Existing law provides various programs and funding to prevent and mitigate the impacts of cancer and other diseases in this state. Existing law defines the duties of the Treasurer, which include, but are not limited to, keeping an account of all money received and disbursed.

This bill would establish, upon appropriation by the Legislature, the Novel Allogeneic Adipose Cell-Based Viral Therapies Clinical Trials Grant Program to provide funding for clinical trials of novel allogeneic adipose cell-based viral therapies for cancer treatment. The program would be administered by the Treasurer, who would be required to award competitive grants to health facilities that meet specific requirements, including providing the Treasurer with specific patient safety data. The bill would require the Treasurer to award a significant amount of grant money to clinical trials conducted in low-income communities, traditionally excluded from leading-edge clinical trials. The bill would require the Treasurer to submit a report to the Legislature on the progress of clinical trials funded pursuant to the program, as specified.

This bill would repeal these provisions on January 1, 2031. The bill would make related findings and declarations.

Existing law establishes the California Firefighter Cancer Prevention and Research Program, pursuant to which the Legislature requests the University of California, in consultation with the FIRESCOPE Program, to develop and administer a competitive grant program to award grants to eligible educational institutions to conduct research on the California fire service using a community-based participatory research model in collaboration with California firefighters. Existing law requires research conducted by program grantees to include, but not be limited to, understanding biomarkers of exposure that quantify chemical carcinogens absorbed and metabolized by firefighters and studying biomarkers of effect that quantify cancer-promoting cellular changes that ultimately lead to a cancer diagnosis. Existing law defines eligible institutions and community-based participatory research for purposes of the program.

This bill would make a technical, nonsubstantive change to the provision that defines those terms.

Date of Hearing: May 15, 2024

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Buffy Wicks, Chair

ABPCA Bill Id:AB 2942

Author:(Villapudua) – As Amended Ver:April 25, 2024

Urgency: No State Mandated Local Program: No Reimbursable: No

SUMMARY:

This bill establishes, upon appropriation by the Legislature, the Novel Allogeneic Adipose Cell-Based Viral Therapies Clinical Trials Grant Program (Program) to provide funding for clinical trials of novel allogeneic adipose cell-based viral therapies for cancer treatment. The bill requires the Treasurer to award competitive grants to health facilities that meet specific requirements, and to award a significant amount of grant money to clinical trials in low-income communities.

Specifically, this bill:

1. Establishes the Novel Allogeneic Adipose Cell-Based Viral Therapies Clinical Trials Grant Program for the purpose of providing funding for clinical trials of novel allogeneic adipose cell-based viral therapies for cancer treatment.
2. Requires the Treasurer to award grants on a competitive basis and to establish minimum standards, funding schedules, and procedures for awarding grants.
   
3. Requires the Treasurer to prioritize awarding grants to health facilities with a demonstrated commitment to patient safety and ethical research practices.
   
4. Requires a health facility that applies for a grant to provide to the Treasurer patient safety data on adipose stem cells combined with vaccinia virus and have a proof of concept using allogeneic adipose cell-based viral therapies via a phase 1 safety or clinical trial.
   
5. Requires grants awarded to be used as follows:
   
   1. The first $20,000,000 for phase 1 of a clinical trial.
   2. A significant portion of grant money will be used in trials in low-income communities.
   3. Clinical trials will include wraparound services, which may include transportation, childcare, and paid medical leave.
      
6. Requires the Treasurer to submit, on or before July 1, 2026, or 18 months following future appropriations by the Legislature, a report to the Legislature on the progress of the clinical trials, including the impact on underserved communities and the success of wraparound services.
   
7. Is operative upon an appropriation by the Legislature, and as of January 1, 2031is repealed.
   

FISCAL EFFECT:

The California Health Facilities Financing Authorities reports it would need six staff positions and one medical consultant, at costs of $1.2 million per year (General Fund).

According to the Legislative Analyst’s Office, the General Fund faces a structural deficit in the tens of billions of dollars over the next several fiscal years. 

COMMENTS:

1. Purpose. According to the author:

The American Cancer Society reports that 2 million new cancer cases are expected in 2024 alone and from this approximately 611,720 deaths are anticipated. Typical cancer trials are costly and require patients to repeatedly travel to a central site for assessments, administration of therapies, tests to monitor results, and medications to take at home. These requirements create a selection bias by eliminating many people with little disposable income, few transportation options, inflexible work hours, and family-care obligations. This bill establishes a grant program that will provide the non-invasive novel allogenic adipose cell-based cancer therapies to low-income individuals, people of color and women, who would otherwise go without.

1. Background. Novel allogenic adipose cell-based viral therapies are used in the treatment of several types of cancer, including breast cancer, ovarian cancer, prostate cancer, thyroid cancer, and squamous cell head and neck carcinoma.
2. Budget Request. The author has requested an allocation of $20 million in the state budget for this bill. The request seeks to fund two clinical trials and all wrap-around services for a total of eighty patients.

Analysis Prepared by: Allegra Kim / APPR. / (916) 319-2081

Date of Hearing: April 23, 2024

ASSEMBLY COMMITTEE ON HEALTH

Mia Bonta, Chair

ABPCA Bill Id:AB 2942

Author:(Villapudua) – As Amended Ver:March 21, 2024

SUBJECT: Novel Allogeneic Adipose Cell-Based Viral Therapies Clinical Trials Grant Program.

SUMMARY: Establishes the Novel Allogeneic Adipose Cell-Based Viral Therapies Clinical Trials Grant Program to be administered by the State Treasurer for the purpose of providing funding for clinical trials of novel allogeneic adipose cell-based viral therapies for cancer treatment. Specifically, this bill:

1. Establishes the Novel Allogeneic Adipose Cell-Based Viral Therapies Clinical Trials Grant Program to be administered by the Treasurer.
   
2. Requires the Treasurer to award grants on a competitive basis. Requires the Treasurer establish minimum standards, funding schedules, and procedures for awarding grants.
   
3. Requires the Treasurer to prioritize awarding grants to health facilities with a demonstrated commitment to patient safety and ethical research practices.
   
4. Requires a health facility that applies for a grant to meet both of the following requirements:
   1. Provide to the Treasurer patient safety data on adipose stem cells combined with vaccinia virus; and,
   2. Possess a proof of concept using allogeneic adipose cell-based viral therapies via a phase 1 safety or clinical trial.
      
5. Requires grants to be used pursuant to the following requirements:
   1. Requires the first $20 million of awarded grants to be allocated for phase 1 of a clinical trial;
   2. Requires a significant portion of grant money to be used in clinical trials conducted in low-income communities, traditionally excluded from leading-edge clinical trials;
   3. Requires clinical trials funded by the grant program to include wraparound services for participants from low-income communities;
   4. Allows wraparound services to include transportation, childcare, and paid medical leave; and,
   5. Requires on or before July 1, 2026, or 18 months following future appropriations by the Legislature, the Treasurer to submit a report to the Legislature, in compliance with existing law, on the progress of clinical trials funded pursuant to this article, including the impact on underserved communities and the success of wraparound services.
6. Specifies that this bill is operative upon an appropriation by the Legislature.
   
7. Specifies the provisions of this bill are in effect only until January 1, 2031, and as of that date are repealed.
   
8. Makes related findings and declarations.
   

EXISTING LAW:

1. Requests the University of California (UC) to establish and administer the Breast Cancer Research Program, as a comprehensive grant and contract program to support research efforts into the cause, cure, treatment, earlier detection, and prevention of breast cancer. [Health and Safety Code (HSC) § 104145.
2. Requires State Department of Health Care Services (DHCS) to develop and maintain the Breast and Cervical Cancer Treatment Program to expand and ensure quality breast and cervical cancer treatment for low-income uninsured and underinsured individuals who are diagnosed with breast or cervical cancer. [HSC § 104145]
3. Establishes the Human Leukocyte Antigen Testing Fund within the State Treasury, to be administered by the State Department of Health Services (now administered by DHCS). [HSC § 104170]
4. Establishes the Cancer Research Fund within the State Treasury. Requires moneys in the fund to be made available for expenditure by DHCS, upon appropriation by the Legislature. Requires the fund to consist of money accepted by DHCS from grants and donations from private entities and of public moneys transferred to the fund. [HSC § 104180}
5. Establishes the California Firefighter Cancer Prevention and Research Program, administered by the Department of Public Health to award grants to eligible institutions to conduct research on biomarkers of exposure that quantify chemical carcinogens absorbed and metabolized by firefighters that ultimately lead to a cancer diagnosis. [HSC § 104210.1]
6. Defines the duties of the Treasurer, which include, but are not limited to, keeping an account of all money received and disbursed to and from the Treasury. [Government Code § 12320 – 12334]

FISCAL EFFECT: Unknown. This bill has not yet been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, the American Cancer Society reports that 2 million new cancer cases are expected in 2024 alone and from this approximately 611,720 deaths are anticipated. The author notes that typical cancer trials are costly and require patients to repeatedly travel to a central site for assessments, administration of therapies, tests to monitor results, and medications to take at home. The author states that these requirements create a selection bias by eliminating many people with little disposable income, few transportation options, inflexible work hours, and family-care obligations. The author concludes that this bill establishes a grant program that will provide the non-invasive novel allogenic adipose cell-based cancer therapies to low-income individuals, people of color and women, who would otherwise go without.
2. BACKGROUND.
   1. Novel allogenic adipose cell-based viral therapies. Novel allogenic adipose cell-based viral therapies are used in the treatment of several types of cancer including but not limited to, breast cancer, ovarian cancer, prostate cancer, thyroid cancer, and squamous cell head and neck carcinoma. This treatment is non-invasive and costs significantly less per-dose than radiation and chemotherapy. Calidi Biotherapeutics (Calidi), who supports this bill, manufactures this kind of treatment. Other vendors include Akamis Bio; GCG oncology; Genelux; IconOVir Bio; KaliVir Immunotherapeutic; and, TILT Biotherapeutics. This bill establishes a statutory framework for a grant program to fund clinical trials for this treatment.
      
   2. Barriers to access clinical trials. According to the National Cancer Institute, when it comes to paying for clinical trials, the sponsor of the study and health insurance plans cover many of the costs. Patient costs in clinical trials are costs such as doctor visits, hospital stays, standard cancer treatments, treatments to improve symptoms of cancer or side effects from treatment, lab tests, X-rays and other imaging tests. These costs are often covered by health insurance. Research costs are those related to taking part in the trial. Examples of research costs include the study drug; lab tests performed purely for research purposes; added X-rays and imaging tests performed solely for the trial; and, extra doctor visits that patients would not have with usual care. These costs are often not covered by health insurance, but may be covered by the trial’s sponsors. Before participating in a clinical trial, patients are encouraged to learn about which costs are covered by the study, which costs they or their health plan need to pay. Participants may be asked to pay for treatments and procedures not covered by insurance. The typical trial also requires patients to repeatedly travel to a central site — such as a university hospital — for assessments, administration of therapies, tests to monitor results, and medications to take at home. This often involves several hours per trip as well as paying for transportation, food, child and elder care. These requirements create a selection bias by eliminating many people with little disposable income, few transportation options, inflexible work hours, and family-care obligations.
   3. Racial disparities in clinical trial participation. Given barriers to access clinical trials, these trials are often limited to those who have the resources to afford participating in the trial, leading to disparities in participation for low-income communities of color. A 2020 report from the U.S. Food and Drug Administration showed, 75% of research participants are white, while white people are 60% of the population in the U.S.; 8% of research participants are African-American/Black, while African-American/Black people are 13% of the population in the U.S.; 11% of research participants are Latino/Hispanic, while Latino/Hispanic people are 18% of the population in the U.S.; 6% of research participants are Asian, while Asian Americans are 6% of the population in the U.S.
   4. Importance of diversity in clinical trials. According to Hopkins Medicine, it is critical to advance diversity in clinical trials for the following reasons: i) race, disability and socioeconomic status, and other demographic factors can affect people’s risk of developing certain conditions. It also can impact their responses to medical interventions and their overall health outcomes. The more that participants who take part in clinical research make up a diverse group, the more likely that the research results — and any decisions to start or stop clinical treatments — will apply to a diverse group of patients; and, ii) It is important that research participants represent the people who are most impacted by the disease or condition being studied. For example, certain cancers and sickle cell disease are much more common among people of color, making it crucial that people of color take part in clinical studies of these serious illnesses.

The author contends that the intent of this bill is to increase access to clinical trials for underrepresented populations by providing funding for clinical trials as well as wrap-around services for participants. The bill includes a report back to the legislature on the success of the program.

1. SUPPORT. Calidi writes in support, stating that currently clinical trials in California are almost exclusively funded by consumers, directly out-of-pocket. This does not account for the limited availability of trials in facilities across California and this means that access to clinical trials is severely limited. Calidi continues that this bill establishes a pilot program that when funded would provide two clinical trials and all wrap-around services for 80 total patients for novel allogenic adipose cell-based viral therapies. Calidi notes that without this pilot program this extraordinary treatment remains available only for those who have the economic and geographic resource to locate a trial and pay out-of-pocket. According to Calidi, by including wrap-around services in this bill is the first of its kind, making this treatment obtainable for single mothers, veterans, non-native speakers, and those lacking access to consistent transportation. Calidi concludes that this bill is essential to advancing California’s long-term goal of increasing access to care and innovating through diverse clinical trials.
   
2. PREVIOUS LEGISLATION.
   1. SB 184 (Committee on Budget and Fiscal Review), Chapter 47, Statutes of 2022, i) expands, effective July 1, 2022, the routine patient care coverage requirements for qualifying clinical cancer trials for purposes of the Medi-Cal program, to conform to the federal Medicaid definition of a qualifying clinical trial; ii) requires treatment to be provided in a qualifying clinical trial, which means a clinical trial, in any clinical phase of development, that is conducted in relation to the prevention, detection, or treatment of any serious or life-threatening disease or condition and is described in Section 1396d(gg)(2)(A) of Title 42 of the United States Code; and, iii) implements this section only if federal approvals are obtained, and federal financial participation is available and not otherwise jeopardized.
   2. AB 1810 (Committee on Budget), Chapter 34, Statutes of 2018, eliminates length-of-treatment caps for breast and cervical cancer treatments within the Breast and Cervical Cancer Treatment Program.
3. AMENDMENTS. The author wishes to amend the bill to strike the reference to the report’s July 1, 2026 due date to instead make the report due 18 months following funding for the program upon appropriation by the legislature.

REGISTERED SUPPORT / OPPOSITION:

Support

Calidi Biotherapeutics, Inc.
One individual

Opposition

None on file.

Analysis Prepared by: Eliza Brooks / HEALTH / (916) 319-2097