On June 14, 2022 Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported that it has rescheduled the reporting of the financial results for its fiscal fourth quarter and year ended March 31, 2022 to Tuesday, June 28, 2022 (Press release, Beyond Air, JUN 14, 2022, View Source [SID1234616006]). The Company’s management team will also host its quarterly conference call and webcast at 4:30 pm Eastern Time on June 28th.

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On June 14, 2022 HALO Diagnostics, a precision diagnostics leader, reported that it has joined forces with the Genomic Testing Cooperative (GTC) to offer innovative, personalized testing to its physician network and 1M+ patients served (Press release, Genomic Testing Cooperative, JUN 14, 2022, View Source [SID1234615999]). This solution combines HALO Diagnostics’ clinical ensemble and image-guided therapies with GTC’s genomic profiling of a patient’s DNA / RNA using liquid biopsy and tissue samples. Together, the companies will help patients on every step of their unique healthcare journey – from detection and diagnosis to prognosis and treatment.

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For decades, patients have faced a one-size-fits-all approach to their health. They are now calling for more prompt, personalized care. With this partnership, HALO Diagnostics and GTC are ready to answer this call.

Recent therapeutic approvals in HALO Diagnostics’ core clinical areas such as prostate, breast, and lung cancers have focused on targeted therapies and immunotherapies. Before treatment can begin, patients undergo biomarker testing. This is where GTC comes in: The company’s comprehensive test panels simultaneously query key DNA / RNA alterations, guiding decision making for patients’ treatment plans.

"By bringing together advanced imaging and molecular biomarkers, HALO Diagnostics and GTC will have a unique impact on driving early detection in healthcare," says Dr. John Feller, Chief Medical Officer at HALO Diagnostics. "We will reduce oversights common in individual diagnostic tests, making early detection, minimally invasive therapies, and precision-focused healthcare possible."

Dr. Maher Albitar, GTC’s Founder, CEO, and Chief Medical Officer, agrees. "Combining imaging with molecular profiling is not only a natural expansion in medical diagnostics, but also provides a unique opportunity for innovation in the era of artificial intelligence." He adds, "We are very excited to be working with HALO Diagnostics. This collaboration will save patient lives and accelerate the development of key radiogenomic biomarkers."

With this partnership, the innovation is just beginning.

GTC recently showcased Liquid Trace, its latest liquid biopsy test that combines cell-free DNA and cell-free RNA to improve the test’s sensitivity for diagnosing solid tumours and blood-related cancers, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s annual meeting from June 3-7, 2022. The Liquid Trace test is now available to HALO Diagnostics’ patients indicated for this precision-focused approach.

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