Immix Biopharma to Present at the 2023 JMP Securities Hematology and Oncology Summit

On November 30, 2023 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us") a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, reported that it will present and host institutional investor meetings at the 2023 JMP Securities Hematology and Oncology Summit (Press release, Immix Biopharma, NOV 30, 2023, View Source [SID1234638067]).

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The JMP Securities Hematology and Oncology Summit

Presentation Date: Tuesday, December 5, 2023
Presentation Time: 3:30 pm ET
Location: Virtual
Webcast: Link
Investor Meetings: The IMMX Team will be available for institutional investor meetings during the conference.
The presentation will be broadcast live and archived on www.immixbio.com under "Events & Presentations" in the Investor Relations section. A replay of the webcast will be available on the Company’s website for approximately 90 days.

Exact Sciences Presents Multiple Studies at San Antonio Breast Cancer Symposium Supporting Optimization and Individualization of Therapy for Breast Cancer Patients

On November 30, 2023 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported that it will present new data and study results across its Precision Oncology and hereditary cancer platforms at the 2023 annual San Antonio Breast Cancer Symposium (SABCS) (Press release, Exact Sciences, NOV 30, 2023, View Source [SID1234638066]).

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A leading provider of cancer screening and diagnostic tests, Exact Sciences gives patients and health care professionals the clarity needed to take life-changing action earlier. (PRNewsfoto/EXACT SCIENCES CORP)

"Exact Sciences is looking forward to presenting new evidence at SABCS that adds important perspectives to treating breast cancer patients and showing that some patients may be able to de-escalate treatments and still have positive outcomes," said Dr. Rick Baehner, Chief Medical Officer, Precision Oncology, Exact Sciences. "Every year, we build upon the precedent set by the Oncotype DX Breast Recurrence Score test and its prognostic and predictive abilities to determine the chemotherapy benefit for specific breast cancer patients. We are pleased to see authorities expanding access to this test as we continue to develop key evidence in collaboration with some of the world’s most prestigious, breast cancer-focused organizations."

In cooperation with several leading breast cancer research organizations, Exact Sciences will present late-breaking data and a study included in the SABCS press program. Results from Puerto Rico will also detail germline findings for a cohort of women, most of whom had a personal or familial history of breast cancer. The results suggest a distinct genetic background for hereditary cancer predisposition in the study population.

Exact Sciences will also host a discussion about the Oncotype DX Breast Recurrence Score test and the RSClin Tool. Christy Russell MD, VP Medical Affairs, Exact Sciences; Jennifer Racz, MD, Director, Oncology Medical Affairs, Exact Sciences; and Jay Andersen, MD, Co-Director, Compass Breast Specialists and Associate Chair, US Oncology Breast Cancer Research Committee; will review the development and validation of the RSClin Tool in patients with node-negative, early-stage breast cancer as well as discuss its utility for patients and providers.

The discussion will take place:

When: Thursday, December 7th, 4:00-5:00 p.m. CT
Where: Exhibit Hall Product Theater A, Henry B. Gonzalez Convention Center, San Antonio, Texas

Exact Sciences will present the following data at SABCS 2023:

1.

Title: Magnetic Resonance Imaging and a 12-Gene Expression Assay to Optimize Local Therapy for Ductal Carcinoma In Situ: 5-year clinical outcomes of E4112 – Chosen for SABCS Press Program

Summary: This prospective trial, the first to evaluate the predictive ability of the 12-gene DCIS score, provides data regarding the omission of radiation therapy after surgery in patients with DCIS breast cancer who have low DCIS score results, and the benefit of radiation therapy in patients with intermediate/high DS results.

Oral Presentation ID: GS03-01: Friday, December 8, 2023, 8:15-11:15 a.m.
2.

Title: Impact of age and ovarian function suppression (OFS) on endocrine response to short preoperative endocrine therapy (ET): Results from the multicenter ADAPTcycle trial Chosen as Late Breaking Abstract at SABCS

Data embargoed until: 7:15 a.m. CT on Friday, December 8

Presentation ID: LBO1-05: Friday, December 8, 2023, 12:00-12:45 p.m.

3.

Title: Comparison of whole exome, whole transcriptome genomic profiling and targeted sequencing with 50-gene panels

Summary: A comparison of the OncoExTra whole-exome, whole-transcriptome, comprehensive genomic profiling test to three commercially available and one custom 50-gene panels in a cohort of breast cancer patients. The study determined the frequency of patient tumors that would have had no actionable alteration identified when employing each of the 50-gene panels, when an actionable alteration identified by the OncoExTra test was present, across the three different breast cancer subtypes. The highest proportion of patients was missed (no actionable finding) by 50-gene panels when the cancer was the TNBC subtype and the lowest for HER2+.

Presentation ID: Poster ID PO5-13-05: Friday, December 8, 2023, 12:00-2:00 p.m. (Poster Session 5)

4.

Title: Classifying HER2-low breast cancer using a combination of ERBB2 mRNA expression and altered genes

Summary: Comparison of ERBB2 gene expression, measured using mRNA levels, with HER2 (encoded by ERBB2 gene) protein expression, measured by IHC/FISH. A comparison of altered biomarkers across HER2 protein expression categories was also made. ERBB2 expression levels and alterations in selected biomarkers were used to train a logistic regression classifier to predict HER2 protein expression status. Preliminary results indicate that some HER2-0 samples were classified as HER2-low by the classifier.

Presentation ID: Poster ID P05-13-06: Friday December 8, 2023, 12:00 -2:00 p.m. (Poster Session 5)

5.

Title: Prevalence of genomic alterations in Xerna tumor microenvironment subtypes in triple negative breast cancer patients

Summary: 203 triple negative breast cancer tumor samples were assigned to four different Xerna tumor-microenvironment categories (high versus low immune score, high versus low angiogenic score) based on gene expression of about 100 genes. The prevalence of actionable alterations in biomarkers was then determined across these four tumor microenvironment subtypes. About half of cancer samples had high immune scores, suggesting possible response to ICI therapy. More than half of patient samples carried actionable alterations. Together, these findings suggest the possibility of novel combination therapies in some TNBC patients.

Presentation ID: Poster ID PO2-06-10: Wednesday Dec 6, 2023, 5:00-7:00 p.m. (Poster Session 2)

6.

Title: Hereditary cancer genetic testing in Puerto Rican females

Summary: Nearly one thousand Puerto Rican females were tested with a hereditary cancer panel containing 29 genes. 90 (9.5%) individuals had a pathogenic or likely pathogenic alteration in their germ line at one or more of these genes. The proportion of individuals carrying a pathogenic/likely pathogenic variant at a cancer gene is within the range reported for other Caribbean countries. However, there was no evidence for enrichment of alterations at BRCA1, BRCA2 and PALB2 as observed in other Caribbean countries. The study also denotes a lack of genetic testing amongst specific disparate populations.

Presentation ID: Poster ID: PO1-08-08: Wednesday, December 6, 2023, 12:00 p.m.-2:00 p.m. (Poster Session 1)

7.

Title: Concordance Study of Oncotype DX Breast Recurrence Score Results from Paired Breast Cancer Core Needle Biopsies and Surgical Excision Specimens

Summary: Comparison of Oncotype DX Recurrence Score results for paired core needle biopsy and surgical samples of the same tumor without intervening systemic therapy, which found high concordance between the two.

Presentation ID: PO4-08-09: Thursday, December 7, 2023, 5:00-7:00 p.m. (Poster Session 4)

8.

Title: Comparison of the cost-effectiveness of multigene assays for HR+/HER2- node-negative early-stage breast cancer in the US

Summary: Compares the cost-effectiveness of using different genomic assays for treatment decisions in HR+HER2- early breast cancer (Oncotype DX, MammaPrint, EndoPredict, and Prosigna ROR) relative to that of using clinical-pathological features alone in the U.S. The modeling found that all were cost-effective as additions to clinical-pathological features, with the Oncotype DX test providing the greatest cost savings among the four.

Presentation ID: PO1-01-10: Wednesday, December 6, 2023, 12:00 -2:00 p.m. (Poster Session 1)

9.

Title: A comparison of chemotherapy recommendations by NPI, Predict, and Oncotype DX testing in UK women with early node-positive breast cancer

Summary: Comparison of the Oncotype DX Recurrence Score test, the Nottingham Prognostic Index, and the Predict Breast Cancer tool in risk stratification and association with chemotherapy recommendations in HR+HER2- node-positive early breast cancer. Of the three, the Oncotype test was the most strongly associated with chemotherapy recommendation.

Presentation ID: PO1-14-05: Wednesday, December 6, 2023, 12:00-2:00 p.m. (Poster Session 1)

10.

Title: Update of RSClin tool with extended TAILORx follow-up and development and validation of a new tool for risk of late distant recurrence

Summary: Update of the TAILORx findings with longer follow-up and resulting refinements to the RSClin tool for estimating 10-year risk of distant recurrence in HR+HER2- early breast cancer. A new tool specifically to estimate late (5-10 year) distant recurrence risk is also presented.

Presentation ID: PO1-02-02: Wednesday, December 6, 2023, 12:00-2:00 p.m. (Poster Session 1)

11.

Title: Irish National Analysis of the Clinical and Economic impact of 21-gene Oncotype DX testing in Early-Stage, 1-3 lymph node-positive, Hormone Receptor positive (HR+), HER2-Negative (HER2-), Breast Cancer (BC)

Summary: An analysis of the impact of Oncotype DX testing in a N1 (disease with 1-3 positive LN) breast cancer population from 2 Irish cancer centers identified a 55% reduction in chemotherapy use with savings of over €1 million. The objectives of this study were to examine the clinical and economic impact of Oncotype DX testing on treatment decisions in N1 patients at a national level with a larger patient population, and to examine changes in the ordering of Oncotype DX tests pre- and post-RxPONDER data. This study extended the analysis to 5 Irish cancer centers.

Presentation ID: PO5-02-04: Friday, December 8, 2023, 12:00-2:00 p.m. (Poster Session 5)

12.

Title: Real-world application of a 21-gene recurrence score in a Swiss single center breast cancer population. A comparative analysis of treatment administration before and after TAILORx

Summary: A comparison of chemotherapy recommendations and use before and after TAILORx. There were some differences in treatment recommendations after TAILORx that included increased recommendation for addition of chemotherapy to endocrine therapy, specifically among younger women, but there were no significant changes in chemotherapy administration.

Presentation ID: Poster Number: P1-14-02: Wednesday December 6, 2023, 12:00-2:00 p.m. (Poster Session 1)

Cidara Therapeutics to Present New Preclinical Data on Novel Dual-Acting Drug-Fc Conjugates at ESMO Immuno-Oncology Annual Congress

On November 30, 2023 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported the company will present new preclinical data on its novel, dual-acting CD73/PD-1 targeting drug-Fc conjugate (DFC) candidate at the ESMO (Free ESMO Whitepaper) Immuno-Oncology (IO) Annual Congress (Press release, Cidara Therapeutics, NOV 30, 2023, View Source [SID1234638065]). Cidara will also present new preclinical data on CBO421, its first-in-class CD73 targeting DFC. The conference is taking place December 6-8, 2023, virtually and in-person in Geneva, Switzerland.

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Presentation details are summarized below:

Title: Discovery of a Novel, Dual CD73 & PD-1 Targeting Multispecific Drug Fc-Conjugate (DFC) for the Treatment of Cancer
Presenter: James Levin, Ph.D., Cidara Therapeutics
Date and Time: Thursday, December 7, 2023, 12:00-1:00 PM CET

Title: Discovery of CBO421, a First-in-Class Drug Fc-Conjugate (DFC), Targeting CD73 in Cancer
Presenter: Simon Döhrmann, Ph.D., Cidara Therapeutics
Date and Time: Thursday, December 7, 2023, 12:00-1:00 PM CET

Can-Fite Reports Third Quarter 2023 Financial Results and Clinical Update

On November 30, 2023 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, reported financial results for the nine months ended September 30, 2023 (Press release, Can-Fite BioPharma, NOV 30, 2023, View Source [SID1234638063]).

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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

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Clinical & Development Milestones Achieved

Namodenoson Drug Candidate:

Complete Response and 6.9 Year Survival Reported in Patient with Advanced Liver Cancer Treated with Namodenoson

A patient who had participated in Can-Fite’s prior Phase II liver cancer study who continues to receive treatment with Namodenoson under a compassionate use program now has overall survival of 6.9 years with the disappearance of ascites, normal liver function, and good quality of life, defined as a complete response. Enrollment is ongoing in Can-Fite’s pivotal Phase III study of Namodenoson in the treatment of advanced liver cancer. During the third quarter, the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) selected Can-Fite for the prestigious Breakthrough Abstract Award from Conquer Cancer for its abstract titled "A novel approach for the treatment of advanced hepatocellular carcinoma (HCC)".

Pancreatic Carcinoma Phase IIa Study with Namodenoson is Underway

Namodenoson inhibited the growth of pancreatic carcinoma in a pre-clinical study through a mechanism that entails the Ras pathway. The Company continues to receive awards and recognition from leading cancer associations, and articles summarizing Namodenoson’s robust anti-cancer effect in pancreatic carcinoma have been published. The American Association of Cancer Research (AACR) (Free AACR Whitepaper) accepted Can-Fite’s study titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via De-regulation of the Wnt/β-catenin Signaling Pathway" for a poster presentation at the AACR (Free AACR Whitepaper) Special Conference on Pancreatic Cancer. Biomolecules, a peer-reviewed scientific journal focused on the function and mechanism of bioactive molecules, published an article titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via Deregulation of the Wnt/β-catenin, NF-κB, and RAS Signaling Pathways".

Piclidenoson Drug Candidate:

Entered Rare Genetic Disease Market with Treatment for Lowe Syndrome

In preclinical studies, Piclidenoson has been found to be effective in Lowe Syndrome, a rare genetic disease with no treatment available, and an estimated $100 million treatment market in the U.S. alone. Lowe Syndrome usually develops in the first year of life, causing brain abnormalities associated with intellectual disabilities and a life span shortened to less than 40 years. The discovery of Piclidenoson’s efficacy in Lowe Syndrome was made by researchers at the University of Naples Federico II and The Telethon Institute of Genetics and Medicine in Italy after testing thousands of compounds in search of a treatment. Can-Fite and Fondazione Telethon signed an agreement outlining their collaboration for the development of Piclidenoson for the treatment of Lowe Syndrome. As a rare genetic disease in dire need of a treatment, Lowe Syndrome may qualify for an accelerated approval path, and Can-Fite plans to move into an advanced stage clinical study in this indication.

Harnessing Artificial Intelligence (AI) to Identify and Accelerate New Oncology Programs:

Through an agreement with Collaborations Pharmaceuticals, Can-Fite is utilizing AI and machine learning (ML) to develop and bring to market next-generation A3 adenosine receptor (A3AR) oncology drugs at a significantly reduced development time and cost. New molecules will be designed with high affinity and selectivity to A3AR, the target of Can-Fite’s platform technology.

"In addition to the several major value-driving milestones achieved during the third quarter, we continue to enroll and treat patients in our pivotal Phase III liver cancer study and Phase IIb study for NASH. Our pivotal Phase III study in psoriasis is expected to commence soon while we also prepare for a Phase IIa study in pancreatic cancer," stated Motti Farbstein, Can-Fite’s CEO and CFO. "We believe our advanced stage pipeline with multiple indications positions Can-Fite well for partnerships and for achieving regulatory and market success based on our robust portfolio."

Financial Results

Revenues for the nine months ended September 30, 2023 were $0.59 million compared to revenues of $0.61 million for the same period in 2022. Revenues for the nine months ended September 30, 2023 and September 30, 2022 comprised of recognition of a portion of advance payments received under distribution agreements with Gebro, CKD, Cipher and Ewopharma.

Research and development expenses for the nine months ended September 30, 2023 were $4.71 million compared with $5.30 million for the same period in 2022. Research and development expenses for the nine months ended September 30, 2023 comprised primarily of expenses associated with the completion of the Phase III study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase III study in the treatment of advanced liver cancer and a Phase IIb study for NASH.

General and administrative expenses were $2.23 million for the nine months ended September 30, 2023 compared to $2.31 million for the same period in 2022. The decrease is primarily due to the decrease in directors and officer’s insurance policy premium. We expect that general and administrative expenses will remain at the same level through 2023.

Financial income, net for the nine months ended September 30, 2023 was $0.38 million compared to financial expense, net of $0.14 million for the same period in 2022. The decrease in financial expense, net was mainly due to revaluation of our short-term investment and increase in interest income from deposits in 2023.

Net loss for the nine months ended September 30, 2023 was $5.98 million compared with a net loss of $7.15 million for the same period in 2022. The decrease in net loss for the nine months ended September 30, 2023 was primarily attributable to the decrease in research and development expenses and in general and administrative expenses.

As of September 30, 2023, Can-Fite had cash and cash equivalents and short term deposits of $7.94 million as compared to $7.98 million at December 31, 2022. The decrease in cash during the nine months ended nine 30, 2023 is due to the ongoing operations of the Company which was offset by the Company’s fundraise during January 2023. During November 2023, Can-Fite raised approximately $3 million from the exercise of certain warrants.

The Company’s consolidated financial results for the nine months ended September 30, 2023 are presented in accordance with US GAAP Reporting Standards.

Bicycle Therapeutics to Host R&D Day on December 14

On November 30, 2023 Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that the company will host its first Research and Development (R&D) Day on Thursday, December 14 (Press release, Bicycle Therapeutics, NOV 30, 2023, View Source [SID1234638062]). The event will take place in New York City from 8 a.m. to 12 p.m. Eastern Time and will be simultaneously webcast.

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Bicycle Therapeutics executives will provide investors and analysts with an overview of the company’s R&D strategy and pipeline opportunities, with an emphasis on clinical updates for BT8009, BT5528 and BT7480. The company will also highlight the broad capabilities of its novel Bicycle platform technology.

Analysts and investors who are interested in attending in person should contact [email protected]. A live webcast of the R&D Day will be accessible from the Investor section of the company’s website, www.bicycletherapeutics.com. A replay of the webcast will be archived and available following the event.