On June 9, 2022 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat ESR1-mutated metastatic breast and gynecological cancers, reported that it will host a virtual update on its ELAINE Phase 2 clinical programs on Wednesday, June 15 at 10:00 a.m. EDT (Press release, Sermonix Pharmaceuticals, JUN 9, 2022, View Source [SID1234615825]).

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The event will feature presentations from Key Opinion Leaders (KOLs) Sarah Sammons, M.D. (Duke University) and Senthil Damodaran, M.D., Ph.D. (The University of Texas MD Anderson Cancer Center) who will discuss lasofoxifene, Sermonix’s investigational treatment for metastatic breast cancer with an acquired estrogen receptor 1 (ESR1) mutation.

Dr. Sammons will provide an overview of the ELAINE-1 study, an open-label, randomized, multicenter study evaluating the activity of lasofoxifene versus fulvestrant (the current standard of care) in patients who have progressed following treatment with an aromatase inhibitor (Al), including in combination with a CDK 4/6 inhibitor.
Dr. Damodaran will then provide an analysis of efficacy and safety data from the ELAINE-2 study, an open-label multicenter study evaluating lasofoxifene in combination with Lilly’s CDK 4/6 inhibitor abemaciclib (VERZENIO), which was provided by Eli Lilly and Co for the study.
Following Dr. Damodaran and Dr. Sammons’ presentations, the Sermonix leadership team will provide a company overview and update.

Interested participants are required to register in advance for the event and may do so here.

Key Opinion Leader Biographies

Sarah Sammons, M.D.

Sarah Sammons, M.D. is currently an assistant professor of medicine at Duke University/Duke Cancer Institute. Her clinical focus is in breast medical oncology and she has expertise in treating patients with all subtypes of metastatic breast cancer. She serves as assistant director of breast cancer clinical research at Duke Cancer Institute and as breast leader for the Centers of Brain Metastases and the Cancer Immunotherapy Research.

Her research focuses on the development of novel therapies for the treatment of metastatic breast cancer. She has designed and implemented several institutional, national and international clinical trials in advanced breast cancer. She also has a translational focus on understanding breast tumors that may respond to immunotherapeutic strategies and how to enhance them.

Senthil Damodaran, M.D., Ph.D.

Senthil Damodaran, M.D., Ph.D. is a medical oncologist/physician scientist with expertise in breast cancers, cancer genomics and development of novel targeted therapies. Dr. Damodaran serves as assistant professor in breast medical oncology with a joint appointment in investigational cancer therapeutics at MD Anderson Cancer Center.

He focuses on 1) genomics-driven clinical trials, 2) application of genomics for target discovery in breast cancers, and 3) characterization of secondary drug resistance mechanisms. At MD Anderson, he led their department’s genomic-directed clinical/translational efforts.

Dr. Damodaran is actively involved in several National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) initiatives. He serves as the chair for the NCI MATCH (Molecular Analysis for Therapy Choice) trial (Sub-protocol Z1F) and co-chair for upcoming ComboMATCH studies. He also serves as PI for genomically matched NCI-ETCTN study evaluating copanlisib in combination with trastuzumab and pertuzumab in HER2 +ve MBC with PIK3CA or PTEN alterations. Additionally, Dr. Damodaran serves as PI for the INTERACT study, which employs real-time ctDNA monitoring to identify secondary ESR1 alterations as well as genomically targeted study of futibatinib (TAS120) in MBC patients with FGFR amplifications. He also serves as the co-lead for post-mortem tissue collection protocol for metastatic breast cancer, a first of its kind at MD Anderson. In addition, he serves on the ABIM/ASCO Breast Question Writing group and the ASCO (Free ASCO Whitepaper) biomarker expert panel.

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

On June 9, 2022 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, reported that the company will participate in the 43rd Annual Goldman Sachs Global Healthcare Conference (Press release, Revolution Medicines, JUN 9, 2022, View Source [SID1234615824]). Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines, will be the featured participant in a live fireside chat at the event.

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Details of the company’s participation are as follows:

Conference Date: June 13 – 16, 2022
Fireside Chat Details: 1:20 p.m. Pacific on Wednesday, June 15, 2022
A live webcast of the fireside chat can be accessed at: View Source An archived replay of the webcast will be available on the investors section of the company’s website for at least 14 days following the event.

On June 9, 2022 Genmab A/S (Nasdaq: GMAB) reported that it has commenced a new arbitration under its license agreement with Janssen Biotech, Inc. (Janssen) for daratumumab (Press release, Genmab, JUN 9, 2022, View Source [SID1234615823]).

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This new arbitration follows from the award in the prior arbitration, where the tribunal ruled in favor of Janssen on the question as to whether Genmab is required to share in Janssen’s royalty payments to Halozyme Therapeutics, Inc. for its technology used in the subcutaneous formulation of daratumumab (marketed as DARZALEX FASPRO in the United States), cf. Company Announcement No 14. The tribunal based its ruling on the finding that DARZALEX FASPRO constitutes a new licensed product under the license agreement.

In this new arbitration, Genmab is consequently seeking an award of $405 million plus interest in accrued milestone payments for DARZALEX FASPRO and a declaration that it is entitled to a new 13-year royalty term from the date of DARZALEX FASPRO’s first commercial sale.

Under the agreement, the arbitration will be conducted in New York pursuant to the rules of the CPR Institute for Dispute Resolution for Non-Administered Arbitration before a panel of three arbitrators. While Genmab intends to vigorously enforce its rights, the outcome of any arbitration proceeding, as well as its duration, is inherently uncertain. The arbitration will be confidential, subject to the parties’ disclosure obligations under applicable law. Other than pursuant to these obligations, Genmab does not intend to comment or provide additional information regarding the arbitration until an award on the merits or other material order is issued in the arbitration or the arbitration is otherwise concluded. While the arbitration is pending, Genmab’s various collaborations with Janssen will continue.

On June 9, 2022 Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, reported the close of a US$126 million Series A financing round (Press release, Tessa Therapeutics, JUN 9, 2022, View Source [SID1234615822]). Polaris Partners led the financing with participation from existing investors, including Temasek, EDBI, Heliconia Capital and Heritas Capital. In conjunction with the financing, Amy Schulman and Darren Carroll, Managing Partners at Polaris Partners, have joined Tessa’s Board of Directors.

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Tessa plans to use the proceeds from the financing to advance the ongoing clinical development of the company’s autologous CD30-CAR-T therapy (TT11) and allogeneic CD30.CAR EBVST therapy (TT11X) programs. The CD30-CAR-T clinical trial supplies will be manufactured in Tessa’s newly qualified state of the art commercial cGMP facility.

"Completion of this financing with leading global healthcare investors is an important inflection point in the growth of Tessa and adds to the momentum surrounding the company following the presentation of clinical data from our TT11 and TT11X programs at the 63rd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper)," stated John Ng, CTO and Acting CEO of Tessa Therapeutics. "As we look to 2022 and beyond, Tessa is poised to emerge as a true leader in the cell therapy industry given the significant potential of our autologous and allogeneic cell therapy platforms combined with the scale and sophistication of our technical operations. This financing will be instrumental to helping us achieve several key near-term milestones, including the initiation of a pivotal clinical trial of our TT11 program and advancement of our TT11X program."

"We are very pleased to have secured this significant round of financing from such a highly regarded syndicate of global healthcare investors, including Temasek and Polaris Partners," said Göran Ando, M.D., Chairman of the Board of Tessa Therapeutics. "Additionally, we are excited to welcome Amy Schulman and Darren Carroll of Polaris to our Board of Directors and look forward to benefitting from their substantial industry experience and business acumen as Tessa enters an important period of growth as we advance our pipeline of revolutionary cell therapies through the clinic to patients in need."

"We are delighted to lead this financing in Tessa Therapeutics to enable the acceleration of the company’s corporate and clinical development activities," said Ms. Schulman. "Tessa is at an exciting point with two differentiated clinical-stage programs pursuing novel approaches for the treatment of CD30-positive lymphomas. We look forward to working with the Tessa team and the Board of Directors in developing the next generation of cancer cell therapies."

Tessa’s lead program TT11, is an autologous CD30 chimeric antigen receptor T-cell (CAR-T) therapy that harvests the patient’s own T-cells and modifies them to target cancer cells expressing the CD30 protein, a well-validated lymphoma target. Clinical data from the pilot stage of the ongoing Phase 2 CHARIOT trial of TT11 presented at ASH (Free ASH Whitepaper) demonstrated a favorable safety profile and promising efficacy in relapsed or refractory CD30-positive classical Hodgkin lymphoma (cHL) patients, with a complete response (CR) rate of 57.1 percent and an overall response rate (ORR) of 71.4 percent. Tessa expects to advance to the pivotal Phase 2 CHARIOT trial later this year.

A second program TT11X, is based on Tessa’s proprietary allogeneic CD30.CAR EBVST platform. The platform overcomes toxicity challenges common to "off the shelf" cell therapies such as Graft vs Host Disease (GVHD) by using allogeneic Virus specific T-cells (VSTs) augmented with CD30-CAR.

Allogeneic VSTs have demonstrated strong safety profile and efficacy in early trials. Clinical data from an ongoing Phase 1 study (NCT04288726) of TT11X also presented at ASH (Free ASH Whitepaper) demonstrated a favorable safety profile and encouraging signs of efficacy with clinical responses observed in seven out of nine patients, including a complete disappearance of tumor reported in four patients.

Mr. Ng continued, "The data presented at ASH (Free ASH Whitepaper) demonstrate the potential of our autologous and allogeneic cell therapy platforms and provide a strong foundation for Tessa to build on as we advance these clinical programs. We believe that Tessa’s CD30-CAR-T therapy, TT11, with its promising efficacy and excellent safety profile, may addresses current gaps in the treatment of relapsed or refractory cHL. Meanwhile, our allogeneic platform appears to overcome toxicity challenges common to ‘off the shelf’ cell therapies by using allogeneic VSTs. Our long-term goal is to develop this platform to tackle a broad range of cancers."

On June 9, 2022 Tempus, a leader in artificial intelligence and precision medicine, reported a new collaboration sponsored by Eli Lilly and Company designed to provide broader access to genomic testing to patients with advanced/metastatic non-small cell lung cancer (NSCLC) (Press release, Tempus, JUN 9, 2022, View Source [SID1234615820]). Leveraging Tempus tests, this collaboration is intended to help physicians understand the benefits of broad-panel genomic sequencing through clinical practice guidelines.

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In advanced metastatic NSCLC, 47% of patients harbor an actionable biomarker that cannot fully be detected by single analyte testing.1 Tempus and Eli Lilly aim to expand access to genomic testing by removing cost as a barrier for patients to receive molecular profiling.

"This collaboration aims to provide eligible NSCLC patients access to our genomic tests, to help reduce disparities in biomarker testing and assist physicians in making data-driven treatment decisions," said Mike Yasiejko, Executive Vice President, Oncology at Tempus. "We look forward to working with Lilly in supporting physicians in identifying the optimal therapeutic path for each of their patients."

Physicians will have the option of using the Tempus xT broad-panel genomic sequencing assay, designed to detect actionable alterations by sequencing tumor samples with matched normal saliva or blood samples, for their NSCLC patients. For patients where tissue is unavailable or is not sufficient to conduct broad-based tissue testing, Tempus’ xF liquid biopsy is available as an alternative. Physicians also will be able to order select immunohistochemistry (IHC) staining. To learn more, visit here.

"Genomic testing allows oncologists to more accurately select effective treatments for patients," said Anthony (Nino) Sireci, M.D. vice president, clinical biomarker and diagnostics development, Loxo Oncology at Lilly. "We look forward to supporting these efforts alongside Tempus to increase accessibility to biomarker testing and potentially create better outcomes for patients."