On May 28, 2024 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, reported business updates and reported financial results for the three-month period ending March 31, 2024 (Press release, Cellectis, MAY 28, 2024, View Source [SID1234644826]).

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"We are thrilled to have announced the closing of the additional equity investment of $140 million by AstraZeneca. This followed AstraZeneca’s initial payment of $105 million, composed of a $80 million equity investment and a $25 million upfront payment under our research collaboration.

Following AstraZeneca’s additional investment, we expect our cash runway to fund operations into 2026. We will continue to focus our efforts and expenses on advancing its core clinical trials BALLI-01, NATHALI-01 and AMELI-01, which remain wholly owned assets, while building, within our owned preclinical pipeline and in collaboration with AstraZeneca, the next generation of medicines to address areas of high unmet patient needs.

We strongly believe that gene edited cell and gene therapy products are revolutionizing medicine across a number of therapeutic areas and will become a large part of molecular medicine of the future." said André Choulika, Ph.D., Chief Executive Officer at Cellectis.

Pipeline Highlights

UCART Clinical Programs

Cellectis continues to focus on the enrollment of patients in the BALLI-01 study (evaluating UCART22) in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), in the NATHALI-01 study (evaluating UCART20x22) in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r B-NHL), and in the AMELI-01 study (evaluating UCART123) in relapsed or refractory acute myeloid leukemia (r/r AML).
We expect to provide updates in the advancements of BALLI-01 and NATHALI-01 by year-end 2024.

Partnerships

Licensed Allogeneic CAR T-cell Development Programs

Anti-CD19 program

Allogene’s investigational oncology products utilize Cellectis technologies. Servier, which has an exclusive license to the anti-CD19 investigational products from Cellectis, has granted Allogene an exclusive sublicense to these products in the U.S., European Union and the United Kingdom.

Allogene announced the execution with Servier of an amendment to the sublicense to expand the licensed territory to the European Union and the United Kingdom.
Allogene announced that it continues to focus on the development of its investigational product cemacabtagene ansegedleucel, or cema-cel (previously known as ALLO-501A), as part of the first line (1L) treatment plan for LBCL patients who are at risk of relapse following 1L chemoimmunotherapy. Allogene announced that start-up activities for the ALPHA3 trial are ongoing with a planned study initiation in mid-2024.
Allogene further announced that enrollment is ongoing in the relapsed/refractory (r/r) CLL cohort of the Phase 1 ALPHA2 trial of cema-cel.

Anti-CD70 program

The anti-CD70 program is licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to this program.

Allogene announced that a Phase 1 data update of the ongoing TRAVERSE trial with ALLO-316 in RCC from approximately 20 patients with CD70 positive RCC is planned by YE 2024.

Corporate Updates

Collaboration and Investment Agreements with AstraZeneca

On May 6, 2024, Cellectis announced the completion of the subsequent investment of $140M in Cellectis by AstraZeneca (LSE/STO/Nasdaq: AZN).
AstraZeneca subscribed for 10,000,000 "class A" convertible preferred shares and 18,000,000 "class B" convertible preferred shares, in each case at a price of $5.00 per convertible preferred share, issued by the board of directors of Cellectis.
AstraZeneca owns approximately 44% of the share capital and 30% of the voting rights of the Company (based on the number of voting rights currently outstanding).

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.