On August 24, 2022 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the European Commission (EC) has granted conditional marketing authorisation (CMA) of TECVAYLI▼ (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) (Press release, Johnson & Johnson, AUG 24, 2022, View Source [SID1234618675]). Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.1 Today’s milestone marks the first approval worldwide for teclistamab, a first-in-class bispecific antibody that redirects CD3-positive T-cells to B-cell maturation antigen (BCMA)-expressing myeloma cells to induce the killing of tumour cells.1

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Multiple myeloma remains an incurable blood cancer, with nearly all patients relapsing and requiring subsequent therapy.2,3 As the disease progresses, relapses for patients become more aggressive with each new line of therapy, and remissions become progressively shorter.4

"Despite important scientific progress, patients who develop relapsed and refractory disease after having been exposed to the three major drug classes have limited therapeutic options and generally face poor outcomes," said Maria-Victoria Mateos, M.D., Ph.D., Consultant Physician in Haematology, University Hospital of Salamanca.* "Teclistamab has the potential to provide substantial clinical benefit and new hope to these patients, with high rates of deep and durable responses, and the added convenience of being off-the-shelf."

"The approval of teclistamab followed an accelerated approval pathway, supported via the EMA’s PRIME scheme," said Edmond Chan, MBChB M.D. (Res), Senior Director EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. "We would like to thank the medical community for recognising the promise of teclistamab. Multiple myeloma is a complex disease that requires a complex set of solutions. Only by working together can we ensure that patients are able to benefit from innovation, such as teclistamab, as early as possible."

CMA is the approval of a medicine that addresses unmet medical needs of patients based on less comprehensive data than normally required, where the benefit of immediate availability of the medicine outweighs the risk, and the applicant is able to provide comprehensive clinical data in the future.5

The CMA was supported by positive results from the multicohort, open-label Phase 1/2 MajesTEC-1 study (NCT03145181 and NCT04557098), evaluating the safety and efficacy of teclistamab in adults with RRMM (n =165).1,6,7 Patients received a weekly subcutaneous injection of teclistamab at a dose of 1.5 mg/kg, after receiving step-up doses of 0.06 mg/kg and 0.3 mg/kg.1 In the study, 104 out of 165 patients achieved an overall response rate (ORR) of 63 percent (95 percent Confidence Interval [CI]; range, 55.2–70.4) after a median of five prior lines of therapy.1 Notably, 58.8 percent of patients receiving teclistamab achieved a very good partial response (VGPR) or better and 39.4 percent achieved a complete response (CR) or better.1 The median time to the first confirmed response was 1.2 months (range, 0.2–5.5 months) and the median duration of response was 18.4 months (95 percent CI; range, 14.9–not estimable).1

Results from the MajesTEC-1 study were also published in The New England Journal of Medicine and showed that treatment with teclistamab resulted in deep and durable responses.8 The median duration of progression-free survival was 11.3 months (95 percent CI; range, 8.8–17.1) and the median duration of overall survival was 18.3 months (95 percent CI; range, 15.1–not estimable).8

Adverse events (AEs) were consistent with this patient population. The most common AEs were cytokine release syndrome (72 percent; 0.6 percent Grade 3, no Grade 4), neutropenia (71 percent; 64 percent Grade 3 or 4) and anaemia (55 percent; 37 percent Grade 3 or 4).1 Infections were frequent with the most common being upper respiratory tract infections (37 percent; 2.4 percent Grade 3 or 4) and pneumonia (28 percent; 19 percent Grade 3 or 4).1 Hypogammaglobinaemia occurred in 123 patients (75 percent) and 39 percent of patients received intravenous or subcutaneous immunoglobulin therapy.1 Neurotoxic events were low grade (15 percent; 14 percent Grade 1 or 2) and five patients (three percent) had immune effector cell-associated neurotoxicity syndrome.1

"With nearly 20 years of dedicated leadership in this area, our ambition to advance the best science to deliver novel therapies and regimens for the treatment of multiple myeloma is as strong today as it has ever been. We now look forward to collaborating with health authorities worldwide to make this treatment available to patients," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC.

"This first approval for teclistamab worldwide marks significant progress for patients with relapsed and refractory multiple myeloma," said William N. Hait, M.D., Ph.D., Executive Vice President, Chief External Innovation, Medical Safety and Global Public Health Officer, Johnson & Johnson. "Teclistamab is an important addition to our multiple myeloma portfolio. We are continuing to invest in clinical development to expand its potential and offer novel options for patients and physicians."

#ENDS#

About Teclistamab

Teclistamab is a first-in-class, off-the-shelf (ready to use) bispecific antibody.1 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight the cancer.1

The application for conditional marketing authorisation was reviewed by the Committee for Medicinal Products for Human Use (CHMP) under an accelerated timetable to enable faster patient access to this medicine.9 This was also supported though the European Medicines Agency’s (EMA) PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients’ unmet medical needs.10

Teclistamab is currently being evaluated in several monotherapy and combination studies.7,11,12,13,14

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.15 In multiple myeloma, cancerous plasma cells change and grow out of control.15 In Europe, more than 50,900 people were diagnosed with multiple myeloma in 2020, and more than 32,400 patients died.16 While some patients with multiple myeloma initially have no symptoms, others can have common symptoms of the disease which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels or kidney failure.17

On August 24, 2022 EDAP TMS SA (Nasdaq: EDAP) (the "Company"), a global leader in robotic energy-based therapies, reported that unaudited financial results for the second quarter 2022 (Press release, EDAP TMS, AUG 24, 2022, View Source [SID1234618666]).

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Marc Oczachowski, EDAP’s Chairman and Chief Executive Officer, said: "For the second quarter 2022, we generated strong year-over-year revenue growth of nearly 37% driven by contribution from all three business segments, including our core HIFU business, which grew nearly 50% over the prior year period. The measured investments that we continue to make in our US team and infrastructure continue to bear fruit as HIFU, and specifically Focal One, becomes integral to the modern prostate cancer treatment paradigm."

"Our pipeline of sales prospects continues to grow, driven by a combination of new world-renowned healthcare institutions that have adopted Focal One, and champion this technology, and our growing presence at important medical meetings such as the annual meeting of the American Urological Association this past May. These trends, together with the proposed increase in reimbursement for CY23 indicated in the preliminary CMS Outpatient Prospective Payment System (OPPS) rule, give me great optimism for the future adoption of our Focal One platform." Mr. Oczachowski concluded.

Ryan Rhodes, Chief Executive Officer of EDAP US, stated, "Following the close of the second quarter, we learned that the Centers for Medicare and Medicaid Services, in its proposed OPPS rule for calendar year 2023, raised Focal One HIFU reimbursement to APC Level 6 from Level 5 currently. It is difficult to overstate the positive impact such a change would have on expanding patient procedure access should the increase stand in the final rule, which we expect to be published in November. We are very pleased with this proposed increase to hospital reimbursement and believe it more accurately reflects the significant clinical value that HIFU brings to the urology suite."

"We also will be hosting an in-person Focal One Expert User Panel Event in New York City in September, to coincide with Prostate Cancer Awareness Month. The event will feature presentations from several renowned thought leaders and will also include a demonstration of the Focal One procedure."

Year-to-Date Results

Total revenue for the six months ended June 30, 2022, was EUR 27.1 million (USD 29.5 million), an increase of 31.5% from total revenue of was EUR 20.7 million (USD 24.8 million) for the same period in 2021.

Total revenue in the HIFU business for the six months ended June 30, 2022, was EUR 6.8 million (USD 7.4 million), an increase of 78.8% as compared to EUR 3.8 million (USD 4.6 million) for the six months ended June 30, 2021.

Total revenue in the LITHO business for the six months ended June 30, 2022, was EUR 5.8 million (USD 6.3 million), an increase of 11.6% from EUR 5.2 million (USD 6.2 million) for the six months ended June 30, 2021.

Total revenue in the Distribution business for the six months ended June 30, 2022, was EUR 14.6 million (USD 15.9 million), a 24.8% increase compared to EUR 11.7 million (USD 14.0 million) for the six months ended June 30, 2021.

Gross profit for the six months ended June 30, 2022, was EUR 12.0 million (USD 13.0 million), compared to EUR 8.6 million (USD 10.3 million) for the year-ago period. Gross profit margin on net sales was 44.0% for the six months ended June 30, 2022, compared to 41.6% for the comparable period in 2021. The increase in gross profit year-over-year was due to higher sales effect on fixed costs, particularly in the HIFU business.

Operating expenses were EUR 12.5 million (USD 13.6 million) for the six months ended June 30, 2022, compared to EUR 8.8 million (USD 10.5 million) for the same period in 2021.

Operating loss for the six months ended June 30, 2022, was EUR 0.5 million (USD 0.6 million), compared to an operating loss of EUR 0.2 million (USD 0.2 million) for the six months ended June 30, 2021.

Net income for the six months ended June 30, 2022, was EUR 2.2 million (USD 2.4 million), or EUR 0.06 per diluted share, as compared to a net income of EUR 0.4 million (USD 0.4 million), or EUR 0.01 per diluted share in the year-ago period.

As of June 30, 2022, the company held cash and cash equivalents of EUR 46.3 million (USD 48.5 million), as compared to EUR 47.2 million (USD 53.4 million) as of December 31, 2021.

Second Quarter 2022 Results

Total revenue for the second quarter 2022 was EUR 14.2 million (USD 15.0 million), a 36.7% increase as compared to total revenue of EUR 10.4 million (USD 12.4 million) for the same period in 2021.

Total revenue in the HIFU business for the second quarter 2022 was EUR 3.0 million (USD 3.2 million), an increase of 49.3% as compared to EUR 2.0 million (USD 2.4 million) for the second quarter of 2021.

Total revenue in the LITHO business for the second quarter 2022 was EUR 3.6 million (USD 3.8 million), an increase of 55.7% from was EUR 2.3 million (USD 2.7 million) for the second quarter of 2021.

Total revenue in the Distribution business for the second quarter 2022 was EUR 7.6 million (USD 8.1 million), a 25.5% increase compared to EUR 6.1 million (USD 7.3 million) for the second quarter of 2021.

Gross profit for the second quarter 2022 was EUR 6.2 million (USD 6.6 million), compared to EUR 4.2 million (USD 5.1 million) for the year-ago period. Gross profit margin on net sales was 43.8% in the second quarter of 2022, compared to 40.7% in the year-ago period. The increase in gross profit year-over-year was driven by the higher sales effect on fixed costs.

Operating expenses were EUR 6.6 million (USD 7.0 million) for the second quarter of 2022, compared to EUR 4.6 million (USD 5.6 million) for the same period in 2021.

Operating loss for the second quarter of 2022 was EUR 0.4 million (USD 0.5 million), compared to an operating loss of EUR 0.4 million (USD 0.5 million) in the second quarter of 2021.

Net income for the second quarter of 2022 was EUR 1.8 million (USD 1.9 million), or EUR 0.05 per diluted share, as compared to a net loss of EUR 0.4 million (USD 0.5 million), or EUR 0.01 per diluted share in the year-ago period.

In-person Focal One Expert User Panel Event
The management team of EDAP will host a In-person Focal One Expert User Panel Event in New York City on Thursday, September 29. View Source

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT tomorrow, August 25, 2022. Please refer to the information below for conference call dial-in information and webcast registration.

On August 24, 2022 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported a regulatory update, that it is no longer seeking approval for Graspa in hypersensitive acute lymphoblastic leukemia (ALL) following feedback from the U.S. Food and Drug Administration (FDA) (Press release, ERYtech Pharma, AUG 24, 2022, View Source [SID1234618656]).

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"We are obviously disappointed to stop the process of seeking approval for Graspa in ALL after all the work done and clinical promise observed in this indication," said Gil Beyen, Chief Executive Officer of ERYTECH. "In multiple clinical trials, Graspa showed promising results for patients, and we were encouraged by the dialogue with the FDA and the Fast Track designation that we received for this indication last year. However, the changing competitive landscape, combined with new FDA’s requests for additional clinical data that would require significant additional resources on our part, led to the difficult decision to stop the development of Graspa in ALL. We are now focusing our resources on our most promising preclinical programs, while pursuing strategic partnering options to maximize value for our shareholders and employees."

Following positive results of a Phase 2 trial, sponsored by the Nordic Organization for Paediatric Haematology and Oncology (NOPHO), presented at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, ERYTECH has been in discussions with the FDA for the approval of Graspa to treat ALL patients who had previously experienced hypersensitivity reactions to pegylated asparaginase therapy.

A meeting to discuss the submission of a Biologics License Application (BLA) took place in June 2021, after which the Company confirmed its intention to submit a BLA, subject to the submission of additional requested information to the FDA and agreement on an Initial Pediatric Study Plan (iPSP).

The Company recently received feedback from the FDA on its iPSP, submitted in July 2022. After thorough evaluation of this feedback, which included a new request for additional data, and taking into account the changing competitive landscape in the treatment of hypersensitive ALL, the Company has determined that it is in the best interests of the Company and its shareholders to no longer seek approval for Graspa in ALL and to focus its resources on its preclinical programs and strategic partnering activities.

Following the sale of its production facility in Princeton, New Jersey, for $44.5 million in April 2022, the Company appointed a specialized advisor to evaluate strategic options to leverage its ERYCAPS platform with complementary assets and/or a broader corporate transaction. Multiple options are under review, and the Company expects to give further updates on these strategic initiatives in the fourth quarter of this year.

On August 24, 2022 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that the Japan Patent Office has granted Compugen a new composition of matter and use patent covering its potentially first-in-class anti-PVRIG, COM701 and backup anti-PVRIG antibodies (Press release, Compugen, AUG 24, 2022, View Source [SID1234618625]).

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Japanese patent No. 2017-562952, titled "Anti-PVRIG antibodies and Methods of Use" augments previously issued patents by expanding and protecting COM701 beyond Europe and the U.S. to include coverage in Japan.

"As part of our strategy to secure broad patent protection for our innovative pipeline, we are delighted to be granted protection to expand the coverage of COM701 to include Japan in addition to patents previously granted in the U.S. and Europe," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen.

Japanese patent No. 2017-562952 is expected to expire no earlier than 2036.

About COM701

COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint discovered computationally by Compugen, blocking the interaction with its ligand, PVRL2. In pre-clinical studies, blockade of PVRIG by COM701 has demonstrated potent, reproducible enhancement of T cell activation, consistent with the desired mechanism of action of activating T cells in the tumor microenvironment to generate anti-tumor immune responses. Compugen has identified PVRIG and TIGIT as key parallel and complementary inhibitory pathways in the DNAM-1 axis, which also intersect with the well-established PD-1 pathway. Research from Compugen suggests that these three pathways have different dominance in different tumor types and patients, implying that to induce effective antitumor responses, certain patient populations may require the blockade of different combinations of these three pathways. To test this hypothesis, Compugen has established a science-driven, biomarker informed clinical program, which evaluates different combinations of these axis members across tumor types. Compugen is the only company with clinical assets targeting both PVRIG and TIGIT in its portfolio allowing it to explore the potential of blocking these parallel and complementary members of the DNAM axis comprehensively to drive robust immune responses.

On August 24, 2022 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported the 2022 Interim Results (Press release, Carsgen Therapeutics, AUG 24, 2022, View Source [SID1234618624]).

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Business Highlights

CARsgen’s pipeline
CARsgen’s pipeline
CT053: completed enrollment for pivotal Phase II trial in China, with plan to submit the NDA to the NMPA in the third quarter of 2022
CT041: initiated a confirmatory Phase II clinical trial in China
CT041: was granted RMAT by the FDA
CT041: data from a China Investigator-Initiated Trial was published in Nature Medicine
Continuous development of innovative CAR T technologies to empower the next generation pipeline products
U.S. CGMP manufacturing facility began operations, with plan to support clinical trials in North America from second half 2022
Appointed CARsgen CMO and CARsgen US President
Dr. Zonghai Li, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited, said that "In the first half of 2022, CARsgen has made significant progresses in advancing our technology innovations, product pipeline, and business operations in the U.S. and China, despite the impact of the COVID-19 pandemic. CT041 has become the world’s first and the only CAR T-cell candidate for the treatment of solid tumors entering a confirmatory Phase II clinical trial. For CT053, we plan to submit the NDA to the NMPA in the third quarter of 2022. Our U.S. CGMP manufacturing facility has also started operations. We continue to dedicate ourselves to advancing innovative CAR T technologies to address the major challenges of the industry. We have also established in-house, vertically integrated manufacturing capabilities. Driven by the vision of Making Cancer Curable, we expect to bring innovative and differentiated cell therapy to cancer patients around the world as soon as possible, creating value for investors and the public."

1. Steady development of product pipeline with leadership position in CAR T cell against solid tumors

CT053

CT053 is an upgraded fully human, autologous BCMA CAR T-cell product candidate for the treatment of R/R MM. It incorporates a CAR construct with a fully human BCMA-specific single-chain variable fragment (scFv) with lower immunogenicity and increased stability, which overcomes the challenge of T-cell exhaustion by reducing the self-activation of CAR T cells in the absence of tumor-associated targets.

CT053 received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations for the treatment of R/R MM from the U.S. FDA in 2019, PRIority Medicines (PRIME) eligibility in 2019 and Orphan Medicinal Product designation in 2020 for the treatment of R/R MM from the European Medicines Agency (EMA), and Breakthrough Therapy designation for the treatment of R/R MM from the NMPA in 2020.

CARsgen has completed the patient enrollment of the pivotal Phase II trial patients in China (LUMMICAR STUDY 1) and plans to submit the NDA to the NMPA in the third quarter of 2022. CARsgen is conducting the pivotal Phase 2 trial in North America (LUMMICAR STUDY 2), and the Company plans to submit the BLA to the U.S. FDA in the end of 2023. The Company also plans to conduct additional clinical trials to develop CT053 as an earlier line of treatment for multiple myeloma.

An update from the China investigator-initiated trials (IITs) was published in Haematologica in 2022.

CT041

CT041 is an autologous CAR T-cell product candidate against the protein Claudin18.2 (CLDN18.2) and has the potential to be first-in-class globally. CT041 targets the treatment of CLDN18.2-positive solid tumors with a primary focus on GC/GEJ and PC. CARsgen was the first in the world to successfully identify, validate and report CLDN18.2 as a solid tumor-associated antigen and viable target for CAR T-cell therapy for solid tumors in which CLDN18.2 is prevalently or highly expressed.

CT041 received Orphan Drug designation from the U.S. FDA in 2020 for the treatment of GC/GEJ and Orphan Medicinal Product designation from the EMA in 2021 for the treatment of advanced gastric cancer. CT041 was granted PRIME eligibility by the EMA for the treatment of advanced gastric cancer in 2021 and was granted RMAT Designation for the treatment of advanced GC/GEJ with CLDN18.2-positive tumors in 2022.

As of the date of the announcement, CT041 is the world’s first and the only CAR T-cell candidate for the treatment of solid tumors entering a confirmatory Phase II clinical trial.

Active trials in CARsgen include a Phase 1b/2 clinical trial for advanced GC/GEJ and PC in North America (CT041-ST-02, NCT04404595), a Phase Ib clinical trial for advanced GC/GEJ and PC and a confirmatory Phase II clinical trial for advanced GC/GEJ in China (CT041-ST-01, NCT04581473), and IITs. CARsgen plans to submit an NDA to the NMPA in China in the first half of 2024. CT041 have now completed the dose escalation and initiated the dose expansion in U.S. CARsgen also plans to initiate a Phase 2 clinical trial in the second half of 2022 in North America and to submit the BLA to the U.S. FDA in 2024.

Updates from the Phase 1b study in the U.S. (NCT04404595) and the Phase Ib/II study in China (NCT04581473) were provided in poster presentations at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2022. An update from a China IIT was published in Nature Medicine in May 2022, which is the largest clinical trial for CAR T-cell therapy in solid tumors to date.

AB011

AB011 is a humanized monoclonal antibody product candidate against CLDN18.2 for the treatment of CLDN18.2-positive solid tumors. The company obtained the second investigational new drug (IND) clearance in the world for a mAb targeting CLDN18.2.

CARsgen has completed Phase I monotherapy cohort enrollment and initiated a trial for combination with chemotherapy.

2. Continuous discovery and technology development

CARsgen has established an integrated research and development platform covering the full CAR T development cycle including target discovery, antibody development, vector design, manufacturing, quality assurance, and quality control. CARsgen continues to dedicate itself to advancing innovative CAR T technologies to address the major challenges of the industry. The four strategic pillars include:

（1） Efficacy: To enhance efficacy against solid tumors, CARsgen continues to develop next generation CAR T technologies, such as CycloCAR. CycloCAR features the co-expression of cytokine IL-7 and chemokine CCL21 in CAR T cells to potentially improve clinical efficacy and reduce the requirement of lymphodepletion conditioning.

（2） Safety: To improve the applicability of adoptive cell therapies, CARsgen developed the sFv-ε-based T-cell therapy powered by a full T-cell receptor (TCR) complex comprising a GPC3-targeted scFv and a CD3ε subunit, which can form a functional TCR complex with other TCR subunits and redirect T cells to kill tumor cells in an MHC-independent manner.

（3） Patient accessibility: CARsgen is developing allogeneic CAR T-cell product candidates using THANK-uCAR technology, which it believes could potentially increase CAR T cell expansion, persistence, and efficacy. CARsgen believes the successful application of THANK-uCAR technology would significantly lower the cost of CAR T-cell therapy and increase patient accessibility.

（4） Target availability: CARsgen developed LADAR technology (local action driven by artificial receptor), in which an artificial receptor is triggered by a LADAR Ligand to induce the transcription of the gene(s) of interest. Through the LADAR artificial receptor, the antitumor CAR transcription is only triggered when the LADAR binds to a LADAR Ligand, making it possible to precisely control when and where immune cells act against cancer cells.

These technologies are currently being developed in-house with global rights and can be used alone or in combination to upgrade CARsgen’s existing product candidates and to generate future pipeline product candidates.

As of June 30, 2022, CARsgen had more than 300 patents of which 70 patents had been issued globally including China, the United States, Europe, and Japan. This is an increase of 7 issued patents and 21 patent applications from the end of 2021.

3. Vertically integrated manufacturing capabilities, supporting clinical trials globally

CARsgen has established in-house, vertically integrated manufacturing capabilities, including the production of plasmids, lentiviral vectors, and CAR T cells.

CARsgen has been expanding its global manufacturing capacity in China and the U.S. to support both clinical trials and the subsequent commercialization of pipeline products. With the clinical manufacturing facility in Xuhui, Shanghai and commercial GMP manufacturing facility in Jinshan, Shanghai, CARsgen manufactures CAR T-cell products in-house to support clinical trials in China and manufacture the lentiviral vectors in-house to support clinical trials globally.

In 2021, CARsgen has made significant progress in expanding CARsgen’s manufacturing capacity outside China by launching a state-of-the-art GMP Manufacturing Facility in Research Triangle Park, Durham, North Carolina. CARsgen successfully passed the official inspections and received the Certificate of Compliance from the City-County Inspections Department of Durham. CARsgen has commenced commissioning, qualification, and validation of RTP Manufacturing Facility through the RMAT consultation with the FDA. Concurrently, CARsgen has been executing the technology transfer to RTP Manufacturing Facility, advancing to the clinical manufacturing of CT041 and CT053 products.

4. Strengthened leadership team with rich experience

As of June 30, 2022, CARsgen had a total of 601 employees. The company has also strengthened the leadership team: CARsgen hired Dr. Raffaele Baffa as the Chief Medical Officer of the Company, and Mr. Richard Daly as the President of CARsgen Therapeutics Corporation. Biographical details of the senior management team are provided on the company’s website at www.CARsgen.com.