Full Press Release Details
Immunocore reports second quarter financial results and provides a business update
KIMMTRAK (tebentafusp-tebn) net revenues of $75.3 million in 2Q 2024 driven by US growth
Registrational Phase 3 TEBE-AM trial with KIMMTRAK in previously treated cutaneous melanoma ongoing,
following conversion of Phase 2/3 trial - expect to complete enrollment in 1H 2026
Registrational Phase 3 (PRISM-MEL-301) evaluating brenetafusp + nivolumab in first-line cutaneous melanoma
started randomization
Presented Phase 1 data of brenetafusp in late-line cutaneous melanoma patients at ASCO 2024; late-line
high-grade serous ovarian data to be presented at ESMO 2024
Conference call today, August 8, 2024 at 8:00 AM ET, 1:00 PM BST
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 08 August 2024) Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company
pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, today announced its financial results for the second quarter ended June 30,
2024 and provided a business update.
"Over the next 18 months, we will present multiple data read-outs including brenetafusp and the HIV MAD data, while progressing three Phase 3 trials, with
registrational data expected in 2026, 2027 and 2028. We will also advance our new autoimmune and oncology clinical and pre-clinical programs," said Bahija Jallal, Chief Executive
Officer of Immunocore.
"In the first half of 2024, we expanded KIMMTRAK's reach in the US community setting and globally with 9 new launches and 2 additional reimbursement agreements, in the
context of a challenging market access environment in Europe," said Ralph Torbay, Immunocore's Chief Commercial Officer. "We are exploring the potential of KIMMTRAK to benefit
more patients and deliver revenue growth beyond metastatic uveal melanoma with our two ongoing Phase 3 registrational trials in previously treated cutaneous melanoma and in adjuvant uveal melanoma."
Second Quarter 2024 Highlights (including post-period)
The Company's lead product, KIMMTRAK, is approved in 38 countries and has been launched in 19 countries globally to date for HLA-A*02:01 positive
patients with unresectable or metastatic uveal melanoma (mUM). KIMMTRAK continues to be the standard of care in most markets where it is launched. The Company sees three key growth areas for the KIMMTRAK opportunity, including: continued global
expansion in mUM, as well as the potential expansion into 2L+ advanced cutaneous melanoma (CM) and adjuvant uveal melanoma.
Metastatic uveal melanoma
2L + Previously treated cutaneous melanoma
Adjuvant uveal (or ocular) melanoma
Brenetafusp (IMC-F106C) is the Company's lead PRAME-A02 ImmTAC bispecific candidate. Brenetafusp is being evaluated in combination with nivolumab,
in a Phase 3 registrational trial (PRISM-MEL-301) in patients with first-line advanced cutaneous melanoma (CM) and in a Phase 1/2 clinical trial, as monotherapy and in combination, across multiple tumor types, including platinum resistant
ovarian, non-small cell lung (NSCLC), and endometrial carcinoma.
PRISM-MEL-301 - First PRAME Phase 3 clinical trial with brenetafusp in first-line advanced or metastatic HLA-A*02:01 positive
Phase 1/2 clinical trial of brenetafusp (PRAME-A02) in multiple solid tumors
IMC-P115C (PRAME-A02 Half-Life Extended) & IMC-T119C (PRAME-A24)
Additional Oncology Candidates
IMC-R117C (first PIWIL1-A02 targeted immunotherapy) for colorectal and other gastrointestinal cancers
The Company has leveraged its proprietary peptidomic database to validate a novel target, PIWIL1. PIWIL1 is a negative prognostic marker and is
expressed across a range of tumors including colorectal, which is historically insensitive to immune checkpoints, as well as gastro-esophageal, and pancreatic cancer.
ImmTAV Candidates for a Functional Cure in Infectious Diseases
The Company's bispecific TCR technology platform has potential to offer a new approach for the treatment of chronic infections and aims to eliminate
evidence of remaining virus in circulation after the patient stops taking medication - known as a "functional cure". Two investigational candidates are in Phase 1 clinical trials for people living with human immunodeficiency virus (HIV) and
people with chronic Hepatitis B infection (HBV).
Phase 1 trial of IMC-M113V (Gag-A02) for people living with HIV
Phase 1 trial of IMC-I109V (Envelope-A02) for people living with HBV or HBV-positive hepatocellular carcinoma
Tissue-specific Down Modulation of the Immune System for Autoimmune Diseases
The Company is expanding its platform into autoimmune diseases with two new, first-in-class bispecific candidates recently entering its pipeline.
The key differentiator of the Company's ImmTAAI (Immune Modulating Monoclonal TCRs Against AutoImmune disease) platform is tissue-specific down modulation of the immune system whereby, when tethered to the tissue of interest, the new candidates
suppress pathogenic T cells via PD1 receptor agonism.
IMC-S118AI (pre-pro insulin A02 x PD1), intended for disease-modifying treatment in type 1 diabetes
Undisclosed non-HLA restricted (universal) candidate for inflammatory dermatological diseases
ESMO Congress 2024 - Presentation and poster details
Title: Phase 1 safety and
efficacy of brenetafusp, a PRAME CD3 ImmTAC T cell engager, in platinum resistant ovarian cancer (PROC) (Poster 750P)
Presenting author: Claire
Session: Poster Session - Gynaecological cancers, Saturday 14 September 2024; 09:00 a.m. - 5:00 p.m. CEST / 04:00 a.m. - 12:00 p.m. ET
Title: Chemotherapy and
hypomethylating agents enhance anti-tumor activity of PRAME ImmTAC
Presenting author: Adel
Session: Poster Session - Investigational immunotherapy, Saturday 14 September 2024; 09:00 a.m. - 5:00 p.m. CEST / 04:00 a.m. - 12:00 p.m. ET (Poster 1021P)
Title: Association of
a blood T cell fitness gene signature with clinical benefit from ImmTAC bispecific T cell engagers (Oral 66O)
Presenting author: Joseph
Session: Proffered paper
session 2 - Basic Science and Translational Research, Monday 16 September 2024; 02:45-04:15 p.m. CEST / 09:45-11:15 a.m. ET
For the second quarter ended June 30, 2024, the Company generated net product sales of $75.3 million compared to $56.9 million for the same period in 2023. This
increase was due to revenue from KIMMTRAK, of which $55.6 million was in the United States, $15.4 million (net of an increase in estimated reserves related to prior periods of $6.7 million) in Europe, and $4.3 million in international regions.
The increase in net product sales was due primarily to increased volume in the United States and global country expansion, as the Company continued its commercialization efforts.
For the second quarter ended June 30, 2024, research and development (R&D) expenses were $51.1 million, compared to $38.2 million for the same period in 2023. This
increase was primarily driven by expenses incurred for the PRAME programs, including the initiation of the Company's Phase 3 clinical trial.
For the quarter ended June 30, 2024, SG&A expenses were $38.6 million, compared to $35.0 million for the same period in 2023. This increase was primarily related to
additional employees engaged in business support functions, including medical and regulatory activities, to support our growing pipeline and commercial activities.
Basic and diluted loss per share was $0.23 for the quarter ended June 30, 2024, as compared to a basic and diluted loss per share of $0.35 for the same period in 2023.
Net loss for the quarter ended June 30, 2024 was $11.6 million, as compared to $17.0 million for the same period in 2023.
Cash, cash equivalents, and marketable securities at June 30, 2024 were $859.6 million. The Company plans to use $50 million to repay its existing loan by the end of
2024, and also expects to pay approximately $40 million in sales-related rebate accruals in the second half of 2024.
About ImmTAC molecules for cancer
Immunocore's proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilizing monoclonal TCRs Against
Cancer) molecules that are designed to redirect the immune system to recognize and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognize intracellular cancer antigens with ultra-high affinity and selectively kill these
cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumors, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumors, regardless of
mutational burden or immune infiltration, including immune "cold" low mutation rate tumors.
About ImmTAV molecules and infectious diseases
ImmTAV (Immune mobilizing monoclonal TCRs Against Virus) molecules are novel bispecifics that are designed to enable the immune system to recognize and eliminate
virally infected cells. Immunocore is advancing clinical candidates to achieve functional cure for patients with HIV and hepatitis B virus (HBV). The Company aims to achieve sustained control of HIV after patients stop anti-retroviral therapy
(ART), without the risk of virological relapse or onward transmission. This is known as functional cure'. For the treatment of HBV, the Company aims to achieve sustained loss of circulating viral antigens and markers of viral replication after
stopping medication for people living with chronic HBV.
About ImmTAAITM molecules and autoimmune diseases
ImmTAAI (Immune mobilizing monoclonal TCRs Against AutoImmune disease) molecules are novel bispecifics that are designed for tissue-specific down modulation of the
immune system. When tethered to the tissue of interest, ImmTAAI candidates suppress pathogenic T cells via PD1 receptor agonism. The Company is currently advancing two candidates for autoimmune diseases, including type 1 diabetes and inflammatory
dermatological diseases.
About PRISM-MEL-301 (NCT06112314) - Phase 3 trial with brenetafusp (IMC-F106C, PRAME-A02) in 1L advanced cutaneous melanoma
The Phase 3 registrational trial is randomizing HLA-A*02:01-positive patients with previously untreated advanced melanoma to brenetafusp + nivolumab versus nivolumab
or nivolumab + relatlimab, depending on the country where the patient is enrolled. The trial will initially randomize to three arms: two brenetafusp dose regimens (40 mcg and 160 mcg) and a control arm. One of the two brenetafusp dose regimens will
be discontinued after an initial review of the first 60 patients randomized to the two experimental arms (90 patients randomized total). The primary endpoint of the trial is progression free survival (PFS) by blinded independent central review
(BICR), with secondary endpoints of overall survival (OS) and overall response rate (ORR).
About the IMC-F106C-101 Phase 1/2 trial
IMC-F106C-101 is a first-in-human, Phase 1/2 dose escalation trial in patients with multiple solid tumors, including non-small cell lung cancer (NSCLC), small-cell
lung cancer (SCLC), endometrial, ovarian, cutaneous melanoma, and breast cancers. The Phase 1 dose escalation trial was designed to determine the maximum tolerated dose (MTD), as well as to evaluate the safety, preliminary anti-tumor activity and
pharmacokinetics of IMC-F106C (brenetafusp), a bispecific protein built on Immunocore's ImmTAC technology, and the Company's first molecule to target the PRAME antigen. The Company is enrolling patients into three expansion arms in NSCLC, as well
as ovarian and endometrial carcinomas. The IMC-F106C-101 trial is adaptive and includes the option for Phase 2 expansion, allowing for approximately 100 patients treated per tumor type in the Phase 1 and 2 expansion arms. Dose escalation continues
in additional solid tumors as well as plans for combination arms with standards-of-care, including checkpoint inhibitors, chemotherapy, and tebentafusp.
About TEBE-AM - Phase 3 registrational trial with tebentafusp in previously treated advanced cutaneous melanoma
The trial is randomizing patients with second-line or later advanced cutaneous melanoma who have progressed on an anti-PD1, received prior ipilimumab and, if
applicable, received a BRAF kinase inhibitor. Patients are randomized to one of three arms, including tebentafusp - as monotherapy or in combination with an anti-PD1 - or a control arm. The primary endpoint is overall survival.