On May 28, 2024 HighField Biopharmaceuticals, a clinical stage company using lipid-based therapeutics to treat cancer, diabetes and other diseases, reported that it will present positive clinical and preclinical data of HFK1, a drug encapsulated immunoliposome for treatment of solid tumors, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting May 31 – June 4, in Chicago, IL (Press release, HighField Biopharmaceuticals, MAY 28, 2024, View Source [SID1234643762]).

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The poster presentation describes preliminary findings from the company’s Phase 1a study of HFK1 for HER2 low expression cancers. The first patient dosed suffers from lung metastasis of a rare HER2 low cancer. The patient has been treated with HFK1 for more than five months with no dose-limiting toxicity and stable disease.

The clinical and preclinical data, which will be presented by HighField CEO and Scientific Founder Yuhong Xu, Ph.D., also includes study results comparing HFK1 to other antibody drug conjugates (ADCs) and PEGylated liposomal doxorubicin (PLD). The findings demonstrate HFK1 improves significantly on the safety and efficacy of ADCs and PLD. In particular, HFK1 exceeded ADCs in expanding the drug therapeutic window and reducing tumor growth.

"We look forward to sharing the encouraging data of our HFK1 studies at ASCO (Free ASCO Whitepaper)," said Dr. Xu. "They confirm our confidence that our unique drug encapsulated immunoliposomes will offer a new alternative for targeting HER2 low cancers with lower off-target toxicities and wider therapeutic windows."

The poster, titled "The design, preclinical study and Phase 1 dose escalation of a HER2 targeted immunoliposome (HF-K1) for HER2 low solid tumor treatment," will be presented Saturday, June 1, 2024 (9am -12pm CDT).

HighField’s Phase 1 open-label clinical trial is enrolling patients who have advanced refractory solid tumors with HER2 low expression. The Phase 1a dose escalation portion will be followed by a Phase 1b dose expansion phase. Both the Phase 1a and 1b studies will assess the safety and preliminary efficacy of HFK1. For more information visit NCT05861895 on clinicaltrials.gov.

HighField’s immunoliposomes represent a new generation of targeted chemotherapy drugs following the success of antibody drug conjugates (ADCs). Due to their unique features, HighField’s immunoliposomes may offer better safety with greater efficacy in treatment of a broad range of solid tumor types.

On May 28, 2024 Affini-T Therapeutics, Inc., a clinical stage biopharmaceutical company focused on the development of precision immunotherapies for treatment of patients with solid tumors, reported that the first patient has been dosed in the Company’s Phase 1 clinical trial evaluating AFNT-211 targeting KRAS G12V (Press release, Affini-T Therapeutics, MAY 28, 2024, View Source [SID1234643761]). A Trial-In-Progress poster for this ongoing Phase 1 trial will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Annual Meeting held in Chicago, IL May 31-June 4.

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"Dosing the first patient in our lead clinical program represents an important milestone for our company, our scientific co-founders that made this possible, and the patients we hope to serve," said Jak Knowles, M.D., Co-Founder, President and Chief Executive Officer, Affini-T Therapeutics. "With our lead programs targeting KRAS G12V in the clinic and a deep research pipeline targeting KRAS G12D and p53 under development, we are well positioned to develop multiple novel therapies for cancer patients with limited treatment options."

"Our goal is to address the significant unmet need of patients with difficult-to-treat solid tumors," said Dirk Nagorsen, M.D., Chief Medical Officer, Affini-T Therapeutics. "AFNT-211 is specifically designed to leverage precision immunotherapy and synthetic biology approaches to target the oncogenic driver mutation KRAS G12V in patients who are HLA-A*11:01-positive. We have made great progress with our clinical trial work since we started enrolling and treating patients across our two programs, AFNT-111 and AFNT-211, earlier this year."

Presentation details are as follows:

Title: AFNT-211: A phase 1 study of autologous CD4+ and CD8+ T cells engineered to express a high avidity HLA-A*11:01-restricted, KRAS G12V-specific, transgenic TCR, a CD8α/β coreceptor, and a FAS41BB switch receptor in patients with advanced/metastatic solid tumors.
Hall A, Abstract # TPS8650, Poster Board # 513a, Session Title: Lung Cancer—Non-Small Cell Metastatic
Session Date/Time: Monday, June 3, 2024, 1:30 PM – 4:30 PM CDT
Presenting Author: Shaunica Mitchell, M.P.A., Senior Director, Clinical Science, Clinical Development, Affini-T Therapeutics

About AFNT-211
AFNT-211 is an investigational autologous T cell therapy that is being administered to patients for the first time. AFNT-211 is currently being evaluated in a Phase 1 clinical trial open to adult patients with solid tumors who have a KRAS G12V mutation. Additional information on the ongoing clinical trial can be accessed at clinicaltrials.gov, NCT06105021.

On May 28, 2024 Eikon Therapeutics, Inc., a pioneering biotechnology company that leverages advanced engineering to enhance drug discovery and development, reported that multiple abstracts highlighting its clinical-stage TLR 7/8 co-agonist (EIK1001) and PARP1-selective inhibitor (EIK1003) programs will be presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held in Chicago May 31 – June 4, 2024 (Press release, Eikon Therapeutics, MAY 28, 2024, View Source [SID1234643760]).

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The oral presentation (Abstract: 2521) highlights safety and preliminary efficacy data from a clinical study (NCT03486301) of EIK1001, a Toll-like receptor 7/8 (TLR7/8) co-agonist, in combination with pembrolizumab in participants with advanced solid tumors. The new data show that EIK1001 was well-tolerated with a manageable safety profile, and showed encouraging preliminary efficacy across several tumor types in combination with pembrolizumab. Responses were observed even in heavily pretreated patients not anticipated to respond to pembrolizumab monotherapy. Anthony W. Tolcher, MD, FASCO, of New Experimental Therapeutics (NEXT), will deliver the presentation on June 2, 2024 at 12:42 PM CDT.

"We are encouraged by the promising data emerging from our lead clinical programs," said Roy D. Baynes, MB.BCh., Ph.D., Chief Medical Officer of Eikon Therapeutics. "The safety and preliminary efficacy results for EIK1001, in combination with pembrolizumab and with atezolizumab, underscore the potential of these promising approaches. We highlight also the advancement of EIK1001 into front-line combinations with standard-of-care pembrolizumab and chemotherapy in non-small cell lung cancer, and of our PARP1-selective inhibitor, EIK1003, into phase 1 studies in cancers selected for specific genotypes."

In addition, three posters will be presented and include:

Title: A first-in-human (FIH), phase 1/2, dose-escalation, dose-optimization, and dose-expansion study of PARP1-selective inhibitor EIK1003 (IMP1734) in participants with advanced solid tumors.
Abstract Number: TPS3191 (Poster Bd# 320b)
Abstract Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Date/Time: June 1, 2024, 9:00 AM – 12:00 PM CDT
Presenter: Guru Sonpavde, MD, Medical Director of Genitourinary Oncology, Assistant Director of the Clinical Research Unit and Christopher K. Glanz Chair for Bladder Cancer Research, AdventHealth Cancer Institute.

Title: Safety and preliminary efficacy of EIK1001 in combination with atezolizumab in participants with advanced solid tumors.
Abstract Number: 2618 (Poster Bd# 97)
Abstract Session: Developmental Therapeutics—Immunotherapy
Date/Time: June 1, 2024, 9:00 AM – 12:00 PM CDT
Presenter: Manish Patel, MD, Director of Drug Development, Florida Cancer Specialists & Research Institute/Sarah Cannon Research Institute.

Title: A phase 2 study of EIK1001, a Toll-like receptor 7/8 (TLR7/8) agonist, in combination with pembrolizumab and chemotherapy in patients with stage 4 non-small cell lung cancer.
Abstract Number: TPS8667 (Poster Bd# 521b)
Abstract Session: Lung Cancer—Non-Small Cell Metastatic
Date/Time: June 3, 2024, 1:30 PM – 4:30 PM CDT
Presenter: Dan Costin, MD, FACP, Director, White Plains Hospital, Center for Cancer Care.

Eikon will also host a booth in the exhibition hall (#32116) at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting.

On May 28, 2024 SOTIO Biotech, a clinical-stage immuno-oncology company owned by PPF Group, reported the dosing of the first patient in its Phase 1, first-in-human clinical trial evaluating SOT201, a next-generation PD-1-targeting immunocytokine (Press release, SOTIO, MAY 28, 2024, View Source [SID1234643759]). The VICTORIA-01 study will evaluate the safety, tolerability and initial efficacy of SOT201 monotherapy for the treatment of advanced solid tumors.

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"While anti-PD-1 therapeutics have been a great advance in cancer medicine, still only a minority of patients respond to them. Additionally, even patients successfully treated frequently acquire resistance to these therapies, leading to cancer progression. Novel treatments are needed to overcome these therapeutic limitations," said Richard Sachse, M.D., Ph.D., chief medical officer of SOTIO. "The initiation of the VICTORIA-01 study demonstrates SOTIO’s continued dedication to deliver innovative immunotherapies that can address the challenges of solid tumor treatment. We look forward to further researching the potential that SOT201 holds for patients who have not seen success with other available treatments."

SOT201 is an antibody-cytokine fusion protein that could improve upon the efficacy of approved checkpoint inhibitors by combining PD-1 targeting with IL-15 immune stimulation in a single therapeutic construct. This combined action of SOT201 makes it promising as a potent standalone therapy that could be especially useful for the treatment of patients with primary or acquired resistance to checkpoint inhibitors (CPIs). The preclinical profile of SOT201 supports its potential to offer best-in-class antitumor activity and broad clinical applicability.

The VICTORIA-01 study is a Phase 1, open-label, dose escalation study of SOT201 which will assess its safety, tolerability, and preliminary efficacy as a monotherapy for patients aged 18 years or above with advanced unresectable or metastatic solid tumors (NCT06163391). The study is now enrolling patients at The University of Texas MD Anderson Cancer Center in Houston, Texas, led by principal investigator Dr. Aung Naing. Additional clinical sites across Europe – including in Belgium, Czech Republic and Spain – will initiate enrollment in the coming months.

On May 28, 2024 Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, reported it will present new data from its Phase 1 DRAGON proof-of-concept trial of SRK-181 in combination with pembrolizumab in patients with advanced solid tumors in an oral presentation during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held May 31 – June 4 in Chicago (Press release, Scholar Rock, MAY 28, 2024, View Source [SID1234643758]). Those data will be discussed further during a webcast on June 4th at 7 a.m. CDT/8 a.m. EDT that includes Jing Marantz, M.D., Ph.D., Chief Medical Officer at Scholar Rock, and Dr. Toni Choueiri, M.D., Director of the Lank Center for Genitourinary (GU) Oncology at Dana-Farber Cancer Institute (DFCI).

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"We continued to observe encouraging responses and tolerability in heavily pretreated patients across multiple cancer types, providing further evidence of SRK-181’s potential to overcome resistance to immune checkpoint inhibitors," said Jay Backstrom, M.D., M.P.H., President and Chief Executive Officer of Scholar Rock. "In addition, biomarker data indicated that treatment with SRK-181 is associated with an enhanced proinflammatory microenvironment and increased anti-tumor activity. Together, these new data provide further validation of the selective approach of our TGFβ platform. We look forward to sharing additional updated data at ASCO (Free ASCO Whitepaper)."

Data highlights are as follows:

– SRK-181 continued to be well tolerated in the dose expansion portion of the DRAGON trial (Part B).

– Encouraging responses were observed across multiple cancer types, including clear cell renal cell carcinoma (ccRCC), head and neck squamous cell carcinoma (HNSCC), melanoma (MEL), and urothelial carcinoma (UC).

– Biomarker data showed that the SRK-181 + pembrolizumab treatment combination created an enhanced proinflammatory microenvironment in anti-PD-(L)1 resistant patients.

– Patients with ccRCC whose tumors were infiltrated at baseline by CD8+ T cells and/or regulatory T cells showed positive correlations between infiltration of each cell type and response rate. This positive correlation between baseline infiltration status type and response rate suggests a potential patient selection strategy.

These results will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting in an oral presentation, details of which can be found below.

Title: Phase 1 study (DRAGON) of SRK-181 (linavonkibart), a latent TGFβ1 inhibitor, combined with pembrolizumab in anti-PD1 resistant patients with advanced solid tumors: Updated results of expansion part
Oral Session: Developmental Therapeutics—Immunotherapy
Presenter: Ulka N. Vaishampayan, MD, Division of Hematology/Oncology, University of Michigan
Location: Hall D2
Date/Time: June 3, 1:50 p.m. CDT

Conference Call Information
Scholar Rock will host a conference call on June 4 at 8 a.m. EDT that can be accessed by registering in advance at the Events and Presentations page of Scholar Rock’s website. Members of Scholar Rock’s executive management team will be joined by Dr. Toni Choueiri, M.D., Director of the Lank Center for Genitourinary (GU) Oncology at Dana-Farber Cancer Institute (DFCI).

The abstracts for these presentations are available on ASCO (Free ASCO Whitepaper)’s website View Source The presentations will be made available in the Publications & Posters section of Scholar Rock’s website following the conference.

For conference information, visit View Source

About SRK-181
SRK-181 is a selective inhibitor of TGFβ1 activation being developed to overcome primary resistance to checkpoint inhibitor therapy, such as anti-PD-(L)1 antibodies, in advanced cancer. TGFβ1 is the predominant TGFβ isoform expressed in many human tumor types. Based on analyses of various human tumors that are resistant to anti-PD-(L)1 therapy, data suggest that TGFβ1 is a key contributor to the immunosuppressive tumor microenvironment, excluding and preventing entry of cytotoxic T cells into the tumor, thereby inhibiting anti-tumor immunity. (2) SRK-181 specifically targets the latent TGFβ1 isoform in a context-independent manner, designed to enable complete inhibition of TGFβ1 in all compartments within the tumor microenvironment. Scholar Rock believes that SRK-181 has the potential to overcome this immune cell exclusion and induce tumor regression when administered in combination with anti-PD-(L)1 therapy while potentially avoiding toxicities associated with non-selective TGFβ inhibition. Enrollment of the DRAGON Phase 1 proof-of-concept clinical trial (NCT04291079) was completed in December 2023, and patients who remain on the study continue to be treated. The trial enrolled patients in multiple proof of concept cohorts conducted in parallel, including urothelial carcinoma (UC), cutaneous melanoma (MEL), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and clear cell renal cell carcinoma (ccRCC). SRK-181 is an investigational product candidate and its efficacy and safety have not been established. SRK-181 has not been approved for any use by the FDA or any other regulatory agency.