On June 8, 2022 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat ESR1-mutated metastatic breast and gynecological cancers, reported that its poster detailing the results of its Phase 2 lasofoxifene trial, known as ELAINE-2, received a GRASP Advocate Choice Award (Press release, Sermonix Pharmaceuticals, JUN 8, 2022, View Source [SID1234615765]). GRASP, which stands for Guiding Researchers and Advocates to Scientific Partnerships, connects patient advocates with cancer researchers to make faster and more impactful progress to improve cancer treatments. The Sermonix poster will be discussed during two GRASP Poster Walkthroughs at the conclusion of the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The poster, Open-Label, Phase 2, Multicenter Study of Lasofoxifene (LAS) Combined with Abemaciclib (Abema) for Treating Pre- and Post-Menopausal Women with Locally Advanced or Metastatic ER+/HER2− Breast Cancer and an ESR1 Mutation after Progression on Prior Therapies, will be examined during virtual GRASP Poster Walkthroughs on June 9 and June 10. The sessions are titled Breast Cancer – Metastatic; ESR1 Mutation.

The ASCO (Free ASCO Whitepaper) poster describes positive findings from the study related to safety and efficacy in women with ER+/HER2- mBC and an ESR1 mutation who had progressed on previous CDK4/6i therapies. Lasofoxifene is the only selective estrogen receptor modulator (SERM) currently being developed exclusively to treat breast cancers with ESR1 mutations.

"Sermonix believes in the potential of lasofoxifene, and we recognize patient advocates play a critical role in bringing awareness to researchers and scientists about the realities of the patient experience," said Dr. Elizabeth Attias, Sermonix chief strategy and development officer. "We thank GRASP for the vitally important work it does to unite patients, clinicians and researchers, and we look forward to discussing our ELAINE-2 study poster and learning more about the needs of women with acquired endocrine resistance and ESR1 mutations."

Attias and Dr. David Portman, Sermonix founder and chief executive officer, will participate in the June 9 Poster Walkthrough. Dr. Senthil Damodaran, the study’s primary investigator, and Dr. Paul Plourde, vice president of oncology clinical development for Sermonix, will participate in the June 10 session.

GRASP was started in 2019 by two women who are living with breast cancer, based on the recognition that facilitating the patient experience and researcher discussion early and often forges powerful collaborations that positively impact the research landscape. It is GRASP’s aspiration to make cancer research more patient-centered, innovative and inclusive. GRASP intentionally keeps its Poster Walkthrough groups small and informal, helping patients to feel comfortable in a conversational atmosphere that informs the patient and researcher exchange.

The ELAINE studies of lasofoxifene were named in honor of Dr. Elaine Davidson Nemzer, sister of Sermonix co-founder Dr. Miriam Davidson Portman. Nemzer was a brilliant and compassionate child psychologist whose life was cut short by metastatic breast cancer at the age of 47.

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

On June 8, 2022 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported completion of patient accrual in its Phase 3 REVELATE clinical trial of 18F-fluciclovine, a positron emission tomography (PET) imaging radiopharmaceutical being studied for potential use in detecting recurrent brain metastases after radiotherapy (Press release, Blue Earth Diagnostics, JUN 8, 2022, View Source [SID1234615781]). The REVELATE study is a prospective Phase 3, multi-center, single-arm imaging study being conducted in the United States.

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Note: 18F-fluciclovine is an approved molecular imaging radiopharmaceutical for use in PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. The safety and efficacy of 18F-fluciclovine PET imaging for the detection of recurrent brain metastases has not been established.

"Expanding our 18F-fluciclovine franchise into neuro-oncology is part of the overall growth strategy for Blue Earth Diagnostics, and completion of Phase 3 patient accrual sets a major milestone in our development plan," said David E. Gauden, D.Phil., Chief Executive Officer. "We look forward to receiving the clinical results from REVELATE, and to presenting results of the Phase 2 PURSUE study at upcoming scientific meetings later this year. Additionally, we wish to thank the patients, physicians and clinical trial sites who worked closely with us to complete enrollment despite the many challenges presented by the COVID-19 pandemic. In line with our mission to develop novel PET radiopharmaceuticals to inform the management and care of patients with cancer, we are hopeful that our efforts may help patients with recurrent metastatic brain cancer."

"Radiation therapy is a mainstay of treatment for brain metastases which provides effective tumor control but can result in radiation necrosis," said Samuel T. Chao, MD, Department of Radiation Oncology, Cleveland Clinic; Professor at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio; and Coordinating Investigator on the REVELATE Phase 3 study. "Serial magnetic resonance imaging (MRI) is often used to monitor patients after treatment. However, physicians face challenges in diagnosing and managing suspicious lesions found upon post-treatment surveillance, as they may represent tumor recurrence or treatment-related changes such as radiation necrosis. Significant progress has been made in diagnostic imaging modalities to assist in differentiating these entities, among them the use of amino acid-based PET radiopharmaceuticals. The Phase 3 REVELATE trial is designed to investigate the diagnostic performance of amino acid 18F-fluciclovine PET imaging as a potential decision-making aid in assessing the status of a patient’s disease."

"Limitations of conventional MRI are recognized in guidelines and recommendations established by the Response Assessment in Neuro-Oncology (RANO) group. Recommendations from the RANO/PET working group in 2019 cite the potential utility of amino acid PET radiopharmaceuticals in distinguishing brain tissue changes after radiation therapy from recurrent brain metastases. In noting that existing data have been derived mainly from single center, retrospective studies, a call for prospective multi-center studies has been re-iterated to validate these observations," said Eugene J. Teoh, MBBS, MRCP, FRCR, D.Phil., Chief Medical Officer of Blue Earth Diagnostics. "18F-Fluciclovine holds potential clinical utility for the detection of other cancers besides recurrent prostate cancer. As an amino acid-based PET radiopharmaceutical, 18F-fluciclovine is designed to visualize the increased amino acid transport that occurs in malignant tumors and we eagerly await the results of the REVELATE and PURSUE clinical trials."

About the REVELATE and PURSUE Clinical Trials in Brain Metastases
Blue Earth Diagnostics has two clinical studies investigating the use of 18F-fluciclovine PET in the detection of recurrent brain metastases. The REVELATE study ("Study to Establish the Diagnostic Performance of 18F-fluciclovine PET in Detecting Recurrent Brain Metastases") is an open-label, single-arm, single-dose, prospective, multi-center Phase 3 study designed to establish the diagnostic performance of 18F-fluciclovine PET in detecting recurrent brain metastases after radiation therapy. The primary endpoint of the REVELATE study is to assess the Negative Percent Agreement (NPA, equivalent to specificity) and Positive Percent Agreement (PPA, equivalent to sensitivity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a patient level. Secondary endpoints will assess the Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of 18F-fluciclovine PET for detecting recurrent brain metastases, among others. The Phase 2 PURSUE trial is designed to establish image interpretation criteria for 18F-fluciclovine PET in detecting recurrent brain metastases. Further information about these trials can be found on www.clinicaltrials.gov (REVELATE, NCT04410133, PURSUE, NCT04410367).

About 18F-Flucivlovine PET and Recurrent Brain Metastases
18F-flucivlovine PET is a novel diagnostic imaging radiopharmaceutical for PET imaging to visualize the increased amino transport that occurs in malignant tumors. It consists of a synthetic amino acid that is preferentially taken up by cancer cells compared with surrounding normal tissues and is labeled with the radioisotope 18F for PET imaging. 18F-flucivlovine is under investigation by Blue Earth Diagnostics for potential use in adults for the detection of recurrent brain metastases in patients who have previously undergone radiation therapy. 18F-fluciclovine is approved by the U.S. Food and Drug Administration (FDA) and in the EU for PET imaging in men with recurrent prostate cancer. 18F-fluciclovine was invented at Emory University, in Atlanta, Ga., with much of the fundamental clinical development carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Blue Earth Diagnostics licensed 18F-fluciclovine from GE Healthcare and is investigating the molecule for other potential cancer indications, including in neuro-oncology.

On June 8, 2022 EpiAxis Therapeutics has reported the results of its pioneering clinical trial EPI-PRIMED, the first time that an epigenetic inhibitor has been used in combination with chemotherapy to treat metastatic cancer (Press release, EpiAxis Therapeutics, JUN 8, 2022, View Source;utm_medium=rss&utm_campaign=epiaxis-therapeutics-clinical-trial-validates-targeting-lsd1-inhibition [SID1234615797]).

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The purpose of the EPI-PRIMED study was to investigate the safety of the combination, nab-paclitaxel and an irreversible LSD1 inhibitor, in patients with metastatic breast cancer (mBC). Women with inoperable or metastatic breast cancer from three Australian facilities: Canberra Region Cancer Centre, Southern Medical Day Care Centre and Liverpool Hospital participated in the study. The results of this trial have now been published in leading cancer journal Frontiers of Oncology.

CEO Jeremy Chrisp said the results of the clinical trial provide proof of concept for the company’s current drug development program for its first in class therapies to inhibit nuclear LSD1. In particular EpiAxis was pleased to note the biomarker results indicate that inhibition of LSD1 was associated with phenotypic change away from an aggressive phenotype in cancer cells.

"The publication of this study is the culmination of several years’ work and the results are important for both patients and the company, as we have demonstrated that nuclear inhibition of LSD1 is possible and results in cell reprogramming," Dr Chrisp said.

"This indicates that we are on the right track to progress our novel first in class candidates to a new clinical trial. We would like to thank the staff and patients of the three sites that participated, as well as EpiAxis Therapeutics founding scientist Professor Sudha Rao. We look forward to sharing the immune data from the study in the near future."

The findings of the EPI-PRIMED study give EpiAxis a solid foundation for its next clinical trial using its novel peptide inhibitors. The company is currently working with The Sage Group to raise US$12million to advance a candidate into an IND enabled program.

Dr Chrisp will be attending the BIO International Convention with The Sage Group from 13-16 June 2022 at San Diego Convention Center to facilitate discussions with interested parties.

On June 08, 2022 Anagenex, a pioneering drug discovery company pairing large-scale data generation with machine learning to discover the next generation of small molecule medicines, reported that it has closed a $30 million Series A financing round led by Catalio Capital Management, with participation from existing investors Lux Capital, Khosla Ventures, Obvious Ventures, Air Street Capital, and Menlo Ventures (Press release, Anagenex, JUN 8, 2022, View Source [SID1234648814]). Catalio’s George Petrocheilos and Dr. Matthew Hobson will be joining the company’s Board as a Director and Observer respectively. Anagenex will use its Series A funds to further expand its novel data generating platform and build a robust pipeline of programs addressing historically challenging unmet medical needs.

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"At Lux, we’ve repeatedly seen how merging state-of-the-art computational tools with custom built lab operations transforms drug discovery to bring innovative medicines to patients"

"Traditional small molecule drugs, which account for the majority of FDA approvals, remain the best and most cost-effective medicines for most patients," said Nicolas Tilmans, CEO of Anagenex. "However, they are still very challenging to develop. At Anagenex we’ve built a closed-loop iterative system inspired by evolution that alternates between massive lab experiments and next-generation, machine learning-powered predictions so that we can deliver novel small molecule medicines to patients faster."

The Anagenex platform iteratively assesses up to billions of compounds in parallel to generate extraordinarily high quality data. First, Anagenex experimentally tests billions of compounds in parallel using a mix of technologies such as DNA Encoded Libraries (DELs) and Affinity Selected Mass Spectrometry. Those measurements feed into proprietary machine learning (ML) algorithms that consider not only the results of that experiment, but also hundreds of billions of other datapoints from internal databases. The trained ML models then design the next "evolved" generation of compounds to test, which Anagenex then synthesizes and tests. This creates a virtuous cycle of real data perfecting ML models, in turn, driving better data with each cycle. Armed with these enormous datasets and highly accurate models, Anagenex has the tools to address some of the hardest targets in drug discovery.

"We see a lot of platform technologies, but were blown away by Anagenex’s potential to fundamentally reshape how small molecule drugs are discovered," said George Petrocheilos, General Partner at Catalio. "Going after targets that have frustrated the industry for decades is always a risky business. The power and efficiency of Anagenex’s platform makes that risk tolerable, especially considering the potential payout."

Since beginning operations in the fall of 2020, Anagenex has built a customized parallel biochemistry lab miniaturizing, automating and carefully measuring every step in its parallel processes. This means Anagenex can rapidly generate data of unmatched quality, giving its ML algorithms an unprecedented clear view of chemical space.

"At Lux, we’ve repeatedly seen how merging state-of-the-art computational tools with custom built lab operations transforms drug discovery to bring innovative medicines to patients," said Zavain Dar, founding investor and Venture Partner at Lux Capital. "By controlling its process from start to finish, Anagenex’s expert team can build tailored neural networks and lab methodologies to achieve game-changing results."

Rapid Progress to Date

Prior to this Series A financing, Anagenex raised $7.2 million in a seed round led by Lux Capital in 2020, with participation from Obvious, Air Street Capital, Menlo, and Khosla. Since then, Anagenex’s team has applied their decades of experience in ML, parallel chemistry and biochemistry to build and validate the first generation of the company’s platform. With the Series A funding, Anagenex has now raised a total $37.2 million in financing to date.

To date, the Anagenex platform has processed over 25 targets and identified biochemically active compounds for eight of those with more coming weekly. Anagenex’s directed evolution platform has also identified small molecule compounds for a validated "undruggable" target. These powerful results have enabled Anagenex to develop a strong pipeline, including several early-stage drugs for cardiovascular and oncology indications.

For more information about Anagenex, go to www.anagenex.com.

On June 8, 2022 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to participate in the Goldman Sachs 43rd Annual Global Healthcare Conference on Wednesday, June 15, 2022, at 9:20 a.m. Pacific Time (PT) (Press release, CRISPR Therapeutics, JUN 8, 2022, View Source [SID1234615750]).

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A live webcast of the presentation will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 14 days following the presentation.