On June 3, 2020 NorthShore University HealthSystem (NorthShore) neurosurgeon, Julian Bailes, MD, reported that it is the first in Illinois to begin offering GammaTile Therapy, a new approach to treating malignant brain tumors (Press release, GT Medical Technologies, JUN 3, 2020, View Source [SID1234560812]). The FDA-cleared, Surgically Targeted Radiation Therapy (STaRT) is designed to delay tumor regrowth for patients with high grade gliomas, meningiomas and brain metastases. The FDA most recently approved GammaTile for the initial surgery and treatment of glioblastoma multiforme — the most common malignant tumor. The first patient in the state was treated by Dr. Bailes, who is chairman of the department of neurosurgery and co-director of the NorthShore Neurological Institute. Neuro-oncologist Ryan Merrell, MD, will also be participating in this new surgical therapy at NorthShore.

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Aggressive brain tumors tend to be resistant to current treatments and have a high likelihood of recurrence. Smaller than a postage stamp (2cm x 2cm), the GammaTile is a 3D-collagen tile embedded with Cesium-131 radiation that can be placed at the tumor site after the tumor is surgically removed. It immediately begins to target any microscopic residual tumor with radiation while limiting the impact on healthy brain tissue. It adds just five to ten minutes to surgery time and is absorbed in the body within two months.

"We are excited to offer this new treatment that protects healthy brain tissue while providing immediate, targeted therapy directly to the area that’s most at risk for recurrence," said Dr. Bailes. "Most patients report fewer side effects and better quality of life since this eliminates the wait time and procedures typically associated with standard treatment after the removal of a tumor."

GammaTile Therapy is a radiation therapy specifically designed for implantation in the brain and offers advantages for patients undergoing surgery for brain tumors. GammaTile begins targeting residual tumor cells immediately at the time of tumor removal surgery, rather than waiting several weeks for surgical wound healing before beginning other treatment. GammaTile protects healthy brain tissue while delivering a targeted dose to any remaining tumor cells. The unique design also limits side effects typically associated with radiation therapy, including hair loss. These patients receive their course of internal, focused radiation while going about their daily lives, requiring no additional trips to the hospital or clinic for radiation therapy.

A male patient in his thirties was the first patient in Illinois to receive this treatment. He had brain surgery and standard chemotherapy and radiation last spring. Dr. Bailes says GammaTile therapy shows great promise for prolonging survival and improving quality of life for this patient and others.

Research has shown that patients who received surgery plus GammaTile Therapy had approximately two times improvement in median time to tumor recurrence. Data supporting the efficacy and safety profile of the therapy for patients with recurrent, previously treated meningioma’s was published in the Journal of Neurosurgery (JNS), the official journal of the American Association of Neurological Surgeons.

"We are honored to be working with the brain tumor specialists at NorthShore to deploy GammaTile Therapy for the purpose of improving the lives of patients with brain tumors," said Matt Likens, president and CEO of GT MedTech. "We are excited to begin expanding the availability of GammaTile Therapy to other leading brain tumor treatment centers across the U.S."

On 3rd June 2020 Enara Bio (formerly Ervaxx), a biotechnology company leveraging its proprietary T-cell/T-cell receptor (TCR) discovery and Dark Antigen platforms to deliver targeted cancer immunotherapies, reported its new name – Enara Bio Limited (Press release, Ervaxx, JUN 3, 2020, View Source [SID1234607515]). This new name reflects the company’s expanded product discovery and development strategy beyond its initial focus on endogenous retroviral (ERV) antigens for the development of cancer vaccines (hence "Ervaxx").

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"Enara" is derived from an Arabic word that means illumination, enlightenment and bringing light into darkness. The company believes this new name more closely illustrates Enara Bio’s mission as a science-led organization exploring the genomic dark matter as a source of novel cancer-specific T-cell antigens. The rebrand also recognizes the company’s new TCR research capabilities, including programs that could enable immune recognition of a broad range of tumor cell types in an HLA-independent fashion, and thus offer broadly applicable T-cell therapies. By building discovery efforts on both sides of the T-cell/cancer-cell interface (the "immune synapse"), Enara Bio is building a pipeline of cancer immunotherapies for broad patient populations.

The company was founded as Ervaxx Ltd. in late 2016 with an initial focus on the development of therapeutic cancer vaccines utilizing novel antigens derived from endogenous retroviral (ERV) DNA sequences. Since then, and based on breakthrough science coming from both internally-generated and in-licensed insights, Enara Bio has broadened its horizons to include TCR-based immunotherapies targeting an extended cancer-associated antigenic repertoire derived from the entire genomic dark matter, termed Dark Antigens.

To accelerate this evolution, Enara Bio in-licensed patents covering T cells and TCRs reactive to cancer-specific antigens and ligands from Cardiff University in January 2020. These exciting new technologies, while early research-stage, present compelling opportunities to develop immunotherapies with the potential to address a broad range of tumor types independent of the patient’s genetic background.

Kevin Pojasek, President and CEO of Enara Bio commented:

"Our new name – Enara Bio – reflects the progression of our strategy and capabilities to align more broadly with our purpose of delivering impactful immunotherapies to all cancer patients. Our ground-breaking work in identifying and characterizing Dark Antigens is now joined by other exciting new programs focused on pan-cancer, pan-HLA targets, which greatly expand our opportunities for the development of novel immunotherapies with broad utility across patients with diverse cancers. While we continue to press ahead with these exciting programs internally, we are increasingly seeking partnerships to advance the full diversity of our science and product opportunities."

***

About Enara Bio

Enara Bio (formerly Ervaxx) is a science-led company targeting the T-cell/cancer-cell interface (the "immune synapse") to develop new targeted cancer immunotherapies designed to treat a broad patient population.

Enara Bio is exploring the hidden depths of cancer and T-cell biology to discover and characterize novel immunotherapy targets, such as Dark Antigens and MR1-presented ligands. We are pioneering approaches to exploit these targets with TCR-directed T-cell immunotherapy and therapeutic vaccines.

To achieve our mission, we are leveraging our differentiated Dark Antigen and TCR discovery platforms that integrate bioinformatics, immunopeptidomics, metabolomics and immunology in our Oxford, UK-based research lab.

Enara Bio is backed by leading life science investors, including SV Health Investors. We have partnerships with world-class academic institutions, including the Francis Crick Institute, Cardiff University, Johns Hopkins School of Medicine and the University of Oxford, to help drive the leading edge of these new areas of science.

On June 3, 2020 Maverick Therapeutics, Inc., a private biopharmaceutical company pioneering conditionally active bispecific T cell targeted immunotherapies, announced pipeline updates for its robust set of Conditional Bispecific Redirected Activation (COBRA) programs at the Jefferies Virtual Healthcare Conference taking place June 2-4, 2020 (Press release, Maverick Therapeutics, JUN 3, 2020, View Source [SID1234570575]).

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By nature of its elegant and innovative design, the COBRA platform is the most mature bispecific T cell engaging platform in its class that can safely target solid tumors with highly specific and potent activity. COBRA molecules are prodrugs selected to bind to specific targets, which may be expressed in both tumor and healthy tissue. However, COBRAs are engineered to take advantage of the tumor’s unique microenvironment for T cell activation; triggering T cell mediated killing only at the site of the tumor while sparing damage to patients’ healthy tissues.

"As we continue to advance our pipeline, we look forward to initiating the clinical development of our lead first-in-class COBRA programs, MVC-101 and MVC-280, both of which have generated promising pre-clinical data designed to validate the COBRA mechanism of action and be predictive of translation to patients. Our pipeline reflects our single focus on developing potent and conditionally active T cell engaging therapies for solid tumor cancers. Beyond our two lead programs, we have also generated compelling in vivo data for two additional COBRA molecules," said Jim Scibetta, Chief Executive Officer, Maverick Therapeutics. "The first patient who is safely and effectively treated for a solid tumor cancer with any form of T cell therapy, whether CAR T cell therapy or redirected T cell engagers like our COBRAs, will serve as a major breakthrough in the field of cancer immunotherapy. For us at Maverick, this is an incredibly important and humbling mission."

"Although evidence of anti-tumor activity has been observed in patients with solid cancers, the full potential of T cell engaging therapies against solid tumor cancers continues to be hindered by unacceptable toxicity," said Jim Vasselli, M.D., Senior Vice President, Clinical Development, Maverick Therapeutics. "Underpinning the pre-clinical development of COBRA technology is Maverick’s commitment to using gold standard in vivo and in vitro models to maximize our understanding of the molecules. We are encouraged by the early results generated by these first two programs and are excited to continue development towards the clinic."

MVC-101 Is a Highly Potent COBRA Targeting Tumors that Express EGFR

Maverick Therapeutics’ lead program candidate, MVC-101, is a proprietary COBRA molecule designed to target Epidermal Growth Factor Receptor (EGFR), a protein expressed on both malignant and healthy tissues. MVC-101 regressed established human tumors in several preclinical models. Exposures of MVC-101 at efficacious relative to tolerated doses in safety studies demonstrates an increased therapeutic index compared to standard T cell engagers. MVC-101 is designed to be a universal solution for patients with EGFR expressing solid tumor cancers. EGFR is expressed on a wide range of solid tumor cancers, including but not limited to colorectal, head & neck, renal, pancreatic, cervical and non small cell lung cancers. Maverick expects to initiate a Phase 1 trial in Q1 2021.

MVC-280 Is a Highly Potent COBRA Targeting Tumors that Express B7H3

Maverick Therapeutics’ second program candidate, MVC-280, is a proprietary COBRA molecule designed to target B7H3 (CD276). B7H3 is expressed in a broad range of malignant and healthy tissues, similar to EGFR. MVC-280 regressed established tumors in several preclinical models. It is cross-reactive to its target protein expressed on mouse tissues, creating an opportunity to measure both efficacy and relative safety in the same preclinical model and use that data to calculate a therapeutic index. MVC-280 is designed to be a universal solution for patients with B7H3 expressing solid tumor cancers. B7H3 is expressed on a wide range of solid tumor cancers, including but not limited to prostate, renal, triple negative breast, head & neck, ovarian and urothelial cancers. Maverick expects to initiate a Phase 1 trial in H2 2021.

About the COBRA Therapeutics Platform

Maverick Therapeutics’ COBRA platform is the most mature conditionally active bispecific T cell engaging platform designed to safely target a broad range of solid tumors with highly specific and potent activity while limiting on-target toxicities in normal tissues. By nature of its highly innovative design, the COBRA platform reflects a novel approach to T cell engaging immunotherapies where T cell activation and resulting cell killing only take place where it is needed – in tumors. This unique design delivers the long sought after trifecta in cancer care; high specificity, high potency and reduced toxicity.

On June 3, 2020 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will participate in the virtual Goldman Sachs 41st Annual Global Healthcare Conference on Wednesday, June 10, 2020 (Press release, AbbVie, JUN 3, 2020, View Source [SID1234560781]). Richard A. Gonzalez, chairman and chief executive officer, AbbVie, will present at 9:30 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On June 3, 2020 Allakos Inc. (Nasdaq: ALLK), a biotechnology company developing antolimab (AK002) for the treatment of eosinophil and mast cell related diseases, reported that it is recruiting patients for two previously announced registrational clinical studies of AK002; a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE) (Press release, Allakos, JUN 3, 2020, View Source [SID1234560797]). Top-line safety and efficacy results from both studies are expected in the second half of 2021. The Phase 3 EG and/or EoD study and the Phase 2/3 EoE study follow positive results from ENIGMA, the Company’s multicenter, randomized, double-blind, placebo-controlled Phase 2 study in patients with EG and/or EoD.

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Phase 3 Eosinophilic Gastritis (EG) and/or Eosinophilic Duodenitis (EoD) Study Design
The multicenter, randomized, double-blind, placebo-controlled Phase 3 study will enroll approximately 160 patients with active, biopsy-confirmed EG (eosinophil count of ≥30 eosinophils in 5 high powered fields [hpfs] in the stomach) and/or EoD (eosinophil count of ≥30 eosinophils in 3 hpfs in duodenum). Patients will be randomized 1:1 to receive: (a) 1.0 mg/kg of antolimab for the first month followed by five doses of 3.0 mg/kg given monthly, or (b) monthly placebo. The co-primary endpoints of the study are: 1) the proportion of patients achieving ≤ 4 eosinophils in 5 hpfs in the stomach and/or ≤15 eosinophils in 3 hpfs in the duodenum and 2) absolute change in Total Symptom Score (TSS-6: abdominal pain, nausea, bloating, early satiety, abdominal cramping, loss of appetite) measured using the daily patient reported symptom questionnaire used in ENIGMA. The TSS-6 comprises the six most frequent and severe symptoms reported in ENIGMA.

Phase 2/3 Eosinophilic Esophagitis (EoE) Study Design
The multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study will enroll approximately 300 patients with active, biopsy-confirmed EoE (eosinophil count of ≥15 eosinophils in a single hpf). Patients will be randomized 1:1:1 to receive: (a) six antolimab doses of 1.0 mg/kg given monthly, (b) 1.0 mg/kg of antolimab for the first month followed by five doses of 3.0 mg/kg given monthly, or (c) monthly placebo. The co-primary endpoints of the study are: (1) the proportion of patients achieving ≤6 eosinophils in a single hpf and (2) absolute change in dysphagia symptoms measured using a daily patient reported symptom questionnaire known as the Dysphagia Symptom Questionnaire (DSQ).

About Eosinophilic Gastritis, Eosinophilic Duodenitis, and Eosinophilic Esophagitis
Eosinophilic gastritis, eosinophilic duodenitis (previously referred to as eosinophilic gastroenteritis), and eosinophilic esophagitis are severe inflammatory orphan diseases characterized by the presence of high levels of eosinophils in the stomach, duodenum, or esophagus, respectively. Common symptoms of the diseases include severe abdominal pain, nausea, diarrhea, bloating, cramping, early satiety, loss of appetite, vomiting, dysphagia, and weight loss. The current estimated prevalence of eosinophilic gastritis and eosinophilic duodenitis in the United States is approximately 50,000 people. The estimated prevalence of eosinophilic esophagitis in the United States is approximately 150,000 people. The Company believes that these diseases may be significantly under-diagnosed, or misdiagnosed, as other gastrointestinal diseases. There are no treatments approved specifically for these diseases. Treatment with systemic steroids can provide symptomatic improvement, but long-term treatment with steroids is generally not possible due to the numerous side effects. Allakos has received orphan drug designation for antolimab in eosinophilic gastritis, eosinophilic gastroenteritis, and eosinophilic esophagitis.