Entry into a Material Definitive Agreement

On May 22, 2023, CohBar, Inc., a Delaware corporation ("CohBar"), Chimera MergeCo, Inc., a Delaware corporation and wholly owned subsidiary of CohBar ("Merger Sub"), and Morphogenesis, Inc., a Delaware corporation ("Morphogenesis"), entered into an Agreement and Plan of Merger, dated as of May 22, 2023 (the "Merger Agreement"), pursuant to which, among other matters and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into Morphogenesis, with Morphogenesis continuing as a wholly owned subsidiary of CohBar and the surviving corporation of the merger (the "Merger") (Filing, 8-K, CohBar, MAY 22, 2023, View Source [SID1234631956]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Subject to the terms and conditions of the Merger Agreement, at the closing of the Merger, (a) each then-outstanding share of common stock, par value $0.001 per share, of Morphogenesis (the "Morphogenesis Common Stock") (other than shares held in treasury and Dissenting Shares (as defined in the Merger Agreement)) will be converted into and become exchangeable for a number of shares of common stock, par value $0.001 per share, of CohBar (the "CohBar Common Stock") calculated in accordance with the Merger Agreement (the "Exchange Ratio"), (b) each then-outstanding option to purchase Morphogenesis Common Stock will be assumed and converted by CohBar into an option to purchase shares of CohBar Common Stock, subject to certain adjustments as set forth in the Merger Agreement, and (c) each then-outstanding warrant to purchase shares of Morphogenesis Common Stock (the "Morphogenesis Warrants") will be converted into and exchangeable for a warrant of like tenor entitling the holder to purchase shares of CohBar Common Stock, subject to certain adjustments as set forth in the Merger Agreement. In addition to the foregoing, the Merger Agreement provides that, at the closing of the Merger, the corporate name of CohBar will be changed to "TuHURA Biosciences, Inc."

On a pro forma basis, including the Stock Dividend (as defined below) and, after taking into account the Financing (as defined and described below), pre-Merger Morphogenesis equityholders would own approximately 77% of the combined company, pre-Merger CohBar equityholders would own approximately 15% of the combined company, and the Investor (as defined below) would own approximately 9% of the combined company (excluding in each such case the effect of out-of-the-money options and warrants of CohBar that will remaining outstanding after the Merger). The Exchange Ratio will be equal to the quotient obtained by dividing (a) the Company Merger Shares by (b) the Company Outstanding Shares, as those terms are defined and further described in the Merger Agreement, which has the effect and purpose of determining the number of shares to be issued to pre-Merger Morphogenesis stockholders (or issuable to pre-Merger Morphogenesis option and warrant holders in respect of such options and warrants) based on the relative valuations and fully-diluted shares of each of CohBar and Morphogenesis as of immediately prior to the closing of the Merger. For purposes of calculating the Exchange Ratio, (i) shares of CohBar Common Stock underlying CohBar stock options and warrants outstanding as of immediately prior to the closing of the Merger with an exercise price per share of less than or equal to $2.00 (subject to adjustment pursuant to the Merger Agreement) will be deemed to be outstanding and (ii) all shares of Morphogenesis Common Stock underlying outstanding Morphogenesis preferred stock, stock options, and warrants will be deemed to be outstanding.

In connection with the Merger, CohBar will seek the approval of its stockholders to, among other things, (a) issue shares of CohBar Common Stock issuable in connection with the Merger under the rules of The Nasdaq Stock Market LLC ("Nasdaq"), (b) if deemed advisable, amend CohBar’s amended and restated certificate of incorporation (i) to increase the number of authorized shares of CohBar Common Stock and/or (ii) to effect a reverse stock split of CohBar Common Stock, (c) elect the post-closing directors of CohBar as contemplated by the Merger Agreement and (d) approve a new equity compensation plan in a form approved by CohBar and Morphogenesis ((a), (b) and (c), collectively, the "Required CohBar Stockholder Proposals" and (a), (b), (c) and (d), collectively, the "CohBar Stockholder Matters").

Each of CohBar and Morphogenesis has agreed to customary representations, warranties and covenants in the Merger Agreement, including, among others, covenants relating to (1) obtaining the requisite approval of its respective stockholders, (2) non-solicitation of alternative acquisition proposals, (3) the conduct of its respective business during the period between the signing of the Merger Agreement and the closing of the Merger, (4) CohBar using commercially reasonable efforts to maintain the existing listing of the CohBar Common Stock on Nasdaq and cause the shares of CohBar Common Stock to be issued in connection with the Merger to be approved for listing on Nasdaq prior to the closing of the Merger, and (5) CohBar filing with the U.S. Securities and Exchange Commission (the "SEC") and causing to become effective a registration statement to register the shares of CohBar Common Stock to be issued in connection with the Merger (the "Registration Statement").

Consummation of the Merger is subject to certain closing conditions, including, among other things, (1) approval by the requisite CohBar stockholders of the Required CohBar Stockholder Proposals, (2) adoption and approval by the requisite Morphogenesis stockholders of the Merger Agreement and the transactions contemplated thereby, (3) Nasdaq’s approval of the listing of the common stock of the combined company, (4) the effectiveness of the Registration Statement, (5) the Parent Closing Cash (as defined in the Merger Agreement) being no less than $4,000,000, (6) the number of shares of Morphogenesis Common Stock issuable upon the exercise of the Morphogenesis Warrants as of immediately prior to the Effective Time being not more than 30,000,000 shares of Morphogenesis Common Stock, and (7) the holders of at least 60% of Morphogenesis fully diluted shares executing Lock-Up Agreements (as defined below). Each party’s obligation to consummate the Merger is also subject to other specified customary conditions, including regarding the accuracy of the representations and warranties of the other party, subject to the applicable materiality standard, and the performance in all material respects by the other party of its obligations under the Merger Agreement required to be performed on or prior to the date of the closing of the Merger.

The Merger Agreement contains certain termination rights of each of CohBar and Morphogenesis. Upon termination of the Merger Agreement under specified circumstances, CohBar may be required to pay Morphogenesis a termination fee of $1 million or reimburse Morphogenesis’ expenses up to a maximum of $1.5 million, and Morphogenesis may be required to pay CohBar a termination fee of $3 million or reimburse CohBar’s expenses up to a maximum of $1.5 million.

At the effective time of the Merger (the "Effective Time"), the board of directors of CohBar (the "Board") is expected to consist of seven members, five of whom will be designated by Morphogenesis and two of whom will be designated by CohBar. At the Effective Time, the officers of Morphogenesis as of immediately prior to the Effective Time will become the officers of CohBar.

Financing Transaction

Concurrently with the execution and delivery of the Merger Agreement, CohBar entered into a Stock Purchase Agreement (the "Stock Purchase Agreement") with K & V Investment Two, LLC, a Florida limited liability company (the "Investor"). Pursuant to the Stock Purchase Agreement, CohBar will issue, subject to adjustments contained in the Stock Purchase Agreement, 7,500,000 shares of CohBar Common Stock for an aggregate purchase price of $15 million (the "Financing") immediately prior to the Effective Time (the "Initial Closing"). The consummation of the Financing is conditioned on the satisfaction or waiver of the conditions set forth in the Stock Purchase Agreement. In addition, pursuant to the Stock Purchase Agreement, CohBar has agreed to sell, at the election of the Investor within six months after the Initial Closing of the Financing and subject to the satisfaction or waiver of the conditions set forth in the Stock Purchase Agreement, an aggregate of 7,500,000 additional shares of CohBar Common Stock, subject to adjustments contained in the Stock Purchase Agreement, for an aggregate purchase price of up to $15 million at the same price per share as sold in connection with the Initial Closing.

The Financing is intended to be exempt from registration pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, as a transaction by an issuer not involving a public offering. The Investor has the intent to acquire the shares of CohBar Common Stock for investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends will be affixed to the shares of CohBar Common Stock issued in the Financing.

Registration Rights Agreement

At or prior to the Effective Time, pursuant to the Stock Purchase Agreement, CohBar will enter into a Registration Rights Agreement (the "Registration Rights Agreement") with the Investor and certain former holders of the Morphogenesis Warrants (collectively, the "Holders"), pursuant to which CohBar will be required to prepare and file a resale registration statement with the SEC within 45 business days following the closing of the Merger to register the resale of shares of CohBar Common Stock issued in the Financing and issuable upon the exercise of CohBar warrants that are received by the Holders in the Merger (the "Filing Deadline"). CohBar will use its commercially reasonable efforts to cause such resale registration statement to be declared effective by the SEC within 30 calendar days of the Filing Deadline (or within 60 calendar days if the SEC reviews the resale registration statement).

Pursuant to the Registration Rights Agreement, CohBar will agree, among other things, to indemnify each of the Holders, and, among others, their respective officers, directors, agents, partners, members, managers, stockholders, affiliates and employees of each of them, from certain liabilities and to pay all fees and expenses (excluding any legal fees of the Holders, and any underwriting discounts and selling commissions) incident to CohBar’s performance of or compliance with its obligations under the Registration Rights Agreement.

Support Agreements and Lock-Up Agreements

Concurrently with the execution of the Merger Agreement, (i) certain stockholders of Morphogenesis (solely in their respective capacities as Morphogenesis stockholders) have entered into support agreements with CohBar and Morphogenesis to vote all of their shares of Morphogenesis Common Stock in favor of the adoption and approval of the Merger Agreement and the transactions contemplated thereby and against any alternative acquisition proposals (the "Morphogenesis Support Agreements") and (ii) certain officers and directors of CohBar have entered into support agreements with CohBar and Morphogenesis to vote all of their shares of CohBar Common Stock in favor of the CohBar Stockholder Matters and against any alternative acquisition proposals (the "CohBar Support Agreements," and, together with the Morphogenesis Support Agreements, the "Support Agreements").

Concurrently with the execution of the Merger Agreement, certain stockholders of Morphogenesis representing approximately 36% of the fully-diluted Morphogenesis Common Stock have entered into lock-up agreements (the "Lock-Up Agreements"), pursuant to which, subject to specified exceptions, they have agreed not to transfer their shares of CohBar Common Stock during the 180-day period following the closing of the Merger. In addition, under the Merger Agreement, CohBar and Morphogenesis will use reasonable best efforts to have each of the persons that will serve as directors and executive officers of CohBar after the closing of the Merger execute and deliver a Lock-Up Agreement prior to the closing of the Merger.

Contingent Value Rights Agreement

At or prior to the Effective Time, CohBar will enter into a Contingent Value Rights Agreement (the "CVR Agreement") with a rights agent ("Rights Agent"), pursuant to which CohBar’s pre-Merger common stockholders and certain warrant holders of record as of the close of business on the business day immediately prior to the date of the closing of the Merger or such other date pursuant to the terms of the Merger Agreement (the "Record Date") will receive one contingent value right (each, a "CVR") for each outstanding share of CohBar Common Stock held by such stockholder (or, in the case of the warrants, each share of CohBar Common Stock for which such warrant is exercisable). The payment date for the CVRs will be three business days after the Effective Time, provided, that CohBar will make additional CVR distributions to certain CohBar warrant holders from time to time to the extent such warrant holders become entitled to the CVR in accordance with the terms of such warrants. Each CVR will entitle the holder thereof to receive certain cash payments from the net proceeds, if any, related to the disposition of CohBar’s legacy assets pursuant to any disposition agreement entered into within three years of the closing of the Merger.

The contingent payments under the CVR Agreement, if they become payable, will become payable to the Rights Agent for subsequent distribution to the holders of the CVRs. In the event that no such proceeds are received, holders of the CVRs will not receive any payment pursuant to the CVR Agreement. There can be no assurance that any holders of CVRs will receive any payments with respect thereto.

The right to the contingent payments contemplated by the CVR Agreement is a contractual right only and will not be transferable, except in the limited circumstances specified in the CVR Agreement. The CVRs will not be evidenced by a certificate or any other instrument and will not be registered with the SEC. The CVRs will not have any voting rights and will not represent any equity or ownership interest in CohBar or any of its affiliates. No interest will accrue on any amounts payable in respect of the CVRs.

Stock Dividend

As contemplated by the Merger Agreement, CohBar will make a dividend to the holders of CohBar Common Stock as of the Record Date equal to approximately 3.3 shares of CohBar Common Stock per each share of CohBar Common Stock issued and outstanding as of the Record Date (the "Stock Dividend"). The payment date for the Stock Dividend is anticipated to be either immediately prior to or immediately after the Effective Time.

The preceding summaries of the Merger Agreement, the Stock Purchase Agreement, the Registration Rights Agreement, the Support Agreements, the Lock-Up Agreements and the CVR Agreement do not purport to be complete and are qualified in their entirety by reference to the Merger Agreement, the Stock Purchase Agreement, the form of Registration Rights Agreement, the form of Morphogenesis Support Agreement, the form of CohBar Support Agreement, the form of Lock-Up Agreement and the form of CVR Agreement, which are filed as Exhibits 2.1, 10.1, 10.2, 10.3, 10.4, 10.5 and 10.6, respectively, to this Current Report on Form 8-K and which are incorporated herein by reference. The Merger Agreement has been attached as an exhibit to this Current Report on Form 8-K to provide investors and securityholders with information regarding its terms. It is not intended to provide any other factual information about Morphogenesis or CohBar or to modify or supplement any factual disclosures about CohBar in its public reports filed with the SEC. The Merger Agreement includes representations, warranties and covenants of Morphogenesis, CohBar and Merger Sub made solely for the purpose of the Merger Agreement and solely for the benefit of the parties thereto in connection with the negotiated terms of the Merger Agreement. Investors should not rely on the representations, warranties and covenants in the Merger Agreement or any descriptions thereof as characterizations of the actual state of facts or conditions of Morphogenesis, CohBar or any of their respective affiliates. Moreover, certain of those representations and warranties may not be accurate or complete as of any specified date, may be subject to a contractual standard of materiality different from those generally applicable to SEC filings or may have been used for purposes of allocating risk among the parties to the Merger Agreement, rather than establishing matters of fact.

Lumicell Announces FDA Acceptance and Priority Review of New Drug Application for LUMISIGHT™ Optical Imaging Agent for Breast Cancer

On May 22, 2023 Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, reported that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for the LUMISIGHT Optical Imaging Agent and accepted the Premarket Approval (PMA) application for the Lumicell Direct Visualization System (DVS) (Press release, Lumicell Diagnostics, MAY 22, 2023, View Source [SID1234631938]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Lumicell DVS is an investigational system designed for use in patients with breast cancer to assist in the detection of residual cancerous tissue within the lumpectomy cavity following removal of the primary specimen during breast conserving surgery. The Lumicell DVS is intended for use with the investigational optical imaging agent LUMISIGHT (pegulicianine) for fluorescence imaging of the lumpectomy cavity.

"The FDA acceptances of both the NDA and PMA submissions for our LUMISIGHT Optical Imaging Agent and Lumicell Direct Visualization System bring us one step closer to advancing care for women with breast cancer," said Kevin Hershberger, president and chief executive officer of Lumicell. "Priority Review designation is further recognition of the potential of our system to significantly improve the effectiveness of breast cancer treatment. We look forward to the FDA’s review of our applications, and the potential to offer surgeons the first visualization system to enable a more complete cancer resection during the initial lumpectomy."

These submissions are supported by data from more than 700 breast cancer patients across five clinical studies at top academic and regional community cancer centers. Results of the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial were published in NEJM Evidence and the Phase C study in JAMA Surgery. The FDA previously granted LUMISIGHT Fast Track designation and the Lumicell DVS Breakthrough Device designation in recognition of the potential important benefit of identifying residual cancer during the initial lumpectomy.

The standard of care for lumpectomy surgery involves breast surgeons and pathologists examining the margins of excised tissue to infer whether any residual cancer remains behind in the breast cavity. As a result, 20-40% of lumpectomies have positive margins only identified days after surgery, necessitating a second surgery to obtain clear margins.1,2 Moreover, as reported in published literature, approximately 14% of patients determined by pathology to have negative margins, implying that no cancer remained inside the cavity, had residual cancer left behind.3 With future approval of our system, surgeons will be able to look inside the lumpectomy cavity to find, and remove residual cancer during the initial lumpectomy, and achieve a more complete cancer resection.

About the Lumicell Direct Visualization System and LUMISIGHT Optical Imaging Agent

The Lumicell DVS is an investigational system designed for use in patients with breast cancer to assist in the detection of residual malignant tissue within the lumpectomy cavity following removal of the primary specimen during breast conserving surgery. The investigational Lumicell Direct Visualization System (DVS) is intended for use with the investigational LUMISIGHT Optical Imaging Agent and features a hand-held imaging probe that is designed to go inside the breast cavity and a patient-calibrated cancer detection software to assist in the detection of residual cancer, thereby enabling a more complete cancer resection. Lumicell’s proprietary, pan-oncologic optical imaging agent LUMISIGHT is also being explored across a wide variety of solid tumor indications.

The Lumicell DVS and LUMISIGHT are limited by Federal (or United States) law to investigational use only. The Lumicell DVS and LUMISIGHT are not commercially available.

RayzeBio to Present at Upcoming Medical Conferences

On May 22, 2023 RayzeBio, Inc., a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, reported that the Company will be presenting data for its lead clinical program, RYZ101 (Ac225 DOTATATE) at two upcoming medical conferences as well as presentations on preclinical programs (Press release, RayzeBio, MAY 22, 2023, View Source [SID1234631937]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

2023 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting: June 2 – 6 in Chicago, IL

Title: ACTION-1 phase 1b/3 trial of RYZ101 in somatostatin receptor subtype 2–expressing (SSTR2+) gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: Initial safety analysis.
Abstract #: 4132
Presenter: Jonathan Strosberg
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Date/Time: 6/5/2023, 8:00 AM-11:00 AM

Australian and New Zealand Society of Nuclear Medicine (ANZSNM): May 26 – 28 in Adelaide, Australia

Title: Anti-tumor activity of RYZ101 in somatostatin receptor-expressing preclinical models of small-cell lung cancer.
Presenter: Jessica Rearden
Session Title: Poster Session
Date/Time: Saturday May 27th / 1-130pm

Title: Novel peptide binder to Glypican-3 for targeted radiopharmaceutical therapy of hepatocellular carcinoma.
Presenter: Ken Song
Session Title: Oral Presentation
Date / Time: Saturday May 27th / 5:15 – 5:30pm

About RYZ101

RYZ101 is an investigational targeted radiopharmaceutical therapy, designed to deliver a highly potent radioisotope, Actinium-225 (Ac225), to tumors expressing SSTR2. RYZ101 is being evaluated in clinical studies for patients with SSTR+ GEP-NETs who have previously been treated with Lu177-based somatostatin therapies and also in patients with extensive stage small cell lung cancer. Details of the studies can be found at View Source and View Source

Ac225 for the study was provided by multiple sources including the U.S. Department of Energy Isotope Program.

Therapeutic Solutions International Spin-Off Res Nova Bio Leverages FDA Cleared Tumor Blood Vessel Targeting Technology to Intravenously Deliver Cancer Killing Viruses

On May 22, 2023 Therapeutic Solutions International (TSOI) reported that its Spin-Off Company, Res Nova Bio, achieved successful delivery of a cancer killing virus to breast cancer, resulting in shrinkage of the tumor without induction of side effects (Press release, Res Nova Bio, MAY 22, 2023, View Source [SID1234631936]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company, which is currently manufacturing the FDA-cleared ValloVax endothelial cell vaccine, has demonstrated that intravenous administration of viral infected ValloVax cells results in direct delivery to the breast cancer, causing regression and generation of immunity. The company plans to generate "next generation" tumor targeting cell therapies based on specific properties of the blood vessels that feed the cancer.

"Cancer cells are selectively sensitive to killing by viruses because in their decision to multiply excessively and metastasize, they forgo antiviral molecular defenses that are present in non-cancer cells," said Dr. James Veltmeyer, Chief Medical Officer. "The FDA has approved one viral derived product, T-Vec by Amgen for treatment of melanoma, however this requires injection directly into the tumor, which has some level of impracticality since not all tumors can be accessed1. The data presented today provides a means of intravenously delivering the virus using cells that selectively deliver it to cancer blood vessels."

ValloVax was cleared by the FDA for a clinical trial for treatment of lung cancer2, and detailed scientific mechanisms of its ability to selectively interact with new tumor blood vessels has been published3. Res Nova Bio collaborates with the Veltmeyer Institute to provide access to ValloVax to no option breast cancer patients4.

"I commend CEO Famela Ramos and her team of collaborators at Res Nova for expanding the "pregnancy-cancer" connection into the area of oncolytic virus delivery, which opens numerous doors for therapeutic possibilities and partnerships," stated Timothy Dixon, President, and CEO of Therapeutic Solutions International, the company from which Res Nova spun-out of. "It is important to remember that the virus used in these studies, Newcastle Disease Virus, is well characterized and has a very favorable safety profile, making this an ideal "proof-of-concept" experiment.

"The focus of Res Nova is finding a cure for breast cancer. We see this new data as providing a potentially new weapon in the armamentarium of the brave clinicians who are waging war against this merciless killer," said Famela Ramos, President, and CEO of Res Nova.

GRAIL to Present New Multi-Cancer Early Detection Data at the 2023 ASCO Annual Meeting

On May 22, 2023 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, reported that it will present new data evaluating the use and potential of its methylation-based multi-cancer early detection (MCED) platform at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, June 2-6 (Press release, Grail, MAY 22, 2023, View Source [SID1234631935]). Presentations include interim results from SYMPLIFY, the first large-scale prospective study to evaluate GRAIL’s MCED test in symptomatic patients referred for cancer suspicion, as well as Galleri real-world clinical surveillance data and subset analyses from the PATHFINDER clinical implementation study. An evaluation of Galleri implementation using a centralized model within Mercy’s multi-state health system will also be presented.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"If we hope to bend the cancer mortality curve, we need a new, population-scale approach for screening people that finds many more cancers than we do today, in earlier stages when treatments are often more effective," said Josh Ofman, MD, MSHS, president at GRAIL. "We believe that adding multi-cancer early detection testing to recommended screening is the best chance to address the growing burden of late-stage cancer in an aging population. We are excited to present new data at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting supporting the use of GRAIL’s MCED technology in adults at elevated risk of cancer, as well as initial findings from SYMPLIFY, a study evaluating patients presenting with signs and symptoms who are referred for a cancer evaluation."

Initial results from SYMPLIFY will be presented during an oral session. SYMPLIFY is the first prospective study assessing the clinical performance of GRAIL’s MCED Methylation Platform in individuals with signs and symptoms that may indicate cancer. Researchers will also present an analysis of the early real-world clinical experience using the Galleri MCED test to detect a shared cancer signal and predict cancer signal of origin (CSO) to guide targeted diagnostic workup. Additionally, doctors from Mercy will present a preliminary analysis of an MCED test implementation model within a large health system utilizing a patient navigation system. A follow-up analysis to the PATHFINDER study assessing clinical implementation of the test following a cancer signal detected result and CSO-guided workups will also be presented. Results from the PATHFINDER study were previously reported during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022.

Abstracts will be available on the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting website. Updated analyses will be presented at the Annual Meeting.

Oral Sessions

Title: Large-scale observational prospective cohort study of a multi-cancer early detection (MCED) test in symptomatic patients referred for cancer investigation
Session Title: Care Delivery and Regulatory Policy
Date/Time: June 3, 2023, 1:27 to 1:39 PM CDT
Location: S100a
Abstract Number: 1501

Title: Methylated DNA biomarkers and incident cancer in the American Cancer Society (ACS) Cancer Prevention Study-3 (CPS-3) cohort
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Date/Time: June 5, 2023, 9:12 to 9:24 AM CDT
Location: Hall D2
Abstract Number: 3004

Posters

Title: Early real-world (RW) experience with a multi-cancer early detection (MCED) test
Session Title: Prevention, Risk Reduction and Hereditary Cancer
Date/Time: June 3, 2023, poster session from 1:15 to 4:15 PM CDT; panel discussion from 5:04 to 5:14 PM CDT
Location: S102
Abstract Number: 10519

Title: Clinical evaluation of cancer signal origin prediction and diagnostic resolution following multi-cancer early detection testing
Session Title: Prevention, Risk Reduction and Hereditary Cancer
Date/Time: June 3, 2023, poster session from 1:15 to 4:15 PM CDT; panel discussion from 5:04 to 5:14 PM CDT
Location: S102
Abstract Number: 10520

Title: Preclinical circulating tumor DNA (ctDNA) shedding duration and prognostic implications of modeling 3669 participants from American Cancer Society Cancer Prevention Study-3 (CPS-3) and Circulating Cell-free Genome Atlas substudy 3 (CCGA3)
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Date/Time: June 3, 2023, 8:00 to 11:00 AM CDT
Location: Hall A
Abstract Number: 3060

Title: Elevated cancer risk among individuals with combinations of cancer-related risk factors: A large claims database analysis
Session Title: Prevention, Risk Reduction and Hereditary Cancer
Date/Time: June 3, 2023, 1:15 to 4:14 PM CDT
Location: Hall A
Abstract Number: 10561

Title: Examining the potential for lead-time bias by estimating stage-specific proportions of deaths due to diagnosed cancer
Session Title: Prevention, Risk Reduction and Hereditary Cancer
Date/Time: June 3, 2023, 1:15 to 4:15 PM CDT
Location: Hall A
Abstract Number: 10535

Title: Overall and non-lung cancer incidence in the National Lung Screening Trial (NLST) as indicators of potential for multi-cancer screening
Session Title: Prevention, Risk Reduction and Hereditary Cancer
Date/Time: June 3, 2023, 1:15 to 4:15 PM CDT
Location: Hall A
Abstract Number: 10633

Title: Methylation-based prediction of myelodysplastic syndrome survival outcomes
Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes and Allotransplant
Date/Time: June 5, 2023, 8:00 to 11:00 AM CDT
Location: Hall A
Abstract Number: 7058

Title: Implementation of a multi-cancer early detection (MCED) test using a centralized model within (w/i) a multi-state health system
Session Title: Care Delivery and Regulatory Policy
Date/Time: June 5, 2023, 1:15 to 4:15 PM CDT
Location: Hall A
Abstract Number: 1526