On February 27, 2023 Leidos (NYSE: LDOS) reported the appointment of Thomas Bell as Chief Executive Officer, expected to be effective May 3, 2023 (Press release, Leidos, FEB 27, 2023, View Source [SID1234627732]).

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Bell, current President – Defense Rolls-Royce plc; Chairman & Chief Executive Officer, Rolls-Royce North America, Inc., will succeed current Chairman and CEO, Roger Krone, who has served in the role since 2014.

Krone will retire as Chairman at the time of the Leidos 2023 annual meeting of stockholders, and CEO when Bell’s appointment becomes effective. The Board expects to appoint Robert S. Shapard independent, non-executive chair after the 2023 annual meeting of stockholders and will also nominate Mr. Bell to the Board.

To facilitate a seamless leadership transition, Krone will continue as a fully employed advisor through July of this year.

Bell was selected by the company’s Board of Directors following a thorough and thoughtful process to select a successor.

"Tom’s exceptional track record in harnessing the power of technology to drive growth and innovation, with his strong leadership skills and focus on understanding the needs of the customer, has resulted in a consistent record of success and value creation in both products and services," said Bob Shapard, lead director of the company’s board. "His deep understanding of many of our customers will facilitate a smooth transition."

Prior to his current role, Bell was senior vice president of global sales & marketing for defense, space & security at The Boeing Company. Before joining Boeing in 2015, he was President of Rolls-Royce Defense Aerospace, having joined as President, Customer Business, North America in mid-2012. Previously he spent more than two decades with Boeing in a variety of leadership positions within the defense, space and security business and began his aerospace career with Lockheed Martin in human space flight.

"Roger Krone’s impact on Leidos and its customers will be felt for years to come. Under his leadership, Leidos has achieved tremendous growth, evolved its business strategy, and made a positive difference in the lives of countless people around the world. Now, Leidos is not only a market leader but, just as importantly, a place where employees feel a deep sense of mission and community," said Shapard. "On behalf of the Board of Directors, I extend our deepest gratitude to Roger for his nearly nine years of dedicated service. He has left an indelible mark on our company and our culture, and we are a better organization because of his leadership. We wish him all the best in his future endeavors, and we look forward to continuing to build on the foundation that he has laid for Leidos’ future success."

"Working with the extraordinary people of Leidos has been the honor of my career," said Krone. "Their dedication, innovation, and unwavering commitment to our mission have been the driving force behind our success. I want to thank them for the privilege of serving as their leader for nearly nine years, and for inspiring me with their passion, their brilliance, and their unwavering commitment to excellence. It has been a privilege to be a part of this remarkable team, and I am confident that the future of Leidos is in the best possible hands with all of them."

On February 27, 2023 InDex Pharmaceuticals Holding AB (publ) reported that the company will attend the annual congress of the European Crohn’s and Colitis Organisation (ECCO), March 1-4, 2023 in Copenhagen. ECCO is the largest forum for specialists in inflammatory bowel disease globally (Press release, InDex Pharmaceuticals, FEB 27, 2023, View Source [SID1234627731]).

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InDex Pharmaceuticals will also be present at booth #C3-17 in the exhibition hall at the Bella Center. InDex’s team members will be available on site to provide information about cobitolimod and the ongoing phase III program CONCLUDE, which is evaluating the Toll-like receptor 9 agonist cobitolimod, as a potential novel treatment for moderate to severe left-sided ulcerative colitis. In addition, InDex’s team member will take the opportunity to meet Investigators of Induction 1 study of the CONCLUDE program to discuss study progress with the coordinating Investigator Professor Raja Atreya.

"ECCO is the largest forum for specialists in inflammatory bowel disease in the world and a very significant industry and healthcare professional event," said Jenny Sundqvist, CEO of InDex Pharmaceuticals. "ECCO provides a great opportunity for the team to further interact with healthcare professionals, potential partners and relevant stakeholders to progress our lead drug candidate cobitolimod and the phase III program CONCLUDE."

For more information:
Jenny Sundqvist, CEO
Phone: +46 8 122 038 50
E-mail: [email protected]

Johan Giléus, deputy CEO and CFO
Phone: +46 8 122 038 50
E-mail: [email protected]

About the CONCLUDE program
The phase III program CONCLUDE is evaluating cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis with an inadequate response or failure to tolerate conventional therapy, biological therapy or JAK inhibitors. The program consists of two sequential induction studies and a one-year maintenance study with patients who have responded to cobitolimod as induction therapy.

Induction Study 1 of the phase III program CONCLUDE is a global randomised, double-blind, placebo-controlled, clinical phase III study designed in consultation with both the US and European regulatory authorities, the FDA and EMA respectively. The study will include approximately 440 patients, and the primary endpoint will be clinical remission at week 6, which is the same primary endpoint as used in the successful phase IIb study CONDUCT. Apart from the dosing 250 mg given at baseline and week 3, which was the highest dose and the one that showed the best efficacy in the phase IIb study, the phase III study also evaluates a higher dose, 500 mg, in an adaptive study design. Patients responding to cobitolimod in the induction study will be eligible to continue in a one-year maintenance study, where they will be treated with either cobitolimod or placebo once every three weeks. Upon a positive read-out of Induction Study 1, InDex plans to initiate Induction Study 2.

Publication
The information was submitted for publication through the agency of the contact person set out above at 12:10 CET on February 27, 2023.

This is an English translation of the Swedish press release. In case of discrepancies between the English translation and the Swedish press release, the Swedish press release shall prevail.

On February 27, 2023 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage biotechnology company, and Break Through Cancer, a public foundation dedicated to empowering outstanding researchers and clinicians to both intercept and find cures for some of the most difficult-to-treat cancers, reported the commencement of patient enrollment in a collaboration to evaluate IMUNON’s IMNN-001 (formerly GEN-1) in combination with bevacizumab in patients with advanced ovarian cancer (Press release, IMUNON, FEB 27, 2023, View Source [SID1234627730]). The trial is now active at the University of Texas MD Anderson Cancer Center. IMNN-001 is a DNA-based interleukin-12 (IL-12) immunotherapy currently in Phase 2 clinical development for the localized treatment of advanced ovarian cancer (the OVATION 2 Study).

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This new Phase 1/2 study, titled "A Phase I/II Study Evaluating the Effect of IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) on Minimal Residual Disease (MRD) as determined by Second Look Laparoscopy when Administered in Combination with Bevacizumab and Neoadjuvant Chemotherapy in Subjects Newly Diagnosed with Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer" is expected to enroll 50 patients with Stage III/IV advanced ovarian cancer and is being led by principal investigator Amir Jazaeri, M.D., Professor of Gynecologic Oncology and Reproductive Medicine at MD Anderson.

Patients undergoing frontline neoadjuvant therapy will be randomized 1:1 to receive standard chemotherapy vs. chemotherapy plus IMNN-001. The primary endpoint is detection of minimal residual disease (MRD) by second look laparoscopy (SLL) and the secondary endpoint is progression-free survival (PFS). Initial SLL data are expected within one year from the completion of enrollment and final PFS data are expected approximately three years from the completion of enrollment. This trial will also include a wealth of translational endpoints aimed at understanding the clonal evolution and immunogenomic features of the MRD phase of ovarian cancer that is currently undetectable by imaging or tumor markers.

Tyler Jacks, Ph.D., President of Break Through Cancer, Founding Director of MIT’s Koch Institute for Integrative Cancer Research, and the David H. Koch Professor of Biology said, "Break Through Cancer is excited to support this important study. Our foundation has brought together some of the nation’s top cancer research centers to collaborate, accelerate research and clinical trials, and ultimately intercept and find cures for the deadliest cancers."

Commenting on the study, Dr. Corinne Le Goff, President and Chief Executive Officer of IMUNON, said, "The medical need for new innovative therapeutic approaches in ovarian cancer is major. The majority of patients with ovarian cancer are diagnosed with Stage III/IV disease and face low cure rates of 15% or less. The amount of data this study will generate will be a huge contribution to the treatment of ovarian cancer and we believe the combination of IMNN-001 and bevacizumab has important potential. In our animal studies, the combination clearly showed strong synergies. We are hoping that with this study we can potentially transform the current treatment landscape and provide new hope to women suffering from this deadly cancer."

"We have been very thoughtful about funding our clinical programs and are delighted that Break Through Cancer will cover approximately two-thirds of the costs of this clinical trial. IMUNON is committing to providing approximately $2.0 million to $2.5 million in IMNN-001 product costs, data and safety monitoring and project management services," Dr. Le Goff concluded.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer (EOC) is the fifth deadliest malignancy among women in the United States. There are approximately 22,000 new cases of ovarian cancer every year and the majority (approximately 70%) are diagnosed in advanced Stages III and IV. EOC is characterized by dissemination of tumor in the peritoneal cavity with a high risk of recurrence (75%, Stages III and IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stages III and IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. The Company previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. It announced full enrollment in the OVATION 2 Study in September 2022 and expects to report topline data in the second half of 2023.

About Break Through Cancer

Launched in February 2021, Break Through Cancer is a public foundation designed to find new solutions to the most intractable challenges in cancer. The foundation was launched with an extraordinary challenge pledge of $250 million from Mr. and Mrs. William H. Goodwin, Jr. and their family, and the estate of William Hunter Goodwin III. This represents one of the largest gifts ever in support of cancer research. Led by Dr. Tyler Jacks, the David H. Koch Professor of Biology and Director of the Koch Institute for Integrative Cancer Research at MIT, Break Through Cancer funds and supports collaborative research teams drawn from several of the country’s top cancer centers.

Multidisciplinary research teams are selected from across five participating institutions: Dana-Farber Cancer Institute, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, MD Anderson, Memorial Sloan Kettering Cancer Center, and MIT’s Koch Institute for Integrative Cancer Research.

Break Through Cancer is focused on historically highly challenging cancer types, including pancreatic cancer, ovarian cancer, glioblastoma and acute myelogenous leukemia for its initial programs, aided by the guidance of a scientific advisory board of cancer experts from outside the participating institutions. Teams will receive substantial funding to bring new approaches and new thinking as rapidly as possible to the clinical challenges of cancer.

Disclosures

The University of Texas MD Anderson Cancer Center’s relationship with Break Through Cancer, and all research conducted at MD Anderson related to Break Through Cancer, has been identified as an institutional financial conflict of interest by MD Anderson’s Institutional Conflict of Interest Committee and therefore is managed under an Institutional Conflict of Interest Management and Monitoring Plan.

On February 27, 2023 Nexcella, Inc. ("Nexcella", "Company"), a biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications and a subsidiary of Immix Biopharma, Inc. (NASDAQ: IMMX), reported 50 relapsed/refractory multiple myeloma patients have already been dosed with next-generation CAR-T NXC-201 in its ongoing Phase 1b/2a clinical trial (Press release, Immix Biopharma, FEB 27, 2023, View Source [SID1234627729]). Nexcella anticipates 100-patient open-label total enrollment to seek U.S. FDA BLA approval.

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Robust enrollment of up to 5 patients per month continues in the NXC-201 ongoing Phase 1b/2a clinical trial. Nexcella is on track to present this 50-patient cohort multiple myeloma data later this year at a premier scientific forum.

"Few companies are as far advanced with the quantity and quality of patient data that we have at Nexcella in multiple myeloma and AL amyloidosis," said Gabriel Morris, President of Nexcella. "50-patient data represents significant progress on our path to BLA submission to seek FDA approval of NXC-201."

Ilya Rachman, M.D., Executive Chairman of Nexcella added, "There are waiting lists with thousands of patients across America who are currently unable to receive these life-saving multiple myeloma CAR-T therapies like NXC-201. Our team is working tirelessly to bring this groundbreaking treatment to patients in the U.S. and worldwide."

About NXC-201
NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis. The design consists of a structurally differentiated CAR-T, with our proprietary BCMA-targeting CAR, which has demonstrated reduced toxicity in NEXICART-1, supporting investigating NXC-201 as an outpatient therapy.

As of the October 23, 2022 data cutoff, updated clinical data from the ongoing Phase 1b portion of the NEXICART-1 (NCT04720313) study of the novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 for the treatment of patients with relapsed or refractory multiple myeloma and light chain amyloidosis (AL) showed:

Multiple Myeloma – 90% overall response rate (59% complete responses) for NXC-201 at the therapeutic dose in an ongoing 42-Patient Phase 1 expansion trial (Haematologica View Source, 5th European CAR-T cell meeting View Source) in relapsed/refractory multiple myeloma. All patients treated with NXC-201 were triple-class refractory (to at least 1 immunomodulatory drug, 1 proteasome inhibitor and 1 anti-CD38 antibody)
AL Amyloidosis – 100% organ response rate, 100% complete responses (MRD negativity 10-5), published for NXC-201 in 5 relapsed/refractory patients (Clinical Cancer Research View Source, 5th European CAR-T cell meeting View Source)
The therapeutic dose of NXC-201 (800 million CAR+T cells) has already been established as the recommended Phase 2 dose (RP2D)
Additional information on NXC-201 clinical data as of October 23, 2022 is available here.

On February 27, 2023 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM, HKEX:​13) reported that it has completed patient enrollment of Phase II registration trial of amdizalisib in patients with relapsed or refractory follicular lymphoma ("FL"), a subtype of non-Hodgkin’s lymphoma ("NHL") (Press release, Hutchison China MediTech, FEB 27, 2023, View Source [SID1234627728]). The last patient was enrolled on February 24, 2023.

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The clinical trial is a multi-center, single-arm, open-label clinical study to evaluate the efficacy and safety of amdizalisib once a day oral monotherapy in patients with relapsed/refractory FL or marginal zone lymphoma ("MZL"). The primary endpoint is objective response rate ("ORR"), with secondary endpoints including complete response rate (CRR), progression-free survival (PFS), time to response (TTR) and duration of response (DoR). A total of 108 relapsed/refractory FL patients were enrolled. The trial is being conducted in over 35 sites in China. Additional details may be found at clinicaltrials.gov, using identifier NCT04849351.

Topline results on the FL patients in this trial are expected to be reported in the second half of 2023, followed by submission of results for presentation at an appropriate medical conference. If positive, HUTCHMED would initiate plans to apply for marketing authorization of amdizalisib for relapsed/refractory FL from the China National Medical Products Administration (NMPA).

About PI3Kδ and NHL

PI3Kδ (phosphoinositide 3-kinase delta) is a lipid kinase that controls the activation of several important signaling proteins. Upon an antigen binding to B-cell receptors, PI3Kδ can be activated through the Lyn and Syk signaling cascade. The abnormal activation of B-cell receptor signaling is closely related to the development of B-cell type hematological cancers, which represent approximately 85% of all NHL cases. Therefore, PI3Kδ is a target for drugs that aim to prevent or treat hematologic cancer.

FL accounts for approximately 17% of NHL and MZL accounts for approximately 8% of NHL. In the U.S., there were estimated 13,000 and 6,000 new cases of FL and MZL in 2020, respectively. In China, there were estimated 16,000 and 7,000 new cases of FL and MZL in 2020, respectively.1,2,3

About Amdizalisib

Amdizalisib (HMPL-689) is a novel, selective and potent oral inhibitor targeting the isoform PI3Kδ. Amdizalisib’s pharmacokinetic ("PK") properties are favorable with good oral absorption, moderate tissue distribution and low clearance in preclinical PK studies, suggesting a low risk of drug accumulation and drug-to-drug interaction. Because of its high target selectivity and optimal PK profile, amdizalisib has the potential to demonstrate an optimal benefit-risk profile in this class.

In addition to the current Phase II trial and the supportive Phase I trial in China, amdizalisib is also being evaluated in combination with tazemetostat (a methyl­trans­ferase inhibitor of EZH2) in patients with relapsed or refractory lymphoma in a Phase II study in China.

HUTCHMED currently retains all rights to amdizalisib worldwide.