On June 14, 2022 Alphamab Oncology (stock code: 9966.HK) reported that the first patient was dosed in a Phase I clinical study (KN052-CHN-001) of KN052, its proprietary PD-L1/OX40 bispecific antibody, in patients with advanced solid tumors in China (Press release, Alphamab, JUN 14, 2022, View Source [SID1234615964]).

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With the development of immunotherapy and further understanding of tumor pathogenesis, cancer therapy has entered a new era, among which PD-(L)1 inhibitors have become a star product. However, PD-1/PD-L1 inhibitors did not bring satisfied response rate when used as monotherapy, and innovative treatment regimens are expected. KN052 is the world’s first PD-L1/OX40 bispecific antibody entering first-in-human clinical study. It can effectively reverse tumor induced immune inhibition by blocking the PD-L1/PD-1 pathway and promote the immune response by activating OX40. In preclinical studies, KN052 showed significantly stronger activity than either single antibody or in combination.

KN052-CHN-001 is a Phase I clinical study in Chinese patients with advanced solid tumors to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN052, and to determine the recommended dose for further development.

Professor Zhengbo Song from Zhejiang Cancer Hospital, the principal investigator, commented, "OX40 is a member of the TNF receptor superfamily. The mechanism of action of OX40 agonism can result in conditions favorable to immune responses, where activated T cells increase in number, while the induction of Tregs is suppressed in the periphery. The combination of OX40 and an immune checkpoint inhibitor is expected to enhance the efficacy. We look forward to exploring the safety and preliminary efficacy of KN052 in this clinical study."

About KN052

KN052 is a PD-L1/OX40 bispecific antibody developed in house by Alphamab Oncology. It can simultaneously bind PD-L1 and OX40, effectively blocking the PD-L1/PD-1 pathway and activating OX40. In February 2022, the IND for KN052 was approved by the National Medical Products Administration (NMPA) to initiate Phase I clinical trials in China.

On June 14, 2022 Immunicom, Inc., a privately held clinical-stage biotechnology company with a transformative immuno-oncology platform, reported that it has been awarded $2 million by the National Cancer Institute (NCI) and National Institutes of Health (NIH) to initiate its first US-based clinical trial at the Baylor College of Medicine in Houston, Texas (Press release, Immunicom, JUN 14, 2022, View Source;Breast-Cancer [SID1234615980]). The trial [NIH/NCI Grant 1R44CA261565-01A1], to be conducted in collaboration with Dr. Mothaffar F. Rimawi, Professor of Medicine/Oncology and Executive Medical Director, Dan L. Duncan Cancer Comprehensive Center, Baylor College of Medicine, will evaluate the safety, tolerability, and efficacy of the FDA Breakthrough Immunopheresis LW-02 Molecular Ligand-Capture Column for treating refractory, hormone-resistant breast cancers.

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"We are honored to receive this grant from the NCI/NIH recognizing the potential of Immunopheresis therapy. This clinical trial is a monumental step for Immunicom to address unmet needs for patients with difficult-to-treat cancers," said Principal Investigator Dr. Robert Segal, Immunicom’s Chief Medical Officer. "We feel confident that further evaluation of Immunopheresis, both alone and as an adjunct to chemotherapy, will demonstrate that this is an essential new modality for immuno-oncology. Through this US-based trial, we will seek further evidence that Immunopheresis safely and effectively treats cancer and has a positive effect on the quality of patients’ lives, as has been observed in the Company’s three ongoing global trials conducted in 67 patients, with over 2,000 treatments completed to date."

The Company’s LW-02 Molecular Ligand-Capture technology, which received FDA Breakthrough designation in 2018, is designed to remove specific factors (sTNF-R1/2) shed by cancer cells that inhibit endogenous tumor necrosis factor alpha (TNF-α), a cytokine widely recognized for its tumoricidal behavior. In a process like dialysis, Immunopheresis therapy removes sTNF-R1/2 from plasma, helping kickstart endogenous TNF-α response to cancer without toxicities that increase the risk of side effects.

The exploratory study of 12 subjects will evaluate Immunopheresis therapy in metastatic, hormone-refractory ER+/HER2- breast cancer patients who have failed at least two lines of hormone therapy, and one to two lines of chemotherapy. These patients will be recruited to receive Immunopheresis LW-02 Column induction monotherapy over a two-week period, then in combination with low-dose chemotherapy for an additional 14 weeks. Throughout treatment, patients will be monitored for reduction of circulating sTNF-R1/2 and adverse events. Objective response and clinical benefit will be exploratory; quality-of-life/clinical function, circulating CT-DNA and tumor cells, and markers of an immunologic response (including in tissue) will also be evaluated. Clinical response to treatment and tumor burden will be monitored by standard RECIST v1.1/iRECIST criteria (MRI/CT), and follow-up for up to one year will include evaluating subjects for progression free survival (PFS), best overall response (BOR), overall response rate (ORR), and overall survival (OS).

Subtractive Therapy – Immunopheresis and the LW-02 Column

Immunicom employs a proprietary, high-affinity, molecular capture-ligand binding matrix within the LW-02 Column to remove specific cytokine receptors, soluble TNF-Receptors 1 and 2 (sTNFR-1/2), that are shed by cancer cells into the extracellular tumor microenvironment. sTNF-Rs serve as decoys, binding to tumor necrosis factor alpha (TNF-α) before it can bind to its membrane-embedded sTNF-R receptors to trigger several cell death pathways, as well as modulate antitumor cytotoxic T-cells and macrophage activity. The selective removal of decoy sTNF-Rs by the LW-02 Column allows the patient’s immune system to identify and aggressively attack the cancer.

Immunopheresis, like dialysis, is a subtractive therapy that occurs outside the body, in contrast to conventional drugs and biologics that are infused into the patient. Immunopheresis is thus intended to be much better tolerated than chemo- and immunotherapies, allowing for its use as an adjunct with these therapies, possibly in lower doses to reduce their toxicity. The Immunopheresis platform is a targeted removal therapy that can selectively remove any soluble factor. Immunicom has multiple cytokine and soluble targets under development, including IL-6, VEGF, IL-1 beta, and soluble PD-L1, with others to follow.

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.