Curis to Host Webcast to Discuss Updated Emavusertib Clinical Data in Leukemia

On December 5, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that it will host a webcast on Monday, December 12, 2022, at 10:00 a.m. ET to discuss new data from the TakeAim Leukemia trial of emavusertib, including data presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Curis, DEC 6, 2022, View Source [SID1234624819]).

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This presentation will include data for 28 additional evaluable AML/MDS patients:

11 patients treated with monotherapy in targeted populations (now 24 patients total)
13 patients treated with monotherapy in non-target populations (now 34 patients total)
4 patients treated with the combination of emavusertib and venetoclax (4 patients total)
Patients in a targeted population are those with FLT3, U2AF1, or SF3B1 mutations.

The call led by James Dentzer, President and CEO, will include a presentation by Robert Martell, M.D., Head of Curis R&D and commentary by Eric Winer, M.D., Clinical Investigator at the Dana-Farber Cancer Institute. The speakers and additional members of Curis leadership will be available to answer questions at the end of the event.

To access the live call, please dial (888) 346-6389 from the United States or (412) 317-5252 from other locations, shortly before 10:00 a.m. ET.

A live webcast will be available under "Events & Presentations" in the Investors section of the Company’s website at www.curis.com. A replay of the webcast will be available on the Curis website shortly after completion of the call.

Kyowa Kirin Announces Launch of “G-Lasta® Subcutaneous Injection 3.6 mg BodyPod” in Japan

On December 6, 2022 Kyowa Kirin Co., Ltd. (TSE: 4151, President and CEO: Masashi Miyamoto, "Kyowa Kirin") reported that G-Lasta Subcutaneous Injection 3.6 mg BodyPod ("the Product"), which is an automated injection device of G-Lasta [KRN125, generic name: pegfilgrastim (genetical recombination), long-acting Granulocyte Colony-Stimulating Factor*1 (G-CSF) preparation], is to be launched in Japan today for decreasing the incidence of febrile neutropenia*2 in patients receiving cancer chemotherapy (Press release, Kyowa Hakko Kirin, DEC 6, 2022, View Source [SID1234624788]).

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G-Lasta is a long-acting G-CSF preparation, which has been licensed from Amgen K-A, Inc. to Kyowa Kirin. It has been marketed in Japan since 2014 with the indication of decreasing the incidence of febrile neutropenia in patients receiving cancer chemotherapy. It is typically administered by medical staff at least one day after chemotherapy. This automated injection device works by delivering a dose of GLasta into the body approximately 27 hours after it is attached to the patient. By attaching it to patients on the day of chemotherapy, an additional outpatient visit required for administration of G-Lasta on the following day can be omitted. Kyowa Kirin thinks that burden on patients undergoing chemotherapy can be reduced with the Product.

"We are very pleased with the launch of G-Lasta Subcutaneous Injection 3.6 mg BodyPod. We would like to express our sincere appreciation to all those who cooperated in the development of the product and to Terumo Corporation who worked with us closely," said Tomohiro Sudo, Executive Officer, Head of Global Product Strategy Department at Kyowa Kirin. "We will continue our activities to bring the new value of this product to patients, caregivers, and medical staff who are involved in cancer chemotherapy."

The Product had been co-developed with Terumo Corporation (TSE:4543). Kyowa Kirin submitted the NDA of the Product based on safety data from the phase 1 clinical study and it was approved in July 2022. It was listed on the National Health Insurance (NHI) pricing list in November 2022. The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

Ellipses Pharma Presents Design of Newly Initiated Phase 1/2a Trial of Vosilasarm (EP0062) at SABCS

On December 5, 2022 Ellipses Pharma Limited ("Ellipses"), a global drug development company focused on accelerating the development of new oncology treatments, reported that it will present a "Trial in Progress" poster detailing the design of a Phase 1/2 trial of vosilasarm (EP0062) in advanced breast cancer at the San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas on Tuesday, 6 December from 5:00pm to 6:15pm CST (Press release, Ellipses Pharma, DEC 5, 2022, View Source [SID1234624817]).

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Vosilasarm is a selective androgen receptor modulator (SARM) under development for the potential treatment of advanced breast cancer. This study is designed to further extend the evaluation of vosilasarm as a potential therapy for AR+/HER2–/ER+ advanced breast cancer, with the primary aim of identifying a recommended phase 2 dose (RP2D). Recruitment has commenced and the study will recruit up to 130 patients globally.

Presentation details

Title

A phase 1/2 study to evaluate the safety and efficacy of EP0062, an oral Selective Androgen Receptor Modulator (SARM), for the treatment of AR+/HER2-/ER+ advanced breast cancer

Presenter

Professor Elgene Lim, Institute of Medical Research, University of New South Wales, Sydney, Australia;

Abstract number

OT1-02-02

Date and time

Tuesday December 6, 2022; 5:00 PM – 6:15 PM

Session name

Trial in Progress Session

Location

Henry B. González Convention, San Antonio, Texas

Professor Hendrik-Tobias Arkenau, Global Head of Drug Development and Chief Medical Officer at Ellipses, said:

"Developing promising assets at speed is fundamental to the work of Ellipses, and we are excited to be presenting this ongoing study at such an important scientific conference. We look forward to presenting further details on this trial, including results, in the future."

Dr Rajan Jethwa, CEO of Ellipses, said:

"The initiation of this trial for vosilasarm is another key milestone towards our goal of accelerating the development of promising cancer drugs. I am excited by the potential across our pipeline to make available much-needed drugs for patients with cancer."

About vosilasarm / EP0062

Vosilasarm is an oral, non-steroidal, SARM currently being developed for the treatment of AR+/HER2-/ER+ advanced breast cancer. The efficacy and safety of vosilasarm has previously been investigated in a small Phase 1 clinical trial of AR+/HER2–/ER+ advanced breast cancer, and was demonstrated to have acceptable tolerability with preliminary evidence of clinical efficacy (LoRusso et al. Clinical Breast Cancer 2022 22;1 67-77).

About AR+/HER2–/ER+ advanced breast cancer

Despite recent progress, advanced ER+/HER2- breast cancer remains an area of high unmet medical need. It is estimated that 75-90% of advanced ER+ breast cancers are androgen receptor (AR) positive. It has been established that the AR acts as a tumour suppressor in multiple contexts of ER+ breast cancer, including where resistance to current endocrine-based regimens develops (Hickey et al. Nature Medicine 2021 27; 310-320). This provides the rationale for evaluating vosilasarm, an AR agonist, as a potential treatment strategy.

ImmuneOncia Announces Phase 2 Results of PD-L1 Immune Checkpoint Inhibitor at ESMO Asia

On December 5, 2022 -ImmuneOncia (CEO Heung Tae Kim) reported the results of its Phase 2 NK/T-cell lymphoma clinical trial of IMC-001, a PD-L1 monoclonal antibody, at the Asian Congress of the European Society for Medical Oncology (ESMO Asia 2022) held in Singapore on December 4th, 2022(Press release, ImmuneOncia Therapeutics, DEC 5, 2022, View Source [SID1234624816]).

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The clinical data demonstrated that 6 out of 10 evaluable patients (60%) achieved an objective response, all of whom showed a complete remission (CR). Additionally, the administration has been continued in 4 of these 6 patients for over a year, which also indicates its outstanding safety (in terms of the long-term toxicity) and durable response.

Thanks to these achievements, the results of IMC-001 were selected for Mini Oral Session at ESMO (Free ESMO Whitepaper) Asia this year.

Professor Won Seog Kim of Samsung Medical Center, a presenter and Principal Investigator of IMC-001, commented, "The complete remission and response rate of 60% of IMC-001 significantly outperform currently available drugs for the treatment, and very rare adverse events of grade 3 or higher also eliminate concerns over the side effects, making it the best-in-class among PD-(L)1 drugs. These results are expected to satisfy the criteria for approval and lead to globalization of an immune checkpoint inhibitor developed by a Korean biotech."

NK/T cell lymphoma is a rare cancer that occurs mostly in Asian countries such as China and Korea, and often treated with radiation and chemotherapy. NK/T cell lymphoma has a high recurrence rate of 75% within 2 years. Due to the absence of standard-of-care treatment for relapsed/refractory, it has high unmet needs. So far, no single immuno-oncology drug has obtained approval in this indication across the globe.

IMC-001 is a PD-L1 antibody, an immune checkpoint inhibitor that serves as the basis of the current immuno-oncology market. This antibody activates the anticancer functions of T cells by strongly inhibiting the binding between PD-1 expressed on T cells and PD-L1 expressed on the surface of cancer cells. Moreover, it can mediate ADCC (antibody-dependent cellular cytotoxicity) against tumor cells, as it maintains the Fc effector function using human IgG1.

Heung Tae Kim, CEO of ImmuneOncia said, "This achievement sets a new standard for the second-line treatment of NK/T-cell lymphoma, which has high unmet needs. This will be a momentum to secure more partnering opportunities in regions with a high incidence of NK/T-cell lymphoma, like China. ImmuneOncia is also preparing additional clinical trials to expand its indications in solid cancer."

ImmuneOncia is a biotechnology company specializing in immuno-oncology drug development, jointly established by Yuhan Corporation of Korea and a Nasdaq-listed Sorrento Therapeutics in the US. In addition to IMC-001, ImmuneOncia has a wide range of new products in the pipeline, such as IMC-002, a CD47 antibody, and IMC-201, a bispecific antibody.

Agendia Spotlights the Future of Personalized Breast Cancer Care at 2022 San Antonio Breast Cancer Symposium

On December 5, 2022 Agendia, Inc., a leader in gene expression profiling for early-stage breast cancer, reported that it has received acceptance for all six abstract submissions that will help guide the future of personalized cancer care and will be presented at the 2022 San Antonio Breast Cancer Symposium (SABCS) (Press release, Agendia, DEC 5, 2022, View Source [SID1234624815]). These studies focus on the impact of MammaPrint and BluePrint test results, unveiling the underlying biology of a breast cancer patient’s unique tumor to help inform more personalized treatment decisions. The data reaffirm Agendia’s commitment to driving the science behind early-stage breast cancer, so women and their providers have access to an accurate assessment of the tumor’s risk of metastasizing, and of which molecular pathway is driving that tumor’s growth. These informative insights come from Agendia’s proprietary signature derived directly from the tumor’s biology and go beyond conventional methods.

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Three of the studies Agendia will present are based on its FLEX trial, the largest real-world evidence database of patients with early-stage breast cancer. With over 10,000 patients enrolled, the FLEX trial allows researchers to conduct sub-studies in parallel to uncover new genomic trends and produce practice-changing results that can improve the lives of women. Because many breast cancer trials lack the diversity needed to adequately inform clear guidance on treatment recommendations for minority groups, FLEX’s inclusion of both genomic data and clinical data across a true representation of the population allows for a critical focus on the needs of diverse, marginalized patient groups.

"The value of unbiased genomic data lies in tailoring treatment plans for each individual tumor with unprecedented precision. The research derived from our FLEX trial is a key example of the type of advancements in breast cancer Agendia is helping to fuel. These critical discoveries will improve the future of personalized care for all women with breast cancer, including those who are often underrepresented in genomic studies," said William Audeh, MD, Chief Medical Officer at Agendia.

Agendia’s Spotlight Poster will showcase one such sub-study on Wednesday, December 7th at 5pm CT, "ImPrint immune signatures in 10,000 early-stage breast cancer patients from the real-world FLEX database." Dr. Adam Brufsky, Professor and Associate Chief of Hematology and Oncology at UPMC Hillman Cancer Center will present research that found Agendia’s 53-gene signature ImPrint test identified women who may benefit from immune therapy, supporting the potential use of checkpoint inhibitors, especially among populations who are underrepresented in clinical trials, including pre-menopausal patients, Black and Latina women.

Additional research areas where Agendia is advancing breast cancer research will be presented through the following FLEX sub-studies:

"FLEX: 30K transcriptome, real-world evidence database for early-stage breast cancer and investigator initiative protocols," presented on Wednesday, December 7th at 5pm CT, by Dr. Alejandra Perez, a medical oncologist from the University of Miami Hospital. Dr. Perez and the FLEX Investigators will detail the methods behind building the FLEX registry and highlight its impact on fast data generation for underserved research areas and on advancing widespread understanding of tumor biology.

"Impact of neoadjuvant endocrine therapy on tumor transcriptome in patients with early-stage breast cancer from the FLEX trial," presented on Thursday, December 8th at 5pm CT, by Dr. Mehran Habibi, Associate Professor of Surgery at Johns Hopkins University. This study evaluated the genomic effect of short-term neoadjuvant endocrine therapy (NET) in early-stage breast cancer tumors and discovered MammaPrint test results can predict patient response within a shorter timeframe than the several months it typically takes to observe immediate genomic changes.

"As the amount of robust gene expression profiling data available for research grows, so does its influence on the way we treat early-stage breast cancer tumors, and on the outcomes of millions of women with breast cancer seeking evidence-based, personalized care plans," said Dr. Adam Brufsky. "By opening up a world of data that otherwise would have been nearly impossible to gather via traditional trial recruitment, we grow our collective understanding of tumor biology and can give patients the confidence they need to trust our treatment planning decisions."

In addition to research from the FLEX database, the following three presentations will help inform personalized treatment decisions:

"Utility of the 70-gene signature and 10-year follow up in patients with early-stage breast cancer in a single institution study," presented on Thursday, December 8th at 7am CT, by Dr. Nasrazadani, Assistant Professor in the Department of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center, and Dr. Adam Brufsky. The presentation will detail findings of a retrospective analysis of women with early-stage breast cancer whose treatment plans may have changed if they had a MammaPrint test result.
On Thursday, December 8th at 10am CT in the Exhibit Product Theater, Dr. William Audeh will address leaders in oncology and highlight recent data in the Journal of Clinical Oncology that supports Agendia’s proven gene expression profiling tests can help inform the most effective treatment approaches for a woman’s unique cancer, regardless of age and menopausal status..
"Utility of the 70-gene MammaPrint test for prediction of extended endocrine therapy benefit in patients with early-stage breast cancer in the IDEAL Trial," presented on Friday, December 9th at 12pm CT, by Dr. Laura van’t Veer PhD, Professor Laboratory Medicine and Director Applied Genomics at the Cancer Center at UCSF and Founder of Agendia. During this oral presentation, Agendia will discuss the breakthrough findings uncovered by the IDEAL study and reiterate the impact of MammaPrint test results in identifying which post-menopausal women could benefit from extended endocrine therapy. The presentation will also share what these findings mean for the future of breast cancer care, most notably the ability to identify patients who can avoid overtreatment if there will be little predicted benefit.
To learn more about Agendia’s solutions being showcased at booth #315 at SABCS, visit View Source Follow Agendia on Twitter, Facebook and LinkedIn for updates throughout the conference.