On July 20, 2021 Agilent Technologies Inc. (NYSE: A) reported that the company’s PD-L1 IHC 22C3 pharmDx assay is now labeled for expanded use in patients with non-small cell lung cancer (NSCLC) in the European Union (Press release, Agilent, JUL 20, 2021, View Source [SID1234584988]). PD-L1 IHC 22C3 pharmDx can now be used as an aid in identifying NSCLC patients with tumor PD-L1 expression of Tumor Proportion Score (TPS) ≥ 50% for treatment with Libtayo (cemiplimab). This announcement underscores Agilent’s continuing commitment to the development of IHC-based diagnostics for cancer therapy.

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"This further demonstrates Agilent’s commitment to partnering with leading pharmaceutical companies to develop IHC-based diagnostics for targeted cancer therapy."

Lung cancer is the leading cause of cancer death overall and the 2nd most commonly diagnosed cancer in Europe.1 NSCLC makes up approximately 85% of all lung cancer cases.2 In Europe, the average five-year survival rate for lung cancer is less than 20%.3

"This expanded indication for PD-L1 IHC 22C3 pharmDx will enable pathologists in Europe to identify patients with NSCLC who may be eligible for treatment with Libtayo," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "This further demonstrates Agilent’s commitment to partnering with leading pharmaceutical companies to develop IHC-based diagnostics for targeted cancer therapy."

Anti-PD-1 immunotherapies such as Libtayo offer new treatment options for patients with advanced NSCLC.4 Sanofi and Regeneron developed Libtayo and partnered with Agilent for the use of PD-L1 IHC 22C3 pharmDx to evaluate PD-L1 expression in patients in the pivotal EMPOWER-Lung 1 (Study 1624) clinical trial.4

Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.4

On July 20, 2021 Shanghai Junshi Bio reported that formed a mRNA Joint Venture with Hangzhou’s Immorna to develop new drugs for cancer, plus infectious and rare diseases (Press release, Shanghai Junshi Bioscience, JUL 20, 2021, View Source [SID1234585126]). Initially, the JV will have a value of $16 million with Junshi contributing half of that in cash and Immora adding in its mRNA IP for the other half. Junshi, a company best known for developing the first domestically developed PD-1 drug approved in China, said it would invest up to $123 million in the JV. Immorna focuses on process development and optimization of mRNA and delivery vehicles along with R&D of novel nucleic acid drugs.

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On July 20, 2021 IMV Inc. ("IMV" or the "Corporation") (NASDAQ: IMV; TSX: IMV), a clinical-stage immuno-oncology corporation, reported the closing of its previously-announced underwritten public offering (the "Offering") of 14,285,714 units (the "Units") at a price to the public of US$1.75 per Unit, for aggregate gross proceeds to the Corporation of approximately US$25 million, before deducting underwriting commissions and Offering expenses and excluding any proceeds the Corporation may receive from the exercise of the underlying warrants (Press release, IMV, JUL 20, 2021, View Source [SID1234584971]). Each Unit is comprised of one common share and three-quarters of one common share purchase warrant (each whole common share purchase warrant, a "Warrant"). Each Warrant entitles the holder thereof to purchase one common share at a price of US$2.10 per common share, subject to adjustment in certain events, until July 20, 2026. If the warrants are fully exercised it will represent approximately $22.5M of additional gross proceeds.

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The Corporation intends to use the net proceeds of the Offering to continue the clinical development of maveropepimut-S (DPX-Survivac) in diffuse large B cell lymphoma (DLBCL), breast cancer, ovarian cancer, bladder cancer and microsatellite instability high (MSI-H), start the clinical development of a new product, DPX-SurMAGE, in bladder cancer, continue the development of its proprietary drug delivery platform (DPX) and for general corporate purposes.

Wells Fargo Securities and Cantor acted as joint book-running managers for the Offering. BTIG acted as lead manager and iA Private Wealth acted as co-manager.

The Offering was made pursuant to a U.S. registration statement on Form F-10, declared effective by the U.S. Securities and Exchange Commission (the "SEC") on October 16, 2020 (the "Registration Statement"), and the Corporation’s Canadian final short form base shelf prospectus dated June 26, 2020, as amended on October 15, 2020 (collectively, the "Base Prospectus"). A preliminary prospectus supplement dated July 14, 2021 relating to the Offering has been filed with the securities commissions in the provinces of British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Québec, Nova Scotia and Newfoundland and Labrador in Canada, and with the SEC in the United States, and a final prospectus supplement dated July 15, 2021 relating to the Offering (the "Supplement") was filed with the securities commissions in the provinces of British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Québec, Nova Scotia and Newfoundland and Labrador in Canada, and with the SEC in the United States. The Supplement and the accompanying Base Prospectus contain important detailed information about the Offering. The Supplement and the accompanying Base Prospectus can be found for free on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Copies of the Supplement and accompanying Base Prospectus may also be obtained in the United States from Wells Fargo Securities, Attn: Equity Syndicate Department, 500 West 33rd Street, New York, NY 10001, by telephone at (800) 326-5897, or by email at [email protected] or from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022 or by email at [email protected], or in Canada from Wells Fargo Securities Canada, Ltd., 22 Adelaide Street West, Suite 2200, Toronto, ON, M5H 4E3, Attn: Akshay Pattni, email: [email protected] or from Cantor Fitzgerald Canada Corporation, Attn: Equity Capital Markets, 181 University Avenue, Suite 1500, Toronto, ON, M5H 3M7, email: [email protected].

This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.

On July 20, 2021 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) reported that it will host a conference call and live webcast on Tuesday, August 3, 2021 at 8:30 a.m. Eastern Time to report its second quarter 2021 financial results and recent corporate and portfolio activity (Press release, Kiniksa Pharmaceuticals, JUL 20, 2021, View Source [SID1234585021]).

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A live webcast will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. A replay of the webcast will be available on Kiniksa’s website for 14 days following the conference. The conference call can be accessed by dialing (866) 614-0636 (U.S. and Canada) or (409) 231-2053 (international) using conference ID number 1485623.

On July 19, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the first patient has been dosed in the cohort expansion arm of the Phase 1/2 study evaluating the triple combination of COM701, Compugen’s first-in-class anti-PVRIG antibody, with Opdivo (nivolumab) and Bristol Myers Squibb’s investigational anti-TIGIT antibody, BMS-986207 (Press release, Compugen, JUL 19, 2021, View Source [SID1234584955]).

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"We continue to push forward as leaders in the DNAM axis space and as the only company evaluating a potential synergistic triple blockade of PVRIG, TIGIT and PD-1 in the clinic," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We believe that the future of immuno-oncology will be driven by combination therapy and this study examining our three-pathway hypothesis is an important component of our overall strategy and a key differentiator for Compugen in the TIGIT space. The study is designed to evaluate simultaneous blockade of three immune checkpoint pathways, PVRIG, TIGIT and PD-1 and test the hypothesis that blockade of both PVRIG and TIGIT, parallel DNAM pathways, may be required in certain tumor types to generate or enhance an anti-tumor immune response. The initiation of the cohort expansion phase of the study, allowing us to focus with the selected dose for expansion on specific patient populations where we believe the DNAM axis is dominant, is an important step to examine the potential benefit of this unique immunotherapy combination in a broader range of patients. We are on track to report preliminary data from the triple combination dose escalation arm of the study in the fourth quarter of this year."

Dr. Cohen-Dayag added, "We are delighted to have Bristol Myers Squibb as our partner in this study and are pleased to have their continued support and commitment to the collaboration."

The open-label Phase 1/2 trial is designed to evaluate the safety, tolerability, and preliminary antitumor activity of COM701 in combination with Opdivo and BMS-986207. Additional information is available at www.clinicaltrials.gov (NCT04570839).

Opdivo is a trademark of Bristol-Myers Squibb Company.

About COM701

COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint discovered computationally by Compugen, blocking the interaction with its ligand, PVRL2. Blockade of PVRIG by COM701 has demonstrated in preclinical studies potent, reproducible enhancement of T cell activation, consistent with the desired mechanism of action of activating T cells in the tumor microenvironment to generate anti-tumor immune responses. Compugen has identified PVRIG and TIGIT as key parallel and complementary inhibitory pathways in the DNAM axis, which also intersect with the well-established PD-1 pathway. Research from Compugen suggests that these three pathways have different dominance in different tumor types and patients, implying that to induce effective antitumor responses, certain patient populations may require the blockade of different combinations of these three pathways. To test this hypothesis, Compugen has established a science-driven, biomarker informed clinical program, which evaluates different combinations of these axis members across tumor types. Compugen is the only company with clinical assets targeting both PVRIG and TIGIT in its portfolio allowing it to more fully exploit the potential of blocking these parallel and complementary members of the DNAM axis to drive robust immune responses.