Immunocore Holdings Plc. (IMCR:NASDAQ) plans to commercially launch Kimmtrak (tebentafusp) as early as this quarter or next. In addition, a handful of other catalysts are on track to happen this year, and the company has other clinical programs underway.
"Immunocore's long-term pipeline potential in solid tumor indications provides a favorable risk-reward in current shares, coupled with the potential for the commercialization of Kimmtrak in the treatment of metastatic uveal melanoma in 2022," wrote Oppenheimer analyst Justin Kim in a Jan. 26 report.
Oppeneheimer rates the stock Outperform and has a $56 per share price target on it. Immunocore's current share price is about $25.
Early Approval, Unmet Need
This England-headquartered biotech is developing a class of T cell receptor (TCR) bispecific immunotherapies for treatment of a wide array of diseases, including cancers and autoimmune, infectious (hepatitis B and human immunodeficiency virus [HIV]) and other diseases, such as diabetes.
The biotech is on the verge of commercializing its most advanced drug candidate, Kimmtrak, for the treatment of unresectable or metastatic uveal melanoma, an eye cancer.
The U.S. Food and Drug Administration (FDA) just approved Kimmtrak in late January, making it the first TCR immunotherapeutic to garner regulatory approval. This validates Immunocore's ImmTAC, or Immune Mobilizing Monoclonal TCRs Against Cancer, platform, designed to redirect and spur T cells to identify and kill cancer cells. Kimmtrak specifically targets gp100, an antigen expressed in melanocytes and melanomas.
Given their mechanism of action, ImmTAC molecules could tackle many types of tumors, including hematologic and solid, regardless of mutational burden or pre-existing immune infiltration.
"The FDA's expeditious approval, one month early, in our view, underscores the unmet need and compelling clinical risk/benefit that Kimmtrak offers for this ultraorphan cancer," Kim commented.
To date, no treatment has existed for this rare but fatal eye cancer. The U.S. sees about 1,670 new cases of uveal melanoma per year. About half of the people who have it eventually develop metastatic disease, and those whose cancer has spread generally die from it within a year's time.
However, Kimmtrak, in clinical trials, demonstrated a statistically and clinically meaningful overall survival (OS) benefit, a hazard ratio of 0.51 and a median OS of almost 22 months.
Taking Kimmtrak Global
The commercial opportunity for Kimmtrak is "nontrivial," Kim noted. The U.S. alone contains about 400 addressable patients, and the median price of treating each patient with Kimmtrak is about $430,000. Immunocore developed and is employing a targeted strategy for reaching those patients, aiming for a 75% success rate to start.
Further, Immunocore intends to commercialize Kimmtrak worldwide and has submitted a marketing authorization application to several agencies. They include Health Canada, the European Medicines Agency, the United Kingdom's Medicines and Healthcare Regulatory Agency, and Australia's Department of Health Therapeutic Goods Administration. The biotech expects a decision from the EMA's Committee for Medicinal Products for Human Use soon.
Immunocore launched a global early access program for Kimmtrak, in which 200 patients in 13 countries already signed up.
"We believe the opportunity could see upside from a strong adoption of the product and potential extended duration of use," wrote Kim.
Many Catalysts on the Horizon
Along with Kimmtrak, the spotlight will also be on two of Immunocore's earlier stage therapeutics this year. One is IMC-F106C, targeting the tumor-associated antigen PRAME. The other is IMC-C103C, targeting the MAGE-A4 gene and being developed with partner Genentech.
In mid-2022, Phase 1 data are expected from the trial of IMC-F106C in small cell lung, nonsmall cell lung, breast, endometrial and ovarian cancers and melanomas.
Readout of Phase 1 data from another study is anticipated in H2/22. Results will be from the slightly more advanced study of IMC-C103C in nonsmall cell lung, small cell lung, head and neck, gastric and ovarian cancers and synovial sarcoma.
"While focus for shares may shift to (or even remain on) the earlier pipeline (MAGE-A4/PRAME), we would not discount the potential for the [Kimmtrak] drug launch to see acceleration to our current timelines, given the high unmet need and benefit of this first approved agent for the indication," Kim wrote. "With Kimmtrak potentially becoming the tip of the spear, we stay bullish."
Two other potential stock moving events slated for this year are the initial dosing in Q2/22 of IMC-M113V in the upcoming HIV trial and start of a randomized study in Q4/22 of Kimmtrak in cutaneous melanoma.
Big Name Collaborators
Also of note, Immunocore is not going it alone in developing new therapies. Rather, it has partnerships with some big players. On the oncology front, partners are GlaxoSmithKline, Genentech, and Eli Lilly. Agreements with the latter two also include new drug copromotion.
Regarding Immunocore's HIV program, the Bill & Melinda Gates Foundation is supporting the development of ImmTAV/ImmTAB (Immune‐Mobilizing Monoclonal TCRs Against Virus or Bacteria) molecules as potential treatments.
Immunocore also is partnering with the Juvenile Diabetes Research Foundation on the biotech's type 1 diabetes program.
"As 2022 unfolds, we expect greater focus on Immunocore, clearing a favorable regulatory binary event and approaching a series of early but increasingly meaningful clinical catalysts with MAGE-A4 and PRAME," wrote Kim.
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