clinical failure? - Marketed therapeutic cancer vaccines and oncolytic virus therapies - Dendreon/Valeant's sipuleucel-T - Amgen's talimogene laherparepvec (T-Vec)/Imlygic - Therapeutic cancer vaccines and oncolytic virus therapies in clinical development - Celldex's CDX-1401 - Bavarian Nordic's PROSTVAC-VF - Argos Therapeutics' AGS-003 - Sydys Corporation's CVac - Aduro Biotech's CRS-207 - TapImmune's TPIV110 HER2/neu and TPIV200 folate receptor alpha multi-epitope vaccines - Genelux's GL-ONC1 oncolytic virus - Conclusions 6: Adoptive Immunotherapy for Cancer - Introduction - Adoptive immunotherapy with tumor infiltrating lymphocytes - A specific immunodominant mutation in a melanoma patient who had a durable complete remission due to TIL therapy - Adoptive immunotherapy based on mutation-specific CD4+ T cells in an epithelial cancer - Successful targeting of KRAS G12D via adoptive immunotherapy in a case of metastatic colorectal cancer - Dr. Rosenberg's recent studies on neoantigen-reactive TILs for use in adoptive cellular immunotherapy - Commercializing TIL therapy - Adoptive immunotherapy with genetically engineered T cells bearing chimeric antigen receptors (CARs) - Leading clinical programs in CAR T-cell based immunotherapy - Kite Pharma's KTE-C19 (axicabtagene ciloleucel) - Novartis' CTL019 - Juno's JCAR015 and other Juno anti-CD19 CARs - Other CAR T-cell therapies that target hematologic malignancies - bluebird bio's bb2121 for multiple myeloma - CAR T-cell therapies that target solid tumors - Novartis/University of Pennsylvania's CARTmeso - EGFRvIII CAR T-cell therapies - Companies developing engineered improvements in CAR T-cell therapy - Bellicum Pharmaceuticals' technologies for modulation of CAR T-cell therapies - Cellectis' technologies for design and manufacture of off-the shelf CAR T-cell therapies - Manufacturing issues with CAR T-cell therapies - Can bispecific antibodies be competitive with CAR T-cell therapies? - Adptimmune recombinant TCR clinical candidates - Kite Pharma recombinant TCR program - Juno Therapeutics' recombinant TCR program - Recombinant TCR studies at the NCI - Conclusions - Market size estimates for the T-cell therapy market 7: General Conclusions - Major theme of this report: Immuno-oncology 2.0 or second-wave immuno-oncology - Approvals of checkpoint inhibitors - Biomarkers for checkpoint inhibitor treatments - Approved and clinical-stage immunotherapy biologics other than checkpoint inhibitors - Immunotherapy with TIL cells - Commercialization of TIL therapy - Adoptive immunotherapy with genetically engineered T cells bearing chimeric antigen receptors (CARs) - Manufacturing issues with CAR T-cell therapies - Adoptive immunotherapy via autologous recombinant TCR technology - General conclusions on the progress of cellular immunotherapy - Insight Pharma Reports survey on cancer immunotherapy - Outlook for cancer immunotherapy For more information about this report visit http://www.researchandmarkets.com/research/r2zn7t/cancer


WEST LAFAYETTE, Ind., May 10, 2017 (GLOBE NEWSWIRE) -- Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, today announced financial results for the first quarter ending March 31, 2017, and provided a clinical and pipeline update. “We look forward to providing safety and efficacy updates for our clinical trials of both EC1169 and EC1456 at the Annual Meeting of the American Society of Clinical Oncology (ASCO) next month,” said Mike Sherman, president and CEO at Endocyte. “In addition, we continue to discover compelling applications of the SMDC platform and are working to more rapidly bring assets toward clinical development in several exciting areas, to drive more value from our pipeline. These include our dual-targeted DNA crosslinker drug that can attack both tumor associated macrophages (TAMs) and cancer cells, EC2629, and our chimeric antigen receptor T-cell (CAR T-cell) SMDC adaptor platform.” “Enrollment in the expansion phase of the EC1169 trial in prostate cancer continues to progress well, and we recently completed our work with EC1456 exploring multiple dosing schedules,” added Dr. Alison Armour, Endocyte’s chief medical officer. “We also enrolled the first patient in the study of EC1456 in ovarian cancer patients undergoing surgery to provide tissue-based characterization following drug administration.” EC1169 (PSMA-targeted tubulysin): Enrolling patients in the expansion phase of the EC1169 trial in up to 50 taxane-exposed metastatic castration-resistant prostate cancer (mCRPC) patients and up to 50 taxane-naïve mCRPC patients at a maximum clinical dose of 6.5 mg/m2 once per week. The primary endpoint of this expansion phase is radiographic progression-free survival (rPFS), with a target of 5 months for taxane-naïve mCRPC patients and 3 months for taxane-exposed mCRPC patients. Secondary endpoints, which will provide earlier insight into drug activity, include overall response rates as measured by response evaluation criteria in solid tumors (RECIST) 1.1 and prostate-specific antigen (PSA). Enrollment is not limited based on the results of the scan with EC0652, but primary endpoints of the trial are to be assessed on PSMA positive patients. EC1456 (folate receptor-targeted tubulysin): Enrolling expansion cohort of up to 40 folate receptor-positive (FR-positive) non-small cell lung cancer (NSCLC) patients, as determined by an etarfolatide scan, to receive the maximum clinical dose of 6.0 mg/m2 twice per week. Patients included in this expansion phase of the trial will have received first-line chemotherapy and may have also been treated with anti-programmed death-1 (anti-PD-1) therapy. Endocyte is also conducting an ovarian cancer surgical study to characterize EC1456 at the tumor level through a multifaceted analysis of collected tissue samples after administration of the drug. EC2629: Pre-clinical development currently underway with a potential Investigational New Drug (IND) filing in mid-2017. EC2629 leverages a proprietary warhead with a dual mechanism of action: targeting both TAMs and FR-positive cancer cells. CAR T-Cell Development Program: Continued progress with next-generation CAR T-cell therapeutic platform, in collaboration with leading experts in the field at Seattle Children's Research Institute. Endocyte announced new research in a late-breaking poster session at the American Association for Cancer Research (AACR) Annual Meeting in April 2017, on the application of Endocyte's SMDC technology. Data demonstrated that Endocyte’s bi-specific adaptor molecules can mitigate or eliminate cytokine storms in animal models and could meaningfully improve the safety and tolerability of CAR T-cell therapies. Pre-clinical evaluations for the CAR T-cell program by Dr. Michael Jensen are expected to be completed in the second half of 2017, in anticipation of a potential IND filing in 2018. Endocyte reported a net loss of $11.5 million, or $0.27 per basic and diluted share, for the first quarter of 2017, compared to a net loss of $10.2 million, or $0.24 per basic and diluted share for the same period in 2016. Research and development expenses were $8.0 million for the first quarter of 2017, compared to $6.5 million for the same period in 2016. The increase was primarily attributable to increases in expenses related to the EC1169 phase 1 trial, including drug manufacturing expenses, expenses related to the development of EC2629 and other pre-clinical work and general research, and expenses related to the EC1456 phase 1 trial, which were partially offset by a decrease related to non-cash stock-based compensation expenses. General and administrative expenses were $3.7 million for the first quarter of 2017, compared to $3.8 million for the same period in 2016. The slight decrease was primarily attributable to a decrease in compensation expense, which was partially offset by an increase in expenses related to professional fees. Cash, cash equivalents and investments were $127.6 million at March 31, 2017, compared to $163.3 million at March 31, 2016, and $138.2 million at December 31, 2016. The company anticipates its cash balance at the end of 2017 to be approximately $100 million. EC1169 is an investigational therapeutic SMDC constructed of a high affinity prostate specific membrane antigen (PSMA)-targeting ligand conjugated through a bioreleasable linker system to a potent microtubule inhibitor, tubulysin B hydrazide (TubBH). Patient PSMA-status is determined using the investigational companion imaging agent, EC0652. EC1456 is an investigational therapeutic SMDC constructed of a high affinity FR-targeting ligand conjugated through a spacer and bioreleasable linker system to a potent cytotoxic microtubule inhibitor, TubBH. Patient FR-status is determined using the investigational companion imaging agent, etarfolatide. Endocyte management will host a conference call today at 8:30 a.m. EDT. A live, listen-only webcast of the conference call may also be accessed by visiting the Investors & News section of the Endocyte website, www.endocyte.com. The webcast will be recorded and available on the company's website for 90 days following the call. 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. Endocyte is a biopharmaceutical company and leader in developing targeted therapies for the treatment of cancer and other serious diseases. Endocyte uses its proprietary drug conjugation technology to create novel SMDCs and companion imaging agents for personalized targeted therapies. The company’s SMDCs actively target receptors that are over-expressed on diseased cells relative to healthy cells. This targeted approach is designed to enable the treatment of patients with highly active drugs at greater doses, delivered more frequently and over longer periods of time than would be possible with the untargeted drug alone. The companion imaging agents are designed to identify patients whose disease over-expresses the target of the therapy and who are therefore more likely to benefit from treatment. For additional information, please visit Endocyte’s website at www.endocyte.com. Certain of the statements made in this press release are forward looking, such as those, among others, relating to future spending, future cash balances, the successful completion of current and future clinical trials, the enrollment period for, and availability and reporting, of data from ongoing and future clinical trials, and the company's future development plans including those relating to the completion of pre-clinical development in preparation for possible future clinical trials. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that the company may experience delays in the completion of its clinical trials (whether caused by competition, adverse events, patient enrollment rates, shortage of clinical trial materials, regulatory issues or other factors); risks that data from its clinical trials may not be indicative of subsequent clinical trial results; risks related to the safety and efficacy of the company’s product candidates; risks that early stage pre-clinical data may not be indicative of subsequent data when expanded to additional pre-clinical models or to subsequent clinical data; risks that evolving competitive activity and intellectual property landscape may impair the company's ability to capture value for the technology; risks that expectations and estimates turn out to be incorrect, including estimates of the potential markets for the company’s product candidates, estimates of the capacity of manufacturing and other facilities required to support its product candidates, projected cash needs, and expected future revenues, operations, expenditures and cash position. More information about the risks and uncertainties faced by Endocyte, Inc. is contained in the company’s periodic reports filed with the Securities and Exchange Commission. Endocyte, Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


WEST LAFAYETTE, Ind., May 10, 2017 (GLOBE NEWSWIRE) -- Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, today announced financial results for the first quarter ending March 31, 2017, and provided a clinical and pipeline update. “We look forward to providing safety and efficacy updates for our clinical trials of both EC1169 and EC1456 at the Annual Meeting of the American Society of Clinical Oncology (ASCO) next month,” said Mike Sherman, president and CEO at Endocyte. “In addition, we continue to discover compelling applications of the SMDC platform and are working to more rapidly bring assets toward clinical development in several exciting areas, to drive more value from our pipeline. These include our dual-targeted DNA crosslinker drug that can attack both tumor associated macrophages (TAMs) and cancer cells, EC2629, and our chimeric antigen receptor T-cell (CAR T-cell) SMDC adaptor platform.” “Enrollment in the expansion phase of the EC1169 trial in prostate cancer continues to progress well, and we recently completed our work with EC1456 exploring multiple dosing schedules,” added Dr. Alison Armour, Endocyte’s chief medical officer. “We also enrolled the first patient in the study of EC1456 in ovarian cancer patients undergoing surgery to provide tissue-based characterization following drug administration.” EC1169 (PSMA-targeted tubulysin): Enrolling patients in the expansion phase of the EC1169 trial in up to 50 taxane-exposed metastatic castration-resistant prostate cancer (mCRPC) patients and up to 50 taxane-naïve mCRPC patients at a maximum clinical dose of 6.5 mg/m2 once per week. The primary endpoint of this expansion phase is radiographic progression-free survival (rPFS), with a target of 5 months for taxane-naïve mCRPC patients and 3 months for taxane-exposed mCRPC patients. Secondary endpoints, which will provide earlier insight into drug activity, include overall response rates as measured by response evaluation criteria in solid tumors (RECIST) 1.1 and prostate-specific antigen (PSA). Enrollment is not limited based on the results of the scan with EC0652, but primary endpoints of the trial are to be assessed on PSMA positive patients. EC1456 (folate receptor-targeted tubulysin): Enrolling expansion cohort of up to 40 folate receptor-positive (FR-positive) non-small cell lung cancer (NSCLC) patients, as determined by an etarfolatide scan, to receive the maximum clinical dose of 6.0 mg/m2 twice per week. Patients included in this expansion phase of the trial will have received first-line chemotherapy and may have also been treated with anti-programmed death-1 (anti-PD-1) therapy. Endocyte is also conducting an ovarian cancer surgical study to characterize EC1456 at the tumor level through a multifaceted analysis of collected tissue samples after administration of the drug. EC2629: Pre-clinical development currently underway with a potential Investigational New Drug (IND) filing in mid-2017. EC2629 leverages a proprietary warhead with a dual mechanism of action: targeting both TAMs and FR-positive cancer cells. CAR T-Cell Development Program: Continued progress with next-generation CAR T-cell therapeutic platform, in collaboration with leading experts in the field at Seattle Children's Research Institute. Endocyte announced new research in a late-breaking poster session at the American Association for Cancer Research (AACR) Annual Meeting in April 2017, on the application of Endocyte's SMDC technology. Data demonstrated that Endocyte’s bi-specific adaptor molecules can mitigate or eliminate cytokine storms in animal models and could meaningfully improve the safety and tolerability of CAR T-cell therapies. Pre-clinical evaluations for the CAR T-cell program by Dr. Michael Jensen are expected to be completed in the second half of 2017, in anticipation of a potential IND filing in 2018. Endocyte reported a net loss of $11.5 million, or $0.27 per basic and diluted share, for the first quarter of 2017, compared to a net loss of $10.2 million, or $0.24 per basic and diluted share for the same period in 2016. Research and development expenses were $8.0 million for the first quarter of 2017, compared to $6.5 million for the same period in 2016. The increase was primarily attributable to increases in expenses related to the EC1169 phase 1 trial, including drug manufacturing expenses, expenses related to the development of EC2629 and other pre-clinical work and general research, and expenses related to the EC1456 phase 1 trial, which were partially offset by a decrease related to non-cash stock-based compensation expenses. General and administrative expenses were $3.7 million for the first quarter of 2017, compared to $3.8 million for the same period in 2016. The slight decrease was primarily attributable to a decrease in compensation expense, which was partially offset by an increase in expenses related to professional fees. Cash, cash equivalents and investments were $127.6 million at March 31, 2017, compared to $163.3 million at March 31, 2016, and $138.2 million at December 31, 2016. The company anticipates its cash balance at the end of 2017 to be approximately $100 million. EC1169 is an investigational therapeutic SMDC constructed of a high affinity prostate specific membrane antigen (PSMA)-targeting ligand conjugated through a bioreleasable linker system to a potent microtubule inhibitor, tubulysin B hydrazide (TubBH). Patient PSMA-status is determined using the investigational companion imaging agent, EC0652. EC1456 is an investigational therapeutic SMDC constructed of a high affinity FR-targeting ligand conjugated through a spacer and bioreleasable linker system to a potent cytotoxic microtubule inhibitor, TubBH. Patient FR-status is determined using the investigational companion imaging agent, etarfolatide. Endocyte management will host a conference call today at 8:30 a.m. EDT. A live, listen-only webcast of the conference call may also be accessed by visiting the Investors & News section of the Endocyte website, www.endocyte.com. The webcast will be recorded and available on the company's website for 90 days following the call. 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. Endocyte is a biopharmaceutical company and leader in developing targeted therapies for the treatment of cancer and other serious diseases. Endocyte uses its proprietary drug conjugation technology to create novel SMDCs and companion imaging agents for personalized targeted therapies. The company’s SMDCs actively target receptors that are over-expressed on diseased cells relative to healthy cells. This targeted approach is designed to enable the treatment of patients with highly active drugs at greater doses, delivered more frequently and over longer periods of time than would be possible with the untargeted drug alone. The companion imaging agents are designed to identify patients whose disease over-expresses the target of the therapy and who are therefore more likely to benefit from treatment. For additional information, please visit Endocyte’s website at www.endocyte.com. Certain of the statements made in this press release are forward looking, such as those, among others, relating to future spending, future cash balances, the successful completion of current and future clinical trials, the enrollment period for, and availability and reporting, of data from ongoing and future clinical trials, and the company's future development plans including those relating to the completion of pre-clinical development in preparation for possible future clinical trials. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that the company may experience delays in the completion of its clinical trials (whether caused by competition, adverse events, patient enrollment rates, shortage of clinical trial materials, regulatory issues or other factors); risks that data from its clinical trials may not be indicative of subsequent clinical trial results; risks related to the safety and efficacy of the company’s product candidates; risks that early stage pre-clinical data may not be indicative of subsequent data when expanded to additional pre-clinical models or to subsequent clinical data; risks that evolving competitive activity and intellectual property landscape may impair the company's ability to capture value for the technology; risks that expectations and estimates turn out to be incorrect, including estimates of the potential markets for the company’s product candidates, estimates of the capacity of manufacturing and other facilities required to support its product candidates, projected cash needs, and expected future revenues, operations, expenditures and cash position. More information about the risks and uncertainties faced by Endocyte, Inc. is contained in the company’s periodic reports filed with the Securities and Exchange Commission. Endocyte, Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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