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.

On July 21, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that its leadership will participate at the Canaccord 40th Annual Growth Conference on Thursday, August 13, 2020 (Press release, TYME, JUL 21, 2020, View Source [SID1234562191]). The Company will present its corporate overview for 2020 with a special focus on multiple growth opportunities driven by advances in the science of cancer metabolism, pivotal and late-stage trials in pancreatic cancer, clinical trial in ultra-rare metastatic sarcoma and expanding clinical plans for its lead candidate SM-88 (racemetyrosine) in pancreatic, prostate, breast and hematological cancers.

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Event: Canaccord Virtual 40th Annual Growth Conference
Presentation Date: Thursday, August 13, 2020
Presentation Time: 3:00PM ET

The presentation will be accessible on the events page under the investor relations section of Tyme Technologies’ website at www.tymeinc.com. There are no planned webcasts for this event.

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. Learn more.

About TYME-18

TYME-18 is composed of a proprietary surfactant delivery agent with a specific sulfonic acid component. It is designed for intra-tumoral administration of difficult to treat tumors and leverages the acidic tumor microenvironment and signaling pathways to kill cancer cells. TYME-18 is distinct in composition, but like SM-88, aims to leverage susceptibilities of a cancer that are related to its altered metabolism. Initial preclinical data for TYME-18 in animal tumor models demonstrate rapid and complete tumor regression, with no reported local or systemic toxicities. TYME-18 continues to be studied as a potential therapy for difficult to treat tumors that may not be eligible for surgical or other interventions. Learn more.

About TYME-88-Panc Pivotal Trial

The TYME-88-Panc pivotal trial applies the latest advances in the field of cancer metabolism by evaluating the efficacy and safety of an oral investigational compound that targets the metabolic mechanisms of the disease at its source. A prospective, open label pivotal trial in metastatic pancreatic cancer for patients who have failed two lines of any prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in advanced pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate. Learn more.

On June 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, (Press release, Cytokinetics, JUL 21, 2020, View Source [SID1234562185]) [SID1234562186]).

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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.