On August 11, 2021 Immunocore Holdings plc (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, reported its financial results for the quarter and six months ended June 30, 2021 and provides a portfolio update (Press release, Immunocore, AUG 11, 2021, View Source [SID1234586345]).

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Immunocore’s recent and second quarter highlights include the acceleration of tebentafusp regulatory submissions in the EU and UK; continued dose escalation of MAGE-A4 and PRAME targeting ImmTACs; and the initiation of a single ascending dose trial for its ImmTAV bispecific molecule for chronic hepatitis B (HBV).

Bahija Jallal, Chief Executive Officer of Immunocore, said: "The team at Immunocore is focused on bringing our pioneering science to patients as quickly as possible. We remain on track to complete the tebentafusp BLA submission in the US in the third quarter and are pleased to have accelerated our submissions in Europe, while also initiating our global early access program to make tebentafusp available to patients who need it now."

"With the positive phase 3 results for tebentafusp in metastatic uveal melanoma, we now have demonstrated the first ever overall survival benefit for any TCR therapeutic," said David Berman, Head of Research and Development. "Our Phase 1 programs targeting MAGE-A4 and PRAME continue to dose escalate, with both now at biologically active doses. The start of our first clinical trial in chronic hepatitis B further highlights our confidence in the potential of our ImmTAX platform across a broad range of indications including cancer and infectious disease."

Second Quarter 2021 Highlights (including post-period)

Tebentafusp

In July, the European Medicines Agency (EMA) granted tebentafusp accelerated assessment procedure for this Marketing Authorization Application (MAA). Accelerated assessment potentially reduces the time frame for the EMA Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) to review a MAA for an Advanced Therapy Medicinal Product (ATMP). The U.S. Food and Drug Administration (FDA) will review the Biologics License application (BLA) for tebentafusp (IMCgp100) under the Real-Time Oncology Review (RTOR) pilot program, an initiative of the FDA’s Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients. Tebentafusp is also being reviewed under the FDA’s Project Orbis initiative, which enables concurrent review by the health authorities in partner countries that have requested participation. Previously, the FDA has granted Breakthrough Therapy Designation (BTD) to tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

In June, the Company presented a subset analysis from the Phase 3 study exploring the overall survival benefit from tebentafusp in patients with best RECIST* response of progressive disease (PD) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In patients with a best response of PD in the Phase 3 trial, the overall survival (OS) was superior for the tebentafusp arm versus the investigator’s choice arm with a hazard ratio (HR) of 0.43 (95% CI 0.27-0.68). More than half of tebentafusp patients with best response PD were treated beyond initial progression and no new safety signals were observed. In addition, analysis from the Phase 2 tebentafusp trial suggests that at least one-third of patients on tebentafusp with a best response of PD have a reduction in circulating tumor DNA and that this may be associated with longer OS.

In April, the Company launched a global early access program for tebentafusp in mUM.

In April, the Company’s Phase 3 data of tebentafusp in mUM was also the subject of an oral presentation in the Phase 3 clinical trials plenary session at the AACR (Free AACR Whitepaper) Virtual Annual Meeting 2021. Tebentafusp demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) as a first-line treatment in mUM. In the intent-to-treat population, tebentafusp demonstrated a median overall survival of 21.7 months compared to 16.0 months for investigator’s choice and with 73% of patients alive at 1 year for tebentafusp vs. 58% for investigator’s choice. The OS Hazard Ratio (HR) favored tebentafusp, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine). In addition, tebentafusp resulted in a statistically significant longer PFS. Treatment-related adverse events were manageable and consistent with the proposed mechanism.

The Company remains on track to complete submission of a BLA to the FDA in the third quarter of 2021. Additionally, the Company has accelerated the submission of a MAA to the EMA, and the United Kingdom’s Medicines and Healthcare Regulatory Agency, or MHRA, to the third quarter of 2021.

Additional Clinical Programs

IMC-C103C targeting MAGE-A4

In the second quarter, the Company continued to dose escalate IMC-C103C, an ImmTAC molecule targeting an HLA-A*02:01 MAGE-A4 antigen, in a first-in-human, Phase 1/2 dose escalation trial in patients with solid tumor cancers including non-small-cell lung cancer (NSCLC), gastric, head and neck, ovarian and synovial sarcoma. As of June 30, 2021, the Company has enrolled 39 patients in the Phase 1 study. Early pharmacodynamic data indicate that IMC-C103C monotherapy is demonstrating biological activity at the doses currently under evaluation. The Company plans to report this initial Phase 1 data in the fourth quarter of 2021.

IMC-F106C targeting PRAME

In the second quarter, the Company continued to dose escalate IMC-F106C, an ImmTAC molecule targeting an HLA-A*02:01 PRAME antigen, in a first-in-human, Phase 1/2 dose escalation trial in patients with multiple solid tumor cancers. PRAME is overexpressed in many solid tumors including NSCLC, SCLC, endometrial, ovarian, melanoma and breast cancers. As of June 30, 2021, the company has enrolled 23 patients in the Phase 1 study. Early pharmacodynamic data indicate that IMC-F106C monotherapy is demonstrating biological activity at the doses currently under evaluation. The Company plans to report this initial Phase 1 data in mid-2022.

IMC-I109V targeting HBV

In the second quarter, the Company initiated dosing in the IMC-I109V global Phase 1 single ascending dose trial. IMC-I109V is the first candidate in development using Immunocore’s immune‐mobilising monoclonal T cell receptors against virus (ImmTAV) platform to enter clinical trials. IMC-I109V targets a conserved Hepatitis B virus (HBV) envelope antigen and is being developed as a potential functional cure.

Financial Results

Basic and diluted loss per share was £0.75 or $1.04 for the three months ended June 30, 2021 as compared to an adjusted £0.63 for the three months ended June 30, 2020. Basic and diluted loss per share was £1.51 or $2.08 for the six months ended June 30, 2021 compared to an adjusted £1.39 for the six months ended June 30, 2020. Total operating loss for the three months ended June 30, 2021 was £34.5 million or $47.6 million compared to £20.5 million for the same period last year, largely due to an increase in employee costs associated with non-cash share-based payment charge. Total operating loss for the six months ended June 30, 2021 was £66.4 million or $91.6 million compared to £42.6 million for the same period last year, largely due to an increase in employee costs associated with non-cash share-based payment charge.

For the three and six months ended June 30, 2021, revenue from collaboration agreements was £5.7 million or $7.9 million and £14.0 million or $19.3 million, respectively, as compared to £7.8 million and £16.0 million, respectively, for the three and six months ended June 30, 2020. For the three and six months ended June 30, 2021, research and development expenses were £16.5 million or $22.7 million and £36.4 million or $50.2 million, respectively, as compared to £16.4 million and £37.2 million, respectively, for the three and six months ended June 30, 2020. For the three and six months ended June 30, 2021, administrative expenses were £23.8 million or $32.9 million and £44.0 million or $60.7 million, respectively, compared to £12.3 million and £21.9 million respectively, for the three and six months ended June 30, 2020 including a £5.1 million and £13.0 million increase, respectively, in the non-cash share-based payment charge.

Cash and cash equivalents are £278.9 million or approximately $385 million as of June 30, 2021 compared to £129.7 million as of December 31, 2020.

About Tebentafusp

Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. Tebentafusp has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. The European Medicine Agency (EMA) has granted the Tebentafusp Marketing Authorization Application (MAA) for an Accelerated Assessment procedure based on the Committee for Medicinal Products for Human Use (CHMP) agreement that tebentafusp is a product of major interest for public health and therapeutic innovation. Tebentafusp is also being reviewed under the FDA’s Project Orbis initiative, which enables concurrent review by the health authorities in partner countries that have requested participation. For more information about enrolling tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).