On December 1, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that new and updated data across its oncology pipeline will be presented at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress 2022 from December 7 to 9 in Geneva, Switzerland (Press release, Regeneron, DEC 1, 2022, View Source [SID1234624696]). Presentation highlights include first clinical results and new exploratory analyses from trials investigating LAG-3 inhibitor fianlimab and/or PD-1 inhibitor Libtayo (cemiplimab) in non-small cell lung cancer (NSCLC), melanoma and cervical cancer.

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"Our ESMO (Free ESMO Whitepaper) IO presentations reflect our continued progress toward developing a differentiated oncology pipeline with the potential to treat a variety of cancers with unique combinations," said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. "Libtayo has already proven to be an effective immunotherapy across multiple tumor types and is poised to serve as a foundational therapy for our investigational combination approaches. Fianlimab combined with Libtayo has generated early-but-promising clinical activity in advanced melanoma and non-small cell lung cancer, demonstrating the potential of Regeneron’s oncology pipeline to potentially advance the standard-of-care in various cancers."

Among the research published by ESMO (Free ESMO Whitepaper) IO today were initial results for an investigational combination of fianlimab and Libtayo in patients with unresectable stage IIIB-C or IV NSCLC. The results are from two expansion cohorts of a Phase 1 trial – one with anti-PD-1/PD-L1-naïve patients (naïve cohort) and the other with anti-PD-1/PD-L1-experienced patients (experienced cohort). Patients received fianlimab 1600 milligrams and Libtayo 350 milligrams intravenously every 3 weeks for 12 months, with a median follow up of 9 months and 5 months for the naïve and experienced cohorts, respectively.

Efficacy results demonstrated an investigator-assessed objective response rate (ORR) of 27% (4 of 15 patients; all partial responses [PR]) in the naïve cohort and 7% in the experienced cohort (1 of 15 patients with a PR). Additionally, exploratory analyses of the naïve cohort found the ORR was 50% (3 patients) among those who had not received any prior systemic therapy and 100% (3 patients) among those with tumors that had ≥50% PD-L1 expression. Median duration of response was not reached in the naïve cohort and was 5 months in the experienced cohort (95% confidence interval: not evaluable to not evaluable).

In terms of safety for the naïve and experienced cohorts, rates of ≥grade 3 adverse events (AE) were respectively 33% (5 patients) and 40% (6 patients), while rates of serious AEs were respectively 20% (3 patients) and 13% (2 patients). One patient in the naïve cohort and no patients in the experienced cohort discontinued treatment due to an AE; there were no treatment-related deaths reported in either cohort. Updated efficacy and safety data will be presented during a poster session (abstract #127P).

Other notable presentations at ESMO (Free ESMO Whitepaper) IO include:

An exploratory analysis of two expansion cohorts from a Phase 1 trial investigating fianlimab in combination with Libtayo in patients with advanced melanoma, which offer new insights on the use of this treatment combination in patients with poor prognostic features at baseline.
A post-hoc exploratory analysis of Regeneron’s Phase 3 EMPOWER trials in advanced NSCLC and advanced cervical cancer, focusing on efficacy outcomes in Libtayo-treated patients with liver metastases compared to those treated with chemotherapy alone.
An oral presentation on EMPOWER-Lung 3 Part 1, a Phase 3 trial which assessed the efficacy and safety of Libtayo plus ipilimumab and platinum-based doublet chemotherapy, compared to Libtayo plus chemotherapy, and chemotherapy alone, in patients with advanced NSCLC and <50% PD-L1 expression.
Regeneron data at ESMO (Free ESMO Whitepaper) IO

Medicine

Abstract title

Abstract

Presentation date/time

(all CET)

Lung cancer

Libtayo,
fianlimab

Phase 1 study of fianlimab: A human lymphocyte activation gene-3 (LAG-3) monoclonal antibody, in combination with cemiplimab in advanced NSCLC

#127P

December 8

12:30-13:15 pm

Libtayo

Cemiplimab (cemi) + platinum doublet chemotherapy (chemo) + ipilimumab (ipi) for first-line treatment of advanced non-small cell lung cancer (NSCLC): EMPOWER-Lung 3 part 1

#122MO

December 8

9:35-9:40 am

Libtayo

An observational study to assess the effectiveness and safety of cemiplimab in patients with advanced non-small cell lung cancer (NSCLC) in routine clinical practice within Europe (CEMI-LUNG)

#119TiP

December 8

12:30-13:15 pm

Skin cancer

Libtayo,
fianlimab

Phase 1 study of fianlimab, a human lymphocyte activation gene-3 (LAG-3) monoclonal antibody, in combination with cemiplimab in advanced melanoma (mel): subgroup analysis

#150P

December 8

12:30-13:15 pm

Ovarian cancer

Libtayo,
ubamatamab

First-in-human (FIH) Phase 1/2 study of ubamatamab, a MUC16xCD3 bispecific antibody, administered alone or in combination with cemiplimab in patients with recurrent ovarian cancer (OC)

#197TiP

December 8

12:30-13:15 pm

Advanced solid tumors

Libtayo

Liver metastases (mets) and treatment effect of cemiplimab-based therapy: An analysis from three Phase 3 trials (EMPOWER-Lung 1, EMPOWER-Lung 3 part 2, and EMPOWER-Cervical 1)

#168P

December 8

12:30-13:15 pm

The potential uses of Libtayo, fianlimab, ubamatamab and REGN6569 described above are investigational, and their safety and efficacy in these uses have not been fully evaluated by any regulatory authority. Fianlimab, ubamatamab and REGN6569 are not currently approved for use in any indication.

On November 30, 2022 RAPT Therapeutics, Inc. (Nasdaq: RAPT) ("RAPT" or the "Company"), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, reported that its abstract from its ongoing Phase 1/2 study of FLX475 as monotherapy and in combination with pembrolizumab in cancer patients has been accepted for poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Annual Congress taking place December 7-9, 2022 in Geneva, Switzerland (Press release, RAPT Therapeutics, DEC 1, 2022, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-present-flx475-phase-12-data-european-society [SID1234624694]). The presentation will include data from checkpoint inhibitor-naïve NSCLC patients treated with the combination of FLX475 plus pembrolizumab including their PD-L1 status, and patients with EBV-positive NK/T cell lymphoma treated with FLX475 monotherapy.

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Poster presentation details as follows:

Title: Phase 1/2 study of the oral CCR4 antagonist, FLX475, as monotherapy and in combination with pembrolizumab in advanced cancer
Abstract #: 187P
Session: Poster Display
Date: Thursday, December 8, 2022
Time: 12:30 – 1:15 p.m. CET
Location: Foyer ABC, Palexpo Exhibition Centre, Geneva, Switzerland
The full abstract is available for viewing on the ESMO (Free ESMO Whitepaper)-IO website at, View Source;r=st~10.

On Decemebr 1, 2022 Quest Diagnostics (NYSE:DGX), the nation’s leading provider of diagnostic information services, reported it has been awarded a group purchasing agreement for its laboratory stewardship solution with Premier Inc. (NASDAQ: PINC), a leading healthcare improvement company uniting an alliance of hospitals, health systems and providers (Press release, Quest Diagnostics, DEC 1, 2022, View Source,-Inc [SID1234624693]).

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Quest Diagnostics Incorporated logo. (PRNewsFoto/Quest Diagnostics Incorporated)

The new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier to access Quest’s laboratory stewardship solutions, including Quest Lab Stewardship Enterprise powered by hc1. The collaboration includes a streamlined, easy-to-use process designed to expedite access and integration of the solution, alleviating the traditional request for proposal (RFP) and negotiation process.

All Premier members, whether they have existing contracts for lab services with Quest Diagnostics or not, can benefit from the new Quest-Premier offering. Quest Lab Stewardship Enterprise is the only laboratory stewardship solution available for purchase through Premier. For more information on Quest’s lab stewardship solutions, please visit www.QuestLSforPremier.com.

"We know that many health systems are experiencing tremendous challenges and resource constraints as we emerge from the COVID-19 pandemic," said David Freeman, General Manager, Healthcare Analytics Solutions, Quest Diagnostics. "At Quest Diagnostics, we take a collaborative approach to provide scalable solutions that create measurable improvements in care, quality and costs. By working with Premier, we’re excited to make our innovative lab stewardship platform even more accessible to clients looking to optimize their lab testing and deliver cost-effective healthcare."

Quest Lab Stewardship Enterprise is a data and analytics platform combined with advisory services designed to provide healthcare organizations access to insights from aggregated deidentified testing data. This platform can track trends in order volume, identify areas for clinical and operational improvement, give insights into care variation, identify gaps in care, provide network insight, measure the results of interventions and discover cost-savings opportunities. In addition, the real-time analytics platform is a secure cloud-based application accessible to an entire organization. With these powerful, actionable insights, the laboratory can move from a transactional cost center to a strategic asset in the transition to high value care.

"hc1 is passionate about ensuring the right patient gets the right test at the right time resulting in a faster diagnosis and better outcomes." said Brad Bostic, chairman and CEO of hc1. "By working with Premier, I am thrilled that Quest Lab Stewardship powered by hc1 can now be adopted by thousands of additional health systems, resulting in more efficient care and tremendous cost savings for hospitals."

Premier is a leading healthcare improvement company, uniting an alliance of approximately 4,400 U.S. hospitals and 250,000 other providers to transform healthcare. With integrated data and analytics, collaboratives, supply chain solutions, consulting and other services, Premier enables better care and outcomes at a lower cost.

On December 1, 2022 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical stage company focused on developing next-generation therapeutics to target difficult-to-treat cancers, reported that it has received clearance for its two Investigational New Drug (IND) applications from the U.S. Food and Drug Administration (FDA) to initiate Phase 1 clinical trials. PYX-201, a novel antibody-drug conjugate (ADC) product candidate, will be investigated for the potential treatment of several solid tumors, including breast, head and neck, lung, and thyroid cancer (Press release, Pyxis Oncology, DEC 1, 2022, View Source [SID1234624692]). PYX-106, an immunotherapy product candidate, will be investigated for the potential treatment of solid tumors, including bladder, cholangio-carcinoma, colorectal, and kidney cancer.

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"We are thrilled to receive two nearly simultaneous IND clearances from the FDA, representing a major moment as we transition to a clinical stage company demonstrating the operational prowess of our team," said Lara Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. "We are proud of both the substantial clinical IND execution capabilities of our organization and the recent expansion of exclusivity of our ADC technology toolkit with Pfizer, both of which solidify Pyxis Oncology as a leading emerging clinical company. We believe the combination of our veteran leadership team and our cash runway into the first half of 2025 positions us to advance these potentially important therapies for patients who desperately need new options."

Jay Feingold, M.D., Ph.D., Chief Medical Officer of Pyxis Oncology, added, "We are excited to advance multiple programs to the clinic. Both product candidates could potentially be applied to a broad range of tumors and address a significant need in the community. PYX-201 represents a new potential class of ADCs with a multifaceted mechanism of action which targets a component of the tumor microenvironment that is highly expressed in a variety of solid tumors. In patient-derived xenograft (PDX) model studies of NSCLC and pancreatic cancer, the ADC delivered a highly potent payload that was shown to attack the tumor and associated cells directly in a dose-dependent manner. PYX-106 is a potential immunotherapy that has demonstrated strong activity in preclinical studies and binds to an immune-regulatory receptor, Siglec-15, that has been shown to have an immune suppressive function and shares little overlap with the most prominent IO targets, the PD-1/PDL-1 pathway. The antibody’s strong activity and its target’s unique expression suggest that PYX-106 could be valuable in both mono and combination treatment settings for a broad range of tumors. We look forward to beginning both clinical trials in early 2023."

About PYX-201-101

The first-in-human trial of PYX-201 will be a dose escalation trial to determine the recommended phase 2 dose. The study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with solid tumors known to have significant expression of EDB of fibronectin.

About PYX-106-101

The first-in-human trial of PYX-106 will be a dose escalation trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with tumors known to have significant infiltration of M2 macrophages and expression of Siglec-15 in order to determine the recommended phase 2 dose.

About PYX-201

PYX-201 is a non-internalizing ADC product candidate that binds to extradomain-B (EDB) fibronectin, an integral component of the extracellular matrix in the tumor that is overexpressed in many malignancies and is minimally expressed in most normal adult tissues. As shown in patient-derived xenograft (PDX) model studies of NSCLC and pancreatic cancer, its highly cell-permeable auristatin payload is enzymatically released after binding, which directly attacks cancer cells and other components that form the supportive tumor infrastructure. Auristatin elicits an antitumor immune response by inducing immunogenic cell death and dendritic cell maturation. While its effects are primarily due to its non-internalizing activity, a fraction of PYX-201 may also be internalized, further enhancing its antitumor activity.

About PYX-106

PYX-106 is an immunotherapy product candidate in development that blocks the activity of Siglec-15, an emerging immune suppressor expressed across a broad range of tumors. Siglec-15 expression does not overlap with one of the most common targets in immuno-oncology, PD-1, supporting its potential use alone and in combination with current immunotherapies. PYX-106 may benefit patients who do not respond to current standards of care. In preclinical studies, PYX-106 has demonstrated broad immune activation, strong binding affinity, and a 7-day half-life. Cumulatively, these advantages may translate to superior anticancer activity and more flexible dosing regimens.

On December 1, 2022 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that it will present a Trials in Progress poster related to its ADVANCED-1 Phase 1 trial at the Annual Meeting of the Society of Urologic Oncology being held in San Diego, California from November 30, 2022 through December 2, 2022 (Press release, Protara Therapeutics, DEC 1, 2022, View Source [SID1234624690]). The ADVANCED-1 study is evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment of non-muscle invasive bladder cancer (NMIBC).

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"This large addressable patient population is underserved by current treatment options which drives significant unmet need in NMIBC, and leaves room for creative therapeutic approaches such as TARA-002," said Jathin Bandari, M.D., Chief Medical Officer of Protara Therapeutics. "Based on TARA-002’s immune-potentiating mechanism of action and supportive clinical data from its predecessor compound OK-432 in multiple solid tumors, we are excited to continue our ongoing ADVANCED-1 trial exploring TARA-002 in NMIBC and look forward to expanding our clinical development program."

Details of the poster presentation are as follows:

Title: Phase 1a/b Safety Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (ADVANCED-1)
Poster Number: 191
Poster Category: Bladder 4 (Bladder Cancer > Non-Muscle Invasive Bladder Cancer)
Session Title: E-Poster Displays
Session Date and Time: Friday, December 2 at 9:00 a.m. – 10:00 a.m.
Location: Sapphire ABEFIJMN, Hilton San Diego Bayfront, San Diego, California

ADVANCED-1 is a Phase 1 dose-finding, open-label trial (NCT05085977 and NCT05085990) evaluating TARA-002 in treatment-naïve and treatment-experienced NMIBC patients with high-grade carcinoma in situ (CIS) and high-grade papillary tumors (Ta). In the initial dose escalation phase of the trial, patients will receive six weekly intravesical doses of TARA-002. The primary objective of the trial is to evaluate the safety, tolerability and preliminary signs of anti-tumor activity of TARA-002, with the goal of establishing a recommended dose for a planned Phase 2 clinical trial.

About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and LMs for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan and Taiwan by Chugai Pharmaceutical Co., Ltd.

When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a strong immune cascade. Neutrophils, monocytes and lymphocytes infiltrate the abnormal cells and various cytokines, including interleukins (IL)-2, IL-6, IL-8, IL-10, IL-12, interferon (IFN)-gamma, tumor necrosis factor (TNF)-alpha, granulocyte colony-stimulating factor, and granulocyte-macrophage colony-stimulating factor, are secreted by immune cells to induce a strong local inflammatory reaction and destroy the abnormal cells.

About Non-Muscle Invasive Bladder Cancer

Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.