Mural Oncology Launches to Advance Pipeline of Novel Engineered Cytokine Immunotherapies

On November 20, 2023 Mural Oncology plc (Nasdaq: MURA) reported to have launched as an independent, publicly traded, clinical-stage immuno-oncology company leveraging its core competencies in immune cell modulation and protein engineering to develop novel, investigational engineered cytokine therapies designed to address areas of unmet need for patients with a variety of cancers (Press release, Mural Oncology, NOV 15, 2023, View Source [SID1234637844]). Mural’s ordinary shares will begin trading on the Nasdaq Global Market tomorrow, November 16th, under the ticker symbol "MURA".

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"Immunotherapies have made a tremendous impact on the treatment of cancers over the past decade," said Caroline Loew, Ph.D., the Company’s chief executive officer. "Unfortunately, many patients either do not respond or do not have durable responses. We believe Mural Oncology can lead the future of immunotherapies for patients. Our protein engineering expertise allows us to reimagine the development of pro-inflammatory cytokine-based therapeutics that could address the key limitations with current cancer immunotherapies. I am thrilled to lead this company and am energized by the enormous potential of our lead clinical candidate, our preclinical programs, and our underlying protein engineering capabilities."

Mural Oncology’s pipeline is built to address difficult-to-treat tumor types where checkpoint inhibitors are not effective. The Company’s lead product candidate, nemvaleukin alfa (nemvaleukin), is an investigational, engineered interleukin-2 (IL-2) cytokine designed to capture and expand the therapeutic benefits of high-dose recombinant human IL-2 (rhIL-2), while mitigating the hallmark toxicities of native IL-2 in difficult-to-treat cancers with high unmet need. Nemvaleukin is currently in two potentially registrational studies: one for the treatment of mucosal melanoma as a monotherapy and one for the treatment of platinum-resistant ovarian cancer (PROC) in combination with pembrolizumab.

In addition to nemvaleukin, Mural Oncology has discovery-stage programs in IL-18 and IL-12, focused on proinflammatory cytokines that leverage the Company’s immune cell modulation expertise and protein engineering capabilities. This multi-faceted approach to cytokine engineering is aimed at maximizing the utility of identified cytokines and includes binding selectivity, tumor-targeting, half-life modification, and stable fusion proteins.

"We believe nemvaleukin has the potential to reduce native IL-2’s toxicities, potentially allowing greater tolerability and efficacy than other IL-2 molecules have shown in the past," Dr. Loew continued. "We plan to report top-line results in each of mucosal melanoma and PROC in the first quarter of 2025 and declare product candidates across both of our other discovery-stage programs in 2024. We are building on years of foundational work from which our engineered cytokines may lead to new therapies for significant patient populations where checkpoint inhibitors either failed to achieve a response or produced a limited response. We believe these new therapies could be effective either as monotherapies or in combination with a range of other therapeutics."

To advance the Company’s pipeline and capitalize on its protein engineering capabilities, Mural has assembled an experienced and highly accomplished executive team and board of directors.

Mural Oncology’s executive officers:

Caroline Loew, Ph.D., chief executive officer, was previously president and chief executive officer of Glympse Bio. Prior to Glympse, she was vice president, head of R&D strategy and planning at Bristol-Myers Squibb (BMS). Dr. Loew joined BMS following leadership roles at Merck and PhRMA, where she led teams responsible for commercial portfolio management, market access, and regulatory policy.
Adam Cutler, chief financial officer, was previously chief financial officer of both Q32 Bio and Molecular Templates. Prior to that, he was senior vice president of corporate affairs at Arbutus Biopharma.
Vicki Goodman, M.D., chief medical officer, was previously executive vice president, product development & medical affairs, and chief medical officer of Exelixis. Previously, she was vice president, clinical research and therapeutic area head, late-stage oncology at Merck where she oversaw the company’s late-stage development portfolio, including pembrolizumab. Prior to Merck, she was a member of BMS’s oncology senior leadership team, managing a team developing nivolumab and ipilimumab.
Maiken Keson-Brookes, chief legal officer, previously served as chief legal officer and corporate secretary of Rubius Therapeutics. Prior to joining Rubius, she served as General Counsel at Synlogic, uniQure, and Forum Pharmaceuticals.

Nykode Therapeutics – Quarterly report Q3 2023

On November 15, 2023 Nykode Therapeutics reported its third quarter 2023 financial results (Presentation, Nykode Therapeutics, NOV 15, 2023, View Source [SID1234637726]).

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Seneca Therapeutics Announces Publication of TEM8 Review Article “TEM8 in Oncogenesis” in Cells Journal

On November 15, 2023 Seneca Therapeutics, Inc., reported the publication of "TEM8 in Oncogenesis" in Cells (Press release, Seneca Therapeutics, NOV 15, 2023, View Source [SID1234637723]). The authors are Dr. Samuel Kareff and Dr. Aman Chauhan from Sylvester Cancer at University of Miami, Dr. Virginia Corbett from Mt. Sinai Tisch Cancer Center and Dr. Paul Hallenbeck from Seneca Therapeutics.

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"In the article, we underline TEM8’s prognostic and predictive abilities in various solid tumors by (1) highlighting its association with more aggressive disease biology and poor clinical outcomes and (2) assessing its associated clinical trial landscape," said Dr. Aman Chauhan. "Finally, we offer future directions for clinical studies involving TEM8, including incorporating preclinical agents into clinical trials and combining previously tested oncologic therapies with currently available treatments, such as immunotherapy."

"The evidence of TEM8’s abilities and role in a broad range of solid tumors continues to grow," said Dr. Paul Hallenbeck. "This review article provides an excellent update on both TEM8, ANTXR1 – the gene that encodes TEM8 – and SVV-001 which targets TEM8. This update provides a foundation for upcoming publications and clinical trials for SVV-001 and TEM8."

Seneca Therapeutics is developing SVV-001, a number of SVV-001 armed constructs and a multiple IV option for SVV-001 sensitive solid tumors. SVV-001 sensitivity is defined as high ANTXR1 (TEM8) expression and a microtumor environment which permits replication of SVV-001 in the tumor. Seneca has developed an SVV-001 Companion Diagnostic and received FDA clearance to use it in clinical trials to identify patients that would benefit from SVV-001.

Foundation Medicine Announces Collaboration with Pierre Fabre Laboratories to Develop Companion Diagnostics in Non-Small Cell Lung Cancer

On November 15, 2023 Foundation Medicine, Inc., and Pierre Fabre Laboratories reported a collaboration to develop Foundation Medicine’s high-quality genomic tests, FoundationOneCDx and FoundationOneLiquid CDx, as companion diagnostics for new targeted therapies to treat patients with non-small cell lung cancer (NSCLC) (Press release, Foundation Medicine, NOV 15, 2023, View Source [SID1234637722]). The companies will work collaboratively to seek the regulatory approval for Foundation Medicine assays which detect mutations including BRAFV600E to identify patients for potential treatment with Pierre Fabre Laboratories’s BRAF/MEK inhibitor combination regimen, BRAFTOVI (encorafenib) and MEKTOVI (binimetinib), in the European Union. This combination therapy is currently under evaluation by the European Medicines Agency for patients with BRAFV600-mutant advanced NSCLC and was evaluated in a clinical trial sponsored by Pfizer and supported by Pierre Fabre.

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Lung cancer – the number one cause of cancer deaths worldwide – remains an area of high unmet need notably for those people living with BRAFV600E mutations, which occur in approximately 2% of all non-small cell lung cancer.1 FoundationOne CDx and FoundationOne Liquid CDx are U.S. Food and Drug Administration (FDA) approved in-vitro diagnostics used to identify potentially targetable mutations, including BRAF, in blood- and tissue-based solid tumor samples.

"Today, as the number of indications and approvals in oncology grow rapidly, companion diagnostics provide information that is critical for the safe and effective use of targeted therapies. And that’s why we are excited to work with Foundation Medicine," said Núria Perez-Cullell, Head of Medical and Patient Consumer Department, Pierre Fabre Laboratories. "Thanks to those companion diagnostics, physicians will have comprehensive, reliable information about what is driving a patient’s cancer, such as BRAFV600E mutations, so they can make personalized treatment decisions."

Foundation Medicine has the only FDA-approved portfolio of comprehensive genomic profiling tests offering physicians both blood- and tissue-based testing options for detecting genomic alterations like BRAFV600E to help guide personalized treatment decisions. Foundation Medicine has demonstrated initial success in navigating the new In Vitro Diagnostics Regulation (IVDR) in Europe through activation of dozens of global clinical studies or using patient samples from over 20 European Union member states in compliance with IVDR Authorization and Notification pathways.2

"High-quality companion diagnostics play a crucial role in helping physicians match their patients with targeted treatment options," said Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine. "We are excited to support Pierre Fabre Laboratories in offering more treatment options for cancer patients, and to increase access to precision therapies in the European Union."

RefleXion Announces Initial Close of $105M Fundraising to Commercialize New Cancer Treatment

On November 15, 2023 RefleXion Medical, a therapeutic oncology company, reported the initial closing of a $105M equity raise, led by The Rise Fund, TPG’s multi-sector global impact investing strategy (Press release, RefleXion Medical, NOV 15, 2023, View Source [SID1234637721]). These new funds will allow RefleXion to extend commercialization of its breakthrough SCINTIX therapy for treating all stages of indicated solid tumor cancers, including metastatic disease.

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"Closing an equity round of this size strongly affirms the conviction of our new and existing investors in fueling innovation for breakthrough treatment options, like SCINTIX therapy, in the battle against cancer," said Todd Powell, president and chief executive officer at RefleXion. "TPG’s support has been foundational in our journey, and we are gratified that they are leading a significant investment in RefleXion.

"We also welcome the support and contributions from new investors, including, Pictet and Square Point Capital," continued Powell.

In addition to TPG, existing RefleXion investors participating in the round include Ally Bridge, global pharmaceutical leaders, Pfizer Ventures and Johnson & Johnson Innovation (JJDC Inc.), funds and accounts advised by T.Rowe Price Associates, Inc., Venrock, Catalio and Hillenbrand.

"RefleXion is singularly focused on expanding the world of radiotherapy to include patients with all stages of disease, not just early-stage patients," said Matthew Hobart, co-managing partner of TPG Growth who leads the investment in RefleXion on behalf of TPG’s Rise Fund. "We are delighted to see RefleXion reach a stage where they can accelerate their impact and deliver treatment and outcomes at scale. We look forward to continuing to work with Todd and the team to support RefleXion’s growth."

SCINTIX is the first and only technology designed to transform an injected radiotracer into real-time signals that drive autonomous radiotherapy. In doing so, SCINTIX therapy becomes the first unified solution that overcomes targeting and motion management, two of the longest-standing barriers to using radiotherapy for definitive treatment of metastatic disease. SCINTIX therapy is delivered via the RefleXion X1 platform, the world’s only dual-treatment modality platform that also offers image-guided radiotherapy for treating early-stage disease.