On June 30, 2020 The EndBrainCancer Initiative (EBCI) reported that GT Medical Technologies, manufacturers of GammaTile Therapy for Brain Cancer Patients, has joined EBCI’s roster of corporate partners (Press release, The End Brain Cancer Initiative, JUN 30, 2020, View Source [SID1234561599]). According to the EndBrainCancer Initiative, GT Medical Technologies is dedicated to improving the lives of patients with brain tumors through a promising new intervention in the treatment of brain cancer, GammaTile Therapy. Part of EBCI’s business model is to partner with other companies that are also offering promising new treatment options to treat brain cancer including metastatic disease to the brain.

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GammaTile Therapy is an FDA-cleared, Surgically Targeted Radiation Therapy (STaRT) for patients with newly diagnosed malignant and recurrent brain tumors including primary and metastatic tumors. The small, bioresorbable GammaTile:

Is placed directly and surgically at the tumor site after the tumor is surgically removed.
Provides immediate radiation treatment to remaining tumor cells before they can replicate while preserving healthy tissue.
Means no additional trips to the hospital or clinic for standard radiation therapy
Allows patients to receive radiation treatment while going about their daily lives.
According to the EndBrainCancer Initiative, the partnership with will result in:

Education, Awareness & Outreach about GammaTile Therapy to a National audience of patients with brain tumors, their caregivers, medical practitioners, industry, and the general public with a total annual reach of over 18,000,000.
Patients facing surgery and radiation who contact EBCI’s "Direct Connect" Patient Services Program and Referral Clinic being provided with information about GammaTile Therapy
IMMEDIATE ACCESS to brain tumor specialists and cancer centers across the country where GammaTile Therapy is offered for those patients who express interest (to get connected please fill out a Patient Advocacy & Inquiry Form or call 425.445.2215).
"We are proud to welcome GT Medical Technologies as an EBCI Corporate Partner," commented Dellann Elliott Mydland, EBCI President & CEO. "Representing a breakthrough in delivering radiation, GammaTile Therapy is a triple win for patients with brain cancer that it:

Has been shown to delay brain tumor recurrence, potentially extending survival
Minimizes side effects and eliminates all those trips to the hospital or clinic that standard radiation requires.
Allows patients and their caregivers to focus on healing, doing those things that are important to them as well as time to explore all of their treatment options, which also include Standard of Care (SOC), advanced treatments, clinical trials and the Optune device."
"We look forward to bringing on additional Corporate Partners who share EBCI’s commitment to improving the lives and extending survivorship for this patient population and who are ‘moving the dial’ through making available new options for treating this disease." To become a Corporate Partner, please contact Dellann Elliott Mydland directly at [email protected], 425-785-8489 or fill out our Partnership Inquiry Form.

On June 30, 2020 Sun BioPharma, Inc. (OTCQB: SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic cancer, reported receipt of Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its lead product, SBP-101, being developed for firstline treatment of patients with metastatic pancreatic ductal adenocarcinoma (PDA) when administered in combination with gemcitabine and nab-paclitaxel (Press release, Sun BioPharma, JUN 30, 2020, View Source [SID1234561621]).

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One of FDA’s Expedited Programs for Serious Conditions, Fast Track is a process designed to facilitate the development and potentially expedite the review of drugs intended to treat serious conditions and address unmet medical needs. Programs with Fast Track Designation may benefit from more frequent meetings with and written communications from FDA, in addition to being eligible for accelerated approval and priority review if certain criteria are met. Fast Track Designation also provides eligibility for a rolling review of a New Drug Application (NDA), which allows for completed sections of an NDA to be submitted for FDA review. Usually NDA review does not begin until the company has submitted the entire application to the FDA.

"Fast Track Designation is important for Sun BioPharma because it enhances our ability to develop SBP-101 as efficiently as possible," said Suzanne Gagnon, M.D., Chief Medical Officer of Sun BioPharma. Michael T. Cullen, M.D., MBA, Co-Founder, Executive Chairman, and CEO, added "There is an urgent need for new therapeutic options for patients with pancreatic cancer, and we look forward to working closely with FDA as we continue to advance our development program of SBP-101 for patients with metastatic PDA."

SBP-101 is currently being evaluated in a Phase 1a/1b clinical trial of patients with previously untreated metastatic PDA at sites in the United States and Australia. For more information please visit clinicaltrials.gov.

About SBP-101

SBP-101 is a proprietary polyamine analogue designed to be a first-in-class product to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for the exocrine pancreas and pancreatic ductal adenocarcinoma. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting complementary activity with an existing FDA-approved chemotherapy regimen. In clinical studies to date, SBP-101 has not shown exacerbation of the typical chemotherapy-related adverse events of bone marrow suppression and peripheral neuropathy. The safety data and PMI profile observed in Sun BioPharma’s current clinical trial provides support for continued evaluation of the compound in a randomized clinical trial.

On June 30, 2020 PharmEnable, a Cambridge-based drug discovery company using advanced medicinal chemistry and AI-enabled approaches to design the next generation of highly complex and specific drug candidate molecules, reported it has closed a £1.8 million seed financing to support its transition into a drug development company (Press release, PharmEnable, JUN 30, 2020, View Source [SID1234561564]). It aims to develop new treatments for conditions with significant unmet clinical need, by designing highly complex molecules for addressing challenging biological targets.

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The round, which was significantly over-subscribed, was led by Cambridge Enterprise, the commercialisation arm of the University of Cambridge, as well as the University of Cambridge Enterprise Fund VI, managed by Parkwalk Advisors. It also attracted support from a wealth of angel investors and notable life science funds, including Jonathan Milner, serial entrepreneur and founder of Abcam; Andy Richards, Cambridge-based entrepreneur and investor; David Ford, Oxford-based life sciences angel investor; the family office of Paul Forster, co-founder of Indeed.com; Ian Tomlinson, chairman of several bio-incubators, entrepreneur and co- founder of Domantis; KQ Labs at the Francis Crick Institute; Martlet Capital, a Cambridge-based investor with a growing portfolio of innovative life science companies; the fast-growing o2h ventures Human Health EIS fund; and Wren Capital, the established London-based angel investor in science, engineering and software businesses.

A spin-out from the University of Cambridge in 2016, and financed to date by its founders and service-based revenues, PharmEnable will use the funding to evolve its business model and invest in a pipeline of drug discovery programmes across a number of disease areas including cancer and neurodegenerative disease. Additionally, PharmEnable will continue to engage in strategic partnerships with pharma, innovative biotechs and academia.

PharmEnable is led by co-founder and CEO Dr Hannah Sore. It has attracted an experienced Board and management team including Dr Jane Dancer, previously of F-star, who joined recently as the new Board Chair. The financing has enabled PharmEnable to expand its scientific team including Dr David Vidal as Director of Technology, with further expansion, including the addition of a Director of Drug Discovery planned for Q3 2020.

The PharmEnable platform technology can predict improved small molecule hits to targets across a range of disease areas. Its approach focuses on exploring and mapping the possible chemical universe and designing novel small molecules that are highly complex with shapes similar to those found in nature. This approach can identify hits with improved specificity compared with traditional screening methods, and allows PharmEnable to take on particularly challenging biological targets, such as protein-protein interactions and epitranscriptomic modifications that have been undruggable by existing approaches. Its solution consists of two elements: ChemUniverse a diversity-focused virtual database of chemically diverse molecules; and ChemSeek, a suite of gold standard AI-enabled tools for finding drug target matches from structure and ligand data.

On June 30, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that the United States Food and Drug Administration (FDA) has granted the company orphan drug designations of cirmtuzumab for treatment of mantle cell lymphoma (MCL) and for treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL) (Press release, Oncternal Therapeutics, JUN 30, 2020, View Source [SID1234561583]). Cirmtuzumab is an investigational anti-ROR1 monoclonal antibody being evaluated in clinical trials in patients with MCL, CLL and HER2-negative breast cancer.

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Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs or biologics intended to treat rare diseases or conditions, which are defined as diseases or conditions that affect fewer than 200,000 people in the United States or that affect more than 200,000 people but where there is no reasonable expectation that the costs of developing and marketing the drug will be recovered through future sales of the drug in the United States. Orphan drug designation for cirmtuzumab qualifies Oncternal for certain benefits including tax credits for qualified clinical trials, exemption from certain FDA application fees, and the potential for market exclusivity upon regulatory approval, if received, for an orphan-designated indication.

"We are pleased to receive orphan drug designations for cirmtuzumab, our potentially first-in-class investigational ROR1 antibody," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We are excited about cirmtuzumab’s potential for the treatment of patients with ROR1-expressing cancers, including MCL, CLL, HER2-negative breast cancer and other solid tumors, and look forward to further advancing its development to benefit patients with significant unmet medical needs."

MCL is an aggressive form of non-Hodgkin’s lymphoma. MCL prevalence is estimated to be approximately 13,000 to 21,000 patients in the United States. MCL is an aggressive cancer that carries a poor prognosis, with a median survival of about two to five years and a 10-year survival rate of approximately 5%-10%.

CLL is the most common form of leukemia in adults, accounting for 25-30% of all leukemias in the United States. CLL prevalence is estimated to be approximately 158,000 to 178,000 patients in the U.S. Despite various recently approved therapies, CLL generally remains incurable.

About Cirmtuzumab

Cirmtuzumab is an investigational, potentially first-in-class monoclonal antibody targeting ROR1, or Receptor tyrosine kinase-like Orphan Receptor 1. Cirmtuzumab is currently being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of CLL or MCL, in a collaboration with the University of California San Diego School of Medicine and the California Institute for Regenerative Medicine (CIRM). In addition, an investigator-initiated Phase 1 clinical trial of cirmtuzumab in combination with paclitaxel for women with HER2-negative metastatic breast cancer is being conducted at the UC San Diego School of Medicine.

ROR1 is a potentially attractive target for cancer therapy because it is an onco-embryonic antigen – not usually expressed on adult cells, and its expression confers a survival and fitness advantage when reactivated and expressed by tumor cells. Researchers at the UC San Diego School of Medicine discovered that targeting a critical epitope on ROR1 was key to specifically targeting ROR1 expressing tumors. This led to the development of cirmtuzumab, that binds this critical epitope of ROR1, which is highly expressed on many different cancers but not on normal tissues. Preclinical data showed that when cirmtuzumab bound to ROR1, it blocked Wnt5a signaling, inhibited tumor cell proliferation, migration and survival, and induced differentiation of the tumor cells. The FDA has granted Orphan Drug Designations to cirmtuzumab for the treatment of mantle cell lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma. Cirmtuzumab is in clinical development and has not been approved by the FDA for any indication.

On June 30, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the Company has initiated the submission of its Biologics License Application ("BLA") for omburtamab under the U.S. Food and Drug Administration’s ("FDA") Rolling Review process. Omburtamab is an investigational, monoclonal antibody that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types (Press release, Y-mAbs Therapeutics, JUN 30, 2020, View Source [SID1234561600]). The omburtamab BLA is for the treatment of pediatric patients with CNS/leptomeningeal metastases from neuroblastoma.

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The non-clinical portion and a part of the CMC portion of the rolling BLA were submitted during June 2020, and completion of the BLA submission is currently expected to take place over the next four to six weeks. The clinical submission will be based on the safety and efficacy results of the pivotal Phase 2 studies 101 and 03-133, which the Company expects to present later this year.

"As the father of a long-term high-risk neuroblastoma survivor with CNS/Leptomeningel metastasis, I know how important this potentially is for families faced with brain metastasis from high-risk neuroblastoma and I am excited to see the initiation of Y-mAbs’ second BLA submission this year in neuroblastoma. We believe this is a key milestone for families facing CNS/leptomeningeal metastases from neuroblastoma and for Y-mAbs. We are very grateful to all clinical sites involved in developing omburtamab, and especially to our employees in the development team." stated Thomas Gad, Founder, Chairman and President.

Dr. Claus Moller, Chief Executive Officer, continued, "We look forward to working with the Agency to bring omburtamab to appropriate patients. We believe omburtamab can potentially address a significant unmet medical need for children with CNS/leptomeningeal metastases from neuroblastoma."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests related to the compound and Y-mAbs.