On September 22, 2015 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq:RDUS) reported that it plans to host a conference call and webcast on Thursday, September 24, 2015, to provide an update on the safety and tolerability profile of RAD1901, a selective estrogen receptor degrader, from the completed Phase I study of RAD1901 in 52 healthy volunteers (Press release, Radius, SEP 22, 2015, View Source [SID:1234507517]).

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On November 5-9, 2015, Radius plans to present one poster with an oral presentation from its investigational drug RAD1901 clinical development program at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) Meeting in Boston, MA. The title of the poster and oral presentation is:

— RAD1901, an orally available selective estrogen receptor down regulator, has potent anti-tumor activity in in vitro and in vivo models of ER+ breast cancer

On December 8-12, 2015, Radius also plans to present three posters from its investigational drug RAD1901 clinical development program at the San Antonio Breast Cancer Symposium ("SABCS") in San Antonio, TX. The titles of the three poster presentations at SABCS are as follows:

— RAD1901, a Novel Oral, Selective Estrogen Receptor Degrader ("SERD") with Single Agent Efficacy in ER+ Primary Patient Derived ERS1 Mutant Xenograft Model

— A Phase 1 Dose Escalation Study of RAD1901, an Oral Selective Estrogen Receptor Degrader, in Healthy Postmenopausal Women

— A Phase 1 Study of RAD1901, a Novel, Orally Available, Selective Estrogen Receptor Degrader, for the Treatment of ER Positive Advanced Breast Cancer

On November 17, 2015, Radius will host an Investor Day in New York City. A SAVE the DATE Card with further details will be sent out soon.

On September 23, 2015 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported updated safety and preliminary efficacy data on its proprietary drug candidate MOR202 from an ongoing phase 1/2a study (Press release, MorphoSys, SEP 22, 2015, View Source [SID:1234507519]). MOR202 is a fully human HuCAL antibody targeting CD38, a highly expressed and validated target in multiple myeloma. The clinical data, which will be presented at the 15th International Myeloma Workshop in Rome, Italy, September 23th-26th, confirm the very good overall safety profile previously reported at this year’s ASCO (Free ASCO Whitepaper) meeting. The update also includes promising first results from the highest dose escalation cohort of 16 mg/kg of MOR202 weekly plus dexamethasone and from the recently initiated combination arms with the immunomodulatory drugs (IMiDs) pomalidomide and lenalidomide.

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As of August 24, 2015, 50 heavily pretreated patients with relapsed/refractory multiple myeloma had received MOR202 with and without dexamethasone and in a few cases in combination with pomalidomide or lenalidomide as part of a recently initiated second part of the study. MOR202 continued to demonstrate long-lasting tumor control, as well as signs of activity. In addition to the earlier reported very good partial response (VGPR) in a cohort dosed weekly with 4 mg/kg of MOR202 plus dexamethasone, a minor response (MR) in the 8 mg/kg MOR202 weekly plus dexamethasone cohort further improved into a partial response (PR). A first MR was observed in one patient in an ongoing cohort at the highest dose level, of 16 mg/kg MOR202 plus dexamethasone. The first evaluable patient in the ongoing combination cohort of 8 mg/kg MOR202 plus pomalidomide and dexamethasone achieved a PR already after the first cycle. In the ongoing combination cohort of 8 mg/kg MOR202 plus lenalidomide and dexamethasone, one patient showed a MR after the first cycle. In total, the data shows one VGPR, two PRs and two MRs so far.

"The MOR202 data have matured nicely since we presented the program at this year’s ASCO (Free ASCO Whitepaper) conference and we expect an even more comprehensive picture as the trial progresses. First results from the combination cohorts with lenalidomide and pomalidomide confirm the synergistic potential we have demonstrated in preclinical studies using our antibody together with these two IMiDs. This bodes well for the future development of MOR202," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.

The data to be presented at the International Myeloma Workshop 2015 show that MOR202 was safe and tolerable and could be administered as a 2-hour infusion. Infusion-related reactions occurred in 15 patients (30%). Only one out of these 15 patients received dexamethasone as co-medication and experienced an infusion-related reaction (grade 1). In the absence of dexamethasone, all infusion reactions were grade 1-2 except for one patient with grade 3, mainly limited to the first infusion. The maximum tolerated dose has not been reached.

"The antibody continues to show a balanced safety and tolerability profile and the preliminary efficacy seen so far with MOR202 as single agent and in combinations is promising. Considering the low rate of infusion reactions, even in cohorts without dexamethasone, the short infusion time and other aspects, MOR202 may turn out to be an excellent choice in terms of safety and tolerability," commented Dr. Marc-Steffen Raab, Group Leader Experimental Therapies for Hematologic Malignancies at the Heidelberg University Hospital and the German Cancer Research Center DKFZ.

The study is ongoing and MorphoSys plans to provide a further update at a medical conference later this year.

The IMW poster can be downloaded from the Company’s website:

Poster #0156

Raab et al.: A phase I/IIa study of the human CD38 antibody MOR202 (MOR03087) in relapsed or refractory multiple myeloma

The poster presentation will take place on Friday Sep 25th, 6:40pm to 7:40pm CEST.

On September 21, 2015 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that new data investigating the anti-tumor activity of KEYTRUDA (pembrolizumab) across a broad range of advanced cancers will be presented at this year’s European Cancer Congress (ECC) in Vienna, Austria, Sept. 25-29 (Press release, Merck & Co, SEP 21, 2015, View Source [SID:1234507505]). In total, 15 KEYTRUDA-related abstracts across nine difficult-to-treat cancers will be presented at this year’s ECC – including four late-breaking oral presentations. First-time data looking at PD-L2 expression in multiple tumors to assess the potential value of this biomarker in patient responsiveness to anti PD-1 therapies will also be presented. With these and other presentations, data on the potential role of KEYTRUDA will have been presented in more than 17 different cancers.

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Studies accepted into this year’s ECC program also include the investigation of KEYTRUDA monotherapy in anal cancer, biliary tract cancer, colorectal cancer, Merkel cell carcinoma (a type of skin cancer), nasopharyngeal carcinoma (a type of head and neck cancer), and non-small cell lung cancer (NSCLC), as well as a study evaluating KEYTRUDA in combination with another immunotherapy treatment in melanoma.

"As we continue to build our growing body of clinical data expanding our understanding of the potential for KEYTRUDA, we are also committed to identifying factors that may help us determine which patients are most likely to respond best to an individual medicine or approach," said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. "The initial data we are seeing with regard to PD-L2 expression now point to the potential relevance of dual PD-L1 and PD-L2 blockade in anti-PD-1 therapy for cancer treatment."

KEYTRUDA, Merck’s anti-PD-1 therapy, is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, KEYTRUDA releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. The KEYTRUDA clinical development program has rapidly expanded to encompass more than 30 tumor types in more than 130 clinical trials, of which more than 70 trials combine KEYTRUDA with other cancer treatments. Registration-enabling trials of KEYTRUDA monotherapy are currently enrolling patients in melanoma, NSCLC, head and neck cancer, bladder cancer, gastric cancer, colorectal cancer, and Hodgkin Lymphoma, with further trials in planning for other cancers.

"At Merck, we are rapidly expanding our clinical studies for KEYTRUDA in a wide range of cancers with the goal of potentially providing cancer patients with promising new options, and helping physicians identify which approaches may be best for an individual patient," said Dr. Roy Baynes, senior vice president and head of global clinical development, Merck Research Laboratories. "We look forward to sharing these new data at the European Cancer Congress as we continue to focus on bringing the breakthrough science of immuno-oncology to as many patients as possible."

Merck’s Immuno-Oncology Data at European Cancer Congress 2015

A listing of the KEYTRUDA late-breaker, oral and poster sessions are included below:

Late-Breaker Oral Presentations

(Abstract #18LBA) PD-L2 expression in human tumors: relevance to anti-PD-1 therapy in cancer. J. Yearley. Sunday, Sept. 27, 10:05 AM CEST. Location: Hall A1.

(Abstract #24LBA) Safety data from the phase 1b part of the MASTERKEY-265 study combining talimogene laherparepvec (T-VEC) and pembrolizumab for unresectable stage IIIB-IV melanoma. G. Long. Sunday, Sept. 27, 12:00 PM CEST. Location: Hall A2.

(Abstract #33LBA) Efficacy and safety of pembrolizumab (pembro; MK-3475) for patients (pts) with previously treated advanced non-small cell lung cancer (NSCLC) Enrolled in KEYNOTE-001. J.C. Soria. Monday, Sept. 28, 10:50 AM CEST. Location: Strauss.

(Abstract #22LBA) Activity of PD-1 blockade with pembrolizumab as first systemic therapy in patients with advanced Merkel cell carcinoma. P. Nghiem. Sunday, Sept. 27, 11:30 AM CEST. Location: Hall A2.

Oral Presentations

(Abstract #2801) Antitumor activity and safety of pembrolizumab in patients with PD-L1–positive nasopharyngeal carcinoma: Interim results from a phase 1b study. C. Hsu. Saturday, Sept. 26, 10:45 CEST. Location: Hall C1.

(Abstract #500) Pembrolizumab (MK-3475) for PD-L1–positive squamous cell carcinoma (SCC) of the anal canal: Preliminary safety and efficacy results from KEYNOTE-028. P. Ott. Sunday, Sept. 27, 5:05 PM CEST. Location: Hall D1.

(Abstract #502) Pembrolizumab (MK-3475) for patients (pts) with advanced colorectal carcinoma (CRC): Preliminary results from KEYNOTE-028. B. O’Neil. Sunday, Sept. 27, 5:35 PM CEST. Location: Hall D1.

Poster Sessions

(Abstract #507) Evaluation of patients with progressive metastatic head and neck cancer treated with PD-1 inhibition with pembrolizumab and radiation therapy: Assessment of local and systemic effects. T.Y. Seiwert. Saturday, Sept. 26, 4:45 PM-6:45 PM CEST. Location: Hall C.

(Abstract #523) Initial clinical experience with pembrolizumab in metastatic heavily pre-treated patients with solid cancers in a single institution. R. Leibowitz-Amit. Saturday, Sept. 26, 4:45 PM-6:45 PM CEST. Location: Hall C.

(Abstract #525) Safety and efficacy of pembrolizumab (MK-3475) in patients (pts) with advanced biliary tract cancer: Interim results of KEYNOTE-028. Y.J. Bang. Saturday, Sept. 26, 4:45 PM-6:45 PM CEST (5:15 PM-6:15 PM CEST spotlight session). Location: Hall C.

(Abstract #2860) Correlation between plasma Epstein-Barr virus DNA and clinical response to pembrolizumab in patients with advanced or metastatic nasopharyngeal carcinoma. H.F. Kao. Sunday, Sept. 27, 9:15 AM-11:15 AM CEST. Location: Hall C.

(Abstract #2866) Antitumor activity of the anti-PD-1 antibody pembrolizumab in subgroups of patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): Exploratory analyses from KEYNOTE-012. L. Chow. Sunday, Sept. 27, 9:15 AM-11:15 AM CEST. Location: Hall C.

(Abstract #3325) Safety and efficacy of pembrolizumab (MK-3475) for Japanese patients (pts) with advanced melanoma: Preliminary results from KEYNOTE-041 Phase 1b study. K. Yokota. Sunday, Sept. 27, 4:45 PM-6:45 PM CEST. Location: Hall C.
(Abstract #3344) Relationship between pembrolizumab exposure and efficacy/safety in 1016 patients (pts) with advanced or metastatic melanoma. S.P. Kang. Sunday, Sept. 27, 4:45 PM-6:45 PM CEST. Location: Hall C.

(Abstract #2622) A Phase I/II study to assess the safety and efficacy of pazopanib (paz) and pembrolizumab (pembro) in patients (pts) with advanced renal cell carcinoma (aRCC). D.F. McDermott. Monday, Sept. 28, 4:45 PM-6:45 PM CEST. Location: Hall C.
For more information, including a complete list of abstract titles, please visit the European Cancer Congress website at View Source

About KEYTRUDA (pembrolizumab)

KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, KEYTRUDA releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Important Safety Information for KEYTRUDA

Pneumonitis occurred in 12 (2.9%) of 411 patients, including Grade 2 or 3 cases in 8 (1.9%) and 1 (0.2%) patients, respectively, receiving KEYTRUDA. Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 pneumonitis.

Colitis (including microscopic colitis) occurred in 4 (1%) of 411 patients, including Grade 2 or 3 cases in 1 (0.2%) and 2 (0.5%) patients, respectively, receiving KEYTRUDA. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Hepatitis (including autoimmune hepatitis) occurred in 2 (0.5%) of 411 patients, including a Grade 4 case in 1 (0.2%) patient, receiving KEYTRUDA. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hypophysitis occurred in 2 (0.5%) of 411 patients, including a Grade 2 case in 1 and a Grade 4 case in 1 (0.2% each) patient, receiving KEYTRUDA. Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency). Administer corticosteroids for Grade 2 or greater hypophysitis. Withhold KEYTRUDA for Grade 2; withhold or discontinue for Grade 3; and permanently discontinue KEYTRUDA for Grade 4 hypophysitis.

Hyperthyroidism occurred in 5 (1.2%) of 411 patients, including Grade 2 or 3 cases in 2 (0.5%) and 1 (0.2%) patients, respectively, receiving KEYTRUDA. Hypothyroidism occurred in 34 (8.3%) of 411 patients, including a Grade 3 case in 1 (0.2%) patient, receiving KEYTRUDA. Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer corticosteroids for Grade 3 or greater hyperthyroidism. Withhold KEYTRUDA for Grade 3; permanently discontinue KEYTRUDA for Grade 4 hyperthyroidism. Isolated hypothyroidism may be managed with replacement therapy without treatment interruption and without corticosteroids.

Type 1 diabetes mellitus, including diabetic ketoacidosis, has occurred in patients receiving KEYTRUDA. Monitor patients for hyperglycemia and other signs and symptoms of diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA in cases of severe hyperglycemia until metabolic control is achieved.

Nephritis occurred in 3 (0.7%) patients, consisting of one case of Grade 2 autoimmune nephritis (0.2%) and two cases of interstitial nephritis with renal failure (0.5%), one Grade 3 and one Grade 4. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.

Other clinically important immune-mediated adverse reactions can occur. The following clinically significant immune-mediated adverse reactions occurred in patients treated with KEYTRUDA: exfoliative dermatitis, uveitis, arthritis, myositis, pancreatitis, hemolytic anemia, partial seizures arising in a patient with inflammatory foci in brain parenchyma, severe dermatitis including bullous pemphigoid, myasthenic syndrome, optic neuritis, and rhabdomyolysis.

For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement of the adverse reaction to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Restart KEYTRUDA if the adverse reaction remains at Grade 1 or less. Permanently discontinue KEYTRUDA for any severe or Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction. [W&P, 5.6, p.6]

Infusion-related reactions, including severe and life-threatening reactions, have occurred in patients receiving KEYTRUDA. Monitor patients for signs and symptoms of infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. For severe or life-threatening reactions, stop infusion and permanently discontinue KEYTRUDA.

Based on its mechanism of action, KEYTRUDA may cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of KEYTRUDA.

KEYTRUDA was discontinued for adverse reactions in 9% of 411 patients. Adverse reactions, reported in at least two patients, that led to discontinuation of KEYTRUDA were: pneumonitis, renal failure, and pain. Serious adverse reactions occurred in 36% of patients. The most frequent serious adverse reactions, reported in 2% or more of patients, were renal failure, dyspnea, pneumonia, and cellulitis.

The most common adverse reactions (reported in at least 20% of patients) were fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash (29%), decreased appetite (26%), constipation (21%), arthralgia (20%), and diarrhea (20%).

The recommended dose of KEYTRUDA is 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks until disease progression or unacceptable toxicity. No formal pharmacokinetic drug interaction studies have been conducted with KEYTRUDA. It is not known whether KEYTRUDA is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with KEYTRUDA. Safety and effectiveness of KEYTRUDA have not been established in pediatric patients.

Our Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck Oncology, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment. Our focus is on pursuing research in immuno-oncology and we are accelerating every step in the journey – from lab to clinic – to potentially bring new hope to people with cancer. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

On September 21, 2015 Nektar Therapeutics (NASDAQ: NKTR) reported positive preclinical results for NKTR-214, a CD122-biased cytokine designed to preferentially stimulate the production and maintenance of tumor-killing T cells which are found naturally in the body (Press release, Nektar Therapeutics, SEP 21, 2015, View Source [SID:1234507510]). CD122, which is also known as the Interleukin-2 receptor beta subunit, is a key signaling receptor that is known to increase the proliferation of CD8-positive effector T cells, and these CD8-positive T cells comprise a key component of the tumor infiltrating lymphocytes that provide cell-mediated anti-tumor effects.1

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Results were presented this past Friday at the Inaugural CRI-CIMT-EATI-AACR Immunotherapy Conference in New York. NKTR-214 shows efficacy in multiple preclinical models as a single agent. Combination regimens with NKTR-214 and either anti-CTLA4 or anti-PD-1 checkpoint inhibitor therapies resulted in durable anti-tumor immunotherapeutic effects, which persisted long after the termination of dosing.

"We are very encouraged by these remarkable preclinical findings, which show an immune-educating vaccine-like effect with the combination and sequencing of NKTR-214 and checkpoint inhibition," said Stephen Doberstein, Ph.D., Senior Vice President and Chief Scientific Officer of Nektar Therapeutics. "This is the ultimate goal of immune-oncology and we look forward to initiating our planned Phase 1/2 clinical trial of NKTR-214 in the fourth quarter of 2015."

In a preclinical tumor re-challenge study presented, sequential dosing of anti-CTLA-4 followed by NKTR-214 resulted in durable and complete responses. At 142 days following the final dose, with no additional treatment, the complete responders demonstrated sustained resistance to multiple tumor re-challenges.

In highly-resistant established melanoma tumor models, data presented show that treatment with NKTR-214 resulted in a controlled, sustained and biased T-cell activating signal and a mean ratio of CD8-positive T cells to T-regulatory cells ratio of 450:1 in the tumor infiltrating lymphocytes.

NKTR-214 Preclinical Data Presentation
The presentation entitled, "Antitumor activity of NKTR-214, a CD122-biased immunostimulatory cytokine, combined with immune checkpoint blockade requires innate and adaptive immunity," which was presented at The Inaugural International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper): Translating Science into Survival by CRI-CIMT-EATI-AACR can be accessed at View Source

About NKTR-214

NKTR-214 is a CD122-biased immune-stimulatory cytokine, which is designed to stimulate the patient’s own immune system to eliminate cancer cells. By biasing activation to the CD122 receptor, NKTR-214 enhances CD8-positive T cells (tumor-killing cells) in the tumor. In preclinical studies, a single dose of NKTR-214 resulted in an approximate 400-fold AUC exposure within the tumor compared with an equivalent dose of aldesleukin, an existing IL-2 therapy. This increase potentially enables, for the first time, an antibody-like dosing regimen for a cytokine.2 In dosing studies in non-human primates, there was no evidence of low blood pressure or vascular leak syndrome with NKTR-214 at predicted clinical therapeutic doses.3

On September 21, 2015 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported that data from ongoing phase 1 trials of Endocyte’s SMDC EC1456 will be presented at the European Cancer Congress 2015, being held Sept. 25 – 29, 2015, in Vienna, Austria (Press release, Endocyte, SEP 21, 2015, View Source [SID:1234507511]).

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The presentation materials will be available on Endocyte’s website following presentation at the conference.

Presentation is as follows:

Poster Presentation: An ongoing Phase 1 dose-escalation study of the folic acid-tubulysin in small-molecule drug conjugate (SMDC) folate-tubulysin EC1456
When: Sunday, Sept. 27, 16:45 – 18:45 p.m. CEST
Poster Session: Early Drug Development
Presenter: Martin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore

About EC1456

EC1456 is an investigational proprietary, injectable, SMDC consisting of folate (vitamin B9) linked to a potent cytotoxic agent, tubulysin B hydrazide (TubBH). EC1456 is wholly owned by Endocyte. TubBH is a member of the tubulysin class of anti-neoplastic agents that inhibit the polymerization of tubulin into microtubules, a critical component during cell division. The targeting ligand folate, essential for cell division, has been investigated with vintafolide. EC1456 is currently being evaluated in a Phase 1 study in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT01999738).