On July 16, 2020 Gilead Sciences, Inc. (Nasdaq: GILD) repored that its second quarter 2020 financial results will be released on Thursday, July 30, after the market closes. At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s second quarter 2020 financial results and will provide a business update (Press release, Gilead Sciences, JUL 16, 2020, View Source [SID1234562040]).

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The live webcast of the call can be accessed at the company’s Investors page at View Source Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 9561515 to access the call. Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, August 1, 2020. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international) and dial the conference ID 9561515. The webcast will be archived on www.gilead.com for one year.

On July 16, 2020 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported that its previously announced underwritten public offering of 4,119,564 shares of its common stock, and, to certain investors in lieu thereof, pre-funded warrants to purchase 1,630,436 shares of its common stock at an exercise price of $0.0001 per share (Press release, Altimmune, JUL 16, 2020, View Source [SID1234562039]). The shares include 750,000 shares of common stock sold pursuant to the option granted by the Company to the underwriters, which option was exercised in full. The public offering price of each share of common stock was $23.00 and the public offering price of each pre-funded warrant was $22.9999 per underlying share.

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The aggregate gross proceeds to Altimmune from the offering were approximately $132.2 million, which includes the exercise of the underwriters’ option to purchase additional shares in full, before deducting underwriting discounts and commissions and offering expenses payable by Altimmune. Altimmune anticipates using the net proceeds from the offering for general corporate purposes, which may include, but are not limited to, scale up of manufacturing and advanced clinical trials of AdCOVID, a single dose intranasal COVID-19 vaccine candidate; the continued development of ALT-801, its dual GLP-1/glucagon receptor agonist for the treatment of non-alcoholic steatohepatitis (NASH), including manufacturing and clinical trials; and for capital expenditures and working capital.

Jefferies, Evercore ISI and Piper Sandler acted as joint book-running managers for the offering. Roth Capital Partners acted as co-manager for the offering.

The securities described above were offered by Altimmune pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed with and became effective by rule of the Securities and Exchange Commission (SEC) on April 12, 2019. A final prospectus supplement and accompanying prospectus related to the offering has been filed with the SEC and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Departments, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by email at [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, New York, NY 10055, by telephone at (888) 474-0200 or by email at [email protected]; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN, 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected].

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

On July 16, 2020 Imvax, Inc., a clinical-stage biotechnology company whose groundbreaking personalized neo-antigen immunotherapy, IGV-001, is being studied in patients with glioblastoma multiforme (GBM), and whose proprietary technology has the potential to advance care for patients with serious, unmet medical needs in other solid tumor cancers, reported the completion of a $112 million Series C financing (Press release, Imvax, JUL 16, 2020, View Source [SID1234562024]). The round was led by existing investor HP WILD Holding AG, with significant participation from other major shareholders – Ziff Capital Partners, Magnetar Capital, and TLP Investment Partners. This round also includes participation from a new institutional investor – Invus.

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The financing will enable Imvax to continue clinical development of lead product candidate IGV-001 for treatment of GBM through Phase 2. IGV-001 is a autologous tumor vaccine made from patients’ tumor cells combined with an antisense molecule to affect a personalized immune response.

Interim results from the Phase 1b trial, which were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper) in 2019, demonstrated treatment with IGV-001 outperformed standard of care with prolonged overall survival (OS) and progression-free survival (PFS) in patients with newly diagnosed GBM. Final results from this trial completed in May of this year confirm the benefit of IGV-001. The company anticipates initiating a Phase 2 trial with IGV-001 in newly diagnosed patients with GBM in early 2021.

The financing will also enable Imvax to broaden the development portfolio into additional oncology therapeutic indications. The team is planning to continue pre-clinical work with a target to start additional solid tumor indications in Phase 1 trials during 2021.

The company will also expand its corporate and manufacturing capabilities.

"We are pleased to receive strong support from our existing and new investors who are aligned with Imvax’s mission to transform the current treatment regimen for glioblastoma and potentially other solid tumor cancers with a unique approach that focuses on long term survival," said Peter B. Corr, Ph.D., Co-Founder and Chairman of the Board of Imvax, inc.

John Furey, Imvax CEO said, "The tremendous response to this round of fundraising reflects the promising results from our Phase 1b trial in glioblastoma which validate the potential of IGV-001 to be a life-changing therapy for patients with malignant gliomas. This funding positions us to advance IGV-001 through the next stage of clinical development in glioblastoma, explore other solid tumor indications, and start the build out of additional capabilities needed to operationalize our unique approach to delivering this therapy. We look forward to creating additional value for our stakeholders and ultimately delivering on our goal of improving outcomes for people living with devastating and intractable solid tumor cancers."

Furey added that Phase 1b clinical study data are compelling, avoiding any off-target effect or cytokine storm issues and demonstrating significant OS and PFS benefit in the patient cohort vs. historical controls with the highest doses of four being taken into the upcoming Phase 2 trial.

On July 16, 2020 Stand Up To Cancer reported a new $5 million grant from Bristol Myers Squibb to fund research and education efforts aimed at achieving health equity for underserved lung cancer patients, including Black people and people living in rural communities (Press release, SU2C, JUL 16, 2020, View Source [SID1234562023]). Despite recent progress in treating lung cancer, the disease remains the leading cause of cancer death in the U.S. with particularly high death rates in rural communities and among Black men.

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The research efforts funded by the three-year grant will consist of supplemental grants to current Stand Up To Cancer research teams. The supplemental grants will focus on identifying new and innovative diagnostic and treatment methods for lung cancer patients in need. These supplemental grants will be designed to jumpstart pilot projects at the intersection of lung cancers, health disparities and rural healthcare, for instance increasing clinical trial enrollment among historically under-represented groups.

In early 2021, a Stand Up To Cancer Innovation Summit will launch the project, bringing together lung cancer experts with researchers specializing in health equity and access. The competitive grant application and selection process for proposed projects will be overseen by Stand Up To Cancer’s Scientific Advisory Committee.

"Stand Up To Cancer’s portfolio already includes 17 team science projects in lung cancer, and 24 lung cancer clinical trials have been funded to date," said Nobel Laureate Phillip A. Sharp, PhD, chair of the SU2C Scientific Advisory Committee, and Institute professor, David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology. "With this comprehensive lung cancer network and the dedication to diversifying cancer clinical trials, Stand Up To Cancer will leverage the Bristol Myers Squibb grant to reach lung cancer patients who have historically been marginalized by our health care system."

"Despite the remarkable recent progress in the diagnosis and treatment of cancer, the disparities in care experienced by underserved patient populations are persistent and acute," said Adam Lenkowsky, general manager and head, U.S., Oncology, Immunology, Cardiovascular, Bristol Myers Squibb. "As a company focused on transforming patients’ lives through science, we are dedicated to improving health outcomes for all patients. Our support of Stand Up to Cancer’s work to address the burden of lung cancer among diverse and rural communities is another extension of our long-standing commitment to ensuring that every patient has access to quality care."

Since 2014, Bristol Myers Squibb has provided funding for important Stand Up To Cancer research initiatives. Bristol Myers Squibb was the inaugural donor for SU2C Catalyst, supporting research and clinical trials targeting a wide range of cancers, including non-small cell lung cancer, metastatic melanoma, smoldering multiple myeloma, pediatric hypermutant cancers, pediatric brain tumors and pediatric neuroblastoma. Funding has also supported Convergence Grants, which harness computational science to understand fundamental cancer biology, Innovative Research Grants focused on immuno-oncology, as well as Dream Teams focused on lung cancer.

Stand Up To Cancer’s Health Equity Initiative formalizes requirements that will apply to all future teams seeking Stand Up To Cancer funding. The requirements include addressing recruitment and retention of patients from different ethnic groups and underserved communities to improve diverse participation in cancer clinical trials. To improve cancer clinical trial education, outreach and recruitment in underserved communities, Stand Up To Cancer is collaborating with advocacy and community-based organizations such as the Black Women’s Health Imperative and Friends of Cancer Research.

Bristol Myers Squibb has long been committed to promoting heath equity and continues to forge collaborations and invest in programs to increase the reach of medical innovation to diverse and heavily burdened populations. An important example of the company’s commitment in this area is the work of the Bristol Myers Squibb Foundation, which for more than 20 years has launched initiatives around the world to improve the health outcomes of those disproportionately affected by serious diseases. This includes initiatives focused on underserved populations in the Southeast United States where the lung cancer burden is the highest, with a tailored focus on innovative models of prevention, detection, and education while helping people with lung cancer access and navigate cancer care and support services. From 2014-2019, the Bristol Myers Squibb Foundation committed $35 million to expand the scope of community-based resources and cancer survivorship support programs to underserved populations in the U.S.

On July 16, 2020 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, repored that it has met the clinical protocol criteria for cohort expansion in the cutaneous (skin) melanoma cohort of its Phase 2 basket arm evaluating IDE196 monotherapy in solid tumors harboring GNAQ or GNA11 hotspot mutations (GNAQ/11) (Press release, Ideaya Biosciences, JUL 16, 2020, https://www.prnewswire.com/news-releases/ideaya-announces-ide196-program-update-and-clinical-protocol-criteria-met-for-cohort-expansion-in-skin-melanoma-for-phase-2-gnaq11-basket-trial-301094514.html [SID1234561989]).

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IDEAYA has enrolled 4 evaluable and 1 non-evaluable skin melanoma patients harboring GNAQ/11 mutations in an initial Stage 1 cohort of the study design. Pursuant to the protocol, if no RECIST (Response Evaluation Criteria in Solid Tumors) responses are observed in the targeted 9 patients of Stage 1 cohort, no additional expansion patients are to be enrolled in that cohort; otherwise, a second Stage 2 of enrollment comprising of 15 additional patients may be enrolled for a total of 24 patients. The 1 confirmed partial response in a GNAQ/11 mutation skin melanoma patient was determined by RECIST guidelines (version 1.1).

"I am pleased IDE196 has met the criteria for Stage 2 expansion in skin melanoma, as these patients with GNAQ/11 mutations may not have actionable BRAF driver mutations and may also have a low tumor mutational burden, and thus be less responsive to existing treatment options," said Marlana Orloff, M.D., Assistant Professor at Thomas Jefferson University Hospital in Philadelphia, who is a Principal Investigator on the IDEAYA clinical trial.

IDEAYA continues to monitor Covid-19 and its potential impact on clinical trials and timing of clinical data results. Covid-19 infection rates have increased over the last weeks in several states in which our enrollment sites are located.

Based on the increased target enrollment and potential impact of the Covid-19 pandemic, further IDE196 monotherapy interim data is anticipated to be in the first half of 2021.

"IDE196 expansion in skin melanoma enables IDEAYA to build a larger data set and to explore potential combinations in this tumor type, and further validates our GNAQ/11 tissue-agnostic approach," said Mick O’Quigley, Vice President, Head of Development Operations at IDEAYA Biosciences.