On June 14, 2022 KBI Biopharma SA (KBI) and Selexis SA, both JSR Life Sciences companies, reported that an expanded, fully-integrated mammalian contract development and manufacturing services facility is now open and operational in Geneva, Switzerland (Press release, JSR, JUN 14, 2022, View Source [SID1234615992]).

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The ~94,000 square-foot integrated KBI/Selexis state-of-the-art facility builds upon the companies’ existing market foothold by combining best-in-class cell line development (CLD) and expert mammalian cell manufacturing in a single location. KBI and Selexis leverage their expertise and efficient end-to-end services for biomanufacturing clients.

This expansion enables industry-leading delivery of client programs through increased quality, efficiency, and time savings across a diverse portfolio of molecule formats. Under one roof, KBI and Selexis provide cell line transfection through cGMP drug manufacturing with Selexis’ specialized high-titer mammalian cell line development technologies and services and KBI’s cGMP bulk drug manufacturing for clinical and commercial requirements.

"This expansion in Geneva will provide our global clients with streamlined capabilities to support mammalian-based therapies," said Mark W. Womack, Chief Executive Officer for KBI Biopharma and Selexis SA. "With a single touchpoint for best-in-class cell line development, process development, and manufacturing, clients experience heightened access to our process and product-based expertise."

He added, "This facility expansion, together with our track record in the space, strengthens our commitment to deliver a seamless experience to the European biopharmaceutical community and clients around the globe."

The fully integrated Selexis and KBI development platform has supported more than 60 clinical development programs with high productivity and robust product quality. The two companies have developed a seamless approach, to optimize the client experience.

"We have always been a science-driven, customer-centric company. This expansion in Geneva helps our clients optimize their complex biomanufacturing processes under accelerated timelines," said Ulrich Valley, Senior Vice President, Operations & Site Head, KBI Biopharma, Geneva.

The KBI Biopharma facility will create more than 200 technical positions in development, operations, and quality assurance. The facility includes a suite of analytical testing laboratories and dual 2,000L single-use cGMP manufacturing trains with downstream processes capable of producing 8-10 kg yields per batch.

With the expanded Geneva facility now operational, KBI and Selexis will celebrate with ribbon-cutting activities and facility tours starting in July 2022.

On June 14, 2022 Cellenkos, Inc., a privately held, clinical stage biotech company that focuses on developing transformative T regulatory cell therapies for rare inflammatory diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 1b, open-label study of CK0804 as an add on therapy to ruxolitinib in patients with myelofibrosis who experience a suboptimal response to ruxolitinib (Press release, Cellenkos, JUN 14, 2022, View Source [SID1234615988]).

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CK0804 is a novel allogeneic, CXCR4 enriched, T regulatory cell therapy product that utilizes Cellenkos’ proprietary CRANE technology to generate disease specific products. This Phase 1b clinical trial is being launched in partnership with Incyte as part of their LIMBER initiative (Leading in MPNs Beyond Ruxolitinib). The study (LIMBER-TREG108) will examine the safety of monthly doses of CK0804 as add on therapy in myelofibrosis patients who will continue treatment with ruxolitinib.

"We are thrilled to have received IND clearance for our CK0804 program in myelofibrosis, marking our fourth IND Clearance as a company and our second hematological malignancy program to reach clinical development," said Tara Sadeghi, Chief Operating Officer of Cellenkos Inc. "Clearance of this IND is a testament to the quality preclinical data supporting CK0804 through our internal R&D and our ongoing partnership with the University of Texas at MD Anderson Cancer Center as well as the strong chemistry, manufacturing, and control (CMC) and cGMP manufacturing capabilities we have developed internally. Our clinical development plans across multiple disease processes utilizes our proprietary CRANE technology that allows for us to create disease specific T regulatory cell therapeutics supporting our rich pipeline. We are excited by the promise of CK0804 to offer a potentially transformative treatment for myelofibrosis patients."

"We are pleased to be partnering with Cellenkos to initiate this new LIMBER study evaluating CK0804 and ruxolitinib as we continue to explore new treatment options for patients with myelofibrosis," said Ekaterine Asatiani, M.D., Division Vice President and Head of Early Development at Incyte.

About Myelofibrosis
Myelofibrosis is a rare, chronic and progressive blood cancer that is part of a group of diseases known as myeloproliferative neoplasms. In myelofibrosis, scar tissue forms in the bone marrow and impairs its ability to produce normal blood cells. This can result in an enlarged spleen, as well as symptoms such as fatigue, itching and night sweats, which can severely impact a patient’s quality of life. About 16,000 to 18,500 people in the U.S. are living with myelofibrosis. Patients who have had a suboptimal response to the standard of care treatment using ruxolitinib have limited options and a poor prognosis.

About CK0804
CK0804 is a novel allogenic cell therapy product consisting of T-regulatory cells that exploit the CXCR4/CXCL12 axis and are derived from clinical-grade umbilical cord blood units and manufactured using Cellenkos’ proprietary CRANE process. Multiple doses of CK0804 can be manufactured from a single umbilical cord blood unit, where the final cryopreserved product is readily available for use. No requirement for HLA matching to the patients makes CK0804 an ideal therapy that can be infused intravenously, in the outpatient setting.

About Ruxolitinib (Jakafi)
Ruxolitinib (Jakafi) is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF and for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

On June 14, 2022 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that the management team will participate in and attend one-on-one meetings at three investor conferences in June 2022 as follows (Press release, Gracell Biotechnologies, JUN 14, 2022, View Source [SID1234615987]):

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Goldman Sachs Virtual Healthcare Corporate Day

One-on-one meetings: June 20 – 24

Truist Securities Cell Therapy Symposium – symposia-cel (in person)

One-on-one meetings: June 28
Location: New York, NY

Stifel 2022 Virtual Cell Therapy Summit

Panel: June 30 at 11:30 am ET
Corporate Panel: Allogeneic CAR-T – What Have We Learned, and Where are We Going

On June 14, 2022 J INTS BIO reported that it will be presenting the preclinical results of its NSCLC candidate ‘JIN-A02’ at the upcoming 2022 IASLC World Conference on Lung Cancer, to be held in Vienna, Austria from 6th to 9th August (Press release, J INTS BIO, JUN 14, 2022, View Source [SID1234615986]).

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‘JIN-A02’ is a novel orally administered 4th generation EGFR TKI that targets NSCLC cancers harboring C797S mutation. C797S is a mutation that occurs after the use of 3rd generation EGFR TKIs such as Osimertinib and Lazertinib, resulting in tumor resistance and disease progression.

According to J INTS BIO, ‘JIN-A02’ showed strong inhibitory activities against NSCLC cancer cell-lines harboring double and triple mutations with C797S mutations in in-vitro studies. In particular, ‘JIN-A02" showed robust inhibition against double mutations (Ex19Del/C797S or L858R/C797S), which with the increasing use of 3rd generation EGFR-TKIs as First Line therapy worldwide, will soon become the dominant mutations leading to resistance and disease progression.

In addition, ‘JIN-A02’ also effectively reduced tumor volume in a dose-dependent manner, compared to Osimertinib, in mouse model harboring EGFR Ex19Del/T790M/C797S triple mutation cancers and exhibited high brain penetrance with efficacy.

A company official added that ‘JIN-A02’ demonstrated a favorable safety profile with a low propensity for cardiotoxicity and did not show significant toxic effects such as weight loss and cytotoxicity in animal models at therapeutic dose levels. It is therefore expected to be a highly valued new drug in the armamentarium for the treatment of NSCLC.

Dr Anna Jo, CEO J INTS BIO, said: "We are determined to rapidly advance our novel NSCLC pipeline program, and to overcome the limitations of developing or approved treatments through rigorous R&D, so as to improve the outcomes of patients around the world who suffered from NSCLC with limited or no viable alternative treatments."

On June 14, 2022 NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), a clinical-stage T cell-focused therapeutics company, reported that Nature Communications (Impact Factor: 14.92) published the results of an in vivo study combining the long-acting human IL-7, NT-I7, with chimeric antigen receptor (CAR) T cells directed against CD19+ B cell lymphoma and acute myeloid leukemia (Press release, NeoImmuneTech, JUN 14, 2022, View Source [SID1234615985]).

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The study led by Dr. DiPersio and his team at Washington University investigated the impact of NT-I7 on in vivo CAR-T cell expansion and anti-tumor response employing sophisticated models of B cell lymphoma or acute myeloid leukemia and an immune competent syngeneic model of acute promyelocytic leukemia. Utilizing these tools, the group tested whether NT-I7 could expand a less differentiated CAR-T product with improved durability and tumor killing abilities in multiple models of hematological cancer.

Over the past 10 years, CAR-T cell therapy has become routinely used to treat patients with refractory hematologic malignancies. Despite progress, long-lived memory responses and long-term in vivo persistence of CAR-T cells have yet to be consistently achieved to prevent tumor cell escape and clinical relapse.

In the study reported in Nature Communications, NT-I7 protected CD19-targeting CAR-T cells from cell death, enhancing their viability while promoting their expansion in the presence of CD19+ tumor cells. CAR-T cells expanded in the presence of NT-I7 were less differentiated but with equivalent effector cytokine secreting abilities. Treatment of tumor bearing mice with NT-I7 enhanced in vivo expansion and subsequent anti-tumor effects of CAR-T cells targeting CD19+ B cell lymphoma or CD33+ acute-myeloid leukemia. The combination of NT-I7 and CAR-T cells dramatically extended survival. Impressively, co-treatment of tumor bearing mice with NT-I7 reduced the minimum number of CAR-T cells needed to achieve a survival benefit by imparting increased tumor killing abilities to CAR-T cells on a per cell basis and expanding CAR-T cells in vivo. These studies provide compelling evidence that NT-I7 has the potential to enhance CAR-T therapy for the treatment of hematological diseases by promoting CAR-T anti-tumor activity, expansion and persistence.

Dr. Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech, Inc. said: "This Nature Communications article highlights the exciting properties of NT-I7 that can increase CAR T cells’ functionality and cytotoxicity. Those results demonstrate the broad applicability of NT-I7 for cellular therapy, in addition to its well-documented benefits as a long-acting human IL-7 that has the potential to amplify T cells across the subsets, boost the immune system, and enhance the anti-tumor response in people with hematologic malignancies and solid tumors."

This study presented in Nature Communications demonstrates the potential for NT-I7 to support impactful clinical use of multiple CAR-T therapies with improved safety and tolerability. Strategic combination of NT-I7 with CD19-targeting CAR-T cells is currently being tested as part of a multi-site clinical trial (NCT05075603) for the treatment of relapsed/refractory large B-cell lymphoma. At ASCO (Free ASCO Whitepaper) 2022, poster #239b presented the most advanced updates on this study (NIT-112) that aims to show if NT-I7 may increase expansion and persistence of CAR-T, leading to increased tumor response rate and improved clinical outcomes without safety concerns.

Reference: Kim, M.Y., Jayasinghe, R., Devenport, J.M. et al. A long-acting interleukin-7, rhIL-7-hyFc, enhances CAR T cell expansion, persistence, and anti-tumor activity. Nat Commun 13, 3296 (2022). View Source

About chimeric antigen receptor (CAR-T) cells therapies

CAR-T cell therapy is a type of treatment in which a patient’s T cells (a type of immune system cell) are changed in the laboratory so they will attack specific cancer cells. T cells are taken from a patient’s blood. Then the gene for a special receptor that binds to a certain protein on the patient’s cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion. Chimeric antigen receptor T-cell therapy is used to treat certain blood cancers, and it is being studied in the treatment of other types of cancer.

About NT-I7 (efineptakin alfa) (rhIL-7-hyFc)

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.