On December 13, 2021 Cellular Biomedicine Group Inc. (CBMG or the "Company"), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, reported that the Food and Drug Administration (FDA) granted clearance of the Investigational New Drug (IND) application to proceed with the Phase 1b clinical development of its chimeric antigen receptor (CAR) T-cell therapy targeting CD19 and CD20 (C-CAR039) (Press release, Cellular Biomedicine Group, DEC 13, 2021, View Source [SID1234596995]). C-CAR039 is a novel autologous bi-specific CAR-T therapy targeting both CD19 and CD20 antigens in the treatment of patients with relapsed or refractory non-Hodgkin lymphoma (r/r B-cell NHL).

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"This is fantastic news for us as we believe we may potentially have best-in-class therapeutics for patients with poor prognosis. The largest subtype of NHL is DLBCL, and those refractory patients whose treatment has failed have limited options. We look forward to initiating the C-CAR039 trial soon," said Tony (Bizuo) Liu, Chairman and CEO. "The FDA’s C-CAR039 IND application clearance is a significant milestone for CBMG. We are fond of our manufacturing, quality control, and clinical development teams for their dedication to our mission of ‘Saving Lives and Revitalizing Lives’ and bringing to market innovative targeted therapies to address cancers."

Yihong Yao, PhD, Chief Scientific Officer of CBMG, commented, "We are excited about the potential of C-CAR039 as a best-in-class treatment in r/r B-NHL. C-CAR039 clearly showed potential superior efficacy and favorable safety results for patients with r/r B-cell NHL. Our C-CAR039 trial is a testament of the teams’ translational medicine capability. We look forward to bringing more potentially promising development to clinical trials."

About C-CAR039
Early clinical results of C-CAR039 from an investigator-initiated trial (IIT) conducted across multiple sites in China demonstrate exciting efficacy and favorable safety data of C-CAR039 in r/r B-cell NHL. As of April 20, 2021, a total of 34 patients received C-CAR039 cell therapies, with 28 patients evaluable for safety analyses and 27 patients evaluable for efficacy analyses. Patients’ median age was 55.5 years, and 75% had cancer of Ann Arbor stage III/IV. Patients had a median of three prior lines of therapy. Bridging therapy had been given to 17.9% of patients. The best overall response rate (ORR) was reported to be 92.6%, with a complete response rate (CRR) of 85.2%. Patients had a median time to response of 1.0 month, and at a median follow-up of 7 months, 74.1% of patients continued to be in complete remission. The 6-month estimated progression-free survival rate was 83.2% (95% CI, 69.1%-100.0%). Cytokine release syndrome (CRS) occurred in 96% of patients. 92% of CRS was of grade 1/2 and only 1 patient had grade 3 CSR. Immune effector cell-associated neurotoxicity syndrome occurred at grade 1 in 2 patients and no ≥grade 2 neurologic events reported in the study. CBMG will continue to evaluate patients with longer follow-up (ClinicalTrials.gov Identifiers: NCT04317885, NCT04655677, NCT04696432, NCT04693676).

Separately, in June 2021, the FDA Office of Orphan Products Development granted CBMG an Orphan Drug Designation to C-CAR039 for the treatment of Follicular Lymphoma, an indolent form of non-Hodgkin lymphoma.

About CBMG
Cellular Biomedicine Group Inc. (CBMG) is a wholly owned subsidiary of CBMG Holdings. CBMG Holdings ("Holdings") develops proprietary cell therapies for the treatment of cancer and degenerative diseases. CBMG operates a state-of-the-art facility in Rockville, Maryland with five GMP rooms in order to augment its global research and development capabilities and to support clinical development of multiple cell therapy platform technologies in the United States. Holdings conducts immuno-oncology and stem cell clinical trials in China using products from its integrated GMP laboratory. Holdings’ GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. Holdings currently conducts ongoing studies in China, for CAR-T therapies targeting blood cancers, including C-CAR039, an anti-CD19, CD20 BiCAR treatment for non-Hodgkin lymphoma (NHL) and CAR088, an anti-BCMA treatment for Multiple Myeloma, in addition to T cell receptor (TCR-T) and tumor-infiltrating lymphocytes (TIL) therapies targeting solid tumors. Holdings has completed patient treatment in a Phase II trial for AlloJoin, its "Off-the-Shelf" allogenic haMPC therapy for the treatment of Knee Osteoarthritis (KOA), and a Phase II trial for ReJoin autologous haMPC therapy for the treatment of KOA.

On December 13, 2021 Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company dedicated to developing a cure for people with chronic hepatitis B virus (HBV) infection, and Qilu Pharmaceutical, one of the leading pharmaceutical companies in China, reported that the companies have entered into an exclusive licensing agreement and strategic partnership for the development and commercialization of AB-729 for the treatment or prevention of hepatitis B in mainland China, Hong Kong, Macau and Taiwan (Press release, Arbutus Biopharma, DEC 13, 2021, View Source [SID1234596909]).

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AB-729 is Arbutus’s lead RNA interference (RNAi) therapeutic that is currently in multiple Phase 2a proof-of-concept clinical trials designed to evaluate it in combination with other approved or investigational agents.

William Collier, President and Chief Executive Officer of Arbutus Biopharma, commented, "Qilu is an ideal partner for our AB-729 RNAi therapeutic given their extensive development, regulatory and commercialization capabilities in China. We are now positioned to bring AB-729 to the largest HBV patient population in need of a cure and to tap into one of the largest and most promising healthcare markets worldwide. We are committed to working with Qilu in this partnership which further validates the potential of AB-729 to address the unmet medical need in HBV."

Qilu Pharmaceutical Chief Executive Officer, Ms. Yan Li commented, "The HBV patient population is significant in China. Based on clinical data achieved to-date, we believe in the potential of AB-729 to be a safe and effective treatment option in treating HBV. We look forward to collaborating with Arbutus to maximize the potential clinical value that AB-729 can bring to and benefit the millions of underserved HBV patients in China."

Under the terms of the agreement, Arbutus will receive a $40 million upfront payment and will be entitled to additional payments of up to $245 million upon reaching certain development, regulatory and sales milestones. The above amounts are net of withholding taxes. Qilu will be responsible for funding all development and commercialization activities for mainland China, Hong Kong, Macau and Taiwan. Arbutus is also entitled to receive double-digit tiered royalties up to the low twenties percent on annual net sales. In addition, Qilu will make a $15 million equity investment in Arbutus common shares at a price of $4.19 per share, a 15% premium of Arbutus’ previous 30-day average closing stock price calculated from December 10, 2021.

The common shares to be sold in the private placement have been offered only to certain institutional and/or accredited investors in reliance upon an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"). The common shares have not been registered under the Securities Act or any state or other securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements of the Securities Act and applicable state securities laws. The Securities and Exchange Commission has not passed upon the merits of or given its approval to the common shares, the terms of the private placement or the accuracy or completeness of any private placement materials. The common shares sold in the private placement are subject to legal restrictions on transfer.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification or otherwise under the securities laws of any such state or jurisdiction.

About AB-729

AB-729 is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens, including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. AB-729 targets hepatocytes using Arbutus’ novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. Clinical data generated thus far has shown single- and multi-doses of AB-729 to be generally safe and well-tolerated while providing meaningful reductions in hepatitis B surface antigen and hepatitis B DNA.

About HBV

Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from chronic HBV infection. Approximately 900,000 people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options.

On December 13, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma), reported that it will be highlighted during a "Best Ideas" virtual fireside chat with B. Riley Biotech research analyst Kalpit Patel on Tuesday, December 14th at 2:30 pm ET. The fireside chat will feature an interactive discussion with Key Opinion Leader (KOL) and MARIO-3 TNBC Investigator, Hatem Soliman, MD (Moffitt Cancer Center), Infinity’s CEO, Adelene Perkins, and Infinity’s CMO, Dr. Robert Ilaria (Press release, Infinity Pharmaceuticals, DEC 13, 2021, View Source [SID1234596926]).

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To register for the webinar please contact a B.Riley sales representative or Kalpit Patel, Pharm.D., 646-885-5447, [email protected].

Hatem Soliman, MD is one of the leading breast cancer physicians in the country and an investigator on the MARIO-3 study. Dr. Soliman serves as the Medical Director of the Clinical Trials Office at the Moffitt Cancer Center, with extensive experience as a clinical investigator conducting both translational research in breast cancer immunotherapy and leading numerous clinical trials as principal investigator since joining the faculty at Moffitt in 2008. He also serves as the Course Director for the fellowship clinical research rotation, medical director of the phase 1 program, chair of Moffitt’s clinical research leadership council, chair of clinical research feasibility committee, and principal investigator for Moffitt’s CPDM CCSG application, which was recently rated as outstanding and awarded funding for an additional five years.

Dr Soliman received his BS in Genetics from the University of Georgia Athens in 1996 and then went on to receive his medical degree from the Medical College of Georgia in 2002. His residency and fellowship training in oncology/hematology was completed through the University of South Florida/Moffitt Cancer Center program in 2008. During fellowship, he authored investigator initiated early phase trials with mentorship from Dr. Daniel Sullivan, former ACD and EVP of Moffitt, in collaboration with the NCI CTEP RAID program investigators Drs. Jaime Zwiebel and Howard Streicher. Upon graduation, Dr. Soliman was offered an assistant member position at Moffitt as a clinical investigator to continue early drug development and translational research activities.

On December 13, 2021 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported that final data from its Phase 1b/2 trial of Nana-val in relapsed/refractory (R/R) EBV+ lymphoma (VT3996-201) were presented in an oral presentation at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting by Bradley Haverkos, M.D., Associate Professor at the University of Colorado School of Medicine (Press release, Viracta Therapeutics, DEC 13, 2021, View Source [SID1234596948]). Nana-val was well tolerated and continues to demonstrate promising activity with complete responses observed across multiple EBV+ lymphoma subtypes and a median duration of response of 10.4 months.

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Key data and conclusions from the ASH (Free ASH Whitepaper) presentation:

As of the October 28, 2021, data cutoff, 55 patients were enrolled. Patients had a median age of 60 (range 19-84) and had a median of two prior therapies. 75% (41/55) were refractory to their last therapy, and 96% (53/55) had exhausted all standard therapies (per Investigator).

Nana-val was generally well tolerated with reversible low-grade toxicities. The most commonly observed treatment emergent adverse events were reversible cytopenias, low grade creatinine elevations, and gastrointestinal symptoms.

Efficacy in evaluable patient (n=43):

Across all lymphoma subtypes: ORR = 40% (17/43); CR = 19% (8/43); Clinical Benefit Rate (CBR) [(CR+ partial response (PR) + stable disease (SD) ≥6 months] = 56% (24/43)
T/NK-NHL: ORR = 60% (9/15); CR = 27% (4/15); CBR = 67% (10/15)
Extranodal NK/T-Cell Lymphoma (ENKTL): ORR = 63% (5/8); CR = 13% (1/8); CBR = 63% (5/8)
Peripheral T-cell lymphoma (PTCL)/ Angioimmunoblastic T-cell lymphoma (AITL): ORR = 67% (4/6); CR = 50% (3/6); CBR = 83% (5/6)
DLBCL: ORR = 67% (4/6); CR = 33% (2/6); CBR = 83% (5/6)
Both DLBCL complete responses were in patients refractory to first line R-CHOP
IA-LPD: ORR = 50% (3/6); CR = 33% (2/6); CBR = 50% (3/6)
Durable responses:

Median DoR was 10.4 months
Three patients achieved responses with durations >2 years
"EBV is easily detectable and can be associated with a number of lymphoma subtypes, having a negative impact on clinical outcomes such as survival," said Dr. Haverkos, lead investigator of the VT3996-201 study. "The clinical safety and efficacy profile demonstrated thus far in this refractory patient population is very encouraging and underscores the utility of this unique EBV-targeted approach."

"Clinicians and key opinion leaders have shown a high level of enthusiasm for our potentially registration-enabling NAVAL-1 study, which we believe underscores the strength of the clinical dataset supporting the trial and the urgency of the unmet need in EBV-associated cancers. We expect this enthusiasm to be further bolstered following this oral presentation at ASH (Free ASH Whitepaper), which has provided us with the opportunity to broadly discuss the final Phase 1b/2 results with the clinical community," said Ivor Royston, M.D., President and Chief Executive Officer of Viracta. "We are encouraged by the final Phase 1b/2 data, as the response rates and median durations observed in the B- and T-cell lymphoma subtypes compare favorably to those seen in other single arm R/R lymphoma studies that have led to accelerated approvals and demonstrate Nana-val’s potential to provide meaningful clinical benefit to patients who currently lack effective treatment options. We look forward to the continued evaluation of this promising combination therapy in NAVAL-1 and anticipate providing further clinical program updates in 2022."

A copy of the ASH (Free ASH Whitepaper) presentation will be available by visiting the Events and Webcasts page of the Viracta website following the conference’s conclusion.

About Nana-Val (Nanatinostat and Valganciclovir)

Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in EBV-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-Val, in various subtypes of EBV-associated malignancies. Ongoing trials include a registration-enabling global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed/refractory EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors.

About EBV-Associated Cancers

Approximately 95% of the world’s adult population is infected with Epstein-Barr virus (EBV). Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of lymphatic cells for the duration of the patient’s life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV+ lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden and is also associated with a variety of solid tumors, including nasopharyngeal carcinoma and gastric cancer.

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