On April 16, 2018 Oncoceutics, Inc. reported that the first patient has been treated in a Phase I/II clinical trial of ONC201 in combination with ixazomib and dexamethasone in relapsed and/or refractory multiple myeloma (Press release, Oncoceutics, APR 16, 2018, View Source [SID1234558369]). The trial, led by Ajai Chari, MD, Associate Professor at the Icahn School of Medicine at Mount Sinai, is entitled "A Phase I/II Study of the Addition of Ixazomib to ONC201 and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma" (NCT03492138) and seeks to combine two oral medications that have shown synergy against multiple myeloma in preclinical models. The study will enroll up to 36 adult patients and will evaluate the safety and tolerability of ONC201 in combination with ixazomib and dexamethasone in Phase I and determine the two-month disease control rate as the primary endpoint of Phase II.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

While Oncoceutics is currently focused on clinical trials of ONC201 in high-grade gliomas as its lead indication, the company continues to advance a number of clinical programs in B cell malignancies because they have shown some of the highest sensitivity against ONC201 in pre-clinical models. Oncoceutics currently has two programs in multiple myeloma: "Oral ONC201 in Relapsed/Refractory Multiple Myeloma" (NCT02863991) and the combination trial with ixazomib described above.

Multiple myeloma is highly sensitive to proteasome inhibitors that activate the integrated stress response, the same pathway activated by ONC201 treatment through unique triggers. ONC201 synergizes with proteasome inhibitors since they converge on some of the same downstream effects as ONC201 even though they use distinct triggers in tumor cells. Based on this rationale, which is supported by published preclinical studies (Prabhu et al, Cell Cycle 2018; Tu et al, Neoplasia 2017), this clinical trial will test the combination of ONC201 with ixazomib and dexamethasone. Ixazomib, which goes by brand name NINLARO, is an oral proteasome inhibitor developed by Takeda Pharmaceutical Company. It is FDA approved in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. In addition to the U.S., NINLARO is approved in more than 50 countries.

"We are excited to have the opportunity to test these two oral agents that have demonstrated efficacy against multiple myeloma in pre-clinical settings to provide therapies to patients with refractory/relapsed multiple myeloma that are in need of novel therapies," said Ajai Chari, Associate Professor, Medicine, Hematology and Medical Oncology, at the Icahn School of Medicine at Mt. Sinai.

On April 16, 2018 Cancer Genetics, Inc. (Nasdaq:CGIX), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, reported that it has received special 510(k) clearance from the U. S. Food and Drug Administration (FDA) for its Tissue of Origin test (TOO) following modifications made to test reagents and software (Press release, Cancer Genetics, APR 16, 2018, View Source [SID1234525337]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

TOO is a microarray-based gene expression test that analyzes a tumor’s genomic information to help identify its origin, which is valuable in classifying metastatic, poorly differentiated, or undifferentiated cancers. TOO assesses 2,000 individual genes, covering 15 of the most common tumor types (representing 58 morphologies) and 90% of all solid tumors [1]. These tumors include thyroid, breast, non-small cell lung, pancreas, gastric, colorectal, liver, bladder, kidney, non-Hodgkin’s lymphoma, melanoma, ovarian, sarcoma, testicular germ cell, and prostate.
TOO is the only FDA-cleared test of its type and is Medicare-reimbursed. It is also the only test that provides a pathologist’s review and interpretation of a patient’s test results and diagnosis. TOO provides extensive analytical and clinical validation for statistically significant improvement in accuracy over other methods, including IHC [2]. TOO results lead to a change in patient treatment 65% of the time. In challenging cancers that require a second round of IHC, TOO increases diagnostic accuracy and confidence in site-specific treatment decisions [1].
"Our TOO Test represents a unique offering with the ability to add significant value to the continuum of care for cancer patients and greatly enhance our biopharma partners’ development efforts. This 510(k) clearance represents an important milestone toward our goal of gaining broad adoption of the test," said John A. (Jay) Roberts, Interim Chief Executive Officer and COO of Cancer Genetics. "An important element of our recently implemented transformation strategy is the identification of new methods through which to monetize our world-class test portfolio. We are currently evaluating several partnering opportunities that would expand the reach of the TOO Test and have the potential to generate high-margin revenue streams. We look forward to continuing this process as we leverage the capabilities of TOO to drive future growth."

Compared to the early version, the current TOO assay uses new labeling reagents and has a higher accuracy rate and a shorter workflow with similar precision and reproducibility. The low RNA input requirement of the early version is maintained. The combined result of these new features offers a further optimized clinical assay to help clinicians make diagnostic decisions and subsequent treatment selections.

Rita Shaknovich, Chief Medical Officer of CGI added, "Despite increasing excellence in the diagnostic workup for malignancies, there are approximately 150,000 newly diagnosed cases of metastatic cancer with unclear diagnosis in the U.S. and Europe each year [3]. This includes the subset of patients with cancers of unknown primary (CUP) and of uncertain origin. Increasingly complex algorithms and testing associated with a diagnostic workup also means that many challenging cases have insufficient amount of sample material for analysis. CGI’s TOO aids in identifying the source of such challenging tumors while using less material, and could be used as a diagnostic or confirmatory tool both for routine clinical testing and for clinical trial enrollment of patients with such tumors, enabling them to be considered for novel drug therapies."
The Company announced on April 2, 2018 that it has engaged Raymond James & Associates, Inc. as a financial advisor to assist with evaluating options for the Company’s strategic direction. These options may include raising additional capital, the acquisition of another company and / or complementary assets, the sale of the Company, or another type of strategic partnership. The Company’s Board of Directors is committed to evaluating all potential strategic opportunities and to pursuing the path most likely to create both near- and longer-term value for Cancer Genetics’ shareholders.
1. R Pillai, et al. Validation and Reproducibility of a Microarray-based Gene Expression Test for Identifying the Primary Site of Tumors in Formalin-Fixed Paraffin-Embedded Specimens. J Molec Diag 13 2011;13:48-56.
2. JP Grenert, et al. Gene Expression Profiling from Formalin-Fixed, Paraffin-Embedded Tissue for Tumor Diagnosis. Clin Chim Acta. 2011 Jul 15;412(15-16):1462-4.
3. Tomuleasa, Ciprian, et al. How to Diagnose and Treat a Cancer of Unknown Primary Site. Journal of Gastrointestinal & Liver Diseases 26.1 (2017).

On April 16, 2018 Navidea Biopharmaceuticals (NYSE MKT: NAVB) ("Navidea" or "the Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will present at the 2nd Annual NASH Summit in Boston, MA being held April 23-25, 2018 (Press release, Navidea Biopharmaceuticals, APR 16, 2018, View Source [SID1234525353]). Michael Goldberg, President and Chief Executive Officer, will be giving a new presentation focused on Navidea’s NASH research; the presentation will be available on Navidea’s website following the conference.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Event: 2nd Annual NASH Conference
Presentation Date: Wednesday, April 25th
Presentation Time: 11:30am EST
Location: Revere Hotel Boston Common, Boston, MA
To schedule a meeting with Navidea management at the conference, please contact Navidea Investor Relations at [email protected].

On 16 April 2018 Crescendo Biologics Ltd (Crescendo), the developer of multifunctional biologics, including targeted T-cell engagers, reported that it has achieved the first major technical milestone under the terms of its collaboration with Takeda Pharmaceutical Company Limited (Takeda; TSE: 4502) (Press release, Crescendo Biologics, APR 16, 2018, View Source [SID1234525320]).
The global, strategic, multi-target collaboration and license agreement with Takeda was announced in October 2016. Under this agreement, Crescendo’s proprietary transgenic platform and engineering expertise is being used to identify and optimally configure Humabody-based therapeutics against targets selected by Takeda.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This milestone, for an undisclosed amount, marks the successful delivery of a highly diverse panel of Humabody leads, directed to the first of Takeda’s selected targets.
Dr Peter Pack, CEO of Crescendo, commented:
"This milestone is an important step forward in our relationship with Takeda. It demonstrates our ability to deliver a diverse selection of characterised Humabody molecules that meet the stringent specifications outlined in the agreement. In conjunction with Takeda’s deep expertise in the field of oncology, this exciting milestone provides further validation of Crescendo’s ability to create optimally configured Humabodies.
"This milestone demonstrates the potential of this innovative technology and brings us closer to our goal of developing next generation, highly modular and targeted biologics against cancer."

On April 16, 2018 Cellectar Biosciences (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported the presentation of CLR 131 preclinical data in a poster discussion entitled "Therapeutic Combination of Radiolabeled CLR1404 with External Beam Radiation in Head and Neck Cancer Murine Xenograft Models" at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting underway in Chicago (Press release, Cellectar Biosciences, APR 16, 2018, View Source [SID1234525338]). The discussion, hosted on Sunday, April 15, 2018 was led by Chunrong Li, assistant scientist, Department of Human Oncology, University of Wisconsin School of Medicine and Public Health.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The purpose of the study was to evaluate the anti-tumor effect of CLR 131 in combination with external beam radiation (XRT). The results demonstrated uptake of CLR 131 across multiple head and neck cancer (HNC) cell lines and xenograft models, and synergistic anti-tumor effects when CLR 131 was combined with XRT. The combination of CLR 131 and fractionated XRT showed enhanced tumor growth inhibition compared with single modality treatment in the 6 HNC xenograft models. Importantly, the findings suggest potential efficacy using CLR 131 combined with reduced-dose XRT in HNC patients. High-dose XRT while effective for localized disease, produces significant co-morbidities for patients, especially those suffering from diffuse disease. The potential to reduce the XRT dose may also result in decreased toxicity to normal tissue, a common side effect of high-dose XRT.

As a key milestone of their Head and Neck SPORE Grant (NIH P50 DE026787), the University of Wisconsin-Madison is initiating the first human clinical trial combining CLR 131 and external beam radiation in patients with recurrent HNC in the second half of 2018. The costs associated with the Phase 1 study will be covered in their entirety through the grant and the study represents a fourth clinical trial using the company’s lead PDC, CLR 131.

"As we continue both preclinical and clinical evaluation of our lead cancer targeting compound CLR 131, our potential to meaningfully impact a broad range of cancers continues to grow," said James Caruso, chief executive officer of Cellectar Biosciences. "We are encouraged by the data highlighted at AACR (Free AACR Whitepaper) showing enhanced receptivity to treatment and inhibition of tumor growth, while potentially reducing toxicities associated with current standard of care treatment."

About CLR 131
CLR 131 is Cellectar’s investigational radioiodinated PDC therapy that exploits the tumor-targeting properties of the company’s proprietary phospholipid ether (PLE) and PLE analogs to selectively deliver radiation to malignant tumor cells, thus minimizing radiation exposure to normal tissues. CLR 131, is in a Phase 2 clinical study in relapsed or refractory (R/R) MM and a range of B-cell malignancies and a Phase 1 clinical study in patients with (R/R) MM exploring fractionated dosing . In 2018 the company plans to initiate a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma, and a second Phase 1 study in combination with external beam radiation for head and neck cancer.