On September 13, 2021 Bristol-Myers Squibb reported that Results of a new multinational survey of healthcare providers revealed that the majority of participants expect immunotherapy to have a positive impact on the treatment landscape for patients with earlier-stage cancers in the adjuvant (after surgery), neo-adjuvant (before surgery) and peri-operative (both before and after surgery) settings, if approved by regulatory bodies (Press release, Bristol-Myers Squibb, SEP 13, 2021, View Source [SID1234587616]). The survey, commissioned by Bristol Myers Squibb (NYSE: BMY), included over 250 oncologists, surgeons and specialists in the U.S., Japan, Germany, Italy and France who currently treat patients with stage I-III disease across eight different types of cancer. While healthcare providers surveyed are more satisfied with current treatments in cancers where earlier options are well established, they do not always use treatment before or after surgery, and the vast majority of respondents express enthusiasm for the potential of immunotherapy in earlier-stage cancers.

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"Cancer recurrence often marks the transition from curable to incurable disease and can be life-altering for patients, which is why we continually investigate ways to improve upon the standard of care," said Michele Maio, M.D., Ph.D., Director of Medical Oncology and Immunotherapy, University Hospital of Siena. "Optimizing cancer treatment in its early phases, before the disease returns or spreads, represents a significant opportunity and unmet need. Research with immunotherapy in these settings is growing, and the survey results announced today reinforce that a majority of healthcare providers surveyed are enthusiastic about its future potential."

Current Treatment Approaches in Earlier Stages of Cancer

Today, treatment in the neoadjuvant, adjuvant or peri-operative settings may consist of chemotherapy, radiation, targeted therapy, chemoradiation therapy, and increasingly in a subset of tumors, immunotherapy. The survey identified a number of trends on the current use, satisfaction and drivers of treatment choices in earlier-stage cancers.

HCPs surveyed do not always use treatment beyond surgery: The majority of HCPs surveyed report that they "sometimes" use neoadjuvant (62%), adjuvant (55%) or peri-operative (54%) treatments for patients with earlier stages of cancer, highlighting the opportunity for earlier intervention.
HCPs surveyed are more satisfied with current treatments in cancers where earlier options are well established :Six out of 10 or more survey respondents are "very" or "fairly" satisfied with current neoadjuvant (67%), adjuvant (70%) and peri-operative (61%) treatment options as a whole. However, satisfaction varies by tumor* and is highest among cancers with well-established therapies, like breast cancer (87% satisfaction in the neoadjuvant/adjuvant settings) and melanoma (77% satisfaction in adjuvant). In kidney and liver cancers, satisfaction is noticeably lower (less than 35% satisfaction with neoadjuvant, adjuvant and peri-operative options), signaling the need for additional research.
HCPs surveyed use immunotherapy in earlier stages (either as approved therapies or in clinical trials), but not as often as other treatments : Currently, respondents report more experience using chemotherapy (85%, 86% and 73% for neoadjuvant, adjuvant and peri-operative, respectively) than immunotherapy (48%, 65% and 39%, respectively), likely reflecting that immunotherapy remains under investigation in a number of tumor types and only recently emerged as an approved option in others.
The Potential of Immunotherapy for the Future of Earlier-Stage Treatment

To better understand the future landscape of neoadjuvant, adjuvant and peri-operative treatment, the survey explored HCPs’ perceptions of immunotherapy and found:

Many HCPs surveyed see potential for a positive impact with immunotherapy in earlier stages of disease: Participants see the greatest potential for positive outcomes in melanoma (92% report positive potential impact in the adjuvant setting), lung cancer (89% in the neoadjuvant setting) and bladder or urothelial cancer (84% in the adjuvant setting).*
HCPs surveyed believe the potential benefits of immunotherapy align with what currently drives treatment preferences in earlier settings : Selecting from a list, HCPs surveyed state the most important potential benefits of immunotherapy as longer overall survival (64%), increased disease-free, event-free or recurrence-free survival (57%) and maintenance of quality of life (54%). These responses align with the factors HCPs surveyed report as most important in making treatment decisions in patients with operable tumors (long-term survival, prevention of relapse or recurrence and quality of life).
HCPs surveyed cite the need for more data as a leading barrier to adoption of immunotherapy in earlier stages of cancer : From a list, surveyed participants selected the need for long-term and overall survival data as leading barriers to adoption of immunotherapy in earlier stages of cancer (53% and 50%, respectively), reinforcing the importance of ongoing research and follow-up analyses.
"Over the past decade, immunotherapy research has evolved, starting with a focus on metastatic cancers, and more recently, expanding to explore the role of these treatments in earlier stages of the disease," said Jonathan Cheng, senior vice president, head of Oncology Development, Bristol Myers Squibb. "We hope that by addressing cancer in earlier stages, when the immune system may be more responsive and intact, immunotherapy may have the potential to prevent recurrence and ultimately lead to patients living longer. Oncologists, surgeons and specialists who responded to this survey are similarly optimistic about the potential of bringing immunotherapy into earlier stages of cancer."

*Tumor-specific results are based on responses from HCPs who currently treat these types of cancer, a subset of the full sample.

About the Survey

On behalf of Bristol Myers Squibb, Ipsos MORI carried out an online survey on treatment perceptions and practices in earlier stages of cancer. A total of 256 healthcare providers across five countries (France n=50, Germany n=50, Italy n=50, U.S. n=56 and Japan n=50) chose to take part in the online survey. Fieldwork took place between June 3 and July 2, 2021. Respondents included medical oncologists, surgeons (general, thoracic, breast, respiratory and gastroenterological surgeons) and specialists (urologists, dermatologists, pulmonologists, gastroenterologists and otolaryngologists) who treat patients with stage I-III disease across eight different cancer types (bladder/urothelial cancer, breast cancer, gastroesophageal cancers, head and neck cancer, kidney cancer, liver cancer, lung cancer and melanoma). A quota was set to obtain a minimum of 25 medical oncologists in France (n=28), Germany (n=29), Italy (n=29) and U.S. (n=25). The sample included a mix of hospital-, university- and community-based HCPs. The respondents were sampled from pre-existing panels of self-selecting HCPs, managed by M3 and SHC.

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

On September 13, 2021 Purple Biotech (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor immune evasion and drug resistance, reported an update on its ongoing Phase 1b/2 clinical trial of CM24, a monoclonal antibody blocking CEACAM1, in combination with nivolumab (Opdivo), a PD-1 inhibitor, in advanced cancer patients, with expansion cohorts in subjects with non-small cell lung cancer (NSCLC) and in combination with nivolumab and nab-paclitaxel (Abraxane) in pancreatic cancer (Press release, Purple Biotech, SEP 13, 2021, View Source [SID1234587615]).

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In a Trials in Progress poster at the ESMO (Free ESMO Whitepaper) 2021 Congress, which will be held on September 16-21, 2021, Purple Biotech will present an overview and the design of the ongoing Phase 1b/2 study. The poster is titled, "A Phase 1b Study of CM24 in Combination with Nivolumab in Adults with Advanced Solid Tumors, followed by a Phase 2a study of CM24 in Combination with Nivolumab in NSCLC, and in Combination with Nivolumab and nab-paclitaxel in Pancreatic Cancer."

Top-line data from the first dose cohort of CM24 10mg/kg included a partial response demonstrated in a patient with refractory advanced pancreatic cancer previously treated with two lines of therapy following two courses of treatment with CM24 in combination with nivolumab 480mg/kg. Additionally, there were no dose-limiting toxicities or serious adverse events observed in any of the three patients enrolled in the first cohort of the study.

"We are encouraged by the early data from the first cohort of this study, which showed combination agent safety, as well as a partial response in one patient," said Bertrand C. Liang, M.D., Ph.D., Chief Medical Officer of Purple Biotech. "The responsive patient showed a 40 percent reduction in tumor size following two courses of treatment with CM24 10mg/kg in combination with nivolumab. In addition, levels of CA19-9 tumor marker dropped by 56%, which was comparable to baseline levels. These results are especially compelling given that pancreatic tumors without high levels of microsatellite instability or deficient mismatch repair, such as the responsive patient, typically do not respond to immuno-oncology agents."

Enrollment in the second dose cohort (15mg/kg) has successfully concluded. Moreover, the Phase 1b/2 study is being expanded to additional sites in the U.S. and Israel.

"The top-line data from the first cohort of this study reinforce our confidence in the potential of CM24 to be a safe and effective treatment for advanced cancer patients. Moreover, we are pleased with the high level of interest in this study from some of the leading academic centers in the world and look forward to completing this dose-escalation study by year-end, as planned," said Isaac Israel, Chief Executive Officer of Purple Biotech.

The study is a Phase 1b/2 clinical trial with expansion cohorts in subjects with NSCLC and pancreatic cancer. CM24 is dose escalated (3+3 design) from 10mg/kg, in combination with nivolumab, 480mg q4w, in Phase 1b, in patients with NSCLC, pancreatic cancer, ovarian carcinoma, colorectal adenocarcinoma, melanoma, or thyroid carcinoma, with the primary objective of evaluating safety, PK and determining the recommended Phase 2 dose. In the Phase 2 component, patients with NSCLC will be treated with CM24 and nivolumab after first-line immuno-oncology failure, and patients with advanced/metastatic pancreatic adenocarcinoma will be treated with CM24, nivolumab, and nab-paclitaxel (Abraxane) after first-line therapy failure, with study endpoints being safety and preliminary efficacy. CEACAM1 level of expression, as well as a number of other immune, biochemical and adhesion-related molecules, will be evaluated as potential biomarkers in the study.

Additional information about the trial can be found at www.clinicaltrials.gov, NCT Identifier NCT04731467.

The trial is being conducted under a clinical collaboration and supply agreement with Bristol Myers Squibb. Purple Biotech is the sponsor of the trial.

Opdivo is a trademark of Bristol-Myers Squibb Company.

Abraxane is a trademark of Abraxis BioScience, LLC, a Bristol Myers Squibb company.

On September 13, 2021 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate DELTA-1, a global Phase 2 clinical trial of ITIL-168 in patients with advanced melanoma whose disease has relapsed after a PD-1 inhibitor and, if positive for a BRAF-activating mutation, a BRAF inhibitor (Press release, Instil Bio, SEP 13, 2021, View Source [SID1234587613]).

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The DELTA-1 trial was expanded during the IND review process, in consultation with FDA, to include additional populations of patients with advanced melanoma. Cohorts 2 and 3 will enroll patients who discontinued PD-1 inhibitor therapy due to intolerable toxicity and patients who had an unsatisfactory response to prior PD-1 inhibitor but have not yet experienced disease progression, respectively. Topline safety and efficacy results are expected in 2023 and, if positive, are anticipated to support the submission of a biologics license application (BLA) to the FDA in 2023 and a Marketing Authorization Application (MAA) to the European Medicines Agency in 2024.

"The IND clearance for the DELTA-1 Phase 2 clinical trial is a testament to the talent, experience and devotion of the Instil Bio team," said Bronson Crouch, Chief Executive Officer of Instil. "Motivated by patients in need, our organization will develop ITIL-168 commercially as we expand our clinical programs with current and next-generation therapies."

"This achievement reflects the depth of cell therapy experience, scientific talent and focused execution of our organizations in both the U.S. and U.K.," said Vijay Chiruvolu, Ph.D., Chief Technical Officer of Instil. "Additionally, the development of the product release plan, encompassing the innovative potency assay as part of QC release as well as the comprehensive characterization strategy, was built on expertise from our broad, cross-functional team including research, process development, analytical sciences and translational medicine."

Zachary Roberts, M.D. Ph.D., Chief Medical Officer of Instil added, "We are pleased to begin this clinical trial of ITIL-168 in an area of marked unmet medical need. Furthermore, the inclusion of additional cohorts of patients who have not been systematically studied with TIL therapy provides us with the opportunity to learn about the potential role of ITIL-168 in other populations who lack effective therapies."

About ITIL-168

ITIL-168 is an investigational, autologous cell therapy made from tumor infiltrating lymphocytes, or TILs. Made from each patient’s digested and cryopreserved tumor, ITIL-168 is a TIL cell therapy manufactured to offer an unrestricted T cell receptor (TCR) repertoire. Instil’s proprietary, optimized, and scalable manufacturing process has been designed to capture and preserve the maximum diversity of each patient’s TILs. By collecting the patient’s tumor and immediately processing and then cryopreserving it, our process offers significant scheduling flexibility for patients and physicians at the time of both tumor resection and TIL treatment. In addition to DELTA-1, Instil plans to investigate ITIL-168 in additional solid tumor indications in Phase 1 clinical trials beginning in 2022.

About DELTA-1

DELTA-1 is a global, multicenter Phase 2 clinical trial of ITIL-168 in adult patients with advanced melanoma. Using an open-label, single-arm design, the main study cohort will evaluate the efficacy and safety of ITIL-168, when administered after a 5-day course of lymphodepleting chemotherapy and followed by up to 8 doses of high-dose interleukin-2 (IL-2), in patients whose cancer has progressed following a PD-1 inhibitor and, if positive for a BRAF-activating mutation, a BRAF inhibitor. Approximately 80 subjects are planned for enrollment and treatment in Cohort 1. Cohort 2 is anticipated to enroll approximately 25 subjects and is designed to evaluate the efficacy and safety of the regimen in patients who required discontinuation of PD-1 inhibitor(s) due to unacceptable toxicity, regardless of best overall disease response. Cohort 3 is also anticipated to enroll approximately 25 subjects and will evaluate efficacy and safety in patients whose best ongoing response to PD-1 inhibitor(s) is stable disease. Patients in Cohorts 2 and 3 whose cancer expresses a BRAF-activating mutation will be required to have experienced disease progression following BRAF inhibitor therapy. The primary endpoint of DELTA-1 is the objective response rate (ORR) according to RECIST v1.1 as assessed by independent central review. Secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, and safety.

On September 13, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported the appointment of Norman LaFrance, M.D. to the position of Chief Medical Officer and Senior Vice President (Press release, Cytori Therapeutics, SEP 13, 2021, View Source [SID1234587612]).

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"We are delighted to have Dr. LaFrance onboard as he brings several decades of highly relevant clinical, regulatory and commercial expertise to the Plus Therapeutics management team," stated Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "His proven track record in radiotherapeutics and drug development coupled with his commercial experience will be invaluable as we expand our pipeline, move key programs to late stage clinical development and best position the company for long-term regulatory and commercial success."

Dr. LaFrance’s appointment begins on or around December 8, 2021 and he joins the Company with nearly 40 years of experience as a nuclear medicine physician and as an executive in the pharmaceutical and healthcare industries. Dr. LaFrance has a particular expertise in radiotherapeutic drug research and development as well as commercialization of molecular imaging, diagnostic and therapeutic products. He was most recently Chief Medical Officer, Senior Vice President, at Jubilant Pharma Ltd, responsible for all Pharma Medical & Regulatory Affairs activities.

"I am excited to join a company which reflects my passion to make an impact on patients with significant unmet medical needs," said Norman LaFrance, M.D. "From an industry perspective, it is clear that Plus Therapeutics’ focus on radiotherapeutics positions it firmly for long-term growth, and I am excited to lead development and expansion of its promising pipeline."

Prior to Jubilant Pharma, Ltd., Dr. LaFrance served as Global Chief Medical Officer at IBA Molecular from 2010 to 2012, and as Senior Vice President, Clinical Development and Chief Medical Officer at Molecular Insight Pharmaceuticals from 2007 to 2010. Prior to industry, Dr. LaFrance practiced medicine and held academic faculty appointments at Johns Hopkins University School of Medicine in the departments of medicine and radiology and the Department of Radiological Sciences in the John Hopkins School of Hygiene and Public Health. He is Double Board Certified with Fellowship status both in internal medicine and nuclear medicine, maintains active medical licensure in the U.S. along with active, professional society membership.

Dr. LaFrance received his bachelor of science and master of engineering degrees in nuclear engineering and science from Rensselaer Polytechnic Institute, and his medial degree from the University of Arizona, College of Medicine, Tucson.

On September 13, 2021 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it will present new data from the dose-escalation portion of the Phase 1 clinical trial of SY-5609, its highly selective and potent oral cyclin-dependent kinase 7 (CDK7) inhibitor, at the ESMO (Free ESMO Whitepaper) Congress 2021, taking place virtually September 16-21, 2021 (Press release, Syros Pharmaceuticals, SEP 13, 2021, View Source [SID1234587611]). The oral presentation will include safety, tolerability, and initial clinical activity data for SY-5609 in patients with breast, colorectal, lung, ovarian and pancreatic cancers, as well as in patients with solid tumors of any histology harboring Rb pathway alterations.

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In separate poster presentations, Syros will present new preclinical data evaluating the antitumor and pharmacodynamic activity of intermittent dosing regimens for SY-5609 in ovarian cancer models, as well as new preclinical data evaluating antitumor activity of SY-5609 as a single agent and in combination with chemotherapy in KRAS-mutant models.

The abstracts for the two poster presentations are now available online on the ESMO (Free ESMO Whitepaper) conference website at: View Source, and the presentations will become available for on-demand viewing starting September 16 at 08:30 CEST (September 16 at 2:30 a.m. ET). The abstract for the oral presentation on the Phase 1 dose-escalation data will remain embargoed until September 17 at 00:05 CEST (September 16 at 6:05 p.m. ET).

Details of the oral presentation are as follows:

Presentation Title: Tolerability and Preliminary Clinical Activity of SY-5609, a Highly Potent and Selective Oral CDK7 Inhibitor, in Patients with Advanced Solid Tumors
Session Date & Time: Monday, September 20, 17:30-18:30 CEST (11:30-12:30 p.m. ET)
Presentation Time: 17:55-18:00 CEST (11:55-12:00 p.m. ET)
Session Title: Mini Oral Session: Developmental Therapeutics
Presenter: Manish Sharma, M.D., START Midwest
Abstract Number: 518MO

Details of the poster presentations are as follows:

Presentation Title: Preclinical Evaluation of Intermittent Dosing Regimens on Antitumor and PD Activity of SY-5609, a Potent and Selective Oral CDK7 Inhibitor, in Ovarian Cancer Xenografts
Abstract Number: 14P
Presentation Title: SY-5609, a Highly Potent and Selective Oral CDK7 inhibitor, Exhibits Robust Antitumor Activity in Preclinical Models of KRAS Mutant Cancers as a Single Agent and in Combination with Chemotherapy
Abstract Number: 13P

Conference Call Information

Syros will host a conference call on Monday, September 20, 2021 at 4:00 p.m. ET to discuss the new clinical and preclinical data for SY-5609, which will be presented at the ESMO (Free ESMO Whitepaper) Congress 2021.

To access the live conference call, please dial 866-595-4538 (domestic) or 636-812-6496 (international) and refer to conference ID 4648345. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the conference call.