On December 5, 2020 Poseida Therapeutics, Inc. (NASDAQ:PSTX), a clinical-stage biopharmaceutical company utilizing proprietary gene engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today reported results of an ongoing Phase 1 clinical trial of P-BCMA-101, an autologous chimeric antigen receptor T-cell (CAR-T) product candidate in relapsed/refractory multiple myeloma, during an oral presentation at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Poseida Therapeutics, DEC 5, 2020, View Source [SID1234572266]). The results show that patients treated with equivalent doses of product manufactured with a modified nanoplasmid process in the expanded Phase 1 trial achieved deeper responses while maintaining a similar safety profile compared to product manufactured with the Company’s legacy plasmid.

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"Based on the dual benefits of improved efficacy and consistent safety demonstrated with the new nanoplasmid, we are moving forward with this optimized manufacturing method in all of our CAR-T programs," said Eric Ostertag, M.D., Ph.D., chief executive officer of Poseida Therapeutics. "Furthermore, using our first-generation plasmid, we saw higher response rates as we escalated to higher dose cohorts not yet reached with the nanoplasmid product. We are currently moving into higher dosing cohorts with the nanoplasmid manufactured P-BCMA-101 product candidate and are optimistic further increases in effectiveness and durability are possible at these higher doses. We expect to finalize our Phase 2 dose in the first quarter of 2021."

The Phase 1 dose escalation trial initially included five cohorts with a product candidate created using a standard plasmid process. The trial was expanded in 2020 to include cohorts utilizing a new nanoplasmid manufacturing process. The nanoplasmid technology allows for a reduction in the plasmid backbone size, enhancing the transposition efficiency during manufacturing and improving the final CAR-T product performance. The expansion part of the trial is also evaluating several novel dosing strategies with 19 patients treated as of the data cutoff with a variety of dosing regimens, including single administration, cyclic dosing, combination with rituximab, and combination with lenalidomide.

Using the new manufacturing process, a dose of 0.75 x 106 cells/kg was administered to eight patients in the initial P-BCMA-101 nanoplasmid expansion cohorts. Patients treated in this cohort and evaluable by International Myeloma Working Group (IMWG) criteria (n=6) showed a higher response rate, with an ORR of 67 percent as compared to an ORR of 50 percent for the same dosing cohort using the standard P-BCMA-101 plasmid (n=2). Additionally, as of the cutoff date, three patients achieved deeper responses of either very good partial response (VGPR) or complete response (CR) in the nanoplasmid expansion cohort as compared to no patients reaching a VGPR or CR in the standard plasmid group at the Cohort 1 dose. As of the data cutoff date, two of the three nanoplasmid patients who reached VGPR or CR remained in durable responses at approximately 6 months.

"We observed an excellent efficacy and safety profile with a single dose escalation. There were very low rates of CRS with no ICU admissions for CRS, resulting in a safety profile suggesting this therapy could be delivered to a greater number of patients in a community hospital or outpatient setting," said Caitlin Costello, MD, Associate Clinical Professor of Medicine and member of the Division of Blood and Marrow Transplantation at University of California, San Diego. Dr. Costello is the principal investigator in the study, who presented the data during the ASH (Free ASH Whitepaper) meeting.

At the 0.75 x 106 cells/kg dose, cytokine release syndrome (CRS) was seen in just one, or 12.5%, of evaluable Phase 1 nanoplasmid patients (n=8) and neurotoxicity was not seen in any patients, demonstrating the preservation of the product safety profile within the expansion cohort. The Company believes this highly favorable safety profile can be attributed to the gradual expansion of stem cell memory T (Tscm) cells when compared with published data from competitor products comprised of a higher percentage of T effector and other differentiated T cells (2-3 weeks to peak versus 3-7 days for most CAR-T cells). There have been no patient deaths, dose limiting toxicities or unexpected/off-target toxicities related to P-BCMA-101. The most common adverse events were cytopenias and infections generally attributable to lymphodepleting chemotherapy regimens. Based on the safety results, the protocol was amended to allow fully outpatient CAR-T cell administration.

The median patient age was 60, with a median time since diagnosis of approximately five years. Patients were heavily pre-treated, with a median of eight prior lines of therapy (2-18). All patients had received a protease inhibitor or at least one IMid, and nearly all patients had been previously treated with a CD38 monoclonal antibody. Sixty percent of the patients were refractory to all three drug classes, and four patients had previously received an anti-BCMA targeted therapy.

This open label, multicenter Phase 1 study is designed to assess the safety of P-BCMA-101 in subjects with relapsed and/or refractory multiple myeloma and includes multiple exploratory cohorts to evaluate the administration of P-BCMA-101 CAR-T within the framework of moving from the standard plasmid CAR-T product to the nanoplasmid product. The primary objective of this study is to determine the safety and maximum-tolerated dose of P-BCMA-101. Secondary objectives include anti-myeloma effect of P-BCMA-101. Additional information about the Phase 1 clinical study of P-BCMA-101 is available at www.clinicaltrials.gov using identifier: NCT03288493.

About P-BCMA-101
P-BCMA-101 is an autologous CAR-T therapy which is currently being evaluated in an expanded Phase 1 clinical trial for the treatment of patients with relapsed/refractory multiple myeloma to inform the potentially registrational Phase 2 clinical trial. P-BCMA-101 targets cells that express B cell maturation antigen, or BCMA, which is expressed on essentially all multiple myeloma cells. P-BCMA-101 is engineered with Poseida’s non-viral piggyBac DNA Modification System, resulting in a high percentage of T stem cell memory cells. P-BCMA-101 is composed primarily of Tscm, a very young subset of T cells that are long-lived, self-renewing and multipotent, with the capacity to reconstitute the entire spectrum of T cell subsets, including T effector cells. They also survive for decades, and potentially for entire lifespans, with non-CAR-Tscm cells normally providing lifelong T cell immunity against some infectious agents. P-BCMA-101 received regenerative medicine advanced therapy (RMAT) status and orphan drug designation from the FDA. Preliminary results from the Company’s ongoing Phase 1 clinical trial suggest that P-BCMA-101 may have improved response rates with a favorable safety profile compared to published results from clinical trials of other CAR-T therapies at similar doses. The Phase 1 study is funded in part by the California Institute for Regenerative Medicine.

On December 5, 2020 Amgen (NASDAQ:AMGN) reported the first presentation of clinical safety and efficacy data from the Phase 1 study of AMG 701 in heavily pre-treated patients with relapsed/refractory multiple myeloma (R/R MM) (Press release, Amgen, DEC 5, 2020, View Source [SID1234572265]). AMG 701 is an investigational half-life extended (HLE) bispecific T cell engager (BiTE) immuno-oncology therapy targeting B-cell maturation antigen (BCMA). The data will be presented during a live oral presentation on Dec. 5 at the virtual 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition.

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"The emerging data from the BiTE platform in hematological malignancies are encouraging. Previously, Amgen provided important evidence for BCMA-directed BiTE molecules as a therapeutic approach in multiple myeloma. AMG 701 continues to show the potential of that strategy in patients who are heavily pre-treated," said David M. Reese, M.D., executive vice president of Research and Development at Amgen.

"These data are the latest in a series that reinforce both the potential versatility of the BiTE platform and Amgen’s commitment to developing innovative medicines for novel targets in difficult-to-treat cancers," Reese continued. "This year alone, Amgen has presented proof-of-concept data for four BiTE molecules in hematological malignancies and solid tumors, and we are proud to end the year with these data in multiple myeloma at ASH (Free ASH Whitepaper)."

This interim analysis of the Phase 1 dose escalation study evaluated AMG 701 in 85 R/R MM patients who had received at least three prior lines of therapy, and a median of six lines. The response rate was 36% at doses of 3-18 mg with responses lasting up to 26 months in one patient. Six of seven patients, who were tested for minimal residual disease (MRD), were MRD-negative. In the most recent evaluable cohort, there was an 83% ORR, with 4/5 responders being triple refractory.

"Despite advances in the treatment of multiple myeloma, there remains an unmet need for patients with this difficult-to-treat disease who have relapsed or refractory disease following current standard therapies," said Professor Simon J. Harrison, director of the Centre of Excellence in Cellular Immunotherapy, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, Australia. "These first-in-human data show that AMG 701, a half-life extended BiTE therapy targeting BCMA, has encouraging signs of activity as a single agent in this heavily pre-treated patient population."

The most common hematological adverse events (AEs) were anemia (42%), neutropenia (25%) and thrombocytopenia (21%). The most common non-hematological AEs were cytokine release syndrome (CRS, 65%), diarrhea (31%) and hypophosphatemia (31%). CRS was mostly grade 1 (27%) or 2 (28%) based on Lee Blood 2014 criteria. All Grade 3 CRS events (9%) were reversible with mitigation procedures outlined in the study protocol, with a median duration of two days.

Learn more about Amgen’s development of innovative medicines for novel targets in difficult-to-treat tumors at AmgenOncology.com/medical, and follow Amgen Oncology on Twitter and LinkedIn.

About BiTE Technology

BiTE (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage patient’s own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential. To learn more about BiTE technology, visit www.AmgenBiTETechnology.com.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse.1 It is a rare and life-threatening disease that accounts for approximately one percent of all cancers.2,3 Worldwide, approximately 160,000 people are diagnosed with multiple myeloma each year, and 106,000 patient deaths are reported on an annual basis.2

About Amgen Oncology

Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

On December 5, 2020 Gracell Biotechnologies Inc. ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported an interim readout to evaluate the safety and efficacy of its potential first-in-class GC012F FasTCAR-enabled dual-targeting BCMA/CD19 cell therapy in patients with relapsed or refractory multiple myeloma (R/R MM) (Press release, Gracell Biotechnologies, DEC 5, 2020, View Source [SID1234572264]). The data were presented by Dr. Weijun Fu, Professor of Hematology, Director at Shanghai Changzheng Hospital, as an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s (ASH) (Free ASH Whitepaper) 2020 Annual Meeting.

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GC012F, a dual BCMA/CD19 targeting CAR-T cell therapy developed on Gracell’s FasTCAR platform – which enables next-day manufacturing – was evaluated in an investigator-initiated Phase 1 trial. As of July 17th, the study enrolled sixteen patients at three dose levels with the highest dose level of 3×10^5 cells per kg. After three days of a standard lymphodepleting regimen, patients received GC012F as a single infusion over 30 minutes.

Early Overall Response Rate (ORR) showed a promising 93.7% with all responses being VGPR or better – showing fast, deep and durable responses in all dose levels
100% of the patients treated at the highest dose level (n=6) obtained a MRD negative sCR which was maintained through the landmark analysis of six months (n=4) at the time of data cut off
The median duration of follow up at time of assessment was 7.3 months (range 1–10 months). Of the sixteen patients treated, 93.7% were classified as high-risk according to mSMART 3.0 guidelines, 19% had double hit R/R MM, and 31% had extramedullary disease. Patients had received a median of 5 prior lines of therapy, with 75% being refractory to last therapy and 19% being primary refractory. 94% of the patients were triple exposed to a PI, IMiD, and at least a third treatment modality, including anti-CD38 targeted therapy. 63% were penta-exposed with at least five different treatment modalities, including PI, IMiD and others. One patient with extramedullary disease obtained MRD negative result at his first bone marrow assessment at month 1, however, he was considered a non-responder based on the increasing size of the extramedullary lesion at month 1.

The safety profile of GC012F was manageable with an overall low grade of cytokine release syndrome (CRS) (87.5 % Grade 1/2, 2 patients Grade 3, no Grade 4 or 5) and a median duration of four days ranging from 1–8 days. CRS was treated with Standard of Care treatment, including tocilizumab and steroids, and resolved in all cases. No ICANS (immune effector cell-associated neurotoxicity) was observed in any of the sixteen patients. Treatment-emergent adverse events (TEAEs) presented predominantly as cytopenias and AST increase. Lower respiratory tract infection was observed in three patients. All TEAEs were resolved with standard therapy.

"We are extremely encouraged about these early findings in sixteen patients with predominately high-risk features," said Dr. Martina Sersch, MD, PhD, CMO of Gracell. "High-risk patients are difficult to treat successfully and to achieve longer-term remission. A 100% MRD-sCR at month six post-infusion after treatment with GC012F at the highest dose level shows promise for heavily pretreated patients who have failed or were no longer responding to standard treatment options. We are planning to expand our program globally and are looking forward to sharing updates as we advance our programs through clinical development."

On December 5, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported initial data for the Phase 1 first-in-human dose escalation study of talquetamab (JNJ-64407564) for the treatment of relapsed or refractory multiple myeloma (NCT03399799) (Press release, Janssen Pharmaceuticals, DEC 5, 2020, View Source [SID1234572263]). Talquetamab is a first-in-class, and the only investigational bispecific antibody that targets both GPRC5D, a novel multiple myeloma target, and CD3 on T-cells. Initial results for both the subcutaneous (SC) and intravenous (IV) formulations show encouraging clinical activity against the GPRC5D target, which is highly expressed on multiple myeloma cells and associated with poor prognostic factors.1,2,3 At the SC recommended Phase 2 dose (RP2D), the overall response rate (ORR) was 69 percent (9/13) and 39 percent achieved a very good partial response (VGPR) or better. The data will be featured during the American Society of Hematology (ASH) (Free ASH Whitepaper) 2020 Annual Meeting as an oral presentation on Saturday, December 5 at 5:00 p.m. ET (Abstract #290).

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"There is a pressing need for continued innovation of multiple myeloma treatments – particularly for patients who have relapsed on other therapies – and the results presented today for talquetamab are encouraging," said Ajai Chari, M.D., Professor of Medicine, the Director of Clinical Research in the Multiple Myeloma Program, and the Associate Director of Clinical Research, Mount Sinai Cancer Clinical Trials Office. "The Phase 1 overall response rate and safety profile support further study of talquetamab in monotherapy and in combination approaches for patients with few options for treatment."

Investigators identified the RP2D of 405 µg/kg SC and concluded subcutaneous treatment may provide an opportunity for less frequent dosing than the intravenous formulation. A response was observed in 6/9 triple-class refractory patients and 2/2 penta-drug refractory patients. Pharmacokinetic results indicate target exposure levels at the RP2D. At the RP2D of 405 µg/kg SC, pharmacodynamic data demonstrate consistent T-cell activation, cytokine production and redistribution.

Patients received talquetamab at doses of 1–180 µg/kg with IV administration and 5–800 µg/kg for the SC formulation. Results from the Phase 1 study showed responses in patients who were treated with talquetamab across dose groups; median time to first confirmed response across all doses was one month (range, 0.2–3).4

The Phase 1 study enrolled patients (n=157) with multiple myeloma who had progressed on, or could not tolerate, any available established therapies. Patients had received a median of six prior lines of treatment (range, 2-20); 87 percent were refractory to the last line of therapy, 82 percent were triple-class refractory, and 33 percent were penta-drug refractory to two or more immunomodulatory agents, two or more PIs, and an anti-CD38 therapy. The study is conducted in two parts: dose escalation (part 1) and dose expansion (part 2).4

In the Phase 1 study, adverse events (AEs) at the RP2D which occurred with a Grade 3 frequency of ≥25 percent among the SC cohort were neutropenia (42 percent). With SC dosing, cytokine release syndrome (CRS) was observed in 64 percent of patients and was low-grade with no Grade 3 or greater CRS events at the RP2D. CRS occurred at a median of two days after dosing, and median duration of CRS was also two days. The incidence of neurotoxicity was five percent at the RP2D, with no patients experiencing Grade 3 or greater events with SC dosing.4

"GPRC5D is a novel target in the treatment of multiple myeloma and, as a bispecific antibody that engages T-cells by also targeting CD3, talquetamab is emerging as a potential therapeutic option for heavily pretreated patients," said Yusri Elsayed, M.D., MHSc., Ph.D., Vice President, Global Head, Hematologic Malignancies, Janssen Research & Development, LLC. "Based on the preliminary efficacy, safety, pharmacokinetic and pharmacodynamic data presented today, we are committed to fully exploring the promise of talquetamab in multiple myeloma."

About Talquetamab
Talquetamab is a first-in-class investigational bispecific antibody targeting both GPRC5D, a novel multiple myeloma target, and CD3, the T-cell receptor.4 CD3 is involved in activating T-cells and GPRC5D is highly expressed on multiple myeloma cells.4,5,6 Results from preclinical studies in mouse models demonstrate that talquetamab induces T-cell-mediated killing of GPRC5D-expressing multiple myeloma cells through the recruitment and activation of CD3-positive T-cells and inhibits tumor formation and growth.6

Talquetamab is currently being evaluated in a Phase 1/2 clinical study for the treatment of relapsed or refractory multiple myeloma and is also being explored in combination studies. The development of the antibody followed Janssen Biotech, Inc.’s licensing agreement with Genmab for use of its DuoBody technology platform.*

*DuoBody is a registered trademark of Genmab A/S.

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.7,8 When damaged, these plasma cells rapidly spread and replace normal cells with tumors in the bone marrow. In 2020, it is estimated that more than 32,000 people will be diagnosed and close to 13,000 will die from the disease in the U.S.9 While some patients with multiple myeloma 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.10

On December 5, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported updated results from an ongoing Phase 1 first-in-human dose escalation study (NCT03145181) of teclistamab (JNJ-64007957) for the treatment of relapsed or refractory multiple myeloma (MM) (Press release, Janssen Pharmaceuticals, DEC 5, 2020, View Source [SID1234572251]). In heavily pretreated patients, the overall response rate (ORR) with teclistamab was 73 percent (16/22) at the recommended SC Phase 2 dose (RP2D).1 These results for the SC formulation support the recommended dose for the pivotal Phase 2 registration trial, which has started. In addition, updated results for the intravenous (IV) formulation demonstrate the durability of responses.1

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"The data presented today for the subcutaneous formulation build on promising results presented earlier this year for the intravenous regimen," said Alfred Garfall, M.D.,* Assistant Professor of Medicine, Perelman School of Medicine, University of Pennsylvania, and presenting author. "The preliminary efficacy, including durability of responses, combined with the initial safety profile in this highly pretreated population is encouraging and supports further studies of teclistamab in patients with relapsed or refractory multiple myeloma who are in need of additional treatment options."

The study is conducted in two parts: dose escalation (part 1) and dose expansion (part 2), and enrolled patients with MM who had relapsed or were refractory to established therapies and had previously been treated with a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD).1 Patients had received a median of six prior lines of treatment (range, 2-14); 96 percent were triple-class exposed, 81 percent were triple-class refractory, 91 percent were refractory to the last line of therapy, and 39 percent were penta-drug refractory (to two or more immunomodulatory agents, two or more PIs, and an anti-CD38 therapy).1 Prognosis is poor for patients with refractory MM as treatment options are limited.1

The RP2D was identified as 1500 µg/kg SC, and the maximum tolerated dose has not been identified. Fifty-five percent of patients achieved a very good partial response or better (12/22), and 23 percent of patients (5/22) achieved a complete response (CR) or better with RP2D SC dosing.1 After median follow-up of 3.9 months (range of 1.7–7.4 months), 94 percent (15/16) of responders treated with the SC RP2D were alive and progression-free.1 Responses appeared durable and deepened over time at the RP2D.1

Of the 11 patients who achieved CR and were evaluable for minimal residual disease (MRD) analysis across all IV and SC doses, eight patients attained MRD-negative CR at a threshold of 10-6 and one at a 10-5 threshold. Sustained MRD-negativity was confirmed for all five evaluable patients across the IV and SC cohorts.1

At the SC RP2D, 64 percent of patients experienced cytokine release syndrome (CRS) events, all of which were Grade 1 or 2 and generally confined to step-up, or a gradual increase in dosing, and first full doses.1 No patients discontinued treatment due to CRS. Of 33 treated patients at the RP2D, only one neurotoxicity event, which was reversible, was observed.1 Selection of the 1500ug/kg SC RP2D is supported by promising safety, efficacy, pharmacokinetics and pharmacodynamics. The SC formulation may provide an opportunity for less frequent dosing for patients than the IV formulation, although this has not been explored in the current study.1

The most common adverse events (AEs) (all grade ≥20 percent) for the RP2D in the SC cohort were CRS (64 percent); neutropenia (52 percent); anaemia (39 percent); thrombocytopenia (33 percent); leukopenia (33 percent); and fatigue (24 percent).1 In patients who experienced Grade 3 and above AEs (≥20 percent), the most common at the RP2D SC dose were neutropenia (33 percent); and anaemia (21 percent).1 One Grade 5 treatment related AE (pneumonia) was reported at the 80 µg/kg IV dose, but none at the RP2D.1

"We are committed to exploring treatment options that use promising modalities in multiple myeloma, including bispecific antibodies like teclistamab, that increase treatment responses through antigen targeting," said Yusri Elsayed, M.D., M.HSc., Ph.D., Vice President, Global Head, Hematologic Malignancies, Janssen Research & Development, LLC. "Our research in multiple myeloma is broad, exploring multiple targets through a variety of approaches. We continue to identify new treatment options, particularly for patients who have relapsed or become refractory to existing therapies."

"These initial results demonstrate the early promise of bispecific antibodies for people living with multiple myeloma and may, in the future, provide healthcare professionals with another tool in their arsenal to treat this devastating disease." said Dr Catherine Taylor, Vice President, Medical Affairs Therapeutic Area Strategy, Europe, Middle East and Africa (EMEA), Janssen-Cilag Ltd., Middle East. "Their development builds on our rich heritage in multiple myeloma, where we have continually sought to investigate new treatment strategies that have the potential to address remaining unmet needs."

Additional pharmacokinetic and ex vivo data for teclistamab will be highlighted in a poster on Monday, December 7 from 4:00pm to 12:30am CET (Abstract #3194).2 This study evaluated the ability of teclistamab to induce cytotoxicity and T-cell activation.2

*Alfred Garfall is lead investigator of the NCT03145181 study and was not compensated for any media work

#ENDS#

About Teclistamab
Teclistamab is an investigational bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3. BCMA is expressed at high levels on multiple myeloma cells.3,4,5,6,7 Teclistamab redirects CD3-positive T-cells to BCMA-expressing myeloma cells to induce cytotoxicity of the targeted cells.5,6 Results from preclinical studies demonstrate that teclistamab kills myeloma cell lines and bone marrow-derived myeloma cells from heavily pretreated patients.6

Teclistamab is currently being evaluated in a Phase 2 clinical study for the treatment of relapsed or refractory multiple myeloma (NCT04557098) and is also being explored in combination studies (NCT04586426, NCT04108195). The production and development of the antibody followed Janssen Biotech, Inc.’s licensing agreement with Genmab for use of its DuoBody technology platform.** In October and November 2020, the European Commission and the U.S. Food and Drug Administration (FDA), respectively, granted teclistamab orphan designation for the treatment of multiple myeloma.8,9

**DuoBody is a registered trademark of Genmab A/S.

About Multiple Myeloma
Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.10 In Europe, more than 48,200 people were diagnosed with MM in 2018, and more than 30,800 patients died.11 Around 50 percent of newly diagnosed patients do not reach five-year survival,12,13 and almost 29 percent of patients with multiple myeloma will die within one year of diagnosis.14

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.15 Relapsed and refractory myeloma is defined as disease that is nonresponsive while on salvage therapy, or progresses within 60 days of last therapy in patients who have achieved minimal response (MR) or better at some point previously before then progressing in their disease course.16 While some patients with MM have no symptoms at all, others are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.17 Patients who relapse after treatment with standard therapies, including proteasome inhibitors and immunomodulatory agents, have poor prognoses and require new therapies for continued disease control.18