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New Data Presented at the 2023 ATA Annual Meeting Demonstrate that Veracyte’s Afirma-Based Testing Can Uncover Key Molecular Hallmarks of Thyroid Cancer

On September 28, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported that new data presented at the 2023 American Thyroid Association (ATA) Annual Meeting demonstrate the type of novel molecular insights for thyroid nodules and cancer that are enabled by analysis with the Afirma Genomic Sequencing Classifier (GSC) (Press release, Veracyte, SEP 28, 2023, View Source [SID1234635505]). Presented by clinical researchers in three posters, the findings are based on Afirma whole-transcriptome RNA sequencing data and reveal novel molecular profiles to advance research of thyroid nodules and cancer. These data represent findings that can be assessed utilizing the company’s Afirma Genomic Resource for Intelligent Discovery (GRID) tool, which will soon be available, upon request, on a research-use-only basis.

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"These ATA presentations underscore the value of personalized, whole-transcriptome-based data for a clearer understanding of the molecular underpinnings of thyroid nodules and cancer, which may ultimately be useful for more tailored treatment of patients," said Joshua Klopper, M.D., Veracyte’s medical director for Endocrinology. "Now with the Afirma GRID, we are pleased to give researchers a new tool to help fuel novel discoveries in the science of thyroid nodules and cancer."

The three ATA posters include results from the analysis of whole-transcriptome data derived from the Afirma GSC. Highlights from the posters include:

Leveraging RNA Sequencing for Pre-Operative Immunophenotyping of BRAFV600E+ Thyroid Nodules
Jarod Olay, M.S., from the UCLA David Geffen School of Medicine and collaborators found that RNA expression profiles derived by Afirma GSC molecular testing may allow for pre-operative immunophenotyping of thyroid cancers instead of the traditional immunohistochemistry performed on surgical specimens. Their study was based on a retrospective analysis of nearly 48,000 thyroid nodules analyzed with the Afirma GSC, confirming that the classifier identified the expected immunophenotype for a specific type of thyroid cancer molecular alteration. While additional research is needed, these findings begin to suggest the potential future use of Afirma GSC testing to predict a thyroid cancer’s response to immune checkpoint inhibitor therapy.
Molecular Assessment of Isthmus Thyroid Carcinomas
Sina Jasim, M.D., from Washington University in St. Louis and collaborators detected molecular differences between thyroid cancers in the isthmus compared to lobar locations, which could help explain why thyroid nodules in the isthmus are more likely to be malignant and demonstrate aggressive behavior. Analysis with Afirma GSC revealed that isthmus-based cancers had increased BRAF-like molecular signatures, ERK, and FMT (follicular mesenchymal transition) signaling compared to lobar-based cancers.
Sodium Iodide Symporter (NIS) Expression in Cytologically Indeterminate and Malignant Thyroid Nodules
Prasana Santhanam, M.B.B.S., M.D., from the Johns Hopkins University School of Medicine and collaborators found that NIS expression varies widely across thyroid nodule cytological classification groups and across molecular alterations. They analyzed Afirma GSC gene expression data from more than 47,000 thyroid nodules and recommend follow-up studies to determine how pre-operative assessment of NIS expression could be used to improve treatment selection for patients.
"Understanding the broad range of molecular profiles associated with thyroid cancer will require sophisticated analysis tools and studies to determine how these profiles can potentially be used to stratify patients and identify the best course of treatment," said Dr. Santhanam. "Our team was pleased to collaborate with the Afirma team for whole-transcriptome analysis of thyroid FNA samples and to gain new insights into the spectrum of NIS expression."

New Research-Use-Only Afirma GRID

The three molecular signatures identified in these studies, along with many other thyroid cancer molecular profiles, will soon be available through the new Afirma GRID research-use-only tool. The database was developed through novel discovery work at Veracyte and through the utilization of published literature. It is designed to serve as a comprehensive resource for research into molecular characteristics that may ultimately help improve the understanding of how to manage patients with thyroid nodules. The tool is available upon request and is intended for use on a research-use-only basis for thyroid nodules that are deemed suspicious for cancer by the Afirma GSC or are reported as Bethesda V or VI by cytopathology.

"We are excited to soon make this new tool available to the thyroid cancer research community," said Dr. Klopper. "Similar to what Veracyte has done for prostate cancer research with our Decipher GRID tool, with Afirma GRID we aim to help usher in a new era of more personalized diagnosis and treatment for patients with thyroid nodules and cancer."

Vaccinex Announces Pricing of $9.6 Million Public Offering

On September 28, 2023 Vaccinex, Inc. (Nasdaq: VCNX) ("Vaccinex" or the "Company"), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D, reported that it has entered into securities purchase agreements with healthcare focused institutional investors along-side significant participation from an entity affiliated with the Chairman of the Company’s Board of Directors, and existing investors of the Company for the purchase and sale of 9,600,000 shares of the Company’s common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to 9,600,000 shares of common stock at a purchase price per share (and accompanying warrant) of $1.00 in its "reasonable best efforts" public offering (Press release, Vaccinex, SEP 28, 2023, View Source [SID1234635504]). The warrants will have an exercise price of $1.00 per share, will be immediately exercisable and will expire five years from the initial exercise date.

The closing of the offering is expected to occur on or about October 3, 2023, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $9.6 million. The Company intends to use the net proceeds from the offering to fund the ongoing development and clinical trials of its lead drug candidate, pepinemab, in Alzheimer’s disease and cancer and for working capital and other general corporate purposes.

A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-274520) previously filed with the Securities and Exchange Commission (SEC) which became effective on September 28, 2023. The offering is being made only by means of a prospectus forming part of the effective registration statement. Copies of the preliminary prospectus and, when available, copies of the final prospectus, relating to the offering may be obtained on the SEC’s website located at View Source Electronic copies of the final prospectus relating to the offering may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

TransCode Therapeutics Announces Pricing of $8 Million Public Offering

On September 28, 2023 TransCode Therapeutics, Inc. (Nasdaq: RNAZ), (the "Company"), an RNA oncology company committed to more effectively treating cancer using RNA therapeutics, reported the pricing of its underwritten public offering of an aggregate of 15,700,000 shares of its common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof) (Press release, TransCode Therapeutics, SEP 28, 2023, View Source [SID1234635503]). Each share of common stock (or Pre-Funded Warrant) is being sold at a public offering price of $0.51 per share (inclusive of the Pre-Funded Warrant exercise price of $0.01). All of the shares and Pre-Funded Warrants in the offering are being sold by the Company. Total gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately $8 million. In addition, the Company has granted the underwriters a 45-day option to purchase up to 2,339,200 additional shares of its common stock and/or Pre-Funded Warrants at the public offering price less the underwriting discount.

ThinkEquity is acting as sole book-running manager for the offering.

The closing of the offering is expected to occur on or about September 28, 2023, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from this offering, together with its existing funds, for one or more clinical trials with TTX-MC138, its lead therapeutic candidate, including related investigational new drug enabling studies, and for working capital and other general corporate purposes.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-274251), which was declared effective by the Securities and Exchange Commission (the "SEC") on September 25, 2023. The offering is being made only by means of a prospectus forming part of the effective registration statement relating to the offering. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at View Source and may also be obtained by contacting ThinkEquity at 17 State St., 41st Floor, New York, NY 10004.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

TAE Life Sciences Celebrates Collaboration Milestones and Unveils Alphabeam for in-hospital BNCT at ASTRO 2023 Annual Meeting

On September 28, 2023 TAE Life Sciences, a pioneer in advancing Boron Neutron Capture Therapy (BNCT) for cancer treatment, reported that it is bringing BNCT to this year’s annual meeting of the American Society for Radiation Oncology (ASTRO) in San Diego (Press release, TAE Life Sciences, SEP 28, 2023, View Source [SID1234635502]). The company is set to revolutionize the way attendees perceive BNCT with an immersive Augmented Reality (AR) experience that offers an in-depth look at the future of cancer treatments, informative talks about the state of BNCT, and a variety of captivating exhibits.

TAE Life Sciences Brings BNCT to ASTRO

The AR experience at the TAE Life Sciences booth will offer visitors a captivating journey into the world of BNCT, featuring:

● A virtual tour of the Alphabeam system, showcasing the clinical workflow of BNCT and illustrating the inner workings of this revolutionary technology.

● Insights into the setup of a BNCT system, including details on building requirements, layout, and the treatment process.

"We’re on the verge of redefining how the world treats cancer and ASTRO is the perfect venue to showcase the capabilities of our Alphabeam BNCT system. We’re not just showing a glimpse of our technology at the show; we’re sharing a vision for a future where cancer is treated with unprecedented precision. We hope that the immersive experience we’re bringing to the show ignites a spark of hope in the hearts of attendees, and together, we can work towards a brighter future for cancer patients," said Rob Hill, CEO at TAE Life Sciences.

TAE Life Sciences will host a presentation, titled "Reimagining BNCT for Biologically Targeted Radiation Therapy," at its booth stage on October 1 at 11:00 AM. Featuring talks from Rob Hill, CEO of TAE Life Sciences, Minesh Mehta, MD, from Miami Cancer Institute, and Sandro Rossi, General Manager and Technical Director at CNAO, this presentation will include updates on the global progress of BNCT, preclinical and clinical results, and insight into the treatment’s profound significance in shaping the future of cancer treatment.

Presentation Details:
Who: Robert Hill, CEO at TAE Life Sciences; Minesh Mehta, Chief of Radiation Oncology at Miami Cancer Institute; Sandro Rossi, General Manager at CNAO

What: Presentation: Reimagining BNCT for Biologically Targeted Radiation Therapy When: October 1, 2023 at 11:00 AM

Where: San Diego Convention Center, Booth 3732

Sandro Rossi from CNAO shared his enthusiasm, stating, "Our collaboration with TAE Life Sciences marks a significant step forward in BNCT and brings an exciting addition to Europe’s first Hadrontherapy center. By incorporating BNCT into our comprehensive treatment offerings, we are expanding the horizons of radiation therapy to treat metastatic cancers. This groundbreaking approach has the potential to redefine how we combat cancer, making treatments more effective and tailored to each patient’s unique needs. Together with TAE Life Sciences, we are not just advancing technology; we are advancing the future of cancer care in Europe and beyond."

At ASTRO, TAE Life Sciences will have several exciting exhibits on display in its booth, including:

● BNCT treatment planning demonstration featuring TAE Life Sciences’ proprietary dose engine running on the Raysearch treatment planning engine.
● Details about TAE Life Sciences’ innovative BNCT drug development program, showcasing the latest advancements in its antibody boron conjugate (ABC) drugs as well as pre-clinical data.
● A compelling poster comparing treatment planning outcomes with TAE Life Sciences’ Boronotyrosine (BTS) drug versus Boronophenylalanine (BPA), shedding light on the significant advantages of BTS in boron delivery for BNCT interventions.

Minesh Mehta, representing Miami Cancer Institute, passionately emphasized the importance of accelerating BNCT research in the United States, stating, "Collaborations like the one between TAE Life Sciences and CNAO are essential to advancing cancer care. The opportunity for BNCT is burgeoning, especially with the increasing availability of antibody-drug conjugates (ADCs). Currently, there are a dozen or more ADCs that can be harnessed for boron conjugation. Fast-tracking BNCT research in the USA is not just a priority; it’s an urgent necessity. We must seize this moment to bring BNCT to the forefront of modern cancer treatment and offer new hope to patients across the nation and beyond."

For more information about TAE Life Sciences, Alphabeam, and the company’s proprietary boronated BNCT drugs, please visit www.taelifesciences.com.

Kura Oncology Reports Preclinical Data Showing Ability of KO-2806 to Enhance Antitumor Activity of KRAS?¹²? Inhibitors in Non-Small Cell Lung Cancer

On September 28, 2023 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported preclinical data supporting the development of its next-generation farnesyl transferase inhibitor (FTI) KO-2806 in combination with KRASG12C inhibitors to drive tumor regressions and durable responses in KRASG12C-mutant non-small cell lung cancer (NSCLC) (Press release, Kura Oncology, SEP 28, 2023, View Source [SID1234635501]).

The new findings are being presented in an oral session today at the 5th RAS-Targeted Drug Development Summit in Boston. A copy of the presentation, entitled "Farnesyl Transferase Inhibitors – Evolution from Targeting HRAS to Overcoming Adaptive Resistance to Targeted Therapies," is available in the Posters and Presentations section on Kura’s website.

KRASG12C inhibitors have previously been shown to activate RTK signaling, leading to ERK-RSK and/or mTOR-S6 pathway reactivation. The Company’s new preclinical data show that co-treatment of preclinical models of KRASG12C-mutant NSCLC with KO-2806 and adagrasib deepens signaling inhibition at multiple nodes, including the MAPK and mTOR pathways, while decreasing cell proliferation. In both cell-derived (CDX) and patient-derived (PDX) xenograft models originating from NSCLC tumors, the combination of KO-2806 with adagrasib induced tumor regressions. In addition, the CDX and PDX models demonstrated enhanced duration and depth of antitumor response compared to adagrasib as a single-agent therapy.

"Despite advances with KRAS-targeted therapies, a significant unmet need remains for patients with KRASG12C-mutant NSCLC as acquired resistance occurs early and often," said Francis Burrows, Ph.D., Senior Vice President, Translational Research. "We are highly encouraged by these first preclinical data for KO-2806, which demonstrate the potential for FTIs as a mechanism-based combination agent to enhance antitumor activity of targeted therapies, such as KRASG12C inhibitors."

Kura is on track to dose the first patient in its Phase 1 dose-escalation trial of KO-2806 (FIT-001) in the second half of 2023. Concurrent with the monotherapy dose escalation, the Company plans to evaluate KO-2806 in dose-escalation combination cohorts with other targeted therapies in advanced solid tumors, including clear cell renal cell carcinoma (ccRCC) and KRASG12C NSCLC.