On February 20, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), reported that company management will participate in two upcoming investment bank conferences (Press release, Crinetics Pharmaceuticals, FEB 20, 2025, View Source [SID1234650412]). The TD Cowen 45th Annual Healthcare Conference is being held in Boston, MA, and the Leerink Global Healthcare Conference is taking place in Miami, FL.

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TD Cowen 45th Annual Healthcare Conference
Fireside chat on Monday, March 3, 2025 at 11:10 a.m. Eastern Time
Webcast link HERE

Leerink Global Healthcare Conference
Fireside chat on Monday, March 10, 2025 at 4:20 p.m. Eastern Time
Webcast link HERE

The live and archived webcasts will be accessible on the Events & Presentations page in the Investors section of the Crinetics’ website at www.crinetics.com/events.

If you are interested in arranging a 1×1 meeting with management, please contact your conference representative.

On February 20, 2025 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) , a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported that its CEO will join the Cancer Progress Panel discussion on February 27th at 1:10 pm CET at the 18th Annual European Life Sciences CEO Forum, which will include HealthTech topics such as AI, convergence, and diagnostics (Press release, TC Biopharm, FEB 20, 2025, View Source [SID1234650431]).

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The forum will take place on the 26th – 27th of February 2025 at the Hilton Zurich Airport Hotel. The main programme for the 18th Annual ELSF will feature more than 12 hours of high-level keynotes and panel discussions.

Additionally, there will be a global company showcase of 50+ presentations by established public, private, emerging, and seed companies, offering innovative solutions and seeking investment and partnering opportunities. For more information about the 18th Annual European Life Sciences CEO Forum.

On February 20, 2025 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, reported financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Dynavax Technologies, FEB 20, 2025, View Source [SID1234650413]).

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"In 2024, we successfully executed on our strategic growth initiatives, achieving record HEPLISAV-B product revenue, advancing our pipeline programs, and maintaining a disciplined approach to capital allocation," said Ryan Spencer, Chief Executive Officer of Dynavax. "Looking ahead to 2025, we plan to drive significant top-line growth as we continue to establish HEPLISAV-B as the market share leader in the expanding hepatitis B vaccine market in the U.S. We also expect to advance our pipeline programs to key milestones this year, including providing top-line results from our shingles vaccine Phase 1/2 program in the third quarter, as well as completing our $200 million share capital return and pursuing external opportunities to generate sustainable long-term value for our shareholders and other stakeholders."

BUSINESS UPDATES
HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]
HEPLISAV-B vaccine is the first and only adult hepatitis B vaccine approved in the U.S., the European Union and the United Kingdom that enables series completion with only two doses in one month. Hepatitis B vaccination is universally recommended for adults aged 19-59 in the U.S.

HEPLISAV-B achieved record net product revenue of $268.4 million for the full year 2024, an increase of 26% compared to $213.3 million for the full year 2023.
HEPLISAV-B achieved quarterly net product revenue of $71.1 million for the fourth quarter of 2024, an increase of 39% compared to $51.1 million for the fourth quarter of 2023.
HEPLISAV-B total estimated market share in the U.S. increased to approximately 44% at the end of 2024, compared to approximately 42% at the end of 2023.
Dynavax continues to expect the hepatitis B adult vaccine market in the U.S. to expand to a peak of over $900 million in annual sales by 2030, with HEPLISAV-B expected to achieve at least 60% total market share. Additionally, Dynavax believes the HEPLISAV-B U.S. market opportunity will remain substantial beyond 2030 due to the ongoing penetration of the unvaccinated eligible adult population, observed revaccination practices by healthcare providers, and continued gains in market share.
Clinical Pipeline
Dynavax is advancing a pipeline of differentiated product candidates that leverage its CpG 1018 adjuvant, which has demonstrated its ability to enhance the immune response with a favorable tolerability profile in a wide range of clinical trials and real-world commercial use.

Shingles Vaccine Program:
Z-1018 is an investigational vaccine candidate being developed for the prevention of shingles in adults aged 50 years and older.

Dynavax is currently conducting a randomized, active-controlled, dose escalation, multicenter Phase 1/2 trial to evaluate the safety, tolerability, and immunogenicity of Z-1018 compared to Shingrix in 441 healthy adults aged 50 to 69.
In the fourth quarter of 2024, the Company completed enrollment in the trial, and Dynavax anticipates reporting top-line immunogenicity and safety data in the third quarter of 2025.
Plague Vaccine Program:
Dynavax is developing a plague (rF1V) vaccine candidate adjuvanted with CpG 1018 in collaboration with, and fully funded by, the U.S. Department of Defense (DoD).

Based on the results from a randomized, active-controlled Phase 2 clinical trial of the plague vaccine adjuvanted with CpG 1018, Dynavax and the DoD executed a new agreement for approximately $30 million through the first half of 2027 to support additional clinical and manufacturing activities, including a Phase 2 clinical trial expected to initiate in the third quarter of 2025.
HEPLISAV-B for Adults on Hemodialysis:
Dynavax is developing a four-dose HEPLISAV-B vaccine regimen for adults on hemodialysis.

In the fourth quarter of 2024, Dynavax received feedback from the FDA regarding the potential to conduct an observational retrospective cohort study to support its sBLA filing for adults on hemodialysis.
FOURTH QUARTER 2024 FINANCIAL HIGHLIGHTS

Total revenues were $72.0 million for the fourth quarter of 2024, a 30% increase compared to $55.6 million for the fourth quarter of 2023.
HEPLISAV-B net product revenue was $71.1 million for the fourth quarter of 2024, a 39% increase compared to $51.1 million for the fourth quarter of 2023.
Cost of sales – product for HEPLISAV-B were $13.4 million for the fourth quarter of 2024, compared to $8.7 million for the fourth quarter of 2023.
Research and development expenses (R&D) were $18.7 million for the fourth quarter of 2024, compared to $14.1 million for the fourth quarter of 2023.
Selling, general, and administrative expenses (SG&A) were $41.6 million for the fourth quarter of 2024, compared to $41.3 million for the fourth quarter of 2023.
GAAP net income was $7.1 million, or $0.06 per share (basic) and $0.05 per share (diluted) for the fourth quarter of 2024, compared to GAAP net income of $0.2 million, or $0.00 per share (basic and diluted) for the fourth quarter of 2023.
Adjusted EBITDA* (excluding stock-based compensation) was $13.4 million for the fourth quarter of 2024, compared to $4.1 million for the fourth quarter of 2023, representing a 225% increase year-over-year.
Cash, cash equivalents and marketable securities were $713.8 million as of December 31, 2024, compared to $742.3 million as of December 31, 2023.
Share Repurchase Program: In November 2024, Dynavax announced a $200 million share repurchase program authorized by its Board of Directors, including $100 million repurchased through an Accelerated Share Repurchase program, which was completed in the first quarter of 2025. The Company expects to complete the remainder of the $200 million share repurchase program by the end of 2025.
FULL YEAR 2024 FINANCIAL HIGHLIGHTS

Total revenues were $277.2 million for the full year 2024, a 19% increase compared to $232.3 million for the full year 2023.
HEPLISAV-B net product revenue was $268.4 million for the full year 2024, a 26% increase compared to $213.3 million for the full year 2023.
Cost of sales – product for HEPLISAV-B were $49.4 million for the full year 2024, compared to $50.2 million for the full year 2023.
Research and development expenses (R&D) were $61.6 million for the full year 2024, compared to $54.9 million for the for the full year 2023.
Selling, general, and administrative expenses (SG&A) were $170.4 million for the full year 2024, compared to $152.9 million for the for the full year 2023.
GAAP net income was $27.3 million, or $0.21 per share (basic) and $0.20 per share (diluted) for the full year 2024, compared to GAAP net loss of $6.4 million, or ($0.05) per share (basic and diluted) for the full year 2023.
Adjusted EBITDA* (excluding stock-based compensation) was $51.9 million for the full year 2024, compared to $12.1 million for the full year 2023, representing a 329% increase year-over-year.
FULL YEAR 2025 FINANCIAL GUIDANCE
Dynavax is providing its full year 2025 financial guidance, based on the Company’s current operating plan:

HEPLISAV-B net product revenue is expected in the range of $305 to $325 million.
Adjusted EBITDA* (excluding stock-based compensation) is expected to be at least $75 million.
* Non-GAAP financial measure. Please refer to the "Non-GAAP Financial Measures" section for details regarding this measure.

Conference Call and Webcast Information
Dynavax will host a conference call and live audio webcast on Thursday, February 20, 2025, at 4:30 p.m. ET/1:30 p.m. PT. The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source A replay of the webcast will be available for 30 days following the live event.

To dial into the call, participants will need to register for the call using the participant call link. It is recommended that participants dial into the conference call or log into the webcast approximately 10 minutes prior to the call.

WHAT IS HEPLISAV-B?
HEPLISAV-B is a shot given to adults 18 years of age and older to help prevent infection caused by the hepatitis B virus. HEPLISAV-B is usually given in the arm muscle. HEPLISAV-B is given in 2 doses, 1 month apart, by a healthcare provider.

IMPORTANT SAFETY INFORMATION
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.

Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23%-39%), fatigue (11%-17%), and headache (8%-17%).

There are no adequate and well-controlled studies of HEPLISAV-B in pregnant individuals. Available data, primarily in individuals who received one dose of HEPLISAV-B in the 28 days prior to or during pregnancy, do not suggest an increased risk of major birth defects and miscarriage.

It is not known whether HEPLISAV-B is excreted in human milk.

Data are not available to assess the effects of HEPLISAV-B on the breastfed infant or on milk production/excretion.

Vaccination with HEPLISAV-B may not result in protection of all vaccine recipients.

Talk to your healthcare provider to determine if HEPLISAV-B is right for you.

On February 20, 2025 Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) reported its financial results for the year ended 31 December 2024 (Press release, Telix Pharmaceuticals, FEB 20, 2025, View Source [SID1234650432]). All figures are in AU$ unless stated otherwise.

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FY2024 highlights

Total revenue, driven primarily from sales of Illuccix of $783.2 million, up by 56%1 from $502.5 million in 2023, beating full year guidance2.
Second year of profitable growth, delivered in a period of investment, including:
R&D investment of $194.6 million, in line with guidance, with a focus on late-stage assets.
Expanded global supply chain and product delivery infrastructure, including acquisitions of ARTMS, Inc. and IsoTherapeutics Group, LLC, and expansion of Telix Manufacturing Solutions’ Brussels South facility, resulting in an incremental increase of $15.8 million in manufacturing and distribution investment.
Adjusted EBITDA of $99.3 million, up by 70%, demonstrating strong underlying growth3.
Telix continued to deliver on its growth strategy. The Company’s key achievements, aligned to its strategic pillars:
Grow precision medicine: Prepared for launch of three new products TLX007-CDx (Gozellix), TLX101-CDx (Pixclara) and TLX250-CDx (Zircaix)4 in 2025 while continuing to increase sales and market share for Illuccix.
Deliver late-stage therapeutics: Expanded ProstACT GLOBAL Phase 3 prostate cancer therapy trial recruitment in the U.S. and continued to advance therapeutic trials for the brain and kidney cancer programs.
Build next generation pipeline: Delivered clinical proof-of-concept for first alpha therapy candidate in prostate cancer (TLX592) and added depth to urology franchise with acquisition of FAP5-targeting theranostic.
Expand global delivery infrastructure: Completed acquisitions of ARTMS, IsoTherapeutics and RLS (USA), Inc. (RLS)6 and expanded Brussels South facility, in preparation to commence GMP7 production in 2025.
For a full list of operational achievements, please refer to the Telix 2024 Annual Report.

1. All comparisons to Full Year 2023 results.

2. Previously stated guidance of AU$745 million to AU$776 million (US$490 million to US$510 million).

3. Adjusted EBITDA excludes one-off expenses related to both the Company’s U.S. capital markets activity ($9.1 million) and strategic acquisitions ($8.2 million).

4. Launch and brand names subject to regulatory approval.

5. Fibroblast activation protein. Transaction subject to customary closing conditions.

6. RLS acquisition completed 27 January 2025, subsequent to year end. Refer to ASX disclosure.

7. Good manufacturing practice.

Summary Group financial results

Full Year 2024

Full Year 2023

AU$M

AU$M

% change

Revenue

783.2

502.5

56 %

Cost of sales

(273.6)

(188.2)

45 %

Gross profit

509.6

314.3

62 %

Research and development (R&D)

(194.6)

(128.5)

51 %

Selling and marketing

(85.5)

(50.1)

71 %

Manufacturing and distribution

(25.7)

(9.9)

160 %

General and administration

(129.8)

(74.2)

75 %

Other gains/(losses) (net)

8.1

(35.9)

*

Operating profit

82.1

15.7

423 %

Profit after tax

49.9

5.2

860 %

Adjusted EBITDA1

99.3

58.4

70 %

Cash from operating activities

43.0

23.9

80 %

1. Earnings before interest, tax, depreciation and amortization.

Commentary

Group CEO, Dr. Christian Behrenbruch, commented on the result:

"2024 has been an extraordinary year for Telix. We generated strong financial growth while investing for the future. The Precision Medicine business is poised for step-change growth with three commercial product launches planned for this year in the U.S. and the European rollout of Illuccix. We have a deep therapeutic pipeline with multiple assets moving into pivotal trials, and we are building out the infrastructure to ensure we can deliver our products to patients around the world. We see 2025 as a year of significant growth and evolution for Telix in terms of international business, multiple product launches and the integration of key infrastructure that will further deliver on our mission to ensure global patient access."

Further details on the Company’s results can be found in the Appendix 4E, investor presentation, and 2024 Annual Report lodged with the ASX and also available on the Company’s website.

Guidance

Telix provides FY2025 revenue guidance of $1.18 billion to $1.23 billion (US$770 million to US$800 million1). This guidance includes revenue from Illuccix (in jurisdictions with a marketing authorization)2 and 11 months of revenue from RLS (and excluding RLS revenue generated from Illuccix). Guidance does not reflect revenue for products that have not yet received a marketing authorization (for example, Gozellix, Pixclara and Zircaix3).

Telix has also provided R&D expenditure guidance, expecting an increased investment range of 20% to 25% compared to FY2024.

lnvestor call

An investor webcast will be held at 9.00am AEDT on Friday 21 February 2025 (5.00pm EST, Thursday 20 February 2025).

Participants can register for the webcast and find audio call details at the following link: View Source diamondpass/10044775-kmnuu.html

On February 20, 2025 Genmab A/S (Nasdaq: GMAB) reported that the Japan Ministry of Health, Labour and Welfare has approved EPKINLY (epcoritamab) for the treatment of patients with relapsed or refractory (R/R) follicular lymphoma (FL; Grades 1 to 3A) who have received two or more prior lines of therapy (Press release, Genmab, FEB 20, 2025, View Source [SID1234650414]). With this additional indication, EPKINLY is now the first and only T-cell engaging bispecific antibody administered subcutaneously to be approved in Japan to treat both R/R FL and R/R large B-cell lymphomas, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma and primary mediastinal large B-cell lymphoma, after two or more prior lines of therapy.

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FL is typically an indolent (or slow growing) form of non-Hodgkin’s lymphoma (NHL) that arises from B-lymphocytes and is the second most common form of NHL, accounting for 20-30 percent of all cases.i There are approximately 19,000 patients currently living with FL in Japan.ii FL is considered incurable with current standard of care therapies.iii Patients often relapse and, with each relapse, the remission and time to next treatment is shorter.iv Over time, transformation to DLBCL, an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25 percent of FL patients.v

"In the treatment of follicular lymphoma, where options become limited with each relapse, there remains a high unmet need for third-line and subsequent therapies in the absence of a clear standard of care," said Dr. Koji Izutsu, Head of the Department of Hematology, National Cancer Center Hospital, who served as the principal investigator of the Japanese Phase 1/2 clinical trial (EPCORE NHL-3 trial). "The responses and tolerability demonstrated in this trial support the potential of epcoritamab to become an important option in future treatment strategies for relapsed/refractory follicular lymphoma."

The approval is based on results from the global Phase 1/2 EPCORE NHL-1 and the Japanese Phase 1/2 EPCORE NHL-3 clinical trials, which were open-label, multicenter studies to evaluate the safety and efficacy of EPKINLY as a monotherapy in patients with R/R mature B-cell non-Hodgkin’s lymphoma, including FL. In the Japanese trial, a 2-step step-up dosing (SUD) regimen was used. In the global trial, two different dose escalation methods were used – 2-step and 3-step SUD regimens – to mitigate a common adverse reaction from T-cell engaging cancer treatments known as cytokine release syndrome (CRS).

EPCORE NHL-1 Global Clinical Trial Results
Among the 128 evaluable patients with R/R FL in the EPCORE NHL-1 trial, the overall response rate (ORR) and the complete response (CR) rate were 82 percent (95 percent CI: 74.3-88.3) and 62.5 percent, respectively (data cut-off: April 21, 2023). Ninety-one patients were evaluable for a minimal residual disease (MRD) analysis, with 67 percent of patients achieving MRD negativity. Additionally, more than half of patients who responded to treatment in the study remained responsive to treatment at the time of data analysis (i.e., at a median follow-up of 14.8 months, median duration of response (DoR) was not reached).

Among the patients who received EPKINLY with the 2-step SUD regimen (n=128), adverse events were observed in 119 patients (93 percent). The most common treatment-emergent adverse events (TEAEs) (≥20 percent) included CRS (66.4 percent) and injection site reactions (36.7 percent).

As part of a separate dose-optimization cohort in the trial, a 3-step SUD regimen was evaluated in 86 patients with FL (Grades 1 to 3A). Adverse events were observed in 78 patients (90.7 percent). The most common TEAEs included CRS (48.8 percent) and injection site reactions (26.7 percent).

EPCORE NHL-3 Japanese Clinical Trial Results
Among the 21 evaluable patients with R/R FL in the Japanese trial, with a median follow up of 21.2 months, the ORR and the CR rate were 95.2 percent (95 percent CI: 76.2-99.9) and 76.2 percent, respectively. Additionally, 88.9 percent of patients achieved MRD negativity (n=18).

Among patients who received EPKINLY with the 2-step SUD regimen, the most common TEAEs included CRS (90.5 percent), injection site reactions (71.4 percent), rash (28.6 percent), neutropenia (28.6 percent), increased alanine aminotransferase (23.8 percent) and increased aspartate aminotransferase (23.8 percent).

"Patients living with relapsed or refractory follicular lymphoma in Japan deserve options, and we are proud that EPKINLY may help treat patients as their cancer returns or stops responding to other therapies," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "Over the last year, EPKINLY has been approved in the U.S., the European Union (as TEPKINLY) and Japan. With a dual indication in relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma after two or more prior therapies, we are committed to making epcoritamab available to patients in need and continuing its broad development as a potential core therapy across B-cell malignancies."

About the EPCORE NHL-1 Trial
EPCORE NHL-1 is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that consists of three parts: a dose escalation part; an expansion part; and an optimization part. The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (B-NHL), including FL. In the expansion part, additional patients were enrolled to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-NHLs who have limited therapeutic options. The expansion part generated pivotal data from patients with FL and DLBCL. The optimization part evaluated additional CRS mitigation strategies during cycle 1. The primary endpoint of the expansion part was overall response rate (ORR) as assessed by an Independent Review Committee. Secondary efficacy endpoints included duration of response (DoR), complete response (CR) rate, duration of complete response (DoCR), progression-free survival (PFS), and time to response as determined by the Lugano criteria. Overall survival (OS), time to next therapy, and rate of minimal residual disease (MRD) negativity were also evaluated as secondary efficacy endpoints. The primary endpoint of the optimization part was the rate of ≥ Grade 2 CRS events and all grade CRS events from first dose of epcoritamab through 7 days following administration of the second full dose of epcoritamab.

About the EPCORE NHL-3 Trial
EPCORE NHL-3 is an open-label, multi-center safety and efficacy trial of epcoritamab that consists of a Phase 1 first-in-human dose escalation part and a Phase 2 expansion part. The Phase 2 expansion part evaluated subcutaneous administration of epcoritamab in Japanese patients with relapsed, progressive, or refractory mature B-cell NHL, including FL. The primary endpoint of the expansion part was ORR as assessed by IRC, and secondary efficacy endpoints included DOR, CR rate, DoCR, PFS, and time to response based on the Lugano criteria.

About EPKINLY (epcoritamab)
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.vi

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with R2 compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.