On January 16, 2024 Instil Bio, Inc. ("Instil" or the "Company") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported a strategic update (Press release, Instil Bio, JAN 16, 2024, View Source [SID1234639260]).

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Instil has entered into an agreement with a collaborator that has a successful track record of manufacturing and dosing patients with cell therapies to conduct preclinical manufacturing feasibility studies in the ITIL-306 program. The feasibility studies have been initiated, and if the feasibility studies are successful, Instil’s collaborator may open an investigator-initiated clinical trial (IIT) to enroll patients with non-small cell lung cancer (NSCLC) in China. In the event the IIT generates compelling proof-of-concept clinical data in 2024, Instil may explore options for a potential transition of ITIL-306 to a US-based CDMO for manufacturing and clinical development primarily at US clinical trial sites.

With the objective of saving costs and improving time efficiency, the Company is announcing the closure of its UK manufacturing and clinical operations, thereby reducing its UK workforce which is expected to be substantially completed by the first half of 2024. Instil plans to retain key process development, research, and related personnel to advance early-stage pipeline development of CoStAR and other novel TIL technologies, and to support the company’s collaboration.

On January 16, 2024 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported presentations on POSLUMA (flotufolastat F 18) injection (formerly known as 18F-rhPSMA-7.3) at the upcoming ASCO (Free ASCO Whitepaper) GU 2024 Genitourinary Cancers Symposium (ASCO GU) (Press release, Blue Earth Diagnostics, JAN 16, 2024, View Source [SID1234639280]). The conference will be held in San Francisco, Calif., from January 25 to 27, 2024. POSLUMA is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

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"Presentations at ASCO (Free ASCO Whitepaper) GU include additional results from the completed Phase 3 SPOTLIGHT study, which evaluated POSLUMA in recurrent prostate cancer and its ability to detect recurrent disease even at low prostate specific antigen (PSA) levels," said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. "Results to be presented by Dr. Przemyslaw Twardowski, MD, will discuss the impact of POSLUMA on treatment plans for men with recurrent disease after curative-intent primary therapy. A presentation by Dr. Benjamin H. Lowentritt, MD, FACS, will speak about the impact of various Standard of Truth methods in evaluating diagnostic PET radiopharmaceuticals, using the SPOTLIGHT trial as a case study. Dr. Zachariah Taylor, DO, will present a Trials in Progress poster for an Investigator Initiated Study which is evaluating the performance of POSLUMA in detecting N1 and M1 disease for newly diagnosed prostate cancer and its impact on clinical management for patients with extraprostatic disease. PET imaging with POSLUMA reveals clinical information crucial to decision-making for men with prostate cancer, and we are excited to share this information with the oncology community at ASCO (Free ASCO Whitepaper) GU."

Details of the presentations are listed below.

Moderated poster presentation sessions will take place on Thursday, January 25, 2024 at 11:30 a.m. PT, on Level 1, West Hall of the George R. Moscone Convention Center, and also be available On Demand.

Poster Session A: Prostate Cancer

Primary Track Prostate Cancer- Advanced

Title:

Impact of 18F-flotufolastat PET on management of patients with recurrent prostate cancer: Data from the SPOTLIGHT study.
Presenter:

Przemyslaw Twardowski, MD, Saint John’s Cancer Institute at Providence Saint John’s Health Center, Santa Monica, Calif., on behalf of the SPOTLIGHT Study Group.
Abstract:

38
Poster Board #:

A17

Title:

Impact of standard-of-truth method on evaluation of a diagnostic PET radiopharmaceutical: Learnings from the phase 3 SPOTLIGHT study.

Presenter:

Benjamin H. Lowentritt, MD, FACS, Chesapeake Urology Research Associates, Baltimore, Md.

Abstract:

39

Poster Board #:

A18

Trials in Progress Poster Session A: Prostate Cancer

Primary Track: Prostate Cancer- Advanced

Title:

Role of 18F-flotufolastat PET/CT imaging in men with high-risk prostate cancer following conventional imaging and associated changes in medical management: A phase 3b investigator-initiated trial.
Presenter:

Zachariah Taylor, DO, Main Line Health, Philadelphia, Pa.
Abstract:

TPS347
Poster Board #:

Q21
Blue Earth Diagnostics invites participants at the ASCO (Free ASCO Whitepaper) 2024 Genitourinary Cancers Symposium to attend the presentations above. Participants onsite are also invited to visit Blue Earth Diagnostics’ booth (#72). For full session details and scientific presentation listings, please see the ASCO (Free ASCO Whitepaper) GU online program here.

Indication and Important Safety Information About POSLUMA

INDICATION

POSLUMA (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer

with suspected metastasis who are candidates for initial definitive therapy
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.
Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline.
POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.
Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.
To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf.

On January 16, 2024 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported new data from Part A of the DeFianCe study, a Phase 2 study evaluating DKN-01, Leap’s anti-Dickkopf-1 (DKK1) antibody, in combination with standard of care bevacizumab and chemotherapy in second-line patients with advanced colorectal cancer (CRC), to be presented at the upcoming 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium taking place in San Francisco, CA and virtually on January 18-20, 2024 (Press release, Leap Therapeutics, JAN 16, 2024, View Source [SID1234639261]).

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"Data from Part A of the DeFianCe study demonstrates that the addition of DKN-01 to bevacizumab and chemotherapy can generate clinically meaningful response rates and durable tumor reductions with a favorable safety profile in second-line CRC patients, particularly those with rectal or rectosigmoid tumors," said Meredith Pelster, MD, Assistant Director of Gastrointestinal Research at Sarah Cannon Research Institute and a study investigator. "We are very interested in utilizing DKN-01 to modulate the Wnt pathway, which is active in a high percentage of CRC patients, particularly left-sided tumors, to overcome resistance to chemotherapy, and to decrease angiogenesis in order to enhance the activity of the standard of care bevacizumab plus chemotherapy regimens. These results provide a strong foundation for the randomized controlled Part B of this study, which is enrolling extremely well and expected to complete enrollment mid-year."

"In this heterogenous second-line population with several unfavorable characteristics, the DKN-01 plus bevacizumab and chemotherapy Part A ORR of 30%, with a disease control rate of over 90%, and enhanced activity in left-sided tumors and rectal tumors, with a 46% ORR and 9.4 month preliminary PFS, represent an encouraging efficacy signal," said Zev Wainberg, MD, Professor of Medicine and Co-Director of the GI Oncology Program at UCLA. "CRC is a heterogenous disease where the selection of therapy and expected outcomes vary based on whether the tumor is on the left or right side, the presence or absence of genetic mutations, microsatellite instability, and prior therapy. Physicians want to be able to select a second-line therapy combination based on the patient’s personalized tumor characteristics, which is what we hope to achieve by adding DKN-01 and understanding the subgroups with the greatest clinical benefit."

Leap will host a conference call on January 23, 2024 at 8:30 a.m. Eastern Time in which Dr. Pelster and Dr. Wainberg will further discuss the new data from the DeFianCe study.

Key Findings:

· As of the December 6, 2023 data cutoff, 33 patients enrolled in Part A of the DeFianCe study
· Across all evaluable patients with second-line microsatellite stable CRC (n=27):
o Objective response rate (ORR) was 30% and disease control rate (DCR) was 93%, including 8 partial responses (PR) and 17 patients with a best response of stable disease (SD)
o Median progression-free survival (PFS) was 6.3 months
o 9 patients remain on therapy beyond 8.5 months
· Analysis revealed a breadth of clinical activity across additional subgroups, including patients with left-sided tumors (n=25)
o 33% ORR and 100% DCR in response-evaluable population (7 PRs, 14 SDs)
o Preliminary median PFS of 8.6 months (9 patients continuing on therapy within subgroup)
· Patients with rectal/rectosigmoid carcinomas (n=15) represent an important subpopulation:
o 46% ORR and 100% DCR in response-evaluable population (6 PRs, 7 SDs)
o Preliminary median PFS of 9.4 months (6 patients continuing on therapy within subgroup)
o Higher baseline plasma DKK1 levels correlated with improved responses
· DKN-01 plus bevacizumab and chemotherapy was well-tolerated, with a majority of DKN-01 related events being low grade (Grade 1/2)
· Randomized controlled Part B of the study is underway with 54 patients currently enrolled

Conference Call:

Leap’s management team, together with Dr. Pelster and Dr. Wainberg, will host a conference call on Tuesday, January 23, 2024 at 8:30 a.m. Eastern Time to further discuss the data. The conference call will be broadcast live in listen-only mode and can be accessed via the website URL: View Source A replay of the event will also be available for a limited time on the Investors page of the Company’s website at View Source

About the DeFianCe Study

The DeFianCe study (NCT05480306) is a Phase 2, open-label, global study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced CRC who have received one prior systemic therapy for advanced disease. The Part A cohort enrolled 33 patients, including significant numbers of patients who had early progression on first-line therapy, previous exposure to bevacizumab, tumors with Ras mutations, or liver metastases. The study has expanded into a 130-patient Part B randomized controlled trial. The primary objective of the study is progression free survival. Secondary objectives include overall response rate, duration of response, and overall survival.

On January 16, 2024 DISCO Pharmaceuticals ("DISCO"), a specialist biotech unlocking the surfaceome of cancer cells at scale to identify new targets and develop first in class drugs, reported the company emerged from stealth (Press release, DISCO Pharmaceuticals, JAN 16, 2024, View Source [SID1234639281]). The Company, operating out of Cologne, Germany and Schlieren, Switzerland, successfully raised seed financing of EUR 20 million and is backed by a world leading investor syndicate, including Sofinnova Partners, which led the round, Panakes Partners, M Ventures and AbbVie Ventures.

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The development of new treatment modalities in oncology is growing at an ever-increasing rate, but the lack of cancer-specific cell surface targets limits the application to a few clinically effective targets. The development of new biologics, such as antibody-drug conjugates (ADCs) and bi-specific antibodies, is on the rise; however, there are currently less than 30 molecular targets which form the basis of all antibody-based therapies. Therefore, there is a significant need to identify novel cancer-specific targets and target pairs.

DISCO’s pioneering surfaceome mapping platform transforms the current approach of target discovery for large molecule R&D. The technology identifies proteins and protein communities across the entire cancer cell surface in a scalable manner, thus addressing the need for target candidates for both mono- and bi-specific antibodies. These insights enable the development of a multitude of cancer-specific therapies, with the potential to boost efficacy and reduce side effects for patients. DISCO has started to create an internal pipeline of novel anti-cancer therapeutics leveraging this knowledge.

DISCO has completed the first-ever map of the surfaceome of a cancer type, Small Cell Lung Cancer, (SCLC) and is developing proprietary antibody-based treatments for SCLC, which has historically been difficult to treat. DISCO is currently working on Microsatellite-Stable Colorectal Cancer, which is associated with a high unmet medical need and for which only a few treatment options are available. The Company’s pipeline includes further undisclosed programs.

DISCO was spun out of ETH Zürich, with founders from ETH, the University of Cologne and Stanford University, and was founded in May 2022 by Prof. Roman Thomas, Dr. Johannes Heuckmann, Prof. Bernd Wollscheid and Prof. Julien Sage. The founders have a deep understanding of surface proteomics, cancer biology and drug discovery, and a track record of value creation. Dr. Stefan Ries, who has previously held leadership positions at Roche and was a venture partner at Versant Ventures, joins DISCO as Chief Scientific Officer. The DISCO team is complemented by a world leading group of scientific advisors.

In addition to the experienced Board of Directors from the investor syndicate, Dieter Weinand will join as Chairman of the Board. Dieter Weinand was previously the CEO of Bayer Pharmaceuticals and has held leadership positions at Pfizer, BMS and Sanofi. He currently serves on the Board of Coya Therapeutics (NASDAQ: COYA), as Chairman of the Boards of Replimune (NASDAQ: REPL), Umoja, and Inspirna, and as Executive Chairman of Mnemo Therapeutics. Furthermore, Carsten Reinhardt, M.D., Ph.D., Chief Development Officer at Immatics (NASDAQ: IMTX), joins the DISCO Board as an Independent Director. Previously, he was EVP and Chief Medical Officer at Micromet Inc, International Medical Leader at Hoffmann-La Roche, and has been serving as a director on supervisory boards to a variety of biopharma companies.

Roman Thomas, Founder and Chief Executive Officer, at DISCO Pharmaceuticals, said: "Today, we are launching DISCO Pharmaceuticals and its breakthrough technology after a decade of research by our exceptional team. We believe that our surfaceome discovery technology is truly disruptive and will transform oncology treatment options and ultimately improve outcomes for patients. The surfaceome mapping in Small Cell Lung Cancer – that we completed within months – has validated our technology platform and approach, demonstrating its potential, and we look forward to applying it to different indications."

Maina Bhaman, Partner at Sofinnova Partners, added: "DISCO is uniquely positioned to transform cancer care. The team, which brings together individuals with diverse backgrounds from academia, biotech and pharma, combined with its unique surfaceome discovery technology, enables comprehensive target information which neither standard proteomics, nor genome or transcriptome sequencing can provide."

Dieter Weinand, newly appointed Chairman of the DISCO Board of Directors, commented: "Expanding the possible target space in oncology has been a bottleneck in the industry for decades. I am thrilled to be working with the truly exceptional people at DISCO as I firmly believe that they will be able to overcome this hurdle by using their disruptive surfaceome discovery engine.

On January 16, 2024 Carcell Biopharma ("Carcell") and CATUG Biotechnology ("CATUG") reported their collaboration to provide lipid nanoparticle (LNP) services worldwide (Press release, Carcell Biopharma, JAN 16, 2024, View Source [SID1234639240]).

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This partnership aims to deliver contract research and manufacturing services globally for clients developing LNP-based drugs. These services will utilize Carcell’s proprietary cationic lipids and unique high throughput in vivo lipid screening platform, coupled with CATUG’s advanced capabilities for large-scale manufacturing of LNP-based drugs. Under the terms of the agreement, CATUG will have non-exclusive rights to utilize Carcell’s LNP technology for servicing its clients.

Lanlin Wu, CEO of Carcell, shared Carcell’s privilege to have CATUG as a strategic partner. She commended CATUG as the embodiment of the high execution speed of Chinese companies and is emerging as an industrial benchmark for gene therapy and nucleic acid drug production. Leveraging a proprietary large lipid library and internally-developed high-throughput formulation technology, Carcell has identified lipids with global intellectual property rights. When compared to industry benchmarks, these novel LNPs have demonstrated superior potency in applications that include vaccines and gene editing. Ms Wu believes that the partnership with CATUG unlocks multiple opportunities in the global non-viral nucleic acid delivery space and will contribute to the dynamic growth of the cell and gene therapy field.

Dr. Xiao Wang, CEO of CATUG, expressed that CATUG is honored to be in a strategic partnership with Carcell, whom possesses a world-class LNP development team and technical capabilities. As CATUG is committed to providing a one-stop CRDMO (Contract Research, Development and Manufacturing Organization) solution to customers globally, she believes that this newly formed strategic partnership with Carcell will empower customers who are seeking unique and high quality LNPs for drug delivery, for instance extra-hepatic delivery to immune cells. Such a partnership presents many opportunities for both parties and greatly accelerates R&D of various gene therapies and nucleic acid drugs.