On March 27, 2023 Immunoprecise Antibodies Ltd. (NASDAQ: IPA) ("Immunoprecise" or "IPA" or the "Company"), the parent company of BioKey and affiliate of BioStrand, reported that the EPO has issued a "Decision to Grant" for BioKey’s patent application covering the company’s HYFT Technology used to organize and analyze biological sequence information (Press release, ImmunoPrecise Antibodies, MAR 27, 2023, View Source [SID1234629379]). The HYFT Technology and methodology provide a novel way to efficiently tap into sequence information, allowing the extraction and use the relevant information therein to address the current problems in omics data integration and analysis. The HYFT Technology serves as the core of the BioStrand’s LENSai Integrated TechnologyTM platform which provides cutting-edge data solutions and antibody discovery.

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The patent will provide BioStrand’s LENSai Integrated Technology with broad protection, further strengthening the Company’s patent portfolio position and enabling exclusive access to the HYFT Technology. The Company anticipates favorable outcomes in other countries as well, as many patent offices worldwide consider the status of related European cases to be highly relevant to the decision to grant patents.

"This is a significant and exciting decision by the EPO, and we view this announcement as a recognition of BioStrand’s important contributions to the fields of omic data integration and analysis, fields paramount to the future of cancer research, precision medicine, biomarker identification, and novel drug discovery and development," stated Dr. Jennifer Bath, CEO of IPA. "This patent provides protection for BioKey’s HYFT Technology, which will give scientists the ability to advance the development of safer and more effective therapies for the toughest medical challenges we face today."

The HYFT Technology

HYFT Technology is a way of organizing information about the natural world by creating connections between patterns found in living things, called HYFTs. These patterns can link genetic sequences to their structures and functions, as well as to other information such as scientific papers and medical records. The output, the HYFT knowledge graph, contains over 660 million patterns and 25 billion connections, and is continuously updated with new information. This provides a powerful tool for exploring relationships in the natural world, which can be used for research and applications in medicine and other fields. The HYFT graph is unique in its explicit representation of information from the whole biosphere, and it provides a transparent intermediate layer between sequences and predictions that allows for new knowledge to be extracted without the limitations of a black box.

HYFT-based technologies have numerous applications in various fields beyond just data integration, organization, and analysis, such as drug immunogenicity testing, drug discovery, and natural language processing (NLP). These applications have the potential to accelerate the drug development process and improve patient outcomes.

In the field of immunogenicity, HYFTs can help predict parts of a molecule that may trigger an immune response. This information is crucial in therapeutic and vaccine development, as it helps identify potential safety concerns before they become problematic. Moreover, HYFTs can predict off-target effects, which occur when a drug or therapy affects unintended targets in the body. Early identification of potential off-target effects allows researchers to design safer and more effective treatments.

In drug discovery, HYFT-based technologies have multiple potential applications, including:

Toxicity Prediction: By linking genetic sequences to toxicological data, HYFTs can predict the toxicity of potential drug candidates, helping researchers identify compounds likely to cause adverse effects before entering clinical trials.

Drug Repurposing: HYFTs can identify existing drugs for repurposing by linking genetic sequences to known targets and functions, accelerating the drug discovery process by finding compounds already approved for other indications.

Clinical Trial Design: HYFTs can optimize clinical trial design by linking genetic sequences to patient data and clinical outcomes, identifying patient subgroups more likely to benefit from specific treatments, and enabling personalized and efficient clinical trials.

Biomarker Discovery: By linking genetic sequences to disease-specific phenotypes, HYFTs can identify biomarkers of disease, helping to identify at-risk patients and enable earlier diagnosis and treatment.

Another application of HYFT-based technologies is tied to NLP, which involves analyzing and extracting information from written or spoken language. HYFTs can link text-based information, such as scientific papers or medical records, to specific genetic sequences or structures, facilitating more efficient and accurate analysis. This is particularly valuable in genomics and personalized medicine, where vast amounts of textual data must be processed and analyzed to identify potential therapies or treatments.

The Company believes that the utilization of HYFT-based technologies in drug discovery and other fields shows great promise for expediting the drug development process and enhancing patient outcomes.

On March 27, 2023 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that it will report its fourth quarter and full year 2022 financial results on Thursday, March 30, 2023 (Press release, IGM Biosciences, MAR 27, 2023, View Source [SID1234629378]).

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In connection with the earnings release, IGM’s management team will host a live conference call and webcast at 4:30 p.m. ET on Thursday, March 30, 2023, to discuss the Company’s financial results and provide a corporate update. The webcast can be accessed by clicking the link: View Source and will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website.

On March 27, 2023 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immuno-oncology company developing novel T cell engagers, reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a corporate update (Press release, Harpoon Therapeutics, MAR 27, 2023, View Source [SID1234629377]).

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"Harpoon is well positioned to reach 2023 key milestones on our HPN217 and HPN328 clinical studies with a solid balance sheet extending the cash runway into the second half of 2024," said Julie Eastland, President and Chief Executive Officer of Harpoon Therapeutics. "Our leadership team remains focused on advancing our clinical pipeline and we anticipate sharing Phase 1 data from our two clinical programs in the second half of 2023."

Corporate Update / Recent and Upcoming Highlights

Tri-specific T cell Activating Construct (TriTAC) Platform

HPN217 (BCMA) Phase 1 trial for relapsed, refractory multiple myeloma

Interim results presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (cut-off of October 17, 2022), with additional observations post-ASH include the following:

Continued evidence of clinical activity with 77% (10/13) ORR observed in the two highest target dose levels (12 and 24 mg).

Early durable responses for responding patients with at least 9 months follow up, the median time on treatment is 12 months.

86% (18 of 21) responders remain on study treatment with sustained response, with many responses deepening over time.

Low incidence of cytokine release syndrome (CRS) across the patient population studied to date.

Transient CRS has occurred in 27% of patients across highest step-dose levels.

Following ASH (Free ASH Whitepaper) 2022, one patient experienced Grade 3 CRS and Grade 1 ICANS followed by a post-traumatic Grade 5 event (subdural hematoma).

Phase 1 dose exploration is expected to complete in the first half of 2023, with up to 94 patients and identification of a recommended Phase 2 dose(s) by the end of 2023.

Data presentation anticipated in the second half of 2023.

Orphan and Fast Track designation granted for the treatment of relapsed and refractory multiple myeloma.

HPN328 (DLL3) Phase 1/2 trial in small cell lung cancer (SCLC) and other neuroendocrine cancers

As of February 2023, observations in the monotherapy cohorts included:

Early signs of anti-tumor activity seen, with two confirmed partial responses per RECIST in patients with SCLC.

Priming dose lowered to 1mg and patients requiring oxygen prior to dosing excluded due to two events of Grade 3 CRS after the initial priming dose of 2 mg including one Grade 5 respiratory failure after higher priming dose.

Phase 1/2 dose and schedule optimization trial ongoing with monotherapy cohorts enrolling at the 12mg target dose.

Enrollment in combination therapy of HPN328 with atezolizumab (Tecentriq) in patients with SCLC, as part of the Phase 1/2 dose escalation trial, is anticipated to begin in the second half of 2023.

Phase 1 dose exploration is expected to complete in the second half of 2023, including the identifying of a recommended Phase 2 dose(s) in the monotherapy setting by the end of 2023.

Data presentation anticipated in the second half of 2023.

ProTriTAC

HPN601 (EpCAM)

HPN601 is our first conditionally active T cell engager based on the ProTriTAC platform. EpCAM is expressed in a broad range of solid tumors, potentially enabling HPN601 to address multiple indications with high unmet medical need.

IND filing timeline to enable a Phase 1 dose exploration study dependent on resource allocation.

Two new candidates for IND-enabling studies from the ProTriTAC platform have been identified against the targets trophoblast cell surface antigen 2,(TROP2) and Integrin-ß6 (ITGB6).

TriTAC-XR

The proprietary TriTAC-XR extended-release T cell engager platform is designed to minimize on-target CRS, a characteristic of many T cell engagers that can lead to dose limiting toxicities and reduce the efficacy of these potent anti-tumor drugs.

AACR 2023 – Five Preclinical Posters to be Presented:

HPN217: Preclinical abstract to be presented at AACR (Free AACR Whitepaper) on April 18, 2023:

"Anti-tumor activity of HPN217, a BCMA-targeting tri-specific T cell engager, is enhanced by y-secretase inhibitors in preclinical models"

HPN328: Two preclinical abstracts to be presented at AACR (Free AACR Whitepaper) on April 18, 2023:

"Long-term anti-tumor immunity induced by HPN328, a DLL3-targeting tri-specific, half-life extended T cell engager, in a preclinical immunocompetent mouse model"

"Anti-tumor activity of HPN328, a DLL3-targeting tri-specific, half-life extended T cell engager, is enhanced by combining with an anti-PD-L1 antibody in an immunocompetent mouse model"

ProTriTAC: Two preclinical abstracts to be presented at AACR (Free AACR Whitepaper) on April 17, 2023:

"TROP2 ProTriTAC, a protease-activated T cell engager prodrug targeting TROP2 for the treatment of solid tumors"

"ITGB6 ProTriTAC, a protease-activated T cell engager prodrug targeting Integrin-ß6 for the treatment of solid tumors"

Corporate Update

Preferred equity financing closed in March 2023, extending cash runway into the second half of 2024.

In November 2022, Harpoon announced a corporate restructuring designed to reduce discovery research and other operating expenses in 2023 and align its core activities with the organization’s clinical pipeline.

In October 2022, Harpoon appointed Luke Walker, M.D., as Chief Medical Officer. Dr. Walker leads the clinical development strategy and execution for Harpoon’s multiple clinical programs.

Fourth Quarter and Full Year 2022 Financial Results

Harpoon ended the fourth quarter of 2022 with $53.1 million in cash, cash equivalents and marketable securities, compared to $136.6 million as of December 31, 2021. Following the $25.0 million preferred equity financing and year to date ATM sales, cash and cash equivalents are expected to fund current operations into the second half of 2024.

Revenue for the quarter ended December 31, 2022 was $4.1 million, compared to $4.3 million for the quarter ended December 30, 2021. For the year ended December 31, 2022, revenue was $31.9 million, compared to $23.7 million for the year ended December 31, 2022. The increase for the year primarily arose from revenue recognized in 2022 for research and development services performed on the third and fourth targets under Harpoon’s Restated Collaboration Agreement with AbbVie, and an increase in revenue recognized related to Harpoon’s Development and Option Agreement with AbbVie for research and development services performed.

Research and development (R&D) expense for the quarter ended December 31, 2022 was $18.9 million, compared to $20.7 million for the quarter ended December 31, 2021. For the year ended December 31, 2022, R&D expense was $81.4 million, compared to $72.1 million for the year ended December 31, 2021. The decrease in the fourth quarter was primarily due to lower costs in research and lab supplies due to the corporate restructuring and lower costs in clinical and development costs due to wind down of the HPN424 and HPN536 programs. The increase for the year primarily arose from higher clinical and development costs and personnel-related expense, which included conducting preclinical studies and the continuation and preparation of the clinical trials for HPN217, HPN328 and HPN601.

General and administrative (G&A) expense for the quarter ended December 31, 2022 was $3.9 million, compared to $5.2 million for the quarter ended December 31, 2021. For the year ended December 31, 2022, G&A expense was $18.8 million, compared to $18.3 million for the year ended December 31, 2021. The decrease in the fourth quarter was primarily due to lower personnel-related expense. The increase for the year was primarily attributable to an increase in legal fees, consulting and other professional services to support Harpoon’s operations.

Net loss for the quarter ended December 31, 2022 was $18.4 million, compared to $21.6 million for the quarter ended December 31, 2021. The net loss for the year ended December 31, 2022 was $67.7 million compared to $116.7 million for the prior year.

On March 27, 2023 GSK plc (LSE/NYSE: GSK) reported interim results from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial investigating Jemperli (dostarlimab) plus standard-of-care chemotherapy (carboplatin-paclitaxel) followed by dostarlimab compared to chemotherapy plus placebo followed by placebo in adult patients with primary advanced or recurrent endometrial cancer (Press release, GlaxoSmithKline, MAR 27, 2023, View Source [SID1234629373]).

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Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK said: "These positive results from the RUBY trial bring us one step closer to addressing the significant unmet needs of endometrial cancer patients and add to the growing body of evidence on dostarlimab, strengthening our belief in its potential to transform cancer treatment as a backbone immuno-oncology therapy."

A statistically significant and clinically meaningful improvement in progression free survival (PFS) was observed for dostarlimab plus carboplatin-paclitaxel in the mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) population (n=118) and in the overall population (n=494) versus placebo plus chemotherapy. The separation of the lines in the Kaplan-Meier curve below illustrates the significant reduction in risk of disease progression or death in patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer in the dostarlimab plus chemotherapy treatment arm compared to the placebo plus chemotherapy treatment arm.

Dr Mansoor Raza Mirza, Chief Oncologist, Copenhagen University Hospital, Denmark and RUBY principal investigator, said: "Clinical practice has been waiting decades for a meaningful advancement in the standard of care for primary advanced or recurrent endometrial cancer. The results from the RUBY clinical trial, especially given the difficult-to-treat histologies included in the trial, demonstrate support for a new treatment standard with the addition of dostarlimab to current standard-of-care chemotherapy."

Additionally, at this first interim analysis, there was a clinically meaningful overall survival (OS) trend in the overall population among patients receiving dostarlimab plus chemotherapy followed by dostarlimab. The analysis was done at 33% maturity and statistical significance was not reached. OS follow-up continues and further analysis is planned. PFS and OS summaries are listed below.

dostarlimab + chemotherapy placebo + chemotherapy
PFS dMMR/MSI-H population
Number of patients evaluated 53 65
HR (95% CI)
0.28
(0.162-0.495)

P-value P<0.0001
At 24 months (95% CI)
61.4%
(46.3–73.4)

18.1%
(13.0%–23.9%)

PFS overall patient population
Number of patients evaluated 245 249
HR (95% CI) 0.64
(0.507–0.800)
P-value P<0.0001
At 24 months (95% CI)
36.1%
(29.3%–42.9%)

18.1%
(13.0%–23.9%)

PFS mismatch repair proficient (MMRp)/microsatellite stable (MSS) populationa
Number of patients evaluated 192 184
HR (95% CI) 0.76
(0.592–0.981)
P-value N/A
At 24 months (95% CI)
28.4%
(21.2–36.0)

18.8%
(12.8–25.7)

OS overall patient populationb
HR (95% CI) 0.64
(0.46­4–0.870)
P-value
P=0.0021c

At 24 months (95% CI)
71.3%
(64.5–77.1)

56.0%
(48.9–62.5)
OS dMMR/MSI-H populationa,d
HR (95% CI)
0.30
(0.127–0.699)

P-value N/A
At 24 months (95% CI)
83.3%
(66.8–92.0)

58.7%
(43.4–71.2)

OS MMRp/MSS populationa,e
HR (95% CI) 0.73
(0.515–1.024)
P-value N/A
At 24 months (95% CI)
67.7%
(59.8–74.4)

55.1%
(46.8–62.5)

aExploratory analyses of PFS in MMRp/MSS, OS in dMMR/MSI-H, and OS in MMRp/MSS populations were pre-specified with no planned hypothesis testing. bMaturity ≈33%. cP-value of ≤0.00177 was required for statistical significance at this OS interim analysis. dMaturity ≈26%. eMaturity ≈36%.

The safety and tolerability profile of dostarlimab in combination with carboplatin-paclitaxel in the RUBY phase III trial was generally consistent with the known safety profiles of the individual agents. The most common (>45%) treatment-emergent adverse events (TEAEs) in both treatment arms in the dMMR/MSI-H and overall populations were nausea, alopecia and fatigue, as well as anaemia in the placebo plus chemotherapy arm in the dMMR/MSI-H population. Severe and serious TEAEs were approximately 10% higher in the dostarlimab plus carboplatin-paclitaxel arm compared with the placebo plus carboplatin-paclitaxel arm in the overall population. The nature and types of immune-related adverse events (irAEs) in the dostarlimab plus chemotherapy safety profile were consistent with the mechanism of action of dostarlimab and similar to those reported for other PD-(L)1 inhibitors. In the overall population, 38.2% of participants in the dostarlimab plus carboplatin-paclitaxel arm and 15.4% of participants in the placebo plus carboplatin-paclitaxel arm had irAEs assessed by the investigator as related to dostarlimab or placebo, respectively. The most frequently reported dostarlimab-related irAE categories were endocrinopathies (15.8% dostarlimab-related versus 3.3% placebo-related) and skin adverse reactions (14.1% dostarlimab-related versus 3.7% placebo-related). Discontinuation of dostarlimab or placebo due to a TEAE occurred in 17.4% of patients in the dostarlimab plus chemotherapy treatment arm and 9.3% of patients in the placebo plus chemotherapy treatment arm in the overall population.

These data were shared in a European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Plenary, presented in a late breaking session at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer (25-28 March) and published simultaneously in The New England Journal of Medicine.

RUBY is part of an international collaboration between the European Network of Gynaecological Oncological Trial groups (ENGOT), a research network of the European Society of Gynaecological Oncology (ESGO) that consists of 22 trial groups from 31 European countries that perform cooperative clinical trials; the GOG Foundation, a non-profit organisation dedicated to transforming the standard of care in gynaecologic oncology; and the Nordic Society of Gynaecological Oncology – Clinical Trial Unit (NSGO-CTU), a non-profit organisation aiming to improve the practice of prevention, diagnosis and treatment for gynaecological cancers by supporting research and conducting clinical trials across countries.

GSK’s ambition is for dostarlimab to become the backbone of the Company’s ongoing immuno-oncology-based research and development programme when used alone and in combination with standard of care and future novel cancer therapies, particularly for patients who currently have limited treatment options. Dostarlimab is being investigated in registrational enabling studies as monotherapy and as part of combination regimens, including in patients with primary advanced or recurrent endometrial cancer, patients with Stage III or IV non-mucinous epithelial ovarian cancer, and patients with other advanced solid tumours or metastatic cancers.

About endometrial cancer
Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. Endometrial cancer is the most common gynaecologic cancer in developed countries, with approximately 417,000 new cases reported each year worldwide[i], and incidence rates are expected to rise by almost 40% by 2040.[ii][iii] Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.[iv]

About RUBY
RUBY is a two-part global, randomised, double-blind, multicentre phase III trial of patients with primary advanced or recurrent endometrial cancer. Part 1 is evaluating dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus carboplatin-paclitaxel plus placebo followed by placebo. Part 2 is evaluating dostarlimab plus carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo. The primary endpoints in Part 1 are investigator-assessed PFS based on the Response Evaluation Criteria in Solid Tumours v1.1 and OS. The statistical analysis plan included pre-specified analyses of PFS in the dMMR/MSI-H and ITT populations and OS in the overall population. Pre-specified exploratory analyses of PFS in the MMRp/MSS population and OS in the dMMR/MSI-H populations were also performed. RUBY Part 1 included a broad population, including histologies often excluded from clinical trials and had approximately 10% of patients with carcinosarcoma and 20% with serous carcinoma. In Part 2, the primary endpoint is investigator-assessed PFS. Secondary endpoints in Part 1 and Part 2 include PFS per blinded independent central review, overall response rate, duration of response, disease control rate, patient-reported outcomes, and safety and tolerability.

About Jemperli (dostarlimab)
Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2.[v]

Jemperli is not approved anywhere in the world for use in combination with standard-of-care chemotherapy (carboplatin-paclitaxel) followed by dostarlimab for primary advanced or recurrent endometrial cancer. In the US, Jemperli is indicated for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by a US FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. Jemperli is also indicated in the US for patients with dMMR recurrent or advanced solid tumours, as determined by a US FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The latter indication is approved in the US under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication in solid tumours may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under a collaboration and exclusive license agreement signed in March 2014. The collaboration has resulted in three monospecific antibody therapies that have progressed into the clinic. These are: Jemperli (GSK4057190), a PD-1 antagonist; cobolimab, (GSK4069889), a TIM-3 antagonist; and GSK4074386, a LAG-3 antagonist. GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of each of these medicines under the agreement.

Important Information for Jemperli in the EU

Indication 
Dostarlimab is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen. 

Refer to the Jemperli EMA Reference Information for a full list of adverse events and the complete important safety information in the EU.

On March 27, 2023 Genmab A/S (Nasdaq: GMAB) reported the initiation of a share buy-back program to honor our commitments under our Restricted Stock Units program (Press release, Genmab, MAR 27, 2023, View Source [SID1234629372]).

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The share buy-back program is expected to be completed no later than March 31, 2023, and comprises up to 220,000 shares.

The following transactions were executed under the program from March 20, 2023, to March 24, 2023:

No. of shares Average price (DKK) Total value (DKK)
Accumulated through last announcement 167,000 427,631,620
March 20, 2023 6,000 2,504.24 15,025,440
March 21, 2023 5,000 2,541.77 12,708,850
March 22,2023 5,000 2,541.44 12,707,200
March 23, 2023 7,000 2,529.99 17,709,930
March 24, 2023 7,000 2,564.91 17,954,370

Total 30,000 76,105,790
Accumulated under the program 197,000 503,737,410
Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 740,416 shares as treasury shares, corresponding to 1.12% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 06 dated February 22, 2023.