On November 8, 2019, Corvus Pharmaceuticals, Inc. (the "Company") reported that it entered into an exchange agreement (the "Exchange Agreement") with entities affiliated with Biotechnology Value Fund, L.P. (the "Exchanging Stockholders"), pursuant to which the Company exchanged an aggregate of 10044135 shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), owned by the Exchanging Stockholders for warrants (the "Exchange Warrants") to purchase an aggregate of 1,458,000 shares of common stock (subject to adjustment in the event of stock splits, recapitalizations and other similar events affecting common stock), with an exercise price of $0.0001 per share (Filing, 8-K, Corvus Pharmaceuticals, NOV 8, 2019, View Source [SID1234550945]). The Exchange Warrants will expire ten years from the date of issuance. The Exchange Warrants are exercisable at any time prior to expiration except that the Exchange Warrants cannot be exercised by the Exchanging Stockholders if, after giving effect thereto, the Exchanging Stockholders would beneficially own more than 9.99% of Common Stock, subject to certain exceptions. The holders of the Exchange Warrants will not have the right to vote on any matter except to the extent required by Delaware law. The Exchange Warrants were issued without registration under the Securities Act of 1933, as amended (the "Securities Act"), in reliance on the exemption from registration contained in Section 3(a)(9) of the Securities Act.

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The description of the Exchange Agreement and the Exchange Warrant are not complete and are qualified in their entirety by reference to the Exchange Agreement and the form of Exchange Warrant, which are filed as Exhibit 10.1 and Exhibit 4.1, respectively, to this Current Report on Form 8-K and incorporated herein by reference. The representations, warranties and covenants made by the Company in the Exchange Agreement and the Exchange Warrant were made solely for the benefit of the parties to the Exchange Agreement and the Exchange Warrant, as applicable, including, in some cases, for the purpose of allocating risk among the parties thereto, and should not be deemed to be a representation, warranty or covenant to investors. Moreover, such representations, warranties or covenants were made as of an earlier date. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.

On November 8, 2019 Precision BioSciences presented the corporate presentation (Presentation, Precision Biosciences, NOV 8, 2019, View Source [SID1234550929]).

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On November 8, 2019 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported that the Company presented data from the Toca 6 Phase 1b study of Toca 511 and Toca FC in patients with non-CNS tumors at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting in National Harbor, MD and will have two presentations related to brain cancer at the 24th Annual Meeting of the Society for Neuro-Oncology (SNO), to be held Nov. 20-24 in Phoenix (Press release, Tocagen, NOV 8, 2019, View Source [SID1234550838]).

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The SITC (Free SITC Whitepaper) poster titled, "Immunomodulation in peripheral blood and tumor following Toca 511 & Toca FC treatment in patients with solid tumors," was a summary of the results in the Toca 6 Phase 1b, single arm study of Toca 511 and Toca FC in advanced non-CNS solid tumors. The objectives of the study were to assess changes in immune activity of peripheral blood mononuclear cells (PBMCs) relative to baseline following treatment and to evaluate immune cell modulation in the tumor microenvironment from tumor biopsies taken at baseline compared to biopsies collected following treatment.

Data Summary

The Toca 6 Phase 1b, single arm study of Toca 511 and Toca FC in advanced non-CNS solid tumors demonstrated vector deposition, immune activity, a potential signal of clinical activity and a favorable safety profile.

Treatment was generally well tolerated, with predominantly Grade 1 and 2 treatment-related gastrointestinal adverse events. Most patients enrolled (81%) had metastatic colorectal cancer; the median lines of prior chemotherapies was four (1, 12).
Clinical activity was supported by observations of partial response and stable disease. The median overall survival was 9.6 months (95% CI 6.3, 16.4) in this heavily pre-treated population.
Toca 511 and Toca FC was associated with a T-cell mediated immune response in peripheral blood and metastatic tumor in some patients, consistent with the mechanism of action observed in preclinical models.
Peripheral blood T-cells shift from naïve to effector phenotypes indicating that T-cells are encountering their target antigens, potentially including proteins released by tumor cell killing.
Expansion of CD4+ memory T-cells after treatment is consistent with engagement of the adaptive immune system.
Increased post-treatment quantities of B-cells further suggests immune activation during the course of Toca 511 and Toca FC therapy.
Toca 511 and Toca FC led to a decrease of CD11b+ myeloid cells in five of six patients with evaluable colorectal metastasis. This immune fluorescence analysis suggests a decrease in the immunosuppressive myeloid cells, as seen in preclinical models, and potentially makes the tumor and the tumor microenvironment more conducive to immunologic modulation.
"Data from our poster at SITC (Free SITC Whitepaper) are encouraging and support the planned exploration of our Toca regimen in non-muscle invasive bladder cancer," said Marty Duvall, chief executive officer of Tocagen. "In addition, we look forward to presenting Toca 5 analyses at the upcoming SNO conference Toca 5 analyses including subgroups and molecular data in addition to details of the planned NRG Oncology trial in patients with newly diagnosed glioblastoma."

Details of the SNO presentations are as follows. Copies of the presentations will be available on Tocagen’s website following the presentations.

Presentation Type: Plenary Presentation (Abstract: LTBK-08)
Title: Toca 511 & Toca FC Versus Standard of Care in Patients With Recurrent High Grade Glioma
Presenter: Timothy Cloughesy, M.D., director of the University of California, Los Angeles, Neuro-Oncology Program
Date and Time: Friday, Nov. 22, 11:50 a.m. – 12:00 p.m. MST

Presentation Type: Poster Presentation (Abstract: RBTT-11)
Title: NRG Oncology NRG-BN006: A phase II/III randomized, open-label study of Toca 511 and Toca FC with standard of care compared to standard of care in patients with newly diagnosed glioblastoma
Presenter: Manmeet Ahluwalia, M.D., head of operations, Burkhardt Brain Tumor and Neuro-Oncology Center, Cleveland Clinic.
Date and Time: Saturday, Nov. 23, 5:00 p.m. – 7:00 p.m. MST

About Toca 511 & Toca FC
Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprising an investigational biologic, Toca 511 (vocimagene amiretrorepvec), and an investigational small molecule, Toca FC (flucytosine, extended-release). Toca 511 is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells resulting in anti-cancer immune activation and subsequent tumor killing.

On November 8, 2019 prismCDX, a highly specialized contract research organization reported the selection and adoption of the UltiMapper platform to broaden its offering of translational biomedical research services (Press release, PrismCDX, NOV 8, 2019, View Source [SID1234550829]). The addition of Ultivue’s highly standardized multiplex tissue marker assays enables the identification of critical cellular phenotypes and tissue marker signatures in support of translational and clinical research programs.

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"The combination of Ultivue’s next generation tissue marker assays with our platforms for genomic and proteomic analysis provides novel biological insights into the characterization of individual tumor microenvironments," commented Dong-Jun Bae, CEO with prismCDX. "Such complete tumor profiling and characterization data support our mission at prismCDX to partner with biopharma organizations developing targeted, precision medicine therapies and associated companion diagnostic tests."

Prior to the launch of those expanded capabilities, prismCDX has received scientific personnel training and certification at both Ultivue’s lab in Cambridge, MA and at its company facilities in Seoul, South Korea.

On November 8, 2019 Biodesix, Inc. reported that it has been named Company of the Year by the Colorado BioScience Association (CBSA) (Press release, Biodesix, NOV 8, 2019, View Source [SID1234550828]). The company was honored at the 16th Annual CBSA Awards Dinner on November 7, 2019. The CBSA serves as the hub for Colorado’s life science industry with member organizations spanning biotechnology, pharmaceutical, medical device, diagnostic, ag bio, mobile digital health, research, academic, and service providers. Biodesix was selected as Company of the Year in recognition of the significant milestones the company reached in advancing patient access to novel diagnostic testing in the clinic, and in ongoing development of new tests that address areas of high unmet clinical needs across the continuum of care in lung cancer. Lung cancer is still the leading cause of cancer death among men and women. In 2018, approximately 234,000 patients were diagnosed and 154,000 died due to lung cancer, which represents over 25 percent of all cancer deaths in the United States.

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"CBSA’s Annual Awards Dinner highlighted how health innovations from Colorado make a global impact. We are proud to honor Biodesix for its innovation and bringing top minds together to strengthen the future of healthcare. As the first company to provide four best-in-class diagnostic tests for patients in lung cancer, Biodesix has demonstrated its commitment to helping physicians and their patients navigate lung cancer therapy decisions. The timing of this award is an additional honor, as it is lung cancer awareness month," said Jennifer Jones Paton, President and CEO of CBSA. "CBSA is proud to honor Biodesix for its breakthroughs for patients, leadership in Colorado’s life sciences community and track record of success."

Key milestones for Biodesix in 2019:

Acquisition of Oncimmune in the U.S. to expand minimally invasive diagnostics to patients in North America with the EarlyCDT Lung test for lung nodule management, adding a 4th blood-based test to the portfolio
Expanded reach of Nodify XL2 testing for lung nodule management
Partnership with Thermo Fisher Scientific to develop a next-generation sequencing blood assay
Patenting of the Biodesix Collection Device (BCD) to improve on ease of blood collection, reduce cost and environmental impact
"Our greatest reward is the positive impact we can have on the lives of patients and their loved ones as they navigate lung cancer treatment decisions," said Scott Hutton, COO and incoming CEO for Biodesix.

"There is no higher honor than knowing that we played a part in improving the quality of life for a person facing the dreadful disease of lung cancer," said David Brunel, CEO for Biodesix. "We are proud to be building a Colorado-based bioscience company with 150 employees. We began as a Colorado start-up and this year we celebrated several important milestones. We greatly appreciate the recognition of the Colorado BioScience Association."

In addition to being headquartered in Colorado, Biodesix operates facilities in Boulder and Steamboat Springs, Colorado.