On June 2, 2022 Sysmex Inostics, Inc. and QIAGEN N.V. reported that it will co-exhibit at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting, the world’s largest clinical cancer research meeting, held June 3, 2022, through June 7, 2022, in Chicago (Press release, Sysmex Inostics, JUN 2, 2022, View Source [SID1234615415]).

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QIAGEN, the leading global provider of sample to insight solutions for molecular testing, and Sysmex Inostics combined forces in July 2021 to accelerate global companion diagnostic access. QIAGEN provides unparalleled global custom cancer companion diagnostics (CDx) development and commercialization capabilities utilizing Sysmex Inostics ultra-sensitive NGS liquid biopsy technology. The goal of the alliance is to promote early clinical implementation of Sysmex Inostics’ technology to expedite clinical trial timelines for pharmaceutical companies that develop molecularly targeted drugs for cancer.

"Sysmex Inostics is focused on developing tools to support the fight against cancer and other devastating diseases. By partnering with industry leaders like QIAGEN we can help accelerate the fight to help patients with these diseases," said Shinichi Sato, CEO of Sysmex Inostics, Inc. "We look forward to highlighting our partnership with QIAGEN at ASCO (Free ASCO Whitepaper) 2022."

"Through our partnership with Sysmex, we can develop ultrasensitive blood-based NGS panels to the specific requirements of our pharma partners for their clinical trials," stated Jonathan Arnold, Vice President, Head of Oncology and Precision Diagnostics of QIAGEN. Arnold added, "If and when a CDx is required, QIAGEN will lead IVD submission, manufacturing, and global commercialization as a kitted product."

Sysmex and QIAGEN will highlight their alliance at ASCO (Free ASCO Whitepaper) booth 8149, Saturday, June 4, 2022, through Monday, June 6, 2022, 9:00 AM – 5:00 PM CDT each day.

Poster Presentations Utilizing Sysmex Inostics’ Technology
Yoshinori Kagawa MD, PhD, Department of Gastroenterological Surgery, Osaka General Medical Center, Osaka, Japan, will present the poster "Plasma RAS dynamics and anti-EGFR rechallenge efficacy in patients with RAS/BRAF wild-type metastatic colorectal cancer: REMARRY and PURSUIT trials." Circulating tumor DNA (ctDNA) was analyzed and monitored using the Sysmex Inostics OncoBEAMTM RAS CRC Kit. Dr. Kagawa will present poster 3518 during the Gastrointestinal Cancer—Colorectal and Anal session on Saturday, June 4, 2022, 3:00 PM-4:30 PM CDT.

Linda (Yilin) Cao, MD, Department of Radiation Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, will present the poster "Dynamic cell free HPV DNA is an early measure of treatment responsiveness in patients receiving induction chemotherapy for HPV-related head and neck cancer." Findings add to the breadth of ongoing clinical studies using HPV-SEQ to investigate de-escalation of HPV-positive patients from unnecessary and potentially harmful head and neck squamous cell carcinomas (HNSCC) treatments. HPV-SEQ is an ultrasensitive test for the detection of HPV16/18 DNA from blood and is CLIA validated to detect as few as five HPV DNA molecules from two tubes of blood.1 See here for additional study information. Dr. Cao will present poster 6062 during the Head and Neck Cancer session on Monday, June 6, 2022, 1:15 PM- 4:15 PM CDT.

On June 2, 2022 Mereo BioPharma Group plc (NASDAQ: MREO), ("Mereo" or "the Company"), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, reported updated clinical data from its open-label Phase 1b/2 Study of Etigilimab and Nivolumab in subjects with Select Locally Advanced or Metastatic Solid Tumors (ACTIVATE) (Press release, Mereo BioPharma, JUN 2, 2022, View Source [SID1234615414]). The data will be presented in a poster session at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 5, 2022. The Company also provided an update on its capital allocation and portfolio prioritization plan.

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The multicenter ACTIVATE study is designed to evaluate the efficacy, safety, tolerability, PK, and pharmacodynamics of etigilimab, in combination with nivolumab, with dosing every two weeks.

As of the cut off date of April 20, 2022, there were 38 efficacy-evaluable subjects with a minimum of 1 staging scan or documented clinical progression. Treatment of etigilimab in combination with nivolumab has shown preliminary efficacy across multiple tumor types with 2 complete responses (CRs), 4 partial responses (PRs), and 10 stable disease (SDs) for an overall response rate (ORR) of 15.8% and disease control rate (DCR) of 42.1% in heavily pre-treated, CPI-naïve subjects. Additionally, 7 subjects with clinical benefit remained on study treatment for ≥ 18 weeks. Clinical benefit was noted in tumor types not typically responsive to immune checkpoint inhibitor monotherapy. The combination of etigilimab and nivolumab has been safe and well tolerated, with no new treatment-related SAEs or safety signals observed to-date.

"We are very pleased with these updated results from the ACTIVATE study and look forward to sharing our findings at ASCO (Free ASCO Whitepaper)," said Dr. Suba Krishnan, Senior Vice President, Clinical Development of Mereo. "We are encouraged by the results reported as of the cut-off date, especially the early efficacy noted in cervical cancer, where we have seen two complete responses and two cases of stable disease among five subjects, and in uveal melanoma subjects in the rare tumor cohort, where we saw one partial response and two stable disease with over 20 weeks on study treatment. While these early data are encouraging for our differentiated clinical strategy, we will continue to monitor emerging clinical data on other anti-TIGIT therapeutics as we determine the most appropriate path forward for etigilimab."

Updated Capital Allocation and Portfolio Prioritization Plan
Mereo also announced the outcome of a review to update its capital allocation strategy, including general and administrative and other costs, and portfolio prioritization in light of current market conditions and recent industry clinical data announcements. This review was undertaken with the aim of maximizing shareholder value. Based on these initiatives, the Company now expects its current cash runway will be extended from "into" 2024 to late 2024.

The portfolio, in order of development stage, is as follows:

Setrusumab for Osteogenesis Imperfecta (OI): As planned, Mereo will target its investment toward the activities required in support of the EU and UK territories and the ongoing collaboration with Ultragenyx Pharmaceutical, Inc. The Phase 2/3 in 5-25 year olds has been initiated by Ultragenyx and an update on the Phase 2 is expected before the end of 2022.
Alvelestat for Alpha-1-Anti-Trypsin Deficiency (AATD): Mereo recently announced positive top-line data from the Phase 2 study of alvelestat in AATD. The Company intends to complete further analysis of the Phase 2 data during 2H 2022 and will evaluate further options for the program once it has completed an end-of-Phase 2 meeting with the FDA (intended by end of 2022) and an EMA scientific advisory meeting (thereafter). As previously planned, no additional clinical development expense will be incurred for this program from the current cash resources.
Etigilimab in Oncology: Mereo intends to complete enrollment in the Phase 1b part of the previously planned Phase 1b/2 study in Q3 2022. The Company will then evaluate further options based on the Phase 1b data and external factors, including clinical data from other anti-TIGIT programs.
Mereo will continue to explore a range of additional financing options for its programs, including partnerships, which may include retention of certain rights and/or territories, as well as non-dilutive financing.

"We conducted this strategic review over the last few months in light of current market conditions and emerging external clinical data, to focus the Company’s resources on our lead programs," said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. "As a result of our updated capital allocation plan, our current cash balance of $111.4 million (as of March 31, 2022) will now support our operating runway into late 2024. We believe this puts Mereo in a stronger position to maximize shareholder value and deliver on multiple milestones over the next two years as we focus on our mission of developing transformative therapies."

Details of the ASCO (Free ASCO Whitepaper) data presentation are as follows:
Abstract Title: A Phase 1b/2 Study of Etigilimab (MPH313) and Nivolumab in Subjects with Select Locally Advanced or Metastatic Solid Tumors (ACTIVATE)
Session Date & Time: Sunday, June 5 at 9AM ET
Session Title: Developmental Therapeutics—Immunotherapy
Abstract ID: 2651

On June 2, 2022 Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company pioneering the development of stem cell-based delivery of oncolytic viruses, reported that Stephen Thesing, Chief Business Officer, will present a company overview at the Jefferies Healthcare Conference on Wednesday, June 8, 2022 at 2:00 p.m. ET (Press release, Calidi Biotherapeutics, JUN 2, 2022, View Source [SID1234615413]). The conference will be taking place June 8-10, 2022 in New York City.

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ON June 2, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that management will participate in the Jefferies Healthcare Conference being held June 8-10, 2022 (Press release, Oncternal Therapeutics, JUN 2, 2022, View Source [SID1234615412]).

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James Breitmeyer, M.D, Ph.D., Oncternal’s President and Chief Executive Officer, will present a corporate overview on Wednesday, June 8th at 9:30am (ET), and the Company will be available for one-on-one meetings.

On June 2, 2022 TRACON Pharmaceuticals (Nasdaq: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with life science companies through a profit-share, revenue share, or franchise model, reported that Charles Theuer, M.D., Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the Jefferies Healthcare Conference on Friday, June 10, 2022 at 11:00 am Eastern Time (Press release, Tracon Pharmaceuticals, JUN 2, 2022, View Source [SID1234615410]).

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To access a live webcast or replay of the presentation, please visit the "Events and Presentations" page within the "Investors" section of the TRACON Pharmaceuticals website at www.traconpharma.com.