Elpiscience Announces First Patient Dosed in Phase 1/2 Clinical Study of ES104 for Treatment of Colorectal Cancer

On February 28, 2022 Elpiscience Biopharmaceuticals, Inc. ("Elpiscience"), a global clinical-stage biopharmaceutical company dedicated to discovering and developing next-generation cancer immunotherapies, reported that the first patient has been dosed in a Phase 1/2 clinical study, evaluating the safety, tolerability, pharmacokinetics and preliminary anti-tumor efficacy of ES104 for the treatment of unresectable locally advanced or metastatic colorectal cancer (CRC) in China (Press release, Elpiscience, FEB 28, 2022, View Source [SID1234609169]). ES104 is a bispecific antibody that simultaneously blocks the Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways that are critical to angiogenesis and tumor vascularization.

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In prior clinical testing, ES104 demonstrated significant anti-tumor activity in patients who had failed multiple lines of therapy and were considered resistant to currently approved anti-VEGF therapies. Elpiscience received Center of Drug Evaluation (CDE) INC clearance for ES104 in October 2021. ES104 is currently the only clinical-stage bispecific antibody targeting VEGF and DLL4 in China.

"We are excited to initiate this Phase 1/2 clinical study of ES104. In a recent Phase 1 study, ES104 showed single-agent activity in advanced gastric cancer and CRC patients who were considered treatment resistant to anti-VEGF containing regimens," said Steve Chin, CMO of Elpiscience. "We look forward to the potential therapeutic benefit of ES104 for the treatment of CRC patients in China."

For more information on the Phase 1/2 clinical study, refer to Clinicaltrials.gov identifier NCT05167448.

About ES104:

ES104 is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Pre-clinical and early clinical data of ES104 show that blocking both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic, and non-small cell lung cancer. Partial responses to ES104 as monotherapy have been observed in heavily pre-treated cancer patients, who were resistant to currently approved anti-VEGF therapies. ES104 has completed a Phase 1 monotherapy dose-escalation and expansion study (NCT03292783). Phase 1b and Phase 2 clinical studies (NCT04492033) in combination with chemotherapy are ongoing. Elpiscience licensed greater China rights to ES104 in January 2021.

Photocure Announces the Publication of Pre-Clinical Study Results Supporting the Anti-tumor Effect of Hexaminolevulinate with Blue Light in Bladder Cancer model

On February 28, 2022 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported the publication of new results from its exploratory research program in the journal Biomedicines, entitled "Antitumor Effect and Induced Immune Response Following Exposure of Hexaminolevulinate (HAL) and Blue Light in an Orthotopic Model of Rat Bladder Cancer" (Press release, PhotoCure, FEB 28, 2022, View Source [SID1234609186]). These results support initial pre-clinical data on the potential anti-tumor effect of HAL, which were presented at the BLADDR 2019 congress [View Source

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The study objective was based on the hypothesis that the positive impact on long-term outcomes in NMIBC patients who had undergone Blue Light Cystoscopy (BLC) prior to cystectomy could be caused by a direct anti-tumor effect and/or activation of the immune system indicating an additional effect of Blue Light with HAL beyond pure detection. Therefore, as an exploratory preclinical study, the authors investigated whether intravesical administration of HAL followed by a diagnostic blue-light illumination-regime, aiming to mimic the one used currently in Photodynamic Diagnosis (PDD), could have anti-tumor and/or immune modulating effects as seen with Photodynamic therapy (PDT). In addition, it was explored if co-administration of a checkpoint inhibitor would increase the susceptibility to the PD-1/PD-L1 pathway inhibition thus increasing the anti-tumor effect. Over the years, Photocure has conducted a number of experiments on "mechanisms of actions" effects of HAL, as well as to see if there potentially are similar anti-tumor and immune modulating effects of PDD with blue light as reported with PDT. For this study, rats were treated with HAL and blue light in an orthotopic model of bladder cancer, and then subjected to histopathological analysis of the bladder samples and additional assessment of immune markers. Co-administration of HAL and blue light with a checkpoint inhibitor was further evaluated in this model aiming to assess for potentiation of anti-tumor effects when combined with an immunotherapy.

Results of the study demonstrated an anti-tumor effect of HAL and blue light when aiming to mimic the dosing regimen of a photodynamic diagnostic procedure (PDD) in an orthotopic bladder cancer model in rats.

The authors conclude "The anti-tumor effect is most probably pertaining to stimulation of the immune system as evident by tumor infiltration of CD3+ and CD8+ T-cells. These results support our hypothesis that the positive impact on patient outcomes observed in patients who had undergone BLC prior to cystectomy could be explained by systemic immune activation induced by HAL and blue light. Combination of HAL and blue light with intravesical anti-PD-L1 resulted in increased anti-tumor effects. Further studies are warranted to explore the long-term effects of HAL and blue light alone or in combination with checkpoint inhibitors which should extend to investigate any systemic (abscopal) effects. Intriguingly is also the idea that local treatment with HAL and blue light can prime an immune response with potential additional effect of checkpoint inhibitors."

"The intriguing results from this pre-clinical study are encouraging and might explain an effect of HAL+BL beyond pure detection. The results motivate further research to evaluate the potential of HAL as a photodynamic therapy (PDT), which may be an innovative technique for treatment of non-muscle invasive bladder cancer.", said Anders Neijber, Vice President, Global Medical Affairs and Clinical Development at Photocure.

Read the full article here: View Source

Note to editors

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA.

This press release may contain product details and information which are not valid, or a product is not accessible, in your country. Please be aware that Photocure does not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin.

About Bladder Cancer

Bladder cancer ranks as the seventh most common cancer worldwide, with 1 720 000 prevalent cases (5-year prevalence rate)1a, 573 000 new cases and more than 200 000 deaths annually in 2020.1b

Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate, with an average of 61% in year one and 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3

Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all cases and include the subtypes Ta, carcinoma in situ (CIS), and T1 lesions. In MIBC, the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3, and T4, are more likely to spread and are harder to treat.4

1 Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at: View Source, accessed [January 2022].

2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657

3 Sievert KD et al. World J Urol 2009;27:295–300

4 Bladder Cancer. American Cancer Society. View Source

About Hexvix/Cysview (hexaminolevulinate HCl)

Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder, making them glow bright pink during Blue Light Cystoscopy (BLC). BLC with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves the detection of tumors and leads to more complete resection, fewer residual tumors, and better management decisions.

Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Chile, Australia, and New Zealand. Please refer to View Source for further information on our commercial partners.

Transcenta Announces First Patient Dosed in Phase IIa Study of Claudin18.2 Monoclonal Antibody TST001 Combined with Cisplatin and Gemcitabine for the First Line Treatment of Biliary Tract Cancer

On February 27, 2022 Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported the successful dosing of first patient in China Phase IIa Study of TST001, a Claudin18.2 monoclonal antibody, combined with Cisplatin and Gemcitabine for the first line treatment of systemic treatment-naïve locally advanced or metastatic biliary tract cancer patients (Press release, Transcenta, FEB 27, 2022, View Source [SID1234609084]). Globally Transcenta is the first company exploring the potential of Claudin 18.2 targeting agent in biliary tract cancer.

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Biliary tract cancer is a relatively rare malignancy, which includes cholangiocarcinoma and gallbladder carcinoma. Cholangiocarcinoma is further classified into extrahepatic and intrahepatic cholangiocarcinoma. In the treatment of biliary tract cancer, radical resection is the standard and only approach for patients at the early stage. However, most of the patients cannot receive surgical resection, as the cancer has stepped into the metastatic stage by the time of diagnosis. For biliary tract cancer, few effective therapies are available for these patients, which leaves significant unmet clinical needs.

This Phase IIa clinical trial is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and anti-tumor efficacy of TST001 in patients with systemic treatment-naïve locally advanced or metastatic biliary tract cancer. These patients will be screened using an immunohistochemistry assay developed by Transcenta and validated by central lab that specifically detects Claudin18.2 but not Claudin 18.1.

"Biliary tract cancer has poor prognosis and the combination of Cisplatin and Gemcitabine is the standard of care for first line treatment." said Dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta." Using our proprietary IHC antibody, Transcenta has shown that Claudin18.2 is over-expressed in the tumor of a subset of biliary tract cancer patients. As the combination of Claudin18.2 targeting agent with chemo backbone has shown promising activity in first line gastric cancer, the addition of TST001 to the first line chemotherapy regimen may also provide better treatment benefit to biliary tract cancer patients with Claudin18.2-expressing tumor."

About TST001
TST001 is a high affinity humanized anti-Claudin18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activities and potent anti-tumor activities in tumor xenograft models. TST001 is the second Claudin18.2 targeting antibody therapeutic candidate being developed globally. TST001 is generated using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. TST001 kills Claudin18.2 expressing tumor cells by mechanisms of antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Leveraging advanced bioprocessing technology, the fucose content of TST001 was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of TST001. Clinical trials for TST001 are ongoing in China and US (NCT04396821, NCT04495296/CTR20201281). TST001 was granted Orphan Drug Designation in the US by FDA for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ).

JW Therapeutics Announces NMPA Acceptance of the Supplemental New Drug Application for Carteyva® in Patients with Relapsed or Refractory Follicular Lymphoma

On February 27, 2022 JW Therapeutics (HKEx: 2126), an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported that the National Medical Products Administration (NMPA) of China accepted the supplemental New Drug Application (sNDA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva (relmacabtagene autoleucel injection) for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) (Press release, JW Therapeutics, FEB 27, 2022, View Source [SID1234609085]). This is the second marketing application on Carteyva submitted by JW Therapeutics, and is expected to be the first cell therapy product approved in China for the treatment of r/r FL patients. Carteyva was granted Breakthrough Therapy Designation by NMPA in September 2020.

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The sNDA was supported by the clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva in adult patients with relapsed or refractory B cell non-hodgkin lymphoma in China. The study results were presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021. The cohort B results showed that Carteyva demonstrated very high rates of durable disease response (Best Complete Response Rate and Overall Response Rate at 3 months was 92.6% and 100%, respectively) and controllable CAR-T associated toxicities in patients with r/r FL (42.9% and 17.9% of the patients had any grade Cytokine Release Syndrome (CRS) and Neurotoxicity (NT), while 0% and 3.6% of the patients experienced CRS and NT of Grade 3 or above).

Professor Yuqin Song, Chief Physician of Lymphoma Department at Peking University Cancer Hospital, Director of China Society of Clinical Oncology (CSCO), noted at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting: "The RELIANCE study results show that Carteyva demonstrated very excellent efficacy and safety profile in patients with r/r FL and we are looking forward to the sNDA approval in China."

About Relmacabtagene Autoleucel Injection (trade name: Carteyva)

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel was approved by the China National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, making it the first CAR-T product approved as Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designations.

About RELIANCE Study (NCT04089215)

RELIANCE study was a single-arm, multi-center, pivotal study to evaluate the efficacy and safety of Carteyva in adult patients with relapsed or refractory B cell non-hodgkin lymphoma (cohort A: relapsed or refractory large B-cell lymphoma, cohort B: relapsed or refractory follicular lymphoma) in China.

RELIANCE cohort B study enrolled 28 patients with r/r FL who had failed the second-line (or above) therapy, including an anti-CD20 agent and anthracycline. Patients received 100*106 CAR-T or 150*106 CAR-T cell of Carteyva infusion, and followed up until 2 years or above for long term outcomes. As of the cut-off date of September 10, 2021, of 27 evaluable patients, the Complete Response Rate (CRR) and Overall Response Rate (ORR) at 3 months were 85.19% and 100%, and the Best Complete Response Rate and Overall Response Rate was 92.6% and 100%, respectively. Of 28 treated patients, 42.9% and 17.9% of the patients had any grade Cytokine Release Syndrome (CRS) and Neurotoxicity (NT), Among these AEs, no CRS of Grade 3 or above occurred, and only 3.6% of the patients experienced NT of Grade 3 or above.

Rubius Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update

On February 25, 2022 Rubius Therapeutics, Inc. (Nasdaq: RUBY), a clinical-stage biopharmaceutical company that is biologically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics for the treatment of cancer and autoimmune diseases, reported fourth quarter and full year 2021 financial results (Press release, Rubius Therapeutics, FEB 25, 2022, View Source [SID1234609047]).

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"Twenty twenty-one was a year of strong execution for Rubius Therapeutics as we advanced our clinical oncology pipeline, strengthened our in-house manufacturing capabilities and showed preclinical proof of concept of our tolerance induction approach in type 1 diabetes, which has the potential to be extended to other T cell-mediated autoimmune diseases," said Pablo J. Cagnoni, M.D., president and chief executive officer of Rubius Therapeutics. "Twenty twenty-two is set to be a catalyst rich year with several clinical data milestones, including, during the first quarter, updated results from our single-agent RTX-240 Phase 1 clinical trial in advanced solid tumors and, during the second half of 2022, initial clinical data from our RTX-240 Phase 1 arm in combination with pembrolizumab in advanced solid tumors and from our RTX-321 clinical trial in advanced HPV 16-positive cancers."

Anticipated 2022 Catalysts and Operational Objectives

Present additional clinical results from the Phase 1 arm of the RTX-240 Phase 1/2 clinical trial in advanced solid tumors and the Phase 1 arm in relapsed/refractory acute myeloid leukemia (AML) during the first quarter of 2022
Initiate RTX-240 Phase 2 expansion cohorts in select solid tumor types during the first quarter of 2022
Report initial clinical results from the Phase 1 clinical trial of RTX-321 in patients with advanced HPV 16-positive cancers during the second half of 2022
Present initial clinical data from the Phase 1 arm of the RTX-240 clinical trial in combination with pembrolizumab in patients with advanced solid tumors during the second half of 2022
Fourth Quarter and Full Year 2021 Highlights

Broad Immune Stimulation

RTX-240

Established clinical proof of concept of RTX-240 in advanced solid tumors, based on initial results reported in March 2021, potentially increasing the likelihood of clinical success across the oncology pipeline
Patients continue to be dosed in the single-agent RTX-240 Phase 1 solid tumor clinical trial, with no dose-limiting toxicities observed to date and a clear dose response in the increase of NK cells and other pharmacodynamic effects
Additional clinical results are expected from this trial and the Phase 1 arm in relapsed/refractory AML during the first quarter of 2022
The Company plans to initiate RTX-240 Phase 2 expansion cohorts in select solid tumor types during the first quarter of 2022
Continuing dose escalation in the RTX-240 Phase 1 combination study with pembrolizumab in patients with advanced solid tumors with initial clinical data expected during the second half of 2022
RTX-224

In January 2022, the first patient was dosed in the Phase 1/2 clinical trial of RTX-224 in selected relapsed/refractory or locally advanced solid tumors that include non-small cell lung cancer, cutaneous melanoma, head and neck squamous cell carcinoma, urothelial (bladder) carcinoma and triple-negative breast cancer
Presented preclinical data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting in November 2021, demonstrating that the mouse surrogate of RTX-224, mRBC-224, generated potent anti-tumor activity in B16F10 melanoma models, intravenously and subcutaneously, that was associated with pharmacodynamic changes in blood and tumors, including activated CD4+ and CD8+ T cells, NK cells and macrophages
Antigen-Specific Immune Stimulation

RTX-321 Artificial Antigen-Presenting Cell (aAPC) Development Program for Human Papillomavirus (HPV) 16-Positive Cancers

Continuing enrollment in the Phase 1 clinical trial of RTX-321 in patients with advanced HPV 16-positive cancers with no dose limiting toxicities observed to date
Planning to report initial clinical results during the second half of 2022
Autoimmune Diseases and Type 1 Diabetes

Demonstrated tolerance induction with bystander suppression in stringent type 1 diabetes preclinical models
Established efficacy in the BDC2.5 adoptive transfer model with data supporting that repeated dosing extended duration of disease protection, reversed established inflammation, which is important for the treatment of existing autoimmunity, and induced two types of regulatory T cells, resulting in protection against re-challenge
Showed efficacy in non-obese diabetes (NOD) preclinical model
Results at 25 weeks exhibit bystander suppression by delivering only two antigens, indicating the mouse surrogate of RTX-T1D prevented or delayed disease caused by many autoantigens
These findings are potentially translatable beyond type 1 diabetes to multiple autoimmune diseases, including other Rubius’ high priority target indications, multiple sclerosis and celiac disease
Manufacturing

Increased cells produced per batch by four times in 50L bioreactors from 2020 to 2021, enabling uninterrupted clinical supply for three Phase 1 arms of the RTX-240 clinical trial and Phase 1 RTX-321 trial
Introduced frozen drug substance for RTX-321 and RTX-224, potentially enabling inventory storage of greater than two years
In process of scaling to 200L bioreactors by mid-2022 to support potential pivotal trials and eventual commercialization
Fourth Quarter 2021 Financial Results

Net loss for the fourth quarter of 2021 was $55.0 million or $0.61 per common share, compared to $40.5 million or $0.50 per common share in the fourth quarter of 2020.

In the fourth quarter of 2021, Rubius invested $39.8 million in research and development (R&D) related to its novel RED PLATFORM and towards expanding and advancing its product pipeline, as compared to $25.6 million in the fourth quarter of 2020. This year-over-year increase was principally due to a $11.0 million increase in costs incurred for the Company’s lead cancer programs, RTX-240 and RTX-321, primarily from clinical research organization (CRO) and internal manufacturing costs incurred in connection with the three arms of its Phase 1/2 clinical trial of RTX-240, for its Phase 1 clinical trial of RTX-321 for the treatment of HPV16-positive cancers and for start-up costs related to its Phase 1 clinical trial of RTX-224. Additionally, personnel-related costs increased $1.4 million principally for additions to headcount to support the Company’s expanded operations and stock-based compensation increased by $1.5 million.

General and administrative (G&A) expenses were $13.9 million during the fourth quarter of 2021, as compared to $14.1 million for the fourth quarter of 2020. While there were increases totaling $1.0 million across professional fees, facility and personnel costs, they were offset by a decline in stock-based compensation expense of $1.2 million following the full vesting of large awards early in the third quarter of 2021.

Full Year 2021 Financial Results

Net loss for the full year 2021 was $196.5 million or $2.23 per common share, compared to $167.7 million or $2.08 per common share for the full year 2020.

For the full year 2021, Rubius invested $141.6 million in R&D related to its novel RED PLATFORM and towards expanding and advancing its product pipeline, as compared to $116.1 million for the full year 2020. The year-over-year increase was driven by $28.7 million of incremental costs to advance the Company’s lead cancer programs, including CRO and internal manufacturing costs. These costs were associated with the three arms of its Phase 1/2 clinical trial of RTX-240, for its Phase 1 clinical trial of RTX-321 in patients with advanced HPV 16-positive cancers, and for start-up costs related to its Phase 1 clinical trial of RTX-224. The increase in cancer program costs was partially offset by a $5.0 million reduction in rare disease program costs following the deprioritization of the Company’s rare disease pipeline in March 2020. Additionally, platform development, early-stage research and other unallocated expenses increased by $1.8 million. This consisted of $4.3 million in additional stock-based compensation and a $3.1 million increase in personnel and facility related costs, which were partially offset by reductions in contract R&D, laboratory supplies and research materials as research activities shifted to support clinical programs.

G&A expenses were $53.0 million during full year of 2021, as compared to $50.3 million for the same period in 2020. The higher costs were driven by a $3.4 million increase in personnel and facility related costs, as well as a $1.6 million increase in professional and consultant fees. These increases were offset by a decrease in stock-based compensation expense following the vesting of large awards early in the second half of 2021.

Cash Position

As of December 31, 2021, cash and cash equivalents were $225.8 million as compared to $176.3 million in cash, cash equivalents and investments as of December 31, 2020, providing Rubius with a cash runway into the second quarter of 2023 and the ability to extend the runway into the middle of 2023. In connection with its underwritten public offering completed in March 2021, the Company received net proceeds of $187.2 million, after deducting underwriting discounts and commission and other offering costs. In addition, in June 2021, the Company amended its debt facility, postponing principal payments by two and a half years, until mid-2024.
About RTX-240
RTX-240, Rubius Therapeutics’ lead oncology program, is an allogeneic, off-the-shelf cellular therapy product candidate that is engineered to simultaneously present hundreds of thousands of copies of the costimulatory molecule 4-1BB ligand (4-1BBL) and IL-15TP (trans-presentation of IL-15 on IL-15Rα) in their native forms. RTX-240 is designed to broadly stimulate the immune system by activating and expanding both NK and memory T cells to generate a potent anti-tumor response.

About RTX-321
RTX-321, the Company’s second oncology program, is an allogeneic, off-the-shelf aAPC therapy product candidate that is engineered to induce a tumor-specific immune response by expanding antigen-specific T cells. RTX-321 expresses hundreds of thousands of copies of an HPV peptide antigen bound to major histocompatibility complex class I proteins, the costimulatory molecule 4-1BBL and the cytokine IL-12 on the cell surface to mimic human T cell-APC interactions.

About RTX-224
RTX-224 is an allogeneic, off-the-shelf cellular therapy product candidate that is engineered to express hundreds of thousands of copies of 4-1BBL and IL-12 on the cell surface. In contrast to RTX-240, RTX-224 is designed as a broad immune agonist of both adaptive and innate responses, activating CD8+ and CD4+ T cells, promoting antigen presentation and activating and expanding NK cells. It is expected to produce a broad and potent anti-tumor T cell response, an innate immune response and have anti-tumor activity in those tumor types with known sensitivity to T cell killing, including tumor types with high mutational burden, PD-L1 expression and prior activity of checkpoint inhibitors.

About Red Cell Therapeutics in Autoimmune Diseases
Red Cell Therapeutics for the treatment of autoimmune disease are biologically engineered to express proteins and peptides inside the cell and are designed to be phagocytized, or ingested, by dendritic cells or macrophages to induce tolerance, retraining the immune system to no longer recognize these self-antigens as foreign.