Dr. Samir Khleif has worn many hats throughout his career as an oncologist. He started the US’s first cancer vaccine program in the mid-90s. A few years later, he led the King Hussein Cancer Center in Jordan.
Then, at the Georgia Cancer Center at Augusta University, he began the research that would eventually spin off into his first startup, Georgiamune.
Georgiamune is working to develop new drugs for cancer and autoimmune diseases by targeting biological mechanisms that differ from those discovered so far in traditional oncology and immunotherapy, Dr. Khleif said.
“I saw the opportunity to be able to develop very novel therapeutics out of that,” he said.
The startup landed $75 million in Series A funding in August of 2023, co-led by top VC firm General Catalyst and the Parker Institute for Cancer Immunotherapy. Investors including Mubadala Capital, Alexandria Venture Investments, Catalio Capital Management, CJNV BioVenture, and Verition Fund Management also participated in the round.
The same month, Georgiamune also got FDA clearance to begin human clinical trials for its first cancer drug candidate.
Georgiamune’s primary drug target works to solve a problem posed by another type of cancer drug on the market, called checkpoint inhibitors. Cancerous cells block T cells, a type of white blood cell in the immune system; checkpoint inhibitors work by interrupting this mechanism in cancer that suppresses the immune system. But that treatment is ineffective for the majority of cancer patients, Dr. Khleif said, because while it intends to block the anti-immunity effects of cancer, it doesn’t actively mobilize the immune system against the tumor.
Georgiamune’s first target, called GIM-122, uses a unique biological mechanism to block the inhibitory effects of cancerous cells, while also activating the T cells to be able to fight against the tumor.
The startup has two other drug candidates that it’s working to bring to human clinical trials, including another candidate to treat cancer and one for autoimmune diseases. Khleif said Georgiamune hopes to begin clinical trials for these two candidates later this year.
The market of biotech startups developing cancer drugs is getting crowded, boasting late-stage players like Bicara Therapeutics, which raised a $165 million Series C round in December, as well as new entrants like Clasp Therapeutics, which launched this March with $150 million in Series A funding.
For a Series A biotech startup, Georgiamune has an unusually extensive pipeline, with nine biological targets identified internally, all of which use different mechanisms of action than existing drugs.
It’s also notched a partnership with Alphabet’s research healthcare company Verily. Dr. Khleif said the partnership will allow both companies to work toward the goal of making clinical trials more efficient, giving Georgiamune access to Verily’s research tech and sharing Georgiamune’s data with Verily for continued development of that tech. Former deputy FDA commissioner Amy Abernethy, an oncologist and the chief medical officer at Verily, now sits on Georgiamune’s board of directors.
The partnership looks like an extension of Dr. Khleif’s previous work as special assistant to the FDA commissioner in the late 2000s. In that role, he said, “we tried to revamp the process of drug development and approval to make it shorter and more efficient.”
Now, he’s putting that work to the test to help patients for whom existing treatments aren’t enough.
“It’s an active process of development, and we are targeting an unmet need both in biology and in human diseases,” he said.
“This is why we’re unique.”
Correction: March 26, 2024 — An earlier version of this story misstated the status of Georgiamune’s clinical trials. Georgiamune has begun human clinical trials for its first target, GIM-122.
