On November 9, 2021 Kezar Life Sciences, Inc., (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported financial results for the third quarter ended September 30, 2021 and provided a business update (Press release, Kezar Life Sciences, NOV 9, 2021, View Source [SID1234594952]).

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"Excellent progress continues across our programs, as we reached target enrollment in both of our Phase 2 trials with KZR-616 and announced our first patient dosed with KZR-261. Achieving full enrollment in our MISSION and PRESIDIO studies is an important milestone for KZR-616 as a potentially differentiated treatment option for patients suffering from lupus nephritis, dermatomyositis and polymyositis. We look forward to sharing interim results from MISSION at our upcoming event this month, with topline results from both studies expected in the second quarter of 2022," said John Fowler, Kezar’s Co-founder and Chief Executive Officer.

Clinical Highlights & Updates

KZR-616: Selective Immunoproteasome Inhibitor

MISSION – Phase 2 clinical trial in patients with lupus nephritis (LN) (NCT03393013)

Kezar’s upcoming Investor and Analyst Day, scheduled for Monday, November 15, 2021, at 4:30 p.m. ET/1:30 p.m. PT, will include a presentation featuring interim MISSION data, as well as a presentation from Samir V. Parikh, MD, Associate Professor of Medicine, Nephrology, The Ohio State University Wexner Medical Center.
The MISSION Phase 2 open-label trial in patients with active, proliferative LN has reached target enrollment of 20 subjects. The primary efficacy endpoint for the trial is the number of patients with a 50% reduction in urine protein/creatine ratio (UPCR) after 24 weeks of treatment when compared to baseline.
Kezar expects to report topline data in the second quarter of 2022.
PRESIDIO – Phase 2 clinical trial in patients with active dermatomyositis (DM) or polymyositis (PM) (NCT04033926)

The PRESIDIO Phase 2, placebo controlled, cross-over trial of KZR-616 in DM and PM has completed target enrollment of 24 subjects. The primary efficacy endpoint for the trial is the mean change from start to end of KZR-616 treatment in the Total Improvement Score (TIS), which ranges from 0 to 100.
Kezar expects to report topline data in the second quarter of 2022.
The PRESIDIO open-label extension study is available for patients completing the PRESIDIO trial, which evaluates KZR-616 for up to a maximum of 96 weeks (NCT04628936).
KZR-261: Protein Secretion Inhibitor

KZR-261-101 – Phase 1 clinical trial in patients with locally advanced or metastatic solid malignancies (NCT05047536)

In August, Kezar announced an IND submission for KZR-261 for the treatment of advanced solid malignant tumors, and in October, the first patient was dosed in its Phase 1 clinical trial.
KZR-261 is a novel, broad-spectrum, anti-tumor agent that acts through direct interaction and inhibition of the Sec61 translocon.
The Phase 1 clinical trial of KZR-261 will be conducted in two parts: dose escalation in subjects with locally advanced or metastatic solid malignancies for whom no therapeutics are available and dose expansion in subjects with selected tumor types. The trial will assess safety and tolerability, including determination of a recommended Phase 2 dose, evaluate pharmacokinetics and pharmacodynamics, and explore the preliminary anti-tumor activity.
Officer Appointment

In October, Gitanjali Jain was appointed as Kezar’s Vice President, Investor Relations and External Affairs, joining with nearly 15 years of healthcare industry and investor relations experience. As a member of the management team and executive committee, Ms. Jain will lead Kezar’s overall investor relations and public relations corporate efforts.

Credit Facility

On November 4, 2021, Kezar entered into a credit facility with Oxford Finance. Under the terms of the loan agreement, Oxford Finance will provide Kezar with borrowing capacity of up to $50 million across five potential tranches. The initial $10 million funded at closing, and an additional $10 million will be available at Kezar’s option in the second half of 2022. Additional tranches would become available upon achieving milestones related to the MISSION Phase 2 clinical trial, PRESIDIO Phase 2 clinical trial and/or KZR-261 Phase 1 clinical trial. There are no warrants or financial covenants associated with the credit facility. Capital Advisors Group, Inc acted as financial advisor to Kezar.

Third Quarter 2021 Financial Results

Cash, cash equivalents and marketable securities totaled $120.8 million as of September 30, 2021, compared to $140.4 million as of December 31, 2020. The decrease in cash, cash equivalents and marketable securities was primarily attributable to cash used by the company in operations to advance its clinical-stage programs, offset by $11.7 million of net proceeds from the issuance of common stock through September 30, 2021, under the company’s "at-the-market" sales program. In October, Kezar received an additional $4.4 million of net proceeds from the issuance of additional common stock under the ATM program.
Research and development expenses for the third quarter of 2021 increased by $2.2 million to $10.5 million compared to $8.3 million in the third quarter of 2020. This increase was primarily related to advancing the KZR-616 clinical program in multiple indications and the KZR-261 clinical program.
General and administrative expenses for the third quarter of 2021 increased by $0.7 million to $4.0 million compared to $3.3 million in the third quarter of 2020. The increase was primarily due to an increase in stock-based compensation and personnel and recruiting expenses as a result of an increase in headcount and salaries.
Net loss for the third quarter of 2021 was $14.5 million, or $0.28 per basic and diluted common share, compared to a net loss of $11.3 million, or $0.23 per basic and diluted common share, for the third quarter of 2020.
Total shares of common stock outstanding were 48.6 million shares as of September 30, 2021. Additionally, there were outstanding pre-funded warrants to purchase 3.8 million shares of common stock at an exercise price of $0.001 per share and outstanding options to purchase 6.9 million shares of common stock at a weighted-average exercise price of $5.85 per share, each as of September 30, 2021.
About KZR-616

KZR-616 is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from Phase 1a and 1b clinical trials provide evidence that KZR-616 exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases. Phase 2 trials are underway in multiple severe autoimmune diseases.

About KZR-261

KZR-261, a novel, first-in-class protein secretion inhibitor, is the first clinical candidate to be nominated from Kezar’s research and discovery efforts targeting the protein secretion pathway. KZR-261 is a broad-spectrum anti-tumor agent that acts through direct interaction and inhibition of Sec61 activity. The compound was discovered by Kezar through a robust medicinal chemistry campaign in which several scaffolds were progressed through the company’s proprietary platform evaluating Sec61 modulation. KZR-261 has demonstrated several encouraging properties that lead to its potential to be an anti-cancer agent, and a Phase 1 trial is underway for the treatment of solid tumor malignancies.

About Lupus Nephritis

Lupus nephritis (LN) is one of the most serious complications of systemic lupus erythematosus (SLE). LN is a disease comprising a spectrum of vascular, glomerular and tubulointerstitial lesions and develops in approximately 50% of SLE patients within 10 years of their initial diagnosis. LN is associated with considerable morbidity, including an increased risk of end-stage renal disease requiring dialysis or renal transplantation and an increased risk of death. There are limited approved therapies for the treatment of LN. Management typically consists of induction therapy to achieve remission and long-term maintenance therapy to prevent relapse.

About Dermatomyositis and Polymyositis

Dermatomyositis (DM) and Polymyositis (PM) are two of the five types of autoimmune myositis diseases. Both are chronic, debilitating, inflammatory autoimmune myopathies that are distinguished by inflammation of the muscles as well as the skin (in DM). Approximately 30,000 to 120,000 people in the United States are living with these severe and progressive inflammatory myopathies that are characterized by marked morbidity and associated mortality. While debilitating muscle weakness is the hallmark of these myopathies, including compromised muscles of respiration, other internal organ system dysfunctions can be equally disabling. The aim of treatment for these diseases is to suppress inflammation, increase muscle strength and prevent long-term damage to muscles and extramuscular organs; however, treatment options are limited for DM, and there are currently no approved treatments for PM.

About Inhibition of Protein Secretion

In mammalian cells, the secretion of proteins such as cytokines and growth factors and the expression of cell surface transmembrane proteins such as receptor tyrosine kinases and immune checkpoint molecules involve a process called cotranslational translocation. For most proteins, this process occurs via the Sec61 translocon, a highly conserved multi-subunit protein complex found in the membrane of the endoplasmic reticulum of all cells. Kezar scientists have been researching the protein secretion pathway and ways to drug this important cellular pathway for more than five years and developed novel and robust assays to discover and develop small molecule inhibitors of Sec61. As a result, Kezar has established a broad library of protein secretion inhibitors for potential development across a wide range of diseases.

On November 9, 2021 NanoString Technologies, Inc. (NASDAQ: NSTG), a leading provider of life science tools for discovery and translational research, reported the first public release of data generated by the CosMx Spatial Molecular Imager (SMI) (Press release, NanoString Technologies, NOV 9, 2021, View Source [SID1234594951]). The data represents the first high-plex, single cell in situ dataset from formalin-fixed paraffin-embedded (FFPE) tissue samples and is accompanied by the simultaneous publication of a manuscript describing the CosMx SMI technology and performance.

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CosMx SMI enables high-resolution imaging of hundreds or thousands of RNAs and proteins within morphologically intact whole tissue sections. The technology combines the power of high-plex profiling with high-resolution imaging, allowing researchers to visualize and quantify gene expression and protein at single cell and subcellular resolutions with both fresh frozen and FFPE tissue samples.

"The ability to characterize both gene expression levels and the topography of single cells within native tissue context will yield new insights into disease pathogenesis and determinants of treatment response," said Christina Curtis, Ph.D., MSc, Associate Professor of Medicine and Genetics, Stanford University School of Medicine. "Importantly, CosMx SMI’s compatibility with FFPE samples makes it a valuable platform for unlocking insights from clinical and bio-banked specimens."

NanoString used the CosMx SMI to characterize FFPE tissue from eight different non-small cell lung cancer (NSCLC) samples from five patients. The SMI data creates a spatial cell atlas of NSCLC tissue by defining a subcellular expression map of 960 genes and a single cell map of 18 identified cell types.

The CosMx SMI dataset is open-source spatial in situ imaging and molecular data that can be accessed through NanoString’s website (www.nanostring.com/cosmx-dataset) and analyzed by the research community. The complete dataset consists of over 800,000 single cells and ~260 million transcripts, and a spatially-resolved cell type map of NSCLC tissue across a ~150 mm2 area.

The data release is accompanied by the simultaneous publication of a manuscript available on BioRxiv entitled, "High-Plex Multiomic Analysis in FFPE Tissue at Single-Cellular and Subcellular Resolution by Spatial Molecular Imaging." The paper describes CosMx SMI’s chemistry, sensitivity, and reproducibility, with detailed discussion of the publicly released NSCLC dataset. In addition, the manuscript demonstrates the proteomic power of SMI using an 81-plex antibody panel to map protein expression within FFPE breast cancer samples.

"NanoString’s mission is to map the universe of biology," said Joseph Beechem, Ph.D., chief scientific officer, NanoString. "Together, the GeoMx DSP and the CosMx SMI platform span the continuum of spatial biology applications and will serve the needs of both discovery and translational researchers. The GeoMx DSP is the leading platform for measuring whole transcriptome in multi-cellular regions, and the CosMx SMI extends capability to single cell and subcellular resolution for targeted panels of up to one thousand targets."

The CosMx SMI is expected to launch in the second half of 2022. In the meantime, researchers can apply the power of SMI to their tissue samples through the SMI Technology Access Program service provided by NanoString. For more information, email [email protected].

To learn more about NanoString’s CosMx Spatial Molecular Imager, visit www.nanostring.com/CosMx

On November 9, 2021 Cellaria Inc (Wakefield, MA, USA), a scientific innovator with breakthrough tools for cancer research, reported the availability of a series of new products, including a panel of cell culture media optimized to grow clinically relevant cell types, an extra-cellular fully defined neutral collagen matrix (ECM), and validated protocols for a scalable and reproducible testing of small patient cohorts for screening of novel drug compounds (Press release, Cellaria, NOV 9, 2021, View Source [SID1234594950]). Cellaria continuously strives to deliver new platforms and methods for precision medicine and personalized drug screening for cancer and other complex diseases. All cell culture media products incorporate Cellaria’s own recombinant proteins in the formulation, where quality controls are combined with economic feasibility and competitiveness for each product.

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One pillar of Cellaria’s new platform is its Renaissance Essential Media, expanded for applications with lymphocytes (T-cells), mesenchymal stromal cells (MSCs), normal cells and cancer-associated fibroblasts (CAFs). The Renaissance line of media has been optimized to simplify the addition of these important cell types into more complex three-dimensional models (organoids) of the tumor microenvironment, which has emerged as critically important for the evaluation of targeted therapeutics, immune-oncology approaches, such as checkpoint inhibitor targets (e.g. PD-1), CAR-T, and multi-drug treatment methods. It also enables complex modeling of inflammatory diseases such as juvenile diabetes (T1D), neurodegenerative and brain diseases, and other difficult to model diseases.

The second pillar of Cellaria’s platform includes patient-matched cell types which can be easily combined in complex organoid models of tumor metastatic nodes and solid tumors. This means drug developers can utilize Cellaria’s 3D Organoid Model system using tumor cells, cancer associated fibroblasts and T cells all from the same patient, greatly increasing the validity of their findings and target identification. Cellaria applies this same approach for enhancing patient-matched models of diabetes, and brain inflammation.

The third pillar, supporting both pillars 1 and 2, is the introduction of Jellagen Extracellular Matrix, a fully defined neutral 3D cell culture scaffold. Cellaria has partnered with UK based Jellagen Ltd, a supplier of next generation Collagen Type 0, a biomaterial offering a paradigm shift in collagen chemistry. This naturally derived scaffold supports enhanced signaling that occurs between cells without artificial effects.

"An often overlooked hurdle for combining different cell types is the formulation of the cell culture medium to support robust function of multiple cell types," says David Deems, Cellaria’s President and Founder. "Our Renaissance Media Platform simplifies the process so anyone can design complex disease models in a high-throughput format, while reducing variability of response and increasing biological fidelity of the model," adds Dr. Dmitry Shvartsman, Cellaria’s Chief Technology Officer. "Cellaria’s approach increases patients’ involvement and the impact of their samples for truly meaningful research."

Cellaria’s Renaissance cell culture medias, and patient-specific cell models for Non-Small Cell Lung Cancer and Pancreatic Cancer have already demonstrated proven value in in vitro studies. Now, Cellaria’s 3D tools simplify the process for screening disease cohorts and understanding drug response on individual patients. Find out more about Cellaria’s 3D and Organoid tools and methods at:
www.cellariainc.com or email at [email protected].

On November 9, 2021 Strand Therapeutics, a privately held biotech company developing next-generation, programmable mRNA therapeutics beyond vaccines, reported that the company was awarded a Phase I Small Business Innovation Research (SBIR) contract from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) to develop an off-the-shelf chimeric antigen receptor T cell (CAR-T) immunotherapy based on the company’s mRNA technology for the treatment of B-cell non-Hodgkin’s lymphoma (NHL) (Press release, Strand Therapeutics, NOV 9, 2021, View Source [SID1234594949]). The total funding amount awarded to Strand is approximately $400,000.

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As one of the most common cancers in the U.S., NHL accounts for approximately 4% of all cancers. According to the American Cancer Society, it is estimated that in 2021 over 80,000 people will be diagnosed with NHL. While CAR-T therapies have shown clinical benefit in patients, many individuals still suffer treatment-induced toxicities including cytokine release syndrome, neurologic complications and adverse effects from lymphodepletion. Furthermore, development of CAR therapies is costly, with manufacturing processes being difficult and time-consuming.

To address these challenges, Strand will use the funds from the contract to develop an in situ, off-the-shelf cell therapy based on the company’s proprietary self-replication, programmable mRNA platform to illicit a targeted CD19 CAR-T response. This novel approach has the capability of providing long-term, temporal and cell-type specific expression, potentially minimizing off-target effects and enabling redosing without lymphodepletion.

"Strand’s in situ CAR delivery approach and its capacity to provide long-term, programmable expression is the first such method that could offer life-saving therapeutics to all patients at a fraction of the cost of currently-available treatments," said Jake Becraft, PhD, co-founder and CEO of Strand. "This opportunity enables us to position ourselves in the field of mRNA-based CAR therapies and sets the stage to further develop our technology in areas of unmet medical need."

The company was recently awarded two Phase I NIH SBIR grants to advance its programmable, long-lasting mRNA therapeutics for melanoma and breast cancer, directed at enhancing the efficacy of anti-PD-1 immunotherapies.

On November 9, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported, together with its partner BeiGene, the launch of HERIZON‑GEA‑01 (Press release, Zymeworks, NOV 9, 2021, View Source [SID1234594948]). This is a randomized, global Phase 3 study evaluating Zymeworks’ investigational HER2‑targeted bispecific antibody, zanidatamab, plus chemotherapy, with or without BeiGene’s anti-PD‑1‑targeted antibody tislelizumab, versus standard of care (trastuzumab plus chemotherapy), for the first-line treatment of metastatic HER2‑postive GEA.

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"We are incredibly excited to launch our second pivotal, and first Phase 3 clinical trial for zanidatamab, HERIZON‑GEA‑01," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "Gastrointestinal cancers have significant unmet patient need and we have the opportunity to help a large and growing patient population. With two potential Biologics License Applications over the next 3 years, we believe zanidatamab has the potential to achieve blockbuster status and position Zymeworks as the leader in the treatment of HER2‑positive GI cancers."

The primary objective of the HERIZON‑GEA‑01 study is to evaluate the efficacy and safety of zanidatamab in combination with physician’s choice chemotherapy [CAPOX (capecitabine/oxaliplatin) or FP (5FU/cisplatin)] with or without tislelizumab compared to trastuzumab plus physician’s choice chemotherapy in subjects with advanced or metastatic HER2-positive GEA. Primary endpoints are progression-free survival by RECIST 1.1, assessed by blinded independent central review, and overall survival.

The HERIZON-GEA-01 study seeks to enroll approximately 700 patients at approximately 300 sites across 38 countries. BeiGene will oversee trial sites in Asia (excluding Japan), Australia and New Zealand, and Zymeworks will oversee trial sites in the rest of the world, including North and South America, Japan, Europe, Middle East, and Africa.

"We are pleased the HERIZON‑GEA‑01 study has begun enrollment and our aim is to establish zanidatamab as the foundational agent of a new standard of care with tislelizumab for the first‑line treatment of HER2‑positive GEA," said Neil Josephson, M.D., Zymeworks’ Interim Chief Medical Officer. "Based on the study design, we expect to have progression-free survival data as soon as 2024, which could enable submission of a supplemental Biologics License Application that same year."

GEA is the fifth most common cancer worldwide and approximately 20 percent of patients diagnosed with this form of cancer are HER2‑positive. HER2‑positive GEA has high morbidity and mortality and patients are urgently in need of new treatment options.

"The encouraging zanidatamab Phase 2 data support its further investigation with tislelizumab in this Phase 3 HERIZON-GEA-01 trial in first-line HER2-positive gastroesophageal adenocarcinomas," said Yong (Ben) Ben, M.D., Chief Medical Officer, Solid Tumors, at BeiGene. "We are excited to continue our collaboration with Zymeworks as we strive to address the unmet medical needs in this patient population by accelerating the development of zanidatamab."

Phase 2 Study Results

In September, Zymeworks presented data at the European Society for Medical Oncology Annual Meeting from a Phase 2 clinical study of 36 patients with HER2‑expressing GEA who received zanidatamab in combination with either CAPOX (n=14), FP (n=2), or mFOLFOX6 (5FU/leucovorin/oxaliplatin; n=20). None of the patients had received prior HER2‑targeted therapies.

In 28 response-evaluable patients with metastatic HER2‑positive GEA, zanidatamab plus chemotherapy resulted in a confirmed objective response rate (cORR) of 75% and disease control rate (DCR) of 89% overall, with a cORR of 93% and DCR of 100% in the proposed Phase 3 regimen of zanidatamab and CAPOX/FP. All patients except one experienced a decrease in their tumor size. Across all treatment regimens, the median duration of response is 16.4 months and the median progression-free survival is 12.0 months, with 61% of patients still on study at the time of data cutoff.

In addition, the data demonstrate that zanidatamab plus chemotherapy is generally well tolerated, with the majority of treatment-related adverse events (TRAEs) considered mild to moderate in severity (Grade 1 or 2). The most common grade ≥ 3 TRAE was diarrhea, which was manageable in the outpatient setting; introduction of prophylactic loperamide reduced the incidence in cycle 1 from 44% to 18%. No severe (grade ≥ 3) infusion-related reactions or cardiac events were observed.

Conference Call and Webcast

The company will host a conference call and webcast to discuss the HERIZON‑GEA‑01 Phase 3 trial design as well as the commercial strategy in HER2‑positive gastrointestinal cancers. The event will be led by Ali Tehrani, Ph.D., Zymeworks’ President and CEO, Neil Josephson, M.D., Zymeworks’ Interim Chief Medical Officer, and James Priour, MBA, Zymeworks’ Chief Commercial Officer. The speakers will be available to answer questions at the conclusion of the call.

Date: Tuesday, November 9th
Time: 4:15 pm ET (1:15 pm PT)

Interested parties can access the live webcast via the Zymeworks’ website at View Source A recorded replay will be accessible after the event through the Zymeworks website.

About Zanidatamab

Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. Zanidatamab’s unique binding properties result in multiple mechanisms of action including HER2-receptor clustering, internalization, and downregulation; inhibition of growth factor-dependent and -independent tumor cell proliferation; antibody-dependent cellular cytotoxicity and phagocytosis; and complement-dependent cytotoxicity. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. The FDA has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancer (BTC), and two Fast Track designations to zanidatamab, one as monotherapy for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab has also received Orphan Drug designations from the FDA as well as the European Medicines Agency for the treatment of biliary tract and gastric cancers.

About the Zymeworks-BeiGene Collaboration

In November 2018, Zymeworks and BeiGene entered into license and collaboration agreements in which BeiGene was granted an exclusive license for the research, development, and commercialization of zanidatamab and ZW49 in Asia (excluding Japan), Australia, and New Zealand. The companies are collaborating on joint global development for selected indications, with the goal of developing zanidatamab and ZW49 worldwide across multiple HER2‑expressing cancers and lines of therapy.