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.

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.

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.

On November 1, 2021 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata," the "Company," or "we"), a clinical-stage biopharmaceutical company, reported that it will report financial results and provide an update on recent progress on its development programs pre-market on November 8, 2021 (Press release, Reata Pharmaceuticals, NOV 1, 2021, View Source [SID1234594026]).

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Reata’s management will host a conference call on November 8, 2021, at 8:30 a.m. ET. The conference call will be accessible by dialing (844) 200-6205 (toll-free domestic) or (929) 526-1599 (international) using the access code: 052919. The webcast link is View Source

Third quarter financial results to be discussed during the call will be included in an earnings press release that will be available on the Company’s website shortly before the call at View Source and will be available for 12 months after the call. The audio recording and webcast will be accessible for at least 90 days after the event at View Source.

On November 1, 2021 Imugene Ltd ("Imugene") (ASX: IMU), a clinical stage immuno-oncology company, and Eureka Therapeutics, Inc. ("Eureka"), a clinical-stage biotechnology company developing novel T-cell therapies to treat solid tumours, reported a strategic collaboration to evaluate Imugene’s CD19 oncolytic virus onCARlytics technology in combination with Eureka’s anti-CD19 ARTEMIS T-cell therapy for the treatment of solid tumours (Press release, Imugene, NOV 1, 2021, View Source [SID1234594043]).

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Oncolytic viruses in combination with T-cell therapies represent a novel and promising approach to treat solid tumours. In preclinical studies conducted by the City of Hope Comprehensive Cancer Center, scientists combined CAR-T therapy with an oncolytic virus to eliminate solid tumours in mice. The virus enters the tumour cells and forces them to express the CD19 protein on the cell surface, presenting a target for anti-CD19 T-cells to pursue and kill. Imugene licensed the patents covering City of Hope’s oncolytic virus technology in May 2021.

"By combining oncolytic virus and CAR T-cell therapies, we have developed a ‘mark and kill’ approach to treating solid tumours with T-cell therapies," said Saul Priceman, Ph.D., Assistant Professor in the Department of Hematology and Hematopoietic Cell Transplantation at City of Hope and co-inventor of the platform. "In our animal studies, we were able to express CD19 in triple-negative breast, pancreatic, prostate, ovarian, and head and neck cancer, as well as brain tumours."

"T-cell and CAR-T therapies have not achieved much success in solid tumours in part because of a lack of tumour-specific targets. By using our proprietary oncolytic technology to force the tumour to express the CD19 target, we now have the ability to address this shortcoming. We believe the synergy between our onCARlytics platform and Eureka’s anti-CD19 ARTEMIS T-cells has the potential to shift the cellular medicine paradigm in treating solid tumours," said Leslie Chong, Managing Director & Chief Executive Officer of Imugene.

"We are delighted to be working with Imugene on tackling solid tumours using this innovative approach," said Dr. Cheng Liu, President and CEO of Eureka Therapeutics. "We believe our ARTEMIS T-cell platform to be the ideal one to evaluate this combination. In head-to-head pre-clinical studies against CAR-T cells, our ARTEMIS T-cells demonstrated superior efficacy, enhanced tumour infiltration, and less T-cell exhaustion. In the clinical context, our ARTEMIS T-cells have demonstrated reduced cytokine release syndrome (CRS) and other cytokine-related toxicities compared to CAR-T cells, potentially improving the efficacy and safety of a combination approach."