On December 13, 2021 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the first presentation of Phase 2 data and updated Phase 1 data from the MajesTEC-1 study of teclistamab, an investigational off-the-shelf T-cell redirecting bispecific antibody, being studied for the treatment of patients with relapsed or refractory multiple myeloma (Press release, Johnson & Johnson, DEC 13, 2021, View Source [SID1234596974]).1 With a median follow-up of nearly eight months, an overall response rate (ORR) of 62 percent was observed at the recommended SC Phase 2 dose (RP2D) of 1.5 mg/kg in heavily pre-treated patients (n=150) across the Phase 1 and 2 studies who had received at least three prior lines of therapy and were triple-class exposed.1 Results were presented during the American Society of Hematology (ASH) (Free ASH Whitepaper) 2021 Annual Meeting as an oral presentation (Abstract # 896) and selected as part of the Highlights of ASH (Free ASH Whitepaper) programmme.1

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MajesTEC-1 Data Highlights

At the median follow-up of nearly eight months, an ORR of 62 percent (93/150; 95 percent Confidence Interval [CI], range, 53.7–69.8) was observed; ORR was consistent regardless of cytogenetic risk or extent of prior therapy refractoriness.1 At the clinical cut-off, median duration of response was not reached and 88 percent (82/93) of responders were alive and continuing treatment.1 Study results suggest that responses to teclistamab were durable and deepened over time.1 Among patients who responded, the median time to first confirmed response was 1.2 months (range 0.2–5.5 months).1

Fifty-eight percent of patients receiving teclistamab achieved a very good partial response (VGPR) or better; 29 percent achieved a complete response (CR) or better; and 21 percent achieved a stringent complete response (sCR).1 By intent-to-treat, 25 percent of patients (37/150) achieved minimal residual disease (MRD) negativity at a threshold of 10-5 (95 percent CI, range, 18.0–32.4).1 In patients who achieved CR or better, the MRD negativity rate was 42 percent.1 The progression-free survival (PFS) rate at nine months was 59 percent (95 percent CI, range, 48.8–67.0). Median overall survival (OS) was not reached.1

"Despite newly approved therapies for triple-class exposed patients with relapsed or refractory multiple myeloma, there remains a high unmet medical need," said Philippe Moreau*, M.D., Clinical Hematology, University Hospital Hôtel-Dieu, Nantes, France, and study investigator. "The objective responsive rate observed in this study suggests a potential benefit for patients with triple-class exposed disease with an off-the-shelf therapy."

As of September 2021, 165 patients were treated with teclistamab at the SC 1.5 mg/kg dose across both Phase 1 and Phase 2 of MajesTEC-1.1 The primary objectives of the MajesTEC-1 Phase 1 study (NCT03145181) were to identify the recommended SC RP2D (Part 1) and characterise the safety and tolerability of teclistamab at the RP2D (Part 2).3 The primary objective of the MajesTEC-1 Phase 2 study (NCT04557098) was to evaluate the efficacy of teclistamab at the RP2D, established at SC 1.5 mg/kg QW, as measured by ORR.1

Teclistamab had a tolerable safety profile and no patients required a dose reduction.1 The most common non-haematologic adverse events (AEs) were cytokine release syndrome (72 percent; all grade 1/2 except for one grade 3 event that was fully resolved; all resolved with no treatment discontinuation), injection site erythema (26 percent; all grade 1/2) and fatigue (25 percent; two percent grade 3/4).1 The most common haematologic AEs were neutropenia (66 percent; 57 percent grade 3/4), anaemia (50 percent; 35 percent grade 3/4) and thrombocytopenia (38 percent; 21 percent grade 3/4).1 Five patients (three percent; all grade 1/2) developed immune effector cell-associated neurotoxicity syndrome (ICANS) all resolved without discontinuation.1

"These longer-term data suggest that heavily pre-treated patients in need of a new option may achieve sustained durable responses and high overall response rates for teclistamab," said Yusri Elsayed, M.D., M.HSc., Ph.D., Vice President, Hematologic Malignancies Disease Area Leader, Janssen Research & Development, LLC. "We remain focused on identifying new treatments for patients with relapsed or refractory multiple myeloma, including T-cell redirecting bispecific antibodies like teclistamab, for use alone and in novel immunotherapy regimens."

"Our mission is to develop transformational treatment regimens that address patient needs and offer physicians options which they have not had before," said Edmond Chan MBChB M.D. (Res), EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. "The data presented at ASH (Free ASH Whitepaper) support the promising potential of teclistamab as an off-the-shelf T-cell redirecting therapy, for patients urgently in need of new options and innovative approaches."

TRIMM-2 Data Highlights

Additional data for teclistamab were highlighted in a poster session at ASH (Free ASH Whitepaper) on Saturday, December 11 (Abstract #1647).2 Results from the TRIMM-2 study (NCT04108195), evaluating teclistamab in combination with daratumumab SC – a CD38-directed monoclonal antibody approved to be given subcutaneously for the treatment of patients with multiple myeloma – suggest a manageable safety profile and preliminary efficacy in patients with relapsed or refractory disease who had received a minimum of three prior lines of treatment.2

# ENDS #

About Teclistamab

Teclistamab is an investigational, off-the-shelf, T-cell redirecting bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3. BCMA is expressed at high levels on multiple myeloma cells.4,5,6,7 Teclistamab appears to redirect CD3-positive T-cells to BCMA-expressing myeloma cells to induce killing of tumour cells.7 Results from preclinical studies demonstrate that teclistamab kills myeloma cell lines and bone marrow-derived myeloma cells from heavily pre-treated patients.5

Teclistamab is currently being evaluated in several monotherapy (NCT04557098)8 and combination (NCT04586426, NCT04108195, NCT04722146, NCT05083169) studies.9,10,11,12 In 2020, the European Commission (EC) and the United States (U.S.) Food and Drug Administration (FDA) each granted teclistamab Orphan Drug Designation for the treatment of multiple myeloma. In January 2021 and June 2021, teclistamab received a PRIority MEdicines (PRIME) designation by the European Medicines Agency (EMA) and Breakthrough Therapy Designation (BTD) by the FDA, respectively. PRIME offers enhanced interaction and early dialogue to optimise drug development plans and speed up evaluation of cutting-edge, scientific advances that target a high unmet medical need.13 The FDA grants BTD to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition and is based on preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.14

About daratumumab and daratumumab SC

Janssen is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease. Daratumumab has been approved in eight indications for multiple myeloma, three of which are in the frontline setting, including newly diagnosed patients who are transplant eligible and ineligible.15

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 227,000 patients worldwide.16 Daratumumab is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma (MM). Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.17

CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.15 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death.15 Daratumumab may also have an effect on normal cells.15 Data across eight Phase 3 clinical trials, in both the frontline and relapsed settings, have shown that daratumumab-based regimens resulted in significant improvement in PFS and/or OS.18,19,20,21,22,23,24,25

For further information on daratumumab, please see the Summary of Product Characteristics at: View Source

About Multiple Myeloma

Multiple myeloma is currently an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.26 When damaged, these plasma cells rapidly spread and replace normal cells with tumours in the bone marrow.26 In Europe, more than 50,900 people were diagnosed with multiple myeloma in 2020, and more than 32,500 patients died.27 While some patients with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms, which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.28

On December 13, 2021 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company on a mission to deliver targeted therapies that treat rare forms of cancer, reported data from new retrospective analyses of the Phase 3 SIMPLIFY studies demonstrate baseline ferritin differentially predicts Week 24 Transfusion Independence Response for momelotinib and ruxolitinib in patients with myelofibrosis (Press release, Sierra Oncology, DEC 13, 2021, View Source [SID1234596973]). The data were presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held virtually and in Atlanta, GA December 11-14, 2021.

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Baseline Serum Ferritin Differentially Predicts W24 Transfusion Independence Response for Momelotinib and Ruxolitinib in Patients with Myelofibrosis

Myelofibrosis is characterized by the presentation of constitutional symptoms, splenomegaly and anemia, with the degree of anemia and transfusion dependence being among the most important predictors of overall survival. Dr. Stephen Oh, MD, PhD, Washington University School of Medicine in St. Louis and Siteman Cancer Center, noted how the analyses identified pre-treatment serum ferritin level as the most predictive biomarker for the treatment effect of momelotinib versus ruxolitinib on Week 24 Transfusion Independence Response (TI-R) in the SIMPLIFY-1 (JAK inhibitor-naïve) and SIMPLIFY-2 (JAK-inhibitor experienced) studies.

Key results for SIMPLIFY-1 include:

Ruxolitinib was associated with a significantly greater increase in ferritin levels over time compared with momelotinib, irrespective of baseline ferritin, highlighting the differential treatment impact on serum ferritin between the two agents
Baseline hemoglobin (Hgb), an indicator of anemic status, differentially predicted Week 24 TI-R in patients randomized to momelotinib or ruxolitinib
Baseline ferritin also differentially predicted Week 24 TI-R in patients randomized to momelotinib or ruxolitinib
For patients with baseline ferritin between 90-650 ng/mL, momelotinib-treated patients had a higher Week 24 TI-R rate than ruxolitinib-treated patients [72% vs. 38%, OR 4.21 (95% CI: 2.24, 7.89); p=0.0439]
In patients with baseline Hgb <12 g/dL, baseline ferritin levels provided additional, differential predictive value for Week 24 TI-R
The differential treatment effect between momelotinib and ruxolitinib was highest for anemic patients with baseline ferritin between 90-650 ng/ml
No correlation was observed between baseline ferritin and Week 24 splenic or symptom response rates
Findings from SIMPLIFY-1 were independently confirmed in the JAK inhibitor experienced setting of the SIMPLIFY-2 study, where Hgb and ferritin each differentially predicted Week 24 TI-R in patients randomized to momelotinib or best available therapy (BAT; 88.5% ruxolitinib), and baseline ferritin predicted additional, differential predictive value for Week 24 TI-R in patients with Hgb <12 g/dL. For patients with baseline ferritin between 90-650 ng/mL, momelotinib-treated patients had higher Week 24 TI-R than those treated with BAT [53% vs 22%, OR 2.27 (95% CI: 1.01,12.77); p=0.03099].

These data suggest that ferritin may be useful in treatment decision making in myelofibrosis, especially in patients with anemia and ferritin 90-650 ng/mL, in which momelotinib demonstrates a greater TI effect than ruxolitinib. Future evaluation may be made in forthcoming clinical trials to further examine the correlation between ferritin and TI response.

About Momelotinib

Momelotinib is a selective and orally bioavailable JAK1, JAK2 and ACVR1/ALK2 inhibitor currently under investigation for the treatment of myelofibrosis. Myelofibrosis results from dysregulated JAK-STAT signaling and is characterized by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia.

Sierra Oncology is currently awaiting topline results of the MOMENTUM clinical trial, a global, randomized, double-blind Phase 3 study evaluating momelotinib for the treatment of symptomatic and anemic myelofibrosis patients. Top-line data are anticipated by February 2022. Assuming positive data, the company plans to file a New Drug Application with the US Food & Drug Administration (FDA) in the second quarter of 2022. The FDA has granted Fast Track designation for momelotinib.

On December 13, 2021 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported efficacy and safety results from its Phase 3 multicenter ALLELE study investigating tabelecleucel (tab-cel) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) following solid organ transplant (SOT) or hematopoietic cell transplant (HCT) (Press release, Atara Biotherapeutics, DEC 13, 2021, View Source [SID1234596972]). These findings, along with combined long-term survival data from Phase 2 and multicenter Expanded Access Protocol (EAP) studies of tab-cel were featured as oral presentations at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

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"Patients with EBV+ PTLD face a poor prognosis with survival measured in weeks to months if initial treatment is unsuccessful. There are no approved treatment options for this devastating disease, underscoring the critical unmet need that exists," said Jakob Dupont, MD, Head of Global Research & Development at Atara. "Our conviction that tab-cel, recently filed with the EMA, is a potential first-in-class treatment option for transplant recipients that develop EBV+ PTLD is validated by almost 90% of patients responding to treatment surviving after one year, and a similar two-year survival benefit of over 86% in patients who achieved a complete or partial response from Phase 2 and EAP studies."

Poor patient survival in relapsed or refractory EBV+ PTLD underscores the significant need for effective, safe, and fast-acting new therapeutic options as highlighted in two additional posters presented at ASH (Free ASH Whitepaper). Patients suffer from poor median survival of 0.7 months (n=81) and 4.1 months (n=86) for HCT and SOT, respectively, reported in EBV+ PTLD patients for whom rituximab ± chemotherapy failed.

In the ongoing Phase 3 ALLELE study, 38 evaluable patients as of May 2021 — 24 EBV+ PTLD patients following SOT after failure of rituximab ± chemotherapy and 14 EBV+ PTLD patients following HCT after failure of rituximab monotherapy — were treated with tab-cel and had the opportunity for a six-month follow-up after response. The median age of evaluable patients for both SOT and HCT was 52.9 years (3.2–81.5) who had tried a median of 1 (range: 1-5) prior systemic treatments including rituximab monotherapy, chemotherapy or immunotherapy.

As measured by independent oncologic response adjudication (IORA) assessment, an ORR of 50% (19/38, 95% CI: 33.4, 66.6) was observed for both HCT and SOT groups. For patients with EBV+ PTLD following SOT, an ORR of 50.0% (12/24, 95% CI: 29.1, 70.9) was observed and similarly, for patients with EBV+ PTLD following HCT, an ORR of 50.0% (7/14, 95% CI: 23.0, 77.0) was observed, with a best overall response of Complete Response (CR; 26.3%; n=10; n=5, SOT, n=5, HCT) or Partial Response (PR; 23.7%; n=9; n=7, SOT, n=2, HCT). The median time to response (TTR) in all patients was 1.1 months (0.7-4.7). In the study, 11 of 19 responders had a duration of response (DOR) lasting more than six months and median DOR has not yet been reached. Of the remaining eight responders, four had events due to IORA-assessed progressive disease (PD) or death and four patients were alive and censored for the DOR at the time of the data cut.

Patients responding to tab-cel had longer survival compared to the non-responders, with a median overall survival (OS) not evaluable (NE) (95% CI: 16.4, NE) and a one-year survival rate of 89.2% (95% CI: 63.1, 97.2) versus non-responders’ OS of 5.7 months (95% CI: 1.8, 12.1) and one-year survival rate of 32.4% (95% CI: 12.1, 54.9).

Safety was consistent with previously published data, and no new safety signals or concerns were reported. There were no reports of tumor flare reaction, infusion reactions, cytokine release syndrome, transmission of infectious diseases, including cytomegalovirus, and no events of graft versus host disease (GvHD) or organ rejection related to tab-cel. Overall, tab-cel was well-tolerated in treatment-refractory and immunocompromised patients.

Atara also reported combined long-term survival data from Phase 2 and multicenter EAP studies of tab-cel in a second oral presentation. Results show that across studies, patients who responded to tab-cel for treatment of EBV+ PTLD experienced a long-term survival benefit with a median OS of 54.6 months (95% CI: 14.8, 115.0) reported in all patients (n=76). An ORR of 63.2% (48/76) was observed in all patients with a best overall response of CR (42.1%; n=32) or PR (21.1%; n=16). Two-year survival rates were 86.2% (95% CI: 67.0, 94.6) and 86.5% (95% CI: 55.8, 96.5) for patients with CR and PR, respectively. Importantly, patients who achieved a PR with tab-cel derived similar OS benefit to those who achieved a CR. Treatment was well tolerated in refractory and immunocompromised patients and there were no fatal events reported related to tab-cel. There were no reports of tumor flare reaction, cytokine release syndrome, organ/marrow rejection, or transmission of infectious diseases and cytomegalovirus. There is no evidence of GvHD or infusion-related reaction risks attributable to tabelecleucel based on current data.

About Tabelecleucel

Tabelecleucel (tab‐cel) is an off-the-shelf, allogeneic T-cell immunotherapy in development for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). EBV+ PTLD is a type of lymphoma (cancer) that may occur after a solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT). There are currently no approved treatments indicated to treat PTLD and if left untreated, PTLD can have life-threatening consequences.

Tab-cel is currently being investigated in the Phase 3 registration-enabling ALLELE study to assess efficacy and safety for the treatment of EBV+ PTLD in SOT and HCT after failure of standard of care. These data support the recent EMA-validated Marketing Authorization Application for tab-cel as the first off-the-shelf allogeneic T-cell therapy ever to be reviewed by a regulatory agency. The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted tab-cel Accelerated Assessment and an EU approval decision is anticipated for second half of 2022.

Tab-cel has been granted Breakthrough Therapy Designation for EBV+ PTLD following allogeneic HCT by the U.S. Food and Drug Administration (FDA) and PRIME designation by the European Medicines Agency (EMA) for the same indication. Tab-cel has orphan drug designation in the U.S. and EU.

On December 13, 2021 BeiGene (NASDAQ: BGNE; HKEX: 06160), a global science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, and Nanjing Leads Biolabs, Inc. (Leads Biolabs), a privately-owned clinical stage biotechnology company in China and the U.S., reported entry into a license and collaboration agreement granting BeiGene worldwide research, development and manufacturing rights and exclusive commercialization rights outside of China to LBL-007, a novel investigational antibody targeting the LAG-3 pathway (Press release, BeiGene, DEC 13, 2021, View Source [SID1234596971]). Data from a Phase 1 clinical trial of LBL-007 in patients with advanced solid tumors were presented at the 2021 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

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"We are excited about the strategic opportunity of adding an anti-LAG-3 agent to our portfolio and the potential to expedite the clinical development and scientific understanding of both LBL-007 and the anti-LAG-3 pathway as monotherapy and in combination with other immuno-oncology assets in BeiGene’s portfolio, including our anti-PD-1 inhibitor tislelizumab, where we see exciting combination potential for improved anti-tumor activity," said Lai Wang, Ph.D., Global Head of R&D at BeiGene. "Nanjing Leads Biolabs has developed a promising clinical candidate, which complements our I/O program and supports our strategic imperatives of global clinical excellence and opportunities to address unmet medical needs around the world."

Under the terms of the agreement, Leads Biolabs will receive $30 million upfront and is eligible to receive up to $742 million in clinical development, regulatory approval, and sales milestones, plus tiered double-digit royalties on sales in the licensed territory.

"Securing a collaboration to further develop LBL-007 has been a key strategic priority, and we are excited to begin working with BeiGene, a global leader in oncology," said Xiaoqiang Kang, M.D., Ph.D., CEO and Chairman of Leads Biolabs. "BeiGene is the ideal partner for Leads Biolabs given its extensive experience in the development of oncology medicines worldwide and the compelling immuno-oncology combination opportunity in its pipeline. By collaborating with BeiGene, Leads Biolabs expects to significantly accelerate the development and commercialization of LBL-007."

About LBL-007
LAG-3 is an immune checkpoint receptor expressed on activated T cells to negatively regulate these cells, resulting in tumor immune escape. LBL-007, a novel investigational anti-LAG-3 antibody, was developed by screening of a human antibody phage display library and demonstrated specific binding to human LAG-3, stimulation of IL-2 release and blockage of LAG-3 binding to MHC II and other known LAG-3 ligands. LBL-007 monotherapy was shown in pre-clinical studies to significantly inhibit tumor growth, with more pronounced tumor inhibition when combined with an anti-PD-1 antibody. LBL-007 has obtained IND clearance in both the U.S. and China, as well as completed a Phase 1a clinical trial, and is currently in Phase 1b/2 clinical trials in China.

BeiGene Oncology
BeiGene is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D team of approximately 2,750 colleagues dedicated to advancing more than 90 ongoing or planned clinical trials (over 70 clinical trials are ongoing) involving more than 14,000 patients and healthy volunteers. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the United States, China, the EU, Canada, Australia, and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma, and Bio-Thera. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

On December 13, 2021 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, reported that two-year follow-up data for GDA-201, the company’s lead candidate in its NAM-enabled NK cell therapy pipeline, will be presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, being held in Atlanta, Georgia (Press release, Gamida Cell, DEC 13, 2021, View Source [SID1234596970]). Additionally, for patients who participated in the phase 3 trial of omidubicel, the company will be presenting a poster of an analysis of resource utilization data from the first 100 days after bone marrow transplant.

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The poster titled "GDA-201, A Novel Metabolically Enhanced Allogeneic Natural Killer (NK) Cell Product Yields High Remission Rates in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma (NHL): 2-year survival and correlation with cytokine IL7" includes longer term follow-up from the phase 1, investigator-led study of GDA-201 in combination with rituximab (NCT03019666) in patients with relapsed or refractory non-Hodgkin lymphoma (NHL) and reports on 2-year outcomes and cytokine biomarkers associated with survival. The data demonstrated a median duration of response of 16 months (range 5- 36 months), an overall survival at 2 years of 78% (95% CI, 51%–91%) and a safety profile similar to that reported previously.

"We are excited to share this compelling two-year data from our investigator-led study of GDA-201 which demonstrate an extended duration of response in patients with NHL," said Julian Adams, Ph.D., Chief Executive Officer, of Gamida Cell. "The durable response in this patient group provides strong support as we work to progress GDA-201 through the development process for patients in need."

Gamida Cell will also present a poster related to its omidubicel program titled "Hospitalization and Healthcare Resource Use of Omidubicel Vs Cord Blood Transplantation for Hematological Malignancies in a Global Randomized Phase III Clinical Trial," which includes an analysis of resource utilization data from the first 100 days after transplant for 108 patients in the phase 3 trial showing that the omidubicel-treated patients had significantly shorter durations of hospitalization, intensive care unit stays, consultant visits, procedures, and transfusions than the control arm. These data provide further evidence of the clinical benefit associated with the more rapid hematopoietic recovery in patients treated with omidubicel and the corresponding reduction in healthcare resource utilization.

"This analysis clearly demonstrates the potential of omidubicel to significantly shorten a patient’s hospital length of stay, reduce time in ICU settings and decrease usage of healthcare resources, likely resulting in lower overall costs to the healthcare system," said Ronit Simantov, M.D., Chief Medical Officer of Gamida Cell. "These findings are particularly important as they demonstrate the impact of omidubicel on the experience for patients during the critical post-transplant period."

Both posters will be available today, Monday, December 13, 2021, 6:00-8:00 p.m. ET, during the ASH (Free ASH Whitepaper) Annual Meeting and Exposition.

About GDA-201

Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. For more information about GDA-201, please visit View Source

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with blood cancers. Omidubicel is the first bone marrow transplant graft to receive Breakthrough Therapy Designation from the U.S. FDA and has also received Orphan Drug Designation in the U.S. and EU. For more information about omidubicel, please visit View Source

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.