On July 8, 2022 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported that effective as of July 7, 2022, the Company closed the Phase 2 study (CP-MGA271-06) evaluating the investigational regimen of enoblituzumab (Fc-optimized B7-H3-directed monoclonal antibody) in combination with either retifanlimab (anti-PD-1 monoclonal antibody) or tebotelimab (PD-1 × LAG-3 bispecific DART molecule) in the first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) (Press release, MacroGenics, JUL 8, 2022, View Source [SID1234616572]).

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 decision to discontinue the study was based on an internal review of safety data, which included the occurrence of seven fatalities potentially associated with hemorrhagic events in both arms of the study (of 62 total patients treated). Six of the seven fatal events observed in the CP-MGA271-06 study were assessed by investigators as secondary to disease progression and/or unrelated to the study treatment, and one event was assessed as possibly related. Fatal tumor-related hemorrhages and airway obstruction are known risks in patients with SCCHN. The incidence of fatal events observed in the study that were potentially hemorrhagic in origin was higher than what has been reported for this patient population in the medical literature (i.e., 1 – 3.6% as per Argiris, et al., J Clin Oncol. 2019 Dec 1, 37(34):3266) and in the context of a risk : benefit analysis, prompted the Company’s decision to close the study. Accordingly, the Company informed investigators and the U.S. Food and Drug Administration (FDA) of the study closure and instructed investigators that no additional patients in the study were to be enrolled or receive further treatments as of July 7, 2022.

MacroGenics continues to investigate and monitor these events, and an analysis of the data is ongoing. There were no hemorrhagic events or coagulopathies observed in nonclinical toxicology studies of enoblituzumab, and the incidence of any fatal hemorrhage reported in earlier studies of enoblituzumab evaluated in over 340 patients across a broad range of tumor types was less than 1%.

"Our top concern in conducting clinical trials is the safety of study participants," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We were surprised by the emergence of these events in first-line SCCHN patients, as we had not observed any such events in an earlier, smaller study in patients with later-line SCCHN disease who were treated with enoblituzumab in combination with an anti-PD-1 antibody. Similar safety events have not been reported in patients treated with MGC018, our B7-H3-targeted ADC molecule, and the decision to close the CP-MGA271-06 study does not impact our ongoing MGC018 study activities. We’d like to thank all patients, their families and caregivers who participated in the CP-MGA271-06 study."

About Enoblituzumab
Enoblituzumab is an investigational anti-B7-H3 monoclonal antibody that incorporates an immunoglobulin G1 fragment crystallizable (Fc) domain designed to enhance Fcγ receptor-mediated antibody-dependent cellular cytotoxicity. B7-H3, a protein in the B7 family of immune regulator proteins, is widely expressed by a number of different tumor types and may play a key role in regulating the immune response to various types of cancer.

About Retifanlimab
Retifanlimab is an investigational anti-PD-1 monoclonal antibody being developed for use as monotherapy as well as in combination with other potential cancer therapeutics. Retifanlimab was licensed to Incyte Corporation in 2017 under a global collaboration and license agreement. MacroGenics retains the right to develop the molecule in combination with product candidates from its pipeline.

About Tebotelimab
Tebotelimab is an investigational, bispecific DART molecule designed to block PD-1 and lymphocyte-activation gene 3 (LAG-3) checkpoint molecules to sustain or restore the function of exhausted T cells.

On July 8, 2022 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, applauds the recently reported that Centers for Medicare and Medicaid Services (CMS) Calendar Year 2023 Physician Fee Schedule proposal, which considers follow-up colonoscopy to an at-home test as a preventive service (Press release, Exact Sciences, JUL 8, 2022, View Source [SID1234616571]). If adopted, the rule would eliminate all cost to Medicare patients for a follow-up colonoscopy after a positive at-home colorectal cancer screening test. Additionally, CMS has proposed covering the service for individuals 45 years of age or older who participate in Medicare, which aligns with the previous recommendation from the United States Preventive Services Task Force (USPSTF) and the American Cancer Society. The final CMS rule is expected to be published in the fall of this year and take effect on January 1, 2023.

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!

"Colorectal cancer is the most preventable, yet least prevented cancer, because approximately 44 million average risk adults remain unscreened in the United States," said Kevin Conroy, Chairman and CEO of Exact Sciences. "Exact Sciences supports the CMS proposal to encourage wider utilization of non-invasive colorectal cancer screening tests, which has the potential to close the screening gap by reducing barriers to screening, prevention and earlier detection for individuals aged 45 and older."

The proposed CMS policy builds on President Biden’s Cancer Moonshot proposal to ensure equitable access to screening and prevention through at-home screening, particularly for colorectal cancer. The Administration’s focus on removing barriers to cancer prevention and early detection advances health equity within rural communities and communities of color that are especially impacted by the incidence of colorectal cancer. The proposed policy also builds upon the recent Department of Labor guidance that mandates coverage for follow-up colonoscopy for most commercial insurance plans.

"This proposal helps patients across the country who are seeking to complete the colorectal cancer screening process but can’t due to financial barriers. This is a huge victory for patients," said Anjee Davis, president, Fight Colorectal Cancer, a leading patient empowerment and advocacy organization.

Colon cancer is the third most common cancer in both men and women of all racesi and is on the rise for people younger than 50.ii Approximately 70 percent of people diagnosed with colon cancer have no family history.iii Despite efforts by leading medical and government organizations to raise awareness, approximately 44 million average-risk Americans aged 45-plus remain unscreened.iv

Exact Sciences is the maker of Cologuard, an FDA-approved, noninvasive stool-based DNA screening test for adults 45 and older who are at average risk for colon cancer. Since its launch in 2014, 9 million people have used Cologuard to screen for colon cancer at home.

On July 8, 2022 Median Technologies (ALMDT) (Paris:ALMDT) reported that the Company will be participating in the 2022 European Congress of Radiology (ECR), to be held in Vienna, Austria, July 13-17 (Press release, MEDIAN Technologies, JUL 8, 2022, View Source [SID1234616569]).

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 will give an industry presentation and a scientific paper presentation. Details of the sessions include:

Industry presentation: "Enabling lung cancer screening with iBiopsy AI-based software as medical device"

Session: AIX Theater
Date: July 13, 2022
Time: 3:25 pm – 3:45 pm CEST

Scientific paper presentation: RPS 1305-6 – "Development and validation of a machine learning based CADx designed to improve patient management in lung cancer screening programmes"

Session: RPS 1305 – Artificial intelligence (AI) in chest imaging: part 2
Categories: Artificial Intelligence & Machine Learning, Imaging Informatics, Chest, Oncologic Imaging
Date: July 15, 2022
Time: 10:30 am – 12:00 pm CEST

Median’s team will be available at booth #AI-29, Expo X1, AI-area to discuss the presentations and present the latest developments on iBiopsy LCS CADe/CADx SaMD from July 13 to 17, 9:00 am-5:00 pm.

The European Congress of Radiology (ECR) organized by the European Society of Radiology (ESR) is the premier European event in radiology and the second largest in the world. The congress conveys more than 20,000 with a split of more than 10,000 professional delegates (radiologists, technologists etc.), and ~8,000 industry participants (imaging modalities, PACS etc.). Radiology professionals from Europe and beyond attend to gather knowledge through educational courses, to see the latest innovations presented by technical exhibitors, and to discover groundbreaking research from scientific paper presentations. More about the ECR: View Source

About iBiopsy: iBiopsy is based on the most advanced technologies in Artificial Intelligence (AI) and Data Science (DS), benefiting from Median’s expertise in medical image processing. iBiopsy targets the development of innovative AI/ML-based Software as Medical Device, to be used in several indications for which there are unmet needs regarding early diagnosis, prognosis and treatment selection in the context of precision medicine. iBiopsy currently focuses on lung cancer, liver cancer (HCC) and liver fibrosis (NASH).

On July 8, 2022 IMV Inc. ("IMV" or the "Company") (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported that on July 7, 2022, IMV Inc. (the "Company") received a letter from the Listing Qualifications Department of the Nasdaq Stock Market ("Nasdaq") indicating that, based upon the closing bid price of the Company’s common shares for the 30 consecutive business day period between May 23, 2022, through July 6, 2022, the Company did not meet the minimum bid price of US$1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (Press release, IMV, JUL 8, 2022, View Source [SID1234616568]). The Notice has no immediate effect on the listing of the Company’s common shares on the Nasdaq Capital Market.

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 letter also indicated that the Company will be provided with a compliance period of 180 calendar days, or until January 3, 2023 (the "Compliance Period"), in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A). In order to regain compliance with Nasdaq’s minimum bid price requirement, the Company’s common shares must maintain a minimum closing bid price of US$1.00 for at least ten consecutive business days during the Compliance Period.

In the event the Company does not regain compliance by the end of the Compliance Period, the Company may be eligible for an additional 180 calendar days to regain compliance. To qualify, the Company will be required to meet the continued listing requirement for the market value of its publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If the Company meets these requirements, the Company may be granted an additional 180 calendar days to regain compliance. However, if it appears to Nasdaq that the Company will be unable to cure the deficiency, or if the Company is not otherwise eligible for the additional cure period, the Company may face delisting.

The letter has no immediate impact on the Company’s business operations or listing of the Company’s common shares, which will continue to be listed and traded on The Nasdaq Capital Market, subject to the Company’s compliance with the other listing requirements of The Nasdaq Capital Market, as well as on the TSX.

On July 8, 2022 InvoX Pharma Limited ("invoX"), a wholly owned subsidiary of Sino Biopharmaceutical Limited ("Sino Biopharm") (HKEX 1177 HK) reported a cash tender offer for all of the issued and outstanding shares of common stock of F-star Therapeutics, Inc. ("F-star") (NASDAQ:FSTX) for a price of $7.12 per share (Press release, InvoX Pharma, JUL 8, 2022, View Source [SID1234616567]). The tender offer is being made pursuant to an Offer to Purchase, dated July 7, 2022 (the "Offer to Purchase"), and in connection with the previously announced Agreement and Plan of Merger, dated June 22, 2022, among invoX, Sino Biopharm, Fennec Acquisition Incorporated ("Purchaser"), an indirect wholly owned subsidiary of Sino Biopharm, and F-star (the "Merger Agreement").

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 tender offer commenced on July 7, 2022 and will expire at one minute past 11:59 p.m., Eastern Time, on August 3, 2022 (the "Expiration Date"), unless otherwise extended or terminated. Any extensions of the tender offer will be followed as promptly as practicable by public announcement thereof, and such announcement will be made no later than 9:00 a.m., Eastern Time, on the next business day after the previously scheduled Expiration Date.

invoX, Sino Biopharm and Purchaser have filed a tender offer statement on Schedule TO with the United States Securities and Exchange Commission (the "SEC"). The Offer to Purchase contained within the Schedule TO sets out the terms and conditions of the tender offer.

F-star has filed a Solicitation/Recommendation Statement on Schedule 14D-9 (the "Schedule 14D-9") with the SEC, which includes, among other things, the recommendation of F-star’s board of directors that F-star stockholders tender all of their shares in the tender offer.

As soon as practicable following the completion of the tender offer, Purchaser will acquire all remaining F-star shares through a merger at the tender offer price.

The tender offer and the merger are subject to customary closing conditions, including (i) the tender by F-star stockholders of at least one more share than 50% of the total number of F-star shares outstanding at the time of the expiration of the tender offer and (ii) required regulatory approvals, including the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, having expired or been terminated. The tender offer is subject to other important conditions set forth in the Offer to Purchase.

Concurrently with entering into the Merger Agreement, invoX and Purchaser entered into Tender and Support Agreements with each of Eliot Forster, Ph.D., Darlene Deptula-Hicks, Louis Kayitalire, M.D., Neil Brewis, PhD., Nessan Bermingham, Ph.D., Edward Benz Jr., M.D., Geoffrey Race, David Arkowitz, Pamela Klein, M.D., and Todd Brady, M.D., Ph.D. (collectively, the "Supporting Stockholders"), pursuant to which such Supporting Stockholders agreed to tender their shares into the tender offer. As of July 5, 2022, the Supporting Stockholders collectively, directly and indirectly own approximately 1.02% of all issued and outstanding shares of F-star.

The Information Agent for the tender offer is Innisfree M&A Incorporated. The Depositary and Paying Agent for the tender offer is Computershare Trust Company, N.A. For all questions relating to the tender offer, please call the Information Agent, Innisfree M&A Incorporated toll-free at (888) 750-5830; banks and brokers may call collect at (212) 750-5833.

Important Notices

This communication is for informational purposes only and is neither a recommendation, an offer to purchase nor a solicitation of an offer to sell securities. On July 7, 2022, invoX, Sino Biopharm and Purchaser filed with the SEC a tender offer statement on Schedule TO regarding the tender offer described in this communication. Holders of shares of common stock of F-star are urged to read the tender offer statement (as it may be updated and amended from time to time) and the Schedule 14D-9 filed by F-star as they contain important information that holders of shares of common stock of F-star should consider before making any decision regarding tendering their shares. These materials will be made available to F-star’s stockholders at no expense to them by Innisfree M&A Incorporated, the Information Agent, for the tender offer. In addition, the tender offer statement and other documents filed by invoX, Sino Biopharm and Purchaser, and F-star with the SEC are available for free at the SEC’s website at www.sec.gov.

This release is not intended for distribution to, or use by, any person or entity in any jurisdiction or country where such distribution or use would be contrary to local law or regulation. This release has been prepared by invoX and Sino Biopharm. No representation or warranty (express or implied) of any nature is given, nor is any responsibility or liability of any kind accepted, with respect to the truthfulness, completeness or accuracy of any information, projection, statement or omission in this release. This release does not constitute, nor does it form part of, any offer or invitation to buy, sell, exchange or otherwise dispose of, or any issuance, or any solicitation of any offer to sell or issue, exchange or otherwise dispose of any securities. This release does not constitute investment, legal, tax, accountancy or other advice or a recommendation with respect to such securities, nor does it constitute the solicitation of any vote or approval in any jurisdiction. There shall not be any offer or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the applicable securities laws of any such jurisdiction (or under exemption from such requirements).