On October 25, 2021 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness a patient’s innate immune system to fight disease, reported that it will host a conference call on Wednesday, November 3, 2021 at 4:30 PM Eastern Time to discuss results for its third quarter ended September 30, 2021 and to provide a corporate update (Press release, INmune Bio, OCT 25, 2021, View Source [SID1234591890]).

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Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Third Quarter Conference Call when reaching an operator.

Date: November 3, 2021
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-877-407-0784
Participant Dial-in (international): 1-201-689-8560
Conference ID: 13724272

A live audio webcast of the call can be accessed using this link:
https://78449.themediaframe.com/dataconf/productusers/vvdb/mediaframe/47068/indexl.html

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through November 10 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13724272.

On October 25, 2021 OPKO Health, Inc. (NASDAQ: OPK) reported that operating and financial results for the three months ended September 30, 2021, as well as discuss financial guidance, after the close of the U.S. financial markets on Thursday, October 28, 2021 (Press release, Opko Health, OCT 25, 2021, View Source [SID1234591889]). OPKO’s senior management will provide a business update and discuss results in greater detail during a conference call and live audio webcast on October 28th beginning at 4:30 p.m. Eastern time.

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CONFERENCE CALL & WEBCAST INFORMATION

OPKO encourages participants to pre-register for the conference call using the link here. Upon registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call. Alternatively, please dial (888) 869-1189 or (706) 643-5902 and use conference ID 6958207.

To access the live call via webcast, please click on the link OPKO 3Q21 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call’s Q&A session are encouraged to listen to the call via the webcast.

For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO’s website at OPKO 3Q21 Results Conference Call. A telephone replay will be available beginning approximately two hours after the close of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 6958207.

On October 25, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that new data being presented at the American Society for Radiation Oncology (ASTRO) 2021 Annual Meeting suggest the company’s Decipher Prostate genomic classifier identifies patients with clinically high-risk prostate cancer who may require treatment intensification beyond standard-of-care therapy (Press release, Veracyte, OCT 25, 2021, View Source [SID1234591888]).

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The findings, from a pre-specified analysis of biopsy samples taken from prostate cancer patients with clinically high-risk disease who were enrolled in multiple phase 3, prospective, randomized studies, show that Decipher Prostate test scores are independently associated with distant metastases (DM), prostate cancer-specific mortality (PCSM) and overall survival (OS) in this patient population. After a median follow up of 11 years, men with disease classified as Decipher high-risk experienced substantially less favorable outcomes compared to men with disease classified as Decipher low-risk.

"Clinically high-risk prostate cancer is a heterogenous disease, and having reliable information about individual patients’ prognoses based on their unique tumor biology can help improve shared decision-making," said Paul L. Nguyen, M.D., of the Dana-Farber Brigham Cancer Center, who presented the data during an ASTRO media briefing today. "The findings we’re sharing at ASTRO are particularly exciting because they are the first to validate use of a gene expression classifier in pre-treatment prostate cancer biopsy samples collected during prospective, randomized clinical trials."

For the analysis, Dr. Nguyen and colleagues obtained Decipher Prostate scores for 265 biopsy samples from the NRG/RTOG 9202, 9413 and 9902 phase 3 randomized trials. After multi-variable analyses adjusting for age, prostate-specific antigen (PSA) levels, Gleason score, cT-stage, trial and randomized treatment arm, researchers found that Decipher Prostate scores were independently associated with distant metastases (HR 1.24), prostate cancer-specific mortality (1.27) and overall survival (1.12). The cumulative incidence of DM at 10 years was 26%, 15% and 6% for men who were Decipher high-risk, intermediate-risk and low-risk, respectively. Among the subset of patients with a Decipher Prostate score >0.85 (within the "high-risk" range of 0.6-1.0), DM was 29% at 5 years and 41% at 10 years.

"This analysis provides the first clinical evidence that the Decipher Prostate classifier can help physicians and patients make critical, personalized treatment decisions in the post-biopsy, clinically high-risk prostate cancer setting," said Elai Davicioni, Ph.D., Veracyte’s senior vice president of scientific and clinical operations, Urologic Cancers. "It adds another important piece to the extensive and growing body of clinical data supporting use of the classifier to help inform treatment decisions across the patient’s prostate cancer journey."

Treatment intensification for men with clinically high-risk prostate cancer and Decipher scores above 0.85 is being studied in the currently enrolling, prospective, phase 3 randomized trial NRG-GU009 (PREDICT-RT), which also studies treatment de-intensification by halving the duration of hormonal therapy in men with Decipher scores 0.85 or less. Along with PREDICT-RT, the Decipher Prostate genomic classifier is currently being investigated in seven National Cancer Institute-sponsored, phase 3, prospective, randomized controlled clinical trials; 13 phase 2/3 prospective trials; and more than 20 retrospective studies of phase 3 randomized controlled trials. Many of these trials require Decipher Prostate testing for study inclusion.

About Decipher Prostate

Decipher Prostate (Decipher Prostate Biopsy and Decipher Prostate RP) is a 22-gene, whole-transcriptome-developed genomic test intended to help inform treatment decisions for men with localized prostate cancer at initial diagnosis and after surgical removal of the prostate. The test reports the Decipher Score, which prognosticates a patient’s risk of metastasis within five years and provides risk estimates of prostate cancer-specific outcomes. Decipher Prostate can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.

On October 25, 2021 Aadi Bioscience, Inc. ("Aadi") (Nasdaq: AADI), a clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported the appointment of Loretta M. Itri, M.D., FACP, to the role of Chief Medical Officer (CMO) (Press release, Aadi Bioscience, OCT 25, 2021, View Source [SID1234591887]). Dr. Itri’s extensive career spans clinical and regulatory global-leadership roles at both major pharmaceutical and biopharmaceutical companies. Most recently, Dr. Itri was Chief Medical Officer at Immunomedics, Inc, where she oversaw the development program and approval of TRODELVY, the first TROP-2 directed antibody-drug conjugate for the treatment of unresectable locally advanced or metastatic triple-negative breast and urothelial cancers. Immunomedics was subsequently acquired by Gilead Sciences, Inc.

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"We are fortunate at Aadi to be able to tap into the experience of another valued former colleague from Immunomedics," stated Behzad Aghazadeh, Ph.D., Managing Partner and Portfolio Manager, Avoro Capital and member of Aadi’s Board of Directors. "Loretta’s insight and experience was critical to Immunomedics gaining FDA approval for TRODELVY. I am excited that she will be lending her extensive development experience to Aadi as we advance nab-sirolimus (ABI-009) forward."

"We are thrilled to have Loretta join Aadi as CMO," stated Neil Desai, Ph.D., Founder, President and Chief Executive Officer of Aadi. "Her deep drug development experience in targeted oncology therapeutics will be crucial as we drive forward our registrational study in TSC1 and TSC2 inactivating alterations. Her unparalleled expertise and track record in designing and executing clinical studies will be invaluable as we broaden the applications of our mTOR inhibitor."

Prior to joining Immunomedics, Dr. Itri was the Executive Vice President of Global Health Sciences and Regulatory Affairs at The Medicines Company (acquired by Novartis) where she oversaw the development and regulatory approval of a variety of products, including the early development of inclisiran, and other cardiovascular drugs and antibiotics. Before that, she was President of Pharmaceutical Development and Chief Medical Officer at Genta, Inc., playing a vital role in the development of diverse therapeutic agents that helped treat conditions such as breast cancer and chronic lymphocytic leukemia.

Dr. Itri has also previously served as Senior Vice President of Medical and Regulatory Affairs at Johnson & Johnson’s Pharmaceutical Research Institute, where she oversaw the development and approval of several therapeutic products, including Procrit, Cladribine, and Tramadol. In addition, she served as Senior Vice President of Clinical Affairs and Chief Medical Officer for Ortho Biotech Inc., where she was responsible for the hematology, oncology and immunology product lines. Dr. Itri began her career at Hoffmann-La Roche, where she served in various positions of increasing responsibility, including most recently as Assistant Vice President of Clinical Development in immunology, virology, hematology, and oncology.

Dr. Itri commented, "I feel fortunate to be joining Aadi at this critical time and ahead of the November 26, 2021 PDUFA target date of its investigational candidate for PEComa. I look forward to leveraging my drug development expertise to further advance and expand the opportunities for ABI-009. I believe that ABI-009 represents both a significant advance for patients with PEComa and potentially also a transformative medicine for patients with solid tumors harboring TSC1 or TSC2 inactivating alterations. With an outstanding group of new colleagues at Aadi, I look forward to initiating our registrational trial PRECISION-1 in this population."

Dr. Itri received her M.D. from New York Medical College, completed her medical residency at SUNY-Stony Brook and her fellowship in medical oncology at Memorial Sloan-Kettering Cancer Center where she was an adjunct attending physician for more than 15 years. Dr. Itri has served as a member of the National Cancer Institute Board of Scientific Counselors in both the Division of Cancer Treatment and the Division of Cancer Prevention and Control. She is the author or co-author of numerous articles in peer-reviewed journals, book chapters and abstracts related to the clinical development of therapeutic agents.

On October 25, 2021 Novartis reported that the CANOPY-1 Phase III study did not demonstrate the statistically significant primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients treated with canakinumab (ACZ885) combined with pembrolizumab plus platinum-based doublet chemotherapy, compared to patients receiving placebo in combination with pembrolizumab plus platinum-based doublet chemotherapy1 (Press release, Novartis, OCT 25, 2021, View Source [SID1234591880]). The trial data, however, showed potentially clinically meaningful improvements in both PFS and OS in pre-specified subgroups of patients based on the baseline inflammatory biomarker, hs-CRP, as well as other biomarker-defined subgroups. These data support further evaluation of canakunimab in lung cancer.

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"CANOPY-1 provides critical insights into the treatment of this devastating disease, and we will continue to analyze the data and conclusions, as well as their potential clinical implications," said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis. "While this trial did not confirm the benefit for all patients we hoped for, we are energized by the overall CANOPY-1 findings as they support our commitment to continue studying canakinumab in lung cancer. We share our gratitude and thanks to the CANOPY-1 study patients and clinical investigators for their partnership."

Novartis and investigators are collaborating on further data analysis and will present the full dataset at an upcoming medical meeting. The company is continuing with the evaluation of canakinumab in lung cancer, and is applying findings to the overall lung cancer development plan.

The comprehensive CANOPY clinical trial program continues with CANOPY-A, a Phase III study investigating canakinumab as an adjuvant therapy (after surgery)2, and CANOPY-N, a Phase II study in the neoadjuvant setting (before surgery)5. Enrollment for both trials is ongoing2,5. Patients in the CANOPY-A trial more closely reflect the earlier CANTOS study population than those in the CANOPY-1 trial2,3,4. CANTOS was the first study to show that blocking the IL-1β inflammatory signal may potentially reduce lung cancer’s incidence and mortality3.

Canakinumab is a potential first-in-class interleukin-1beta (IL-1β) inhibitor of the Pro-Tumor Inflammation (PTI) pathway in NSCLC6. PTI, which enables tumor development by driving cancer-causing processes and suppressing anti-tumor immune responses, is one of the potential hallmarks of cancer and targets in NSCLC3,6. Novartis is developing other potential PTI pathway inhibitors, which are at various stages of development, including gevokizumab7,8.

About canakinumab (ACZ885)
Canakinumab is a human monoclonal antibody that binds with high affinity and selectivity to human interleukin-1beta (IL-1β) and neutralizes IL-1β activity by blocking its interaction with its receptors9,10. By neutralizing IL-1β, preliminary evidence suggests that canakinumab may inhibit Pro-Tumor Inflammation (PTI) to 1) enhance anti-tumor immune response; 2) reduce tumor cell proliferation, survival, and invasiveness; and 3) impair angiogenesis11. PTI enables tumor development by driving cancer-causing processes and suppressing anti-tumor immune responses3,6. Canakinumab is a potential first-in-class IL-1β inhibitor of the PTI pathway in NSCLC6.

About the CANOPY program
Novartis launched the CANOPY study program after observing significantly lower than expected rates of lung cancer mortality among patients in the Phase III cardiovascular CANTOS trial. The CANTOS trial evaluated canakinumab as a secondary prevention measure for cardiovascular events in patients following a heart attack3,11. Patients in the CANTOS trial also were at high risk for inflammatory cancers, like lung cancer, due to advanced age, smoking history, and other clinical risk factors3,11. Based on these findings, Novartis launched three large-scale, randomized, Phase III clinical trials and a Phase II clinical trial to investigate canakinumab as a potential treatment option in non-small cell lung cancer (NSCLC).

CANOPY-A (NCT03447769) is a double-blind, placebo-controlled Phase III trial studying canakinumab in the adjuvant setting following surgical resection and cisplatin-based chemotherapy, if required2. The adjuvant study is designed to determine if treatment with canakinumab can prevent cancer relapse2.
CANOPY-N (NCT03968419) is a Phase II neoadjuvant trial evaluating canakinumab either as monotherapy or in combination with pembrolizumab among patients with resectable NSCLC prior to their planned surgery5.
CANOPY-1 (NCT03631199) was a double-blind, placebo-controlled Phase III trial evaluating canakinumab as a first-line treatment for locally advanced or metastatic NSCLC in combination with pembrolizumab and platinum-based doublet chemotherapy4. As reported today, the trial did not met its primary endpoints of overall survival (OS) and progression-free survival (PFS)1.
CANOPY-2 (NCT03626545) was a double-blind, placebo-controlled Phase III trial investigating the role of canakinumab in combination with the chemotherapy agent docetaxel in second- or third-line therapy versus docetaxel alone in NSCLC12. In March 2021, Novartis announced that the trial did not meet its primary endpoint, and data were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2021 Congress13.
Novartis and lung cancer
Lung cancer is one of the most common cancers worldwide, accounting for more than 2 million new cases diagnosed each year14. More people die of lung cancer every year than any other cancer14. There are two main types of lung cancer—small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC)15. NSCLC accounts for approximately 85% of lung cancer diagnoses14,16.

Novartis is committed to working with the scientific and medical communities to reimagine the treatment of lung cancer and pursue advances in medicine that could extend the survival of people living with lung cancer. With one of the most diverse lung cancer development programs in the industry, Novartis is: developing experimental therapies that block cancer growth; learning more about ways to activate the body’s immune system; increasing understanding of the relationship between chronic inflammation and tumor growth and progression; and exploring the potential for advanced nuclear medicine to fight the disease. As part of this continuing and broad commitment to targeting lung cancer, data from CANOPY-1 will be evaluated and used to inform canakinumab’s future development program, including potential combination studies with tislelizumab.