On March 15, 2023 Invitae (NYSE: NVTA), a leading medical genetics company, reported seven studies, including one oral presentation and six posters, to be presented at the 2023 American College of Medical Genetics Meeting held in Salt Lake City from March 14-18, 2023 (Press release, Invitae, MAR 15, 2023, View Source [SID1234628901]). The research reinforces the importance of universal genetic testing for patients with cancer, with much of the data highlighting the need for increased representation in clinical genetic testing data across racial, ethnic and ancestry groups that have long been underrepresented in genetic studies and databases. Such inclusion can uncover unique insights and expand the clinical validity of genetic testing to more populations, helping inform health journeys and potentially improving health outcomes. Invitae will also be highlighting powerful innovative technological advances that include multiplex assays of variant effects, machine learning and big data approaches to address current challenges in variant classification and promote reduction of variants of uncertain clinical significance (VUS).

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

Key data being presented at ACMG 2023 include several studies that underscore the importance of removing barriers to germline genetic testing, whether that means expanding NCCN guidelines to go beyond familial risk-associated gene variants, increasing testing rates, or utilizing new innovations in variant classification to help reduce VUS across racial and ethnic groups.

Diversifying clinical studies to reveal impact across various race, ethnicity and ancestry identities

One such study, conducted in collaboration with researchers from University of California, Davis, highlights the inconsistencies between clinician entries and patients’ self-identified race, ethnicity and ancestry, particularly for non-White groups. The role of such inaccuracies for the implementation of precision medicine in minority groups is an area for further investigation. Another study compares and contrasts the rates of VUS in cancer predisposition genes in Black and White individuals. Although the rate of VUS-only results is higher in Black compared to White individuals, the number of unique VUS decreases at a higher rate in Black individuals over time.

"We look forward to presenting data at ACMG this year that is reflective of a more diverse patient population, and are committed to expanding these research efforts in the year ahead," said Robert Nussbaum, M.D., Invitae’s chief medical officer. "We’re continuing to explore race, ethnicity and ancestry implications to ensure clinical guidelines advance inclusivity and uncover clinically-actionable insights to support traditionally underrepresented groups."

Support for the expansion of clinical guidelines to support universal genetic testing for all patients

Several studies being presented at ACMG will highlight evidence around the benefits of genetic testing insights to advance testing as a standard of care for all patients. One particular study, conducted in collaboration with the City of Hope, analyzes the limitations of cascade testing for only the familial risk-associated gene variant, which is traditionally the course of action. Additionally, an oral presentation from David R. Wise, M.D., Ph.D., from New York University will explore how germline genetic testing has impacted clinical decisions for patients with prostate cancer, one of the most common cancers for American men.

"Each year, ACMG serves as a leading forum to present our findings to clinical geneticists who can change medical practice by making genetic testing part of the standard of care. We’re thrilled to share more data this year to advance precision medicine for all," said Dr. Nussbaum.

The following is a guide to Invitae-affiliated presentations at ACMG 2023.

2023 ACMG presentations:

Oral presentation: Titled: Real world impact of germline genetic testing on clinical decision making for prostate cancer patients. Presenter: David R. Wise, M.D., Ph.D. – Wednesday, March 15, 4:00–4:15 pm MST
Poster ID: P537: Titled: Reliability of clinician entries of patient self-identified race, ethnicity, and ancestry in clinical genetic testing. Presenter: Alice Popejoy Ph.D. – Thursday, March 16, 10:30 am–12:00 pm MST
Poster ID: P277: Titled: Modeling Cellular Evidence: Scalable Approaches for Generating, Validating and Incorporating Data from High-Throughput Functional Assays to Improve Clinical Variant Interpretation. Presented by Jason A. Reuter, Ph.D. – Thursday, March 16, 10:30 am–12:00 pm MST
Poster ID: P490: Titled: The impact of machine learning algorithms in reducing VUS for individuals from underrepresented populations compared to well studied populations. Presented by Britt Johnson, Ph.D., FACMG. – Friday, March 17, 10:30 am–12:00 pm MST
Poster ID: P088: Titled: What’s Trending: Comparing Variant of Uncertain Significance (VUS) Rates in Cancer Predisposition Genes Over Time in Black and White Individuals. Presented by Gail Tomlinson, M.D., Ph.D. – Friday, March 17, 10:30 am–12:00 pm MST
Poster ID: P058: Titled: Cascade testing with comprehensive multigene panels for hereditary cancer identifies unexpected findings in relatives. Presented by Brandie Heald, MS, CGC. – Friday, March 17, 10:30 am–12:00 pm MST
Poster ID: P244: Titled: Developing Probabilistic Graphical Models for Improved Variant Interpretation. Presented by Toby Manders, M.D. – Friday, March 17, 10:30 am–12:00 pm MST

On March 15, 2023 Vaxart, Inc. (NASDAQ: VXRT) issued its business update today for the full year 2022, during which Vaxart reported it is prioritizing development of the Company’s bivalent norovirus candidate (Press release, Vaxart, MAR 15, 2023, View Source [SID1234628890]).

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"After completing six norovirus clinical trials, we are encouraged by the robust immunogenicity data in both young adult and elderly populations and the encouraging safety profile of our oral norovirus program. We are therefore focusing our resources on our bivalent norovirus candidate and are excited about the two important upcoming data readouts from this program over the next two quarters. We believe this is the best strategy for advancing our oral vaccine platform while positioning Vaxart for future success," said Andrei Floroiu, Vaxart’s Chief Executive Officer. "There currently is no approved vaccine against norovirus, which sickens approximately 21 million people each year in the U.S. alone1 and is estimated to be responsible for more than $10 billion in annual disease burden2. The global annual burden is estimated at over $60 billion3. Vaxart is focused on providing an oral tablet vaccine to address this significant unmet need

Recent Business Highlights

Norovirus Vaccine Developments

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As part of the prioritization of its norovirus program, Vaxart is expanding the ongoing Phase 2 GI.1 norovirus challenge study to include additional challenge cohorts. Vaxart believes the expanded dataset will improve the likelihood of identifying a correlate of protection between immune responses to the vaccine and a reduction in risk of norovirus infection and / or acute gastroenteritis

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Vaxart expects that identifying novel correlates of protection may reduce the size and duration of a Phase 3 trial. With the inclusion of the additional cohorts, Vaxart expects to report topline efficacy data from its Phase 2 challenge study in Q3 2023

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In February 2023, Vaxart initiated a Phase 2 dose-ranging study of its bivalent norovirus oral vaccine candidate and expects to report topline data from this study in mid-2023

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In December 2022, Vaxart announced it will commence a new study of Vaxart’s oral norovirus vaccine candidate focused on protecting breastfeeding mothers and their infants. The study has received significant funding and support from the Bill & Melinda Gates Foundation ("Gates Foundation") and is expected to be initiated in 2023

COVID-19 Vaccine Development

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Vaxart continues to conduct preclinical development of novel constructs for its COVID-19 oral vaccine candidate. Based on the mucosal cross-reactivity data seen in Vaxart’s clinical studies of its COVID-19 vaccine candidates, Vaxart believes it may be able to create an oral pan-betacoronavirus vaccine, which may provide improved protection against SARS-CoV-2 as the virus continues to evolve as well as protection against other types of betacoronaviruses, which include SARS-CoV-1 and Middle East respiratory syndrome coronavirus (MERS-CoV).

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Vaxart is postponing further COVID-19 clinical trials, including the Omicron Human Challenge Trial in the U.K. As Vaxart advances new vaccine candidates, it will determine the best development plan.

Corporate Updates

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Consistent with its prioritization, Vaxart reduced its workforce by 27 percent in Q1 2023.

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Vaxart has access to all cash and other deposits previously held at Silicon Valley Bank (SVB), and has decided to move these deposits to larger financial institutions. The Company does not anticipate any material impact as a result of SVB’s circumstances.

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Vaxart expects its cash on hand will extend into Q2 2024.

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Vaxart remains engaged in discussions with regulatory agencies, governments, non-governmental organizations and other potential strategic parties to maximize the value for all its vaccine candidates.

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In December 2022, Vaxart named Phillip Lee as Chief Financial Officer.

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Mr. Lee has almost 15 years of strategic finance and advisory experience in the biotechnology industry. During his career, he has helped raise over $1 billion of capital and worked on more than $20 billion of M&A transactions, including partnerships, asset acquisitions, mergers, spin-offs and royalty monetization. Most recently, he was CFO and Chief Operating Officer at Clover Biopharmaceuticals and prior to that held finance leadership positions at several biotechnology companies.

Anticipated 2023 Clinical Milestones

Vaxart expects to make progress on its anticipated milestones in 2023:

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Report topline data from the ongoing Phase 2 challenge study of Vaxart’s monovalent norovirus vaccine candidate in Q3 2023.

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Report topline data from the ongoing Phase 2 dose-ranging study of Vaxart’s bivalent norovirus vaccine candidate in mid-2023.

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Initiate Gates Foundation-funded clinical trial to evaluate the ability of Vaxart’s norovirus vaccine candidate to induce antibodies in breast milk and transfer of antibodies to young infants.

Financial Results for the Full Year Ended December 31, 2022

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Vaxart ended the year with cash, cash equivalents, restricted cash and marketable securities of $95.7 million

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Vaxart reported a net loss of $107.8 million for the full year 2022, compared to $70.5 million for the full year 2021. Net loss per share for 2022 was $0.84, compared to $0.58 for 2021.

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Revenue in 2022 was $0.1 million, compared to $0.9 million in 2021. The decrease was principally due to lower royalty revenue from sales of Inavir in Japan.

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Research and development expenses were $81.1 million for 2022, compared to $48.7 million for 2021. The increase was mainly due to a larger headcount and related costs, and in higher manufacturing and clinical trial expenses related to our norovirus and COVID-19 vaccine candidates.

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General and administrative expenses were $29.4 million for 2022, compared to $21.9 million for 2021. The increase was mainly due to a larger headcount and related costs and higher legal and professional costs.

Conference Call

The Vaxart senior management team will host a conference call to discuss the business update and financial results for the full year 2022 today, beginning at 4:30 p.m. ET.

The conference call can be accessed using the following information:

Webcast: Click here

Date: Wednesday, March 15, 2023 – 4:30 p.m. ET

Domestic: 888-407-0832

International: 201-689-8433

Conference ID: 13735958

Investors may submit written questions in advance of the conference call to [email protected].

A replay of the webcast will be available for 30 days on Vaxart’s website at www.vaxart.com following the conclusion of the event.

References

1)

CDC Website Norovirus Section

2)

Potential Clinical and Economic Value of Norovirus Vaccination in the Community Setting, Bartsch S et al., AJPM 2021

3)

Global Economic Burden of Norovirus, Bartsch S et al., PLOS ONE 2016

On March 15, 2023 Resolve Biosciences, a company pioneering Molecular Cartography technology, reported that it has appointed John Stark as Chief Executive Officer (Press release, Resolve Biosciences, MAR 15, 2023, View Source [SID1234628858]). As part of this transition, Resolve Biosciences’ previous CEO, Jason Gammack, will be leaving the company.

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Mr. Stark brings more than 20 years of experience commercializing early-stage technologies, scaling organizations, and navigating capital markets for some of the most innovative life sciences companies. Most recently, Mr. Stark was Chief Executive Officer of Quantum-Si (NASDAQ: QSI), a next-generation, single-molecule protein sequencing platform company. Prior to that, he served as CEO of Celsee, a novel single-cell genomics platform company that was acquired by Bio-Rad (NYSE: BIO) in 2020. Earlier in his career, Mr. Stark held senior leadership positions at Life Technologies (acquired by Thermo Fisher Scientific, NYSE:TMO), Pacific Biosciences (NASDAQ: PACB), and Affymetrix (acquired by Thermo Fisher Scientific).

"The Board is excited to welcome John to Resolve Biosciences to lead our next chapter of growth and success," said Peer M. Schatz, co-founder and Chairman of the Board. "John brings an impressive track record of execution, operational excellence, and successful team building to drive innovation. Throughout his career, John has consistently delivered high-growth results for numerous industry-defining platforms. We look forward to working with him on our quest to shape the future of spatial biology and realize the massive opportunities and vast applications in science and medicine."

Mr. Schatz added, "We deeply appreciate Jason Gammack for his contributions and leadership of the company as former CEO, including shepherding the company through the COVID-19 pandemic and initial launch of our commercial platform and service offering."

"I am honored to join Resolve Biosciences as its next Chief Executive Officer," said Mr. Stark. "It is rare to find an opportunity like this to lead a growing company with a transformative technology and a brilliant and passionate team. I’m looking forward to empowering our global partners and customers with the ability to realize the full potential of our Molecular Cartography technology. We are dedicated to delivering best-in-class products that will enable the understanding of the molecular causes of disease and associated immune response."

On March 15, 2023 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update (Press release, Nuvation Bio, MAR 15, 2023, View Source [SID1234628857]).

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"In the fourth quarter, we dosed the first patient in both dosing regimens of our Phase 1b study of NUV-868 in combination with olaparib or enzalutamide. This milestone sustains the program’s strong momentum, which we expect to continue in 2023. As we advance the Phase 1 monotherapy and combination studies of NUV-868, we look forward to more deeply understanding how this therapy may be able to improve the lives of patients with advanced solid tumors," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We also expect to submit an IND for the first clinical candidate from our DDC platform by the end of the year."

Recent Business Updates

NUV-868, BD2-Selective BETi: Advanced solid tumors

Dosed the first patient in both dosing regimens of the Phase 1b combination study. In December 2022, Nuvation Bio initiated a Phase 1b study of NUV-868 in combination with olaparib in patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer, and other solid tumors, and in combination with enzalutamide in patients with mCRPC.
Dosing underway in the Phase 1 monotherapy study. The Company continues to enroll the Phase 1 monotherapy study in advanced solid tumors.
Drug-Drug Conjugate Platform: Solid tumors

Nominated first clinical candidate. Nuvation Bio expects to submit an Investigational New Drug (IND) application for an undisclosed DDC candidate with the U.S. Food and Drug Administration by year end 2023.
Fourth Quarter and Full Year 2022 Financial Results

As of December 31, 2022, Nuvation Bio had cash, cash equivalents and marketable securities of $661.0 million.

For the three months ended December 31, 2022, research and development expenses were $16.9 million, compared to $22.0 million for the three months ended December 31, 2021. The decrease was primarily due to a $3.7 million decrease in third-party costs related to research services and manufacturing, as well as a $1.5 million decrease in personnel-related costs driven by the termination of the NUV-422 program offset by a $0.1 million increase in miscellaneous expenses. Research and development expenses for the year ended December 31, 2022 were $87.8 million compared to $69.0 million for the year ended December 31, 2021.

For the three months ended December 31, 2022, general and administrative expenses were $7.4 million, compared to $7.6 million for the three months ended December 31, 2021. The decrease was primarily due to a $0.4 million decrease in legal fees, a $0.2 million decrease in professional fees, and a $0.2 million decrease in miscellaneous expenses offset by a $0.5 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation and a $0.1 million increase in taxes. General and administrative expenses for the year ended December 31, 2022 were $31.9 million compared to $24.3 million for the year ended December 31, 2021.

For the three months ended December 31, 2022, Nuvation Bio reported a net loss of $20.8 million, or $(0.10) per share. This compares to a net loss of $25.1 million, or $(0.12) per share, for the comparable period in 2021. Net loss for the year ended December 31, 2022 was $104.2 million compared to $86.8 million for the year ended December 31, 2021.

On March 15, 2023 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) (Paris:OSE) reported it will be presenting five posters at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, OSE Immunotherapeutics, MAR 15, 2023, View Source [SID1234628856]). AACR (Free AACR Whitepaper) will be held in person in Orlando (Florida) on April 14-19.

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Four communications will feature the latest research on pre-IND programs for the pioneering Myeloid and BiCKI platforms, namely presentations on CLEC-1 (new myeloid immune checkpoint) and BiCKI-IL7 (new bifunctional therapy targeting PD-1 and IL-7), and OSE-127 (anti-IL-7 receptor antagonist) hematology program. A fifth communication will feature biomarker analyses on BI 765063 (anti-SIRPα monoclonal antibody on CD47/SIRPα pathway) from the ongoing Phase 1 clinical trial in advanced solid tumors.

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: "We are very pleased to have several poster presentations at the prestigious AACR (Free AACR Whitepaper) annual meeting. This selection by the international scientific community underlines the recognition and the interest in the quality of our R&D engines with preclinical and clinical innovative research programs. It further highlights our long-term commitment to fight against debilitating cancer and chronic diseases through the development of first-in-class innovative immunotherapies."

Poster presentation details:

Poster CLEC#1*

Title: ""CLEC-1 inhibitory myeloid checkpoint blockade enhances antitumor responses and tumor phagocytosis by macrophages""
Session Category: Immunology
Session Title: Immune Checkpoints
Session Date and Time: April 19, 2023 – 9:00 AM – 12:30 PM
Location: Section 23
Poster Board Number: 2

Poster CLEC#2*

Title: "TRIM21 is a novel endogenous partner of the inhibitory myeloid checkpoint CLEC-1 involved in tumor antigen cross-presentation"
Session Category: Immunology
Session Title: Immune Checkpoints
Session Date and Time: April 19, 2023 – 9:00 AM – 12:30 PM
Location: Poster Section 23
Poster Board Number: 9

Poster BiCKI-IL-7

Title: "Anti-PD-1/IL-7v bispecific antibody promotes TCF1+ stem like CD8 T cells expansion and long-lasting in vivo efficacy"
Session Category: Immunology
Session Title: Therapeutic Antibodies 3
Session Date and Time: April 17, 2023 – 1:30 PM – 5:00 PM
Location: Poster Section 24
Poster Board Number: 2

Poster OSE-127

Title: "CD127 is expressed by acute lymphoblastic leukemias and is efficiently targeted by the IL7R-antagonist OSE-127 through macrophage-mediated antibody dependent phagocytosis"
Session Category: Immunology
Session Title: Therapeutic Antibodies 3
Session Date and Time: April 17, 2023 – 1:30 PM – 5:00 PM
Location: Poster Section 24
Poster Board Number: 4

In parallel, OSE-127 is currently being developed in clinical stage in partnership with Servier. Two clinical studies are ongoing in inflammatory diseases: a phase 2a study conducted in primary Sjögren’s syndrome by Servier, for which completion of patient enrollment has been announced in November 2022, and a Phase 2 study conducted in ulcerative colitis by OSE Immunotherapeutics.

Poster BI 765063

Title: "Predictive response biomarkers from Phase I clinical trial of a SIRPalpha inhibitor BI765063, stand-alone and in combination with ezabenlimab, a PD1 inhibitor, in patients with advanced solid tumors"
Session Category: Clinical Research Excluding Trials
Session Title: Biomarkers of Therapeutic Benefit 2
Date & Time: April 17, 2023 – 9:00 AM – 12:30 PM
Location: Poster Section 39, Poster Board 3
Poster Number: 2129

BI 765063 is being evaluated in combination with Ezabenlimab in a Phase 1 expansion clinical trial in patients with microsatellite stable (MSS) advanced colorectal cancer and MSS advanced endometrium cancer whose disease relapsed after standard of care and who received no prior anti-PD-L1 inhibitors.

This Phase 1 clinical trial with BI 765063 is conducted by OSE Immunotherapeutics as part of a collaboration and license agreement under which Boehringer Ingelheim obtained exclusive rights to BI 765063.

* Collaborative academic program between OSE Immunotherapeutics and Dr Elise Chiffoleau’s research teams (Center for Research in Transplantation and Translational Immunology (CR2TI), UMR1064, INSERM, Nantes University at Nantes University Hospital, View Source).