On May 13, 2021 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported financial results for the first quarter ended March 31, 2021, and provided an overview of recent developments (Press release, Atreca, MAY 13, 2021, View Source [SID1234579974]).

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"The first few months of 2021 have been a productive period at Atreca, and we look forward to reporting initial summary data from our Phase 1b trial of ATRC-101 in July of this year," said John Orwin, Chief Executive Officer. "We are making good progress enrolling the monotherapy cohorts, and are moving quickly to commence the combination cohorts evaluating ATRC-101 with both checkpoint inhibitors targeting the PD-1/PD-L1 axis and with chemotherapy. We also continue to advance our pre-clinical pipeline and are excited to announce our next program, targeting EphA2."

Recent Developments and Highlights

ATRC-101 Clinical Update

To date, 20 patients have been enrolled and treated in the first-in-human trial evaluating ATRC-101 in multiple solid tumor cancers. Atreca has completed enrollment in the fourth cohort (10 mg/kg) of the dose escalation portion of the trial, and all patients treated at that dose have now completed the 21 day dose-limiting toxicity (DLT) assessment period. No DLTs have been observed in the trial. Atreca and its investigators decided, out of an abundance of caution, to enroll three additional patients in the fourth dose cohort (10 mg/kg), after the first two patients enrolled experienced rapid deterioration associated with disease progression, assessed as unrelated to ATRC-101, relatively soon after completion of the DLT assesment period. Atreca anticipates commencing enrollment in the fifth and final cohort (30 mg/kg) shortly, pending review by the Dose Review Committee, and expects to announce initial summary data from the study in July 2021.

Enrollment includes additional patients treated at 3 mg/kg through backfill of the third dose escalation cohort and the initiation of a monotherapy dose expansion cohort, as previously disclosed. Atreca expects to enroll additional cohorts evaluating ATRC-101 in combination with a PD-1 inhibitor and in combination with a chemotherapeutic agent in 2Q 2021 and 2H 2021, respectively.

Pipeline Update

Atreca has designated a second program, with APN-122597, an antibody derived from the active immune response of a cancer patient, as the program lead. APN-122597 binds to a membrane proximal extracellular epitope of EphA2, a receptor tyrosine kinase (RTK) validated as a known tumor target that is overexpressed in multiple cancers, but with no approved therapies targeting it. A human normal tissue cross-reactivity study showed no reactivity of toxicological significance, and APN-122597 is active in vitro in multiple formats. Atreca expects to provide additional information on APN-122597 and other pipeline assets, including timelines for development, at an R&D Day in 4Q 2021.

"APN-122597 is another example of the power of our discovery approach," said Dr. Tito Serafini, Atreca founder and Chief Strategy Officer. "While EphA2 is validated as a known and potentially high value target, there are only a limited number of development-stage programs currently targeting EphA2, and no therapies on the market. We believe our antibody is differentiated by its apparent lack of both EphA2 activation and interference with ligand-induced activation, its unique patterns of reactivity with tumor tissue and cells, and its structural features. Furthermore, lead optimization has already yielded improved molecules with an anticipated low level of sequence-based CMC risk."

IP Update

In April 2021, the United States Patent and Trademark Office issued a Notice of Allowance for U.S. patent application serial no. 13/261,763 (exclusively licensed to Atreca), covering fundamental aspects of Atreca’s Immune Repertoire Capture technology (IRC), which forms a core part of the company’s discovery platform. This patent, once issued, further bolsters our global patent coverage for compositions of matter that are a key output of Atreca’s IRC technology.

First Quarter 2021 Financial Results

As of March 31, 2021, cash and cash equivalents and short-term investments totaled $211.7 million.

Research and development expenses for the three months ended March 31, 2021 were $18.4 million, including non-cash share-based compensation expense of $2.2 million.

General and administrative expenses for the three months ended March 31, 2021 were $7.8 million, including non-cash share-based compensation expense of $2.2 million.

Atreca reported a net loss of $25.8 million, or basic and diluted net loss per share attributable to common stockholders of $0.70, for the three months ended March 31, 2021.

On May 13, 2021 ZAP Surgical Systems, Inc. reported the imminent installation of its advanced ZAP-X Gyroscopic Radiosurgery platform at the Swiss Neuro Radiosurgery Center (SNRC), an organization within the Swiss Clinical Neuroscience Institute (SCNSI) in Zurich, Switzerland (Press release, ZAP Surgical Systems, MAY 13, 2021, View Source [SID1234579963])

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Stereotactic radiosurgery (SRS) is a well-studied and effective treatment for many brain cancers including primary and metastatic brain tumors, as well as select intracranial functional and vascular disorders. Considered an alternative to surgery for these indications, SRS is a non-invasive outpatient procedure that often provides equivalent to superior outcomes, yet no surgical incision, and little to no recovery period.

The ZAP-X system is recognized for using gyroscopic motion to direct radiosurgical beams from a multitude of unique angles which precisely concentrate radiation to the tumor target, resulting in significantly less healthy brain tissue exposure than those of multi-purpose radiation delivery systems. This unique approach supports the clinical objective of protecting healthy brain tissue and neuro-cognitive function.

ZAP-X is also the first and only dedicated radiosurgery system to no longer require Cobalt-60 radioactive sources, thus eliminating the significant costs to license, secure and regularly replace live radioactive isotopes.

"The local core-team consisting of neurosurgeon Christoph Weber, MD, radiation oncologist Cristina Picardi, MD, and myself are looking forward to putting Switzerland’s first ZAP-X into operation," said Andreas Mack, PHD, founder and chief executive officer of SNRC.

"With an interdisciplinary focus on neuro-radiosurgical treatments, the project is a cooperative effort including the Klinik Hirslanden Institute for Radiotherapy, the Center for Endoscopic and Minimally Invasive Neurosurgery, namely Robert Reisch, MD, and Nikolai Hopf, MD, and the Center for Micro Neurosurgery, namely Ralf Kockro, MD," added Mack. "Additionally, SNRC is scientifically advised by the clinical team at the University Hospital of Basel, Department of Neurosurgery, namely Luigi Mariani, MD, Raphael Guzman, MD, and Ethan Taub, MD."

"ZAP Surgical is excited to partner with SNRC to bring world-class radiosurgery to Zurich and the surrounding communities," said Hakan Baraner, ZAP Surgical’s Senior Vice President for Europe, Middle East, and Africa. "We believe SNRC’s ZAP-X program will serve as an example to many other medical centers, both locally and globally."

SNRC estimates first patient treatments with ZAP-X will commence in the summer of 2021.

On May 13, 2021 Seattle Cancer Care Alliance (SCCA), the only National Comprehensive Cancer Network designated cancer center in Washington State, reported that it is an authorized treatment center for the new B-cell maturation antigen (BCMA) targeted chimeric antigen receptor (CAR) T-cell therapy, idecabtagene vicleucel, also known as ide-ce (Press release, Seattle Cancer Care Alliance, MAY 13, 2021, View Source [SID1234579962]).

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Ide-cel was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2021, and is indicated for the treatment of adult patients with relapsed refractory multiple myeloma after four or more prior lines of therapy including a proteasome inhibitor, an immunomodulatory therapy and an anti-CD38 antibody. It is the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma and is being marketed under the brand name Abecma.

"We are pleased to offer this new advanced therapy to patients who are suffering from relapsed or refractory multiple myeloma," said Nancy Davidson, MD, president and executive director of Seattle Cancer Care Alliance. "We are committed to delivering personalized care to our patients and improving patient outcomes and excited to be among the first cancer centers in the nation to offer this treatment to adult patients with multiple myeloma."

Multiple myeloma is a cancer of plasma cells in which abnormal plasma cells build up in bone marrow and limit the body’s ability to make enough healthy blood cells, thus resulting in low blood counts. Multiple myeloma is also associated with bone and kidney damage as well as a weakened immune system. There are over 140,000 people in the United States living with this cancer and according the American Cancer Society approximately 34,920 new cases will be diagnosed in 2021, and 12,410 deaths among those with multiple myeloma will occur.

Ide-cel is a one-time therapy that is created from a patient’s own white blood cells, which have been modified to recognize and attack myeloma cells. As an anti-BCMA CAR T-cell therapy, ide-cel recognizes and binds to BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of BCMA-expressing cells.

In the clinical study that supported its approval, ide-cel was shown to be safe and effective. Approximately 72% of patients partially or completely responded to the treatment with 28% of patients showing complete response. An estimated 65% of this group remained in complete response to ide-cel for at least 12 months.

"The FDA approval of this novel therapy is a significant milestone in the advancement of new, innovative therapies for multiple myeloma," said David Maloney, MD, PhD, medical director for cellular immunotherapy at the Bezos Family Immunotherapy Clinic at Seattle Cancer Care Alliance. "We are excited about the continued expansion of CAR T-cell treatment options available to our patients, and the potential ide-cel offers to extend the lives of those who have multiple myeloma."

"Our clinical trials at the SCCA have provided us with extensive experience using BCMA CAR T-cells for multiple myeloma. The new FDA approval allows our to leverage this knowledge and safely bring a promising therapy to a wider population of adult patients with multiple myeloma," said Damian Green, MD, Seattle Cancer Care Alliance and Associate Professor, and who leads translational myeloma research programs at Seattle Cancer Care Alliance and the Fred Hutchinson Cancer Research Center.

SCCA is home to several of the world’s leading immunotherapy experts whose research has contributed to the foundation of many immunotherapies currently used to treat cancer. SCCA’s Bezos Family Immunotherapy Clinic, which opened in 2016, is a state-of-the-art center dedicated to offering the newest cellular immunotherapy clinical trials and FDA approved treatments.

On May 13, 2021 Osmol Therapeutics reported that it has initiated Investigational New Drug (IND) enabling studies to develop a therapy to prevent chemotherapy-induced peripheral neuropathy (CIPN) (Press release, Osmol Therapeutics, MAY 13, 2021, View Source [SID1234579961]). A phase 1 clinical study is projected to begin in 2022 . There are currently no Food and Drug Administration (FDA) approved therapies for the prevention or treatment of CIPN, a debilitating condition resulting from the off-target toxicity of many chemotherapy treatments.

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Osmol was founded by Dr. Barbara Ehrlich, Professor of Pharmacology and of Cellular and Molecular Physiology, Yale School of Medicine. Her research on neuronal calcium sensor-1 (NCS1), a critical calcium binding protein that regulates intracellular calcium levels, forms the basis of Osmol’s CIPN treatment, OSM-0205 and future potential NCS1 therapeutics. OSM-0205’s mechanism addresses the off-target toxicity of microtubule-based chemotherapy agents that results in a calcium surge leading to CIPN. OSM-0205 modulates NCS1 to prevent the calcium surge and maintain neuronal integrity.

The company’s initial focus is CIPN in breast cancer patients resulting from taxane-based chemotherapy treatment. Taxanes are the most widely used chemotherapy treatment for breast cancer and can lead to CIPN in up to 80% of patients. Independent market research conducted with breast cancer oncologists at leading US cancer centers confirmed that CIPN is the most significant toxicity issue facing clinicians and patients when treating breast cancer.

"Chemotherapy-induced peripheral neuropathy is a devastating adverse event that can leave patients and their treating physicians with a very difficult choice – reduce taxane therapy with the possibility of negatively impacting patient outcomes or continue therapy at the recommended dose with the potential of causing increased and possibly permanent, disabling CIPN," said Dr. Ehrlich. "OSM-0205 is being developed with the goal of preventing CIPN before it occurs. By blocking the calcium surge that causes neuropathy, optimal treatment with taxanes can continue. This is particularly important in the treatment of breast cancer where taxanes remain the foundation of most therapeutic regimens."

"There are currently no FDA-approved therapies to avoid or reduce CIPN, creating an urgent need for patients being treated with chemotherapy," said Robert Berman, M.D., Executive Chairman of Osmol Therapeutics and co-founder and former Chief Medical Officer at Biohaven Pharmaceuticals. "Over 225,000 patients in the U.S. and the European Union with early stage or metastatic breast cancer are treated with taxanes each year. We have recruited an experienced and capable executive team, led by Bob Linke, Osmol’s Chief Executive Officer, to advance OSM-0205 to address this need as well as explore the potential use of neuronal calcium sensor-1 (NCS1) in other indications. We are excited by the potential of OSM-0205 and expect to begin clinical development as early as next year."

Bob Linke, MBA, is an experienced biopharma entrepreneur, who is also Executive Chairman of Embera NeuroTherapeutics and IonSense. He has an established track record developing strategies, building and leading emerging companies through all phases of growth – from research, product development and clinical studies to successful commercialization, partnership and acquisitions. Bob brings an open management style to create cohesive, high-functioning teams. He has raised over $70 million in private equity and non-dilutive financing to fund these companies’ development and commercialization efforts. His early career was spent at Baxter, developing and commercializing pharmaceuticals and drug delivery systems.

About OSM-0205 and CIPN

Osmol’s lead drug, OSM-0205, is based on Dr. Barbara Ehrlich’s research in neuronal calcium sensor-1 (NCS1) at Yale University and is designed to prevent the off-target calcium surge caused by taxanes and potentially other chemotherapy treatments associated with peripheral nerve damage. Data from preclinical studies conducted by Osmol show that pre-treatment with OSM-0205 prevents neuronal damage from taxanes in mice by preventing the off-target intracellular calcium surge caused by these chemotherapy agents. It is hypothesized that OSM-0205 modulates NCS1 in patients to protect neurons from damage leading to a reduction of CIPN. CIPN affects hundreds of thousands of cancer patients every year and can compromise optimum chemotherapy dosing. There are no effective treatments for CIPN, a condition which can diminish quality of life and lead to lifelong disability.

On May 13, 2021 Genetron Holdings Limited ("Genetron Health" or the "Company", NASDAQ:GTH), a leading precision oncology platform company in China that specializes in offering molecular profiling tests, early cancer screening products and companion diagnostics development, reported a strategic partnership with Siemens Healthineers at the China Medical Equipment Fair (Press release, Genetron Health Technologies, MAY 13, 2021, View Source [SID1234579960]).

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This partnership aims to promote large scale application of Genetron’s S5 platform and lung cancer 8-gene IVD assay in Chinese hospitals, in order to provide non-small cell lung cancer (NSCLC) patients with efficient and accurate personalized diagnosis and treatment guidance. The companies also plan to work together to standardize cancer molecular testing in hospitals.

Representing Genetron Health at the signing ceremony in Shanghai were Co-founder and CEO Sizhen Wang, and Vice President Zhaohui Yin. Elisabeth Staudinger, President of Siemens Healthineers Asia Pacific, and Guo Yiming, Vice President of Siemens Healthineers Laboratory Diagnostic System, Greater China Region, also attended the event.

"Genetron Health focuses on the innovation, clinical transformation and commercialization of cancer genomics technologies. Both our lab developed test (LDT) and in vitro diagnostic (IVD) products’ business models have been progressing well," said Sizhen Wang, Co-founder and CEO of Genetron Health. "We are pleased to collaborate with Siemens Healthineers for our S5 instrument and lung 8 IVD assay, which helps diagnose and treat cancer patients. We also expect this partnership to help standardize cancer molecular testing in China, and reach more patients in need," Wang said.

"As a global leader in healthcare technology, Siemens Healthineers stays committed to addressing the needs of patients. To help Chinese cancer patients access quality care, we are not only introducing cutting-edge testing analyzers and reagents to China, but are also working with local innovators to offer personalized diagnostics. We are excited to forge a strategic partnership with Genetron Health, an industry leading precision oncology platform company. Meanwhile, we expect to push forward precision care in the field of lung cancer, therefore contributing to the vision of a Healthy China," said Guo Yiming, Vice President of Laboratory Diagnostics, Siemens Healthineers Greater China.

At present, lung cancer is one of the most serious diseases in China, placing the highest amongst morbidity and mortality rankings of all cancer types. In China, 787,000 cases of lung cancer are diagnosed every year, with about 631,000 deaths [1] caused annually as well. NSCLC is the most common type of lung cancer. In recent years, with the development of more advanced diagnostics and the emergence of targeted drugs, more NSCLC patients have been able to receive quicker and more accurate treatment. As the "first step" of targeted therapy for lung cancer, cancer molecular gene detection is the key to guided clinical treatment and drug applications. The U.S. National Comprehensive Cancer Network (NCCN) Guidelines for NSCLC also recommend that molecular testing of lung cancer-related genes be used to guide targeted therapies for NSCLC patients. Accurate lung cancer gene detection for NSCLC patients can help clinicians opt for more precise treatment.

Based on Genetron Health’s One-Step Seq technology (Chinese invention patent ZL 201710218529.4), the lung cancer 8-gene IVD assay can detect many mutations and fusions across 8 different genes at once, for targeted therapy selection in NSCLC. The assay can offer patients rapid and accurate molecular typing, medication guidance and drug resistance monitoring. Combined with Genetron S5, it offers advantages in detection efficiency, ease of use, economic cost, sample size, and can achieve a two-day turnaround time. It is suitable for independent clinical molecular testing in Chinese hospitals at all levels.

[1] Zheng R., Sun K., Zhang S., et al. Report of cancer epidemiology in China, 2015, Chinese Journal of Oncology, 2019, 41(1):19-28.