On September 13, 2022 RayzeBio, Inc., a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, reported significant progress in clinical development of its lead product candidate, RYZ101 (Press release, RayzeBio, SEP 13, 2022, View Source [SID1234619513]). RYZ101 is an investigational, targeted radiopharmaceutical drug designed to deliver Actinium-225 (Ac225), a highly potent alpha-emitting radioisotope, to solid tumors expressing the somatostatin receptor (SSTR).

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The Company is enrolling patients in the Phase 1b portion of the ACTION-1 Phase 1b/3 trial of RYZ101 (NCT05477576). Safety, tolerability, and pharmacokinetics of RYZ101 will be evaluated in patients SSTR+ gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who have progressed on Lu-177 labelled somatostatin analogue therapy. Enrollment is progressing as planned and RayzeBio expects to announce data from the trial in 2023.

Additionally, RayzeBio received Investigational New Drug Application (IND) clearance from the U.S. Food and Drug Administration (FDA) to investigate RYZ101 for first-line treatment of patients with SSTR+ extensive-stage small cell lung cancer (ES-SCLC) in combination with standard of care.

RYZ101 is positioned to be the first approved Ac225 radiopharmaceutical therapy for the industry.
"Clinicians and patients are very excited about the mechanism of action of RYZ101 and the advantages it offers. Significant interest is growing to explore Ac225, a highly potent radioisotope, for treatment of solid tumors. We believe RYZ101 has strong scientific rationale for treatment of both GEP-NETs and small cell lung cancer. We are very encouraged with the level of interest we have seen in the program and look forward to reporting results from RYZ101 in due course," said Susan Moran, M.D., M.S.C.E., Chief Medical Officer of RayzeBio.

"Ac225 has the potential to provided increased efficacy compared to existing beta particle therapy, and we are excited to see the first randomized phase 3 trial evaluating an actinium labeled compound (RYZ101). ACTION-1 will study this treatment in patients with advanced neuroendocrine tumors of the GI tract and pancreas, who have limited effective treatment options. This trial will be the next step forward in improving treatment of these patients," said Dr. Thomas Hope, M.D., Vice Chair of Clinical Operations and Strategy in the Department of Radiology. Dr. Hope is the chair of the steering committee for the phase 3 portion of ACTION-1 study.

As referenced in another press release issued today, RayzeBio has raised $418 million in equity capital since inception in 2020, including $160 million raised in a Series D financing, to advance targeted radiopharmaceutical therapies for cancer.

About gastroenteropancreatic neuroendocrine tumors

Gastroenteropancreatic neuroendocrine tumors, or GEP-NETs, are rare tumors with an incidence of approximately 18,000 patients annually in the United States. Despite this low incidence, many GEP-NETs follow an indolent disease course and thus the prevalence of patients with GEP-NETs in the United States is considerably higher, but still considered an orphan disease. The prognosis for patients with GEP-NET tumors depends on tumor grade and other histopathologic characteristics. Approximately 80% of GEP-NETs express the somatostatin receptor type 2 (SSTR2). Lutathera is a targeted radiopharmaceutical therapy comprised of a somatostatin analog peptide labeled with the beta-emitting radioisotope Lutetium-177 (Lu177), which received regulatory approval for treatment of adult patients with SSTR+ GEP-NETs in Europe and the United States in 2017 and 2018, respectively. However, most patients who receive Lu177-based somatostatin therapies eventually experience tumor progression and have limited subsequent treatment options.

About RYZ101

RYZ101 is an investigational targeted radiopharmaceutical therapy, designed to deliver a highly potent radioisotope, Actinium-225 (Ac225), to tumors expressing SSTR2. RYZ101 is being evaluated in clinical studies for patients with SSTR+ GEP-NETs who have previously been treated with Lu177-based somatostatin therapies and also in patients with extensive stage small cell lung cancer. Details of the study can be found at View Source

On September 13, 2022 City of Hope, one of the largest cancer research and treatment organizations in the United States, reported that it has received a $25 million gift from Julia and George Argyros, visionary philanthropists and longtime City of Hope supporters (Press release, City of Hope, SEP 13, 2022, View Source [SID1234619512]). The transformational gift, announced by Argyros Family Foundation president Julia A. Argyros during the Sept. 10 Hope Gala, advances City of Hope’s mission to deliver world-renowned research, treatment and cancer cures to Orange County. The gala raised $2.3 million, in addition to the announcement of the Argyros family’s transformational $25 million gift to City of Hope Orange County.

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The Argyros family gift continues a decades-long legacy of extraordinary generosity and support from the family to City of Hope that has been pivotal to its evolution into a leading cancer research and treatment system.

Argyros is a treasured name at City of Hope, one that is deeply connected to the daily rhythms of the first City of Hope campus near Los Angeles. The stunning Argyros Family Garden of Hope is a testament to the importance of caring for the whole person. Julia Argyros recalls sitting in the serene space in Duarte, observing patients and families pause and reflect in a place that represents healing.

Now, in recognition of the transformational gift, the Argyros name will grace the healing garden at Orange County’s most advanced comprehensive cancer center, extending a shared commitment to healing mind, body and spirit.

The Argyros family has made deep investments in health care, education, childhood development and arts foundations across Southern California.

"We are honored to be in the position to support City of Hope, which is saving lives and expanding access to its advanced cancer care. We believe it is our privilege to give back to the community. We hope that this gift helps people get the care they need and that everyone who walks through the healing gardens at the new cancer center is filled with peace and hope," Julia Argyros said.

Robert Stone, CEO, City of Hope, and the Helen and Morgan Chu Chief Executive Officer Distinguished Chair, said Julia and George Argyros have been exceptional supporters of City of Hope for nearly 40 years, including during George’s 20-year tenure as Chair of the Arnold and Mabel Beckman Foundation.

"City of Hope’s ability to provide advanced breakthroughs in cancer care to the people of Orange County is due to visionary supporters like Julia and George Argyros who empower our scientists and physicians to rapidly discover and develop lifesaving therapies for patients," Stone said. "We remain profoundly grateful for such an important and longstanding partnership in our mission to eradicate cancer."

City of Hope, now one of the largest cancer research and treatment organizations in the United States, recently opened City of Hope Orange County Lennar Foundation Cancer Center in Irvine. It is home to acclaimed physician-scientists who solely focus on preventing, treating and curing cancer. The Argyros gift demonstrates City of Hope’s strong base of philanthropic support in Orange County.

"City of Hope came to Orange County to answer a pressing need in the community, and we are grateful for those foresighted supporters who help us ignite a movement that is changing the health care landscape," said Annette M. Walker, president, City of Hope Orange County. "Supporters like Julia and George Argyros, and everyone whose contributions are helping to make this vision possible, are evidence of the incredible support for City of Hope in Orange County. Together, we can achieve our goal of making our communities cancer-free."

A Gala Filled With Hope

The gala at the Segerstrom Center for the Arts in Costa Mesa, California, brought together leaders and luminaries to honor Julia A. Argyros and celebrate the partnership of City of Hope’s many philanthropic supporters in Orange County and nationally. The gala featured a performance by Grammy-nominated recording artist Nick Jonas.

"I am honored to lend my voice to the important cause of expanding access to world-renowned cancer care," said Jonas, whose father is a cancer survivor.

Julia and George Argyros and George Wall and family were the evening’s presenting sponsors. The Wall family supported the gala in tribute to Cathy "Cate" Roth Wall, who received exceptional care at City of Hope.

Kristin J. Bertell, chief philanthropy officer, City of Hope, expressed gratitude for the overwhelming number of philanthropic contributions to City of Hope Orange County.

"Orange County recognizes that philanthropy speeds cancer advances and makes health care transformation possible," Bertell said. "Our patients and their families cannot afford to wait when it comes to receiving lifesaving cancer treatments and care. We are deeply grateful to Julia and George Argyros, George Wall and family, Nick Jonas, and everyone who is showing remarkable generosity in helping us get tomorrow’s cures to patients who need them today."

City of Hope Is Orange County’s Most Advanced Cancer Care

City of Hope, one of only 52 National Cancer Institute-designated comprehensive cancer centers in the country, is delivering advanced treatment, research and cancer cures to Orange County’s 3.2 million people.

Patients at City of Hope Orange County Lennar Foundation Cancer Center receive fully integrated, multidisciplinary care — from prevention through survivorship — in one convenient location where every physician and staff member is solely focused on treating and curing cancer. They have access to City of Hope’s 575 physicians and more than 1,000 researchers and scientists who only focus on cancer and nearly 1,000 Phase 1-3 clinical trials conducted at City of Hope each year.

The outpatient cancer center features a suite of market-leading technology, 67 spacious exam and treatment rooms, an infusion center designed around patient preferences, and a full-service salon and specialty shopping experience. It will be seamlessly connected to Orange County’s only specialty cancer hospital, opening in 2025.

City of Hope’s Orange County cancer care network currently includes four regional clinics — two in Newport Beach, one in Huntington Beach and one in Irvine. The cancer center, the regional clinics and the planned hospital will create Orange County’s largest network dedicated exclusively to cancer treatment and cures.

To make an appointment, call 888-333-HOPE (4673). To give to City of Hope Orange County, go to CityofHope.org/giving.

On September 13, 2022 METiS Therapeutics, a Boston-area company integrating drug discovery and delivery with AI and machine learning, reported they have entered a license agreement with Voronoi, Inc., a Korean company focused on precision medicine (Press release, MêTiS Biotechnologies, SEP 13, 2022, View Source [SID1234619511]). Under the terms of this license agreement, METiS will receive exclusive license to develop and commercialize Voronoi’s pan-RAF inhibitor program worldwide. In exchange, Voronoi will receive up to $1.7 million in upfront cash and success-based near-term discovery milestones. Voronoi will also be eligible for success-based payment up to $480.5 million in development, regulatory and sales milestones and tiered royalties based on annual net sales.

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"We view this program as a potential best-in-class asset addressing high unmet clinical needs for Class II and Class III BRAF mutant cancer patients, particularly those with CNS metastasis," said Chris Lai, Co-Founder and CEO of METiS Therapeutics. "We see it as a compelling proof-of-concept opportunity for our AiTEM platform to improve compound pharmacokinetics and deliver a differentiated profile, including CNS penetration. In addition, we view this as a foundational asset for our oncology portfolio."

BRAF is a protein kinase involved in cancer cell growth and BRAF mutations are the most common mutation found in tumor cells1. While several BRAF v600E inhibitors have been approved, this mutation only represents about 45% of total BRAF mutations, compared to Class II and III mutations which represent 55 percent of total BRAF mutations. This underscores the need for new therapeutic options in this space.

"We developed our structurally distinguished type II pan-RAF inhibitor to address unmet medical needs, and this partnership brings us closer to our goal of delivering this candidate to patients," says Daekwon Kim, CEO of Voronoi. "We are excited to partner with METiS’ seasoned team to continue on development of our pan-RAF inhibitor," added Daekwon.

This news follows METiS’ announcement that the company had joined the Roche Accelerator earlier this year. In December, METiS closed an $86 million Series A financing round. The company recently leased 14,000 square feet of mixed office and laboratory space at 101 Cambridgepark Drive in Cambridge, MA.

On September 13, 2022 One Biosciences, a biotech company co-founded by Dr. Céline Vallot, Institut Curie and Home Biosciences, combining the power of AI and single-cell technologies to discover new therapeutic targets and develop novel precision medicines, reported that it initiated the LARYCARE prospective clinical study for single-cell profiling of larynx and hypopharynx carcinoma (Press release, One Biosciences, SEP 13, 2022, View Source [SID1234619510]).

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This new study aims at better understanding, with unprecedented granularity of information, the mechanisms involved in neoadjuvant chemotherapy response and resistance. The objective is to identify new predictive biomarkers of the response to neoadjuvant treatment in advanced larynx and hypopharynx carcinoma as well as discover potential new targeted therapies. One Biosciences will evaluate samples from patients enrolled at the Hartmann Clinic and Paris Saint-Joseph Hospital, in partnership with the Research Center of Institut Rafaël (Institut Rafaël Centre de Recherche).

This clinical study follows a first program launched in May 2021 in collaboration with Institut Curie in high grade serous ovarian cancer patients, aiming to identify new precision medicines, evaluating samples from the Institute’s SCANDARE trial.

One Biosciences has completed a seven million euros financing initiated at its inception in July 2020 with Home Biosciences, an asset centric biotech company, itself backed by US-based Redmile Group and France-based Sofinnova Partners, two leading VCs in the field of biotech. One Biosciences has also benefited from BPI France’s support through non-dilutive grants (BFTE, PIA and Aide au Développement DeepTech).

Dr Céline Vallot, co-founder and chair of One Biosciences’ Scientific Advisory Board, said: "Single-cell analysis of tumor tissues during treatment now allows researchers to access an unprecedented level of understanding of cellular mechanisms at work in cancer patients. Using unique molecular technologies and proprietary artificial intelligence algorithms, One Biosciences maps tumors with an unmatched resolution to shed light on new biological markers, making it possible to anticipate the response of each patient to chemotherapy. Our technological platform also paves the way for the development of ultra-targeted therapies against cancers and complex diseases that are difficult to treat."

Dr. Magali Richard, co-founder of Home Biosciences and CEO of One Biosciences, said "We have assembled a unique discovery engine in a record timeframe. We are now pursuing our aggressive growth trajectory with two programs already ongoing and two new projects to be soon initiated in high unmet medical needs. We are in line with our initial roadmap and reaffirm our ambition to make One Biosciences a leader in AI and single-cell powered therapeutics development."

One Biosciences is supported by a strong multidisciplinary Scientific Advisory Board, chaired by Dr. Céline Vallot, One Biosciences’ co-founder, who was awarded, on June 16, 2022, the prestigious CNRS Innovation medal. One Biosciences’ SAB is composed of Alexandre Gramfort, PhD Research Director in artificial intelligence at Inria, Sophie Postel-Vinay, MD/PhD, Senior Medical Oncologist – Clinician Scientist, Drug Development Department (DITEP), Team Leader ATIP U981 INSERM at Gustave Roussy Cancer Campus and Julien Zuber, MD/PhD, Transplant nephrologist at Necker Hospital and Professor of Clinical Immunology at Paris Descartes University.

On September 13, 2022 ProMIS Neurosciences, Inc. (Nasdaq: PMN) (TSX: PMN), a biotechnology company focused on the discovery and development of antibody therapeutics targeting misfolded proteins such as toxic oligomers, implicated in the development of neurodegenerative diseases, reported that it has appointed Gail M. Farfel, Ph.D., as Chief Executive Officer, effective September 19, 2022 (Press release, ProMIS Neurosciences, SEP 13, 2022, View Source [SID1234619509]).

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"The past 18 months have been transformative for ProMIS," stated Eugene Williams, ProMIS Chairman and Co-Founder. "During this period, we achieved strong capital formation led by a prominent group of Boston-based investors, and with tremendous shareholder, support accomplished our goal of listing ProMIS on Nasdaq. We also have expanded and strengthened our Board of Directors, with the addition of three industry veterans as Independent Directors: Josh Mandel-Brehm, Dr. Maggie Shafmaster, and Neil Warma. Our amyloid oligomer-selective lead therapeutic antibody candidate for Alzheimer’s disease (AD), PMN310, is poised for IND submission by year end and we have continued to expand our portfolio of antibody and therapeutic vaccine candidates targeting other neurodegenerative diseases. We have also continued to expand our strong management team, having added to the team earlier this year Dr. Larry Altstiel as Chief Medical Officer and, in late 2021, Gavin Malenfant as Chief Operating Officer. Perhaps the most important of these transformational accomplishments is bringing on Gail Farfel as CEO."

"Gail has a distinguished track record of accomplishments in both large pharma and biotech, and she has invaluable expertise in neurologic disease drug development. After an extensive search, we are confident that under Gail’s leadership ProMIS can achieve its tremendous potential. ProMIS’ Board and management welcome her to the CEO role as we work to complete the transition to a clinical stage, multi-product, Nasdaq listed company," added Gene Williams.

"I am honored and excited to take on the role of CEO at ProMIS," remarked Gail Farfel. "There is a rapidly growing number of emerging companies in the neurology space, an area of tremendous growth, but I feel ProMIS is uniquely well-positioned to make a meaningful contribution to the field. A very strong foundation has been built, anchored on a unique discovery platform, giving us the potential to advance what we believe to be differentiated products to address urgent unmet medical needs. I look forward to working with this impressive team and to providing my leadership as ProMIS seeks to become a clinical phase biotechnology company with multiple development opportunities."

Gail M. Farfel, Ph.D., is an accomplished pharma development and regulatory leader with over 25 years of experience in large and small pharma, including venture-backed and public companies. Gail has a strong record of accomplishments in neuropsychiatric clinical development and global regulatory submissions, including multiple successful investigational new drug (IND), new drug application (NDA) and marketing authorization application (MAA) registrations, U.S. Food and Drug Administration (FDA) Advisory Committee experience, and three successful global "first" indications. On the business side, Gail has played leadership roles in strategic planning and commercial positioning for partnership and launch, IPO, fundraising for publicly traded and private companies, and licensing and asset integration.

Prior to joining ProMIS, Gail served as Executive Vice-President and Chief Development Officer of Zogenix Inc, where she delivered successful Phase 3 programs in Dravet syndrome and Lennox-Gastaut syndrome (LGS), leading to approvals from FDA (Dravet and LGS) and European Medicines Agency (EMA) approval for Fintepla in 2020 and 2021. Further, while an executive at Zogenix she supported capital raises in excess of US $700M; the acquisition of Modis Therapeutics; the alliance with Tevard Biosciences; and the acquisition of Zogenix by UCB Pharma in March 2022. In her earlier career, Gail held positions of increasing responsibility at Smithkline Beecham, Pfizer, Novartis, G. Meredith Consulting and Marinus Pharmaceuticals. Gail obtained her Ph.D. in neuropsychopharmacology from the University of Chicago.