IMU (ASX) Ann: Three Complete Responses in Azer-Cel Phase 1b Trial

Originally posted by Raki: ↑

Azer-Cel (Azercabtagene Zapreleucel) Phase 1b Trial Results:
Clinical Trial Overview:
Imugene is conducting a Phase 1b trial of Azer-cel, an allogeneic (off-the-shelf) CD19 CAR T-cell therapy, targeting relapsed/refractory diffuse large B-cell lymphoma (DLBCL), a type of non-Hodgkin's lymphoma (NHL).
The trial includes two cohorts:
Cohort A: Patients treated with Azer-cel and lymphodepletion (chemotherapy).
Cohort B: Patients treated with Azer-cel, lymphodepletion, and interleukin 2 (IL-2), which is intended to enhance T-cell survival and efficacy.
Promising Results:
Complete Responses (CR): Three patients have achieved complete responses (CRs), with two in Cohort B and one in Cohort A.
Durability of Responses: The complete responses in Cohort B have shown durability of over 120 days and 90 days, respectively, with all patients still on the study.
Overall Response Rate (ORR):
Cohort A: 33% ORR (1 CR, 1 partial response).
Cohort B: 67% ORR (2 CRs).
Safety Profile: Treatment with Azer-cel has been reported as safe and tolerable across both cohorts.
High Unmet Need:
The patient population in the trial consists of individuals with relapsed/refractory DLBCL who have failed multiple prior treatments, including autologous CAR T therapies, highlighting a high unmet medical need.
Potential Valuation and Takeover Consideration for Imugene
To determine what big pharma might pay for a takeover of Imugene, let’s evaluate the potential value of their drug pipeline based on this new data.
Potential Market Opportunity:
DLBCL Market: DLBCL is the most common type of NHL, with approximately 30,000 new cases per year in the U.S. alone. The market for CAR T-cell therapies targeting blood cancers is substantial, with therapies like Yescarta and Kymriah generating over $500 million to $1 billion annually in sales.
Expansion into Solid Tumors: Imugene also plans to expand Azer-cel's use in combination with its onCARlytics program to treat solid tumors, potentially opening a much larger market beyond blood cancers.
Valuation Multiples and Precedent Acquisitions:
Recent biotech acquisitions in the CAR T and immuno-oncology space have seen substantial valuations. For example, Gilead’s acquisition of Kite Pharma for $11.9 billion and Pfizer’s acquisition of Seagen for $43 billion highlight the potential high valuations for companies with promising immuno-oncology pipelines.
If Azer-cel achieves similar clinical success and market adoption, Imugene’s valuation could range significantly:
Early-stage Valuation (Pre-Phase 2/3): $500 million to $1 billion, given the promising Phase 1b data and safety profile.
Mid to Late-stage Valuation (Post-Phase 3 or Approval): Could range from $1 billion to $3 billion or more, especially if the expansion into solid tumors proves successful and significantly increases the target market.
Takeover Premium Considerations:
Big pharma companies often pay a premium for companies with promising clinical assets, strategic alignment with their existing portfolios, and a high unmet medical need.
Given the positive clinical data from the Phase 1b trial, a big pharma company might be willing to pay a premium to acquire Imugene, particularly if it sees potential for Azer-cel to become a first-in-class or best-in-class therapy.
Conclusion:
Based on Imugene's current clinical trial data, particularly the promising results from the Phase 1b trial of Azer-cel in relapsed/refractory DLBCL, the company could be an attractive target for a big pharma acquisition. Depending on future clinical outcomes and market conditions, a potential takeover valuation could range from $500 million to over $3 billion, aligning with recent trends in the biotech and oncology space. This range considers both the high potential upside if clinical trials are successful and the typical risk adjustments made by big pharma during acquisitions.

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Raki,

IMU is worth $450M now. Do you think that taking into account "the high potential upside" that you mention, that an offer of $500M would be in the range for a takeover?

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Last 4.9¢		Change 0.001(2.08%)		Mkt cap ! $368.1M

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Ann: Three Complete Responses in Azer-Cel Phase 1b Trial, page-120

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