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.

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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.

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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.

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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.

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.

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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 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 a late breaker poster entitled "Phospholipid drug conjugates (PDC) show specificity for a broad range of tumor cells and provides a novel approach for targeted or precision therapy" 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 [SID1234525339]). Jarrod Longcor, chief business officer at Cellectar Biosciences will present this poster today, from 8:00 am – 12:00 pm (CT), poster section 43.

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The poster articulates how phospholipid ether platform provides tumor targeting for PDC molecules, irrespective of payload/warhead and their behavior once inside cells. These data provide valuable insight for the successful design of molecules for targeted delivery of cytotoxic payloads. In one of the studies presented, the result shows that Cellectar’s PDCs can effectively deliver cytotoxic payloads to the tumor cells without killing normal cells and that there is a 20-fold difference in the delivery of PDCs to the tumor versus normal cells.

"Many cancer treatments have clinical limitations that could be improved by the targeting our novel phospholipid ether technology and PDCs provide. Our research continues to suggest that our PDCs may offer an attractive method of targeting therapeutics to tumors. Our platform may provide distinct advantages over other technologies, not least of which is the diversity of payloads and linkers we can utilize," said James Caruso, chief executive officer of Cellectar Biosciences. "It is our goal to demonstrate that this level of diversity and specificity can translate into outcomes that will benefit cancer patients."

About Phospholipid Drug Conjugates
Cellectar’s product candidates are built upon a patented delivery and retention platform that utilizes optimized PDCs to target cancer cells. The PDC platform selectively delivers diverse oncologic payloads to cancerous cells and cancer stem cells, including hematologic cancers and solid tumors. This selective delivery allows the payloads’ therapeutic window to be modified, which may maintain or enhance drug potency while reducing the number and severity of adverse events. This platform takes advantage of a metabolic pathway utilized by all tumor cell types in all cell cycle stages. Compared with other targeted delivery platforms, the PDC platform’s mechanism of entry does not rely upon specific cell surface epitopes or antigens. In addition, PDCs can be conjugated to molecules in numerous ways, thereby increasing the types of molecules selectively delivered. Cellectar believes the PDC platform holds potential for the discovery and development of the next generation of cancer-targeting agents.