Immutep (known as Prima BioMed until November 2017) is an Australian clinical-stage biotechnology company that develops immunotherapies for cancer and autoimmune diseases. Given the encouraging overall survival data, IMM will continue to talk to regulators and potential partners about the development of efti in breast cancer the efti mBC programme in China should hopefully in any case move forwards. The ongoing TACTI-002 and -003 trials will continue to generate efti-PD-X combo data in HNSCC, where, with the right data, FDA Fast Track status could open the door to accelerated approval. Under threat from biosimilars, large pharma will be hungry for new products to protect and extend their proprietary markets few other PD-X combos have delivered, and the chemo combo is not sufficient to extend patents.įurther opportunities in solid cancers: While NSCLC will be the focus for Phase 3, IMM will continue to explore opportunities in HNSCC and mBC. With increased penetration from the substitution for chemo and triple therapy, we estimate that global peak revenues in NSCLC could reach $6.5bn, with Fast Track designation hoping to expedite this launch.Īpproaching PD-X patent expiry feed pharma appetite: Key patents are due to expire on PD-X products including pembrolizumab. NSCLC opportunity in excess of $6bn: The bulk of Merck's $17.2bn pembro revenues come from NSCLC. INSIGHT-003 is testing the additional first line impact of efti-PD-X-chemo triple therapy in NSCLC due to report first data Q4/2022E. Potential to expand responsive patient population: Safe and well tolerated, efti has already shown signs of synergy with chemo in the AIPAC Phase 2 in metastatic breast cancer ("mBC"). Avoiding the severe acute and long-term side effects, efti could provide an alternative to chemo for the majority of NSCLC patients. Pembro- efti combinations delivered a 42% overall response rate ("ORR") and 9.3-month median progression free survival ("mPFS") compared to 50% and 7.2 month with pembro-chemo SoC respectively. PD-X- chemo is the current 1st line SoC for 70% of late-stage NSCLC patients. Safer and better tolerated alternative to chemo: Governed by PD-L1 status, We reiterate both our OUTPERFORM recommendation and our AUD $2.00 target price. Financed to 2024E and with more data in the pipeline, IMM looks dramatically undervalued, in our view. The share price has been hit by market turbulence and flight from risk, but efti looks an attractive asset as PD-X patents expire. We anticipate efti total peak sales of at least $8bn valuing the company at c.AUD 1.7bn (AUD 2.03 / share). IMM has provided a constant flow of positive efti data across indications, including HNSCC and AIPAC metastatic breast ("mBC") phase 2b trial providing improvements in overall survival. Other perks can include Rolling Review, Accelerated Approval and Priority Review. Often speeding approvals, Fast Track takes IMM closer to the potential $6bn opportunity in NSCLC. Allowing for more frequent meetings with the FDA and streamlining the trial design and approval process, a welcome lift as IMM plan for phase 3 efti-pembro NSCLC trial. Through Fast Track designation FDA acknowledges the potential benefits of efti-pembro combo over existing therapies. Already with FDA Fast Track in head and neck cancer ("HNSCC"), the expedited review process was awarded based on the phase 2 data from the TACTI-002 study, indicating efti-PD-1 / L1 (PD-X) combinations could provide a safer and better tolerated alternative to the chemotherapy SoC in first line NSCLC, substantially expanding treatment responsive populations and decreasing toxicity-linked treatment discontinuation. FDA fast-tracks efti as chemo alternative in NSCLCįDA has granted Fast Track to eftilagimod alpha ("efti") in combination with Merck's anti-PD-1 therapy pembrolizumab ("pembro"), for first line treatment in NSCLC.
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