On March 12, 2024 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported new data being presented on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, and hereditary cancer test, Empower, at the 2024 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer taking place March 16-18, 2024 (Press release, Natera, MAR 12, 2024, View Source [SID1234641088]).

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A total of seven abstracts will be presented, including two oral presentations and five poster presentations. The presentations will feature new data highlighting Signatera’s predictive and prognostic utility in ovarian cancer and other gynecologic malignancies.

"On the heels of receiving Medicare coverage for Signatera in ovarian cancer and for breast cancer in the neoadjuvant setting, we are thrilled to share new Signatera and Empower data with the gynecologic oncology community," said Adam ElNaggar, MD, medical director of oncology at Natera. "We believe this momentum is indicative of the growing clinical value our tests provide for patients across the continuum of gynecologic cancer care, and demonstrate our continued leadership in MRD."

Below is the full list of Signatera and Empower data presentations at the SGO Annual Meeting.

Oral Presentations:

Focused Plenary I: The Science to Drive Purpose | March 16, 2:15 – 3:30 PM | Presenter: Anne Knisely, MD | Ovarian Cancer
Prognostic implications of minimal residual disease detection by second look laparoscopy and circulating tumor DNA (ctDNA) in patients with ovarian cancer after frontline therapy
Focused Plenary IV: ctDNA: Molecular Mirrors & Markers | March 17, 1:45 – 2:45 PM | Presenter: Mike Shalamov | Gynecologic Cancers
Utility of ctDNA as an early predictive biomarker of response to radiation in gynecologic malignancies
Poster Presentations:

Poster #1241 | Session 1 | March 17, 1:15 – 2:45 PM | Presenter: Michael Toboni, MD | Ovarian Cancer
PARPi response monitoring using personalized ctDNA testing in patients with ovarian cancer
Poster #1242 | Session 1 | March 17, 1:15 – 2:45 PM | Presenter: Peter W. Ketch, MD | Uterine Cancer
Treatment Monitoring Utilizing ctDNA-based MRD Detection in Early Stage Uterine Cancer
Poster #1243 | Session 1 | March 17, 1:15 – 2:45 PM | Presenter: Michael Toboni, MD | Uterine Cancer
Personalized ctDNA analysis used for ctDNA detection and response monitoring in patients with advanced or recurrent uterine cancer
Poster #1274 | Session 1 | March 17, 1:15 – 2:45 PM | Presenter: Floortje Backes, MD | Endometrial and Ovarian Cancer
Utility of ctDNA in assessment of treatment response in patients with Recurrent/Metastatic Endometrial Cancer and Recurrent/Platinum-Resistant Ovarian Cancer
Poster #1181 | Session 1 | March 17, 1:15 – 2:45 PM | Presenter: Sarah Lee, MD | Pan-cancer
Diagnostic yield and characteristics of germline-positive genetic testing ordered by obstetricians and gynecologists in female patients with a personal history of cancer
About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 50 peer-reviewed papers.

On March 12, 2024 OBI Pharma reported that Dr. Ming-Tain Lai, Chief Scientific Officer, has been invited to present an oral presentation at the upcoming 14th World ADC conference in London, United Kingdom (Press release, OBI Pharma, MAR 12, 2024, View Source [SID1234641070]).

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This conference will be held on March 12th-15th, 2024. It united 800+ leading players in the field under one roof, including experts from major pharmaceutical companies, biotech, and academic institutions. The World ADC Event Series is the largest academic event in the global ADC (Antibody-Drug Conjugate) field.

Dr. Lai’s title is "OBI-992: An Anti-TROP2 ADC With Distinct Properties." Dr. Lai will be presenting at a Speaker Session on Thursday, March 14, 2024 at 2:30 PM London time. He will share the following:

Exploring the in vitro characterization of the ADC
Discussing in vivo animal efficacy studies of the ADC
Analyzing the pharmacokinetics/pharmacodynamics of the ADC
OBI-992 is a TROP2-targeted ADC that carries a potent topoisomerase I inhibitor payload to kill tumor cells. TROP2 is highly expressed in a variety of solid tumors such as lung, breast, ovarian, and gastric cancer, rendering it an ideal target for cancer therapy.

OBI-992 uses a unique hydrophilic, enzyme-cleavable linker that is stable in circulation but releases the cytotoxic payload inside tumor cells. OBI-992 demonstrates remarkable antitumor efficacy, improved pharmacokinetic characteristics, and a favorable safety profile in animal models. The US FDA has cleared an Investigational New Drug (IND) application for OBI-992 in January 2024. The Phase 1/2 efficacy and safety human studies are planned to commence Q2,2024.

The TROP2 targeting antibody was in-licensed from Biosion, Inc. , in December 2021. OBI Pharma owns ex-China commercial rights for OBI-992.

On March 12, 2024 Pearl Bio (a synthetic biology company backed by Khosla Ventures) reported that it has entered a license, collaboration and option agreement with Merck, known as MSD outside of the United States and Canada, to discover biologic therapies comprising non-standard amino acids (Press release, Pearl Bio, MAR 12, 2024, View Source [SID1234641089]). Bolstering this collaboration is the deep expertise and patent portfolio licensed from the labs of scientific co-founders, Farren Isaacs (Yale) and Michael Jewett (Stanford) for using Genomically Recoded Organisms (GROs) to encode synthetic chemistries, paving the road for entirely new classes of multi-functionalized biologics with tunable properties.

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The Pearl team is excited to leverage our blocking IP on genome recoding and translation engineering to advance novel biologics with synthetic amino acids in partnership with Merck.

The collaboration will initially focus on discovery and development of biologic therapies for the treatment of cancer leveraging Pearl’s exclusive GRO technology, unique ability to work in both cell-based and cell-free systems and proprietary tethered ribosomes to encode synthetic monomers and target previously inaccessible epitopes.

"We are excited to demonstrate the power of Pearl’s technology in our partnership with Merck to create multi-functionalized therapeutic candidates with tunable properties solving for some of the key shortcomings confronting biologics," explained Co-Founder and President, Amy Cayne Schwartz.

Under the agreement, Pearl is eligible to receive payments totaling up to $1B across upfront, option and milestone payments in addition to potential royalties on sales of approved products derived from the collaboration.

"Merck is excited to collaborate with Pearl, a pioneer in developing recoded organisms, to produce novel biologics enabled by synthetic chemistries," shared Juan Alvarez, Vice President of Discovery Biologics at Merck Research Laboratories.

On March 12, 2024 Lamassu Bio Inc., a cutting-edge biotech company dedicated to innovative cancer therapies, reported the company has been awarded a grant from the National Institutes of Health (NIH) and National Cancer Institute ( NCI) for the development of their groundbreaking treatment for p53 wild-type sarcomas (Press release, Lamassu Pharma, MAR 12, 2024, View Source [SID1234646265]). The $2.05 million grant will help fund the clinical trial integral to this new cancer treatment. The trial will be conducted in collaboration with Cleveland Clinic Taussig Cancer Center and Cleveland Clinic Children’s Pediatric Hematology and Oncology Department.

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P53 is a crucial tumor suppressor gene commonly mutated in human cancers. Its role in preventing tumor formation by inducing programmed cell death in response to cellular stress makes it a key target for cancer therapy. The project focuses on advancing SA53, a novel therapeutic that targets p53 wild-type sarcomas, malignant tumors of connective or non-epithelial tissue.

SA53 has demonstrated remarkable potency, efficacy and safety in preclinical models, positioning it for an Investigational New Drug (IND) submission. This innovative approach offers promising prospects for addressing chemo-resistant cancer and presents a significant pathway for advancing cancer care.

"We are looking forward to investigating how this drug could work to possibly teach cancer cells how to die in a variety of cancers. We are pleased to be a part of research focused on a disease that impacts so many," said Dr. Peter Anderson, pediatric oncologist at Cleveland Clinic Children’s and Principal Investigator of the study.

Sarcomas represent approximately 13,000 cancer cases each year in the United States and pose significant challenges in terms of treatment due to their complexity and propensity for metastasis. Current therapies involve invasive surgery, toxic chemotherapy, and radiation, but many patients do not respond to these treatments.

The proposed therapy aims to trigger the body’s natural defense mechanism, p53 by blocking MDM2, a protein that deactivates p53 and contributes to treatment resistance. The clinical trial will focus on achieving objectives such as determining a safe dosage for future trials, understanding pharmacokinetic profiles, and assessing early signs of effectiveness in treating soft tissue sarcomas with wild-type p53. The main goal is to advance SA53 through trials to offer a potential new and effective treatment option for patients.

"We believe that this genetically targeted therapy is potentially game-changing and can bring new hope for thousands of patients dealing with these cancers," said Gabi Hanna, Lamassu CEO and Founder. "The NIH grant will play a pivotal role in facilitating the transition of our research from the laboratory to the bedside. Collaborating with the exceptional team at Cleveland Clinic and NCI will also help accelerate the advancement of this therapy to the next phase of development. Together, we’re poised to make meaningful strides in bringing innovative treatments to those in need who has no good option."

The collaboration between Lamassu and Cleveland Clinic represents a significant step forward in cancer research, offering hope for improved outcomes for patients with sarcomas and potentially other cancers that may respond to p53 deactivation.

On March 11, 2024 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that preclinical data on multiple novel bispecific antibodies as well as antibody-drug-conjugates (ADCs) from its oncology pipeline will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 (Press release, Innovent Biologics, MAR 11, 2024, View Source [SID1234641027]). The AACR (Free AACR Whitepaper) meeting will take place April 5-10, 2024, in San Diego, California.

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Late-Breaking Research: Experimental and Molecular Therapeutics 1
Topic: IBI3001: a potentially first-in-class site-specifically conjugated B7-H3/EGFR bispecific ADC for multiple solid tumors
Abstract Number: LB055
Presentation Form: Poster
Presentation Time：Sunday Apr 7, 2024 1:30 PM – 5:00 PM
Location: Poster Section 53
Presenting Author: Dr. Kaijie He

Topic: IBI334, a novel ADCC-enhanced B7-H3/EGFR bispecific antibody, demonstrated potent pre-clinical efficacy in solid tumors
Abstract Number: LB056
Presentation Form: Poster
Presentation Time：Sunday Apr 7, 2024 1:30 PM – 5:00 PM
Location: Poster Section 53
Presenting Author: Dr. Kaijie He

Topic: Discovery and preclinical characterization of IBI343, a site-specifically conjugated anti-Claudin18.2 ADC for treating solid tumors
Abstract Number: LB057
Presentation Form: Poster
Presentation Time：Sunday Apr 7, 2024 1:30 PM – 5:00 PM
Location: Poster Section 53
Presenting Author: Dr. Kaijie He

Poster Session: Immunology – Single Target and Bispecific Antibodies
Topic: A novel TROP2-targeted immune stimulating antibody conjugate (ISAC) with potent anti-tumoral activity and acceptable safety
Abstract Number: 2718
Presentation Form: Poster
Presentation Time: Monday Apr 8, 2024 1:30 PM – 5:00 PM
Location: Poster Section 6
Poster Board Number: 9
Presenting Author: Dr. Huizhong Xiong

Poster Session: Immunology – Immune Modulation Employing Agonist or Co-Stimulatory Approaches
Topic: Tumor targeted-CD28 bispecific antibody with optimized potency, robust anti-tumoral activity and stringent CD3-dependence
Abstract Number: 5295
Presentation Form: Poster
Presentation Time: Tuesday Apr 9, 2024 1:30 PM – 5:00 PM
Location: Poster Section 3
Poster Board Number: 4
Presenting Author: Dr. Huizhong Xiong

Dr. Kaijie He, Vice President of Innovent, stated: "We aim to tackle drug resistance and enhance treatment outcomes in immunotherapy by developing next-generation bispecific antibodies, multi-specific antibodies and ADCs candidates. To select targets that can address broad-spectrum of tumor types is one of our main research direction. We are pleased to present preclinical data of innovative molecules at the AACR (Free AACR Whitepaper) and accepted as Late-breaking Researches. We hope to benefit more patients with continuous advances in life science and technology. "