On September 29, 2023 Novocure (NASDAQ: NVCR) reported its participation in the upcoming American Society for Radiation Oncology (ASTRO) 2023 Annual Meeting from October 1 – 4 in San Diego (Press release, NovoCure, SEP 29, 2023, View Source [SID1234635553]). Presentations will describe preclinical, clinical and simulation modeling studies on Tumor Treating Fields (TTFields) therapy, including new insights about methods to optimize TTFields intensities delivered at the target tumor during treatment.

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Highlights of Novocure’s poster presentations include:

a new process to identify optimized, personalized TTFields array layouts for each patient with glioblastoma (GBM) using segmentation-based treatment planning (SBTP) software

retrospective, simulated testing of SBTP to compare outputs from array layouts generated with SBTP versus array layouts generated with NovoTAL, the current standard treatment planning software, with results suggesting that SBTP-generated layouts meet established treatment thresholds for TTFields therapy, and could potentially lead to improved clinical outcomes for patients with GBM

a simulation study evaluating the effects of body mass index (BMI) on field intensities delivered to the lungs with TTFields therapy. Results support the feasibility of TTFields therapy delivery to the lungs regardless of BMI and highlight the importance of choosing the appropriate array size for each patient.
"We are committed to continuous innovation, and we look forward to sharing new insights about the use of TTFields therapy with the scientific community," said Pritesh Shah, Novocure’s Chief Growth Officer. "By developing segmentation-based treatment planning software to optimize array placement and exploring how factors such as array size affect the delivery of TTFields therapy, we aim to advance our therapy as we pursue our mission to extend survival in some of the most aggressive forms of cancer."

Presentations on TTFields at the 2023 ASTRO Annual Meeting will include:

The Effect of Body Mass Index on Tumor Treating Fields (TTFields) Intensity Distribution in the Lungs. Presenter: Nadav Shapira. 4:45 p.m. – 6 p.m. PT on Sunday, Oct. 1.

Patient-Specific Segmentation-Based Treatment Planning vs. NovoTAL for TTFields Therapy in Glioblastoma. Presenter: Brian Berger. 10:45 a.m. – 12 p.m. PT on Monday, Oct. 2.

Retrospective Review of the Factors Limiting Optune Initiation in GBM patients. Presenter: Luis Carranza Pena. 10:45 a.m. – 12 p.m. PT on Monday, Oct. 2.

Tumor Treating Fields (TTFields) in the Real World for Newly Diagnosed Glioblastoma: A Survival Meta-analysis With Systematic Review. Presenter: Matthew Ballo. 10:45 a.m. – 12 p.m. PT on Monday, Oct. 2.

Compatibility of Topical Products to Manage Skin Irritation Associated With TTFields. Presenter: Narasimha Kumar Karanam. 2:30 p.m. – 3:45 p.m. PT on Tuesday, Oct. 3.

A Working TTFields Therapy Framework for Patient-Specific Segmentation-Based Treatment Planning and Dosimetry. Presenter: Brian Berger. 12:30 p.m. – 1:45 p.m. PT on Wednesday, Oct. 4.

Alternating Tumor Treating Fields Layouts for Effective Treatment of the Epigastric Region. Presenter: Nadav Shapira. 12:30 p.m. – 1:45 p.m. PT on Wednesday, Oct. 4.
About Tumor Treating Fields Therapy

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

On September 29, 2023 Physician-scientists from Rutgers Cancer Institute of New Jersey and RWJBarnabas Health reported that it will present new, novel, and expansive radiation oncology data from their clinical research program at the 2023 American Society for Radiation Oncology (ASTRO) Annual Meeting, to be held in San Diego from October 1-4 (Press release, Rutgers Cancer Institute of New Jersey, SEP 29, 2023, View Source [SID1234635552]). A total of 10 abstracts have been accepted, comprising clinical data and analyses that advance the understanding and use of radiation therapy in the treatment of lung, breast, pancreatic, and other cancers. Rutgers Cancer Institute and RWJBarnabas Health is New Jersey’s only National Cancer Institute-designated Comprehensive Cancer Center and the leading cancer program in the state.

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"We are excited that the physician-scientists from our health system will be presenting significant and valuable information to advance the use of radiotherapy in cancer treatment at this year’s ASTRO meeting," said Bruce Haffty, MD, MS, Chair, Radiation Oncology, Associate Vice Chancellor for Cancer Programs at Rutgers Cancer Institute of New Jersey, and System Director of Radiation Oncology at RWJBarnabas Health. "The variety and nature of the abstracts being presented speak to our team’s commitment, passion, and innovation in their quest to develop disruptive strategies to advance the use of radiation therapy in cancer treatment, improve patient outcomes and save lives. Our team of world-class cancer specialists and researchers is dedicated to advancing and refining the role of radiation therapy in cancer management to improve the lives of the patients we serve."

Highlights of accepted abstracts include the following:

Findings of an analysis to explore genetic changes in aggressive pancreatic cancer. Over 90 percent of patients with pancreatic ductal adenocarcinoma (PDA) have mutations in the gene KRAS, a major driver in PDA. The aim of this research was to investigate genomic alterations based on KRAS status and identify driver mutations with KRAS wild type.
Results of a Phase 1 study combining a methionine-restricted diet (MRD) and radiation therapy to treat human malignancy, which has never been evaluated. Methionine is an amino acid critical to cell growth and survival, the deficiency of which, while tolerated by normal cells, causes cancer cell death. An MRD also enhances radio sensitization without significant adverse events.
Results of a study to determine whether dynamic changes in tumor volume in Stage III non-small cell lung cancer treated with concurrent chemoradiation followed by immunotherapy, the standard of care, may predict patient outcomes.
The full list of presentations at this year’s ASTRO Annual Meeting follows:

Oral Presentations

Abstract and
Session No.

Title

Presentation
Date/Time

Location

Abstract 106
(Session 2)

Prognostic Impact of Mismatch Repair
Deficiency on Stage I-II Endometrioid
Endometrial Cancer Treated With
Adjuvant Radiation Therapy: A Multi-
Institutional Analysis

Sunday, October 1,
2023, from 8:10-8:17
AM PST

Room 5

Abstract 136

(Session 7)
Prognostic Significance of Pretreatment
Immune Cell Infiltration in Muscle
Invasive Bladder Cancer Treated with
Definitive Chemoradiation: Analysis of
NRG RTOG 0524 and 0712

Monday, October 2,
2023, from 8:30-8:37
AM PST

Room 4

Abstract 138
(Session 7)

Comprehensive Genomic Analysis
Stratified by KRAS Status in Patients with
Pancreatic Adenocarcinoma and Its
Prognostic Significance

Monday, October 2,
2023, from 8:50-8:57
AM PST

Room 4

Abstract 1114
(QP 11)

First Results of the Primary Outcome of a
Phase II Prospective Clinical Trial to
Assess the Feasibility of Preoperative
Radiation Boost in Breast Cancer Patients

Tuesday, October 3,
2023, from
2:50-2:55 PM PST

Room 7

Abstract 280
(Session 31)

Unplanned Hospitalization and
Subsequent Mortality in Lung Cancer
Patients Undergoing Concomitant Chemo-
/Immuno-therapy and Radiotherapy: An
Analysis of Over 10,000 Patients in a
Nationwide Database

Wednesday, October
4, 2023, from 11:20-
11:27 AM PST

Room 4

Poster Presentations

Abstract and
Session No.

Title

Presentation
Date/Time

Location

Abstract 2069

(PQA 01)

Predictive Value of Dynamic Tumor
Volume Changes in Stage III Non-Small
Cell Lung Cancer treated with
Chemoradiation and Consolidative
Immunotherapy

Sunday, October 1,
2023, from 4:45-6:00
PM PST

Hal B2

Abstract 2518

(PQA 04)

The Landscape of Genetic Alterations
Associated with Metachronous Metastasis
in Patients with Pancreatic Ductal
Adenocarcinoma and Its Prognostic
significance

Monday, October 2,
2023, from 5:00-6:00
PM PST

Hall B2

Abstract 2540

(PQA 04)

Safety and Feasibility of the Addition of a
Radiosenitizing Methionine Restricted
Diet to Radiation Therapy

Monday, October 2,
2023, from 5:00-6:00
PM PST

Hall B2

Abstract 2678

(PQA 05)

Predictive Value of Tumor Volume on
Local Control in Hepatocellular
Carcinoma treated with Image Guided
Hypofractionated Radiation Treatment

Tuesday, October 3,
2023, from 12:45-2:00
PM PST

Hall B2

Abstract 3165

(PQA 08)

Pilot Study Assessing Student Interest in
Combined Residency Training Pathways
With Radiation Oncology

Tuesday, October 3,
2023, from 5:15-6:15
PM PST

Hall B2

On September 29, 2023 Akeso (9926.HK) reported that its subsidiary, Akeso Pharma, will collaborate with RemeGen (Yantai) Co., Ltd. (688331.SH/09995.HK) to advance the development of Akeso’s globally first PD-1/CTLA-4 bispecific antibody, cadonilimab (trade name: 开坦尼), and RemeGen’s first domestically developed antibody-drug conjugate (ADC) injection, Disitamab Vedotin (trade name: 爱地希) in combination therapy (Press release, Akeso Biopharma, SEP 29, 2023, View Source [SID1234635551]). The collaboration will also initiate a phase II clinical study for gastric cancer.

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Cadonilimab is a human tetravalent bispecific IgG1 antibody with symmetric IgG-single-chain variable fragment (scFv) structure that targets both PD-1 and CTLA-4. It has shown higher affinity for tumor-infiltrating lymphocytes (TILs) than for surrounding tissues in the tumor microenvironment (TME). With Fc-null design, cadonilimab contributes to better safety compared to combination of anti-PD-1 and anti-CTLA-4 antibodies while fully exerting the synergistic anti-tumor effects of inhibiting PD-1 and CTLA-4 immune checkpoints.

Cadonilimab has shown excellent anti-tumor efficacy in clinical trials for various solid tumors. According to the two-year follow-up data presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, cadonilimab demonstrated a high overall response rate and long-term survival benefit in the first-line treatment of advanced gastric/esophagogastric junction adenocarcinoma in the entire population (regardless of PD-L1 expression). The study results also indicate that cadonilimab has the potential to overcome the limited efficacy of immunotherapy in populations with low PD-L1 expression or negative PD-L1 expression, making it a superior immunotherapeutic option for patients with advanced gastric cancer.

爱地希 (Disitamab Vedotin) utilizes a novel, highly affinity, and better internalization effect humanized antibody, Disitamab Vedotin monoclonal antibody, combined with advanced linker and small molecule cytotoxic drugs. It demonstrates specific targeting abilities, exceptional efficacy, and excellent safety profiles. The study results have been presented at major domestic and international conferences such as the ASCO (Free ASCO Whitepaper) Annual Meeting.

The 2023 version of the Chinese Society of Clinical Oncology (CSCO) Guidelines for Diagnosis and Treatment of Gastric Cancer, announced in April this year, recommends Disitamab Vedotin as a preferred third-line treatment for HER2-positive (IHC3+ or 2+) advanced gastric cancer, upgrading its recommendation level from "Grade II Recommendation" to "Grade I Recommendation."

Multiple preclinical studies have demonstrated the synergistic and enhanced efficacy of immune checkpoint inhibitors in combination with ADC drugs. The combination therapy of cadonilimab and Disitamab Vedotin has a solid theoretical basis and may achieve synergistic efficacy in anti-tumor treatment, potentially bringing a new generation of more efficient and safer combination therapy for cancer patients.

Currently, Akeso is fully committed to advancing the exploration of cadonilimab as a cornerstone cancer treatment by developing more combination therapies. This includes not only the development of combination therapies with the Akeso’s self-developed innovative product pipeline but also the development of combination therapies with new molecules and mechanisms within the industry that have excellent clinical value potential, in order to fully tap into the clinical value of cadonilimab.

On September 29, 2023 Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, reported the pricing of an underwritten public offering of (i) 7,394,363 shares of common stock (or common stock equivalents in lieu thereof) and (ii) accompanying common warrants to purchase up to an aggregate of 7,394,363 shares of common stock (Press release, Synlogic, SEP 29, 2023, View Source [SID1234635550]). The combined effective offering price to the public of each share of common stock (or pre-funded warrant) and accompanying warrant is $2.84. The accompanying warrants will have an exercise price of $3.408 per share, will be exercisable immediately, and will expire five years from the initial exercise date. All of the securities are being offered by Synlogic, Inc. The Company expects to receive total gross proceeds of approximately $21.0 million, before deducting underwriting discounts, commissions and offering expenses. The offering is expected to close on or about October 3, 2023, subject to satisfaction of customary closing conditions.

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

The securities will be offered pursuant to a registration statement on Form S-1, as amended (File No. 333-274421), which was declared effective by the Securities and Exchange Commission (the "SEC") on September 28, 2023. The offering is being made solely by means of a prospectus. A preliminary prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus and, when available, copies of the final prospectus relating to this offering can be obtained at the SEC’s website at www.sec.gov or from Chardan Capital Markets, LLC, 17 State Street, Suite 2130, New York, New York 10004, at (646) 465-9000, or by email at [email protected].

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

On September 29, 2023 Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that it will host a conference call and live webcast to share topline results from the pivotal AUGMENT-101 trial in patients with relapsed/refractory KMT2Ar acute leukemia on Monday, October 2, 2023 at 8:00 a.m. ET (Press release, Syndax, SEP 29, 2023, View Source [SID1234635549]).

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The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website. Alternatively, the conference call may be accessed through the following:

Conference ID: SNDX0923
Domestic Dial-in Number: 800-590-8290
International Dial-in Number: 240-690-8800
Live webcast: https://www.veracast.com/webcasts/syndax/events/Kwl396.cfm

For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company’s website at www.syndax.com approximately 24 hours after the conference call and will be available for 90 days following the call.