On May 20, 2024 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported the successful completion of CUPID[1], a first-in-human Phase I dose escalation study of TLX592 in patients with advanced prostate cancer (Press release, Telix Pharmaceuticals, MAY 20, 2024, View Source [SID1234643469]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

TLX592 (225Ac-PSMA-RADmAb) is Telix’s investigational "next generation" targeted alpha therapy (TAT) for the treatment of prostate cancer and is the first clinical program to utilise Telix’s proprietary RADmAb engineered antibody technology. The RADmAb approach accelerates blood clearance and reduces bone marrow residence time compared with standard monoclonal antibodies (mAbs), while retaining target selectivity, internalisation and retention. The RADmAb platform is currently under pre-clinical and clinical evaluation for multiple cancer targets.

The CUPID (64Cu PSMA Imaging and (Bio) Distribution) study is a 3+3 mass dose escalation study with four patient cohorts intended to evaluate the safety, tolerability, pharmacokinetics, biodistribution and radiation dosimetry of TLX592. The study utilises copper-64 (64Cu) which is detectable by Positron Emission Tomography (PET) as a surrogate for actinium-225 (225Ac), enabling a successful proof-of-targeting study as well as predictive dosimetry calculations for future studies with 225Ac. Preliminary results in 11 evaluable patients enrolled in the study demonstrated accelerated blood kinetics compared to the standard antibody TLX591, while demonstrating similar (favourable) on-target and off-target biodistribution and hepatic clearance. There were no serious adverse events observed in the study.

Based on these encouraging results, Telix expects to advance TLX592 into a therapeutic Phase I/II study with 225Ac in the second half of 2024, subject to regulatory approval. TLX592 further deepens Telix’s PSMA[2]-targeting prostate cancer therapy portfolio and supplements its lead investigational radio antibody-drug conjugate (rADC) TLX591 (177Lu rosopatamab tetraxetan), currently being investigated in the ProstACT GLOBAL Phase III study. The Company intends to publish and present non-clinical and clinical data supporting these results at several upcoming symposia.

Dr David N. Cade, Group Chief Medical Officer at Telix stated, "The CUPID study demonstrated clearly how theranostic approaches can be used to streamline novel radiopharmaceutical drug development. In this case, PET imaging was used to dose-find a targeting agent for future use with an alpha emitter, while establishing basic safety and utility parameters that will greatly inform ongoing development of this product candidate.

"There is a significant unmet need for novel targeting platforms that may be used with alpha emitting isotopes and avoid renal toxicity and other off-target effects, such as the exocrine gland uptake typical of PSMA small molecule agents. We are excited to progress TLX592 into therapeutic studies where our aim is to develop this agent for both early metastatic prostate cancer and late-stage patients who are no longer responding to lutetium therapy. We would like to thank all participants for their commitment to the CUPID study."

On May 20, 2024 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that Atara has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tabelecleucel (tab-cel) indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy (Press release, Atara Biotherapeutics, MAY 20, 2024, View Source [SID1234643454]). For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. There are no FDA approved therapies in this treatment setting.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The BLA submission for tab-cel represents a significant moment for Atara, our partner Pierre Fabre, and the broader allogeneic T-cell therapy field, and is a critical step towards our goal of delivering this first-of-its-kind treatment to EBV+ PTLD patients in the U.S.," said Pascal Touchon, President and Chief Executive Officer of Atara. "I would like to thank the patients and physicians who participated in the tab-cel clinical trials, our long-time collaborators at Memorial Sloan Kettering Cancer Center, as well as our internal teams for their remarkable dedication and hard work. We now look forward to continued collaboration with the FDA on its review and with Pierre Fabre as they actively prepare for the potential launch of this innovative therapy in the U.S."

Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. The BLA is supported by pivotal and supportive data covering more than 430 patients treated with tab-cel across multiple life-threatening diseases including the latest pivotal ALLELE study data that demonstrated a statistically significant 48.8% Objective Response Rate (ORR) (p<0.0001) and favorable safety profile consistent with previous analyses.

Tab-cel has been granted Breakthrough Therapy Designation for the treatment of rituximab-refractory EBV-associated lymphoproliferative disease by the U.S. FDA and has orphan drug designation.

In December 2023, Atara announced the closing of the expanded global partnership with Pierre Fabre Laboratories for the U.S. and remaining global commercial markets for tab-cel, building on an initial partnership covering Europe, Middle East, Africa, and other select emerging markets. With the completion of the tab-cel BLA submission, Atara continues to advance the Pierre Fabre expanded global partnership, which includes potential milestone payments of $20 million and $60 million from Pierre Fabre contingent upon the successful FDA acceptance and approval of the tab-cel BLA, respectively. In addition, Pierre Fabre is reimbursing Atara for expected tab-cel global development costs through the BLA transfer and purchasing tab-cel inventory through the manufacturing transfer date. Atara is also eligible to receive double-digit tiered royalties on net sales of tab-cel in the U.S. and remaining global commercial markets referenced above.

Tab-cel was granted marketing authorization under the brand name Ebvallo in December 2022 by the European Commission. Marketing authorization was also granted by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom in May 2023 and by Swissmedic in Switzerland in May 2024. In all three territories, Ebvallo is indicated as monotherapy for the treatment of adult and pediatric patients two years of age and older with relapsed or refractory EBV+ PTLD who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.

On May 20, 2024 YGION Biomedical GmbH, a company dedicated to developing individualized neoantigen-based cancer vaccines, reported the completion of a Series A financing round of €15 million from an Austrian private trust (Press release, YGION Biomedical, MAY 20, 2024, View Source [SID1234643470]). The proceeds will be used to further develop YGION’s unique YGNITETM technology platform and advance the lead program YG-01 into preclinical and clinical development.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Founded in 2022, YGION’s high-profile team of experienced biotech veterans and entrepreneurs are focused on developing individualized "plug-and-play" cancer vaccines through a proprietary suite of technologies to identify, produce and target the delivery of relevant peptide neoepitopes resulting in safe, exceptionally potent, and precise targeted activation of the patient’s immune system.

"We are on the cusp of a breakthrough in individualized cancer treatments" said Dr. Wolfgang Fischl, Chief Executive Officer of YGION. "This financing is truly exciting for YGION as we see it as a strong validation of our unique approach, and we are grateful for the support of our investors enabling us to take a significant step towards clinical validation of our technology. With the continued demonstration of the efficacy of our approach, we are open to additional investors and collaborators interested in our ground-breaking approach."

"We are confident that with our technology, we can realize the promise of simple, safe and effective cancer vaccines" added Dr. Geert Mudde, Chief Technology Officer of YGION. "Our YGNITETM platform gives us the unique ability to identify, select and synthesise relevant neoantigens, and combined with our CARGONAUTTM immune-modulating carrier induces a powerful cell-mediated tumor specific response that targets and eliminates malignant cells with unmatched safety."

YGION’s lead program YG-01 is currently in preclinical development.

On May 20, 2024 The Experimental Drug Development Centre (EDDC), Singapore’s national platform for drug discovery and development, reported that the Phase 1 trial for EBC-129 has progressed into dose expansion (Press release, Experimental Drug Development Centre, MAY 20, 2024, View Source [SID1234654037]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

EBC-129 is the first made-in-Singapore ADC to enter clinical development. The tumour antigen it targets is a specific N-glycosylated site conserved on both CEACAM 5 and 6 which is selectively expressed on cancer cells, over normal cells. This allows EBC-129 to address a broad range of solid cancers expressing either one or both tumour markers, including cancers prevalent in Asia like gastroesophageal and lung cancers, as well as cancers with very limited treatment options like pancreatic cancer and cholangiocarcinoma.

The Phase 1 trial began with a dose escalation study which evaluated the safety and tolerability of EBC-129 in patients with unresectable metastatic solid tumours. The first patient for the dose escalation was dosed at the National Cancer Centre Singapore (NCCS) in May 2023. EBC-129 is also being tested at the National University Cancer Institute, Singapore (NCIS), as well as the MD Anderson Cancer Center and the University of Colorado Cancer Center in the United States. The dose escalation study showed that EBC-129 is well-tolerated by cancer patients. Tumour shrinkage was observed in an oesophageal cancer patient as well as a pancreatic cancer patient.

The Phase 1 trial has now progressed into dose expansion, with the first patient for this part of the study dosed on 13th May 2024. The dose expansion study comprises three groups of 15 patients each with gastroesophageal cancers, pancreatic ductal adenocarcinomas, and solid tumours expressing the tumour antigen at moderate or high levels.

The ADC and the immunohistochemistry (IHC)-based test used for patient selection were developed collaboratively by NCCS, A*STAR’s Bioprocessing Technology Institute (BTI) and the Institute for Molecular and Cell Biology (IMCB), as well as EDDC.

"Our team at NCCS has been very encouraged by the progress of this ongoing trial for EBC-129 which has shown good tolerability and early signs of efficacy in the dose escalation study," said Clinical Assistant Professor Matthew Ng, Head, Department of Gastrointestinal and Neurological Medical Oncology, NCCS. "We have strong patient interest for participation in the dose expansion study and look forward to the development of EBC-129 as a potential treatment for cancer patients in the future."

"I am excited to delve deeper into EBC-129’s promise as a therapeutic option for pancreatic and gastroesophageal cancers through the dose expansion study. The demand for safe and effective treatments in these cancer types remains substantial, and we are dedicated to addressing these unmet needs," said Dr Yong Wei Peng, Senior Consultant, Department of Haematology-Oncology, NCIS.

"We are thrilled by the positive developments we have seen in the dose escalation study, and grateful for all our collaborators as well as the team at EDDC, who have been instrumental for us to reach this milestone", said Prof Damian O’Connell, EDDC’s Chief Executive Officer. "We will continue to work with our clinical partners to progress the dose expansion study and advance the potential of EBC-129 as an effective, targeted therapy for cancer patients."

About EBC-129
EBC-129 targets a specific N-glycosylated site conserved on CEACAM5 and CEACAM6 and is highly tumour-specific. This epitope has functional importance in tumour formation, migration and metastasis. Thus, EBC-129 is able to address a wide range of solid tumours with high unmet medical needs, including lung, gastric, oesophageal, pancreatic, breast, ovarian and biliary tract cancers. The payload used in EBC-129 is monomethyl auristatin E (MMAE), which has been extensively tested and approved for clinical use in other marketed ADCs, and has shown synergy with PD-1 inhibitors.

For more information on EBC-129 and its development, please refer to View Source

For information about the trial, please visit Clinicaltrial.gov, trial identifier NCT05701527.

On May 20, 2024 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported financial results for the first quarter ended March 31, 2024 and provided a corporate update (Press release, Compugen, MAY 20, 2024, View Source [SID1234643455]).

"I am proud of our continued progress across our pipeline in the first quarter of 2024, and planned catalyst rich 2024 ahead of us," said Anat Cohen-Dayag, Ph.D., President and Chief Executive Officer of Compugen. "We are on track to present data from our ongoing studies this year. First up, microsatellite stable colorectal cancer (MSS CRC) at ASCO (Free ASCO Whitepaper) followed by platinum resistant ovarian cancer in the fourth quarter of 2024. We are also well advanced in our preparation for a COM503 Phase 1 study. In addition, our partner, AstraZeneca, has advanced its PD-1/TIGIT bispecific, rilvegostomig, into its second Phase 3 program, in nonsquamous NSCLC, bringing us closer to realizing potential future milestone payments and royalties."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Cohen-Dayag continued, "Our first data will come from the very difficult to treat MSS CRC patient population, the majority of whom have liver metastases. This patient population historically have not responded to immune-oncology (IO) therapies. We pursued this indication based on an encouraging 12% overall response rate in the liver metastases population supported by immune activation in the tumor microenvironment suggestive of COM701 mediated activity. The data planned to be presented in June at ASCO (Free ASCO Whitepaper) remains supportive of COM701’s activity and safety with some patients continuing treatment at the data cutoff date. However, based on the data planned to be presented at ASCO (Free ASCO Whitepaper), we believe that IO-IO approach in patients with MSS CRC and liver metastases is not the way forward for Compugen at this time."

Dr. Cohen-Dayag added, "Our second data set this year will come from our platinum resistant ovarian cancer study, which is biologically distinct from MSS CRC, and in which our reported data suggest more dominant PVRIG pathway expression levels. We selected this indication to be pursued in the ongoing triplet study based on the deep durable responses, associated immune activation and potential associated biomarker data observed in our prior study, following treatment with our COM701 triple combination. It is important to note that observations made in tumors that are biologically distinct from each other, such as MSS CRC and platinum resistant ovarian cancer, are not indicative of each other. We believe that data showing clinical benefit in platinum resistant ovarian cancer would allow us to pursue the next studies towards a path to registration."

Dr. Cohen-Dayag concluded, "Compugen is a pioneer in computational discovery of novel drug targets. Our discovery platform, powered by AI and machine learning is fueling our pipeline and provides us with a competitive advantage. It has already delivered multiple proprietary clinical assets, multiple validating partnerships with pharma, and multiple early-stage undisclosed assets, all having the potential to deliver long term value creation."

Upcoming Expected Milestones
COM701 +COM902 + pembrolizumab proof-of-concept studies
•
Microsatellite stable colorectal cancer – ASCO (Free ASCO Whitepaper) poster presentation, June 1, 2024
•
Platinum resistant ovarian cancer – planned data presentation in the fourth quarter of 2024

COM503 (licenced to Gilead, Compugen lead through Phase 1 development)
•
IND submission in the second half of 2024 with subsequent initiation of the Phase 1 study following IND clearance

Rilvegostomig (AstraZeneca’s PD-1/TIGIT bispecific, TIGIT component derived from COM902)
•
Data in the second half of 2024 from Phase 1/2 ARTEMIDE-01 trial in advanced/metastatic NSCLC

First Quarter 2024 Financial Highlights
Cash: As of March 31, 2024, Compugen had approximately $101.3 million cash, cash equivalents, restricted cash, and cash investments, compared with approximately $51.1 million as of December 31, 2023. The cash balance as of March 31, 2024, includes $60 million upfront payment received from Gilead related to the licensing of COM503 and $10 million milestone payment received from AstraZeneca on dosing the first patient in the Phase 3 ARTEMIDE-Biliary01 study in biliary tract cancer. All payments from Gilead are subject to a 15% withholding tax. During the three months ended March 31, 2024, the Company sold approximately 0.3 million ordinary shares, under its at the market offering (ATM) facility pursuant to a sales agreement entered into with Leerink Partners on January 31, 2023, for aggregate gross proceeds of approximately $0.6 million.

Compugen expects that its cash and cash-related balances together with a $30 million milestone payment on COM503 IND clearance expected in 2024, will be sufficient to fund its operating plans into 2027. This does not include any additional cash inflows from partners. The Company has no debt.

Revenue: Compugen reported approximately $2.6 million in revenue for the first quarter ended March 31, 2024, compared to no revenue for the comparable period in 2023. The revenue reported reflects recognition of a portion of the upfront payment from the license agreement with Gilead.

R&D expenses for the first quarter of 2024 were approximately $6.4 million compared with approximately $7.4 million for the comparable period in 2023.

G&A expenses for the first quarter of 2024 were approximately $2.4 million, compared with approximately $2.6 million for the comparable period in 2023.

Net loss for the first quarter of 2024 was approximately $7.3 million, or $0.08 per basic and diluted share, compared with a net loss of approximately $9.3 million, or $0.11 per basic and diluted share, in the first quarter of 2023.

Full financial tables are included below.

Conference Call and Webcast Information
Compugen will hold a conference call today, May 20, 2024, at 8:30 AM ET to review its first quarter 2024 results. To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S., or +972-3-918-0644 internationally. The call will be available via live webcast through Compugen’s website, located at the following link. Following the live webcast, a replay will be available on Compugen’s website.