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Hamlet Pharma secures Alpha1H production for continued clinical trials

By November 2, 2021 No Comments

Lund October 29, 2021

It is a great pleasure to announce that Hamlet Pharma has secured the
production of larger quantities of Alpha1H, using a stable, large scale
manufacturing process. The new batches will be essential to extend the
clinical trial program in patients with bladder cancer.

The clinical trial program in bladder cancer is proceeding according to plan, using Alpha1H
secured from previous production rounds. Larger amounts of Alpha1H will be needed
moving forward, as the clinical trial program is expanding to involve larger patient numbers.

As previously announced, Hamlet Pharma is collaborating with Rechon Life Science for the
production and formulation of the drug candidate Alpha1H. Rechon Life Science AB is a
manufacturer approved for pharmaceutical supply worldwide, including the US. Together
with Hamlet Pharma, Rechon has now successfully established large scale Alpha1H
production technology. Production is carried out in accordance with Good Manufacturing
Practice (GMP) and Alpha1H, packaged for clinical use, will be distributed to the clinical trial
site.

”Scaling up the production of of Alpha1H is essential for the growth of Hamlet Pharma and
for future clinical trials” says Catharina Svanborg, CMO and chairman of the board of Hamlet
Pharma Ltd.

‘’Securing a robust production of our drug candidate is an important milestone for the
company”, says Mats Persson, CEO of Hamlet Pharma Ltd.

For more information, please contact

Catharina Svanborg, Chairman and founder of Hamlet Pharma, +46-709 42 65 49
catharina.svanborg@med.lu.se

Mats Persson, CEO Hamlet Pharma, +46 705 17 67 57
mats.persson@hamletpharma.com

This information is insider information that Hamlet Pharma AB is obliged to make
public pursuant to the EU Market Abuse Regulation. The information was submitted
for publication through the agency of the contact persons set out above, on October
29, 2021 at 12.55 CET.

About HAMLET Pharma

HAMLET Pharma, listed on Spotlight, develops drugs based on the unique tumoricidal protein-lipid
complex, HAMLET, formed by two natural and harmless molecules found in breast milk. Development
focuses primarily on drugs, for the treatment and prevention of cancer. HAMLET kills tumour cells and
has proven safe in proof-of-concept studies in animal models. Alpha1H is the synthetic variant of
HAMLET, which has enabled development of the agent for clinical trials. Alpha1H kills different types of
tumour cells and has demonstrated therapeutic effects on bladder cancer in animal models. Hamlet
Pharma has one ongoing Phase I/II clinical trial with Alpha1H in patients with bladder cancer, a costly
form of cancer that is difficult to treat and intends to expand its activities into other types of cancer. The
first results from the ongoing clinical Phase I/II study shows no side effects of Alpha1H, indicating that
the treatment is safe and well tolerated. Alpha1H also demonstrated clinical efficacy compared with
patients who received placebo. In addition, Hamlet Pharma develops BAMLET, which is a molecular
complex formed by bovine α-lactalbumin and oleic acid. Data from animal models suggest that local
BAMLET treatment may be effective against colon cancer.

Hamlet Pharma

Author Hamlet Pharma

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Hamlet Pharma AB

BMC D10
Klinikgatan 32
SE-222 42 Lund, Sweden
+46 40 12 25 00
info@hamletpharma.com

Swedish