Kulicke & Soffa Donation Expands Access to Investigational Therapies

EAP program will help patients who don’t qualify for clinical trials

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by Mary Chapman |

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Kulicke & Soffa Industries has announced a multi-year donation that ultimately will increase amyotrophic lateral sclerosis (ALS) patients’ access to potentially life-saving treatments.

The contribution, for which an amount was not specified, will establish and support the multicenter expanded access protocol (EAP) companion program to the HEALEY ALS platform trial (NCT04297683), led by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital (MGH), in Boston.

EAP programs, also known as compassionate use programs, are meant to make specific experimental therapies — those whose benefits are considered to outweigh their potential risks — available outside the clinical trial setting to people whose serious or life-threatening conditions have few or no adequate treatments.

They are aimed at patients who don’t qualify for participation in a clinical trial, and generate data that can be used in treatment development.

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“This generous gift from Kulicke & Soffa will allow the Healey & AMG Center to explore the next generation of ALS therapies and investigational drugs that have promise to slow and perhaps stop the progression of ALS,” Merit Cudkowicz, MD, director of the Sean M. Healey & AMG Center for ALS, said in a press release.

“These funds will make our promising advanced therapies available to many more patients battling this disease,” added Cudkowicz, who also is chief of MGH’s neurology department and HEALEY’s principal investigator and sponsor.

The EAP program also will expand to the Jefferson Weinberg ALS Center to provide ALS patients in Philadelphia, where the center is located, with better access to experimental treatments. The center is a clinical and research-integrated program of the Vickie and Jack Farber Institute for Neuroscience — Jefferson Health.

“We are grateful for the opportunity to expand access to new medications in development for ALS patients,” said Piera Pasinelli, PhD, director of the Jefferson Weinberg ALS Center. “At the Weinberg ALS Center, we provide comprehensive care that puts mission at the core of what we do. Our mission will be strengthened by this donation, which will allow us to work with and hopefully help more patients in the Philadelphia region.”

The donation was inspired by TechVsALS, a charitable organization that raises funds to establish widespread EAP programs for ALS in collaboration with the Healey & AMG Center.

The ongoing Phase 2/3 HEALEY platform trial is a multicenter, multi-regimen study that’s evaluating the safety and efficacy of several potential ALS treatments simultaneously.

The goal is to advance development of the most-promising candidates while lowering related costs. Therapy candidates entering the platform trial are selected by ALS experts and members of the science advisory committee at the Healey & AMG Center for ALS.

In July, it was announced the experimental compound ABBV-CLS-7262, under development by Calico Life Sciences and AbbVie for ALS, likely would become the sixth therapy in the HEALEY study.

Other treatment candidates

Other treatment candidates being tested in the trial include Clene Nanomedicine’s CNM-Au8 (NCT04414345), Biohaven Pharmaceuticals’ verdiperstat (NCT04436510), Prilenia Therapeutic’s pridopidine (NCT04615923), and Seelos Therapeutics’ SLS-005 (NCT05136885),

UCB’s zilucoplan (NCT04436497), another of its regimens, was discontinued in the trial due to a lack of effectiveness following a pre-specified interim analysis.

“Considering our long history of development and ongoing commitment to philanthropy, we are very pleased to have the opportunity to contribute towards this initiative,” said Lester Wong, Kulicke & Soffa’s executive vice president and chief financial officer.

“We anticipate our participation can meaningfully help spur faster pharmacological advancements leading to better treatment options and near-term outcomes for individuals facing ALS,” Wong added.

The overarching goal of the initiative is to improve the life quality of people with ALS.

“Our ultimate goal is to transform the care for ALS patients into an individualized, likely multi-prong approach able to prevent disease progression sufficiently to allow for a dignified life with limited disability,” said Hristelina Ilieva, MD, PhD, clinical director of the Jefferson Weinberg ALS Center.

“This program is a significant step forward to achieve our goal.”

Kulicke & Soffa supplies semiconductor, LED, and electronic assembly solutions to automotive and other markets.