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 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 Promega reported that a research published today in Nature Communications demonstrates a new potential approach for managing multiple myeloma and other hematological cancers (Press release, Promega, JAN 16, 2024, View Source [SID1234639279]). The molecule, called SJ3149, demonstrates potent anti-proliferative activity in a variety of human cancer cell lines through selective degradation of the cancer-causing protein CK1α. The authors suggest that this degrader shows great promise for broad-spectrum anti-cancer applications.

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"The rapid and robust degradation of CK1α affects the target’s cellular pathway, leading to broad killing in a variety of cancer cell models," says Promega Research Scientist Elizabeth Caine. "We believe the research in this paper will provide valuable insights to researchers developing all types of degrader molecules."

Targeted protein degradation is an emerging form of treatment in which a therapeutic molecule recruits the cell’s own machinery to destroy defective proteins. In this study, the team primarily focused on degrading a protein called CK1α, which is linked to uncontrolled cell proliferation. They report that SJ3149 potently and selectively degrades CK1α and limits the proliferation of multiple cancer cell lines spanning a wide range of disease subtypes. Their results strongly support future research on applying selective CK1α degraders to many different cancer types.

Promega scientists collaborated with researchers at St. Jude Children’s Research Hospital on this study. The paper is available open access from Nature Communications at View Source

Learn more about how Promega technologies are used to study targeted protein degradation here.

On January 16, 2024 MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company evaluating novel drug candidates to address known resistance mechanisms to standard-of-care cancer therapies, reported the design of the ongoing Phase 1b study of the mitochondrial oxidative phosphorylation (OXPHOS) inhibitor ME-344 in combination with bevacizumab (Avastin) in refractory metastatic colorectal cancer patients will be presented during a poster session at the 2024 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium to be held January 18 – 20, 2024 (Press release, MEI Pharma, JAN 16, 2024, View Source [SID1234639278]).

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Presentation Title: A Phase 1b Study of the OXPHOS Inhibitor ME-344 in Combination with Bevacizumab in Refractory Metastatic Colorectal Cancer
Session Title: Trials in Progress Poster Session C: Cancers of the Colon, Rectum, and Anus
Presenter: Patrick M. Boland
Date: Saturday, January 20, 2024, 6:30-7:45 AM (Pacific Time)
Abstract Number: TPS222

The poster can be viewed on the MEI Pharma website here:
View Source

About the Phase 1b Study

The ongoing Phase 1b study is evaluating ME-344 plus bevacizumab across two cohorts in patients with metastatic colorectal cancer after failure of standard therapies. The combination of ME-344 and bevacizumab is intended to create metabolic synthetic lethality by leveraging the ability of antiangiogenics like bevacizumab to reduce glycolysis, forcing tumors to switch to mitochondrial respiration via OXPHOS, which is inhibited by ME-344.

In the first cohort of approximately 20 patients ME-344 is administered at 10 mg/kg once weekly for 3 weeks in combination with bevacizumab every two weeks, with cycles repeated every 4 weeks. If the rate of non-progression in Cohort 1 reaches a predetermined progression free survival threshold, Cohort 2 will enroll an additional 20 patients. Patients will be treated until disease progression or intolerability. The primary endpoint of the study is progression free survival. Secondary endpoints include overall response rate, duration of response, overall survival and safety.

The study is being conducted at member centers of the Academic GI Cancer Consortium (AGICC), an oncology consortium dedicated to identifying new drugs to treat gastrointestinal (GI) cancers.

About ME-344

ME-344 is a novel drug candidate that inhibits mitochondrial oxidative phosphorylation (OXPHOS), a fundamental metabolic pathway involved in the production of adenosine triphosphate (ATP) in the mitochondria. ATP provides energy to drive many metabolic cell processes, including division, proliferation, and growth. By disrupting the production of ATP, ME-344 has been shown to induce cancer cell death in nonclinical models and was associated with antitumor activity in clinical studies.

The two main sources of ATP production in cells are OXPHOS and glycolysis; the latter is highly active in most tumors. Anti-angiogenics, like the vascular endothelial growth factor (VEGF) inhibitor bevacizumab (AVASTIN), have the potential to normalize vasculature and decrease reliance on glycolysis. The resulting reduction in glycolysis may trigger an increased dependence on mitochondrial ATP production for energy to support continued tumor proliferation.

In such cases of tumor plasticity, the combination of ME-344 and bevacizumab may induce metabolic synthetic lethality, providing a novel therapeutic strategy. Specifically, leveraging the ability of antiangiogenics like bevacizumab to reduce glycolysis and force tumor cells to switch to mitochondrial respiration via OXPHOS, which is inhibited by ME-344, may reduce access to ATP needed for cell division and growth in tumors.

This approach was first clinically evaluated in a multicenter, investigator-initiated, randomized, open-label, window of opportunity clinical study, evaluating ME-344 (3 doses) plus bevacizumab (1 dose) in 42 women with early HER2-negative breast cancer. Study results demonstrated significant biological antitumor activity as measured by a reduction in the proliferative biomarker Ki-67 compared to placebo. The combination appeared to be generally well tolerated. The data from this study were consistent with preclinical data suggesting that combining ME-344 can augment anti-angiogenic therapy and provided validation for continued evaluation of the combination of ME-344 with bevacizumab and other VEGF inhibitors.

An earlier Phase 1 clinical study evaluating ME-344 as a single-agent in patients with refractory solid tumors also demonstrated anti-tumor activity, further validating the potential of mitochondrial inhibition as a promising therapeutic modality.

On January 16, 2024 Presage Biosciences, a biotechnology company whose mission is to enable precision drug response evaluation in the human tumor microenvironment (TME), reported that the U.S. Food and Drug Administration (FDA) has issued a Study May Proceed notification for testing a pre-GMP drug candidate with the CIVO platform (Press release, Presage Biosciences, JAN 16, 2024, View Source [SID1234639277]). The drug candidate, PBA-0405, is owned by Poland-based biopharmaceutical company, Pure Biologics, and represents the earliest stage material to date that will be evaluated in patients in a CIVO Phase 0 clinical trial. PBA-0405 is a ROR1-targeting compound that has been engineered to induce tumor cell killing by cytotoxic immune cells.

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"We are very excited by this first opportunity to evaluate pre-GMP material in partnership with Pure Biologics," said Patrick Gray, PhD, Presage CEO. "This is a tremendous step forward for both Presage and overall drug development. We continue to push the bounds on finding alternatives to using preclinical models that fail to capture the effects of novel agents in the intact TME."

"The Pure Biologics team is incredibly proud of this momentous achievement," said Dr. Filip Jelen, Pure Biologics Co-Founder and President of the Management Board." "Our partnership with Presage was key in achieving this milestone and we eagerly await the first insights into drug efficacy and impact on the tumor microenvironment."

About CIVO
Comparative In Vivo Oncology (CIVO) is Presage’s patented platform that enables multiplexed intratumoral microdosing and generation of detailed tumor profiling. The CIVO device can deliver up to eight different drugs or drug combinations simultaneously into trackable drug columns. Presage’s CIVO technology and analysis capabilities are unparalleled at providing insight into drug-exposed areas of the intact tumor microenvironment. Presage is pairing the use of CIVO with molecular profiling technologies in both preclinical and Phase 0 trials in order to inform and de-risk oncology drug development.