On January 26, 2023 Celularity Inc. (Nasdaq: CELU) ("Celularity," the "Company"), a U.S.-based biotechnology company developing placental-derived allogenic cell therapies and biomaterial-based regenerative therapeutics products, reported the results of a strategic review of its 2023 key initiatives (Press release, Celularity, JAN 26, 2023, View Source [SID1234626596]). This strategic review included the recently announced territory distribution agreement covering more than 100 countries for Celularity’s Halal-Certified products and the exclusive distribution agreement with the Tamer Group in Saudi Arabia. Celularity’s review also included pipeline prioritization and targeted expense reductions to align operating priorities in advance of an anticipated biomaterials production ramp-up this year.

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"Celularity’s novel business model leverages a diversified portfolio of therapeutic technologies all derived from a single source material — the post-partum placenta. As the Company that pioneered the use of placental-derived stem, progenitor and immune cells, and as an innovator in placental biomaterial product development, Celularity’s business model is to generate commercial revenue from both cellular and regenerative therapeutics, including technologies that combine cellular and regenerative therapeutics. Already this year, we’ve been presented with a series of unique opportunities, and the environment continues to be extremely favorable," said Robert J. Hariri, M.D., Ph.D. Celularity’s CEO, Chairman and Founder. "As we invest to scale production of our commercial biomaterial products to meet expected demand in the United States and the Middle East, we are prioritizing our most promising cell therapy product candidates and programs, and are rebalancing our workforce and identifying targeted expense reductions to support these priorities."

Advanced Biomaterial Products

Celularity markets a suite of commercial placenta-derived biomaterial products. Most recently, the Company announced an exclusive territory agreement with CH Trading Group, an international import, export, and trading company, to distribute Celularity’s branded regenerative biomaterial products — which are Halal-Certified under globally recognized Circle H International Inc. standards — in more than 100 countries.

Celularity’s advanced biomaterial products include:

Biovance, a decellularized, dehydrated human amniotic membrane derived from the placenta of a healthy, full-term pregnancy. Biovance is an intact, extracellular matrix structure that is indicated for use in the United States as a natural scaffold to support the body’s wound healing process.
Biovance 3L and Biovance 3L Ocular, tri-layer human amniotic membrane products focused on the surgical and ocular markets and available in both sheet and disk form.
Interfyl, a human connective tissue matrix derived from the placenta of a healthy, full-term pregnancy. It is indicated for use in the United States to replace or supplement damaged or inadequate integumental tissue resulting from wounds, trauma, or surgery.
CentaFlex, a decellularized human placental matrix derived from the umbilical cord that is indicated for use in the United States as a surgical covering, wrap or barrier to protect and support the repair of damaged tissue.
Opportunities in Osteoarthritis for Advanced Biomaterials and Combination Biomaterial-Cell Therapies

In a preclinical in vivo study of Celularity’s placental extracellular matrix (ECM) product candidate in a joint destructive, acid-derived osteoarthritis (OA) model, a 31-40 percent improvement of chondrogenic properties at Day 60 was observed. Additionally, a reduction in the number of pro-inflammatory cytokines at Day 60, including Monocyte Chemoattractant Protein-1 (MCP-1), was observed.

Celularity plans to complete the required preclinical work on its ECM product candidate over the next several months to support an investigational new drug (IND) application this year for the formation of new cartilage.

Celularity also is conducting preclinical work in knee osteoarthritis (KOA) using its placenta-derived exosomes (pEXO). In a rat study, scientifically measurable improvements in chondrogenesis, reduction in pain and pro-inflammatory cytokines in the synovial fluid were observed after injection into the arthritic knee at Day 60.

Celularity’s initial focus is osteoarthritis of the knee, which accounts for 80 percent of the total OA burden worldwide according to the World Health Organization. A 2017 study published in Proceedings of the National Academy of Sciences estimated that individuals now have a 45 percent lifetime risk of developing symptomatic KOA, resulting in a market with 9.3 percent compound annual growth rate (CAGR) reaching $12.02 billion by 2029, according to Data Bridge Market Research.

Degenerative Diseases

Crohn’s Disease. Celularity previously announced its re-analysis of long-term follow-up data from three legacy Phase 1, Phase 1b/2a and Phase 1b studies of its legacy placental-derived mesenchymal-like adherent stromal cell (MLASC) therapy in patients with moderate-to-severe Crohn’s disease, which showed clinically meaningful and durable benefit for up to two years in the limited number of patients studied. The Company will continue to assess MLASC therapy for this condition using its next-generation MLASC therapeutic candidate, as well as pursuing development partnering opportunities.
Fasculoscapulohumeral Muscular Dystrophy (FSHD). FSHD is one of the most common genetically defined progressive muscular dystrophies. The Company will investigate its next-generation placental-derived MLASCs with their anti-inflammatory, immune-modulatory, and regenerative properties to potentially bring a novel treatment approach to FSHD. Importantly, FSHD also serves as a model for potential age-related loss of muscle mass.
T-cell Programs

Hematologic Cancers and Solid Tumors. Celularity will continue to develop CYCART-19, an allogeneic placental-derived T-cell therapy engineered with a CD19 chimeric antigen receptor (CAR) with T-cell receptor (TCR) knockout that has demonstrated potent anti-tumor activity both in vitro and in vivo. The Company continues to work to address FDA questions on its IND and anticipates commencing its Phase 1 trial in 2023.
Celularity will continue to partner with Imugene Ltd. (ASX: IMU) to utilize its novel onCARlytics (CF33-CD19) technology to prime solid tumor cells to express CD19, making them a target for CD19 CAR-T therapy. Celularity also will continue to advance other select innovative T-cell programs through preclinical development.
Other Oncology Programs

Acute Myeloid Leukemia (AML). Celularity continues to review emerging cohort data from its CYNK-001 unmodified natural killer cell trial for the treatment of Relapsed Refractory (rrAML) and minimal resistant disease AML. This trial has progressed through to Cohort 6b in patients with rrAML and continues to successfully achieve its objective of evaluating safety and biological activity, understanding the optimal lymphodepletion regimen and the roles of both IL-15 and IL-2 in achieving NK-Cell persistence. The trial data also continue to provide important insights which will enable us to optimize our genetically modified NK cell and CAR-NK platforms moving forward to address the significant unmet medical need for patients.
Glioblastoma Multiforme (GBM). Celularity has worked with investigators to gain further insight into the optimal approach for utilizing cell therapies in the management of GBM. Celularity has determined not to pursue this trial, which uses only unmodified NK cells, at this time. The Company will continue to strategically enhance its NK platform, including modified and unmodified NK cells, to address some of the very significant challenges posed in treating this devastating disease.

HER2+ Gastric Cancer. Celularity continues to believe that genetically modified NK cells will be an important option to improve the current standard of care. However, given the Company’s strategic review, it will deprioritize this study while it continues to optimize its modified and unmodified NK cell platform.
As part of Celularity’s reprioritization efforts, the Company has notified a substantial portion of its workforce that their employment may be impacted in order to achieve its strategic objectives. While Celularity is hopeful that there will be no need to substantially reduce its headcount, the notifications were provided in accordance with applicable law and to maintain full transparency with its employees.

On January 26, 2023 Bristol Myers Squibb (NYSE: BMY) reported topline results from TRANSCEND CLL 004, a Phase 1/2, open-label, single-arm, multicenter study evaluating Breyanzi (lisocabtagene maraleucel) in adults with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (Press release, Bristol-Myers Squibb, JAN 26, 2023, View Source [SID1234626595]). Results from TRANSCEND CLL 004 showed the study met the primary endpoint of complete response rate compared to historical controlin the prespecified subset of patients with R/R CLL that was refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor. No new safety signals were reported for Breyanzi in this study.

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"CLL is an incurable disease with complex biology and immune dysregulation that has made the development of T cell-based therapies that provide deep remission very challenging," said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb. "In a population that has limited options, the TRANSCEND CLL 004 study represents the first multicenter trial evaluating a CAR T cell therapy in heavily pre-treated patients with relapsed or refractory CLL or SLL, with results showing the potential of Breyanzi as a personalized one-time treatment approach for patients with this difficult-to-treat disease."

Bristol Myers Squibb will complete a full evaluation of the TRANSCEND CLL 004 data and work with investigators to present detailed results at an upcoming medical meeting, as well as discuss these results with health authorities. Bristol Myers Squibb thanks the patients and investigators who are participating in the TRANSCEND CLL 004 clinical trial.

About TRANSCEND CLL 004

TRANSCEND CLL 004 (NCT03331198) is a Phase 1/2 open-label, single-arm, multicenter study evaluating Breyanzi in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. The Phase 1 dose escalation portion of the study assessed the safety and recommended dose for the subsequent Phase 2 expansion cohort. The Phase 2 portion of the study is evaluating Breyanzi at the recommended dose from the Phase 1 monotherapy arm. The primary endpoint of the Phase 2 portion of the study was complete response rate, including complete remission with incomplete bone marrow recovery, based on independent review committee according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines.

About CLL and SLL

Chronic lymphocytic leukemia (CLL) is one of the most common types of leukemia in adults. In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes, and these abnormal cells have difficulty fighting infections. As the number of abnormal cells grows, there is less room for healthy white blood cells, red blood cells and platelets. Small lymphocytic lymphoma (SLL) also affects the lymphocytes, with cancer cells found mostly in the lymph nodes. While there are several treatments available for CLL and SLL, there is a need for additional effective therapies as there is no standard of care for relapsed or refractory CLL or SLL after prior therapy with targeted agents. Patients with relapsed or refractory disease have limited treatment options and generally experience shorter periods of response with each subsequent treatment.

About Breyanzi

Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. Breyanzi is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal LBCL, and follicular lymphoma grade 3B who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy, or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant due to comorbidities or age, or relapsed or refractory disease after two or more lines of systemic therapy. Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma. Please see the Important Safety Information section below, including Boxed WARNINGS for Breyanzi regarding cytokine release syndrome and neurotoxicity.

Breyanzi is also approved in Europe, Switzerland, Canada and Japan for relapsed and refractory LBCL after two or more lines of systemic therapy. Bristol Myers Squibb’s clinical development program for Breyanzi includes clinical studies in earlier lines of treatment for patients with relapsed or refractory LBCL and other types of lymphoma and leukemias. For more information, visit clinicaltrials.gov.

Important Safety Information

BOXED WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids.
Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed.
BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS.
Cytokine Release Syndrome (CRS)

CRS, including fatal or life-threatening reactions, occurred following treatment with BREYANZI. CRS occurred in 46% (122/268) of patients receiving BREYANZI, including ≥ Grade 3 (Lee grading system) CRS in 4% (11/268) of patients. One patient had fatal CRS and 2 had ongoing CRS at time of death. The median time to onset was 5 days (range: 1 to 15 days). CRS resolved in 119 of 122 patients (98%) with a median duration of 5 days (range: 1 to 17 days). Median duration of CRS was 5 days (range 1 to 30 days) in all patients, including those who died or had CRS ongoing at time of death.

Among patients with CRS, the most common manifestations of CRS include fever (93%), hypotension (49%), tachycardia (39%), chills (28%), and hypoxia (21%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).

Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI. Sixty-one of 268 (23%) patients received tocilizumab and/or a corticosteroid for CRS after infusion of BREYANZI. Twenty-seven (10%) patients received tocilizumab only, 25 (9%) received tocilizumab and a corticosteroid, and 9 (3%) received corticosteroids only.

Neurologic Toxicities

Neurologic toxicities that were fatal or life-threatening, occurred following treatment with BREYANZI. CAR T cell-associated neurologic toxicities occurred in 35% (95/268) of patients receiving BREYANZI, including ≥ Grade 3 in 12% (31/268) of patients. Three patients had fatal neurologic toxicity and 7 had ongoing neurologic toxicity at time of death. The median time to onset of the first event was 8 days (range: 1 to 46 days). The onset of all neurologic events occurred within the first 8 weeks following BREYANZI infusion. Neurologic toxicities resolved in 81 of 95 patients (85%) with a median duration of 12 days (range: 1 to 87 days). Three of four patients with ongoing neurologic toxicity at data cutoff had tremor and one subject had encephalopathy. Median duration of neurologic toxicity was 15 days (range: 1 to 785 days) in all patients, including those with ongoing neurologic events at the time of death or at data cutoff.

Seventy-eight (78) of 95 (82%) patients with neurologic toxicity experienced CRS. Neurologic toxicity overlapped with CRS in 57 patients. The onset of neurologic toxicity was after onset of CRS in 30 patients, before CRS onset in 13 patients, same day as CRS onset in 7 patients, and same day as CRS resolution in 7 patients. Neurologic toxicity resolved in three patients before the onset of CRS. Eighteen patients experienced neurologic toxicity after resolution of CRS.

The most common neurologic toxicities included encephalopathy (24%), tremor (14%), aphasia (9%), delirium (7%), headache (7%), dizziness (6%), and ataxia (6%). Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, have occurred in patients treated with BREYANZI.

CRS and Neurologic Toxicities Monitoring

Monitor patients daily at a certified healthcare facility during the first week following infusion, for signs and symptoms of CRS and neurologic toxicities. Monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 4 weeks after infusion; evaluate and treat promptly. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab or tocilizumab and corticosteroids as indicated.

BREYANZI REMS

Because of the risk of CRS and neurologic toxicities, BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS. The required components of the BREYANZI REMS are:

Healthcare facilities that dispense and administer BREYANZI must be enrolled and comply with the REMS requirements.
Certified healthcare facilities must have on-site, immediate access to tocilizumab.
Ensure that a minimum of 2 doses of tocilizumab are available for each patient for infusion within 2 hours after BREYANZI infusion, if needed for treatment of CRS.
Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer BREYANZI are trained on the management of CRS and neurologic toxicities.
Further information is available at www.BreyanziREMS.com, or contact Bristol Myers Squibb at 1-888-423-5436.

Hypersensitivity Reactions

Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO).

Serious Infections

Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. Infections (all grades) occurred in 45% (121/268) of patients. Grade 3 or higher infections occurred in 19% of patients. Grade 3 or higher infections with an unspecified pathogen occurred in 16% of patients, bacterial infections occurred in 5%, and viral and fungal infections occurred in 1.5% and 0.4% of patients, respectively. Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines.

Febrile neutropenia has been observed in 9% (24/268) of patients after BREYANZI infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated.

Avoid administration of BREYANZI in patients with clinically significant active systemic infections.

Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. Ten of the 11 patients in the TRANSCEND study with a prior history of HBV were treated with concurrent antiviral suppressive therapy to prevent HBV reactivation during and after treatment with BREYANZI. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

Prolonged Cytopenias

Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 31% (84/268) of patients, and included thrombocytopenia (26%), neutropenia (14%), and anemia (3%). Monitor complete blood counts prior to and after BREYANZI administration.

Hypogammaglobulinemia

B-cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with BREYANZI. The adverse event of hypogammaglobulinemia was reported as an adverse reaction in 14% (37/268) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 21% (56/268) of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 32% (85/268) of patients. Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated.

Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI.

Secondary Malignancies

Patients treated with BREYANZI may develop secondary malignancies. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing.

Effects on Ability to Drive and Use Machines

Due to the potential for neurologic events, including altered mental status or seizures, patients receiving BREYANZI are at risk for altered or decreased consciousness or impaired coordination in the 8 weeks following BREYANZI administration. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

Adverse Reactions

Serious adverse reactions occurred in 46% of patients. The most common nonlaboratory, serious adverse reactions (> 2%) were CRS, encephalopathy, sepsis, febrile neutropenia, aphasia, pneumonia, fever, hypotension, dizziness, and delirium. Fatal adverse reactions occurred in 4% of patients.

The most common nonlaboratory adverse reactions of any grade (≥ 20%) were fatigue, CRS, musculoskeletal pain, nausea, headache, encephalopathy, infections (pathogen unspecified), decreased appetite, diarrhea, hypotension, tachycardia, dizziness, cough, constipation, abdominal pain, vomiting, and edema.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

On January 26, 2023 Aprea Therapeutics presented its corporate presentation (Presentation, Aprea, JAN 26, 2023, View Source [SID1234626594]).

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On January 26, 2013 Amgen (NASDAQ:AMGN) reported that it will report its fourth quarter and full year 2022 financial results on Tuesday, Jan. 31, 2023, after the close of the U.S. financial markets (Press release, Amgen, JAN 26, 2023, View Source [SID1234626593]). The announcement will be followed by a conference call with the investment community at 4:30 p.m. ET. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.

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Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On January 26, 2023 NETRIS Pharma, a clinical-stage private biopharmaceutical company developing a new class of drugs based on dependence receptor biology, reported dosing of the first patients in a multicenter, prospective, single arm, proof-of-concept trial of the anti-netrin-1 antibody, NP137, in combination with atezolizumab-bevacizumab (Atezo-bev) in first line patients with advanced hepatocellular carcinoma (Press release, Netris Pharma, JAN 26, 2023, View Source [SID1234626587]). Called Liver-NET1 (NCT05546879), the study will enroll 43 to 52 patients and consists of two parts: a safety lead-in phase, with 3-12 patients, and an expansion phase of 40 patients, where efficacy endpoints, including best overall objective response rate (ORR), will be measured. Netrin-1 is a protein ligand found to be over-expressed in many cancers.

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"Liver-NET1 is our third clinical trial and the second we have launched within the last 2 months, illustrating the acceleration of our clinical development plan and the interest of combining NP137 with standard of care in multiple oncology indications," said Patrick Mehlen, CEO of NETRIS Pharma. "The company is already including patients in GYNET and IMMUNONET trials to evaluate the potential incremental benefit of combining NP137 with immunotherapies and chemotherapies, and we believe there could also be great promise in HCC ."
Liver-NET1 is an investigator initiated trial led Dr. Gael Roth, a GI oncologist expert in primary liver cancers, from the Centre Hospitalier Universitaire Grenoble Alpes (CHUGA). Ten other clinical centers in France will participate in the study.

"Despite the demonstrated benefits of Atezo-bev as new standard of care, only 30% of patients respond to this treatment. The unique mode of action of NP137, impacting on the tumoral plasticity, is generating significant interest from clinicians to potentially increase patient response and reduce resistance in HCC treatment," said Dr. Roth. "We look forward to evaluate this combination in advanced HCC in a first line setting, in which therapeutic advances are seriously needed to better treat patients."