Epizyme Launches In My Blood Online Resource to Empower People Living with Follicular Lymphoma to Play a Proactive Role in Treatment-Decision Making

On November 1, 2021 Epizyme reported the launch of In My Blood, an online resource designed to empower people living with follicular lymphoma to partner with their healthcare providers and play a proactive role in treatment decision-making based on where they are in their follicular lymphoma journey (Press release, Epizyme, NOV 1, 2021, View Source [SID1234594042]).

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In My Blood offers follicular lymphoma patients, and their care partners, unique resources to aid them in taking a proactive role in their care as they navigate life with this typically incurable blood cancer. A central feature is My Follicular Lymphoma Coach, a first-of-its-kind quiz for follicular lymphoma patients. This brief questionnaire takes key information into consideration, including stage of disease, current symptoms, and lifestyle. Patients are then provided with a customized, downloadable guide to support them in having proactive, informed discussions with their healthcare providers. The personalized guide is designed for patients at any stage of their experience with follicular lymphoma and provides tools for them to engage proactively in their health, during both periods of treatment and remission.

"Over the years, through continued partnership with healthcare providers and patient advocates in the follicular lymphoma community, we’ve seen firsthand the importance of the healthcare provider-patient relationship when dealing with the complexities of navigating this typically incurable blood cancer over many years, sometimes even decades," said Cheya Pope, Vice President, Corporate Affairs at Epizyme. "Knowing this relationship is paramount, we created In My Blood and My Follicular Lymphoma Coach, with input from the follicular lymphoma advocacy community, to fulfill a need for patients. We hope the resources provided will enable meaningful conversations between patients and healthcare providers to ultimately improve care."

As clear and proactive communication with healthcare providers is essential in order to detect signs of a potential relapse in follicular lymphoma, In My Blood also offers downloadable daily and weekly symptom trackers to support patients and care partners with disease monitoring. It also features stories and insights from individuals living with follicular lymphoma, which highlight how they have been able to proactively manage their disease and celebrates how they continue living life to the fullest. Additional resources, background information and links to related advocacy organization resources are also available.

"Upon learning you have follicular lymphoma the sheer volume of information, choices, and decisions you have to make can feel overwhelming. When I was newly diagnosed, I knew that I would need to advocate for myself to ensure that I received the best care and treatment based on my diagnosis and individual needs," said Kendra Munger, In My Blood patient ambassador. "Now with In My Blood and My Follicular Lymphoma Coach, patients like me who are navigating life with follicular lymphoma can create a personalized guide with relevant information for where they are in their follicular lymphoma journey, along with important questions to ask their doctors as they work together to determine the best path forward."

For more information on In My Blood and to access My Follicular Lymphoma Coach, visit FollicularLymphoma.com.

About Follicular Lymphoma

Follicular lymphoma is a type of cancer that starts in the lymphatic system, a system of lymph nodes found throughout the body.i Of the estimated 74,000 individuals diagnosed with non-Hodgkin’s lymphoma in the United States each year, follicular lymphoma accounts for approximately 20% of all cases, or about 14,800 individuals.ii People with follicular lymphoma often experience periods of remission before the disease returns (relapse), and they typically undergo treatment with numerous therapies during their disease journey. In addition, many patients find their cancer has become resistant to treatments they’ve received before, leaving them with fewer options when their cancer returns. To learn more about follicular lymphoma and In My Blood, visit FollicularLymphoma.com.

Lab Genomics Announces MolDX® Coverage for Follow It® Circulating Tumor DNA Assay in Partnership with Canexia Health

On November 1, 2021 Lab Genomics, a personalized medicine company providing state of the art molecular genetic testing in Southern California and other US locations, reported in partnership with Canexia Health that MolDX has finalized coverage determination under the policy "Plasma-Based Genomic Profiling in Solid Tumors” for Follow It, a circulating tumor DNA (ctDNA) assay (Press release, Lab Genomics, NOV 1, 2021, View Source [SID1234594058]). The coverage decision provides Medicare reimbursement for Follow It for use in breast, lung, and colorectal cancers.

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Follow It, which requires only a simple blood draw from patients, analyzes ctDNA in plasma to evaluate somatic mutations in 337 hotspots and 26 exons in 38 cancer associated genes. This information can be used to guide targeted treatment selection, which has been shown to improve patient outcomes up to threefold.

"Medicare coverage for liquid biopsy is a critical step in helping cancer patients gain access to targeted therapies," said Leena Dalal, Founder of Lab Genomics. "We commend MolDX for this decision that supports our focus on delivering individualized medical care."

"Reimbursement for Follow It greatly expands access to a minimally-invasive test for cancer treatment selection for some of the most prevalent forms of solid tumor cancer," said Michael Ball, CEO of Canexia Health. "This MolDX decision marks a significant milestone in our mission to transform cancer care."

The CREB-binding protein (CBP)/?-catenin inhibitor E7386, co-created by Eisai and PRISM BioLab, achieved the clinical POC (Proof of Concept)

On November 1, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and PRISM BioLab Co., Ltd. (Headquarters: Kanagawa, President and CEO: Dai Takehara, "PRISM") reported that the CREB-binding protein (CBP) / β-catenin inhibitor E7386, a medium-molecular weight compound created through collaboration research between Eisai and PRISM, has achieved the clinical POC (Proof of Concept) (Press release, Eisai, NOV 1, 2021, View Source [SID1234593967]).

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Eisai is conducting a Phase I clinical study of E7386 monotherapy for solid tumors, and a Phase Ib clinical trial of E7386 plus lenvatinib mesylate (product name: LENVIMA, "lenvatinib"), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for solid tumors including hepatocellular carcinoma. The achievement of the POC, which is defined in a collaborative research agreement between Eisai and PRISM, was confirmed based on data such as antitumor activity and changes of biomarkers in these clinical trials.

The E7386 targets, β-catenin, is considered to be one of the undruggable targets that are particularly difficult to develop into drug discovery. β-catenin, along with CBP, which is also the target of E7386, is located at the downstream of the Wnt signaling and regulates the Wnt signaling-dependent transcription activity. E7386 is a CBP / β-catenin inhibitor that inhibits CBP and β-catenin protein-protein interactions and regulates the Wnt signal-dependent gene expression. It is expected to suppress tumor growth dependent on the Wnt signaling. 1 E7386 is also expected to release the suppression of tumor-infiltrating T cells by the Wnt signaling activation, and to enhance the effect of immune checkpoint inhibitors1. The antitumor effect of E7386 alone and the combination of E7386 and anti-PD-1 antibody has been confirmed in a cancer-bearing mouse model. 1

Based on the POC achievement, Eisai has initiated a phase Ib/II clinical trial (Study 201) of E7386 in combination with anti-PD-1 therapy pembrolizumab for solid tumors in Japan.*

Dr. Takashi Owa, Senior Vice President, President of Oncology Business Group, at Eisai said, "With achieving the POC, we are confident with the prospect of offering E7386 to patients as a cancer treatment. E7386 may overcome lenvatinib and pembrolizumab treatment resistances through its combination therapy with lenvatinib or pembrolizumab. Eisai will accelerate clinical trials of E7386 in combination with lenvatinib or pembrolizumab, and do its utmost aiming to create new treatments for cancers with high unmet medical needs."

Dai Takehara, President and CEO of PRISM commented, "The approval of the clinical POC for the E7386 demonstrates that PRISM’s drug discovery platform is an effective option for novel drug targets which have been considered difficult. We are grateful to Eisai for advancing this development. We will continue to take on the challenge of targeting more novel targets, with the aim of providing new treatment to as many patients as possible."

* Study 201 is being conducted under a clinical trial collaboration and supply agreement between Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A.

Kinnate Biopharma Inc. in Collaboration with Guardant Health Announces Initial Findings from BRAF Kinase Alteration Genomic Landscape and Real-World Clinical Outcomes Study

On November 1, 2021 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported a collaboration with Guardant Health, a leading precision oncology company, focused on characterizing the prevalence of patients with advanced solid tumors bearing BRAF Class I, II and III alterations (Press release, Kinnate Biopharma, NOV 1, 2021, View Source [SID1234593987]). The study will also assess real-world clinical outcomes stratified by BRAF alteration class and by treatment type.

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"Currently, patients with Class II and III BRAF alterations have no available targeted therapies and represent a significant and potentially greater unmet clinical need than previously understood," said Richard Williams, MBBS, Ph.D., Chief Medical Officer at Kinnate. "With a focus on metastatic disease and longitudinal genomics data, GuardantINFORM has provided valuable insights into this important biomarker that will help us to guide the development of our lead BRAF candidate. We believe that this collaboration with Guardant Health will enable a deeper look at the occurrence rates of functionally distinct classes of BRAF alterations across patient groups and help advance our efforts to develop novel targeted therapies that improve their lives."

Preliminary analyses conducted utilizing the GuardantINFORM platform suggest that the prevalence of Class II and III alterations across patients with advanced and metastatic solid tumors screened via liquid biopsy-based comprehensive genomic profiling (CGP) is higher than previously understood. Among the nearly 6,000 patients who were identified as having BRAF alteration-positive cancers, approximately 55% were found to be harboring Class II and III alterations across all tumor types. When looking across common tumor types – Non-Small Cell Lung Cancer (NSCLC), Melanoma and Colorectal Cancer (CRC) – approximately 65%, 20% and 30% of oncogenic BRAF alterations, respectively, are BRAF Class II and III. In addition to NSCLC, Melanoma, and CRC, BRAF Class II and III alterations are also detected at substantial rates in other common and rare tumor types such as prostate, breast, duodenal adenocarcinoma, renal pelvis urothelial carcinoma, and cholangiocarcinoma. These findings, as well as other studies that will assess real-world clinical outcomes stratified by BRAF Class and by treatment, are planned for presentation at a future date.

"Analysis of large-scale, real-world clinical-genomic datasets has become a critical approach for our biopharmaceutical partners like Kinnate to gain unique insights into disease biology, prevalence, and clinical outcomes across diverse patient populations," said Daniel Simon, Senior Vice President of Biopharma Solutions at Guardant Health. "Through GuardantINFORM, we can provide our partners like Kinnate with a unique perspective into biomarkers such as BRAF that drive tumors for patient populations where there is greatest unmet need."

Kinnate is utilizing the GuardantINFORM platform which combines de-identified longitudinal clinical information and genomic data collected from the Guardant360 liquid biopsy test which has been provided to more than 175,000 patients to date in the United States. Its robust dataset offers real-world insights into anti-cancer therapy use in the clinic, tumor evolution, and treatment resistance throughout each patient’s treatment journey for many advanced solid tumor cancers including NSCLC, Melanoma, Breast, CRC and Prostrate.

Viracta Therapeutics to Present at Upcoming Investor Conferences

On November 1, 2021 Viracta Therapeutics, Inc. (NASDAQ: VIRX), a precision oncology company targeting virus-associated malignancies, reported that company management is scheduled to present and host one-on-one meetings at the following upcoming investor conferences (Press release, Viracta Therapeutics, NOV 1, 2021, View Source [SID1234594009]):

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Credit Suisse 30th Annual Healthcare Conference (virtual)

Conference Dates:

November 8 – 12, 2021

Presentation Date:

November 11, 2021

Presentation Time:

1:50 PM ET

Format:

Corporate presentation

Jefferies London Healthcare Conference (in-person)

Conference Dates:

November 16 – 17, 2021

Presentation Date:

November 17, 2021

Presentation Time:

10:40 AM GMT/ 5:40 AM ET

Format:

Corporate presentation

Piper Sandler 33rd Annual Healthcare Conference (virtual)

Conference Dates:

November 29 – December 2, 2021

Presentation Available:

November 22, 2021, at 10:00 AM ET

Format:

Corporate presentation

Evercore ISI 4th Annual HealthCONx Conference (virtual)

Conference Dates:

November 29 – December 2, 2021

Presentation Date:

December 2, 2021

Presentation Time:

3:55 PM ET

Format:

Fireside chat

A live webcast of each of the presentations will be available under "Events and Webcasts" in the Investors section of the Viracta website at View Source Replays of each webcast will be archived on the Viracta website for at least 30 days following the presentation.