On July 21, 2020 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported a poster presentation at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting being held virtually on August 17-19, 2020 (Press release, Cellectar Biosciences, JUL 21, 2020, View Source [SID1234562221]).

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Poster presentation details:

Poster Title CLR 131 Demonstrates 100% Overall Response Rate in Relapsed or Refractory Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom’s Macroglobulinemia (WM): Initial Results from Ongoing Phase 2 trial, CLOVER-1 Study

A copy of the presentation materials can be accessed on the Events and Presentations section of the Cellectar website once the presentation has concluded.

About CLR 131

CLR 131 is a small-molecule Phospholipid Drug Conjugate designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells unlike many traditional on-market treatment options. CLR 131 is the company’s lead product candidate and is currently being evaluated in a Phase 2 study in B-cell lymphomas, and a Phase 1 dose-escalating clinical study in pediatric solid tumors and lymphomas. The company recently completed a Phase 1 dose-escalation clinical study in r/r multiple myeloma. The FDA granted CLR 131 Fast Track Designation for both r/r multiple myeloma and r/r diffuse large b-cell lymphoma and Orphan Drug Designation (ODD) for the treatment of multiple myeloma, lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia, neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. CLR 131 was also granted Rare Pediatric Disease Designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Most recently, the European Commission granted an ODD for r/r multiple myeloma.

About the Phase 2 CLOVER-1 Study

CLOVER-1 is a Phase 2 study of CLR 131 being conducted in 10 leading cancer centers in the United States in patients with relapsed/refractory B-cell hematologic cancers. The hematologic cancers studied include multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma/ Waldenstrom’s macroglobulinemia (LPL/WM), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL).

The study can enroll up to 80 patients with its primary endpoint being clinical benefit response (CBR), which is defined as the proportion of MM patients following infusion of CLR 131 with stringent complete response, complete response, very good partial response, partial response and stable disease per International Myeloma Working Group criteria, or the proportion of lymphomas patients (CLL/SLL, LPL, MZL, MCL, and DLBCL) following infusion of CLR 131 with CR, PR and SD per the Lugano classification CT-based response criteria or International Waldenstrom’s Macroglobulinemia Society criteria or the International Chronic Lymphocytic Leukemia criteria. Additional endpoints include overall response rate (ORR), progression free survival (PFS), median overall survival (OS) and other markers of efficacy. Patients were treated with three different doses (<60mCi single cycle, >60mCi single cycle and >60 mCi multi-cycle total body dose).

The CLOVER-1 Phase 2 study completed the Part A dose-exploration portion conducted in relapsed/refractory (r/r) B-cell malignancies and is now enrolling in the Part B expansion cohorts in relapsed/refractory (r/r) multiple myeloma (MM) and lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia (LPL/WM). Part B is evaluating the two cycle dosing of CLR 131 in additional patients. Each cycle is defined as two doses provided 14 days apart (+/- 1 day). Cycle 2 shall be given 8-weeks post the initial infusion. Additional cycles can be considered following an additional 8-week period. The Part A portion of the study met its primary and secondary endpoints with detailed data being announced on February 19, 2020.

Cellectar was awarded approximately $2 million in non-dilutive grant funding from the National Cancer Institute to help fund the study. More information about the study, including eligibility requirements, can be found at www.clinicaltrials.gov, reference NCT02952508.

On July 21, 2020 Dragonfly Therapeutics, Inc. ("Dragonfly" or the "Company"), a clinical stage biotechnology company developing novel immunotherapies, reported it has dosed its first patient in a Phase 1/2 study of the Company’s proprietary IL12 investigational immunotherapy, DF6002 (Press release, Dragonfly Therapeutics, JUL 21, 2020, View Source [SID1234562206]). Dragonfly’s DF6002 clinical trial is currently recruiting patients with advanced solid tumors at Lifespan Cancer Institute at Rhode Island Hospital, the principal teaching hospital of Brown University, with additional sites scheduled to open shortly. DF6002 will be Dragonfly’s second drug in the clinic, with its NK cell engager therapy DF1001 having started clinical testing in the fall of 2019.

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"DF6002’s therapeutic potential is particularly exciting," said Dr. Mario Sznol, Dragonfly Clinical Advisory Board member and Professor of Medicine & Co-Leader, Cancer Immunology, Yale Cancer Center. "Dragonfly’s extended half-life IL12 with retained potency and remarkable in vivo anti-tumor data may help fulfill the long-awaited potential of this cytokine in a broad population of cancer patients."

"Dragonfly’s pre-clinical data package on IL12 is extraordinary, and we are eager to demonstrate its effects in cancer patients"," said said Dr. Tyler Jacks, Director of the Koch Institute at MIT and Chairman of the Company’s Scientific Advisory Board. "DF6002 is Dragonfly’s first cytokine and has demonstrated preclinically superior efficacy to native IL12 combined with a compelling preclinical safety profile and wide therapeutic window."

Dragonfly Therapeutics received investigational new drug approval for DF6002 from the U.S. Food and Drug Administration (FDA) in late May. The company’s Phase 1/2 clinical trial is a first-in-human, multi-part, open-label, non-randomized, multiple-ascending dose study to investigate the safety, tolerability, pharmacokinetics, biological, and clinical activity of DF6002 alone and in combination with PD-1 inhibition in patients with locally advanced or metastatic solid tumors, followed by expansion in selected indications.

Initiating clinical trials with our first cytokine underscores both the breadth of Dragonfly’s portfolio of innovative therapeutics, and the pace with which our team is bringing important new treatment options to patients with cancer and autoimmune disease," said Bill Haney, CEO and Dragonfly co-founder. "In addition to DF6002, our productive collaborations building drugs for BMS, Merck, and Abbvie, and our DF1001 TriNKET presently advancing in the clinic, we’re already racing to bring our second TriNKET to IND in 2021."

Additional information about the trial, including eligibility criteria, can be found at: View Source (ClinicalTrials.gov Identifier: NCT04423029).

About DF6002
DF6002, Dragonfly’s extended half-life IL12 cytokine, is an investigational immunotherapy being evaluated in adult patients for the treatment of advanced solid tumors. DF6002 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. DF6002 is the most advanced in a pipeline of cytokines that Dragonfly is developing to address the high unmet need in patients with advanced cancer.

On July 21, 2020 Tubulis reported the close of a €10.7 million Series A financing round to accelerate the development of a new class of highly stable and efficient antibody-drug conjugates (ADCs) and to support the further growth of the company (Press release, Tubulis, JUL 21, 2020, View Source [SID1234562205]). The financing round was co-led by BioMedPartners and High-Tech Gründerfonds (HTGF) with support from Seventure Partners, coparion, Bayern Kapital, and OCCIDENT alongside significant contributions by high net worth individuals and the founders. Tubulis was spun out in 2019 from the Leibniz Research Institute in Berlin (FMP) and the Ludwig Maximilians University (LMU) in Munich with the aim of expanding the therapeutic potential of ADCs for cancer and other disease indications.

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"Tubulis’ objective is to use our dual platform approach to generate uniquely matched and disease-specific ADCs that combine selective antibodies with effective payloads," said Dominik Schumacher, CEO and co-founder of Tubulis. "The funding committed by this experienced syndicate represents a validation of our technology and reflects the recent renaissance in ADC development in our industry. These proceeds will enable us to continue validating our platforms and to move our first two selected ADC candidates towards the clinic."

Michael Wacker, Partner at BioMed Partners commented: "Tubulis is tackling the limitations of current ADCs head-on and is helping to shape the future of ADCs for the treatment of a broad range of diseases. We look forward to supporting the team at Tubulis as they continue to build the company in a growing field with a high need for innovative solutions."

Tubulis’ uniquely versatile and customizable ADC technology portfolio consists of two proprietary technologies which are based on scientific discoveries made in the research groups of Prof. Christian Hackenberger (FMP), Prof. Heinrich Leonhardt (LMU) and Dr. Jonas Helma-Smets, who are all co-founders of the company. Jonas Helma-Smets also joined the company as CSO.

The platforms accommodate the complexities of modern ADC design with regard to protein format, payload potency and payload hydrophobicity. P5 conjugation is a novel chemistry for cysteine-selective conjugation. It allows for ultra-stable ADC generation with unprecedented linker stability and chemical flexibility, enabling rapid lead identification. The Tub-tag platform was inspired by microtubule biology and adds a significant amount of stability to the ADC product candidates by modulating the antibody to provide a highly beneficial microenvironment for the payload. Moreover, the human-derived nature of the Tub-tag reduces the risk of unwanted immune responses. Combining these platforms addresses the main bottlenecks in the field, ADC stability and payload-driven toxicity. Tubulis will prioritize the use of these technologies for internal drug discovery and development activities to generate uniquely matched antibody-drug conjugates, tailored to the respective indication.

During the spin-out phase the company has already been recognized by several early-stage start-up awards including the Outstanding Start-up Award at Venture.Med 2019, the Leibniz Entrepreneurship Award as well as being an official EIT Health success story. Tubulis is an EIT Health Investor Network supported company.

On July 21, 2020 Acentrus Specialty, a national network of health systems and hospitals committed to providing specialty pharmacy care for their patients, reported that it has finalized an agreement with Puma Biotechnology, Inc. (NASDAQ: PBYI) to provide qualified Acentrus clients access to NERLYNX (neratinib) (Press release, Acentrus Specialty, JUL 21, 2020, View Source [SID1234562203]).

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"We are pleased to provide our network hospitals and their patients access to an important breast cancer treatment"

"We are pleased to provide our network hospitals and their patients access to an important breast cancer treatment," said Acentrus Specialty Vice President George Zula. "Limited distribution drugs like NERLYNX are highly sought after but can be difficult to obtain. Acentrus works with drug companies to open the door to these medications for specialty pharmacies operated by our network hospitals. This means that patients can begin potentially life-saving treatments sooner and with the significant advantage of integrated care from pharmacy professionals they know and trust."

Participation in Acentrus is open to hospital organizations of all sizes, types and affiliations. Clients, which range from academic medical centers to community-based hospitals, share one goal: to provide their patients with high-quality care in a setting where clinical and pharmacy services are integrated.

There is no cost for an organization to join the Acentrus network, which provides more than 100 health systems and hospitals with the following benefits:

Access to difficult-to-obtain specialty medications
Data management
Collaboration with health system peers dedicated to sharing best practices
Portfolio of other services to help hospital-based specialty pharmacies meet the needs of their patients, including backup and contract pharmacy as well as expertise in licensing and accreditation
Specialty medications represent the fastest growth sector in pharmacy, with 1-2% of all claims accounting for 50-60% of all expenses. Specialty pharmaceuticals are typically limited distribution drugs (LDDs) available only to certain providers through exclusive networks established by manufacturers.

On July 21, 2020 Genetics Institute of America reported that it has received IRB approval to expand its Prostate Cancer Study (GH215) to include: Breast, Ovarian and Lung Cancers (Press release, Genetics Institute of America, JUL 21, 2020, View Source [SID1234562192]).

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Entopsis had earlier entered into a diagnostics commercialization agreement with Genetics Institute of America of Delray Beach, Florida focusing on Prostate Cancer. Genetics Institute of America will develop additional laboratory developed tests (LDT) based on Entopsis’ OpsisDxTM diagnostics platform. The purpose of these tests in Breast, Ovarian and Lung Cancers will be to enhance early detection and diagnosis while reducing unnecessary invasive procedures for patients who are suspected of having cancer.

Genetics Institute of America will run prospective, Institutional Review Board approved, validation studies in its CLIA licensed facility for each cancer type, and launch each laboratory developed test upon successful completion and acceptance of the study.

Entopsis consists of a team of scientists and engineers looking to re-focus the diagnostics industry on early detection and disease prevention with an eye towards improved ‘healthspans’. In 2016, Entopsis was awarded the "Most Disruptive Technology Award" by the Greater Miami Chamber of Commerce.

"We’re pure research scientists, so we’re excited to be working with the team at Genetics Institute of America on this venture," said Obdulio Piloto, PhD, Co-founder and CEO of Entopsis. "The ability to positively impact patients’ lives is one of the missions of Genetics Institute of America. Bringing additional OpsisDxTM tests to market will help in the care of thousands of patients," said Holly Magliochetti, CEO and Founder of Genetics Institute of America.

Genetics Institute of America will recruit leading physicians as co-investigators and additional study sites commencing immediately.