On January 30, 2023 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing novel synthetic lethality-based cancer therapeutics targeting DNA damage response (DDR) pathways, reported the appointment of John Hamill as Chief Financial Officer. Mr. Hamill joins Aprea with more than 30 years of finance and accounting experience (Press release, Aprea, JAN 30, 2023, View Sourcenews-releases/news-release-details/aprea-therapeutics-appoints-john-hamill-chief-financial-officer" target="_blank" title="View Sourcenews-releases/news-release-details/aprea-therapeutics-appoints-john-hamill-chief-financial-officer" rel="nofollow">View Source [SID1234626640]).

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"Aprea Therapeutics has made substantial progress and is now reaching an exciting inflection point given the advancement of our ATR inhibitor in Phase 1 human clinical trials. I look forward to working closely with John to advance our mission of finding ways to revolutionize the treatment of cancer for patients in need of new therapies," said Oren Gilad, Ph.D., President, and CEO. "Mr. Hamill is an excellent addition to our team and will help take the company to the next level given his extensive experience in finance, accounting and strategic execution."

"This is an exciting time to be joining Aprea as it continues its mission to improve the lives of those suffering from cancer," said Mr. Hamill. "I’m excited to work with this team of accomplished and dedicated executives and scientists to advance the pipeline and position the Company for continued success and future growth."

Mr. Hamill joins Aprea with vast financial leadership experience in the pharmaceutical, biopharmaceutical, and clinical research sectors. He brings broad-based experience in financial, administrative and information technology, in addition to his success in completing IPO and follow-on offerings for several pharmaceutical companies. Mr. Hamill received his Accounting/Business and Computer Science from DeSales University and is a certified public accountant.

The Company also announced that Scott Coiante will be stepping down as Chief Financial Officer to pursue other opportunities, but will remain with the Company through March 31, 2023 to ensure a smooth leadership transition. "We thank Scott for his years of dedication to Aprea and wish him well in his future pursuits," said Mr. Christian Schade, Aprea’s Executive Chairman of the Board of Directors.

About Aprea Therapeutics, Inc.

Aprea Therapeutics, Inc. is a biopharmaceutical company headquartered Doylestown, Pennsylvania, focused on developing and commercializing novel synthetic lethality-based cancer therapeutics targeting a critical pathway and some of the most central targets in DDR and cancer progression. The Company’s lead program is ATRN-119, a clinical-stage small molecule ATR inhibitor being developed for solid tumor indications. Our WEE1inhibitor is being advanced to IND submission. For more information, please visit the company website at www.aprea.com.

The Company may use, and intends to use, its investor relations website at View Source as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.

On January 30, 2023 Ribon Therapeutics, a clinical-stage biotechnology company developing therapeutics to target stress support pathways, reported a $25 million investment from Pfizer (Press release, Ribon Therapeutics, JAN 30, 2023, View Source [SID1234626639]). Ribon plans to use the proceeds to support clinical development of its potentially first-in-class oral small molecule programs in oncology (RBN-2397, a PARP7 inhibitor) and immunology (RBN-3143, a PARP14 inhibitor). As part of the investment, Robert Rickert, Ph.D., Senior Vice President and Head of Cancer Immunology Discovery, Pfizer, will join Ribon’s Scientific Advisory Board.

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Separately, Ribon and Pfizer have entered into an agreement to leverage Pfizer’s global development expertise and capabilities to support the advancement of Ribon’s pipeline. Ribon will retain economic rights and control of clinical development across all its programs.

"We thank Pfizer for its investment in Ribon and support of our novel approach to developing potential first-in-class treatments targeting stress support pathways, and we welcome Dr. Rickert to our Scientific Advisory Board," said Prakash Raman, Ph.D., President and Chief Executive Officer, Ribon Therapeutics. "Pfizer’s capital support and expertise will be instrumental as we work to advance our lead programs—RBN-2397 in cancer and RBN-3143 in immunology—to key clinical milestones and enable further drug discovery and development from our proprietary BEACON+ platform."

"We believe Ribon’s pioneering work to develop therapeutics that target stress support pathways represents a potential breakthrough for patients living with cancer and inflammatory diseases," said Dr. Rickert. "I look forward to working with the Ribon team to help advance their important clinical programs."

On January 30, 2023 Ocean Biomedical and Aesther Healthcare Acquisition Corp. (NASDAQ: AEHA) reported the discovery of a second major anti-tumor pathway and therapeutic approach that targets CTLA-4, inhibiting the metastasis of malignant melanoma cells to the lung using a novel bispecific antibody approach (Press release, Ocean Biomedical, JAN 30, 2023, View Source [SID1234626638]). This major regulating mechanism discovery, recently published in Frontiers in Immunology, by Ocean Biomedical’s Scientific Co-founder and Brown University’s Emeritus Dean of Medicine and Biological Sciences, Dr. Jack A. Elias, builds on his team’s prior discoveries that target Chitinase 3-like-1 (CHI3LI) and its role in inhibiting T-cell proliferation. Additionally, this promising research reveals a third anti-tumor pathway targeting T-cell co-stimulation using the inducible co-stimulator (ICOS) and its ligand ICOSL, and Cluster of Differentiation 28 (CD28) and its ligands B7-1 and B7-2. Ocean Biomedical’s novel approach to tumor suppression, focused on controlling CHI3LI, other immune checkpoint inhibitors, and T-cell co-stimulators, has potential application for tumor suppression across multiple cancer pathways.

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"If you control CH3L1, you don’t just control one anti-cancer pathway, you simultaneously control many anti-cancer pathways. This is an unprecedented leap forward and we are very pleased at the spotlight that Frontiers in Immunology has placed on it," commented Dr. Jack A. Elias, Scientific co-founder. "In searching for and narrowing in on major pathways that are applicable across cancer types, we are making discoveries that will drive cancer research, and eventually treatment and patient outcomes, forward."

"We are excited to extend the tumor-control application of Dr. Elias’ discovery that CHI3L1 is a critical regulator of T-cell activity. These therapies have the potential to save lives of people affected not just by lung metastasis, and melanoma, but also non-small cell lung cancer, glioblastoma and other forms of cancer," said Dr. Chirinjeev Kathuria, co-founder and Executive Chairman.

Malignant melanoma, a very serious skin cancer with a 22.5% five-year survival for patients with Stage IV disease, can metastasize to other organs. Once it has spread to other organs, it is difficult to treat – in some cases, it can spread to the lungs and result in non-small cell lung cancer (NSCLC), a major unmet medical need that accounts for 85% of pulmonary malignancies and affects approximately 450,000 individuals. In over 50% of affected NSCLC patients, tumors are not diagnosed until the advanced stages, with metastatic spread that precludes curative surgical resection.

Recent studies of NSCLC have highlighted the effectiveness of immune checkpoint inhibitor (ICPI), therapies that block cancer-proliferating proteins like CHI3L1 and help the patient’s body recognize and attack cancer cells. Unfortunately, only a minority of patients respond to these therapies and the responses are often not durable.

Recent studies from Ocean Biomedical have demonstrated that CHI3L1 is a critical regulator of a number of key cancer-causing pathways, highlighting its ability to inhibit tumor cell death (apoptosis), its inhibition of the expression of the tumor suppressors P53 and PTEN and its stimulation of the B-RAF protooncogene. Most recently Dr. Elias’s research team has discovered that CHI3L1 is a "master regulator" of ICPI, including key elements of the PD-1 and CTLA4 pathways. In accord with the importance of these pathways, Ocean has also generated antibodies: 1.) a monoclonal antibody against CHI3L1, 2.) bispecific antibodies that simultaneously target CHI3L1 and PD-1, and 3.) a new bispecific antibody that simultaneously targets CHI3L1 and CTLA4. The impressive ability of these bispecific antibodies to control primary and metastatic lung cancer in murine experimental modeling systems have been discussed in detail in an earlier article in the Journal of Clinical Investigation, and this expanded approach in Frontiers in Immunology.

Suren Ajjarapu, Chairman and CEO of Aesther, commented, "Immunotherapy is the future of cancer care, and Aesther is proud to be partnering with Ocean Biomedical in advancing the development of their cancer treatments, along with their fibrosis treatments, and their global malaria program. We look forward to working with Ocean Biomedical to bring all of these therapies to patients, for the long-term shareholder value and the continued advancement of medical science."

On January 30, 2023 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that Robert E. Hoffman, President and CEO of Kintara, will be presenting at the BIO CEO & Investor Conference on Monday, February 6, 2023 (Press release, Kintara Therapeutics, JAN 30, 2023, View Source [SID1234626637]).

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Mr. Hoffman’s presentation will highlight the recent Company developments on its novel therapies for hard to treat cancers, ongoing pipeline progress, clinical trial updates, and anticipated milestones. Details about the presentation are as follows:

Presenter: Robert E. Hoffman, President and CEO of Kintara
Date: Monday, February 6, 2023, at 4:30 p.m. EST
Location: Marriott Marquis, New York, NY
Registration: Here

In its 25th year, BIO CEO is one of the largest investor conferences in the life science industry. Kintara will be available for in person and virtual partnering meetings. Those interested in scheduling a meeting may do so through the BIO One-on-One Partnering system: View Source

On January 30, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has approved its Guardant360 CDx liquid biopsy test as a companion diagnostic to identify advanced or metastatic breast cancer patients with ESR1 mutations who may benefit from treatment with ORSERDU (elacestrant), a nonsteroidal selective estrogen receptor degrader to be commercialized by Stemline Therapeutics, Inc., a wholly-owned subsidiary of Menarini Group (Press release, Guardant Health, JAN 30, 2023, View Source;advanced-or-metastatic-breast-cancer/default.aspx [SID1234626636]).

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Breast cancer is the second leading cause of cancer death in women. The American Cancer Society estimates that about 297,790 new cases of invasive breast cancer will be diagnosed in women in 2023, and about 43,700 women will die from breast cancer.2 ORSERDU is the first therapy to be approved by the FDA for advanced breast cancer patients with ESR1 mutations, with disease progression following at least one line of endocrine therapy. ESR1 mutations are present in approximately 40% of ER+/HER2- advanced breast cancers.

"This FDA approval is great news for breast cancer patients with ESR1 mutations, who now have, for the first time, an approved treatment for their specific type of cancer and a blood-based companion diagnostic," said Helmy Eltoukhy, Guardant Health co-CEO. "We are pleased that the Guardant360 CDx liquid biopsy is now approved so that oncologists and their patients can access comprehensive genomic profiling to see if they are eligible to receive this therapy."

The FDA approved Guardant360 CDx as a companion diagnostic (CDx) in conjunction with the approval of ORSERDU for postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated, advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

"We are proud to bring the very first treatment targeting ESR1 mutations which are present in up to 40% of ER+/HER2- advanced breast cancers," commented Elcin Barker Ergun, CEO of Menarini Group. "We’re also pleased with the approval of the Guardant360 CDx blood test as the companion diagnostic to help oncologists identify patients who may benefit from this innovative endocrine therapy."

The approval as a companion diagnostic for ORSERDU is Guardant Health’s fifth FDA approval for the Guardant360 CDx test and its first in breast cancer.

About ORSERDU (elacestrant)

ORSERDU is approved under the FDA’s Priority Review designation based on the results of the registrational Phase III trial EMERALD, that demonstrated statistically significant progression-free survival (PFS) with elacestrant vs SOC endocrine monotherapy (fulvestrant, letrozole, anastrozole, exemestane), meeting both primary endpoints in all patients and in those patients whose tumors harbor an ESR1-mutation. In the group with patients whose tumors had an ESR1 mutation, median PFS was doubled (3.8 vs 1.9 months), and a 45% reduction of death or progression was achieved over SOC. Safety data is consistent with the other endocrine therapies. Most of the adverse events (AEs), including nausea and musculoskeletal pain were grade 1 and 2. No hematological safety signal was observed and none of the patients in either of the two treatment arms had sinus bradycardia. For more information about ORSERDU, please visit www.orserdu.com.

About Guardant360 CDx

For oncologists, the FDA-approved Guardant360 CDx test provides comprehensive genomic results from a simple blood draw in seven days, helping them move beyond the limitations of tissue biopsies to rapidly obtain clinically relevant information in time to match patients to the optimal personalized treatment. Guardant360 CDx covers all genes recommended by the National Comprehensive Cancer Network, including those most relevant to clinical care and NSCLC treatment guidelines.

The first FDA-approved blood test for complete genomic testing, Guardant360 CDx is approved as a companion diagnostic to identify patients with non-small cell lung cancer who may benefit from treatment with TAGRISSO (osimertinib), RYBREVANT (amivantamab-vmjw), ENHERTU (fam-trastuzumab deruxtecan-nxki) or LUMAKRAS (sotorasib). It is also FDA approved to identify advanced breast cancer patients with ESR1 mutations who may benefit from treatment with ORSERDU (elacestrant). For more information, visit guardant360cdx.com.

Since being introduced, the Guardant360 test has become widely accepted for blood-based comprehensive genomic profiling with more than 350 peer-reviewed publications. It has been trusted by more than 12,000 oncologists, with more than 250,000 tests performed to date, and is broadly covered by Medicare and many private payers, representing over 230 million lives.