On June 17, 2020 Foundation Medicine, Inc., reported that the U.S. Food and Drug Administration (FDA) approved FoundationOneCDx as a companion diagnostic for KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, which was also approved under accelerated approval for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options (Press release, Foundation Medicine, JUN 17, 2020, View Source [SID1234561192]). FoundationOne CDx is the first and only FDA-approved companion diagnostic to measure TMB and help identify patients who may be appropriate for treatment with KEYTRUDA, regardless of solid tumor type.

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TMB is a measure of the number of somatic mutations per coding region within a tumor’s genome.1 This genomic signature can help determine a patient’s likelihood to respond to immunotherapies. FoundationOne CDx, Foundation Medicine’s comprehensive genomic profiling (CGP) assay approved for all solid tumors, enables oncologists to identify TMB-H patients (≥ 10 mutations/megabase) with unresectable or metastatic solid tumors across all tumor types who could potentially benefit from KEYTRUDA.

"Immunotherapy is revolutionizing cancer treatment. Not only does this approval mean that clinicians will be able to identify more patients who could benefit from this treatment option, but it’s an important milestone in the shift toward making biomarker-driven, tumor agnostic therapies available to patients, which is possible through an FDA-approved companion diagnostic," said Brian Alexander, M.D., M.P.H., chief medical officer at Foundation Medicine. "We’re proud to have been at the forefront of efforts to bring TMB from research into clinical practice in partnership with the oncology community. It’s exciting to see this breakthrough translate into advanced care for patients."

FoundationOne CDx is the first FDA-approved CGP test that is clinically and analytically validated for all solid tumors and incorporates multiple companion diagnostic claims. It is currently approved as the companion diagnostic test for more than 20 therapies across multiple cancer types.

"This approval represents a paradigm shift toward biomarker-driven cancer treatment. It’s made possible in part by an unparalleled collaboration to better understand how TMB levels are measured and reported," said Jeff Allen, President and CEO of Friends of Cancer Research. "TMB provides an additional tool to inform clinical care, especially for cancer patients previously ineligible for immunotherapy based on existing biomarkers."

Merck also announced today that the FDA approved its supplemental Biologics License Application (sBLA) for KEYTRUDA, for adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. The accelerated approval was based on a prospectively planned and retrospective analysis of the KEYNOTE-158 open-label trial, which used a clinical trial assay (CTA) based on FoundationOne CDx to determine TMB status in patients’ tumor tissue. The results showed that patients with TMB-H in solid tumors (≥ 10 mutations/megabase) who were treated with KEYTRUDA had a higher overall response rate (29%) compared to patients with TMB <10 mut/Mb (6%).2

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is now approved for two pan-tumor indications. In 2017, KEYTRUDA was granted FDA approval as the first cancer treatment based on a genomic signature, regardless of cancer type, in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. More information about KEYTRUDA can be found at www.keytruda.com.

About FoundationOne CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit View Source

About TMB

Tumor mutational burden (TMB) is a measure of the total number of mutations per coding area of a tumor genome.3 TMB is an additional genomic signature, similar to a biomarker, that can help identify more candidates likely to benefit from immunotherapy across a range of tumor types. Levels are measured by the number of non-inherited mutations occurring per megabase (1 million DNA base pairs) of the tumor genome.4 TMB-H tumors may be more likely to respond to certain immunotherapies because their high number of mutations make them easier for the immune system to identify. Higher TMB levels are correlated with higher levels of neoantigens, which help the immune system recognize and attack cancer cells.5 TMB can be measured with both tissue and blood-based comprehensive genomic tests.

On June 17, 2020 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, adoptive cell therapies and cancer vaccines, reported that Dr. Jennifer Buell, PhD, President and Chief Operating Officer of Agenus, will present an update on Agenus’ progress and host one-on-one meetings with investors at the Raymond James Virtual Human Health Innovation Conference on June 18, 2020 (Press release, Agenus, JUN 17, 2020, View Source [SID1234561191]).

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Date: Thursday, June 18, 2020

Time: 4:20 pm – 4:450 p.m. ET / Virtual Track 1

Webcast: The presentation will be webcast and can be accessed through the following link: View Source

On June 17, 2020 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported new information regarding its participation in two upcoming investor virtual conferences. Gerald McMahon, Ph.D., President and Chief Executive Officer, will now participate in (Press release, Harpoon Therapeutics, JUN 17, 2020, View Source [SID1234561190]):

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A fireside chat at the JMP Securities Hematology & Oncology Forum on Thursday, June 18, 2020 at 3:40 p.m. ET / 12:40 p.m. PT (revised time); and

A presentation (revised format) at the BMO 2020 Prescriptions for Success Healthcare Conference on Tuesday, June 23, 2020 at 2:30 p.m. ET / 11:30 a.m. PT.
A live audio webcast of the fireside chat and presentation will be available in the Investors section of Harpoon Therapeutics’ website at www.harpoontx.com.

On June 17, 2020 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported the successful completion of the first dose cohort in a Phase 1/2a clinical trial of AFM24 (Press release, Affimed, JUN 17, 2020, View Source [SID1234561189]). This first-in-human study evaluates AFM24 as monotherapy in patients with advanced solid EGFR expressing malignancies whose disease has progressed after treatment with previous anticancer therapies. AFM24, a tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-binding innate cell engager, is novel due to its activation of innate immunity to kill solid tumors, inducing both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). Other therapies rely heavily on signal or checkpoint inhibition.

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The company reports that no dose limiting toxicity was observed and the study is cleared to proceed the next dose level (cohort 2). No efficacy yet was observed, however, efficacy was not expected at this dose level.

"As we progress to the 2nd dose cohort, we take another step closer to giving patients a new treatment option with a distinctive mechanism that mobilizes the innate immune system to attack cancer cells" said Dr. Andreas Harstrick, Chief Medical Officer of Affimed. "The innate immune system is inherently powerful, yet it has been largely untapped as a therapeutic approach to fight cancer. With the clinical progress we are making we are hopeful that AFM24 will become an important option to provide long-lasting, multilayered tumor control."

AFM24 has demonstrated preclinically the ability to bridge NK cells and macrophages to EGFR-expressing tumor cell lines, and to induce lysis through ADCC and ADCP, respectively, independent of RAS or BRAF mutational status.

The study is an open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study to evaluate AFM24 as monotherapy in adult patients with advanced solid malignancies known to be EGFR-positive. The aim of the dose escalation phase is the determination of the maximum tolerated dose and the establishment of a recommended Phase 2a dose. The dose expansion phase is intended to collect preliminary evidence of efficacy and to further confirm the safety of AFM24. For more information including eligibility criteria, visit www.clinicaltrials.gov, using Identifier NCT04259450.

About AFM24
AFM24 is a tetravalent, bispecific EGFR- and CD16A-binding innate cell engager generated from Affimed’s fit-for-purpose ROCK platform. AFM24 uses the cytotoxic potential of the innate immune system by redirecting and activating NK cells and macrophages to kill EGFR-positive cancer cells through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), respectively. Due to its unique mechanism of action, AFM24 is potentially not limited to patient subtypes based on mutational status. Toxicology studies in cynomolgus monkeys with AFM24 showed a favorable safety profile, even when the animals were treated at high dose levels, demonstrating AFM24’s potential to have lower toxicities in humans compared to other EGFR-targeted therapies.

On June 17, 2020 Orca Bio reported that it closed on a Series D financing worth $192 million, bringing the total raised since 2016 to $300 million (Press release, ORCA Biosystems, JUN 17, 2020, View Source [SID1234561188]). The round was co-led by Lightspeed Venture Partners and an undisclosed investor. New and existing investors included 8VC, DCVC Bio, ND Capital, Mubadala Investment Company, Kaiser Foundation Hospitals, Kaiser Permanente Group Trust and IMRF.

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Orca focuses on high-precision allogeneic cell therapy with the goal of being able to replace a patient’s diseased blood and immune system with a healthy one. Its approach is based on a proprietary mix of cells that can cure disease and eliminate dangerous side effects.

The funds will be used to continue advancing its cell therapy pipeline and novel manufacturing platform. The technology sorts blood at the single-cell level with a high level of purity. There can be a trade-off when it comes to bone marrow transplants, with using only a few cells with great precision or using a lot of cells and giving up some of that precision. The most common approach is to have less precision in order to utilize large numbers of cells to treat patients. Orca’s technology processes large numbers of cells while maintaining single-cell precision.

The most advanced program is TRGFT-201, a formulation of T-cells that includes subsets of regulatory T-Cells. Currently there is an ongoing Phase Ib trial in advanced hematologic malignancies that is projected to wrap in September 2022. The second trial is of OGFT-001, which is in a Phase I trial in acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes and acute leukemia. It is projected to be completed on July 1, 2022.

"The capital we have raised has formed the launch pad for a world-class, fully integrated allogeneic cell therapy company differentiated from all others," said Ivan Dimov, co-founder and chief executive officer of Orca Bio. "Replacing bone marrow transplants is a logical first step in next-generation allogeneic cell therapy. While a conventional bone marrow transplant administers an uncontrolled cell product, Orca Bio has been the first to deliver a high precision cell therapy. We are initially focused on advancing two clinical programs in patients with blood cancers and have successfully treated the largest-ever number of patients with a high precision cell therapy. We believe our approach has the potential to transform allogeneic cell therapy, and thus the treatment of not only blood cancer, but also many other diseases with significant unmet need, such as a variety of genetic diseases and autoimmune disorders."

The company’s leadership team also includes Nate Fernhoff, chief scientific officer and Jeroen Bekaert, chief operating officer, who all met at Stanford University and launched the company in 2016.

Orca’s board of directors and scientific advisory board includes Irv Weissman, director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine; Ted Love, president and chief executive officer of Global Blood Therapeutics (GBT); Jonathan MacQuitty, Venture Partner at Lightspeed; Joe Jimenez, former chief executive officer of Novartis; Mike Knapp, founder and former chief executive officer of Caliper Life Sciences; Ronald Martell, president and chief executive officer of Nuvelution Pharma; Alex Kolicich, Founding Partner at 8VC; and Rich Klausner, founder and chief executive officer of Lyell Immunopharma, founder and director of Juno Therapeutics and GRAIL, former director of the National Cancer Institute.

"With precise reconstitution using highly defined cell preps and a swift reboot of the patient’s immune system, Orca Bio’s product candidates have the potential to eliminate fatal side effects, such as graft-versus-host disease, and infections commonly associated with bone marrow transplants while maintaining or enhancing anti-tumor efficacy," said Klausner. "The possibility of improving cure rates and minimizing toxicity holds the promise of expanding the eligible patient population for successful bone marrow transplantation in cancer."