Pseudomyxoma Peritonei

Abdominal Cancers Alliance to provide education and resources to patients, families and physicians surrounding abdominal cancers and CRS/HIPEC procedure BALTIMORE (September 25, 2023) Partners for Cancer Care and Prevention (PFCCAP), a 501(c)(3) public health nonprofit, today announced the launch of their newest program, the Abdominal Cancers Alliance. International in scope but led by renowned Baltimore-based surgical oncologist Dr. Armando Sardi, the Abdominal Cancers Alliance is a central education hub providing resources and accurate, updated information to patients and families about abdominal cancers and the Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS/HIPEC) procedure, an aggressive treatment for a variety of intra-abdominal malignancies in advanced stages. The success of this approach is significant with data showing 10- and even 20-year survival. Even with these promising results and over 3,000 publications worldwide on CRS/HIPEC, most patients are still referred late. “We give hope to those with late-stage abdominal cancers and provide options and resources for treatment,” said Armando Sardi, M.D., FACS, president & founder of Partners for Cancer Care and Prevention. “CRS/HIPEC is a treatment option for a variety of gynecological and gastrointestinal malignancies. Early referral to treatment is key to improving survival and a potential cure. After nearly 30 years of being in this space, we’ve understood the patient journey well and see that there is a series of needs from education on the front end to care on the back end of treatment, and that is why we are launching the Abdominal Cancers Alliance.” The Abdominal Cancers Alliance, a patient-led organization, assists patients in getting the proper information regarding their cancer treatment in a timely manner and connects them with organizations, other patients, and the medical community, to provide lifesaving treatments. As the central hub, the Abdominal Cancers Alliance will focus on these core initiatives: Establish a central information system of resources on abdominal cancers and treatment options such as CRS/HIPEC. Educate the public and medical community about the importance of early diagnosis and proper treatment of abdominal cancers. Advocate for patients and families, helping them navigate through a promising journey. Advance and promote the work of existing organizations already making an impact. The CRS/HIPEC procedures involve the removal of visible tumors from the abdominal area combined with a heated chemotherapy solution added to the abdominal cavity to destroy non-visible tumor cells that may remain after surgery. CRS/HIPEC is a treatment option for cancers including appendix, colon and rectal, gastric and stomach, ovarian, fallopian tube, uterine, Peritoneal Mesothelioma, Primary Peritoneal Cancer, Pseudomyxoma Peritonei (PMP), and several others. In addition to leading PFCCAP and the Abdominal Cancers Alliance, Dr. Sardi serves as the Director of The Institute for Cancer Care at Mercy Medical Center in Baltimore’s Surgical Oncology Division. He is an internationally renowned surgeon and one of the foremost surgical oncologists in the United States using CRS/HIPEC. Dr. Sardi is a National Cancer Institute Clinical Investigator and is committed to conducting vital research. As of early 2023, the medical team including Dr. Sardi and his medical partner Dr. Vadim Gushchin, have performed more than 1,000 successful CRS/HIPEC procedures. In addition to their work in Baltimore, the procedure is being done in various hospitals across the US and in several countries worldwide. It has been the subject of thousands of published journal articles with information detailing how successful this treatment can be for treating late-stage cancer. Despite the volume of data and over 35 years of successful use, CRS/HIPEC is still not a widely known and utilized treatment option by the medical community. ### About Partners for Cancer Care and Prevention: Established in 2011 by Dr. Armando Sardi, MD, FACS, Dr. Ruth Singer, MD, and Dr. John Singer, MD, Partners for Cancer Care and Prevention is bridging the gap in cancer care by assembling a network of people and organizations that make better treatment a reality, improving the outcomes for patients and families. Its mission is to advocate for cancer patients by making connections, providing education, and guiding patient navigation to improve the quality and length of their life, with a focus on breast, cervical, and abdominal cancers. Partners for Cancer Care and Prevention’s programs in North and South America continue to significantly increase patients’ chances of long-term survival, potential cure, and increased quality of life. For more information, please visit . CONTACTS: Eric Hammond | Maroon PR | 443-614-9456 | Eric@MaroonPR.com Madison McGovern | Maroon PR | 202-430-1753 | Madison@MaroonPR.com Tyler Horton | PFCCAP | 317-471-7593 | thorton@pfccap.org

Updated LuMIERE Phase 1 data demonstrated a manageable safety pro some preliminary evidence of anti-tumor activity Eleven patients treated to date with 177Lu-FAP-2286 up to 7.4 GBq/dose No serious adverse events, treatment discontinuations, or deaths related to 177Lu-FAP-2286 observed Confirmed partial response (PR) in one patient who completed the maximum six administrations of 177Lu-FAP-2286 in the 3.7 GBq dose cohort Patient continues without disease progression or subsequent anti-cancer therapy more than twelve months after first dose Stable disease (SD) in one heavily pretreated patient who completed four administrations of 177Lu-FAP-2286 in the 5.55 GBq dose cohort Recruitment of the 7.4 GBq dose cohort is ongoing FAP-2286 has shown high tumor uptake and good prolonged retention across a range of solid tumors BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced an oral presentation at the 35th Annual European Association of Nuclear Medicine Congress (EANM) detailing updated Phase 1 data from the Clovis Oncology-sponsored Phase 1/2 LuMIERE clinical study (NCT04939610) investigating the safety, pharmacokinetics, dosimetry, and preliminary anti-tumor activity of its targeted radiotherapy candidate, FAP-2286 labeled with lutetium-177 (177Lu-FAP-2286). Overall, in eleven patients treated in the first three dose cohorts, 177Lu-FAP-2286 demonstrated a manageable safety pro encouraging evidence of anti-tumor activity, including previously reported confirmed partial response (PR) per RECIST in one patient and an additional patient with RECIST stable disease (SD) through cycle four of treatment. This dataset will be presented in an oral presentation by Thomas A. Hope, M.D., Director of Molecular Therapy in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco (UCSF), and principal investigator of the LuMIERE trial. 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 Q1 2023. “The LuMIERE trial is the first prospective trial of a FAP peptide targeted radionuclide therapy and is currently in the dose escalation phase. To date we have not seen evidence of significant associated toxicities that would limit therapy, and have seen some evidence of early efficacy,” said Thomas A. Hope, M.D., Director of Molecular Therapy in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco (UCSF), and principal investigator of the LuMIERE trial. “We are excited about these results and the fact that FAP is expressed across a number of tumor types, and we look forward to seeing the future results.” Updated results from the Phase 1 portion of the ongoing Phase 1/2 LuMIERE study found treatment-emergent adverse events (TEAEs) were mostly Grade 1 and 2 across cohorts. Data from the 7.4 GBq/dose cohort includes two patients who have completed the first cycle with enrollment ongoing. A dose-limiting toxicity of Grade 4 lymphopenia related to 177Lu-FAP-2286 was reported in one of six patients in the 5.55 GBq cohort; the patient had grade 2 lymphopenia at baseline. Overall, five patients (45.5%) had a Grade ≥3 TEAE, including abdominal distension (9.1%), cholangitis (9.1%), hyponatremia (9.1%), increased blood bilirubin (9.1%), and spinal compression fracture (9.1%); none were considered as related to 177Lu-FAP-2286. There was good tumor uptake across a range of tumor types with prolonged tumor retention of 177Lu-FAP-2286 after dosing. Kidney and bone marrow radiation exposure observed appeared comparable to those reported in the literature for other lutetium-177 labeled radionuclide therapies with non-FAP targets. A confirmed RECIST PR was reported in one heavily pre-treated patient in the 3.7 GBq dose cohort with pseudomyxoma peritonei of appendiceal origin, who completed the maximum six administrations of 177Lu-FAP-2286. The patient continues without disease progression or subsequent anti-cancer therapy more than twelve months after first dose. A RECIST best response of SD was reported in one heavily pre-treated patient in the 5.55 GBq dose cohort with gallbladder cancer who completed four administrations of 177Lu-FAP-2286 and remained stable without progressive disease through cycle four of treatment with subsequent progression. “This presentation of updated data from the Phase 1/2 LuMIERE study continues to support 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 anticipate additional clinical data from the LuMIERE study to be presented at a medical conference in the first quarter of 2023.” Presentation of the initial LuMIERE Phase 1 data, titled “177Lu-FAP-2286 in Patients With Advanced or Metastatic Solid Tumors: Updated Data From a Phase 1/2 Study Investigating Safety, Pharmacokinetics, Dosimetry, and Preliminary Antitumor Activity (LuMIERE)” (Presentation #OP-355), is scheduled for Monday, October 17 at 9:45am CEST. This presentation can also be viewed at following presentation on October 17. 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) is being 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 the 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. About Clovis Oncology Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing, and commercializing innovative anti-cancer agents in the US, Europe, and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the US and Europe. Please visit for more information. To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements contained in this press release include, among others, statements of our intentions and expectations for our development and discovery programs, including the timing and pace of pre-clinical development, plans for clinical development, plans for additional applications of the FAP-2286 peptide, including potential indications, tumor types and combination trials, and regulatory plans with respect to FAP-2286. Such forward-looking statements involve substantial risks and uncertainties that could cause Clovis Oncology’s actual results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in drug discovery and pre-clinical and clinical development, including the outcome of pre-clinical studies and clinical trials, whether initial results, findings or research will support future studies or development, whether future study results will be consistent with previous study findings or other results, including pre-clinical studies, results in named-patient or similar programs or clinical trials, whether additional studies not originally contemplated are determined to be necessary, the timing of initiation, enrollment and completion of planned studies and actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to approve drug applications. Clovis Oncology undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Clovis Oncology’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and its other reports filed with the Securities and Exchange Commission. View source version on businesswire.com: Contacts Clovis Investor Contacts: investorinquiries@clovisoncology.com Clovis Media Contacts: clovismedia@clovisoncology.com Source: Clovis View this news release online at:

BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced 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). Overall, in nine patients treated in the first two dose cohorts,177Lu-FAP-2286 demonstrated a manageable safety pro 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. 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 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. About Clovis Oncology Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing, and commercializing innovative anti-cancer agents in the US, Europe, and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the US and Europe. Please visit for more information.