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22 May 2023, by Amy Sarcevic
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When Leslie Chong took over Imugene as Chief Executive in 2015, she was excited to progress the development of what could be the world’s first cancer vaccines.
HER-VAXX, which creates antibodies from a patients’ own B cells, has already shown great efficacy in tackling HER2-positive cancers, such as breast and gastric, during phase 2 clinical trials.
By blocking the signalling pathway and killing the cancer cell, the vaccine has demonstrated a 41.5 percent reduction in mortality risk when combined with chemotherapy, compared with patients who use chemotherapy alone.
The vaccine also boasts a survival rate of 13.9 percent – 5.6 percent higher than that observed among chemotherapy patients.
What’s more, the therapeutic has a low toxicity profile, with clear advantages in terms of patient safety and side-effect reduction.
Since taking over the company, Ms Chong has helped the vaccine achieve strong clinical trial results and blown Imugene’s market capitalisation from seven to eight figures. The company is now valued at just under 1 billion dollars.
Despite her success, Ms Chong admits she has encountered the same challenges and hurdles that every drug developer faces.
She says, at times, she has been forced to abate her excitement over the products, and remain cool-headed in response to the realities of therapeutic development.
“Cancer therapy, in particular, is a highly competitive market, so you have to keep evaluating the landscape […],” Ms Chong told Informa Connect ahead of the Bio Connections Australia Conference.
“Yes positive data is exciting, but if everybody is trying to cure a certain type of cancer in a certain line of therapy, or targeting the same biomarker or mutation, you need to keep a close eye on them. They may become the new standard of care that you need to compete with.”
Although she boasts 24 years in therapeutic development and a strong track record – having brought four cancer drugs to market – Ms Chong finds herself “constantly pivoting and learning” in her practice and admits she cannot afford to get complacent.
“Nobody is immune to failing when it comes to drug development. There are some things you just can’t mitigate against, as you never know for sure how patients are going to react to drugs in clinical trial.
“In small biotech companies with limited funding, these failures can be costly. They might prohibit you from doing your next clinical trial. So you have to keep innovating, pivoting your study and anticipating anything that might go wrong.”
Indeed, Imugene is a relatively small biotech company, with a team of just eight permanent clinical development staff members. Despite this, Ms Chong describes her team as her strength.
“I believe people’s experience is critical to the success of drug development, and that’s why we have a small, but strong, team of highly experienced staff. Anything our team doesn’t have the experience or capacity to take on, we outsource to highly experienced key players in the oncology landscape.”
Alongside HER-VAXX, Ms Chong and team are also progressing PD1-Vaxx, another immunotherapy which works by activating B-cells and promising oncolytic virus which only attack and replicate in cancer cells.
The drug which helps people create antibodies to inhibit the immune regulator PD1 has shown promising results in Phase 1 trials and will soon enter Phase 1b, where it is hoped to demonstrate further promise as a cure for lung cancer.
Key to the development of all therapeutics in her pipeline, is a pre-emptive equity raising strategy, Ms Chong says. She takes the opportunity to raise whenever she can.
“You just never know what will happen, so my advice is to raise equity whenever the opportunity arises.
“Companies do not go out of business due to dilution, companies go out of business due to funding,” she said.
Additionally, she pays close attention to the USA’s Food and Drugs Administration (FDA) and says failure to do so is a disservice to any therapeutic developer.
“If you are not conducting a clinical trial under a FDA IND then you are doing a disservice to your technology or assets. Ultimately, this is the body that will license your drug in patients, so it pays to listen to their experience and validation.”
Sharing more insights into her strategy, Ms Chong will form part of an expert panel at the upcoming Bio Connections Australia Conference, hosted by Informa Connect.
The theme of the panel is: “The biotech crystal ball: road-bumps to success”, with panellists to address questions such as:
• If I knew then what I know now – planning for success
• Did your therapy face any unexpected challenges along the way? What would we do differently?
• Challenges vs failures vs learnings
• Would I do anything differently? When emerging? Clinical trial planning? Equity raising? Regulation?
Joining Ms Chong on the stage are Jaime McCoy, General Manager ANZ, Gilead Australia; Hugh Alsop, CEO, Kinoxis Therapeutics Pty Ltd; and Jon Pilcher, CEO, Neuren Pharmaceuticals.
About Leslie Chong
Ms Chong has 24 years of oncology experience in Phase I – III of clinical program development, including leadership role involvement in four marketed oncology products. She was previously Senior Clinical Program Lead at Genentech, Inc., in San Francisco. Genentech is widely regarded as one of the world’s most successful biotech companies with a strong oncology franchise including the best-selling breast cancer drug Herceptin.
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