On March 15, 2022 MorphoSys U.S. Inc., a fully owned subsidiary of MorphoSys AG (FSE: MOR; NASDAQ: MOR), reported that the National Comprehensive Cancer Network(R) (NCCN) Clinical Practice Guidelines (NCCN Guidelines(R)) in Oncology for B-cell Lymphomas have been updated, and the designation for Monjuvi(R) (tafasitamab-cxix) in combination with lenalidomide is now a Preferred Regimen for second-line therapy in patients with Diffuse Large B-cell Lymphoma (DLBCL) who are not candidates for transplant (Press release, MorphoSys, MAR 15, 2022, View Source [SID1234610177]).

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"Updates to NCCN Guidelines are made periodically when additional efficacy and safety data are available, providing current information on the use of cancer therapies," said Joe Horvat, U.S. General Manager, MorphoSys. "Monjuvi is a targeted immunotherapy that addresses an immediate medical need for certain adult patients living with Diffuse Large B-cell Lymphoma. We are gratified the NCCN panel acknowledged the additional data submitted for Monjuvi and updated the designation of Monjuvi in combination with lenalidomide to a Preferred Regimen in its Clinical Practice Guidelines in Oncology."

In July 2020, the U.S. Food and Drug Administration (FDA) approved Monjuvi in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate (ORR) from the one-year primary analysis of the L-MIND study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In the U.S., Monjuvi is the only approved second-line targeted immunotherapy for this patient population.

The NCCN is a not-for-profit alliance of 30 leading cancer centers devoted to patient care, research, and education. The intent of the NCCN Guidelines is to assist in the decision-making process of individuals involved in cancer care – including physicians, nurses, pharmacists, payers, patients, and their families – with the ultimate goal of improving patient care and outcomes. The updated NCCN Guidelines are available at www.nccn.org.

NCCN(R) and the NCCN Guidelines(R) are registered trademarks of National Comprehensive Cancer Network.

About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide, characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs.1 It is an aggressive disease with about 40% of patients not responding to initial therapy or relapsing thereafter, leading to a high medical need for new, effective therapies, especially for patients who are not eligible for an autologous stem cell transplant in this setting.2

About Monjuvi (tafasitamab-cxix)
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeted immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi(R) (tafasitamab) received conditional marketing authorization in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Monjuvi and Minjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S., and marketed by Incyte under the brand name Minjuvi in the EU.

XmAb(R) is a registered trademark of Xencor, Inc.

Important Safety Information

What are the possible side effects of MONJUVI?
MONJUVI may cause serious side effects, including:

– Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, rash, flushing, headache, or shortness of breath during an infusion of MONJUVI.

– Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4ºF (38ºC) or above, or any bruising or bleeding.

– Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4ºF (38ºC) or above, or develop any signs and symptoms of an infection.

The most common side effects of MONJUVI include:

– Feeling tired or weak

– Diarrhea

– Cough

– Fever

– Swelling of lower legs or hands

– Respiratory tract infection

– Decreased appetite

These are not all the possible side effects of MONJUVI.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you

– Have an active infection or have had one recently.

– Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.

o You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.

o Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.

– Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.

You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.
Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

On March 15, 2022 Brickell Biotech, Inc. ("Brickell" or the "Company") (Nasdaq: BBI), a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of autoimmune, inflammatory, and other debilitating diseases reported financial results for the fourth quarter and full year ended December 31, 2021 and provided a corporate update (Press release, Vical, MAR 15, 2022, View Source [SID1234610148]).

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"Over the course of the last year, the entire Brickell team successfully executed on our strategic plan," commented Robert Brown, Chief Executive Officer of Brickell. "Our robust pipeline of recently-acquired proprietary drug candidates firmly establishes our presence in the immunology and inflammation fields with multiple promising and novel targets. We are on track to advance our lead DYRK1A inhibitor, BBI-02, into a Phase 1 clinical study in the coming months, and the team is progressing the development of our lead STING inhibitor, BBI-10, and other next-generation kinase inhibitors through early preclinical stage studies. In addition, we continue to execute towards a mid-2022 NDA submission for sofpironium bromide gel, 15% for the treatment of primary axillary hyperhidrosis and evaluate all available options designed to maximize commercial product success. We believe 2022 is shaping up to be a pivotal year for Brickell, and we look forward to providing updates on our progress across these exciting programs in the coming months."

Research and Development Highlights
BBI-02: a potential first-in-class DYRK1A inhibitor for the treatment of autoimmune and inflammatory diseases
•Brickell is on track to progress BBI-02, its lead development-stage program, into a Phase 1 clinical trial (BBI-02-101) in Canada in the second quarter of 2022.
•BBI-02-101: This Phase 1 study is expected to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BBI-02 in both healthy volunteers and subjects with atopic dermatitis (AD) and will also include a preliminary assessment of efficacy as to AD.
•Part 1A of the study will be a single ascending dose (SAD) assessment in healthy volunteers, Part 1B of the study will be a multiple ascending dose (MAD) assessment in healthy volunteers, and Part 2 of the study will compare BBI-02 to placebo in moderate-to-severe AD patients.
•Topline results from the SAD and MAD parts of the Phase 1 study anticipated year-end 2022.
BBI-10: a covalent STING inhibitor for the potential treatment of autoinflammatory and rare genetic diseases
•In February 2022, Brickell acquired exclusive global rights to develop and commercialize a portfolio of novel, potent, and orally available Stimulator of Interferon Genes (STING) inhibitors from Carna Biosciences, Inc., which have potential to treat autoinflammatory disorders, such as systemic lupus erythematosus and rheumatoid arthritis, rare genetic interferonopathies, and potentially other diseases.
•Preclinical development activities for BBI-10 are underway, and the Company expects to conduct experimental characterization of the STING inhibitor library throughout 2022.

Next-Generation Kinase Inhibitors: a cutting-edge platform with the potential to produce treatments for autoimmune, inflammatory, and other debilitating diseases
•Currently engaged in research to identify both brain penetrant and non-brain penetrant kinase inhibitors from the Company’s licensed library of compounds, including next-generation DYRK1A inhibitors and other new chemical entities that specifically inhibit LRRK2, TTK, and CLK kinases, as potential treatments for autoimmune, inflammatory, and other debilitating diseases.
Sofpironium Bromide: a potential best-in-class investigational product for the treatment of primary axillary hyperhidrosis
•Following a pre-NDA meeting held with the U.S. FDA earlier this quarter, the Company remains on track to file an NDA for sofpironium gel, 15% in mid-2022.
•Results from Brickell’s U.S. Phase 3 pivotal Cardigan I and Cardigan II studies of sofpironium bromide gel, 15% were selected for an oral presentation at the Late-Breaking Research session during the American Academy of Dermatology’s 2022 Annual Meeting, which is being held from March 25-29 in Boston, MA.
•Brickell’s development partner, Kaken Pharmaceutical Co., Ltd. (Kaken), continues to commercialize sofpironium bromide gel, 5% (ECCLOCK) for the treatment of primary axillary hyperhidrosis in Japan.
Financial Results
Fourth Quarter 2021 Financial Results
The Company reported cash and cash equivalents of $26.9 million as of December 31, 2021, compared to $30.1 million as of December 31, 2020. The Company expects its cash and cash equivalents will support operations beyond the receipt of Phase 1 SAD and MAD topline results for BBI-02, which are anticipated year-end 2022.
Revenue was $104.0 thousand for the fourth quarter of 2021, compared to $27.0 thousand for the fourth quarter of 2020. Revenue in both periods related to royalty revenue recognized from sales of ECCLOCK in Japan by Kaken.
Research and development expenses were $3.1 million for the fourth quarter of 2021, compared to $4.6 million for the fourth quarter of 2020. This decrease was primarily due to a $2.9 million reduction in clinical costs related to sofpironium bromide, which was partially offset by a $0.9 million increase in regulatory, personnel, and other expenses, and a $0.5 million increase related to development of the Company’s DYRK1A inhibitor programs.
General and administrative expenses were $3.3 million for the fourth quarter of 2021, compared to $2.9 million for the fourth quarter of 2020. The increase of $0.4 million was primarily due to compensation and administrative expenses.
Brickell’s net loss was $6.1 million for the fourth quarter of 2021 compared to $7.4 million for the fourth quarter of 2020.
2021 Annual Financial Results
Revenue was $0.4 million for the year ended December 31, 2021, compared to $1.8 million for the year ended December 31, 2020. Revenue in 2021 consisted of royalty revenue recognized related to sales of ECCLOCK in Japan by Kaken, while revenue in 2020 was driven primarily by collaboration revenue recognized for research and development activities under an agreement pursuant to which Kaken provided research and development funding to the Company.
Research and development expenses were $28.2 million for the year ended December 31, 2021, compared to $11.2 million for the year ended December 31, 2020, which was primarily due to an increase of $10.7 million in clinical costs related to the Company’s U.S. Phase 3 pivotal clinical program for sofpironium bromide gel, 15%, an increase of $5.4 million in upfront costs and development expenses related to the Company’s DYRK1A inhibitor programs and next-generation kinase inhibitor platform, and an increase of $0.9 million in personnel and other expenses.
General and administrative expenses were $12.4 million for the year ended December 31, 2021, compared to $11.6 million for the year ended December 31, 2020. The increase of $0.8 million was primarily due to compensation and administrative expenses.

Total other income, net was $0.8 million for the year ended December 31, 2021, compared to $0.1 million for the year ended December 31, 2020. The increase of $0.7 million was primarily due to a gain on extinguishment of debt of approximately $0.4 million that resulted from the forgiveness of a loan in June 2021 and other miscellaneous income of $0.3 million.
Brickell’s net loss was $39.5 million for the year ended December 31, 2021, compared to $20.9 million for the year ended December 31, 2020.
Conference Call and Webcast Information
Brickell’s management will host a conference call today at 8:30 a.m. EDT to discuss the financial results and recent corporate developments. The dial-in number for the conference call is 1-877-705-6003 for domestic participants and 1-201-493-6725 for international participants, with Conference ID #13726693. A live webcast of the conference call can be accessed at (click here) (View Source;tp_key=b8f4008a0e) or through the Investors section of the Brickell website at View Source A replay will be available on this website shortly after conclusion of the event for approximately 90 days.

On March 15, 2022 Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported its move from Cambridge, MA to a larger facility in Boston’s Seaport District and an update on its programs for 2022 (Press release, Elicio Therapeutics, MAR 15, 2022, View Source [SID1234610146]). Elicio joins a growing collection of emerging and established biotech companies in the Seaport District, which has become Boston’s new hub for biotech innovation. The move will allow for further expansion given the promising advances being made with the Company’s lead asset, ELI-002, an investigational KRAS-targeted cancer vaccine designed with Elicio’s proprietary lymph node-targeting Amphiphile (AMP) platform. In addition, the move will also allow for the continuing development of the Company’s TCR-T and infectious disease programs.

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"As someone who’s been with the Company from the very beginning, I’m immensely proud of how we have continued to expand our team and our pipeline over the last few years. We have had a 50% increase in staff over the last two years. In addition, we are collecting our first set of clinical data for ELI-002 and continuing to take key steps in developing the cell therapy and infectious disease parts of our pipeline," said Peter DeMuth, Ph.D., Elicio’s Chief Scientific Officer. "We believe in the potential of our lymph node-targeted approach to build a niche within the immunotherapy space and to meet the unmet need in a number of aggressive cancers and infectious diseases. I’m proud of our team of scientists who are doing the important groundwork and look forward to our progress this year."

Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer, added, "We’re excited to progress the ELI-002 program which holds promise to induce durable remissions in early-stage KRAS-mutated cancers. There is an initial focus on patients with minimal residual disease (MRD) and patients with low volume metastases while planning has begun for trials to explore all cancer stages and combination therapies. With approximately 25% of tumors containing KRAS mutations, this is a critically important target for cancer treatment. We are extremely encouraged by the preclinical data generated so far and expect AMPLIFY-201 readouts in the coming months to validate the mechanism of ELI-002 and to support a Phase 1b/2 trial early next year."

ELI-002 is poised to address the shortcomings of past cancer vaccine development efforts by hijacking the body’s natural biodistribution to traffic AMP mKRAS peptides, alongside ELI-004, an activity-boosting AMP adjuvant, directly to the lymph nodes. The lymph nodes are often considered "the schoolhouse of the immune system" as they host the selection and activation of T cells to elicit an immune response. Through this approach, ELI-002 has shown the ability to significantly enhance immune responses in preclinical models across a wide range of KRAS mutations versus conventional peptides, leading to greater infiltration and elimination of tumors.

The clinical development strategy for ELI-002 takes advantage of recent advances in therapy response monitoring to rapidly assess the clinical activity of ELI-002 as adjuvant therapy in patients with early-stage KRAS-driven cancers who have MRD following surgery and chemotherapy.
In the Phase 1 AMPLIFY-201 study, circulating tumor DNA (ctDNA) and serum tumor biomarkers will be measured as a biomarker indicating anti-tumor response, in addition to the primary safety endpoint and identification of a recommended Phase 2 dose.
This novel approach will allow Elicio to validate the clinical activity of ELI-002 more efficiently, before moving into a Phase 1b/2 trial with a more traditional endpoint of Relapse-Free Survival (RFS).
Enrollment in the Phase 1 AMPLIFY-201 study continues, following the dosing of the first patient at MD Anderson in October 2021, with the expectation to move from Cohort 1 to Cohort 2 in the next quarter, and the Phase 1b/2 trial planned for early 2023.
The anticipated Phase 1b/2 trial will study the broad spectrum 7-peptide formulation of ELI-002. This formulation is designed to provide immune response coverage against the seven of the most common KRAS mutations, thereby increasing the potential patient population for ELI-002 and potentially reducing the chance of bypass resistance mechanisms. Most other KRAS-targeted therapeutics in development — particularly small molecule KRAS inhibitors —are only able to target one or two KRAS mutations.

Elicio’s pipeline of preclinical and clinical programs originates from the Company’s proprietary AMP platform technology. Each program seeks to anticipate and solve challenges in conventional immunomodulation through targeted delivery of payloads (e.g., peptides, proteins, small molecules, nucleic acids) to the lymph nodes. Elicio has investigated the platform in preclinical models across several modalities and therapeutic areas, beyond its focus on cancer vaccines. This also includes Elicio’s universal CpG adjuvant, ELI-004, which is being explored in a variety of indications besides in the lead ELI-002 program.

In addition, with TCR-T cell therapies, Elicio’s "AMP-lification" approach has shown enhanced immune activation as well as tumor infiltration and elimination against several TCR-T targets with evaluation of further targets underway. Peptide and protein subunit vaccines against infectious diseases are another area of interest, with vaccines that include Elicio’s AMP adjuvants demonstrating potent T cell responses against a range of antigens such as influenza, Epstein-Barr virus (EBV), human papillomavirus (HPV) and SARS-CoV-2, including in non-human primates. The Company has a development pipeline of adjuvants with differentiated profiles to meet the needs for the full infectious disease vaccine part of the pipeline.

Annette Matthies, Ph.D., Elicio’s Chief Business Officer, added, "We view Elicio as the partner of choice for the enablement of immunotherapies via lymph node-targeting. By concentrating an immunotherapeutic molecule’s effect in the lymph node, the AMP platform has shown it can enable that molecule’s full therapeutic potential, from enhancing immunogenicity with increased T cell activation and proliferation to improving risk-benefit by reducing systemic exposure. We have had particular success in boosting TCR-T cell therapies as well as traditional peptide and protein-based infectious disease vaccines, and consider these to be prime partnership opportunities."

About the Amphiphile Platform

Our proprietary Amphiphile, or AMP, platform delivers investigational immunotherapeutics directly to the "brain center" of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants, and other immunomodulators may efficiently educate, activate, and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function, and durability. We believe our AMP lymph node targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes.

Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential across cancers, infectious diseases, and other disease indications to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The Amphiphile platform is thought to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function, and durability.

On March 15, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of small protein therapeutics to address difficult-to-treat cancers, reported that management will participate in one-on-one meetings with investors at the SVB Leerink Biopharma Private Company Connect event, being held virtually March 29-31, 2022 (Press release, Sapience Therapeutics, MAR 15, 2022, View Source [SID1234610143]).

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On March 15, 2022 Ultivue, Inc. an industry leader in multiplexing tools and novel image analysis solutions for tissue biomarker studies, and Sirona Dx, a technical contract research organization (CRO), providing advanced, single cell proteomics and genomics services to accelerate the pace of immunotherapy and targeted therapy development, reported a co-marketing agreement to deliver tissue-based spatial multiplexed immunophenotyping solutions for translational research groups and Biopharma (Press release, Ultivue, MAR 15, 2022, View Source [SID1234610142]).

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Ultivue, a leader in advancing precision medicine solutions by accelerating tissue biomarker discovery and validation, develops unique solutions for use in both multiplex immunofluorescence (mIF) imaging and spatial phenomics. Its proprietary InSituPlex technology, designed for fast and comprehensive exploration of biologically relevant targets, up to 12-plex, with same slide-H&E analysis in precious tissue samples combines the power of computational pathology & spatial biology to guide translational science in immuno-oncology. "Our InSituPlex technology offers valuable profiling of the tissue and expands the depth of information possible from a single section that is complementary to the high-parameter capabilities offered by Sirona Dx. We believe this joint offering will now provide researchers a seamless workflow enabling a far more efficient biomarker discovery and drug development process." said Mark Rees, Ph.D. Vice President Corporate Development at Ultivue.

Sirona Dx are original pioneers of spatial biology, having launched ultra-high parameter, multiplexed imaging services to Biopharma in 2018. Their technology agnostic, full service, spatial biology suite, contributed to their selection as a Top 10 CRO of 2021 by Medhealth Outlook.

"We are delighted to announce this partnership with Ultivue" said Andrew Brown, Ph.D. Chief Commercial Officer at Sirona Dx. "Since 2018, clients have relied on our leading expertise to develop and implement customized, high performance multiplexed imaging panels of up to 40 markers. Having cast a wide net to identify the most informative tissue biomarker signatures, we can now harness Ultivue’s powerful InSituPlex technology to rapidly develop, robustly validated mid-plex panels of up to 12 markers enabling our clients to accelerate their drug development programs with transformative biomarker capabilities.