On March 21, 2024 HanAll Biopharma Co., Ltd. (KRX: 009420.KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, reported financial results for 2023 and provided business updates (Press release, HanAll Biopharma, MAR 21, 2024, View Source [SID1234641358]).

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HanAll delivered a strong full-year performance, with a 23 percent increase in sales compared to 2022, demonstrating continued innovation momentum through multiple meaningful data readouts for anti-FcRn assets and the dry eye disease program.

Total revenues for 2023 were 135 billion Korean won (KRW), mainly driven by strong sales growth from key products. Operating income for the year recorded 2.2 billion KRW.

"2023 marked a significant milestone as we celebrated our 50th anniversary. We have delivered record-high sales performance, with continued advancements in our R&D programs by adding the Parkinson’s disease program, completing the VELOS-3 study in dry eye, and securing meaningful outcomes from the Phase 1 study of HL161ANS, our second anti-FcRn asset," said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma.

"As we anticipate further advancements in 2024, including the VELOS-4 study in dry eye and additional data readouts from the anti-FcRn assets and Parkinson’s program, we will continue to focus our efforts to serve patients," he added.

Full-Year 2023 BUSINESS UPDATE

Pipeline Development Highlights

A comprehensive update of HanAll’s pipeline development below includes an overview of research along with lists of compounds, targeted indications, and developmental phases.

AUTOIMMUNE DISEASES PROGRAMS

Batoclimab (HL161BKN)

A novel, fully human, subcutaneously administered antibody targeting FcRn with the potential to address multiple IgG-mediated autoimmune diseases. Batoclimab is designed to selectively bind to FcRn, which plays a role in recycling IgG, thereby reducing levels of harmful IgG antibodies.

Immunovant, HanAll’s licensed partner in the United States and Europe, has reported positive initial results from a Phase 2 proof-of-concept trial evaluating the safety and efficacy of batoclimab in patients with Graves’ disease. The study demonstrated that batoclimab achieved response rates exceeding 50% in patients who are hyperthyroid despite treatment with an anti-thyroid medication (ATD) for more than 12 weeks. Treatment response is defined as normalization of T3 and T4 hormone levels without increasing ATD dose. Consistent with studies of batoclimab in other indications, the subcutaneous administration of 680 mg batoclimab showed an impressive reduction of up to 87% in IgG levels, with a mean IgG reduction of 81% after 12 weeks of treatment. Batoclimab was generally well tolerated with no new safety signals identified from the initial data set. Immunovant plans to assess the development of the second anti-FcRn, ‘HL161ANS (IMVT-1402)’, for Graves’ disease, with details expected to be unveiled later in 2024.

Harbour BioMed, a licensed partner in China, provided updates on the progress of the Biologics License Application (BLA) submission for batoclimab, intended for the treatment of generalized myasthenia gravis (gMG). In line with the clinical study protocol, the company is currently in the extension period of the Phase 3 clinical trial to gather additional long-term safety data. Harbour BioMed plans to include the supplementary long-term safety data and aims to re-submit the BLA for batoclimab to the National Medical Products Administration (NMPA) in the first half of 2024. BLA submission for batoclimab for the treatment of gMG was made in June 2023, prompted by a positive topline result obtained from the Phase 3 clinical trial.

HanAll and Immunovant are progressing a Phase 3 clinical study of batoclimab in generalized myasthenia gravis (gMG) in Japan. Clinical trial notification (CTN) was approved to initiate a Phase 3 clinical study of batoclimab in thyroid eye disease (TED) in Japan.
HL161ANS

Another novel, fully human, subcutaneous antibody molecule that inhibits FcRn-mediated recycling of IgG is designed to deliver maximum lgG reductions while minimizing interference with albumin recycling.

Immunovant announced positive initial Phase 1 600 mg MAD results for HL161ANS (IMVT-1402) in November 2023. In the study, four once-weekly subcutaneous injections of 600 mg HL161ANS reduced total IgG level by a mean of 74%, demonstrating comparable potency to batoclimab 680 mg, which reduced IgG by 76% after four weekly doses. Overall, HL161ANS consistently demonstrated a significant reduction in IgG levels with potency similar to or greater than that of batoclimab, with no significant decrease in serum albumin or significant increase in LDL-cholesterol levels at day 29 (peak pharmacodynamics impact) from baseline (p-values > 0.05).
OPHTHALMIC DISEASE PROGRAM

Tanfanercept (HL036)

A novel topical protein therapy for ophthalmic diseases, including dry eye disease (DED), which inhibits TNF, a key mediator of ocular inflammation

HanAll Biopharma and Daewoong Pharmaceutical successfully concluded discussions with the FDA in the second half of 2023, finalizing the Phase 3 VELOS-4 study design and development plan. The anticipated initiation of the VELOS-4 study is set for the first half of 2024.

The concluded Phase 3 VELOS-3 study revealed a significant improvement in the unanesthetized Schirmer test, a secondary efficacy endpoint measuring changes in tear volume from baseline in individuals treated with tanfanercept 0.25% compared to the vehicle. This improvement, assessed at week 8, demonstrated a highly statistically significant outcome (p=0.002). Furthermore, a noteworthy proportion of participants in the tanfanercept group (13%) exhibited a Schirmer test improvement of at least 10 mm from baseline at week 8, which was statistically significant (p=0.011) compared to the vehicle group (4%). It is worth mentioning that, according to the FDA’s 2020 Draft Guidance on Dry Eye Drug Development, achieving a statistically significant difference in the percentage of patients with a minimum 10 mm increase in the Schirmer test is considered an acceptable primary efficacy endpoint. The FDA has also outlined an alternative approval pathway, requiring the demonstration of a statistically significant difference in an objective predefined sign of dry eye and, additionally, at least one subjective predefined symptom of dry eye. However, this second pathway often involves increased complexity, necessitating additional studies.
NEUROLOGY PROGRAM

HL192 (ATH-399A)

A pipeline candidate originated from NurrOn Pharmaceuticals that targets Nurr1, a master regulator in dopaminergic neuron development and maintenance, is being developed to treat neurodegenerative diseases, including Parkinson’s disease (PD).

HanAll Biopharma, Daewoong Pharmaceutical, and NurrOn Pharmaceuticals are progressing with the Phase 1 clinical trial of HL192 in healthy participants. The results from the Phase 1 clinical trial of HL192 are expected in the second half of 2024.
ONCOLOGY PROGRAMS

HL187/ HL186

HL187 is a monoclonal antibody that targets TIGIT (T cell immunoreceptors with Ig and ITIM domains {Immunoreceptor tyrosine-based inhibitory motif domains}). HL186 is a monoclonal antibody that targets TIM-3 (T cell Ig and mucin domain-3). These antibodies are being developed in collaboration with Daewoong Pharmaceutical as potential oncology treatments.

HanAll is currently advancing the pre-clinical examination of HL187 (anti-TIGIT) and concurrently evaluating the prospects of HL186 (anti-TIM-3) as part of the ongoing strategic portfolio review.
FINANCIAL HIGHLIGHTS (CONSOLIDATED)

Key Highlights

(KRW in billion)

2023

2022

% change

Sales

135

110

+22.7 %

Gross Profit

75

62

+21.3 %

Selling, marketing and administrative expenses

49

44

+11.5 %

Research and development expenses

24

16

+45.1 %

Operating income

2.2

1.5

+46.9 %

Net Income

3.5

0.3

+1295.2 %

Sales generated 135 billion KRW in 2023, a 22.7% increase compared to 2022. Sales remained strong with its major products including Normix, Eligard, and Biotop.

R&D expenses, reported as 24 billion KRW, a 45.1% increase compared to 2022.

Operating income was 2.2 billion KRW, a 46.9% increase compared to the same period in 2022.

Net income was 3.5 billion KRW, compared to 300 million KRW in 2022.

On March 21, 2024 ONO Pharmaceuticals, Co., Ltd. reported it has completed target patient enrollment of the first arm (Part A) of the PROSPECT Study, a Phase 2 clinical trial evaluating the safety and efficacy of tirabrutinib (ONO-4059) in U.S. patients with relapsed or refractory primary central nervous system lymphoma (R/R PCNSL) (Press release, Ono, MAR 21, 2024, View Source [SID1234641357]).

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"A PCNSL diagnosis can be frightening for patients, and treatment options approved by the FDA are critically needed in the U.S.," said Kiyoaki Idemitsu, Executive Officer / Executive Director, Clinical Development of ONO PHARMA. "Completing enrollment of the first arm of this U.S. study is an important step in bringing a therapeutic option to patients with R/R PCNSL in the U.S. We are very grateful to everyone involved with this clinical trial."

The first arm (Part A) of the PROSPECT Study is evaluating the safety and efficacy of tirabrutinib in patients with R/R PCNSL who received previous treatment with high-dose methotrexate-based regimens. Enrollment is now complete for Part A. ONO PHARMA continues to enroll newly diagnosed and previously untreated PCNSL patients in the second arm of the study (Part B), evaluating tirabrutinib in combination with one of two high-dose methotrexate-based regimens as first-line therapy in the PROSPECT Study (theprospectstudy.com and clinicaltrials.gov).

PCNSL is a rare and aggressive extranodal non-Hodgkin lymphoma with historically poor survival rates.1 PCNSL affects the brain, its protective membranes, the spinal cord, and/or eye, without systemic involvement at the time of diagnosis.1 In the U.S., the incidence of PCNSL is approximately five out of 1,000,000 people per year, with higher rates in people over 65 years old.2

Tirabrutinib is a highly selective irreversible Bruton’s tyrosine kinase inhibitor discovered by ONO PHARMA in Japan. In March 2023, the U.S. Food and Drug Administration granted Orphan Drug Designation to tirabrutinib for the treatment of PCNSL.3 Tirabrutinib is currently approved for R/R PCNSL treatment in Japan, Taiwan, and South Korea.3

"This is an important milestone for ONO as it builds its clinical trial program in the U.S.," said Kunihiko Ito, President and CEO of ONO PHARMA USA. "For decades, ONO’s commitment to innovation in oncology has helped change treatment paradigms for patients all over the world. We look forward to continuing this legacy as we investigate tirabrutinib for PCNSL in the U.S."

About PCNSL
PCNSL is a rare and aggressive extra nodal non-Hodgkin lymphoma (NHL) that is confined to the brain parenchyma, spinal cord, eye, or leptomeninges, without systemic involvement. The annual incidence rate of PCNSL is approximately five cases per 1,000,000 people in the U.S. The rate can further increase among immunocompetent people aged 65 years and older. The signs and symptoms presented in patients with PCNSL vary depending on the neuroanatomical site of the lesion, and include cranial neuropathy, neuropsychiatric symptoms, symptoms associated with increased intracranial pressure, seizures, ocular symptoms, headache, dysmotility, cranial neuropathy, and radiculopathy. There are no therapeutic products approved for the treatment of PCNSL in the U.S., and data guiding therapeutic approaches are very limited. Despite recent progress resulting in the improvement of clinical outcomes in newly diagnosed patients with PCNSL after an induction treatment, approximately 20 to 30 percent of patients are refractory to the initial treatment, and up to 60 percent of patients will eventually relapse. To learn more about R/R PCNSL, please visit navigatingpcnsl.com.

About Tirabrutinib
Tirabrutinib, discovered and developed by Ono Pharmaceutical Co., Ltd. is a highly potent selective BTK inhibitor. Signaling through the B-cell receptor (BCR) regulates cellular proliferation and activation, and promotes survival, differentiation, and clonal expansion of B-cells. The BCR signaling pathway plays an important role in a number of B-cell malignancies. Gene expression profiling data revealed BCR signaling as the most prominent pathway activated in chronic lymphocytic leukemia (CLL) cells isolated from lymphatic tissues. In Japan, tirabrutinib was approved in March 2020 for the treatment of relapsed or refractory PCNSL and launched under the tradename of Velexbru in May 2020. In addition, tirabrutinib was approved for the treatment of relapsed or refractory PCNSL in South Korea in November 2021 and in Taiwan in February 2022. Moreover, Velexbru was approved for the treatment of Waldenstrom macroglobulinemia and lymphoplasmacytic lymphoma in Japan in August 2020.

About the PROSPECT Study
The PROSPECT Study is a Phase 2 trial (NCT04947319) evaluating the safety and effectiveness of an investigational oral medicine called tirabrutinib for the potential treatment of newly diagnosed or relapsed/refractory (R/R) primary central nervous system lymphoma (PCNSL), which is a type of cancer that either does not improve from treatment (refractory) or improves only for a limited time (relapsed). Current treatment options for R/R PCNSL are limited, and there are no medications approved in the U.S. for the treatment of PCNSL. Learn more about the PROSPECT Study here: theprospectstudy.com.

On March 21, 2024 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, reported "Mtoxin Payload Applied in IDDC ADC Platform Significant Increases Therapeutic Index and Overcome MultiDrug Resistance in Various Tumor" as poster presentation from March 12 to 15, 2024 at the 14th World ADC London (Press release, Mabwell Biotech, MAR 21, 2024, View Source [SID1234641356]). The development of several ADC drugs under the capabilities of IDDC, a next generation ADC technology platform, was demonstrated.

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Evolutions of conjugation technologies, new release structures, and multiple mechanism payloads have prompted the development of ADC field. However, further improving drug delivery and overcoming drug resistance are urgent problems for the next generation of ADC drugs. Mabwell has independently developed IDDC technology and novel payload Mtoxin. The study results show:

1. DARfinity produces site-specific conjugated drugs with DAR 4 as the main component (DAR 4 ≥ 95%).

2. IDconnect enhances plasma stability and payload transfer efficiency of ADC drugs (40% increase from control group).

3. LysOnly technology enhances tumor-specific release capacity of ADC drugs and reduces off-target effects.

4. Mtoxin has good tumor penetration, bystander killing effect and anti-multidrug resistance.

5. ADC drugs developed based on IDDC and Mtoxin have good pharmacodynamic and safety characteristics, especially in the DXd-resistant multidrug resistance model.

Summary

IDDC is a clinically validated site-specific conjugation technology with good homogeneity, efficacy, and safety advantages. In addition, the novel payload Mtoxin (MF6) has good pharmacodynamics, bystander killing efficacy, and anti-multidrug resistance.

Novel ADC Drugs Developed Based on IDDC Platform

The IDDC platform has been validated in multiple drugs under study.

9MW2821 – novel Nectin-4-targeting ADC:
For the indication of urothelial carcinoma, 9MW2821 is the first Nectin-4 ADC developed by a Chinese company to enter phase III clinical studies, making it the second globally in terms of progress. 9MW2821 is also the first therapeutic drug with the same target in the world to disclose clinical efficacy data for indications of cervical cancer and esophageal carcinoma. It has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

7MW3711 – novel B7-H3-targeting ADC:
Clinical trials have been conducted for 7MW3711 for the indication of advanced solid tumors in China, and it has received FDA approval to conduct clinical trials for patients with advanced malignant solid tumors.

9MW2921 – novel Trop-2-targeting ADC:
Clinical trials have been conducted for 9MW2921 for the indication of advanced solid tumors in China.

On March 21, 2024 4SC AG (4SC, FSE Prime Standard: VSC) reported its financial results for the financial year ended 31 December 2023, presenting all material reporting period developments and providing an outlook for 2024 (Press release, 4SC, MAR 21, 2024, View Source [SID1234641355]). The full report is available at 4SC’s website.

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Jason Loveridge, Ph.D., CEO of 4SC, commented: "2023 was a real breakout year for 4SC, culminating with the filing of our MAA for resminostat (Kinselby) with the EMA in February 2024. This represents a very significant step forward for 4SC and was a great achievement for our team. It further de-risks our resminostat program and will assist our ongoing efforts to not only bring this important treatment to patients, but also commercialise the asset and create value for shareholders."

Key highlights of 2023
4SC had a very busy year in 2023, with key achievements summarized below, and further detail provided in respective press releases.

In January 2023, the company’s pre-authorisation eligibility request to the European Medicines Agency (EMA) for resminostat in cutaneous T-cell lymphoma was accepted. During its meeting in December 2022, the CHMP agreed, on the basis of the documentation provided, that resminostat was eligible to submit an application for European Union Marketing Authorisation according to the centralized procedure as detailed in Regulation (EC) No 726/2004.
In May 2023, 4SC announced topline data from its pivotal RESMAIN study, confirming resminostat had successfully met the primary endpoint in the study, demonstrating a statistically significant improvement in progression free survival in CTCL patients of 97.6%, with a risk reduction of 38% compared to placebo. The study confirmed the already well-known safety profile of resminostat.
Also in May 2023, the company submitted its letter of intent to file for Marketing Authorization for resminostat in CTCL and requested the appointment of a rapporteur with the EMA.
In June 2023, the EMA notified 4SC that it had accepted its Letter of Intent to Submit a Marketing Authorization Application (MAA) and rapporteurs would be appointed. The EMA also notified 4SC that its nominated trade name for resminostat – Kinselby – had been accepted by its Name Review Group (NRG).
In September 2023, RESMAIN study investigator, Professor Dr. Rudolf Stadler (University Hospital Johannes Wesling, Minden, Germany) presented positive new data from the pivotal RESMAN study at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting. The presented findings showed that maintenance therapy with resminostat is now clinically proven to postpone disease progression in advanced CTCL, which he expected, would lead to a significantly change in current clinical practice. Additional analyses established that patients receiving resminostat showed a clinically meaningful improvement in median "total" PFS (defined from the start of the last prior therapy to disease progression) of 24.3 months, compared to 14.9 months for those in the placebo group. Additionally, there was a significant delay in the development of new, or worsening of existing, skin tumours.
Also in September 2023, the US Food and Drug Administration (FDA) granted 4SC’s application for Orphan Drug Designation for resminostat for the treatment of CTCL.
In October 2023, the EMA granted Orphan Drug Designation for resminostat for the treatment of CTCL.
In December 2023, the Management Board of 4SC AG announced that the company had incurred a cumulative loss amounting to more than half of its share capital and pursuant to Section 92 (1) German Stock Corporation Act (AktG) would convene a general meeting. The meeting took place on 7 February 2024.
Business outlook for 2024
4SC’s future success, or failure, as a company is closely linked to the outcome of the company’s marketing authorization application for resminostat, an orally administered class I, IIb and IV histone deacetylase (HDAC) inhibitor that is in development as a maintenance therapy in CTCL.

Resminostat demonstrated significant benefit as maintenance therapy in the RESMAIN pivotal study – prolonging the period patients remain stable without progression and study results were published in May and September 2023. Given these data were positive, 4SC subsequently filed with the EMA for marketing approval for resminostat for the treatment of CTCL in Europe in February 2024. Filings for the UK and Switzerland are in preparation and, in addition, a pre-New Drug Application (NDA) meeting request was also submitted to the FDA in February 2024. In Japan, Yakult Honsha Co., Ltd. (Yakult Honsha) is responsible for filing the marketing authorization application for resminostat.

In 2024, 4SC expects to focus its resources on addressing questions from the EMA with respect to its MAA for resminostat as well as obtaining and assessing feedback from the USA FDA on 4SC’s pre-NDA submission. In addition, 4SC continues to hold discussions with potential partners in the pharmaceutical industry regarding the commercialization of its resminostat program with the assistance of a global investment bank.

Cash balance development in full year 2023 and financial forecast
4SC’s cash balance/funds were at €8,321 thousand on 31 December 2023. The average monthly operating cash burn in 2023 was €792 thousand, which was slightly lower than the forecast range of between €800 thousand and €1,100 thousand forecast for 2023. This is the result of later payments for agreed milestones in existing contracts for clinical trials. Taking into account the current financial planning and the intended operating activities, the Management Board estimates that current funds should be sufficient to finance 4SC for at least the next 12 months of operations.

Whilst 4SC’s funds of €8,321 thousand at the end of 2023 represent a solid cash position entering 2024, it is also clear that the funding environment for biotech companies deteriorated significantly in 2023 and as such management remains cautious as to 4SC’s ability to raise additional funds through further capital measures and to generate income with business partners. To address this risk, 4SC entered into a second loan agreement in the first quarter of 2024 with its largest shareholder giving the Company access to a further €3.5 million in available funding. For 2024, 4SC is expecting an average monthly use of cash from operations of between €600 thousand and €900 thousand.

On March 21, 2024 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, reported it is presenting new data about INTASYL on March 21st (Press release, Phio Pharmaceuticals, MAR 21, 2024, View Source [SID1234641354]). The event is scheduled to take place at the 10th Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference (ITOC10), which will be held in Munich, Germany from March 21-23, 2024.

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The poster, Enhancing NK cell cytotoxicity against tumor cells with a novel self-delivering RNAi compound targeting Cbl-b, reveals new preclinical data demonstrating the potential of treatment with INTASYL self-delivering siRNA Compound PH-905, formerly known as Compound 27547, to improve function of natural killer (NK) cells. The data reveals a consistent silencing of Cbl-b mRNA, which has been shown to limit NK cell activation. Cytotoxic activity of NK cells against K562 (Chronic Myelogenous Leukemia) cancer cells was also increased. By reducing the expression of Cbl-b, INTASYL promotes NK cell activation and proliferation. These preclinical data demonstrate the potential of INTASYL Compound PH-905 to improve Adoptive Cell Therapy (ACT) by targeting and silencing Cbl-b. This may result in a more effective cell therapy for hematological malignancies.

"These data underscore the versatility and potential of Phio’s INTASYL siRNA technology," said Phio’s President & CEO Robert Bitterman. "It offers a strategy to enhance the effectiveness of ACT therapies in hematological malignancies."

The preclinical data demonstrate the following:

INTASYL self-delivering RNAi compound PH-905 effectively targets and silences Cbl-b in primary NK cells without negative impact on their viability.
Silencing of Cbl-b results in increased proliferation of primary NK cells.
INTASYL silencing of Cbl-b in primary NK cells enhanced their functional cytotoxicity towards tumor cells.
Silencing of Cbl-b leads to enhanced fitness of NK cells through increased expression of CD98 and CD25, potentially improving NK metabolism and promoting activation in response to IL-2.
INTASYL compound PH-905 may be used to improve the anti-tumor response of NK cells to provide a more effective cell therapy for cancer treatment.
Presentation Details are as follows:
Title: Enhancing NK cell cytotoxicity against tumor cells with a novel self-delivering
RNAi compound targeting Cbl-b
Poster Number: P01.03
Topic: 01.Emerging concepts / New Agents
Presenting Author: Melissa Maxwell
Date and Time: 18:00 hrs Thursday, March 21, 2024
18:00-19:00 hrs Friday, March 22, 2024
Location: Ludwig Maximilian University Campus Großhadern,
Lecture Room 3, Marchioninistrasse 15
81377 Munich, Germany