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.

On July 19, 2021 Oblato, Inc. (the Company) reported that it has received an agreement from the FDA for its plan to submit an intermediate size expanded access protocol for use of OKN-007 in patients with high-grade gliomas (Press release, Oblato, JUL 19, 2021, View Source [SID1234584954]). The company is already developing OKN-007 as a treatment of glioblastoma multiforme.

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In a December 2020 meeting with the FDA, the agency agreed to Oblato’s plan to initiate a clinical trial for diffuse intrinsic pontine glioma (DIPG) pediatric patients, a rare and difficult to treat brain cancer. Currently, the Company is in discussion for this trial with a consortium consisting of pediatric cancer hospitals. The eligible patients who can participate in this clinical trial for pediatric DIPG must meet specific inclusion and exclusion criteria.

Unfortunately, there are many additional patients with similar aggressive gliomas with a poor prognosis and some of these patients will not have access this treatment as they are not eligible for the clinical trial or are unable to get to the clinical trial sites. Based on this difficult situation faced by many patients who have various life-threatening malignant gliomas including DIPG, Oblato recently received an agreement from the FDA that OKN-007 can be administered outside of the clinical trial to both pediatric and adult patients diagnosed with several types of high-grade gliomas under an intermediate size expanded access program (iEAP). The FDA recommended that the Oblato submit a complete protocol for FDA review and feedback. The Company will submit the protocol as soon as possible to initiate the iEAP.

Expanded access refers to a pathway in which patients with serious or life-threatening diseases with no available treatment options may gain access to investigational medical products, which are either under development or have not yet received marketing approved. In particular, iEAPs are used for a wide range of patients in a number of medical institutions. Pediatric and adult patients who will be eligible for the iEAP using OKN-007 include those with gliomas similar to DIPG involving the thalamus, hypothalamus, brain stem, pons, bone marrow, or spinal cord, or midline tumors including malignant gliomas, gangliocytoma, and anaplastic astrocytoma morphologies.

Regarding the iEAP, an official from the Company stated that "After we released the news regarding the development of our new DIPG treatment, several DIPG patient families reached out to the Company asking to participate in the clinical trial. Since DIPG and other gliomas progress rapidly, Oblato wanted to make the treatment available as quickly as possible and to as many of these patients as possible. The Company decided to use the iEAP first to give an opportunity for patients with either DIPG or high-grade gliomas for which there is either no effective treatment or they are ineligible to participate in a clinical trial. Using the iEAP, Oblato can administer our investigational medicinal product even before we initiate the clinical trial. Currently, we are in discussion with a firm experienced with the iEAP and plan to submit the protocol for the iEAP to the FDA as soon as possible."

"iEAP not only meets the target to provide treatment opportunities to patients, but accords with our company’s GBM and DIPG development strategy. There are a number of new orphan drugs that were approved using the clinical data obtained through an iEAP. An iEAP can also be one way to determine the potential benefit and risk through treatment outcomes with various types of patients," stated an official from the Company regarding the strategic background.

On July 19, 2021 Johnson & Johnson (NYSE: JNJ) reported that its Board of Directors has declared a cash dividend for the third quarter of 2021 of $1.06 per share on the company’s common stock (Press release, Johnson & Johnson, JUL 19, 2021, View Source;johnson-announces-quarterly-dividend-for-third-quarter-2021-301336582.html [SID1234584953]). The dividend is payable on September 7, 2021 to shareholders of record at the close of business on August 24, 2021. The ex-dividend date is August 23, 2021.

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On July 19, 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 closing of an underwritten public offering of 4,500,000 shares of its common stock at a public offering price of $10.00 per share (Press release, Immunic, JUL 19, 2021, View Source [SID1234584952]).

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The Company received total proceeds from the offering, before deducting the underwriting discounts and other offering expenses, of $45.0 million.

Piper Sandler acted as sole book-runner for the offering. Ladenburg Thalmann & Co. Inc., Roth Capital Partners and Aegis Capital Corp. acted 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 were offered by the Company pursuant to a shelf registration statement filed by the Company with the Securities and Exchange Commission ("SEC"), which was declared effective on November 24, 2020. A final prospectus supplement and accompanying prospectus related to the offering were filed with the SEC on July 16, 2021 and are available for free on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus related to the offering may be obtained 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 does 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 19, 2021 Lunit, a leading AI startup in AI-powered cancer solutions, reported a strategic investment of $26 million from Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company (Press release, Guardant Health, JUL 19, 2021, View Source [SID1234584951]).

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The deal, which includes the investment made by Guardant Health and also a groundbreaking collaboration between a liquid biopsy company and a medical AI startup, is intended to help reshape and innovate the precision oncology landscape.

Lunit has closed its Series C Tranche B funding round with the investment from Guardant Health. Lunit is expected to file for an initial public offering on the Korean Stock Exchange later this year.

At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 annual meeting, Lunit presented that its tissue analysis platform, Lunit SCOPE, was able to find 50% more patients who would respond to immunotherapy, compared to traditional diagnostic pathology.1 Lunit has been presenting its findings at ASCO (Free ASCO Whitepaper) and American Association for Cancer Research (AACR) (Free AACR Whitepaper) since 2019.

"Artificial intelligence is rapidly gaining ground in cancer research and it’s exciting to see the excellent progress Lunit has made in developing innovative AI-powered radiology and pathology solutions that have the potential to significantly improve the diagnoses and treatment of cancer," said Helmy Eltoukhy, Guardant Health CEO. "We’re very impressed with Lunit’s approach and believe this investment will help them advance their important AI work for eventual clinical use. Through this investment, we also expect to utilize their AI platform to usher in new precision oncology products that contribute in a meaningful way to improving cancer care for patients."

"We believe that AI in the field of medicine is an inevitable future to come," said Brandon Suh, M.D., Chief Executive Officer of Lunit. "As one of the early starters and front-runners in this new and innovative field, we have been validating the effectiveness of Lunit SCOPE through various studies, and now we are pushing to show its value in clinical research and real practice. We are more than delighted to announce the investment and collaboration with Guardant Health. With our AI technology in tissue phenomics and Guardant Health’s commitment to advancing our work, we are looking forward to making impactful changes in cancer diagnosis and treatment."