On November 1, 2022 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics (EPBs), reported the appointment of Daniel O’Connor as Chief Executive Officer (Press release, Ambrx, NOV 1, 2022, View Source [SID1234622737]).

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"On behalf of the board of directors and management team, I would like to welcome Dan to Ambrx. I very much look forward to working with him to execute on Ambrx’s new strategic direction," said Katrin Rupalla, Chair of Ambrx’s Board of Directors. "Dan is the ideal candidate for the role of CEO, given his extensive leadership experience in oncology drug development, strategic partnership formation, and streamlining operations within the biotech industry. I would also like to thank Kate Hermans, our interim CEO and board member, for her hard work, dedication, and leadership over the past several months to reprioritize Ambrx’s development pipeline."

"I am thrilled by the opportunity to lead Ambrx as the company focuses on the development of ARX517, potentially the first PSMA-targeting ADC therapy for prostate cancer," said Daniel O’Connor, chief executive officer of Ambrx. "Ambrx’s proprietary EPB platform enables us to produce biologic product candidates with highly stable, site-specific conjugation, thereby overcoming the inherent limitations of conventional drug conjugation approaches. This has the potential to play a key role in changing the current treatment paradigm for cancer patients. I look forward to working together with the Ambrx management team to bring the promise of Ambrx’s technology to cancer patients currently underserved by the standard of care."

Mr. O’Connor has over 23 years of executive experience and leadership in all aspects of the biopharmaceutical industry, including CEO leadership of two public oncology-focused companies, OncoSec Medical and Advaxis, Inc., as well as C-Suite leadership roles at ImClone Systems, Bracco Diagnostics, and PharmaNet, Inc. (today, Syneos Health). He has a proven record of accomplishment in oncology drug development, with a focus on business strategy, clinical execution, product development, business transformation and corporate development. He has overseen the successful initiation of several early phase oncology clinical trials, including combination trials with several different FDA approved checkpoint inhibitors. Additionally, he has led numerous life science licensing transactions and drug development collaborations with major pharmaceutical companies and has raised hundreds of millions in the capital marketplace. Mr. O’Connor earned a J.D. from the Dickinson School of Law of Pennsylvania State University and a B.A. from Boston University.

On November 1, 2022 Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, reported it will host a conference call on Tuesday, November 8, 2022, to discuss its third quarter 2022 financial results. The call will begin at 4:30 PM Eastern Time (Press release, Quanterix, NOV 1, 2022, View Source [SID1234622735]). It will be hosted by Masoud Toloue, the Company’s President and Chief Executive Officer, and Michael Doyle, the Company’s Chief Financial Officer.

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Quanterix will issue a press release regarding the third quarter 2022 earnings prior to the conference call. The press release will be posted on the Quanterix website at View Source

Please click here to pre-register for the conference call and obtain your dial in number and passcode. You can also visit this link to listen to the call via live webcast. You may also access the live webcast by visiting the News & Events page within the Investors section of the Quanterix website at www.quanterix.com. The webcast will be available on the Company’s website for one year following completion of the call.

On November 1, 2022 Teon Therapeutics (Teon), a clinical-stage biopharmaceutical company targeting metabolic signaling pathways and pioneering the development of G-Protein Coupled Receptor (GPCR) immuno-oncology therapies in difficult-to-treat cancers, reported that the first patient has been treated in its Phase 1/2 clinical trial evaluating the safety and efficacy of TT-816, an oral CB2 receptor antagonist acting as an immune checkpoint inhibitor while promoting T cell infiltration of cold tumors and stimulating NK cell tumor killing (Press release, Teon Therapeutics, NOV 1, 2022, View Source [SID1234622734]).

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The study (NCT05525455) is an open-label, first-in-human multiple ascending dose and dose-expansion study evaluating TT-816 administered orally as a monotherapy in Phase 1 and, in Phase 2, as a monotherapy and in combination with a PD-1 inhibitor. The study will include patients with advanced solid tumors with high unmet medical need who have not responded to the standard-of-care and may have no more treatment options.

"The initiation of our Phase 1/2 trial of TT-816 is an important step in our mission to invent new hope for patients by providing meaningful treatments to those with few remaining alternatives. It’s our hope that TT-816 represents a new option for these patients who haven’t been served by current immunotherapies," said Serge Messerlian, Chief Executive Officer of Teon. "Supported by strong preclinical data, we believe TT-816 has unique mechanisms of action that go beyond current checkpoint inhibitors by enhancing both T cell and NK cell antitumor immunity, preventing broad-based T cell exhaustion, synergizing antitumor effects with current immune checkpoint inhibitor therapies, and directly promoting T cell infiltration into solid tumors."

"Today, most patients fail on current immunotherapy treatment options and a therapy that is able to overcome tumor resistance mechanisms in many difficult-to-treat cancers is desperately needed in oncology care," said Anthony W. Tolcher, M.D., FRCPC, FACP, principal investigator and CEO, founder of NEXT Oncology. "As a novel checkpoint inhibitor with unique mechanisms of action, I am hopeful about the role of TT-816 in the treatment landscape. TT-816 could potentially offer a clinically meaningful, new option for the treatment of patients with many types of difficult-to-treat cancers."

The Phase 1/2 clinical trial is actively recruiting patients with advanced solid tumors in several sites. More information on the clinical trial including eligibility, enrollment information and trial sites can be found on clinicaltrials.gov using the study identifier (NCT05525455).

About Teon’s Multicenter TT-816 Phase 1/2 Clinical Trial

This clinical trial is an open-label, Phase 1/2, first-in-human (FIH), multiple ascending dose and dose-expansion study of TT-816 orally administered as monotherapy and in combination with a PD-1 inhibitor. An estimated 200 patients will be enrolled. Phase 1 will evaluate safety, tolerability, pharmacokinetics, preliminary clinical activity and establish a recommended dose of TT-816 to be used as a monotherapy and in a combination therapy for Phase 2. Phase 2 will continue to evaluate safety and define the preliminary efficacy of these regimens in the setting of advanced solid tumors with high unmet medical needs including Non-Small Cell Lung Cancer (NSCLC), Ovarian Cancer and Renal Cell Carcinoma (RCC).

Additional information about the trial can be found on clinicaltrials.gov using the study identifier (NCT05525455).

About TT-816

TT-816 is a first-in-class, oral cannabinoid CB2 receptor antagonist acting as an immune checkpoint inhibitor for the treatment of a broad range of solid tumors and is highly selective for the CB2 receptor versus the CB1 receptor. By inhibiting the actions of the CB2 receptors on immune cells in many difficult-to-treat cancers, including lung, renal, and ovarian, TT-816 has the potential to enhance T cell and NK cell activity and directly promote T cell infiltration into solid tumors.

Preclinical results indicate that TT-816 enhances both the effect of NK cell tumor killing and T cell activation in vitro, increases both tumor infiltrating T cells and NK cells in vivo and prevents broad-based T cell exhaustion. TT-816 dose-dependently inhibits tumor growth in animal models, has an additive effect with anti-PD-1 in the ‘hot’ tumor model and acts synergistically with anti-PD-1 in the ‘cold’ tumor model where the anti-PD-1 alone had no effect.

About the CB2 receptor

The cannabinoid CB2 receptor belongs to the G protein-coupled receptor (GPCR) family. The cannabinoid CB2 receptor, selectively inhibited by TT-816, is a peripheral receptor found predominantly in the immune system and regulates inflammation and the immune response. Elevated CB2 receptor expression is associated with worse overall survival and aggressiveness of cancer. Research has shown that CB2 receptor activation does not have any psychoactive properties unlike CB1 receptors which are located primarily in the brain.

On November 1, 2022 IEEE, the world’s largest technical professional organization dedicated to advancing technology for humanity, and the IEEE Engineering in Medicine and Biology Society (EMBS) reported the publication of a study on a new artificial intelligence (AI) framework for identifying a particular type of gene mutation and its connection to improved survival rate for colorectal cancer patients (Press release, IEEE, NOV 1, 2022, View Source [SID1234622733]). The report, derived from the research of a team of members from The Chinese University of Hong Kong and a startup company, GMed IT Ltd, has been published in IEEE Open Journal of Engineering in Medicine and Biology, and is freely available for open access and full-text viewing by all readers around the world.

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The report, "Identification of Tissue Types and Gene Mutations from Histopathology Images for Advancing Colorectal Cancer Biology," available in the IEEE Xplore digital library, details how AI can be used to more rapidly predict mutant KRAS (Kirsten rat sarcoma) genes in cancer patients—a key step in assessing and recommending treatment options. Patients with predicted mutant KRAS genes in the study showed a higher survival rate two and a half years after diagnosis.

"AI is emerging as a very useful assistive tool for clinicians in making decisions about care because it can show them insights they cannot see with their bare eyes and provide an important benchmark for many procedures," said one of the report’s authors, Dr. Carmen Poon with GMed IT Ltd. "In the current cancer biology field, we normally associate KRAS gene mutations with poor prognosis for colorectal cancer patients. But our study showed improved survival rates when a unique AI framework leveraging both endoscopy and histopathology information was used to predict the mutants."

In typical clinical practice, an endoscopist or surgeon will examine a patient’s tissue and then send the sample to a pathologist for deeper, microscopic analysis to identify KRAS mutations, which are associated with colorectal and other types of cancer. The IEEE Open Journal of Engineering in Medicine and Biology report details a study in which that process is compressed by leveraging AI to classify the tissue types and identify the KRAS mutations in real time. The study was based on data collected from 501 patients.

"This report is a breakthrough for showing the potential of AI for advancing cancer treatment," said Paolo Bonato, editor-in-chief of IEEE Open Journal of Engineering in Medicine and Biology. "We are eager for our journal’s unique combination of readers from science and engineering across medicine and biology to build on the study’s findings and bring innovative capabilities to bear in real-world clinical practice."

On November 1, 2022 Kovina Therapeutics Inc. reported that receipt of a Small Business Innovation Research (SBIR) one-year Phase I award from the National Institute of Dental and Craniofacial Research (NIDCR/NIH) to treat oropharyngeal cancers caused by Human Papillomavirus (HPV) infections (Press release, Kovina Therapeutics, NOV 1, 2022, View Source [SID1234622732]). The award provides approximately $275,000 with the opportunity for advancement to Phase 2.

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"Kovina’s science continues to receive validation and support from the NIH. The NIDCR award represents Kovina’s third NIH grant received this year. The award will advance Kovina’s HPV related oropharyngeal (head and neck) cancer research and development efforts to address the increasing incidence and morbidity challenges associated with this disease," said Kristin Sherman, CEO of Kovina Therapeutics.

"Oropharyngeal cancers arising from HPV infections are increasing across many age groups and around the world. There are no directed antiviral treatments for these malignancies, and current treatment protocols lead to devastating side effects. The need for targeted therapeutics is clear and expert NIH reviewers supported our plans to identify a drug that inactivates a critical oncogenic HPV protein. This SBIR grant funds testing of our novel HPV inhibitory compounds for activity in preclinical models of oropharyngeal cancer. A safe and effective antiviral agent would increase survival and reduce the potential incapacitating side effects of current therapeutic regimens," said Dr. Elliot Androphy, CSO of Kovina Therapeutics.