XyloCor Therapeutics’ XC001 (AdVEGFXC1), an investigational 

 intended to treat refractory angina, has demonstrated promising safety and efficacy in newly announced data from the phase 2 portion of the phase 1/2 EXACT clinical trial (NCT04125732).

 muscle via a transthoracic epicardial procedure as a 1-time treatment. It is intended to increase the expression of vascular endothelial growth factor (VEGF) in order to induce the creation of new blood vessels, which is expected to reduce ischemic burden. The phase 2 portion of EXACT treated 28 patients. At 6 months of follow-up, decreases in ischemic burden on cardiac positron emission tomography (PET) imaging were observed in the patients. It was additionally noted that prior to administration of the therapy, almost all of the participants' physical activity was substantially limited, while nearly half of the participants were able to engage in normal physical activity without angina at 6 months post-treatment. In terms of safety, there were no unexpected serious adverse events (AEs) observed in relation to the therapy’s administration, and no safety issues related to the therapy were reported.

"We are excited to see EXACT completing its 6-month endpoint,” Thomas Povsic, MD, PhD, professor of Medicine, Duke University School of Medicine, and national principal investigator for the EXACT study, said in a statement regarding the news.

 “The trial met all of its safety and exploratory objectives, showing intriguing benefits in these needy patients across a variety of objective and subjective measures. The strong range of mechanistic evidence demonstrate that administration of XC001 is a scientifically-sound approach for achieving a biological effect that has the potential to improve patients’ quality of life."

The phase 2 data builds on the results of the trial’s phase 1 portion, data from which were announced in May 2022.

 Among 7 of the 12 patients treated in the first phase, there were 17 serious AEs reported by 6 months of follow-up, but none were deemed related to the gene therapy. These AEs included 6 events deemed related to the administration procedure for XC001 and 11 events deemed related to the underlying disease or other causes. The 6 administration-related AEs occurred in 4 patients and were not considered to be unexpected.

The multicenter, open-label EXACT study enrolled 41 participants in total, with an age eligibility of 18 years to 80 years. The phase 1, dose-escalation portion treated participants at 4 ascending dose levels, with 3 participants in each dose cohort: 1x10

 vp. A dose-dependent correlation was inferred based on a preliminary efficacy data analysis, and as such, the highest of the dose levels was selected for the study’s phase 2 expansion portion. The trial’s primary end point is safety as assessed by AEs and serious AEs. Secondary end points include an exercise tolerance test, the Seattle Angina Questionnaire, Canadian Cardiovascular Society angina class, and angina episodes.

"We are excited to share this positive topline data from the phase 2 portion of the EXACT trial, reinforcing our confidence in XC001 as a novel therapeutic approach with the potential to address the significant unmet medical needs of people with refractory angina," Al Gianchetti, president and chief executive officer, XyloCor Therapeutics, added to the statement.

 "We now look forward to pursuing key upcoming milestones in XC001’s continued development, including finalizing our pivotal trial design through our ongoing discussions with the FDA and other regulatory authorities."

1. Xylocor Therapeutics reports positive topline safety and efficacy results from phase 2 EXACT clinical trial of XC001 novel gene therapy for refractory angina. News release. XyloCor Therapeutics. January 26, 2023. Accessed January 26, 2023. 

http://www.xylocor.com/news.html#:~:text=XyloCor%20Therapeutics%20Reports%20Positive%20Topline%20Safety%20and%20Efficacy%20Results%20from%20Phase%C2%A02%20EXACT%20Clinical%20Trial%20of%20XC001%20Novel%20Gene%20Therapy%20for%20Refractory%C2%A0Angina

2. Xylocor Therapeutics announces presentation of preliminary clinical data from phase 1 portion of the EXACT phase 1/2 study of XC001 novel gene therapy for refractory angina at AATS and ASGCT. News release. XyloCor Therapeutics. May 18, 2022. Accessed January 26, 2023. 

http://www.xylocor.com/news.html#:~:text=XyloCor%20Therapeutics%20Announces%20Presentation%20of%20Preliminary%20Clinical%20Data%20from%20Phase%C2%A01%20Portion%20of%20the%20EXACT%20Phase%C2%A01/2%20Study%20of%20XC001%20Novel%20Gene%20Therapy%20for%20Refractory%20Angina%20at%20AATS%20and%C2%A0ASGCT

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Nearly half of participants were able to engage in normal physical activity without angina at 6 months post-treatment.

Refractory Angina Gene Therapy Demonstrates Safety and Efficacy in Phase 2 Trial 

The phase 1/2 TRANSCEND CLL 004 trial (NCT03331198) of

(Breyanzi; Bristol Myers Squibb) met its primary endpoint of achieving complete responses (CRs) compared to historical control in the prespecified subset of patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor, according to topline results from the study announced today.

“CLL is an incurable disease with complex biology and immune dysregulation that has made the development of T cell-based therapies that provide deep remission very challenging,” Anne Kerber, senior vice president and head, Cell Therapy Development, Bristol Myers Squibb (BMS), said in a statement.

 “In a population that has limited options, the TRANSCEND CLL 004 study represents the first multicenter trial evaluating a CAR T cell therapy in heavily pre-treated patients with relapsed or refractory CLL or SLL, with results showing the potential of Breyanzi as a personalized one-time treatment approach for patients with this difficult-to-treat disease.”

The multicenter, open-label, single-arm TRANSCEND CLL 004 study is evaluating Breyanzi, a CD19-targted chimeric antigen receptor (CAR) T-cell therapy, in patients with R/R CLL or small lymphocytic lymphoma. The trial started off with a phase 1 portion which evaluated safety and determined the phase 2 recommended dose while the phase 2 portion is currently evaluating efficacy of this dose. The phase 2 portion met its primary endpoint of CR rate including CR with incomplete bone marrow recovery, based on independent review committee according to the International Workshop on Chronic Lymphocytic Leukemia 2018 guidelines. More detailed data from TRANSCENNE CLL 004 will be presented at an upcoming medical meeting and BMS will discuss these results with regulatory agencies.

 for patients with large B-cell lymphomas (LBCL) that relapsed or were refractory within 12 months of first-line treatment who are not eligible for hematopoietic stem cell transplant in June 2022.The therapy was original approved in February 2021 for adults with relapsed or refractory diffuse LBCL who have not responded to at least 2 other treatments based off data from the pivotal phase 3 TRANSFORM (NCT03575351) trial.

 It is also approved in Europe, Switzerland, Canada and Japan for R/R LBCL 2 or more lines of systemic therapy and is currently being evaluated in earlier lines of treatment of LBCL and other types of lymphoma and leukemias.

Advocating for Patients With Chronic Lymphocytic Leukemia

BMS also recently announced results from the phase 3 TRANSFORM study (NCT03575351) that demonstrated 

 (SOC) chemotherapy induction and autologous stem cell transplant (ASCT) in second-line treatment of high-risk, R/R LBCL. Second-line liso-cel was found to reduce the risk of an event occurring by 64.4% compared with SOC chemoimmunotherapy induction and ASCT.

 The median event-free survival (EFS) was not yet reached with liso-cel compared with 2.4 months for SOC (HR, 0.356; 95% CI, 0.243-0.522) after a median follow-up of 17.5 months in the open-label study. The 18-month EFS rate was 52.6% with liso-cel (95% CI, 42.3%-62.9%) vs 20.8% with SOC (95% CI, 12.2%-29.5%).

“The primary analysis of the TRANSFORM study confirms the superiority of liso-cel over SOC. Liso-cel resulted in significant improvements in event-free survival, complete response rates, and progression-free survival, with 18-month event-free and progression-free survival rates for liso-cel more than double those of standard of care,” lead study author Jeremy S. Abramson, MD, from the Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, said in a statement.

 “Despite allowing for crossover, overall survival numerically favored liso-cel and a supportive overall survival adjusting for crossover showed an overall survival benefit in favor of liso-cel."


1. Bristol Myers Squibb announces TRANSCEND CLL 004 trial of Breyanzi® (lisocabtagenemaraleucel) met primary endpoint of complete response rate in patients with relapsed or refractory chronic lymphocytic leukemia. News release. Bristol Myers Squibb. January 25, 2023. 

https://www.businesswire.com/news/home/20230125005878/en/Bristol-Myers-Squibb-Announces-TRANSCEND-CLL-004-Trial-of-Breyanzi%C2%AE-lisocabtagene-maraleucel-Met-Primary-Endpoint-of-Complete-Response-Rate-in-Patients-with-Relapsed-or-Refractory-Chronic-Lymphocytic-Leukemia


2. U.S. FDA Approves Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi® for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy. News release. Bristol Myers Squibb. June 24, 2022. 

https://news.bms.com/news/details/2022/U.S.-FDA-Approves-Bristol-Myers-Squibbs-CAR-T-Cell-Therapy-Breyanzifor-Relapsed-or-Refractory-Large-B-cell-Lymphoma-After-One-Prior-Therapy/default.aspx


3. FDA Approves New Treatment For Adults With Relapsed Or Refractory Large-B-Cell Lymphoma. News release. FDA. February 5, 2021. 

https://www.prnewswire.com/news-releases/fda-approves-new-treatment-for-adults-with-relapsed-or-refractory-large-b-cell-lymphoma-301223275.html


4. Abramson JS, Solomon SR, Arnason JE, et al. Lisocabtagenemaraleucel (liso-cel) versus standard of care (soc) with salvage chemotherapy followed by autologous stem cell transplantation (asct) as second-line (2L) treatment in patients with relapsed or refractory large B-cell lymphoma (LBCL): primary analysis of the randomized, phase 3 Transform study. 

. 2022;140(suppl 1):1581-1583. doi:10.1182/blood-2022-159702

Breyanzi is currently approved for the second-line or later treatment of large B-cell lymphomas. 

New Data Supports Breyanzi’s Expansion to Chronic Lymphocytic Leukemia 

Capricor Therapeutics’ CAP-1002, an investigational allogeneic cardiosphere-derived cell therapy intended to treat 

, has demonstrated efficacy in updated 18-month data from the HOPE-2 clinical trial (NCT03406780)’s open-label extension (OLE) study (HOPE-2-OLE; NCT04428476).

HOPE-2-OLE enrolled 13 of the 20 patients who had previously participated in HOPE-2, 6 of whom had received CAP-1002 in HOPE-2 and 7 of whom had received a placebo. Twelve of these 13 patients completed 18 months of follow-up after treatment with CAP-1002 in HOPE-2-OLE. Capricor Therapeutics reported that at the 18-month follow-up, the patients demonstrated statistically significant (

 = 0.02) improvements on the Performance of the Upper Limb (PUL version 2.0) scale compared to the placebo group from HOPE-2. Patients who received CAP-1002 in HOPE-2-OLE also demonstrated attenuation of disease progression, regardless of whether they had participated in the treatment group or the placebo group in HOPE-2. During the OLE, CAP-1002 was well-tolerated with a consistent safety profile.

The new data from HOPE-2-OLE builds on the positive data from HOPE-2, including PUL, cardiac MRI assessments, and left ventricular ejection fraction (LVEF) findings. Patients who received CAP-1002 had a favorable mean 2.6-point improvement difference from baseline on the PUL 1.2 mid-level dimension compared to the patients who received placebo (

 = 0.014), improvements in heart structure and function on cardiac MRI assessments, and an increase in LVEF indicating slowing of cardiac disease progression by 107% (

 = 0.002). HOPE-2 included pediatric and young adult male patients with DMD who are non-ambulant. The patients received infusions of either CAP-1002 or the placebo every 3 months, with the data analyzed at 12 months after the first infusion. In terms of safety, it was noted that 3 patients in HOPE-2 experienced infusion-related hypersensitivity reactions without long-term sequelae and 1 patient discontinued participation in relation to a severe allergic rection

“DMD is a progressive disease associated with loss of function over time and there is a critical need for treatment options to slow the rate of decline and preserve upper limb function to enable key everyday activities,” Craig McDonald, national principal investigator and University of California, Davis, professor and Department of Physical Medicine and Rehabilitation chair, said in a statement regarding the news.

 “We are encouraged by the improvements in upper limb function in the treatment group at 18-months and will continue to treat and follow these patients to further evaluate the disease modifying potential of CAP-1002. Taken together, these data build on the impressive results from HOPE-2 and suggest that patients accumulate benefit over time with steady preservation of skeletal muscle functions, which underscore the potential long-term benefit of CAP-1002.”

The participants in HOPE-2-OLE began treatment between 239 and 567 days (mean, 392) after ending treatment with CAP-1002 or the placebo in HOPE-2. In HOPE-2-OLE, the participants received infusions of 150 million CAP-1002 cells every 3 months for 18 months. The trial’s primary end points are the incidence and severity of all treatment-emergent adverse events (TEAEs) at 12 months and the mean change from baseline in upper limb function according to PUL 2.0 at 12 months. Secondary end points include the incidence and severity of all TEAEs at 24 and 36 months; the change from baseline in PUL at 24 and 36 months; the change from baseline in distal-level PUL at 12, 24, and 36 months; the change from baseline in mid-level PUL at 12, 24, and 36 months; and the mean change from baseline in LVEF at 24 and 36 months.

CAP-1002 is now also being evaluated in the phase 3 HOPE-3 clinical trial (NCT05126758). The randomized, double-blind, placebo-controlled study is currently enrolling, with an expected total enrollment of approximately 70 patients. In July 2022, 

“In the OLE phase of the HOPE-2 study, we observed statistically significant slowing of the progression of disease across patients treated with CAP-1002,” Linda Marbán, PhD, chief executive officer, Capricor, added to the statement.

 “We are extremely pleased by the robust and consistent results observed to date, which, together with the favorable safety/tolerability profile, suggest that CAP-1002 holds promise as a potential anchor therapy for DMD patients. Further, the long-term efficacy and potential disease modification effect will augment our clinical package as we continue on our regulatory pathway towards potential approval of CAP-1002 for treatment of patients with DMD. We thank the patients, their families, caregivers, and the broader Duchenne community for working with us on this promising therapy.”

1. Capricor Therapeutics announces positive 18-month results from ongoing HOPE-2 open label extension study of CAP-1002 in Duchenne muscular dystrophy patients. News release. Capricor Therapeutics. January 25, 2023. Accessed January 25, 2023. 

https://feeds.issuerdirect.com/news-release.html?newsid=7181150467767720

2. McDonald CM, Marbán E, Hendrix S, et al. Repeated intravenous cardiosphere-derived cell therapy in late-stage Duchenne muscular dystrophy (HOPE-2): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. The Lancet. 2022;399(10329):1049-1058. Doi: 10.1016/S0140-6736(22)00012-5

3. Capricor Therapeutics announces first patient dosed in pivotal phase 3 study of CAP-1002 for the treatment of Duchenne muscular dystrophy. News release. Capricor Therapeutics. July 19, 2022. Accessed January 25, 2023. 

https://feeds.issuerdirect.com/news-release.html?newsid=7011515935297837

Patients continued to show statistically significant upper limb performance improvements. 

DMD Cell Therapy Continues to Demonstrate Efficacy After 18-month Follow-up 

Iovance Biotherapeutics’ tumor infiltrating lymphocyte (TIL) therapy 

 is creeping closer to clinic for treating both advanced melanoma and metastatic non-small cell lung cancer, according to a recent update from the company.

After discussions with the FDA in the fourth quarter of 2022, Iovance announced the phase 3, confirmatory, TILVANCE-301 study that will investigate lifileucel in combination with pembrolizumab in 670 randomized patients with frontline advanced melanoma compared to pembrolizumab monotherapy. The study’s primary endpoints of objective response rate (ORR) and progression free survival will be used to support approval of the therapy’s biologics license application (BLA) in both frontline advanced melanoma and post-anti-PD-1 therapy advanced melanoma

After initiating in August 2022, Iovance had previously expected to complete the rolling BLA submission for lifileucel for unresectable or metastatic melanoma that progressed on or after prior anti-PD-1/L1 therapy, and if BRAF mutation positive, also prior BRAF or BRAF/MEK inhibitor therapy, by the end of 2022, however, this was 

, and remains on track for, the first quarter of 2023.

 The delay came after the FDA requested supplemental validation information and comparability data for the therapy.

“We continue to make substantial progress with our ongoing BLA submission and remain close to the finish line. The FDA has provided recent valuable feedback to the IND application and remains supportive during the rolling BLA submission process. Iovance is fully committed to securing FDA approval as soon as possible to deliver the first individualized, 1-time cell therapy for advanced melanoma patients, who have a significant unmet medical need,” Frederick Vogt, PhD, JD, interim president and chief executive officer, Iovance, said in a statement.

Amod Sarnaik, MD, on Lifileucel’s Place in the Treatment Lanscape for Advanced Melanoma

In the frontline advanced melanoma indication, Iovance announced positive data on lifileucel in combination with pembrolizumab from 20 participants treated in cohort 1A of the IOV-COM-202 phase 2 trial (NCT03645928).

 The data were consistent with that previously reported, with robust and durable ORRS. More detailed data will be shared later in 2023. 

Iovance also shared data from cohort 3A of patients with non-small cell lung cancer (NSCLC) of the IOV-COM-202 trial, including an ORR of 47% (n =8) in treated patients, with responses observed regardless of PD-L1 status. The study is continuing to enroll,and safety findings have been consistent with  findings of Iovance’s other TIL therapy/pembrolizumab combinations.

In this cohort, response rates were highest in patients who had treatment-naïve disease (80% ORR; n = 4) or post-chemotherapy anti-PD-1-naïve disease (43% ORR; n = 3) and lower in patients with EGFR-mutant disease after prior treatment with tyrosine kinase inhibitors (TKI; 20% ORR; n = 1). Two patients, 1 with post-chemotherapy anti-PD-1 naïve disease and 1 with EGFR-mutant disease after prior treatment with TKI, achieved complete responses and remain in the study. More data will be presented at future medical meetings.

The results and sub analyses will inform a future registration trial of lifileucelin patients with NSCLC, which Iovance plans to meet with the FDA about in 2023. Iovance plans to propose a registration trial in patients with frontline, advanced, EGFR wild-type NSCLC that will be a frontline maintenance study of standard-of-care pembrolizumab and limited duration chemotherapy followed by lifileucel and pembrolizumab combination therapy compared with pembrolizumab monotherapy in responding patients.

1. Iovance Biotherapeutics provides corporate, clinical, and regulatory updates.News release. Iovance Biotherapeutics. January 23, 2023. 

https://finance.yahoo.com/news/iovance-biotherapeutics-provides-corporate-clinical-130000862.html


2. Iovance Biotherapeutics provides update on biologics license application submission for lifileucel in advanced melanoma. News release. Iovance Biotherapeutics. November 18, 2022. https://finance.yahoo.com/news/iovance-biotherapeutics-provides-biologics-license-113000414.html


Iovance is on track to complete its rolling BLA submission for lifileucel in the post-anti-PD1 melanoma indication in the first quarter of 2023. 

Lifileucel Creeps Closer to Clinic for Melanoma, NSCLC 

The cell and gene therapy sectors are growing exponentially, with new players emerging daily and much progress being made both in and out of the lab. 

Around the Helix is your chance to catch up with the latest news in cell and gene therapies, including partnerships, pipeline updates, and more.

1. 10 Cell and Gene Therapies to Watch in 2023

With several Prescription Drug User Fee Act dates already on the calendar and a host of biologics license applications on the horizon, there are 10 therapies we’ll have our eyes on in 2023.

2. Editas Sells off iNK Preclinical Cell Therapy Program, Gene-Editing Technologies to Shoreline

Shoreline Biosciences’ is acquiring Editas Medicines’ cell therapy programs, including its induced pluripotent stem cell derived natural killer cell (iNK) preclinical programs, and licensing its SLEEK (SeLection by Essential-gene Exon Knock-in) and AsCas12a gene editing technologies for oncologic and other indications.

3. Late-Onset Pompe Disease Gene Therapy Cleared to Continue Trial

The FDA has lifted the clinical hold on Astellas Pharma’s phase 1/2 FORTIS trial (NCT04174105) of AT845 in patients with late-onset Pompe disease (LOPD). Astellas is working to resume dosing in the trial.

4. Rett Syndrome Gene Therapy Cleared for Clinical Trial

The FDA has cleared Neurogene’s investigational new drug application of NGN-401 and the company is planning to initiate a phase 1/2 clinical trial to evaluate intracerebroventricular (ICV) injection of the gene therapy in girls with Rett syndrome in 2023.

5. Catalent Announces New Case Management Service for Cell and Gene Therapy Supply Chains

The service will assign customers a case manager who serves as a point of contact for the entire process of supply, manufacture, and delivery.

6. Regen BioPharma Files Patent Application for Method of Stimulating Immune Response to Cancer

The use of survivin-engineered dendritic cells and exosomes to stimulate anti-cancer immunity is the focus of the provisional patent application.

7. Cellectis Makes Changes to Terms of $20 Million Convertible Note Issued by Cytovia Therapeutics

The note was originally issued in relation to the research collaboration and non-exclusive license agreement between the 2 companies.

8. University of Virginia Announces Plans to Launch Paul and Dian Manning Institute of Biotechnology

The institute, which will be launched with the assistance of a $100 million gift, will conduct research and provide care related to advanced medicines, including cell and gene therapies.

9. Medigene Gets $20 Million Milestone Payment from 2seventy bio 

The payment relates to a MAGE-A4 cell therapy 2seventy bio is developing  in a collaboration with JW Therapeutics that uses a T-cell receptor discovered with Medigene's technology platform.

10. bluebird bio to Put Proceeds from Public Stock Offering Towards ZYNTEGLO and SKYSONA

The net proceeds from the $120 million public offering of common stock will be used in part to fund commercialization and manufacturing activities related to the 2 approved gene therapies.

11. 4D Molecular Therapeutics Pauses Enrollment in Fabry Disease Clinical Trials

Cases of atypical hemolytic uremic syndrome occurred in some patients treated with 4D-310. The company announced intention to use a different immune inhibition regimen in any potential future studies of the gene therapy.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies. 

Around the Helix: Cell and Gene Therapy Company Updates – January 25, 2023

The FDA has cleared ImmPACT Bio’s investigational new drug application (IND) of its 

chimeric antigen receptor (CAR) T-cell therapy IMPT-314 to be evaluated for safety and preliminary efficacy in a phase 1/2 clinical trial expected to launch in early 2023 in patients with aggressive B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL).

"This IND clearance is a significant milestone for our company," Sumant Ramachandra, MD, PhD, president and chief executive officer, ImmPACT Bio, said in a statement.

 "Results from an investigator-led study evaluating this CAR T-cell therapy demonstrated that 70% of patients achieved a complete response with significant durability of remission. These initial efficacy results combined with the favorable safety profile show that IMPT-314 could potentially be a best-in-class treatment for patients with B-cell lymphomas. We look forward to initiating this phase 1/2 trial to help cancer patients who need new therapies."

IMPT-314 is a CD19/CD20-targeted bispecific "OR-Gate" autologous CAR T-cell therapy based off pioneering work by Yvonne Chen, PhD, associate professor, University of California, Los Angeles (UCLA). The bispecific CAR has demonstrated clinically meaningful results in an ongoing investigator-led phase 1 study at UCLA (NCT04007029) in 10 participants with non-Hodgkin lymphoma (NHL), aggressive B-cell lymphoma, DLBCL, non-indolent or refractory follicular lymphoma (FL), and mantle cell lymphoma (MCL).

 Investigators found that treated participants had a 90% overall response rate and a 70% durable complete response rate. No patients experienced neurotoxicity and cytokine release syndromewas limited to grade 1. The median progression-free survival is 18.2 months with median follow-up time of over 20 months. The study is continuing to enroll patients.

Marty Giedlin, PhD, on Advantages of Allogeneic NK Cell Therapy Approaches

"Dr. Chen designed this bispecific CAR to address antigen escape, which is a key challenge for current approved CD19 therapies for hematological malignancies," principal investigator of the UCLA study Sarah Larson, MD, associate clinical professor of medicine, UCLA, added to the statement.

 "We tested this anti-CD19/CD20 CAR-T cell therapy in patients with relapsed or refractory NHL and are encouraged about the potential of this therapy for patients."

ImmPACT Bio is also developing 2 other platform logic-gated CAR technologies for solid tumor indications. These are a “not”-gated, iCAR-targeted therapy for lung cancer in IND-enabling studies and another “or”-gated, transforming growth factor beta-targeted therapy for glioblastoma multiforme currently in preclinical studies.

1. ImmPACT Bio announces FDA clearance of IND for novel bispecific CAR to treat aggressive B-cell lymphoma. News release. ImmPACT Bio. January 24, 2023. 

https://www.prnewswire.com/news-releases/immpact-bio-announces-fda-clearance-of-ind-for-novel-bispecific-car-to-treat-aggressive-b-cell-lymphoma-301728582.html


2. Larson SM, Walthers CM, Ji B, et al. CD19/CD20 bispecific chimeric antigen receptor (CAR) in naïve/memory T Cells for the treatment of relapsed or refractory non-Hodgkin lymphoma. 

 Published online November 21, 2022. doi: 10.1158/2159-8290.CD-22-0964

The CD19/CD20 dual-targeted CAR is currently under investigation in an investigator-initiated study in UCLA. 