On March 16, 2023 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported that the United States Food and Drug Administration (FDA) has approved a supplementary New Drug Application (sNDA) for Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) to enable its use for the selection of patients with metastatic prostate cancer, for whom 177Lu 177 PSMA-directed therapy is indicated (Press release, Telix Pharmaceuticals, MAR 16, 2023, View Source [SID1234628961]).

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The label expansion means Illuccix is now approved in the U.S. to select patients who are candidates for the only FDA-approved prostate-specific membrane antigen (PSMA)- directed radioligand therapy (Pluvicto),[2] providing doctors with critical information to help optimize and guide treatment decisions. To qualify for radioligand therapy, patients must be imaged with an approved gallium-based PSMA-PET agent.[3]

As the only diagnostic agent for suspected metastatic and recurrent prostate cancer that combines the accuracy of gallium imaging with the reliability and flexibility of Telix’s distribution network, the expanded indication for Illuccix has the potential to improve access to imaging for patients who are candidates for radioligand therapy.

Kevin Richardson, Chief Executive Officer for Telix Americas said, "We welcome the FDA’s decision to expand the label indication for Illuccix. This additional indication further demonstrates our continued commitment to support patients fighting prostate cancer and to empower the doctors who treat them. Clinicians now have the ability to use Illuccix in more stages of the patient journey, to confidently and accurately detect and help manage this disease."

Use of Illuccix in the VISION Phase III study (ClinicalTrials.gov Identifier: NCT03511664)[4] helped doctors detect prostate cancer and identify the appropriate patients for PSMA-based radioligand therapy. Telix wishes to acknowledge collaboration with Novartis to deliver this outcome to patients.

Dr Oliver Sartor, Medical Director at Tulane Cancer Center, added, "As radioligand therapy for prostate cancer becomes more prevalent, it is critical for doctors to understand who may or may not respond to those treatments. There’s no doubt that appropriate selection of patients for PSMA targeted radioligand therapy is dependent on appropriate imaging. Ga-68 PSMA-11 PET was used in the VISION trial and, when used in combination with contrast-enhanced CT, represents a powerful tool for detecting prostate cancer and helping guide patient management."

It is estimated that 32,000 patients per year in the U.S. may be considered for PSMA-directed radioligand therapy.[5]

INDICATIONS AND USAGE

ILLUCCIX, after radiolabeling with Ga 68, is for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

With suspected metastasis who are candidates for initial definitive therapy
With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
For selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated.
IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Risk for Misinterpretation

Image interpretation errors can occur with ILLUCCIX PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Imaging Prior to Initial Definitive or Suspected Recurrence Therapy

The performance of ILLUCCIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of ILLUCCIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.

Imaging to Select Patients for Lutetium Lu 177 Vipivotide Tetraxetan Therapy

The interpretation of ILLUCCIX PET may differ depending on imaging readers. ILLUCCIX PET interpretations to select patients for lutetium Lu 177 vipivotide tetraxetan therapy may be more consistent when judging gallium Ga 68 gozetotide uptake in any one tumor lesion compared to judging uptake for all lesions larger than size criteria. Multidisciplinary consultation to select patients for lutetium Lu 177 vipivotide tetraxetan therapy is recommended, particularly for ILLUCCIX imaging that a single reader finds borderline or difficult to interpret, or when patient eligibility hinges only on judgment of gallium Ga 68 gozetotide uptake for all lesions larger than size criteria.

Radiation Risks

Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.

ADVERSE REACTIONS

The safety of gallium Ga 68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMA-BCR studies, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

In the VISION study, 1003 patients received one dose of gallium Ga 68 gozetotide intravenously with the amount of radioactivity 167.1 ± 23.1 MBq (4.52 ± 0.62 mCi). Adverse reactions occurring at ≥0.5% in patients with metastatic prostate cancer who received gallium Ga 68 gozetotide injection in the clinical study were fatigue (1.2%), nausea (0.8%), constipation (0.5%), and vomiting (0.5%).

Adverse reactions occurring at a rate of < 0.5% in the VISION study were diarrhea, dry mouth, injection site reactions, including injection site hematoma and injection site warmth and chills.

DRUG INTERACTIONS

Androgen deprivation therapy and other therapies targeting the androgen pathway

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.

Please note that this information is not comprehensive.
Please see the Full Prescribing Information at illuccix.com/prescribinginformation

You are encouraged to report suspected adverse reactions of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix by calling 1-844-455-8638 or emailing [email protected].

On March 16, 2023 Glenmark Specialty SA, the subsidiary of Glenmark Pharmaceuticals Ltd., an innovation-driven, global pharmaceuticals company reported that it has received acceptance from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) application for GRC 54276 to proceed with a Phase 1/2, first-in-human, clinical study of GRC 54276 for the treatment of patients with advanced solid tumors and lymphomas (Press release, Glenmark, MAR 16, 2023, View Source [SID1234628959]).

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GRC 54276 is an orally available, small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor developed by Glenmark. HPK1-regulated functions are involved in nearly every step of the cancer-immunity cycle making it an attractive target for immuno-oncology. By inhibiting HPK1, GRC 54276 is designed to potentially enhance the patient’s own immune system to fight cancers.

A Phase 1/2 multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of GRC 54276 is currently underway in India. GRC 54276 is being studied as monotherapy or in combination with Anti PD-1 or Anti PDL-1 therapy in adults with advanced solid tumors and lymphomas. To date, 16 patients with various type of advanced cancers have been enrolled in this ongoing study in India, and company plans to expand the study at ex-India research sites in the subsequent months.

"Now that the FDA has accepted our IND application, we look forward to initiating the ongoing Phase 1/2 study at the US sites. This is an important milestone for Glenmark as we continue to advance our oncology pipeline. We are excited about the prospects of what this new class of immune-oncology medicines may mean for patients in need," said Nikhil Amin (MD), Chief scientific officer and President, innovative Medicine Group, Glenmark Pharmaceuticals Ltd.

On March 16, 2023 Researchers at City of Hope, one of the largest cancer research and treatment organizations in the United States, reported that it will present a number of new findings at this year’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which will take place April 14 to 19 (Press release, City of Hope, MAR 16, 2023, View Source [SID1234628958]).

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Chimeric Antigen Receptor (CAR) T Cell Therapy

CAR T cells being developed to target tough-to-treat type of prostate cancer
"Development of adoptive T-cell therapies to target heterogeneity of mCRPC"
Poster Presentation 4104: Tuesday, April 18, 2023, 9 a.m. to 12:30 p.m.

For patients with metastatic castration resistant prostate cancer (mCRPC), durable treatment options are currently limited. Lupita Lopez, who is in Saul Priceman’s lab at City of Hope, and team are aiming to find an innovative strategy to improve outcomes for those with prostate cancer by developing a chimeric antigen receptor (CAR) T cell therapy that specifically targets disease heterogeneity. An ongoing Phase 1 clinical trial at City of Hope with prostate stem cell antigen (PSCA)-directed CAR T cells has revealed that additional targets for neuroendocrine prostate cancer may be required to see lasting anti-tumor responses in mCRPC. Lopez and the team have established dual-targeted CAR T cell approaches that have potential to reach clinical trial for patients with mCRPC.

Cancer Disparities

Interventions in ethnic minority communities elucidate strategies for increasing colorectal cancer screenings
"Community outreach and engagement to increase colorectal cancer screening in ethnic minority communities"
Poster Presentation 1930: Monday, April 17, 2023, 9 a.m. to 12:30 p.m.

In an effort to increase colorectal cancer (CRC) screenings in medically vulnerable and minority populations, Kimlin Ashing and other researchers implemented a multicomponent intervention that included community outreach via a population-level, multiethnic media campaign and clinic-based interventions focused on provider training and patient education. To do this, City of Hope partnered with four federally qualified health centers as well as local organizations to help improve CRC screenings. In a two-year period, the team saw an overall increase in colorectal cancer screening rates across all four health center locations, despite staffing challenges during the COVID-19 pandemic. Ashing and others continue to evaluate the intervention’s success with attempts to document individual and clinic improvements by race and ethnicity, and use implementation science for broad intervention dissemination.

Minority patients with both cancer and diabetes face more barriers to clinical care
"Racial/ethnic disparities in diabetes-related clinical care service use among cancer patients with cooccurring diabetes"
Poster Presentation 1928: Monday, April 17, 2023, 9 a.m. to 12:30 p.m.

By reviewing data from The Behavioral Risk Factor Surveillance System 2017-2021 on adult patients diagnosed with cancer and diabetes, Gaole Song and colleagues have identified racial and ethnic disparities in clinical care for this population. By investigating rates of annual diabetes-related hemoglobin tests and eye and foot examinations, the researchers found that Hispanic/Latinx and Pacific Islanders were less likely than their white counterparts to complete all three of these important health care activities. Other factors, like lack of insurance, also played a role in quality of care. These findings suggest that to fulfil appropriate standard of care gaps for minority patients, health coverage expansion, health system intervention (e.g., workflows, culturally and linguistically competent care) and provider training (e.g., bias, communications) are urgently needed toward fixing disparities, including inequities experienced among minority patients with concurrent cancer and diabetes.

Natural Products

Plant chemical compounds have potential to treat chemoresistant pancreatic cancer
"Berberine and emodin synergistically suppress the EGFR signaling cascade by targeting LAMB3 in pancreatic ductal adenocarcinoma"
Poster Presentation 3821: Tuesday, April 18, 2023, 9 a.m. to 12:30 p.m.

Caiming Xu, Silei Sui and colleagues, who are part of Ajay Goel’s lab at City of Hope, have provided the first evidence that a combination of berberine and emodine, two naturally occurring dietary botanicals, have anti-cancer properties when used to treat pancreatic ductal adenocarcinoma (PDAC). The compounds found in plants were shown to have synergistic anti-tumor potential in PDAC cells when used together as opposed to individually. In addition, the combination of botanicals altered the expression of key proteins involved in tumor growth, making them a promising cost-effective and safe therapeutic target for PDAC patients, who often develop a resistance to further chemotherapy after the initial round and need alternative treatment options.

Aronia berry extract shows anti-cancer activity in colorectal cancer cells
"Novel evidence for the role of the p53 signaling pathway in mediating the anticancer effects of aronia berry extract in colorectal cancer cells"
Poster Presentation 3821: Tuesday, April 18, 2023, 9 a.m. to 12:30 p.m.

Yoh Asahi, who is in Ajay Goel’s lab, and a team of researchers have investigated the anti-cancer properties of aronia berry extract, a naturally occurring phytochemical, for use against colorectal cancers (CRC). Because the extract is rich in polyphenols, which can protect the body from cancer cells, including CRC, Asahi and others believed it could be a novel complementary therapeutic option for patients with CRC, especially those for whom surgery is not an option. The team’s studies found that aronia berry extract decreased the viability of CRC cells by inhibiting proliferation, migration, cellular survival and invasion of the cells, as well as inducing cell death in the cancer cells. The findings show that by modulating numerous cancer-related pathways, aronia berry extract acts as a safe and effective complementary and integrative medicine approach against CRC.

Potential new therapies

Early study of combination therapy shows promise for chemoresistant colorectal cancer
"Exploratory biomarker analyses in phase 1 study of regorafenib, ipilimumab, and nivolumab (RIN) in chemotherapy resistant microsatellite stable (MSS) metastatic colorectal cancer (mCRC)"
Poster Presentation 6676: Wednesday, April 19, 2023, 9 a.m. to 12:30 p.m.

Jian Ye and a team of researchers led a Phase 1 clinical trial that combined regorafenib (a multikinase inhibitor) with ipilimumab and nivolumab (both immunotherapies) to treat colorectal cancer that has metastasized and has not responded to chemotherapy. Their findings show that some patients without liver metastases responded to the combination therapy (RIN) while those with liver metastases did not. Those who experienced a clinical benefit from RIN had a more robust immune activation of the tumor microenvironment after one cycle. The researchers hypothesize that those with liver metastases may not be responsive to the immunotherapies due to a lower ratio of CD4 helper T cells to CD8 cytotoxic T cells than the other patients.

LATE-BREAKING AND CLINICAL TRIAL ABSTRACTS

Poster Presentation CT261: "A Phase 1, open-label, dose-escalation study of selinexor plus ruxolitinib in patients with treatment-naïve myelofibrosis"
Poster Presentation CT166: "Similar outcomes regardless of post-randomization treatment with ibrutinib or ibrutinib + venetoclax in the phase 2 CAPTIVATE study of first-line ibrutinib + venetoclax in CLL"

On March 16, 2023 The Lung Cancer Research Foundation (LCRF) reported a collaboration with Daiichi Sankyo and AstraZeneca to fund up to three research grants focused on antibody drug conjugates (ADCs) to improve outcomes for people with lung cancer (Press release, Lung Cancer Research Foundation, MAR 16, 2023, https://www.prnewswire.com/news-releases/lung-cancer-research-foundation-announces-new-research-collaboration-with-daiichi-sankyo-and-astrazeneca-301772983.html [SID1234628957]). Applications for these grants are being accepted through May 31, 2023.

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Lung cancer is currently the number one cause of cancer death both in the U.S. and globally among both men and women, with more than 652 new diagnoses per day in the United States. 1 In many cases, lung cancer is not detected until it is in advanced stages of the disease, when the disease is more aggressive, and patients’ outcomes are significantly poorer than if the disease is treated early. Often, there is disease recurrence after initial treatment.

Unlike conventional chemotherapy treatments, ADCs are designed to specifically target cancer cells and selectively deliver a highly potent payload, which may limit damage to healthy cells. An ADC comprises a monoclonal antibody that recognizes a protein present on the cancer cells, and is bound to a cytotoxic agent, known as the payload. The use of ADCs is already common practice in several cancers, thanks to their efficacy and potentially more manageable toxicity profile, resulting from the release of the cytostatic payload directly in the tumors.2 Currently, early phase trials of ADCs in non-small cell lung cancer are rapidly gaining ground, with promising results.

This collaboration seeks to support research to study HER2 directed and TROP2 directed ADCs including mechanism of action, biomarkers, and resistance mechanisms.

"LCRF is honored to continue its long legacy of identifying and supporting outstanding lung cancer research projects over the years. We are excited to collaborate with these generous supporters of our mission," said Katerina Politi, PhD, Chair, LCRF Scientific Advisory Board. "The specific focus of this grant program is to further study ADCs and how they might be applied to lung cancer treatment. It is an exciting and promising area in lung cancer research."

The LCRF – Daiichi Sankyo – AstraZeneca Research Grant on Antibody Drug Conjugates will develop further understanding of the mechanism of action and biomarkers for TROP2 directed ADCs in lung cancer and HER2 directed ADCs in HER2 mutant NSCLC and primary and acquired resistance to TROP2 directed and HER2 directed ADCs. The deadline to submit proposals for this two-year $270,000 award is midnight on May 31, 2023, ET. More details about this Request for Proposal, along with eligibility, requirements, and deadlines can be found at LCRF.org/Funding.

To learn more about LCRF and its grants program, visit www.lcrf.org.

On March 16, 2023 Aflac Incorporated reported that the company has released its 2022 Business and Sustainability Report, titled "The Aflac Way: Making a Difference While Balancing Purpose and Profit" (Press release, Aflac, MAR 16, 2023, View Source [SID1234628956]). The 2022 Business and Sustainability report is available at investors.aflac.com under "Sustainability."

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The 2022 Business and Sustainability Report provides key insights into how Aflac Incorporated focuses on the Company’s long tradition of doing what is right for its employees and communities and an overview of operations and financial results for the 2022 fiscal year. This year’s report also highlights achievements of the company advancing integration of responsible investing into its investment and ownership decisions; progressing on its path to net zero emissions; committing $741 million in 2022 to sustainable and DEI investments; completely allocating the net proceeds from the $400 million sustainability bond issued by Aflac Incorporated on March 8, 2021; continuing to foster an inclusive culture in Japan and the U.S.; exceeding $165 million in contributions in support of the Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta; supporting 149,000 pediatric patients and their families who stay at the Aflac Parents House in Japan during treatments; and giving a My Special Aflac Duck to more than 21,000 children since 2018 to provide comfort through their treatment for cancer and most recently, sickle cell disease. It also highlights Aflac Incorporated’s focus on strong governance and commitment to being a good steward of the environment.

About the 2022 Business and Sustainability Report, Aflac Incorporated Chairman and CEO Dan Amos commented: "Let’s be clear: profits and shareholder returns determine whether a company is successful, but we have always been a company that has viewed giving back to our community as the right thing to do. This has become a part of our culture and reflected in how we operate, what we refer to as "The Aflac Way," for as long as I can remember. I’m proud of what we have accomplished by delivering solid results while focused on our social purpose. Today, customers, investors and other stakeholders want to know about a company’s purpose before making decisions. We’ve always given back, but now it is also important to proactively share information, as we do in this report about how we balance purpose and profit."

Aflac Incorporated President and Chief Operating Officer Frederick J. Crawford added: "We believe that sustainability and financial performance must be pursued in a way that naturally coexists and serves to enhance our overall franchise value. Simply put, we focus on diversity, environment and social commitments to attract the best talent and connect with the communities we serve in a way that supports our brand and the expectations of our distribution partners and policyholders. In turn, we perform better, which attracts capital to our company, such that we can continue to grow. In the spirit of the transparency we prioritize, we’ve posted material that our investors have expressed an interest in seeing,"

The report also integrates various reporting frameworks, including the Sustainability Accounting Standards Board (SASB), the Task Force on Climate-related Financial Disclosures (TCFD), United Nations Sustainable Development Goals (SDGs) and the Global Reporting Initiative (GRI), which are easily located in the report’s ESG Reporting Index.

Investors may learn more about how Aflac Incorporated balances purpose and profit at investors.aflac.com under "Sustainability" including the company’s most recent TCFD Report, the Aflac U.S. 2021 EEO-1 Disclosure and the company’s Carbon Disclosure Project (CDP) submission.