FDA approves first cell therapy for a solid tumor.

The U.S. Food and Drug Administration (FDA) made history in February by approving the first cell therapy for any type of solid tumor.

The FDA approved a T-cell therapy called lifileucel to treat unresectable or metastatic melanoma, a skin cancer diagnosed in approximately 100,000 people in the U.S. each year. According to the Melanoma Research Alliance, the 5-year survival rate of metastatic melanoma (stage 4) is approximately 22%.

Lifileucel uses immune cells called tumor-infiltrating lymphocytes, or TILs, that have started attacking the cancer. People with cancer usually have TILs naturally attacking their tumors, but not enough to destroy the disease. These cells also become exhausted and ineffective over time. TIL therapy provides patients more of these cells to help them fight their cancer.

TIL therapies are created by collecting a sample of the patient’s tumor, removing the TILs that are present, multiplying them, and returning the cells to the patient where they continue to infiltrate the cancer in much larger numbers.

The FDA approval is the result of a successful phase 2 clinical trial using lifileucel for people with advanced melanoma. Among 73 people in the study, 23 (31.5%) had at least a partial anti-tumor response and three patients had complete responses (meaning there was no sign of cancer on scans).

Lifileucel is the first TIL therapy approved for cancer. It is manufactured by Iovance Biotherapeutics, Inc., and will be sold under the brand name Amtagvi.

Donor’s journey: The transformational power of education and experience.

Leigh Haskell Perkins III was not your typical 13-year-old girl. While most kids her age were busy with school, friends and hobbies, Leigh had a burning desire to make a difference in the world. Growing up in a family that believed in the power of giving back, she knew from an early age that she wanted to be a difference-maker.

Her journey into the world of charitable giving started 10 years ago when she stumbled upon ACGT. Intrigued by the foundation’s mission to help advance cancer cell and gene therapy research and driven by her passion for science, Leigh decided to donate to the organization.

As the years passed, Leigh’s contributions to ACGT grew, reflecting her unwavering commitment to its work. She devoted time to research and educate herself on different charities, but ACGT always stood out for Leigh. Her decision was backed by meticulous research and ratings from the Better Business Bureau, which confirmed the organization’s credibility.

Her faith in ACGT was rewarded with the knowledge that her donations were being utilized in the most impactful way. The organization’s dedication to vetting grant applications and supporting the best and brightest ideas in the field of cancer cell and gene therapy fill Leigh with a sense of pride.

“It’s not just about donating money,” says Leigh, now 23 years old and a 10-year donor to ACGT. “It’s about knowing that your contribution is making a real impact, and ACGT ensures that by involving renowned experts on the ACGT Scientific Advisory Council.”

Leigh’s donations to ACGT have now reached a 10-year milestone of continuous support, a testament to her commitment and compassion. Her journey from a young girl with a desire to help to becoming a savvy donor exemplifies the transformational power of education and experience – proving how a small act of generosity can lead to a world of change.

How cell and gene therapy is different than standard cancer treatments.

Established approaches for treating cancer include removing it with surgery, burning it with radiation or poisoning it with chemotherapy — all of which can come with side effects that potentially cripple a person’s quality of life. Cell and gene therapies are transforming how cancer is treated, especially in blood cancers.

Unlike standard treatments, cell and gene therapies can harness the power of the immune system to destroy cancer cells without harming healthy tissue. These therapies are often given only once to patients – rather than multiple times over months – and avoid the challenging side effects cancer patients face when undergoing surgery, chemotherapy or radiation.

ACGT Research Fellow and Scientific Advisory Council member Carl June, MD (University of Pennsylvania), further explains the differences between cell and gene therapy and standard treatments, plus how funding from ACGT supports cell and gene therapy researchers.

Donor-advised funds maximize charitable tax deductions – any time of the year.

Giving through a donor-advised fund (DAF) empowers donors to engage in strategic philanthropic planning.

DAFs are simple, flexible and tax-efficient investment accounts established by individuals to benefit causes they care about (IRS-qualified public charities). DAFs can be set up with most brokerages by donating cash, securities or other assets. Gifts typically are fully tax-deductible.

With the new calendar year unfolding, making a gift to ACGT from your DAF presents numerous advantages while also helping to ensure that ACGT has the necessary resources to propel groundbreaking research initiatives in the months ahead. It also helps with ACGT’s final push before our fiscal year ends on April 30 and new fiscal year begins on May 1. Giving via your DAF provides unparalleled flexibility, allowing you to support ACGT at any time and as frequently as desired throughout the year.

As you embark on your philanthropic journey in 2024, consider the transformative impact of supporting ACGT through a donor-advised fund – both now and year-round. To designate Alliance for Cancer Gene Therapy as a beneficiary, use tax ID number is 06-1619523.  

In the news

The latest from around the cancer cell and gene therapy research world.

Astellas is pursuing “convertible” in-vivo CAR T-cell therapies with Kelonia Therapeutics.

BioNTech, Autolus strike a wide-ranging licensing and manufacturing deal for CAR T-cell therapies.

ACGT Scientific Advisory Council member and Research Fellow, Crystal Mackall, MD, featured in new Parker Institute podcast “From the Origins of Immunotherapy to Curing Pediatric Cancers”.

The Journal for Immunotherapy for Cancer announces its new Editor-In-Chief, Michael T. Lotze, MD, Chair of the ACGT Scientific Advisory Council.