On September 29, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "company"), an oncology-focused biotechnology company, reported positive data from the second cohort of patients enrolled in its orphan-drug designated Phase I study of CLR 131 in patients with relapsed or refractory multiple myeloma. Following these outcomes, the study’s Data Monitoring Committee approved patient enrollment to the third cohort, which will include a 33 percent dose increase from 18.75 to 25mCi/m2 of CLR 131 from the previous cohort (Filing, 8-K, Cellectar Biosciences, SEP 29, 2016, View Source [SID:SID1234515512]).

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All evaluable study participants (n=8) have achieved stable disease and progression-free survival (PFS), which includes four evaluable patients from Cohort 1 and four evaluable patients from Cohort 2. To date, Cohort 2 subjects have attained an average increase in PFS of greater than 30 percent as compared to Cohort 1. Cellectar continues to follow patient outcomes within Cohort 2, including PFS. After these patients have fully completed the study, the company looks forward to providing additional study data, including the full extent of the increase in PFS from Cohort 2 over Cohort 1. While patients in Cohort 2 received a 50 percent increase in dose, they did not experience a proportional increase in adverse events and demonstrated a similarly favorable safety and tolerability profile as experienced by patients in Cohort 1.

"As seen in the results to date, CLR 131 has demonstrated an outstanding safety profile in heavily pretreated, relapsed or refractory multiple myeloma patients with limited treatment options," stated Natalie Callander, MD, Associate Professor of Medicine, Director, University of Wisconsin Carbone Cancer Center Myeloma Clinical Program, and the study’s lead investigator. "I am excited that Cellectar will open the next treatment cohort to offer patients access to this novel treatment’s encouraging efficacy signals."

In this multi-center, open label Phase I dose escalation study, CLR 131 is administered as a single dose, 30-minute infusion. The primary study objective is to characterize the safety and tolerability of CLR 131 in patients with relapsed or refractory multiple myeloma. Prior to enrollment, all study participants had received a minimum of three systemic regimens and up to 12 lines of therapy. Many also received a stem cell transplant. Secondary study objectives include establishment of a recommended Phase II dose, both with and without dexamethasone, as well as an assessment of therapeutic activity.

"This important clinical milestone further validates the potential of our patented PDC delivery platform as well as the clinical benefits of CLR 131 for the treatment of an extremely challenging hematologic cancer," said Jim Caruso, president and CEO of Cellectar Biosciences. "We are focused on successfully executing this Phase I Study for relapsed or refractory multiple myeloma, as well as initiating our National Cancer Institute-supported Phase II study to further explore dose, regimen and clinical utility of CLR 131 in multiple myeloma and other selected hematologic malignancies with unmet medical need."

About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. The company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first half of 2017. Based upon pre-clinical and interim Phase I study data, treatment with CLR 131 provides patients with a novel approach to treating hematological diseases and may provide patients with an improvement in progression-free survival and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131 directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131.

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). Its phospholipid ether (PLE) carrier platform was deliberately designed to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in over 70 different xenograft models of cancer.

About Relapsed or Refractory Multiple Myeloma
Multiple myeloma is the second most common blood or hematologic cancer with approximately 30,000 new cases in the United States every year. It affects a specific type of blood cells known as plasma cells. Plasma cells are white blood cells that produce antibodies to help fight infections. While treatable for a time, multiple myeloma is incurable and almost all patients will relapse or the cancer will become resistant/refractory to current therapies.

On September 28, 2016 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that safety data for two Phase I studies of lirilumab in combination with nivolumab or ipilimumab conducted by Bristol-Myers Squibb in patients with advanced refractory solid tumors will be presented by Dr. Neil H. Segal, Memorial Sloan-Kettering Cancer Center, in a poster at the ESMO (Free ESMO Whitepaper) 2016 congress (October 7 – 11, 2016) in Copenhagen, Denmark (Press release, Innate Pharma, SEP 28, 2016, View Source [SID:SID1234515479]). Lirilumab is Innate Pharma’s anti-KIR antibody partnered with Bristol-Myers Squibb.

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On Septemer 28, 2016 Medivation, Inc. (NASDAQ: MDVN) reported that new data from Company-sponsored and investigator-initiated clinical trials will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress, being held October 7-11, in Copenhagen (Press release, Medivation, SEP 28, 2016, View Source [SID:SID1234515480]). Presentations include a pilot study of the company’s investigational PARP inhibitor talazoparib in patients with BRCA-mutated breast cancer, and analyses of enzalutamide in the advanced prostate cancer setting, representing research advances in serious diseases for which there are limited options.

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"We are excited to share data highlighting the clinical impact and potency of our potential best-in-class PARP inhibitor, talazoparib," said David Hung, M.D., founder, president and CEO of Medivation. "In addition, the breadth of enzalutamide data presentations shows our commitment to fully investigating its utility in patients with advanced prostate cancer."

Data presentations include:

Talazoparib: Investigational data demonstrating potential in BRCA-mutated breast cancer, for which there are no targeted treatment options:

A pilot study of neoadjuvant talazoparib for early-stage breast cancer patients with a BRCA mutation [Abstract #153P; Saturday, October 8, 15:00 CEST]
Enzalutamide*: Updates on efficacy and safety, and additional analyses, in advanced prostate cancer:

EMBARK: A Phase 3, randomized, efficacy and safety study of enzalutamide plus leuprolide, enzalutamide monotherapy, and placebo plus leuprolide in men with high-risk nonmetastatic prostate cancer progressing after definitive therapy [Abstract #770TiP; Sunday, October 9, 13:00 CEST]
Prognostic factors in men with metastatic castration-resistant prostate cancer treated with enzalutamide or bicalutamide in TERRAIN [Abstract #759P; Sunday, October 9, 13:00 CEST]
Efficacy and safety of enzalutamide plus androgen deprivation therapy vs placebo plus androgen deprivation therapy in men with metastatic hormone-sensitive prostate cancer: the ongoing ARCHES trial [Abstract #767TiP; Sunday, October 9, 13:00 CEST]
Efficacy and safety of enzalutamide vs placebo in chemotherapy-naïve patients with progressive metastatic castration-resistant prostate cancer following androgen deprivation therapy: an Asian multinational study [Abstract #749P; Sunday, October 9, 13:00 CEST]
* Enzalutamide is developed through a collaboration between Medivation and Astellas and commercialized under the brand name XTANDI .

About Talazoparib
Talazoparib is a potent and specific inhibitor of PARP 1 and 2 that is being developed for the treatment of selected solid tumors. In pre-clinical studies, talazoparib has shown single-agent anti-tumor activity, as well as synergy in combination with lowered doses of DNA-damaging agents, due to its dual mechanisms of cytotoxicity, PARP trapping, and inhibition of PARP enzyme activity. Trapping of PARP on DNA impairs DNA replication resulting in tumor cell death. Talazoparib is in Phase III development for patients with locally advanced and/or metastatic breast cancer who harbor a germline BRCA1/2 mutation.

About XTANDI (enzalutamide) capsules
XTANDI (enzalutamide) capsules are an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. In preclinical studies, enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors as well as inhibit androgen receptor nuclear translocation and interaction with DNA. The clinical significance of this MOA is unknown.

XTANDI is approved by the U.S. Food and Drug Administration for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

Important Safety Information
Contraindications XTANDI is not indicated for women and is contraindicated in women who are or may become pregnant. XTANDI can cause fetal harm when administered to a pregnant woman.

Warnings and Precautions
Seizure In Study 1, conducted in patients with metastatic castration-resistant prostate cancer (CRPC) who previously received docetaxel, seizure occurred in 0.9% of XTANDI patients and 0% of placebo patients. In Study 2, conducted in patients with chemotherapy-naive metastatic CRPC, seizure occurred in 0.1% of XTANDI patients and 0.1% of placebo patients. There is no clinical trial experience re-administering XTANDI to patients who experienced a seizure, and limited safety data are available in patients with predisposing factors for seizure. Study 1 excluded the use of concomitant medications that may lower threshold; Study 2 permitted the use of these medications. Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity during which sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES) In post approval use, there have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.

Adverse Reactions
The most common adverse reactions (≥ 10%) reported from two combined clinical studies that occurred more commonly (≥ 2% over placebo) in XTANDI patients were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo.

In Study 1, Grade 3 and higher adverse reactions were reported among 47% of XTANDI patients and 53% of placebo patients. Discontinuations due to adverse events were reported for 16% of XTANDI patients and 18% of placebo patients. In Study 2, Grade 3-4 adverse reactions were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to adverse events were reported for 6% of both study groups.

Lab Abnormalities: Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and 6% of placebo patients (0.5% Grade 3-4). Grade 1-4 thrombocytopenia occurred in 6% of XTANDI patients (0.3% Grade 3-4) and 5% of placebo patients (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of XTANDI patients (0.2% Grade 3-4) and 16% of placebo patients (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients (0.1% Grade 3-4) and 2% of placebo patients (no Grade 3-4).
Infections: In Study 1, 1% of XTANDI patients compared to 0.3% of placebo patients died from infections or sepsis. In Study 2, 1 patient in each treatment group (0.1%) had an infection resulting in death.
Falls (including fall-related injuries), occurred in 9% of XTANDI patients and 4% of placebo patients. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients, and included non-pathologic fractures, joint injuries, and hematomas.
Hypertension occurred in 11% of XTANDI patients and 4% of placebo patients. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in < 1% of all patients.
Drug Interactions

Effect of Other Drugs on XTANDI Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co-administration is necessary, reduce the dose of XTANDI. Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. If co-administration is necessary, increase the dose of XTANDI.

Effect of XTANDI on Other Drugs Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.

For Full Prescribing Information for XTANDI (enzalutamide) capsules, please visit View Source

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

On September 28, 2016 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age‐related macular degeneration and fibrotic diseases, reported a strategic licensing collaboration with Janssen Pharmaceutica N.V. (Janssen) for two novel oncology assets from Janssen’s early development portfolio, with Janssen retaining certain rights to potentially reacquire the programs (Press release, Tracon Pharmaceuticals, SEP 28, 2016, View Source;p=irol-newsArticle&ID=2206472 [SID:SID1234515481]). Johnson & Johnson Innovation facilitated the collaboration. Johnson & Johnson Innovation – JJDC, Inc. (JJDC) also made a $5 million equity investment in TRACON through the purchase of common stock at a price of $5.95 per share.

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Key Elements of the Transaction:

The transaction grants TRACON the rights to develop two Janssen oncology programs: TRC253 (formerly JNJ-63576253), a novel small molecule high affinity competitive inhibitor of wild type androgen receptor (AR) and multiple AR mutations that confer drug resistance, which is intended for the treatment of men with prostate cancer, and TRC694 (formerly JNJ-64290694), a novel, potent, orally bioavailable inhibitor of NF-kB inducing kinase (NIK), which is intended for the treatment of patients with hematologic malignancies, including myeloma.

TRC253 has completed IND-enabling studies and TRACON expects to initiate a Phase 1/2 proof of concept (POC) clinical study in the first half of 2017. Following completion of the initial POC study, Janssen will have an exclusive option to reacquire full rights to TRC253 for an upfront payment of $45 million to TRACON, and obligations to pay regulatory and commercialization milestones totaling up to $137.5 million upon achievement of specified events and a low single-digit royalty. If Janssen does not exercise its exclusive option to reacquire the program, TRACON would then retain worldwide development and commercialization rights to the program and would be obligated to pay Janssen a total of up to $45 million in development and regulatory milestones upon achievement of specified events, in addition to a low single digit royalty.

TRC694 is currently in preclinical development and TRACON expects to file an Investigational New Drug (IND) Application in 2018, following completion of additional preclinical studies. Upon completion of an initial clinical POC study, or at any time prior thereto, Janssen will have a right of first negotiation to reacquire the program on terms to be negotiated between the parties. If Janssen does not exercise the negotiation right or the parties cannot agree to terms following negotiations, and if TRACON continues development of TRC694, TRACON would be obligated to pay Janssen development and regulatory milestones totaling up to $60 million upon achievement of specified events and a low single-digit royalty.
"We are excited to enter into this innovative transaction with Janssen and Johnson & Johnson Innovation, and for the potential upside it provides our shareholders," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "This agreement expands our portfolio of potential first-in-class oncology therapies and leverages our existing drug development expertise. It also creates incremental opportunities for near-term non-dilutive funding and long-term value creation that complement our ongoing clinical development efforts with TRC105, our lead late-stage product candidate. Additionally, JJDC’s $5 million equity investment strengthens our balance sheet and is expected to offset the development expenses associated with these programs over the next 12 months."

About TRC253 (formerly JNJ-63576253)

TRC253 is a novel, orally bioavailable small molecule discovered and developed by Janssen that is a potent, high affinity competitive inhibitor of the androgen receptor (AR). TRC253 is also a pan-inhibitor of multiple AR mutations, including the F876L mutation, and is under development for the treatment of men with prostate cancer. The AR F876L mutation results in an alteration in the ligand binding domain that confers resistance to current AR inhibitors. IND-enabling studies have been completed for TRC253 and TRACON expects to initiate clinical development for the product candidate in the first half of 2017, following the completion of technology transfer from Janssen.

Activation of the AR is crucial for the growth of prostate cancer at all stages of the disease. Therapies targeting the AR have demonstrated clinical efficacy by extending time to disease progression, and in some cases, the survival of patients with metastatic castration-resistant prostate cancer. However, resistance to these agents is often observed and several molecular mechanisms of resistance have been identified, including amplification, overexpression or mutation of the AR.

TRC253 is intended to address resistance mechanisms to current AR inhibitors by specifically targeting mutations in the AR ligand binding domain. TRC253 also potently inhibits signalling through the wild type AR. These susceptible AR mutations have been identified using circulating tumor DNA assays, potentially allowing for selected patient biomarker-directed therapy.

About TRC694 (formerly JNJ-64290694)

TRC694 is a novel, potent, orally bioavailable inhibitor of NF-kB inducing kinase (NIK) with the potential to be first-in-class and was discovered by Janssen. In pre-clinical studies, TRC694 selectively repressed P52/RelB mediated non-canonical NF-kB gene expression and inhibited NIK and TRAF3 mutant cell line proliferation in vitro and tumor growth in vivo. TRACON anticipates completing development of a companion diagnostic to enable patient-directed therapy and submitting an IND for TRC694 in 2018.

Genetic alterations leading to stabilization of NIK are found in a subset of B-cell malignancies: multiple myeloma, mantle-cell lymphoma (MCL, associated with ibrutinib), diffuse large B-cell lymphoma (DLBCL), cHL and CLL.

About TRC105 (carotuximab)

TRC105 (carotuximab) is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in multiple Phase 2 clinical trials sponsored by TRACON or the National Cancer Institute for the treatment of solid tumor types in combination with VEGF inhibitors. The ophthalmic formulation of TRC105, DE-122, is currently in a Phase 1/2 trial for patients with wet AMD. TRC205, a second generation antibody to endoglin, is undergoing preclinical testing in models of fibrosis. For further information about the clinical trials, please visit TRACON’s website at View Source

On September 28, 2016Genomic Health, Inc. (Nasdaq: GHDX) reported that the company will present results from nine studies at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress, which will take place October 7-11 at the Bella Center in Copenhagen, Denmark (Press release, Genomic Health, SEP 28, 2016, View Source [SID:SID1234515482]). The results will include:

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Analytical validation study results for the recently launched Oncotype SEQ Liquid Select test. Oncotype SEQ is the first non-invasive liquid biopsy test that the company is delivering through its Oncotype IQ Genomic Intelligence Platform.
Two presentations highlighting updated prospective outcomes from a large population-based observational study based on the Surveillance, Epidemiology, and End Results (SEER) program of the National Cancer Institute (NCI). The primary SEER Registry study results, published in Nature Partner Journals Breast Cancer, demonstrated that the Oncotype DX Breast Recurrence Score accurately predicted prospective patient outcomes in more than 44,500 patients, including those with node-negative and node-positive breast cancer. The updated results to be presented at ESMO (Free ESMO Whitepaper) will include an additional year of patient data and an additional year of follow-up for patients included in the original study.
New prospective outcomes data on the Oncotype DX Breast Recurrence Score from a multi-center study in node-positive disease from Clalit Health Services, the largest health maintenance organization in Israel.
Five international studies demonstrating the value of the Oncotype DX Breast Recurrence Score on treatment decisions in Canada, the Czech Republic, Italy and Spain. These studies include new prospective clinical utility evidence for node-positive disease and results on the clinical impact of Oncotype DX beyond immunohistochemistry for Ki-67.
The ESMO (Free ESMO Whitepaper) abstracts are now available at www.esmo.org. Following are details for each presentation (all times are in Central European Summer Time):

Friday, October 7

Abstract: 146 O
Proffered Paper Session: "Outcome disparities by age and 21-gene recurrence score (RS) result in hormone receptor positive (HR+) breast cancer (BC)"
Author: S. Shak, M.D.
Location: Stockholm
Time: 16:00 – 17:30
Saturday, October 8

Abstract: 147 PD
Poster Discussion Session: "First prospectively-designed outcome study in estrogen receptor (ER)+ breast cancer (BC) patients (pts) with N1mi or 1-3 positive nodes in whom treatment decisions in clinical practice incorporated the 21-gene Recurrence Score result"
Authors: S. Stemmer, M.D.
Location: Berlin
Time: 15:00 – 16:00

Abstract: 150 PD
Poster Discussion Session: "Breast cancer-specific survival in > 4,600 patients with lymph node-positive (LN+) hormone receptor-positive (HR+) invasive breast cancer (BC) and 21-gene Recurrence Score (RS) results in the SEER registries"
Authors: D.P. Miller
Location: Berlin
Time: 15:00 – 16:00
Monday, October 10

Abstract: 175 P
Poster Display: "First prospective multicenter Italian study on the impact of the 21-gene Recurrence Score (RS) in adjuvant clinical decisions for ER+/HER2- early breast cancer patients"
Author: M.V. Dieci
Location: Hall E
Session Time: 13:00 – 14:00

Abstract: 181 P
Poster Display: "Budget impact analysis of the 21-gene assay (Oncotype DX Breast Cancer) for the breast cancer treatment in the Basque country"
Author: Toribio, M.D.
Location: Hall E
Session Time: 13:00 – 14:00

Abstract: 177 P
Poster Display: "The impact of the 21-gene assay in the Czech Republic on adjuvant chemotherapy (CT) recommendations and costs in estrogen receptor positive (ER+) early stage breast cancer (ESBC) patients with grade 2 tumors and risk factors"
Author: K. Petrakova, M.D., Ph.D.
Location: Hall E
Session Time: 13:00 – 14:00

Abstract: 180 P
Poster Display: "Use of Oncotype DX Recurrence Score (RS) reduces chemotherapy (CT) beyond treatment decisions using Ki67-based determinations of luminal A and B breast cancer subtypes: A retrospective study in the Spanish population"
Author: L. Garcia-Estevez, M.D.
Location: Hall E
Session Time: 13:00 – 14:00

Abstract: 183 P
Poster Display: "Prospective evaluation of the impact of the 21-gene Recurrence Score assay on adjuvant treatment decisions for women with node-positive breast cancer in Ontario, Canada"
Author: S. Torres, M.D.
Location: Hall E
Session Time: 13:00 – 14:00

Abstract: 1162 P
Poster Display: "Analytical performance of a new liquid biopsy mutation panel for detection of clinically actionable variants"
Author: C. Svedman, M.D.
Location: Hall E
Session Time: 13:00 – 14:00

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. With more than 600,000 patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeDX.com, www.mybreastcancertreatment.org and www.myprostatecancertreatment.org.