On September 12, 2023 CYTEA|BIO, reported its collaboration with EFS Besançon (PIBT) and Bionoveo (Press release, CYTEA BIO, SEP 12, 2023, View Source [SID1234635099]). This partnership is aimed at propelling the development and manufacturing of our state-of-the-art cell therapy products. These groundbreaking therapies signify a novel category of medical progress, harnessing the potential of allogeneic natural killer (NK) cells sourced from human umbilical cord blood (UCB) armed with a chosen monoclonal antibody (mAb), expertly designed with a high-affinity Fc region.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Alan Cookson, the CEO of CYTEA|BIO, remarked, "Through this collaboration, our commitment lies in advancing the realm of cell therapy and addressing a pressing, unmet medical necessity for patients grappling with glioblastoma. At the forefront of our inaugural clinical trial stands our flagship product, CYT-102, holding the promise of enhanced treatment outcomes and renewed hope."

This collaboration marks a milestone where expertise converges, aspirations align, and medical innovation takes center stage. Together, we are venturing into uncharted territories, guided by our dedication to scientific excellence and patient well-being. The synergy between CYTEA|BIO, EFS Besançon, and Bionoveo resonates with the potential to redefine medical standards and reinvigorate the lives of countless individuals.

As we embark on this remarkable journey, the path ahead may present challenges, yet it is illuminated by the prospect of reshaping the landscape of healthcare. Through relentless determination and collaborative spirit, we strive to make a lasting impact. The core of our endeavor remains rooted in compassion, guided by purpose, and driven by a commitment to improving lives. The future is promising, and we are poised to drive positive change.

On September 12, 2023 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib, an orally available, small molecule IRAK4 inhibitor for the treatment of hematologic malignancies, reported the 2nd Symposium on IRAK4 in Cancer taking place virtually on September 22, 9:00am-1:00pm ET (Press release, Curis, SEP 12, 2023, View Source [SID1234635098]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Hosted by Dr. Guillermo Garcia-Manero and Dr. Eric Winer, this symposium will focus on IRAK4, a key protein in the innate immune response and an emerging target in the treatment of hematologic malignancies and solid tumors. Experts across academia and industry will discuss IRAK4’s biological and immunological roles as well as the promising role of targeting IRAK4 in cancer therapeutics.

"Following the success of last year’s symposium on IRAK4 in cancer, Curis is pleased to continue its sponsorship of the Annual IRAK4 Symposium," said James Dentzer, President, and Chief Executive Officer of Curis. "As a leader in IRAK4 inhibition in oncology with emavusertib, we are honored to provide a forum for discussing the biology of the IRAK4 pathway and IRAK4 inhibition in the research and development of therapies to benefit patients living with cancer."

Symposium hosts:

Guillermo Garcia-Manero, M.D. – Symposium Co-Chair – Professor, Department of Leukemia; Chief, Section of Myelodysplastic Syndromes and Deputy Chair, Translational Research, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center
Eric Winer, M.D. – Symposium Co-Chair – Clinical Director, Adult Leukemia Institute Physician, Dana-Farber Cancer Institute; Assistant Professor of Medicine, Harvard Medical School
Joining our hosts will be the following speakers and participants:

Omar Abdel-Wahab, M.D. – Edward P. Evans Chair in MDS, Director, Memorial Sloan Kettering Cancer Center (MSK) for Hematologic Malignancies; Member, Human Oncology and Pathogenesis Program & Leukemia Service
Claudio Cerchione, M.D., Ph.D. – Hematologist, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
Bentley Doonan, M.D., M.S. – Assistant Professor, Division of Hematology & Oncology, University of Florida College of Medicine
Matthew Galsky, M.D. – Professor of Medicine (Hematology and Medical Oncology), Director of Genitourinary Medical Oncology, Co-Director of the Center of Excellence for Bladder Cancer, Associate Director for Translational Research, Tisch Cancer institute
Christian Grommes, M.D. – Associate Professor of Neurology, Weill Cornell Medical College; Assistant Professor of Neuroscience, Brain and Mind Research Institute, Weill Cornell Medical College; Neuro-oncologist, Memorial Sloan-Kettering Cancer Center
Kian-Huat Lim, M.D., Ph.D. – Associate Professor, Division of Oncology, Department of Medicine, Washington University School of Medicine in St. Louis
Daniel Starczynowski, Ph.D. – Institute Associate Director for Basic Science Research, University of Cincinnati Cancer Center; Co-Chief Scientific Officer, Innovations Ventures; Katherine Stewart Waters Endowed Chair of Hematologic Malignancies, Professor in Pediatrics, Co-Leader, Hematologic Malignancies Program, Cincinnati Children’s Hospital
Richard Stone, M.D. – Chief of Staff, Dana-Farber Cancer Institute; Director of Translational Research, Adult Acute Leukemia Program, Dana-Farber Cancer Institute; Professor of Medicine, Harvard Medical School
Amit Verma, M.B.B.S. – Professor, Department of Oncology (Medical Oncology), Department of Medicine (Oncology & Hematology), and Department of Developmental & Molecular Biology, Albert Einstein College of Medicine; Director, Division of Hemato-Oncology, Montefiore Department of Oncology; Associate Director, Translational Science, Montefiore Einstein Cancer Center; Co-Director, Montefiore Einstein Blood Cancer Institute
The virtual event will address topics including the biology of the IRAK4 pathway and the potential of IRAK4 inhibition in both hematologic malignancies and solid tumors. Presentations and a panel discussion will address IRAK4 biology and clinical experience with IRAK4 inhibition, the potential to overcome treatment resistance, biomarkers, and next steps in the field. To learn more about this free-to-attend symposium and register, please visit View Source

On September 12, 2023 Cerus Corporation (Nasdaq: CERS) reported that Kevin Green, Cerus’ chief financial officer, is scheduled to participate at the 2023 Cantor Global Healthcare Conference on Tuesday, September 26, at 10:30 a.m. EST (Press release, Cerus, SEP 12, 2023, View Source [SID1234635097]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the fireside chat will be available at View Source replay will be available for 90 days after the event.

On September 12, 2023 2seventy bio, Inc. (Nasdaq: TSVT), reported a restructuring of its business operations and research and development model to significantly reduce costs while supporting the execution of a prioritized plan for the long-term growth of the company (Press release, 2seventy bio, SEP 12, 2023, View Sourcenews-releases/news-release-details/2seventy-bio-announces-strategic-restructuring-prioritize-growth" target="_blank" title="View Sourcenews-releases/news-release-details/2seventy-bio-announces-strategic-restructuring-prioritize-growth" rel="nofollow">View Source [SID1234635094]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2seventy’s mission remains the same: to unleash the power of the T-cell and develop un-incremental treatments for people living with cancer," said Nick Leschly, chief kairos officer. "However, the macro environment for oncology cell therapy companies and the near-term headwinds we have seen in our own business have led us to examine how we pursue our mission. Today we are taking hard but necessary steps to streamline our team and optimize our R&D approach and cost structure. In this process, we have focused on how to move efficiently and more cost effectively to develop innovative therapies for patients and create value for shareholders. Unfortunately, we will be saying goodbye to many highly talented and committed members of our team. I want to thank each of them for their amazing dedication to 2seventy and our mission to help those in need, doing everything we can to deliver more TIME."

"The difficult but necessary changes we are making to our workforce, our programs and our cost structure reflect our commitment to advancing our pipeline and achieving value creating milestones with existing cash," said Chip Baird, chief operating officer. "Our U.S. Abecma collaboration provides a source of revenue to offset investment in our pipeline programs, and while we continue to be optimistic about Abecma’s future, particularly given the potential third-line label expansion at the end of the year, we are planning conservatively. We expect today’s changes will preserve runway into at least 2026, and we will continue to focus on careful expense management and thoughtful capital allocation while staying true to our mission of driving programs forward for patients in need. I echo Nick’s gratitude to the members of our team who will be departing 2seventy and look forward to continuing to uphold 2seventy’s unwavering focus on patients as we move into a new chapter."

Business Updates, Restructure Actions and Financial Impacts

Elimination of 176 roles, representing approximately 40% of our workforce
Expected annualized cost savings of at least $65 million, or approximately $130 million in the 2024-2025 period; additional savings possible as we continue rigorous efforts to right-size facilities and related external spend by 2025 to better reflect our current needs.
One-time restructuring costs of approximately $9 million, primarily incurred in the third quarter of 2023.
Implemented a capital-efficient translational development paradigm blending internal manufacturing (270-MPH), our expanded JW Therapeutics collaboration as well as select academic centers to efficiently explore our innovative cell therapies in the clinic
Current balance of cash, cash equivalents, and marketable securities expected to support operations into 2026
Abecma and Pipeline Portfolio Updates

Abecma "Return to Growth:"
Revenue and impact to 2seventy: Based on an anticipated decline in Abecma sales in the third quarter, we believe full-year 2023 U.S. revenue for Abecma could be lower than the $470-$570 million range previously projected. 2seventy continues to expect Abecma to remain profitable this year and contribute significantly toward our cash runway into at least 2026 and remains confident in Abecma’s long-term commercial potential.
Upcoming Milestones: The December 16, 2023 PDUFA date for potential label expansion based on the KarMMa-3 data in adult patients with triple-class exposed relapsed or refractory multiple myeloma and the planned initiation of the KarMMa-9 study in patients with newly diagnosed multiple myeloma with sub-optimal response post-ASCT later this year provide both short- and medium-term grounds for continued optimism in the commercial potential of Abecma.
Updates on bbT369 and SC-DARIC-33 Programs
Phase I CRC-403 study of bbT369 in patients with relapsed and/or refractory B cell non-Hodgkin lymphoma (B-NHL) (wholly-owned)
Clinical Data Update: Today, 2seventy is disclosing that the safety profile, CAR expansion kinetics, including the potential role of the CBL-B gene edit, and the clinical efficacy data, including complete responses in some patients observed to date is supportive of the Company’s decision to continue the Phase I study.
Future Development: While interest and enrollment at clinical study sites has been strong and initial data are encouraging, the Phase I dose escalation study of bbT369 has progressed slower than anticipated, due in part to the FDA mandated safety stagger and the often-aggressive nature of relapsed and/or refractory B-NHL, which can result in patients becoming ineligible for treatment. Despite these challenges, the study is actively enrolling at the third dose level. Given the anticipated pace of accrual and treatment, the Company expects to present the first data from the bbT369 study at a medical meeting in 2024.
Consistent with the rest of the pipeline, the Company has markedly streamlined the cost structure for this program, gating further investment beyond Phase I on the achievement of transformational efficacy.
PLAT-08 clinical study of SC-DARIC-33 in acute myeloid leukemia (AML) and next generation AML program (wholly-owned)
The Company is working with the FDA to enable restart of the Phase 1 study, which is currently on clinical hold. 2seventy plans to limit financial commitment to the current Phase I trial.
The Company will provide the next update on the PLAT-08 study upon completion of the Phase I dose escalation.
Partnered pipeline continues to develop and expand – two new programs approaching the clinic at year end
MUC-16 program in ovarian cancer (Regeneron partnership)
IND submission is on track and anticipated by the end of 2023
MAGE-A4 T cell receptor (TCR) program in solid tumors (led by JW Therapeutics)
Led by JW Therapeutics, initiation of an investigator-initiated study in China is ahead of schedule and anticipated by end of 2023.
JW Therapeutics Partnership Expansion
As announced in a separate press release today, 2seventy bio and JW Therapeutics are planning to expand their collaboration to include an additional solid tumor program and the first-in-human assessment of 2seventy’s proprietary autoimmune-directed CAR T cell product.
Leadership Transitions
Nick Leschly has informed the Company’s Board of Directors that he intends to step down as CEO upon the Board’s identification of his successor. The Company expects that Mr. Leschly will be appointed Chairman of the Board upon this transition. The Board has retained an executive recruitment firm to assist with the search for Mr. Leschly’s successor as CEO.

"After nearly 14 years as CEO of bluebird and 2seventy I feel beyond grateful and humbled to have had the opportunity to help bring four cell therapies to patients and do our part to advance the field," said Nick Leschly, chief kairos officer. "I very much look forward to continuing to work closely with the board and leadership team to advance 2seventy’s mission for patients."

Additionally, Chip Baird, formerly Chief Financial Officer, is now Chief Operating Officer expanding his responsibilities to include finance, corporate development, investor relations and corporate communications as well as portfolio and program/alliance management.

Conference Call Information
2seventy bio will host a conference call and live webcast today, September 12, at 8:00 a.m. ET to discuss today’s announcement. To join the live conference call, please register at: https://register.vevent.com/register/BIc10c340a7f244db5a5fc17394a8f3552. Upon registering, each participant will be provided with call details and access codes. The live webcast may be accessed by visiting the event link at: View Source A replay of the webcast may be accessed from the "News and Events" page in the Investors and Media section of the Company’s website at View Source and will be available for 30 days following the event.

On September 12, 2023 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, and JW Therapeutics (HKEX: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, reported their intention to expand their strategic alliance (Press release, 2seventy bio, SEP 12, 2023, View Source [SID1234635093]). The expansion, based on the partnership that was established last year, builds upon the companies’ translational and clinical cell therapy development platform originally designed to more rapidly explore T cell-based immunotherapy therapy products in Greater China. Specifically, the companies intend to add up to two additional candidates from the 2seventy portfolio, one in solid tumor indications using T-cell receptor (TCR) based technology and a second in autoimmune disease using a CAR T cell approach.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Since our partnership was established, our companies have built a deeply collaborative and successful approach to progressing cell therapy candidates," said Steve Bernstein, chief medical officer, 2seventy bio. "At the time, our primary goal was to build a collaboration with a focus on our potency-enhanced MAGE-A4 solid tumor program that could demonstrate our collective capabilities to rapidly test, learn and progress our innovative cell therapy programs to the clinic. We’re excited to have done just that, with this initial program running ahead of schedule and on track to initiate an investigator-initiated study in China by the end of this year. Given the progress with MAGE-A4, today’s announcement is a natural evolution, doubling down on the success to date by extending our collaboration into additional programs in solid tumors and autoimmune disease."

As announced in October 2022, the initial focus of the collaboration was 2seventy bio’s potency enhanced MAGE-A4 TCR program in solid tumors which is being developed as part of a collaboration with Regeneron. Over the last 10 months, JW Therapeutics has successfully progressed this candidate and is on track to initiate an investigator-initiated study in China by the end of 2023 and well ahead of the original timeline. In addition to the pace of development, the significantly better cost structure of preclinical and early clinic development performed through JW Therapeutics’ internal and external development network provides additional rationale for further collaboration. To this end, the intent of the expanded collaboration is to add two new programs: an additional solid tumor program and 2seventy’s first autoimmune disease (AID) targeted CAR T cell program.

2seventy’s AID program is a natural extension of its’ internal expertise in CAR T cell research and significant clinical experience in both B-cell targeted and plasma cell-targeted CAR T cells in oncology – the two antibody secreting cell types in the body that play a role in the pathobiology of autoimmune disorders. 2seventy’s construct has been designed to achieve the breadth and depth of target cell elimination necessary to potentially provide a superior outcome for patients suffering from the plethora of antibody-mediated autoimmune diseases.

"From the start of our collaboration with 2seventy bio last year, we knew that there was the potential of working on other assets in China so we are excited to announce the intended expansion of our partnership," said Dr. Mark J. Gilbert, Chief Medical Officer, JW Therapeutics. "Our work together has proven that combining our companies’ strength and capabilities carries significant advantages including world-class translational research, process development and clinical development. We look forward to building upon our success, incorporating 2seventy’s advanced technology and collaborating with their highly-experienced team to accelerate the development of potential new medicines with breakthrough therapeutic value to serve more patients in China and possibly worldwide. This is testament to the highly versatile application and effectiveness of our end-to-end platform that successfully expedite our as much as third party R&D processes."