On April 30, 2021 KIYATEC, Inc reported that it secured a $2.5 million investment from Boston-based healthcare service and technology venture capital fund Seae Ventures (Press release, KIYATEC, APR 30, 2021, View Source [SID1234578904]). The fund’s focus in disruptive healthcare technologies aligns with KIYATEC’s goal to fundamentally change the way cancer drugs are selected by providing oncologists with patient-specific evidence of response, prior to treatment initiation.

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Although significant strides toward personalized medicine have been achieved in the past two decades, oncologists remain largely unable to predict treatment response for individual patients. As a result, many patients receive ineffective drug therapies, while unnecessarily experiencing toxic side effects and shouldering high cost of treatment. KIYATEC’s 3D-Predict platform and associated tests increase the patient-centric value of cancer drugs by informing oncologists’ pre-treatment cancer drug selection. Importantly, the platform also aids pharmaceutical companies by improving decision-making across drug lifecycles.

"We are grateful for Seae Venture’s ’yes’ to KIYATEC and welcome the addition of their managing partner, Jason Robart, to our board of directors. The fund’s healthcare industry relationships coupled with Jason’s personal experience with health insurance innovation will be beneficial as we implement our strategy to impact those who need it most – cancer patients and their providers," said Matthew Gevaert, CEO and co-founder of KIYATEC.

The investment comes on the heels of other recent announcements of success for KIYATEC. The first release of the 3D-PREDICT clinical study data in late 2020, combined with the more recent March 2021 publication demonstrating platform expansion into immuno-oncology, highlight the rapid and disruptive nature of KIYATEC’s progress. The company’s platform has been shown to be clinically predictive for patient-specific response to chemotherapy and targeted agents, and it has been analytically validated in both ovarian cancer and high-grade gliomas.

Robart said, "KIYATEC has the potential to significantly improve outcomes for patients and their providers, not just for one cancer type, but across many solid tumors. We’re excited about the science, the team and the potential. We welcome KIYATEC into our portfolio of companies and I’m thrilled to join its board of directors."

On April 30, 2021 Guardant Health reported that For patients with early-stage colorectal cancer (CRC), the presence of circulating tumor DNA (ctDNA) or minimal residual disease (MRD) after curative intent treatment is becoming an important prognostic biomarker for cancer recurrence, and can also be used to evaluate the potential need for adjuvant treatment in post-surgical patients (Press release, Guardant Health, APR 30, 2021, View Source [SID1234578903]). Until recently, tests developed to detect MRD required tumor tissue to gain the necessary genomic information needed to accurately identify high-risk patients. A new study led by Massachusetts General Hospital Cancer Center and published in Clinical Cancer Research demonstrates that Guardant Reveal, the first blood-only liquid biopsy to identify MRD, identifies those patients most likely to recur, with industry-leading sensitivity, without the need for tumor tissue.1,2

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The single-center, prospective study evaluated the effectiveness of the Guardant Reveal liquid biopsy test to detect MRD in patients with stage I-IV colorectal cancer after curative intent therapy. Blood draws were taken one month after completion of definitive treatment, either surgery or adjuvant therapy, and at various surveillance or monitoring timepoints. Blood samples were analyzed using the Guardant Reveal test, which integrates both cancer-specific epigenomic signatures and genomic alterations, unlike standard MRD tests which analyze only genomic alterations.

In the primary landmark analysis (n=84), blood samples were taken from the curative intent patient population one month (median 31.5 days) after completion of definitive treatment. In the subset of patients with at least one year of clinical follow-up, all patients with detectable ctDNA recurred (100% PPV). Guardant Reveal test sensitivity and specificity were 55.6% and 100% respectively for this single timepoint. By incorporating longitudinal surveillance samples, sensitivity improved to 91%. Integrating epigenomic signatures increased test sensitivity by 36% versus using genomic alterations alone. Additionally, CEA tests, the traditional biomarker for colorectal cancer, did not predict recurrence in this patient cohort.

"The integration of cancer-specific epigenomic and genomic signatures allows Guardant Reveal to detect minimal residual disease in early-stage colorectal cancers with industry-leading performance and without the need for tumor tissue," said AmirAli Talasaz, Guardant Health president. "We believe that Guardant Reveal can be a powerful decision-making tool for oncologists managing patients with early-stage colorectal cancer. In addition, our blood-only approach offers a more streamlined workflow and faster turnaround time for clinical decision making."

"By detecting minimal residual disease after curative intent treatment, we can have a better understanding of which patients are at high-risk for recurrence and perhaps tailor additional therapy," said Aparna Parikh, MD, MPH, Gastrointestinal Oncologist at Massachusetts General Hospital and Assistant Professor of Medicine, Harvard Medical School. "This study demonstrates that the incorporation of epigenomic signatures with genomic alterations allows for Guardant Reveal to have comparable sensitivity and specificity as tumor informed approaches, but without the need for tumor tissue."

Tissue-dependent MRD tests have previously reported sensitivities of 40%-50% with a single post-surgical blood draw.1,3 When looking only at the subset of patients with stage II or III CRC in this study, Guardant Reveal had a sensitivity of 63% and a specificity of 100% for recurrence. These data show that Guardant Reveal can detect minimal residual disease from a simple blood draw. In addition, the sensitivity of the test increases with additional longitudinal blood draws, allowing for earlier detection of recurrence in the patient surveillance setting compared with standard imaging methods.

The Guardant Reveal test achieves industry-leading sensitivity (91%)2 for detecting ctDNA by simultaneously interrogating genomic and epigenomic alterations. The test accurately identifies genomic alterations down to allele frequencies of 0.01% and effectively filters out biological noise sources such as mutations caused by clonal hematopoiesis. The incorporation of biologically relevant epigenomic signatures is essential to increasing test sensitivity in the post curative intent and surveillance patient populations.

The publication titled, "Minimal Residual Disease Detection using a Plasma-Only Circulating Tumor DNA Assay in Colorectal Cancer Patients" can be found here.

On April 30, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported its national sponsorship of the American Academy of Dermatology’s (AAD) "Skin Cancer, Take a Hike!" steps challenge for Skin Cancer Awareness Month (Press release, Castle Biosciences, APR 30, 2021, View Source [SID1234578902]).

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"Skin Cancer, Take a Hike!" is a participant-driven fundraising event that has raised $1.5 million since its inaugural 2014 hike. By educating the public about skin cancer prevention and early detection, the AAD and its partners like Castle aim to drive sun-safety behaviors that can reduce skin cancer and ultimately save lives. "Skin Cancer, Take a Hike!" proceeds are dedicated to reducing the incidence of skin cancer through public education and access to life-saving programs and services, including free skin cancer screenings, permanent shade structures where children learn and play, and sunscreen dispensers in public areas, such as parks and pools.

At this year’s virtual event, held throughout May for Skin Cancer Awareness Month, hundreds of participants across the country will complete 9,500 miles in honor of the approximately 9,500 people diagnosed with skin cancer every day.

"We greatly appreciate the support of Castle Biosciences in our efforts to help the public prevent skin cancer and detect it early, when it’s most treatable," says dermatologist Kenneth J. Tomecki, M.D., FAAD, president of the AAD. "Skin cancer is the most common cancer in the U.S., and nearly 20 Americans die from melanoma, the deadliest form of skin cancer, every day. By working together to raise awareness through ‘Skin Cancer, Take a Hike!’, we want to remind the public that they can protect their skin from the sun and reduce their risk of skin cancer by seeking shade, wearing protective clothing — including a wide-brimmed hat and sunglasses with UV protection — and applying a broad-spectrum sunscreen with an SPF of 30 or higher to all skin not covered by clothing."

"Skin Cancer, Take a Hike!" is part of the AAD’s SPOT Skin Cancer initiative to reduce skin cancer mortality and incidence through public awareness, community outreach programs and services, and advocacy that promotes the prevention, detection and treatment of skin cancer. Thanks to the campaign’s dedicated volunteers and donors, SPOT Skin Cancer has provided more than 2.8 million free skin cancer screenings and awarded 432 shade structure grants, which provide shade for nearly 3.5 million individuals daily.

"Among the viable techniques to mitigate harm caused by skin cancer, the importance of prevention and early detection cannot be overstated," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Castle’s primary focus is to improve the lives of patients with skin cancer. In addition to our suite of prognostic and diagnostic tests, we recognize that reducing sun exposure, wearing sunscreen and UV-blocking clothing and getting screened for cancer are critical for improving health outcomes. Often, the largest barriers to wide uptake of those measures include insufficient awareness and insufficient financial allocation to their distribution—two barriers that we are proud to confront alongside the AAD."

About the AAD

Headquartered in Rosemont, Ill., the American Academy of Dermatology, founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of more than 20,000 physicians worldwide, the AAD is committed to: advancing the diagnosis and medical, surgical and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair and nails. For more information, contact the AAD at (888) 462-DERM (3376) or aad.org. Follow the AAD on Facebook (American Academy of Dermatology), Twitter (@AADskin), Instagram (@AADskin1), or YouTube (AcademyofDermatology).

On April 30, 2021 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ: EGRX) reported that TREAKISYM ready-to-dilute ("RTD") (bendamustine hydrochloride 120 mg/m2) liquid formulation has been approved for a new indication in combination with rituximab ("BR therapy") as treatment for relapsed or refractory diffuse large B-cell lymphoma ("r/r DLBCL") by the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan (Press release, Eagle Pharmaceuticals, APR 30, 2021, View Source [SID1234578901]).

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"This latest approval is another meaningful extension of our bendamustine franchise. We believe this expanded label will significantly increase the market opportunity for TREAKISYM in Japan. Based on this additional indication, as well as the anticipated approval of the ten-minute RI liquid formulation, we are reiterating our belief that the combined royalty and milestones revenue from these products will generate $25 million at peak," stated Scott Tarriff, Chief Executive Officer.

In September 2017, Eagle licensed to SymBio intellectual property necessary to develop, market and sell RTD and RI formulations of bendamustine under the trade name TREAKISYM in Japan utilizing Eagle’s proprietary technology. As part of the agreement, SymBio assumed responsibility for securing regulatory approval of the TREAKISYM RTD and RI products using the licensed technology in Japan.

SymBio received approval for the TREAKISYM RTD (250 ml) liquid formulation in September 2020 and is currently conducting a clinical safety trial for the ten-minute RI (50 ml) liquid formulation, for which it plans to seek approval in the second half of 2022.

Key benefits to patients and healthcare providers of these products include eliminating the need for manual reconstitution and significantly reducing preparation time as compared to the lyophilized formulation.

On April 30, 2021 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that they have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of cilta-cel, an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients with relapsed and/or refractory multiple myeloma (Press release, Janssen Pharmaceuticals, APR 30, 2021, View Source [SID1234578899]).

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The application is supported by positive results from the ongoing Phase 1b/2 CARTITUDE-1 study, investigating the safety and efficacy of cilta-cel.1,2 The latest results were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2020 Annual Meeting. Clinical development is ongoing with patients enrolled globally in various studies, including sites in Europe, the United States of America, China and Japan.1,2

"Despite advances in the treatment of multiple myeloma, there remains a high unmet need, especially for patients whose disease continues to progress," said Peter Lebowitz, M.D., PhD., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "Through our collaboration with Legend Biotech, we continue to expedite the development of cilta-cel with a focus and priority on the patients who may benefit from this novel immunotherapy in the future."

CAR‑T therapy is a highly personalised treatment platform where a patient’s own T-cells are re-programmed to recognise and attack cancer cells.3 In early 2021, the EMA granted accelerated assessment for cilta-cel.4 Accelerated assessment is granted when a medicinal product is expected to be of major public health interest and a therapeutic innovation, and can significantly reduce the review timelines to evaluate an MAA.5

"Janssen has been advancing the science of oncology for more than 30 years, and we see great opportunity in the area of cell therapy and through our innovative platforms," says Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "We are continuing to harness our deep scientific expertise in multiple myeloma as we look to advance therapeutic options, deepen clinical responses, and drive towards improved patient outcomes."

"Today’s submission to the EMA epitomises how we strive to make a meaningful impact in the multiple myeloma landscape through advancing innovative treatments for patients," says Saskia De Haes, Vice President, EMEA Regulatory Affairs, Janssen R&D BE. "We look forward to working in partnership with health authorities, as part of the accelerated assessment process, to support these patients by ensuring timely access to the latest therapeutic options."

A Biologics License Application seeking approval of cilta-cel for the treatment of relapsed and/or refractory multiple myeloma is currently under review by the United States Food and Drug Administration.6

# ENDS #

About CARTITUDE-1

CARTITUDE-1 (NCT03548207) is an ongoing Phase 1b/2, open-label, multicentre study evaluating the safety and efficacy of JNJ-68284528 (JNJ-4528) in adults with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy or are double refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD); have received a PI, IMiD and an anti-CD38 antibody.2 The primary objective of the Phase 1b portion of the study is to characterise the safety and confirm the dose of JNJ-68284528 (JNJ-4528), which was informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2).2 The primary objective for the Phase 2 portion of the study is to evaluate the efficacy of JNJ-4528 (primary endpoint: overall response rate as defined by the International Myeloma Working Group response criteria).2

About Ciltacabtagene Autoleucel (cilta-cel)

Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy for the treatment of patients with multiple myeloma. Cilta-cel is a differentiated CAR-T therapy with two BCMA-targeting single domain antibodies.1 CAR-T cells are an innovative approach to targeting cancer cells by harnessing the power of a patient’s own immune system. 7 BCMA is a protein that is highly expressed on myeloma cells.8

In December 2017, Janssen Biotech, Inc. (Janssen) entered into an exclusive worldwide license and collaboration agreement with Legend Biotech to develop and commercialise cilta-cel.9 In May 2018, Janssen initiated a Phase 1b/2 CARTITUDE-1 trial (NCT03548207) to evaluate the efficacy and safety of cilta-cel in adults with relapsed and/or refractory multiple myeloma, informed by the LEGEND-2 study results.2,10

In 2019, cilta-cel was granted PRIME (PRIority MEdicines) designation by the European Medicines Agency (EMA).11 PRIME offers enhanced interaction and early dialogue with developers of promising medicines, to optimise drug development plans and speed up evaluation of cutting-edge, scientific advances that target a high unmet medical need.12 In 2020, the European Commission granted orphan designation for cilta-cel.13

About Multiple Myeloma

Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.14 In Europe, 50,918 people were diagnosed with MM in 2020, and more than 32,400 patients died.15 Around 50 percent of newly diagnosed patients do not reach five-year survival,16 and approximately 10 percent of patients with multiple myeloma will die within one year of diagnosis.17

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.18 Refractory MM is when a patient’s disease progresses within 60 days of their last therapy.19 Relapsed cancer is when the disease has returned after a period of initial, partial or complete remission.20 While some patients with MM have no symptoms at all, others are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.21 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and require new therapies for continued disease control.22