On January 10, 2022 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported that highlighted its 2021 corporate achievements and outlined its expected milestones for 2022 (Press release, Elevation Oncology, JAN 10, 2022, View Source;utm_medium=rss&utm_campaign=elevation-oncology-highlights-2021-achievements-and-outlines-expected-2022-milestones [SID1234605454]). Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer, will present these corporate priorities on Wednesday, January 12, 2022, at 9:45 a.m. ET at the virtual 40th Annual J.P. Morgan Healthcare Conference.

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"In 2021, Elevation Oncology made outstanding operational progress, marked by the advancement of seribantumab in the Phase 2 CRESTONE study, a successful initial public offering, strong growth in building an industry-leading team, and the launch of a novel partnership with Caris Life Sciences to accelerate the identification of new, actionable genomic targets for potential future drug development," said Dr. Leland. "Looking ahead, 2022 is set to be a transformative year with the planned reporting of our initial clinical data for seribantumab on approximately 10 patients from Cohort 1 in the Phase 2 CRESTONE study in mid-2022. A priority throughout 2022 is to execute on our strategy aimed at expanding our product candidate pipeline, including maximizing the potential of seribantumab, advancing new discoveries through our Caris Life Sciences collaboration, and progressing our ongoing business development activities. We believe we are well-positioned to deliver on our mission to advance precision medicines for patients with genomically defined cancers."

2021 Key Corporate Achievements

Seribantumab

Launched new global clinical trial sites with the Phase 2 CRESTONE study now enrolling patients across the US, Australia, and Canada
Announced an investigator-presented case study under a compassionate use program that highlighted a patient with pancreatic cancer harboring an NRG1 fusion and treated with seribantumab which showed a confirmed partial response and durable clinical benefit
Established 3 grams weekly as the optimized dose for the Phase 2 CRESTONE study
Presented new preclinical data on additional tumor models harboring an NRG1 fusion at AACR (Free AACR Whitepaper) 2021
Published a preclinical manuscript on the effect of seribantumab in NRG1 fusion models in Clinical Cancer Research
Business Objectives

Entered into a joint discovery and development collaboration with Caris Life Sciences whereby the partners will utilize the diagnostic data to accelerate the identification of new, actionable genomic alterations for potential future drug development
Formed new strategic diagnostic collaborations bringing the total diagnostic consortium to a total of 10 patient identification collaborators for the Phase 2 CRESTONE study
Completed a successful initial public offering, raising $106.5 million in gross proceeds, before deducting underwriting discounts, commissions, and estimated offering expenses
Strengthened corporate leadership team with the addition of Joseph Ferra as Chief Financial Officer, the promotion of Valerie Malyvanh Jansen, MD, PhD to Chief Medical Officer and the appointment of R. Michael Carruthers to the Board of Directors
Expected 2022 Milestones and Operational Objectives

Complete enrollment of the first 20 patients in Cohort 1 of the CRESTONE study in mid-2022
Present initial clinical data from approximately 10 patients from Cohort 1 of the CRESTONE study treated with seribantumab at 3 grams weekly at a major medical meeting in mid-2022
Ongoing target evaluation and continued execution of our strategy for future pipeline expansion
Financial Outlook

Elevation Oncology anticipates that cash and cash equivalents totaling $155.2 million as of September 30, 2021 are expected to fund current operations into the second quarter of 2023.

Webcast

A live audio webcast of Dr. Leland’s presentation will be available on January 12, 2022 at 9:45 a.m. ET within the Investors & Media section of the Elevation Oncology website. An archived replay will be accessible following the event for a period of 30 days.

About Seribantumab and NRG1 Gene Fusions

Seribantumab is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (HER3). HER3 is traditionally activated through binding of its primary ligand, neuregulin-1 (NRG1). The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner protein to create chimeric NRG1 "fusion proteins". The NRG1 fusion protein is often also able to activate the HER3 pathway, leading to unregulated cell growth and proliferation. Importantly, NRG1 gene fusions are predominantly mutually exclusive with other known genomic driver mutations and are considered a unique oncogenic driver event associated with tumor cell survival.

NRG1 fusions have been identified in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, neuroendocrine, cholangiocarcinomas, and sarcomas. In preclinical experiments, seribantumab prevented the activation of HER3 signaling in cells that harbor an NRG1 gene fusion and destabilized the entire ERBB family signaling pathway including the activation of HER2, EGFR, and HER4. In addition to extensive nonclinical characterization and testing, seribantumab has been administered to over 800 patients across twelve Phase 1 and 2 studies, both as a monotherapy and in combination with various anti-cancer therapies. Seribantumab is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 fusion.

About the Phase 2 CRESTONE Study

Clinical Study of Response to Seribantumab in Tumors with Neuregulin-1 (NRG1) Fusions. CRESTONE is a Phase 2 tumor-agnostic "basket trial" of seribantumab in patients with solid tumors that harbor an NRG1 fusion and have progressed after at least one prior line of standard therapy. The primary objective of the study is to describe the anti-tumor activity and safety of seribantumab as a monotherapy specifically in patients whose solid tumor is uniquely driven by an NRG1 gene fusion. CRESTONE offers a clinical trial opportunity for patients with advanced solid tumors who have not responded or are no longer responding to treatment. Patients are encouraged to talk to their doctor about genomic testing of their tumor. CRESTONE is open and enrolling today in the United States, Australia, and Canada. For more information visit www.NRG1fusion.com.

On January 10, 2022 Zerion Pharma A/S (ZERION) reported that it has completed a new animal study (in dogs) that clearly demonstrates the potential of its patented Dispersome technology for reducing the amount of drug in tablet formulations (Press release, Zerion, JAN 10, 2022, View Source [SID1234598620]). The Dispersome technology is a leading drug solubility enhancing technology for tablet formulations, resulting in improved bioavailability. ZERION believes that this technology can be applied to a major part of all new oral drugs in development as well as many marketed drug products that suffer from low solubility and as a result low bioavailability. Low solubility is one of the biggest challenges in drug development and the Dispersome technology provides an innovative solution.

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ZERION’s lead program ZN002 is aimed at improving the formulation of a currently marketed cancer treatment by obtaining bioequivalence to the originator product but with a substantial reduction in the amount of active drug, and consequently number of tablets per administration. In the animal study, where ZERION tested Dispersome tablet formulations against a marketed reference tablet formulation, it was shown that the amount of active drug could be reduced by 75% while maintaining the same plasma concentration as the originator product. This corresponds to 4 times increase in bioavailability.

"These are remarkable results that prove that the drug solubility increase provided by our Dispersome technology translates into significant improvements in bioavailability. This is not the first time we have demonstrated this critical link, but these results are the most convincing to date and exceeded our expectations", says Dr. Korbinian Löbmann, Chief Scientific Officer in ZERION.: "We are now further optimizing our formulations to select the most promising Dispersome tablet formulation in a follow up animal study. Our goal is to confirm the results in a human bioequivalence study as soon as possible during 2022."
The study results are positive news for the patients, according to Ole Wiborg, ZERION’s CEO:

"More than anything, this is good news for the millions of patients that struggle with having to take a large number of tablets every day. Many elderly patients suffering from cancer and/or chronic diseases need to take several different medications. This can run up to dozens of tablets daily and in addition to the logistical nightmare, difficulties in swallowing the tablets makes this a real burden for many patients, says Ole Wiborg. "We cannot solve all the challenges associated with complex medications, but we are convinced that the reduction in the amount of active drug ingredient and the number of tablets enabled by our Dispersome technology is an important step on the way."
On a global scale, cancer patients are annually taking more than 100 million tablets containing the originator drug that is improved in ZERION’s ZN002 program. The study results indicate that, everything else equal, this could potentially be reduced to as little as 25 million tablets with a new Dispersome product that is patent protected.

In addition to the benefits to the patients, there will be significant positive environment impact. Cancer drugs are most often very toxic and can be poorly degradable in the environment. The reduction in amount of active drug will therefore result in a lower environmental burden both at the site of manufacture as well as in wastewater, since less unabsorbed drug will be excreted from the patients. In addition, the Dispersome technology is based on using beta-lactoglobulin, which is produced from a sustainable source of whey protein, a by-product from cheese production.

On January 10, 2022 AccessHope, LLC, a company that provides cancer expertise to employers and their health care affiliates, reported a new foundational collaboration with Emory Healthcare and Winship Cancer Institute of Emory University, extending access to specialized cancer expertise to more people living with complex cancers across the United States (Press release, AccessHope, JAN 10, 2022, View Source [SID1234598600]). Emory Healthcare, along with Winship, joins AccessHope’s existing collaboration with three other National Cancer Institute (NCI)-Designated Comprehensive Cancer Centers to offer innovative support and deliver advanced, expert knowledge for employees with cancer to their health plans and their local treating oncologists.

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Cancer specialists from Winship will provide tumor type-specific expertise for AccessHope’s core services — Accountable Precision Oncology, Expert Advisory Review and Cancer Support Team — to plan members in southeastern states, including Alabama, Florida, Georgia, Mississippi, North Carolina, South Carolina and Tennessee, and across the United States.

"People deserve access to the latest cancer care knowledge, regardless of their geographic location. The ability to remotely access health information has become increasingly important for the patient experience, particularly during the COVID-19 pandemic when people’s ability or willingness to travel for cancer care may have been impacted," says Mark Stadler, chief executive officer, AccessHope.

Through an employer benefit that provides access to a broad network of oncology experts, AccessHope’s cancer support services help employees and their families navigate the complexity of a cancer diagnosis to improve quality of life and health outcomes, return to their work and lives, and reduce expenses. Medical specialists at Emory Healthcare and Winship are at the forefront of lifesaving discoveries and the latest cancer research, and they can help health plans and treating oncologists guide their patients to clinical trials, genetic/genomic testing and the newest personalized treatments, such as breakthrough medications and targeted therapies.

"We are honored to welcome Emory Healthcare and Winship into our growing family of foundational collaborators, which also includes City of Hope, Dana-Farber Cancer Institute, and Northwestern Medicine and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University," adds Stadler. "As we continue connecting plan members and their local treating oncologists with these world-renowned specialists who can review their cases, our primary goal is to share insights they can use to optimize cancer treatment plans and improve clinical outcomes."

Emory Healthcare, with 24,000 employees and 11 hospital campuses, is the most comprehensive academic health system in Georgia. System-wide, it has 2,722 licensed beds and more than 3,300 physicians practicing in more than 70 specialties, serving metro Atlanta and the state of Georgia with 250 locations.

"At Emory Healthcare, patients are at the center of everything we do, and our mission is to improve lives and provide hope," says Jonathan S. Lewin, M.D., executive vice president for health affairs of Emory University and chief executive officer of Emory Healthcare. "Through innovation and discovery, our clinicians and cancer specialists are focused on advancing medical research and progressive cancer treatments that will benefit those who are diagnosed, and we are pleased to collaborate with AccessHope to provide further access to patients in need of cancer expertise."

Winship Cancer Institute expertise available for patients with complex cancers

As Georgia’s only NCI-Designated Comprehensive Cancer Center, Winship is the epicenter of the state’s cancer research, education and care, and is ranked in the top 50 in the United States and No. 1 in Georgia for cancer care, according to U.S. News & World Report. Winship clinicians see more than 17,000 newly diagnosed patients each year. The center is poised to grow; construction is underway on a new 17-story cancer facility, the largest expansion in Winship’s history.

"Winship is proud to work with AccessHope to provide top-notch expertise to the care of patients in our region at an exciting time of new possibilities in cancer care," says Winship Executive Director Suresh S. Ramalingam, M.D. "Winship’s leading experts will work with individuals’ health plans and their local care teams to provide specialized knowledge and insights."

Research is also a key component of Winship’s mission. Investigators enrolled more than 900 participants in more than 300 clinical trials in 2020, the same year it received $80 million in research funding. Winship collaborates with professionals from around the world and with national and state agencies, including the Centers for Disease Control and Prevention, the American Cancer Society and the Georgia Research Alliance.

"Winship oncologists are seeing a recent trend of more patients coming through our doors with advanced or later-stage cancers, which likely progressed from delayed screenings or treatment during the COVID-19 pandemic," says Sagar Lonial, M.D., FACP, chief medical officer of Winship Cancer Institute of Emory University. "Through our new collaboration with AccessHope, Winship clinicians will provide valuable medical expertise for patients with complex cancers, including our multidisciplinary teams that care for head and neck, lung, prostate and breast cancers, as well as the rapidly changing field of blood cancers. Those experts can then provide recommendations to local oncologists, so individuals then receive state-of-the-art care as quickly as possible."

Increased quality of and access to health care

Emory Healthcare was named as one of the top 10 most trusted health care brands in the United States and the top health care system in Georgia in a recent survey conducted by the American Hospital Association of more than 30,000 consumers. Consumers reported that three strategies were paramount to boost trust: being transparent and clear with information, listening and being empathetic, and offering care and treatment choices to patients.

"Improving access, increasing options and expanding health literacy can go a long way in addressing critical issues in health care such as health disparities, trust in health care and health care providers, and patients proactively seeking out specialized medical care. AccessHope’s unique approach in connecting people with cancer expertise, regardless of their geographic location, was a natural fit for Emory Healthcare and Winship Cancer Institute, where patients come first," says Dane Peterson, president and chief operating officer, Emory Healthcare. "Together, Emory Healthcare and AccessHope will increase access to medical expertise, and we will further transform health and healing at home in Georgia and beyond."

In December 2021, the medical journal JCO Oncology Practice published a peer-reviewed study on how AccessHope influences lung cancer cases. Titled "A Novel Program Offering Remote, Asynchronous Subspecialist Input in Thoracic Oncology: Early Experience During a Pandemic," the study found that AccessHope’s NCI-level subspecialists provided evidence-based recommendations to influence 93% of the cases AccessHope received. Accompanying the clinical and humanistic benefits was an average of $19,000 in cost savings per plan member.

Today, AccessHope serves approximately 3.3 million plan members who have access to its cancer support services through 75 employers and collaborative relationships with Collective Health via its Premier Partner Program and with Health Transformation Alliance and Quantum Health.

On January 10, 2022 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported nomination of the first targeted alpha therapy (TAT) candidate under the Company’s collaboration agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) (Press release, Fusion Pharmaceuticals, JAN 10, 2022, View Source [SID1234598589]). Both companies will jointly develop through a Phase 1 study the novel TAT which utilizes Fusion’s Fast-Clear linker technology to radiolabel an AstraZeneca-owned bispecific antibody with the alpha-emitting isotope, actinium-225.

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"Fusion is at the forefront developing a new wave of cancer therapies using alpha-emitting medical isotopes and various targeting vehicles," said John Valliant, Ph.D. "One of the pillars of our platform is to create next-generation immunoconjugates, and we are excited to be working with AstraZeneca to pursue a novel radioimmunoconjugate for oncology. We had strong alignment among our joint development committee to move this novel TAT forward into a planned Phase 1 study and we look forward to sharing more information as we approach the investigational new drug application (IND) filing."

Under the terms of the previously announced collaboration agreement, Fusion will be operationally responsible for preclinical development through first-in-human studies, while AstraZeneca will be responsible for subsequent clinical development. The companies will share costs equally through clinical development. IND enabling studies are ongoing.

On January 10, 2022, Sutro Biopharma, Inc. (the "Company") Presented the corporate presentation (Presentation, Sutro Biopharma, JAN 10, 2022, View Source [SID1234598567]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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