On July 15, 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 its Phase 1 clinical study evaluating the dual combination of COM902, the Company’s potential best-in-class, high-affinity anti-TIGIT antibody and COM701, Compugen’s first-in-class anti-PVRIG antibody in patients with advanced malignancies who have exhausted all available standard therapies (Press release, Compugen, JUL 15, 2021, View Source [SID1234584895]).

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"This Phase 1 combination study is an important component in our clinical strategy, evaluating the dual blockade of DNAM axis members PVRIG and TIGIT," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "Our belief is that dual blockade of these distinct checkpoint pathways has the potential to expand the number of patients who respond to treatment with immunotherapy. We continue to move forward as leaders in the DNAM axis space with ongoing single, dual and triple combination clinical studies. We look forward to initial results of the COM902 monotherapy dose escalation study expected in Q4 2021".

The COM902 monotherapy dose escalation arm of this Phase 1 open-label study is complete. The Phase 1 study is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of COM902 alone and in combination with COM701 in patients with advanced malignancies who have exhausted all available standard therapies. The COM902 monotherapy dose expansion study, will be in subjects with select tumor types, preferably multiple myeloma. The COM902 in combination with COM701 dose expansion arm is expected to be in select tumor types, PD1 refractory or relapsing HNSCC, NSCLC and CRC (MSS). The study is being conducted in multiple leading oncology clinical centers in the United States with an estimated enrolment of 90 participants across all arms. (NCT04354246).

About COM902

COM902 is a high affinity, fully human antibody that blocks the interaction of TIGIT with PVR, its ligand, and consequently enhances T cell function. Data suggests that COM902 has in vitro activity comparable or superior to TIGIT antibodies in clinical development. It is currently being evaluated in a Phase 1 clinical studies in patients with advanced malignancies who have exhausted all available standard therapies. Compugen has demonstrated in preclinical studies that simultaneous inhibition of TIGIT and PVRIG, the two coinhibitory arms of the DNAM axis, can increase antitumor immune responses, which may be further enhanced with the addition of PD-1 blockade. These data suggest that treatment with COM701 and COM902, targeting PVRIG and TIGIT, respectively, alone or in combination with a PD-1 inhibitor, has the potential to expand immuno-oncology treatment to patient populations who are non-responsive or refractory to existing immunotherapies. The discovery of TIGIT, using the Company’s computational discovery platform, was published by Compugen in October 2009 in the Proceedings of the National Academy of Sciences (PNAS).

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. PVRIG and TIGIT, also discovered by Compugen’s computational discovery platform in 2009, constitute parallel immune checkpoint pathways that counteract DNAM, a costimulatory molecule on T cells and NK cells. As such, preclinical data suggest that the inhibition of PVRIG together with TIGIT and/or PD-1 has the potential to further enhance anti-tumor immune response and improve patient outcomes in a broad variety of tumor types.

On July 15, 2021 Immunic, Inc. (the "Company") (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, reported the pricing of an underwritten public offering of 4,500,000 shares of its common stock at a public offering price of $10 per share (Press release, Immunic, JUL 15, 2021, View Source [SID1234584894]). The gross proceeds of the offering to the Company are expected to be approximately $45 million, before deducting underwriting discounts and commissions and other estimated offering expenses. In addition, the Company granted the underwriters a 30-day option to purchase up to an additional 675,000 shares of its common stock at the public offering price.

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The closing of the offering is expected to occur on or about July 19, 2021, subject to the satisfaction of customary closing conditions.

Piper Sandler is acting as sole book-runner for the offering. Ladenburg Thalmann & Co. Inc., Roth Capital Partners and Aegis Capital Corp. are acting as co-managers for the offering.

The Company intends to use the net proceeds of the offering to fund the ongoing clinical development of its three lead product candidates, IMU-838, IMU-935 and IMU-856, and for other general corporate purposes.

The securities described above are being offered by the Company pursuant to an effective shelf registration statement on Form S-3 (File No. 333-250083) previously filed with the Securities and Exchange Commission ("SEC") on November 13, 2020, which registration statement was declared effective on November 24, 2020.

A preliminary prospectus supplement relating to the offering was filed with the SEC on July 14, 2021 and is available on the SEC’s website at www.sec.gov. The final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website. Before investing in the offering, you should read each of the prospectus supplement and accompanying prospectus relating to the offering in their entirety as well as the other documents that the Company has filed with the SEC that are incorporated by reference in the prospectus supplement and accompanying prospectus relating to the offering, which provide more information about the Company and the offering. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may also be obtained, when available, from Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by email at [email protected], or by telephone at (800) 747-3924.

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

On July 15, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases reported that the first patient has been dosed in a Phase 1a/1b study of IBI319, an anti-PD-1/CD137 bispecific antibody (Press release, Innovent Biologics, JUL 15, 2021, View Source [SID1234584893]).

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The objective of this open-label, multi-center Phase 1a/1b dose escalation and expansion study is to evaluate the safety, tolerability, potential optimal dosage and preliminary efficacy of IBI319 in patients with advanced malignant tumors whose cancer progressed on standard-of-care treatment. The trial is being conducted in China.

In preclinical studies, IBI319 has demonstrated synergistically targeting both PD-1 and CD137 to simultaneously achieve anti-tumor activity and enhance efficacy.

Professor Yilong Wu, Tenured Professor of Guangdong Provincial People’s Hospital and Honorary Director of Guangdong Lung Cancer Research Institute, stated, "While immune checkpoint inhibitors have shown efficacy in treating a variety of tumor types, we still face challenges of primary and secondary drug resistance. The development of next-generation bispecific antibodies can have important clinical value implications. CD137 is a key co-stimulatory immune checkpoint molecule that plays a role in maintaining immune homeostasis and enhancing anti-tumor immune memory. With the innovative mechanism of a bispecific antibody that provides additional immune activation through CD137 axis in the suppressed tumor microenvironment, the preclinical research results of IBI319 are very promising."

Dr. Hui Zhou, Senior Vice President of Clinical Development, Innovent Biologics, stated: "Currently, there is no other bispecific antibody with the same target in clinical development in the world. Preclinical results have shown that IBI319 can further enhance the immune activation with improved convenience of administration, compared to the combination of two monoclonal antibodies. "

About IBI319 (anti-PD-1/CD137 bispecific antibody)

IBI319 was discovered through a collaboration between Innovent and Eli Lilly and Company and has been developed in China by Innovent. The IND for IBI319 has been approved by the NMPA in China, and clinical trial in China are actively being conducted.

About the Phase 1 Study of IBI319 (CIBI319A101)

Conducted by Innovent in China, this Phase 1a/1b study (CIBI319A101) will assess the efficacy and safety of IBI319 in patients with advanced malignant tumors. Phase 1a of the study will evaluate dosing and Phase 1b will further explore the efficacy of IBI319 in a variety of solid and hematological tumors (ClinicalTrials.gov, NCT04708210).

On July 15, 2021 Foundation Medicine, Inc. reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneLiquid CDx to be used as a companion diagnostic to aid in identifying patients with MET exon 14 skipping (METex14) in metastatic non-small cell lung cancer (NSCLC) for whom treatment with TABRECTA (capmatinib) may be appropriate (Press release, Foundation Medicine, JUL 15, 2021, View Source [SID1234584892]). TABRECTA is the first therapy approved by the FDA for adult patients with metastatic NSCLC whose tumors have an alteration that leads to METex14. FoundationOne Liquid CDx analyzes the largest genomic region of any FDA-approved comprehensive liquid biopsy test and was approved by the FDA in August 2020 to report genomic alteration results for patients with any solid tumor.

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NSCLC accounts for approximately 85% of lung cancer diagnoses,[1] 3 to 4% of which are associated with METex14.[2] Today’s approval adds to the number of therapies for which both of Foundation Medicine’s FDA-approved comprehensive genomic tests are listed as companion diagnostics. FoundationOneCDx, Foundation Medicine’s tissue test, was approved as a companion diagnostic for TABRECTA in May 2020.

"For lung cancer patients with METex14, having the option of a non-invasive liquid biopsy expands access to this first-of-its kind therapy and helps meet a critical patient need," said Brian Alexander, M.D., M.P.H., chief executive officer at Foundation Medicine. "This approval, coupled with last year’s simultaneous therapy and companion diagnostic approval for TABRECTA and our tissue test, FoundationOne CDx, is an important advancement and demonstrates the value of having multiple highly-validated comprehensive genomic testing options for physicians to consider for the individual needs of each patient."

Using a simple blood sample, FoundationOne Liquid CDx analyzes over 300 cancer-related genes for genomic alterations. The test is now approved as a companion diagnostic for nine targeted therapies across four cancer types. TABRECTA is the second therapy for which both of Foundation Medicine’s FDA-approved tests, FoundationOne CDx and FoundationOne Liquid CDx, are listed as companion diagnostics.

Additionally, as a laboratory professional service which has not been reviewed or approved by the FDA, the FoundationOne Liquid CDx report delivers information about the genomic signatures microsatellite instability (MSI) and blood tumor mutational burden (bTMB), as well as single gene alterations, including NTRK fusions, to help inform the use of other therapies including immunotherapies. Also, as a laboratory professional service, the report provides relevant clinical trial information and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor.

Foundation Medicine’s strategic collaboration with Novartis now includes four companion diagnostics for the Novartis portfolio of targeted oncology therapeutics.

On July 15, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its second quarter 2021 financial results will be released on Thursday, July 29, after the market closes (Press release, Gilead Sciences, JUL 15, 2021, View Source [SID1234584891]). At 4:30 p.m. Eastern Time that day, Gilead’s management will host a webcast to discuss the company’s second quarter 2021 financial results and will provide a business update .

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A live webcast will be available on the investor relations page of View Source and will be archived on www.gilead.com for one year.