On June 14, 2022 Clovis Oncology, Inc. (NASDAQ: CLVS) reported an oral presentation detailing initial Phase 1 data from the Clovis Oncology-sponsored Phase 1/2 LuMIERE clinical study (NCT04939610) investigating the safety, pharmacokinetics, dosimetry, and preliminary antitumor activity of its targeted radiotherapy candidate, FAP-2286 labelled with lutetium-177 (177Lu-FAP-2286) (Press release, Clovis Oncology, JUN 14, 2022, View Source [SID1234615965]). Overall, in nine patients treated in the first two dose cohorts,177Lu-FAP-2286 demonstrated a manageable safety profile and encouraging evidence of activity, including a confirmed RECIST partial response in one patient. In addition, updated data from an investigator-initiated Phase 1 study of FAP-2286 labelled with gallium-68 (68Ga-FAP-2286) as a novel imaging agent to identify metastatic cancer in patients with solid tumors are also being presented today (NCT04621435). These datasets will be presented in oral presentations by Jonathan McConathy, M.D., Ph.D., Associate Professor and Director of the Division of Molecular Imaging and Therapeutics in the University of Alabama at Birmingham Department of Radiology in the Marnix E. Heersink School of Medicine, and Brad Kline, Clinical Research Coordinator at the University of California, San Francisco (UCSF), respectively, at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting 2022 in Vancouver, British Columbia.

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FAP-2286 targets fibroblast activation protein (FAP), a promising theranostic target with expression across many tumor types. FAP-2286 is the first peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting FAP to enter clinical development and is the lead candidate in Clovis Oncology’s targeted radionuclide therapy (TRT) development program. The Phase 1 portion of the LuMIERE study is evaluating the safety of the investigational therapeutic agent 177Lu-FAP-2286 to identify the recommended Phase 2 dose and schedule. The safety and tumor uptake of the imaging agent 68Ga-FAP-2286 is also being evaluated, with plans for Phase 2 expansion cohorts in multiple tumor types to initiate in Q4 2022.

"These initial results demonstrate that FAP is a promising theranostic target with expression across many types of solid tumors," said Jonathan McConathy, M.D., Ph.D., Associate Professor and Director of the Division of Molecular Imaging and Therapeutics in the University of Alabama at Birmingham Department of Radiology in the Marnix E. Heersink School of Medicine. "These LuMIERE data from the first two dose cohorts demonstrated a manageable safety profile, with some preliminary evidence of activity, both of which are encouraging as we seek to better understand the potential of FAP-2286 as a treatment and imaging agent across a wide range of malignancies."

Initial results from the Phase 1 portion of the ongoing Phase 1/2 LuMIERE study found treatment-emergent adverse events (TEAEs) to be generally mild to moderate among the nine patients in the safety population receiving 3.7 or 5.55 GBq/dose of the investigational therapeutic agent 177Lu-FAP-2286. Three patients (33.3%) had a Grade ≥3 TEAE of back pain (11.1%), abdominal distension (11.1%), increased bilirubin (11.1%) and hyponatremia (11.1%); none were judged as related to 177Lu-FAP-2286. There was one serious adverse event (SAE) of back pain not related to 177Lu-FAP-2286. No dose-limiting toxicities were observed in the 3.7 or 5.55 GBq cohorts (n=3 evaluable in each cohort).

At the two dose levels evaluated to date, organ dosimetry revealed target organ exposure within the expected range to support administration of multiple doses. There was tumor uptake across a range of tumor types with prolonged tumor retention of 177Lu-FAP-2286 after dosing.

A confirmed RECIST partial response was reported in one heavily pre-treated patient in the 3.7 GBq dose cohort with pseudomyxoma peritonei of appendiceal origin who completed six administrations of 177Lu-FAP-2286. A decrease in the level of the serum tumor marker carcinoembryonic antigen (CEA) was also observed in the patient over the course of 177Lu-FAP-2286 administration.

Recruitment for the third dose cohort (7.4 GBq) is ongoing.

"This first presentation of data from the Phase 1/2 LuMIERE study supports the hypothesis that FAP-2286 gets to the tumor, stays in the tumor, and avoids off-target tissue, and these initial Phase 1 data further support the potential clinical utility of FAP-2286 as a targeted radionuclide therapy to treat a variety of advanced solid tumors," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We look forward to presenting additional clinical data from the LuMIERE study at another nuclear medical meeting and initiating Phase 2 expansion cohorts in multiple tumor types later in 2022."

Presentation of the initial LuMIERE Phase 1 data, titled "177Lu-FAP-2286 in Patients With Advanced or Metastatic Solid Tumors: Initial Data From a Phase 1/2 Study Investigating Safety, Pharmacokinetics, Dosimetry, and Preliminary Antitumor Activity (LuMIERE)" (Abstract #2271), is scheduled for Tuesday, June 14 at 11:00 am PT, as part of the Basic Oncology: Early Phase Human Studies I session from 10:00 – 11:30 am PT.

Presentation of the investigator-initiated imaging study, titled "First-in-human evaluation of 68Ga-FAP-2286, a fibroblast activation protein targeted radioligand" (Abstract #2279), evaluating the ability of imaging agent 68Ga-FAP-2286 to detect metastatic cancer in patients with solid tumors, is scheduled for Tuesday, June 14 at 1:50 pm PT, as part of the Basic Oncology: Early Phase Human Studies II session from 1:00 – 2:30 pm PT.

These presentations can also be viewed at View Source following their presentations on June 14.

For more information about FAP-2286, targeted radionuclide therapy (TRT), or Clovis’ TRT development program, please visit targetedradiotherapy.com.

About the LuMIERE Clinical Study

LuMIERE is a Phase 1/2 study evaluating FAP-2286 as a peptide-targeted radionuclide therapy (PTRT) targeting fibroblast activation protein, or FAP, in patients with advanced solid tumors. The Phase 1 portion of the LuMIERE study is evaluating the safety of the investigational therapeutic agent and will identify the recommended Phase 2 dose and schedule of lutetium-177 labeled FAP-2286 (177Lu-FAP-2286). FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) will be utilized as an investigational imaging agent to identify patients with FAP-positive tumors appropriate for treatment with the therapeutic agent. Once the Phase 2 dose is determined, Phase 2 expansion cohorts are planned in multiple tumor types.

About FAP-2286

FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. High FAP expression has been shown in pancreatic ductal adenocarcinoma, cancer of unknown primary, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous non–small cell lung, and squamous head and neck cancers. High FAP expression was detected in both primary and metastatic tumor samples and was independent of tumor stage or grade. Clovis holds US and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel.

FAP-2286 is an unlicensed medical product.

About Targeted Radionuclide Therapy

Targeted radionuclide therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing delivery of radiation to normal tissue. Targeted radionuclides are created by linking radioactive isotopes, also known as radionuclides, to targeting molecules (e.g., peptides, antibodies, small molecules) that can bind specifically to tumor cells or other cells in the tumor environment. Based on the radioactive isotope selected, the resulting agent can be used to image and/or treat certain types of cancer. Agents that can be adapted for both therapeutic and imaging use are known as "theranostics." Clovis, together with licensing partner 3B Pharmaceuticals, is developing a pipeline of novel, targeted radiotherapies for cancer treatment and imaging, including its lead candidate, FAP-2286, an investigational peptide-targeted radionuclide therapeutic (PTRT) and imaging agent, as well as three additional discovery-stage compounds.

On June 14, 2022 City of Hope, one of the largest cancer research and treatment organizations in the United States, reported that Philip Okala, chief operating officer at the University of Pennsylvania Health System, will join the organization as system president (Press release, City of Hope, JUN 14, 2022, View Source [SID1234615981]). In his role, Okala will be responsible for City of Hope’s portfolio of clinical care and research entities, which include City of Hope Los Angeles, City of Hope Orange County, Translational Genomics Research Institute (TGen), Beckman Research Institute of City of Hope and the recently acquired Cancer Treatment Centers of America. He will also have executive oversight of City of Hope’s medical foundation and clinical and research operations. Okala will report to Robert Stone, City of Hope’s chief executive officer, and join the organization in September of this year.

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Okala joins City of Hope after serving for the past five years as chief operating officer at the University of Pennsylvania Health System, which represents six acute care hospitals/health systems and the expansive Penn Medicine at Home enterprise, in addition to more than 43,000 employees, 8,900 credentialed physicians on staff across the system and approximately $9 billion in annual revenue. In his role, Okala had executive oversight of the health system’s hospitals, clinical service line operations, corporate emergency management and overall system integration. Prior to this role, Okala served for five years as senior vice president for business development at Penn Medicine, overseeing strategy and business development initiatives. He has previously held leadership roles at the Geisinger Health System, Roswell Park Cancer Institute, MD Anderson Cancer Center and the Michael E. DeBakey VA Medical Center.

"As we set the stage for City of Hope’s next 100 years of service to cancer patients and their families, I could not imagine a better leader to accelerate our mission than Phil Okala," said Robert Stone, the Helen and Morgan Chu Chief Executive Officer Distinguished Chair. "Phil has an extraordinary set of leadership skills and experience, managing operations and executive teams across a complex health system and research organization. His expertise will be immensely valuable as we further our goal to democratize cancer care and create a system that develops the next generation of research discoveries, treatment and care and makes them accessible to more patients, families and communities across the country."

Today’s leadership announcement is the latest milestone in City of Hope’s transformation into a national cancer research and treatment system. In recent years, City of Hope has grown substantially with the expansion of its clinical network in Southern California, addition of genomics leader TGen, launch of its employer cancer care benefits offering AccessHopeTM, the acquisition of Cancer Treatment Centers of America and a new cancer center in Orange County, California, scheduled to open in 2022.

"City of Hope’s vision to make cancer care more accessible to more people across the country is part of what really attracted me and got me excited about the opportunity," said Okala, incoming City of Hope system president. "When you talk to people who work at City of Hope or walk through the campus, you feel the culture, values and absolute commitment to the patient that comes through in each and everything they do. It’s a special place, and the system we’re building will allow even more people to experience the unique power and talent this organization has to offer patients in their moments of need."

City of Hope’s system of provider and research entities serves approximately 115,000 patients each year, with more than 11,000 team members, 575 physicians and more than 1,000 scientists and researchers across a network of locations in California, Arizona, Illinois and Georgia.

On June 14, 2022 HALO Diagnostics, a precision diagnostics leader, reported that it has joined forces with the Genomic Testing Cooperative (GTC) to offer innovative, personalized testing to its physician network and 1M+ patients served (Press release, Genomic Testing Cooperative, JUN 14, 2022, View Source [SID1234615999]). This solution combines HALO Diagnostics’ clinical ensemble and image-guided therapies with GTC’s genomic profiling of a patient’s DNA / RNA using liquid biopsy and tissue samples. Together, the companies will help patients on every step of their unique healthcare journey – from detection and diagnosis to prognosis and treatment.

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For decades, patients have faced a one-size-fits-all approach to their health. They are now calling for more prompt, personalized care. With this partnership, HALO Diagnostics and GTC are ready to answer this call.

Recent therapeutic approvals in HALO Diagnostics’ core clinical areas such as prostate, breast, and lung cancers have focused on targeted therapies and immunotherapies. Before treatment can begin, patients undergo biomarker testing. This is where GTC comes in: The company’s comprehensive test panels simultaneously query key DNA / RNA alterations, guiding decision making for patients’ treatment plans.

"By bringing together advanced imaging and molecular biomarkers, HALO Diagnostics and GTC will have a unique impact on driving early detection in healthcare," says Dr. John Feller, Chief Medical Officer at HALO Diagnostics. "We will reduce oversights common in individual diagnostic tests, making early detection, minimally invasive therapies, and precision-focused healthcare possible."

Dr. Maher Albitar, GTC’s Founder, CEO, and Chief Medical Officer, agrees. "Combining imaging with molecular profiling is not only a natural expansion in medical diagnostics, but also provides a unique opportunity for innovation in the era of artificial intelligence." He adds, "We are very excited to be working with HALO Diagnostics. This collaboration will save patient lives and accelerate the development of key radiogenomic biomarkers."

With this partnership, the innovation is just beginning.

GTC recently showcased Liquid Trace, its latest liquid biopsy test that combines cell-free DNA and cell-free RNA to improve the test’s sensitivity for diagnosing solid tumours and blood-related cancers, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s annual meeting from June 3-7, 2022. The Liquid Trace test is now available to HALO Diagnostics’ patients indicated for this precision-focused approach.

On June 14, 2022 CivicaScript,TM which is dedicated to bringing lower-cost generic medicines to U.S. consumers, and EmsanaRx, PBC, the only pharmacy benefit manager built by employers, for employers, reported that EmsanaRx is joining CivicaScript as a partnering member (Press release, CivicaScript, JUN 14, 2022, https://civicascript.com/2022/05/22/emsana-announcement-to-come/ [SID1234617442]). The partnership will make CivicaScript medicines available to EmsanaRx’s self-funded employer members.

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"We welcome the partnership of EmsanaRx as we work to provide quality generic medicines that are affordable and available to everyone," said CivicaScript President Gina Guinasso. "Everyone deserves access to the medicines they need to stay healthy. CivicaScript partners with organizations that share our belief that the needs of families and patients come first."

While many generic medicines cost less than brand-name drugs, some high-cost generics are more expensive than they need to be due to lack of market competition. Numerous studies confirm that medication costs can dictate whether patients ration their prescriptions or even fill them in the first place. CivicaScript and its members are intent on addressing that problem.

Created in 2020 to bring affordable versions of common but high-priced generic medicines to market, CivicaScript’s model is to develop quality generic medicines with its trusted manufacturing partners, then work with like-minded payors, pharmacy benefit managers (PBMs) and pharmacies across the country that pass along the cost savings to their customers.

CivicaScript will initially develop and manufacture six to 10 medicines for which there is currently not enough market competition to drive down price. Its first medication is expected to be available in the U.S. late this summer.

EmsanaRx joins Health Care Service Corporation (HCSC), the Blue Cross Blue Shield Association (BCBSA) and 18 independent and locally operated Blue Cross and Blue Shield (BCBS) companies and Anthem, Inc. as CivicaScript members. The PBM was launched last year by the Purchaser Business Group on Health (PBGH) to tackle the challenges large, self-funded employers face in providing high-quality, cost-effective medications to millions of Americans and their families.

"High drug costs are a big problem for self-funded employers. They spend more than $140 billion each year for prescription drugs on behalf of employees and their families. They are looking for ways to curb the costs of prescription drugs, which are rising by 20% each year and eating away at jobs, wages and other business costs," said Greg Baker, EmsanaRx founder and CEO. "Our partnership with CivicaScript has the potential to expand the availability of needed medications at lower cost to millions of Americans."

On June 14, 2022 Boehringer Ingelheim reported the signing of an option to acquire Trutino Biosciences Inc. (the "Transaction"), a San Diego-based biotech company (Press release, Boehringer Ingelheim, JUN 14, 2022, View Source [SID1234615982]).

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Trutino Biosciences is a pre-clinical stage biotech company dedicated to the discovery and development of next-generation cytokine therapies to treat immuno-oncology and autoimmune diseases. Boehringer Ingelheim is dedicated to a two-pronged research strategy to fight cancers: through cancer cell-directed and immune cell-targeting compounds. The ongoing research partnership between Boehringer Ingelheim and Trutino is part of an overarching effort to mobilize a patient’s immune system to fight cancer.

"Boehringer Ingelheim is excited to extend our partnership with Dr. Kim and his outstanding team at Trutino Biosciences. Our existing collaboration has made rapid and impressive progress in a short time frame, and we expect this field to have potential combination benefits with our existing immune-targeting assets," said Clive R. Wood, Ph.D., Corporate Senior Vice President and Global Head of Discovery Research, Boehringer Ingelheim. "The selective activation of specific cytokines localized in the tumor microenvironment holds enormous promise and has the potential to be a key element in fully harnessing the power of the immune system to fight cancer."

"It’s been two years since our initial strategic alliance began and we are very excited to further strengthen our partnership with Boehringer Ingelheim, a leader in cancer immunology, to advance potential cytokine therapeutic options that will transform the lives of cancer patients worldwide," said Phillip Kim, Ph.D., MBA, Founder and CEO of Trutino Biosciences. "Boehringer Ingelheim has a deep commitment to our innovative scientific approaches and to bringing novel cancer therapies to patients. This global partnership validates the broad potential of our proprietary ‘On Demand Cytokine’ platform. As part of this expanded collaborative framework, we aim to rapidly develop a new generation of cytokine therapies as single agent and in combination with Boehringer Ingelheim’s pipeline portfolio of cancer vaccines, oncolytic viruses, T cell engagers and other therapeutic modalities."

Under the agreement, Boehringer Ingelheim reserves the right to purchase all shares of Trutino Biosciences once specified program milestones have been achieved within a given timeframe. Until that time, Trutino will continue to operate as an independent company, with the existing fruitful strategic partnership and collaboration agreement between the companies continuing uninterrupted.

The transaction consideration consists of an option fee, the issuance of a convertible note and fixed purchase price terms to acquire Trutino Biosciences once pre-defined milestones are achieved. The option fee and principal amount of the convertible note funded by Boehringer Ingelheim at the signing of the option will collectively fully finance Trutino Biosciences through the next major development milestones of Trutino Biosciences.

Boehringer Ingelheim and Trutino Biosciences were introduced in 2019 during one of Boehringer Ingelheim’s "Grass Roots Innovation" events in San Diego. From there, in 2020 the companies forged a multi-target strategic partnership on conditionally masked cytokines. Boehringer Ingelheim’s Grass Roots programs provide biotech entrepreneurs mentoring and access to expertise and possible funding. To learn more, visit Grass Roots Innovation.