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Xilio Therapeutics Reports Pipeline and Business Progress and Fourth Quarter and Full Year 2021 Financial Results

On March 1, 2022 Xilio Therapeutics, Inc. (Nasdaq: XLO), a biotechnology company developing tumor-selective immuno-oncology therapies for people living with cancer, reported pipeline and business progress and reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Xilio Therapeutics, MAR 1, 2022, View Source [SID1234609247]).

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"Xilio made significant pipeline and business progress in 2021, becoming a clinical-stage organization and transitioning to a publicly traded company through the successful completion of our IPO," said René Russo, Pharm.D., president and chief executive officer of Xilio. "As we look to 2022, I am excited about the many opportunities ahead of us, including anticipated initial clinical data readouts for XTX101, our tumor-selective anti-CTLA-4 monoclonal antibody, and XTX202, our tumor-selective IL-2. In addition, we plan to submit an IND for XTX301, our tumor-selective IL-12, in the second half of the year and continue to generate new research programs by leveraging our robust platform. With our exceptional team and strong financial position, we believe we have the resources in place to advance our vision of bringing transformative immuno-oncology therapies to people living with cancer."

Pipeline and Business Progress

Cytokine Programs

●Xilio continues to advance enrollment in the Phase 1 portion of its Phase 1/2 clinical trial evaluating XTX202 for the treatment of patients with solid tumors. XTX202, a modified form of interleukin-2 (IL-2), is designed to localize activity in the tumor microenvironment, with the goal of overcoming the known tolerability challenges of existing IL-2 therapies while achieving enhanced anti-tumor activity. Xilio expects to report preliminary data from the Phase 1 portion of the trial in the second half of 2022.

●Xilio continues to progress preclinical studies for XTX301, a tumor-selective IL-12. The company plans to submit an investigational new drug application (IND) for XTX301 as a potential treatment for patients with solid tumors in the second half of 2022.

Checkpoint Inhibitor Program

●Xilio continues to advance enrollment in the Phase 1 portion of its Phase 1/2 clinical trial evaluating XTX101, a tumor-selective anti-CTLA-4 monoclonal antibody, as a monotherapy and in combination with pembrolizumab, an anti-PD-1, for the treatment of patients with advanced solid tumors. Xilio expects to report preliminary data from the monotherapy cohort of the Phase 1 portion of the trial in the middle of 2022 and preliminary data from the combination cohort of the Phase 1 portion of the trial in the second half of 2022.

Recent Business Highlights

●In January 2022, Xilio appointed Yuan Xu, Ph.D., to its board of directors.

Fourth Quarter and Full Year 2021 Financial Results

●Cash Position: Cash and cash equivalents were $198.1 million as of December 31, 2021, compared to $19.2 million as of December 31, 2020. The increase was primarily related to $144.9 million in net proceeds received from convertible preferred stock financings in the first quarter of 2021 and $116.4 million in net proceeds received from Xilio’s initial public offering in the fourth quarter of 2021. Net cash proceeds from financings were partially offset by operating uses of cash for the year ended December 31, 2021.

●Research & Development (R&D) Expenses: R&D expenses were $11.4 million for the quarter ended December 31, 2021, compared to $17.7 million for the quarter ended December 31, 2020. R&D expenses were $51.2 million for the year ended December 31, 2021, compared to $43.9 million for the year ended December 31, 2020. The year-over-year increase was primarily driven by higher personnel-related costs due to increased headcount and expenses associated with R&D programs.

●General & Administrative (G&A) Expenses: G&A expenses were $8.2 million for the quarter ended December 31, 2021, compared to $2.9 million for the quarter ended December 30, 2020. G&A expenses were $23.9 million for the year ended December 31, 2021, compared to $10.7 million for the year ended December 31, 2020. The year-over-year increase was primarily driven by higher personnel-related costs due to increased headcount and professional and consulting fees related to transitioning to and operating as a publicly traded company.

●Net Loss: Net loss was $19.7 million for the quarter ended December 31, 2021 and $75.8 million for the year ended December 31, 2021.

Financial Guidance

Xilio continues to believe that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into 2024.

PerkinElmer to Present at Upcoming Investor Conferences

On March 1, 2022 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported that the Company will present at the Cowen 42nd Annual Health Care Conference and the Barclays Global Healthcare Conference (Press release, PerkinElmer, MAR 1, 2022, View Source [SID1234609246]).

Cowen 42nd Annual Health Care Conference – Virtual
Monday, March 7, 2022
10:30 a.m. ET – Jamey Mock, senior vice president and chief financial officer

Barclays Global Healthcare Conference – Miami, FL
Tuesday, March 15, 2022
1:30 p.m. ET – Prahlad Singh, president and chief executive officer

Attendees will receive an overview of the Company and its strategic priorities.

Live audio webcasts will be available on the Investors section of the Company’s website at www.perkinelmer.com. A replay of the presentations will be posted on the PerkinElmer website after the event and will be available for 90 days following.

Seagen to Present at the Cowen 42nd Annual Health Care Conference

On March 1, 2022 Seagen Inc. (Nasdaq: SGEN) reported that management will participate in a virtual fireside chat at the Cowen 42nd Annual Health Care Conference on Monday, March 7, 2022 at 11:10 a.m. Eastern Time (Press release, Seagen, MAR 1, 2022, View Source [SID1234609245]). The presentation will be webcast live and available for replay from the investor section of Seagen’s website at investor.seagen.com.

Thermo Fisher Scientific continues collaboration to support biopharmaceutical discovery and development

On March 1, 2022 Thermo Fisher and Symphogen reported that extend their collaboration using innovative and efficient workflows to improve data confidence, aiding the creation of new cancer treatments (Press release, Lifescience Newswire, MAR 1, 2022, View Source [SID1234609244])

Thermo Fisher Scientific, the world leader in serving science, and Symphogen, an affiliate of and the antibody center of excellence within the international pharmaceutical company Servier, announce the continuation of their collaboration to provide biopharmaceutical discovery and development laboratories with innovative tools and streamlined workflows for efficient characterization of complex therapeutic proteins.

Since the collaboration began in 2018, Symphogen has adopted new and innovative instruments and software to improve data quality and processes to develop, test and routinely implement platform workflows for intact and native mass analysis of therapeutic monoclonal antibody (mAb) mixtures. Most recently, the implementation of the Thermo Scientific Orbitrap Exploris MX Mass Detector allows for the highest level of data confidence and an efficient workflow, with seamless method transfer from development instruments. This new system adds to Symphogen’s range of High-Resolution Accurate Mass (HRAM) mass spectrometry technologies, including the Thermo Scientific Q Exactive Plus Orbitrap Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) system and the Thermo Scientific Orbitrap Exploris 240 and 480 Mass Spectrometers. These systems will be controlled using the Thermo Scientific Chromeleon Chromatography Data System (CDS) software, allowing secure, remote operations and data processing from anywhere in the world, providing working flexibility and improved data protection.

"The extension of our collaborative relationship with Symphogen demonstrates our continued commitment to solve tangible scientific challenges within the biopharmaceutical industry," said Eric Grumbach, director biopharma, pharma business, chromatography and mass spectrometry, Thermo Fisher. "Further investment in this collaboration enables critical insights that feed directly into the development of new analytical tools, providing meaningful impact to the characterization of complex biotherapeutics."

Dan Bach Kristensen, principal investigator, Symphogen, said, "Mass spectrometry is playing an increasingly important role in biopharmaceutical development at Symphogen, as exemplified in 2021, when we analyzed over 10,000 biopharmaceutical samples by intact mass analysis on our Orbitrap mass spectrometers. A multitude of separation techniques are now routinely hyphenated to our mass spectrometers, providing unrivalled insight into product quality, from early discovery to late-stage clinical development."

For more information about Thermo Fisher’s chromatography and mass spectrometry workflows for biopharmaceutical characterization, please visit www.thermofisher.com/biopharma. To learn more about the collaboration between Thermo Fisher and Symphogen, please visit www.thermofisher.com/symphogen.

UroGen Submits Investigational New Drug Application Supporting Planned Phase 1 Clinical Study of UGN-301 (zalifrelimab) Intravesical Solution in Recurrent Non-Muscle Invasive Bladder Cancer

On March 1, 2022 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported the submission of an Investigational New Drug application (IND) for UGN-301 (zalifrelimab) to the U.S. Food and Drug Administration (FDA) in support of the planned initiation of a multi-arm, Phase I clinical study for its anti-CTLA4 antibody (Press release, UroGen Pharma, MAR 1, 2022, View Source [SID1234609243]). The study is expected to begin in the second quarter of 2022 and will evaluate the safety and tolerability of UGN-301 as monotherapy and in combination with other immunomodulators and chemotherapies in recurrent non-muscle invasive bladder cancer (NMIBC). This clinical program builds on encouraging preclinical data showing that intravesical administration of anti-CTLA4 and a TLR agonist leveraging the RTGel platform can produce clinical benefit in the setting of high-grade bladder cancer. It will take approximately 12 months to complete the monotherapy arm of the study.

"UroGen has shown that combination immunotherapy, when delivered intravesically, is potentially synergistic. While CTLA-4 has long been considered a good target for overcoming the immune suppression produced by tumor cells, anti-CTLA4 antibodies are associated with toxicities when administered systemically," said Mark Schoenberg, Chief Medical Officer, UroGen Pharma. "Local delivery using our RTGel proprietary technology may permit us to leverage the power of a potent antibody while avoiding the toxicity associated with intravenous administration. This is critical because anti-CTLA4 antibodies stimulate cytotoxic T cells while inhibiting suppressive T-regulatory cells, making this class a potentially more comprehensively acting immunomodulator than antibodies to PD-1 and PD-L1."

In the nonclinical study of UGN-301 in cynomolgus monkeys, UroGen assessed the potential toxicity via instillation into the urinary bladder delivered with RTGel reverse thermal hydrogel. The results showed that instillation of UGN-301 at different dose concentrations for a pre-defined period was not associated with mortality, changes in body weights, organ weight differences or meaningful changes among other endpoints, or macroscopic or microscopic findings following a specified recovery period.

According to Dr. Schoenberg, "We view intravesical delivery of our anti-CTLA4 antibody UGN-301 as a cornerstone of the urologic cancers program that we are pursuing in collaboration with MD Anderson Cancer Center, and we are thrilled at the prospect of advancing this program in the form of a multi-arm, Phase 1 study of UGN-301 in combination with other agents. We believe that this approach is unique and leverages our proprietary drug delivery technology and provides an opportunity to evaluate a variety of novel immunomodulatory drug combinations."