On June 9, 2022 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that management will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference in Rancho Palos Verdes, CA on Wednesday, June 15th at 8:40 a.m. PT / 11:40 a.m. ET (Press release, SpringWorks Therapeutics, JUN 9, 2022, View Source [SID1234615827]).

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To access the live webcast please visit the Events & Presentations page within the Investors & Media section of the company’s website at View Source A replay of the webcast will be available on SpringWorks’ website for a limited time following the conference.

On June 9, 2022 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported data from a preclinical combination study of SON-1010 with a commercially available anti-PD1 compound (Press release, Sonnet BioTherapeutics, JUN 9, 2022, View Source [SID1234615826]). These results suggest that dosing of SON-1010 (IL12- FHAB) in combination with anti-PD1 demonstrated strong efficacy in the B16F10 mouse melanoma model, historically known as an immunologically insensitive model to anti-PD1.

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Checkpoint inhibitors provide viable treatment alternatives to chemotherapy and/or radiation for patients with solid tumors, but there remains a robust need for more effective combination treatment regimens. With the objective of improving the checkpoint inhibitor response rate, Sonnet BioTherapeutics is developing a targeted approach using the company’s Fully Human Albumin binding (FHAB) platform. The FHAB technology targets tumor and lymphatic tissue, providing a mechanism for dose sparing and an opportunity to improve the safety and efficacy profile of not only Interleukin 12 (IL-12), but a variety of synergistic and potent immunomodulators. SON-1010 is currently undergoing Phase 1 clinical study in cancer patients and this preclinical study was designed to explore the combination potential with a checkpoint inhibitor (anti-PD1).

"We are excited to see that the combination of SON-1010 with an anti-PD1 antibody yielded compelling data in this preclinical model" said Pankaj Mohan, Ph.D., Sonnet Founder and Chief Executive Officer, and further added that, "These data support our strategy of pairing SON-1010 with a checkpoint inhibitor, with the goal of developing an improved treatment option for cancer patients."

Experimental Study Design: Three randomized cohorts of nine mice (n = 27), each with 150 mm3 B16F10 melanoma tumors, were dosed with 3µg IL12-FHAB and/or 10µg anti-PD1 antibody on days 0, 4 and 8 while the placebo cohort was not treated. Mean tumor volumes were measured every two or three days through an 18-day period.

Table 1: Mean Comparisons of Tumor Volume Growth Inhibition

Test Article

Mean Tumor
Volume (mm3) – Day 14

Tumor Growth Inhibition Ratios
( % Inhibition )

Placebo (n = 9)

2260

–

Anti-PD1 antibody (n = 9)

2016

10.7%

Anti-PD1 + IL12-FHAB (n = 9)

472

79.1%

Compared to the tumor-bearing placebo group at day 14, the treatment groups administered three doses of anti-PD1 antibody or three doses of the IL12-FHAB + anti-PD1 antibody combination resulted in 10.7% and 79.1% tumor growth inhibition, respectively.

Survival data for study mice at 18 days further supports the efficacy synergy of IL12-FHAB co-injected with anti-PD1 by improving the survival rate: (i) for anti-PD1 administration, only one mouse survived out of a total of nine, and (ii) for anti-PD1 + IL12-FHAB administration, seven mice survived out of a total of nine. Additionally, the mice cohorts used in the preclinical efficacy study did not show any weight loss during the study in either the single agent or combination dosing arms.

"We are excited to have demonstrated these important data in an immunologically distinct animal model when IL12-FHAB was dosed in combination with an anti-PD1 antibody," said John Cini, Ph.D., Sonnet’s Chief Scientific Officer. "Further, this study evaluated the sequence of test article administration, whereby co-injection of IL12-FHAB and anti-PD1 antibody was optimal when compared to administration of either anti-PD1 or IL12-FHAB first. Targeting the tumor by linking IL-12 to an albumin-binding domain extends the cytokine half-life in the body, and we believe that is the key to inducing a successful local immune response in the tumor microenvironment."

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.