On November 17, 2023 CG Pharmaceuticals reported the commencement of Phase 2 study for metastatic pancreatic ductal adenocarcinoma (PDAC) with the recommended Phase 2 dose (RP2D) of ivaltinostat (ClinicalTrials.gov ID NCT05249101) (Press release, CrystalGenomics, NOV 17, 2023, View Source [SID1234637783]).

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The RP2D of ivaltinostat (250 mg/m2) was determined by the Safety Review Committee (SRC) following a thorough safety data review from 3 cohorts of increasing dose levels of ivaltinostat in combination with a fixed dose of capecitabine. The SRC has unanimously recommended proceeding to Phase 2, marking a significant milestone, effective immediately, the study is open for the enrollment of patients.

In Phase 2, metastatic PDAC patients who show no evidence of disease progression after an initial treatment with FOLFIRINOX will receive either combination therapy or capecitabine monotherapy. The primary endpoint is progression free survival.

Dr. Gene Cho, Vice President of Global Strategic Planning at CG Pharmaceuticals, expressed his excitement, "I am thrilled and honored to share this important study milestone and witness the commencement of Phase 2, with an enrollment target of 52 patients. We extend our heartfelt gratitude to our investigators, partners, and, most importantly, our patients for their invaluable participation in this critical study."

The study abstract has been accepted by the ASCO (Free ASCO Whitepaper) GI and will be presented on January 19, 2024, San Francisco, California.

About Ivaltinostat:

Ivaltinostat, a novel anticancer therapeutic candidate that inhibits enzymatic activity of histone deacetylase, has been evaluated for solid tumors and hematologic malignancies.

On November 17, 2023 GT Medical Technologies, Inc., a medical device company dedicated to improving the lives of patients with brain tumors, reported an increase of clinical cases in the United States using its GammaTile Therapy in patients diagnosed with several brain tumor types (Press release, GT Medical Technologies, NOV 17, 2023, View Source [SID1234637781]). The data was presented at the Society for Neuro-Oncology (SNO) 28th Annual Meeting and Education Day taking place from November 15-19, 2023, at the Vancouver Convention Center in Vancouver, Canada.

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The results were presented by Chief Medical Officer Dr. Michael Garcia of GT Medical Technologies as a poster entitled, "Usage Trends of Collagen Tile Brachytherapy for the First 1,000 Orders," (Abstract INNV-05) on Friday, November 17. GammaTile has been used in over 1,000 patients with both newly diagnosed malignant brain tumors and recurrent brain tumors since 2019 and has been used in different tumor types, including glioblastoma, brain metastasis and meningioma. Within this poster, study authors reported that GammaTile usage is rising over time. They saw an increase of orders in every quarter over more than 4 years.

"It is encouraging to see an increase in adoption of GammaTile across the country as this demonstrates that more and more patients are having access to this treatment option, especially since treatment options can be limited in the recurrent brain tumor setting," said Dr. Garcia. "It was rewarding to present these results to the neuro-oncology community. I’m also proud of GammaTile’s commitment in investing in clinical trials and the fact that we are studying quality of life on these trials."

Currently, GammaTile is sponsoring 4 clinical trials including a multi-institute registry trial (NCT0442738) that includes quality of life as a study metric. Another poster presented by Dr. Garcia on November 17, titled, "Impact of Collagen Tile Brachytherapy as Treatment for Recurrent Glioblastoma on Functional Status and Quality of Life," (Abstract: NCOG-36) outlines how quality of life is being studied for patients who receive GammaTile for recurrent glioblastoma.

On November 17, Adam Turner, PhD, DABR, and Senior Director of Medical Physics of GT Medical Technologies, presented a poster presentation, entitled," A Biologically Effective Dose Comparison between Radiosurgery and Collagen Tile Brachytherapy for Post-operative Treatment of a Brain Metastasis Resection Cavity," (Abstract: RADT-13). The poster reported that GammaTile provided excellent biologically effective dose (BED) coverage to oncologically at-risk brain tissue adjacent to the resected tumor bed, while demonstrating a rapid radiation dose fall-off outside of the target volume. These dose characteristics might underlie the durable local control seen in the recurrent brain metastasis setting, though larger-scale analyses are being performed with clinical outcomes on the multi-institute registry trial (NCT0442738), and there is a Phase 3 trial evaluating GammaTile for newly diagnosed brain metastases needing resection (NCT04365374).

All posters were presented on November 17 from 7:30 pm to 9:30 pm in Exhibit Hall A/B of the convention center. The full poster abstracts can be access by the meeting mobile app.

GammaTile Therapy is a Surgically Targeted Radiation Therapy (STaRT) that delivers immediate radiation and eradicates brain tumor cells before they can replicate post-surgery while helping to protect healthy brain tissue. GammaTiles are bioresorbable collagen embedded with radioactive seeds, Cesium 131.

Since GammaTile Therapy received FDA clearance in 2018 for recurrent brain tumors and in 2020 for newly diagnosed malignant tumors, more than 1,000 patients have benefitted from its innovative design that targets remaining cancer cells after a tumor is surgically removed.

On November 17, 2023 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported the presentation of new Phase 2 clinical data for ST101 at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting 2023 (Press release, Sapience Therapeutics, NOV 17, 2023, View Source [SID1234637780]). The poster summarized results from an ongoing surgical window of opportunity sub-study in newly diagnosed GBM (ndGBM) and recurrent GBM (rGBM) patients.

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Poster Presentation Details and Summary of Data:

Title: "Neoadjuvant treatment with monotherapy ST101, a C/EBPβ antagonist, results in pathological and clinical responses in glioblastoma patients. Tissue-based analysis and clinical outcomes from a surgical window of opportunity clinical trial."
Poster Number: CTNI-44
Date and Time: Friday, November 17, 2023, 7:30 pm – 9:30 pm PT
Presenter: Fabio M. Iwamoto, Division of Neuro-Oncology, New York-Presbyterian/Columbia University Medical Center

The SNO poster summarized data from an ongoing surgical window of opportunity sub-study designed to assess the effect of neoadjuvant and adjuvant treatment with ST101 on tumor tissue and clinical outcomes, as well as assessment of biomarkers in tumors and blood.
In the sub-study, patients receive 2-4 doses of IV 500 mg ST101 QW neoadjuvant.
Following surgery, ndGBM patients continue ST101 QW + temozolomide (TMZ) + radiation; rGBM patients continue ST101 as monotherapy.
MRI assessment is conducted at screening, post ST101 neoadjuvant and before surgery, after surgery, and every 9 weeks thereafter.
As of November 7, 2023, 12 patients received 2-4 doses of ST101 before surgery and were evaluable (6 with ndGBM and 6 with rGBM).
Key Results as of November 7, 2023:

Newly diagnosed GBM:
83% Disease Control Rate (DCR), including 1 Complete Response (CR) and 4 patients with Stable Disease (SD), in 6 patients treated with neoadjuvant and adjuvant ST101 as part of their standard of care treatment.
5/6 patients remain on study, with a treatment duration of ~15-38 weeks.
Recurrent GBM:
67% DCR, including 2 Partial Responses (PRs) and 2 SD, in 6 patients treated with neoadjuvant and adjuvant ST101 monotherapy.
3/6 patients remain on study with disease control beyond 6 months (2 PR and 1 SD), resulting in a 6-month PFS of 50%.
Extensive treatment-related effects (geographical necrotic tissue) were observed in GBM patients treated with neoadjuvant ST101 monotherapy, including patients who were previously treatment-naïve.
"The results demonstrated with ST101 in this GBM study are very encouraging, given the poor prognosis associated with this devastating brain cancer. Based on the results thus far, administration of ST101, before and/or after brain surgery, has a direct impact on GBM cells and a favorable effect on the tumor microenvironment, which translates to longer disease control and potential partial or complete responses to therapy," said Dr. Fabio M. Iwamoto, Division of Neuro-Oncology, New York-Presbyterian/Columbia University Medical Center. "I look forward to continuing to evaluate ST101 in the ongoing Phase 2 study and delivering hope to my GBM patients and their families."

More information can be found on the 2023 SNO website.

About ST101

ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). In the ongoing Phase 2 dose expansion rGBM cohort (n=30), ST101 weekly administration resulted in a 30% Disease Control Rate (DCR) with 1 Partial Response (PR) and 8 patients with Stable Disease (SD), with a 6-month median duration of SD. In the ongoing surgical window of opportunity sub-study, ST101 is being evaluated as a monotherapy in rGBM and in combination with radiation and temozolomide in newly diagnosed GBM (ndGBM).

ST101 has been granted Fast Track designation for rGBM from the U.S. FDA and Orphan Drug designations for glioma from the U.S. FDA and the European Commission.

On November 17, 2023 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported financial results and business highlights for the fourth quarter and full year fiscal 2023 ended September 30, 2023 (Press release, Twist Bioscience, NOV 17, 2023, View Source [SID1234637778]).

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"Fiscal 2023 was a defining year for Twist as we grew our revenue 20% year over year with strength in NGS and synbio in particular," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "We took decisive action to align our cost structure with our accelerated path to profitability and implemented our strategy for key products to set the stage for near and long-term success."

Dr. Leproust continued, "Moving into fiscal 2024, we expect the momentum behind our SynBio product group will be bolstered by Express Genes with NGS revenue increasing as customers continue to advance development and commercial plans. This fiscal year, we will be focused on the path to increasing gross margin over time and driving toward profitability for the business. In parallel, resulting from the work over the last six months, we are cautiously optimistic that the Biopharma Solutions trajectory has turned positive and that we are positioned to scale the business."

FISCAL 2023 FINANCIAL RESULTS

•Orders: Total orders received for fiscal 2023 grew to $264 million compared to $226.4 million for fiscal 2022.
•Revenue: Total revenues for fiscal 2023 grew to $245.1 million compared to $203.6 million for fiscal 2022.
•Cost of Revenues: Cost of revenues for fiscal 2023 grew to $155.4 million compared to $119.3 million for fiscal 2022.
•Research and Development Expenses: Research and development expenses for fiscal 2023 decreased to $106.9 million compared to $120.3 million for fiscal 2022.

•Selling, General and Administrative Expenses: Selling, general and administrative expenses for fiscal 2023 decreased to $189.7 million compared to $212.9 million for fiscal 2022.
•Net Loss: Net loss attributable to common stockholders for fiscal 2023 decreased to $204.6 million, or $3.60 per share, compared to $217.9 million, or $4.04 per share, for fiscal 2022.
•Cash Position: As of September 30, 2023, the company had $336.4 million in cash, cash equivalents and investments.

FISCAL 2023 FOURTH QUARTER FINANCIAL RESULTS

•Orders: Total orders received for the fourth quarter of fiscal 2023 grew to $71.1 million compared to $62.1 million for the same period of fiscal 2022.
•Revenue: Total revenues for the fourth quarter of fiscal 2023 grew to $66.9 million compared to $57.3 million for the same period of fiscal 2022.
•Cost of Revenues: Cost of revenues for the fourth quarter of fiscal 2023 increased to $42.4 million compared to $31.6 million for the same period of fiscal 2022.
•Research and Development Expenses: Research and development expenses for the fourth quarter of fiscal 2023 decreased to $23.7 million compared to $29.6 million for the same period of fiscal 2022.
•Selling, General and Administrative Expenses: Selling, general and administrative expenses for the fourth quarter of fiscal 2023 decreased to $47.4 million compared to $54.2 million for the same period of fiscal 2022.
•Net Loss: Net loss attributable to common stockholders for the fourth quarter of fiscal 2023 decreased to $46.2 million, or $0.81 per share, compared to $51.1 million, or $0.91 per share, for the same period of fiscal 2022.

Recent Highlights:

•Grew customer base to approximately 3,450 customers in fiscal 2023, versus approximately 3,300 in fiscal 2022.
•Increased genes shipped to approximately 634,000 during fiscal 2023, compared with approximately 558,000 in fiscal 2022.
•Strengthened executive team with the appointment of Mark Buck as senior vice president, operations.
•Released 2023 ESG report and quantified the carbon footprint of manufacturing a single gene. The carbon footprint of the Twist DNA synthesis method to manufacture one gene is the equivalent of emissions from driving a car 0.092 miles (0.15 kilometers) while the carbon footprint of the 96 well plate-based methods of making one gene is the equivalent of driving a car 59 miles (95 kilometers).1

•Launched Twist Express Genes (formerly known as Fast Genes) with a rapid turnaround time of five to seven business days.
•Launched Twist Full Length Unique Dual Index Adapters (UDIs) to enable PCR-free whole genome sequencing (WGS) and multiplexing at scale.
•Signed new antibody discovery and licensing option agreement with Bayer worth up to $188 million in clinical and commercial milestone payments plus royalties.
•Entered into an agreement with Ono Pharma to discover and develop novel antibodies for the treatment of autoimmune diseases.
•Announced a multi-program collaboration with IMIDomics whereby Twist will utilize its antigen development capabilities and Library of Libraries to conduct antibody discovery activities against targets identified by IMIDomics.

Fiscal 2024 Financial Guidance

The following statements are based on Twist’s current expectations for fiscal 2024. The following statements are forward-looking, and actual results could differ materially depending on market conditions and the factors set forth under "Forward-Looking Statements" below.

For the full fiscal year 2024, Twist expects:

•Total revenue is expected to be in the range of $285 million to $290 million, growth of 16 to 18 percent, including:
◦SynBio revenue of $113 to $116 million, growth of 16 to 18 percent
◦NGS revenue of $147 to $149 million, growth of 19 to 20 percent
◦Biopharma revenue of approximately $25 million, growth of 8 percent
•Gross margin is projected to be approximately 39% to 40%
•Operating expenses of approximately $294 to $298 million including:
◦R&D expense of $100 to $102 million
◦SG&A expense of $194 to $196 million
•Loss from operations before taxes of approximately $180 to 188 million, a decrease of 15 to 18 percent, which includes:
◦Stock based compensation of approximately $58 to 60 million
◦Depreciation and amortization of approximately $40 million
◦DNA data storage spend of approximately $37 to $39 million
•Capital expenditure of approximately $20 million
•Ending cash at September 30, 2024 of approximately $245 million

For the first quarter, Twist expects:

•Total revenue of $67 to $68 million
◦SynBio revenue of approximately $27 million
◦NGS revenue of $36 to $37 million
◦Biopharma revenue of approximately $4 million
•Gross margin of 38 to 39%
•Operating expenses of approximately $73 million
•Loss from operations of $47 to $48 million

For the fourth quarter of fiscal 2024, Twist expects:

•Total revenue of approximately $78 million
•Loss from operations of $38 to $40 million, excluding any one-time adjustments
◦Stock based compensation expense of approximately $15 million
◦Depreciation expense of approximately $10 million
◦DNA data storage spend of approximately $8 million

Conference Call Information

The company plans to hold a conference call and live audio webcast for analysts and investors at 8:00 a.m. Eastern Time today to discuss its financial results and provide an update on the company’s business. The conference call will be webcast live through the Investor Relations section under the "Company" tab at www.twistbioscience.com. Those parties interested in participating via telephone must register on the Company’s Investor Relations website or by clicking here. Upon registration, all telephone participants will receive the dial-in number along with a unique PIN number that can be used to access the call. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The webcast replay will be available for two weeks.

On November 17, 2023 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported that on November 16, 2023 (the "Date of Grant"), the Company approved the grant of inducement stock options covering an aggregate of 59,950 shares of Iovance’s common stock to nine new non-executive employees (Press release, Iovance Biotherapeutics, NOV 17, 2023, View Source [SID1234637776]).

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The awards were granted under Iovance’s 2021 Inducement Plan, which was adopted on September 22, 2021 and amended on January 12, 2022 and May 10, 2023, and provides for the granting of equity awards to new employees of Iovance by the Company’s compensation committee in accordance with Nasdaq Listing Rule 5635(c)(4). Each of the stock options granted as referenced in this press release has an exercise price of $4.40, the closing price of Iovance’s common stock on the Date of Grant. Each stock option vests over a three-year period, with one-third of the shares vesting on the first anniversary of the employee’s start date (referred to as the "First Vesting Date"), and the remaining shares vesting in eight quarterly installments over the next two years, commencing with the first quarter following the First Vesting Date, subject to continued employment with the Company through the applicable vesting dates.