On October 4, 2021 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patient’s body, reported three poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36th Anniversary Annual Meeting (SITC 2021), to be held both in Washington, D.C. at the Walter E. Washington Convention Center and virtually November 10-14, 2021 (Press release, Cue Biopharma, OCT 4, 2021, View Source [SID1234608269]).

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Presentation Details:
Title: A phase 1 trial of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, alone and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer
Poster #: 438
Presenter: Dr. Sara I. Pai, M.D., Ph.D., associate professor of surgery, Division of Gastrointestinal and Oncologic Surgery; Director, Translational Research in Head and Neck Cancer Massachusetts General Hospital, Boston MA
Date: Saturday, November 13, 2021, Poster Hall (Hall E) 7 a.m.–8:30 p.m. EST

Title: CUE-102 selectively activates and expands WT1-specific T cells for the treatment of patients
with WT1+ malignancies
Poster #: 720
Presenter: Dr. Christie Zhang, Ph.D., senior scientist, discovery and translational immunology, Cue Biopharma
Date: Saturday, November 13, 2021, Poster Hall (Hall E) 7 a.m.–8:30 p.m. EST

Title: Targeting engineered interleukin-2 (IL-2) to antigen specific T cells via novel biologic platforms
Poster #: 793
Presenter: Raymond J. Moniz, associate director, discovery and translational immunology, Cue Biopharma
Date: Friday, November 12, 2021, Poster Hall (Hall E) 7 a.m.–8:30 p.m. EST

ePosters will be on display on the SITC (Free SITC Whitepaper) 2021 virtual meeting platform from 7 a.m. EST on Friday, Nov. 12, 2021 until the virtual meeting platform is closed on Jan. 9, 2022.

"We look forward to presenting additional preclinical and clinical data that continues to validate the therapeutic potential of our IL-2 based CUE-100 series Immuno-STAT platforms and biologics," said Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma. "We believe the data demonstrated in these posters show great promise in selective and specific tumor targeting for the treatment of multiple cancers and other life-threatening diseases."

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About SITC (Free SITC Whitepaper)
The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) is the world’s leading member-driven organization specifically dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy.

SITC is a 501(c)(3) not-for-profit medical professional society of influential research scientists, physician scientists, clinicians, patients, patient advocates, government representatives and industry leaders dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Through educational programs that foster scientific exchange and collaboration, SITC (Free SITC Whitepaper) aims to one day make the word "cure" a reality for cancer patients everywhere.

Currently, SITC (Free SITC Whitepaper) has more than 4,650 members who represent over 35 medical specialties in 63 countries around the world.

Through emphasis on high-caliber scientific meetings; dedication to education and outreach activities; focus on initiatives of major importance in the field; and commitment to collaborations with like-minded domestic and international organizations, government and regulatory agencies, associations and patient advocacy groups, SITC (Free SITC Whitepaper) brings together all aspects of the cancer immunology and immunotherapy community.

On October 4, 2021 Vaccibody AS, a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported that its Chief Executive Officer, Michael Engsig and Chief Innovation and Strategy Officer, Agnete Fredriksen, will participate in a fireside chat at Guggenheim Securities’ 2nd Annual Vaccine and Infectious Disease Days on October 6, 2021 at 3.30 pm EDT / 9.30 pm CEST (Press release, Vaccibody, OCT 4, 2021, View Source [SID1234595950]).

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On October 4, 2021 BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) reported that the Company hired two industry veterans Harold S. Bernstein, M.D., Ph.D. as Senior Vice President, Chief Medical Officer and Head of Clinical Development and Ganesh Vedantham, Ph.D. as Senior Vice President, Technical Development filling two key strategic roles (Press release, BioMarin, OCT 4, 2021, View Source [SID1234591819]).

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"We are proud of the amazing executive talent that are attracted to BioMarin and welcome both Harold and Ganesh to BioMarin. Their arrival represents a thoughtful succession plan to identify not only people with the right skills, but with values consistent with BioMarin. They both come with a level of expertise, enthusiasm and empathy to build upon the strong foundations that their predecessors astutely created to support the future growth of our pipeline," said Jean-Jacques Bienaimé, Chairman and Chief Executive Officer at BioMarin. "I look forward to working with Harold and Ganesh as we continue to advance a pipeline of potentially transformative medicines for people affected by genetic diseases."

Harold Bernstein, M.D., Ph.D., Senior Vice President, Chief Medical Officer and Head of Clinical Development

Dr. Bernstein brings more than three decades of experience in translational medicine and clinical development both in industry and academia. In this role, he will be responsible for fortifying clinical development from early to late stages, working seamlessly with research discovery and overseeing the late stage and life cycle products. Most recently, Dr. Bernstein was Head of Translational Medicine, and Vice President of Global Medicines Development at Vertex. He previously had roles of increasing responsibility at Merck including Head of Cardiometabolic Diseases. He was Professor of Pediatric Cardiology and a senior investigator at the Cardiovascular Research Institute and the Broad Center of Regeneration Medicine at the University of California, San Francisco (UCSF). He also served as attending physician at UCSF Benioff Children’s Hospital in Pediatric Cardiology, and in Cardiovascular Genetics. Dr. Bernstein currently holds appointments as attending cardiologist at Mount Sinai Kravis Children’s Hospital in New York, as well as Adjunct Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai. He studied biomedical science, human genetics, and medicine at the Mount Sinai School of Medicine, earning an MPhil, PhD, and MD. He completed a pediatric residency, cardiology fellowship, and postdoctoral fellowship at UCSF and earned an undergraduate degree in biological sciences from Harvard University.

"Harold brings a wealth of drug development experience, experience in precision and translational medicine, along with a commitment to patient care, which is an ideal background for our bold product development efforts," said Dr. Fuchs. "Harold’s deep experience in translational medicine and genetics will further bolster our pipeline. He shares our focus on the underlying cause of disease to develop therapies that are transformational. His is committed to scientific and medical innovation to improve the lives of patients as exemplified by the more than 60 peer-reviewed publications in basic, clinical and translational science that he authored and the five patents to his name."

"I was drawn to BioMarin’s pioneering approach to drug discovery and development, as well as its collegial and caring culture. As a physician scientist, I am compelled by BioMarin’s laser focus on genetics combined with the freedom to use therapeutic modalities that are best suited to treat the root cause of disease," said Dr. Bernstein. "BioMarin is well positioned to unlock advances in human genetics, genomics and DNA sequencing to deliver the next generation of breakthrough therapies. I am thrilled to have joined the Company at an exciting time as the late stage assets move towards commercialization opening a range of possibilities in genetic diseases."

Consistent with BioMarin’s regular planning, Dr. Bernstein will succeed Geoff Nichol M.B. Ch.B., MBA, FRACP, who has served for almost five years making significant contributions to the Company’s clinical development program including three product approvals. Dr. Nichol will remain at the Company to assist with the transition and to serve in an advisory capacity on late stage clinical programs.

Ganesh Vedantham, Ph.D., Senior Vice President, Technical Development

Dr. Vedantham is a seasoned leader in the biopharmaceutical industry, with global experience in various chemistry, manufacturing, and controls (CMC) functions across R&D and Technical Operations. He brings a strong scientific background; breadth and depth in many different aspects of technical development; experience in leading technical operation groups in the strategic development, production, and distribution of diverse and complex biological products on a worldwide basis; and a strong quality and regulatory foundation that build on BioMarin’s outstanding compliance record. Previously, Dr. Vedantham spent more than two decades at Amgen/Immunex in increasingly senior roles across the organization. He is known for demonstrating strategic vision, the ability to build and lead diverse and high-performing teams, and encouraging open, collaborative, supportive, and driven cultures. Dr. Vedantham earned a Ph.D. in chemical engineering from Carnegie Mellon University, a M.S. in chemical engineering from Rensselaer Polytechnic Institute, and a B.Tech in chemical engineering from the Indian Institute of Technology, Kharagpur.

"I am delighted that Ganesh has joined BioMarin. His unique background and experience are well suited to carry on the great BioMarin tradition of melding science, compliance and strategic product development into a coherent and effective regulatory strategy. This has been and will continue to be the hallmark of BioMarin’s CMC approach to drug development," said C. Greg Guyer, Ph.D., Chief Technical Officer and Executive Vice President. "His technical skills, regulatory perspective, quality insights, business acumen combined with his affinity for our culture are a potent combination that will continue to fuel our growth."

"I am thrilled to join BioMarin, an industry leader at the cutting-edge of drug development and manufacturing complex therapies. I have a high regard for the way BioMarin focuses on addressing the root cause of genetic disease, which results in a diverse portfolio of investigational and commercial therapies that range from gene therapy to oligonucleotides to biologics to small molecules," said Dr. Vedantham. "I am impressed with the depth and breadth of manufacturing capabilities at BioMarin to meet the demands of developing both pipeline and commercial therapies through highly reliable, innovative and cost-effective processes. I share the company’s tireless commitment to ensure that current and future patients have access to our therapies."

Consistent with BioMarin’s regular planning, Dr. Vedantham will succeed Victoria Sluzky, Ph.D. who previously announced her intent to retire after almost 19 years at the Company. She took on critical leadership roles within Technical Operations, initially building out the Quality organization and then expanding her scope to lead Technical Development. Dr. Sluzky has committed to working until the end of the year to facilitate a smooth transition.

On October 4, 2021 Curaleaf Holdings, Inc. (CSE: CURA / OTCQX: CURLF) ("Curaleaf" or the "Company"), a leading international provider of consumer products in cannabis, reported that it has successfully completed the acquisition of Los Sueños Farms and its related entities ("Los Sueños"), the largest outdoor grow in Colorado (Press release, Curaleaf Holdings, OCT 4, 2021, View Source [SID1234591159]).

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Boris Jordan, Executive Chairman of Curaleaf, stated, "We’re very excited about the closing of the Los Sueños acquisition. The vertical integration of our business in Colorado significantly strengthens Curaleaf’s market presence in the second largest state cannabis market in the U.S. This deal provides Curaleaf with a high-quality, efficient, and low-cost supply of biomass to support our wholesale and retail customers in Colorado and, once interstate commerce is allowed, on a regional scale. Overall, our newly expanded cultivation capacity will allow us to better serve Colorado’s $2.2 billion annual cannabis market opportunity."

Following the successful completion of the Los Sueños acquisition, Curaleaf gains three Pueblo, Colorado outdoor cannabis grow facilities covering 66 acres of cultivation capacity including land, equipment and licensed operating entities; an 1,800 plant indoor grow; and two retail cannabis dispensary locations serving adult use customers. As the largest cannabis biomass producer in the state, the Los Sueños facilities will help fuel the Company’s Select brand’s already market-leading presence in Colorado with a variety of best-in-class cannabis products distributed to nearly 2,000 locations across 18 states.

Bob DeGabrielle, Los Sueños founder and Colorado cannabis industry expert, will continue to oversee the Los Sueños operation and will take responsibility for Curaleaf’s Colorado wholesale and retail businesses.

Joseph Bayern, CEO of Curaleaf, commented, "The Los Sueños acquisition provides important new cultivation capacity to accelerate our growth and share in the fast-growing Colorado market. By leveraging the outdoor grow expertise of the talented Los Sueños team, we will optimize our new outdoor scale and cultivation technologies to lower our total cost of delivery, with the genetics that we perfect there serving as a center of excellence for all our future U.S. outdoor cultivation capabilities."

On October 4, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune T-cell activating technology, reported the completion of enrollment for the first stage of the checkpoint inhibitor naïve arm of its VERSATILE-002 Phase 2 study for the treatment of recurrent and/or metastatic human papillomavirus (HPV16)-associated head and neck cancer (Press release, PDS Biotechnology, OCT 4, 2021, View Source [SID1234590865]). 90% of HPV-associated head and neck cancers are reported to be caused by HPV16 as reported by a study published in the Journal of Clinical Medicine.

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VERSATILE-002 is studying two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group has not been previously treated with a checkpoint inhibitor (CPI naïve). The second group of patients have failed multiple treatments including checkpoint inhibitor therapy (CPI refractory). As specified in the clinical trial design, objective response is measured by radiographic tumor responses according to RECIST 1.1 (tumor reduction of 30% or more). If objective response is achieved among at least four of the first 17 patients in the CPI naïve arm, this will trigger advancement to the second stage of the study arm and enrollment of the planned 54 patients in the CPI naïve arm. The trial is being conducted in collaboration with Merck & Co.

"Completion of enrollment among checkpoint inhibitor naïve patients in this first stage of our VERSATILE-002 Phase 2 study in the CPI naïve arm is an important milestone, and we would like to thank the patients for their participation in this clinical trial," said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "Through their involvement, together with site Investigators and study staff, this trial will help us better understand the potential contribution that PDS0101 may have in improving the lives of patients with advanced head and neck cancer."

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Lead Principal Investigator of VERSATILE-002. Patients interested in enrolling in this clinical study should email [email protected] or visit the website at View Source to learn more.