On June 17, 2020 IDEAYA Biosciences, Inc. (Nasdaq: IDYA) reported the pricing of an underwritten public offering of 6,666,667 shares of its common stock at a public offering price of $15.00 per share, before underwriting discounts and commissions (Press release, Ideaya Biosciences, JUN 17, 2020, View Source [SID1234561196]). In addition, IDEAYA has granted the underwriters a 30-day option to purchase up to an additional 1,000,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by IDEAYA, are expected to be $100.0 million excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on or about June 22, 2020, subject to the satisfaction of customary closing conditions.

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IDEAYA intends to use the net proceeds of the offering, along with its existing cash, cash equivalents and short-term and long-term marketable securities to fund (i) preclinical and clinical development of IDE397, its MAT2A inhibitor development candidate, and other product candidates in its research pipeline targeting poly (ADP-ribose) glycohydrolase, or PARG, and a DNA Damage Target, or DDT, as well as its share of costs for targeting WRN under the previously announced Collaboration, Option and License Agreement with GSK, (ii) ongoing early clinical development of IDE196, its PKC inhibitor, and binimetinib, a MEK inhibitor to which Pfizer has exclusive rights in the U.S. and Canada, as combination therapy in metastatic uveal melanoma, or MUM and other solid tumors having GNAQ/11 hotspot mutations, as well as ongoing clinical trials evaluating IDE196 as monotherapy in such indications, (iii) biomarker research and development activities and (iv) working capital and other general corporate purposes.

J.P. Morgan, Citigroup and Jefferies are acting as joint book-running managers for the offering.

The securities described above are being offered by IDEAYA pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the U.S. Securities and Exchange Commission (the "SEC"). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, copies of which may be obtained, when available, by request from: J.P. Morgan, by mail at J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 866-803-9204, or by email at [email protected]; Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; or Jefferies, by mail at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected].

This press release shall not constitute an offer to sell or a 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 June 17, 2020 NANOBIOTIX (Euronext : NANO – ISIN : FR0011341205 – the ‘‘Company’’) (Paris:NANO), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported that the FDA has provided necessary feedback regarding the design of NANORAY-312, the Company’s pivotal phase III global registration trial in head and neck cancer (Press release, Nanobiotix, JUN 17, 2020, View Source [SID1234561195]). The FDA also agreed to the NBTXR3 chemistry, manufacturing, and controls (CMC) Development Plan to support the phase III trial and a future New Drug Application (NDA) for the product.

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NANORAY-312: A Phase III Study of NBTXR3 Activated by Investigator’s Choice of Radiotherapy Alone or Radiotherapy in Combination with Cetuximab for Platinum-based Chemotherapy-ineligible Elderly Patients with Locally Advanced Head and Neck Squamous Cell Carcinoma.

NANORAY-312 will be a phase III investigator’s choice, dual-arm, randomized (1:1) global registration trial including elderly head and neck cancer patients who are ineligible for platinum-based chemotherapy.

Patients in the control arm will receive radiation therapy with or without cetuximab (investigator’s choice), and patients in the treatment arm will receive NBTXR3 activated by radiation therapy with or without cetuximab (investigator’s choice).

The trial is expected to recruit approximately 500 patients. A futility analysis is expected 18 months after the first patient in the trial is randomized, and the interim analysis for progression-free survival (PFS) superiority is expected at 24-30 months. The final analysis will report on PFS and overall survival. Quality of Life will also be measured as a key secondary outcome. In the event of favorable data from the interim analysis, the FDA has advised that NBTXR3 could potentially qualify for accelerated approval.

In support of the phase III trial and a future NBTXR3 New Drug Application (NDA), Nanobiotix met with the FDA in a Type B end-of-phase I meeting on October 16, 2019. Following additional correspondence with the FDA, including written responses to the FDA’s recommendations, the Company received written FDA guidance on April 3, 2020. The Company expects to commence NANORAY-312 after making protocol refinements and securing the requisite financing to fund the trial.

Agreement to CMC Development Plan

The FDA’s written response regarding the CMC Development Plan does not raise any safety concerns for continued clinical development of NBTXR3, and the FDA agreed to the updated CMC Plan for NBTXR3 during an ongoing phase III clinical trial.

About NBTXR3
NBTXR3 is a first-in-class product designed to destroy tumors through physical cell death when activated by radiotherapy. NBTXR3 has a high degree of biocompatibility, requires one single administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The physical mode of action of NBTXR3 makes it applicable across solid tumors.

NBTXR3 is actively being evaluated in clinical trials worldwide as a potential treatment in various cancer indications. The Company is prioritizing the development of NBTXR3 in the United States and the EU for the treatment of patients with locally advanced head and neck cancers ineligible for chemotherapy.

Nanobiotix is also running an Immuno-Oncology development program, evaluating NBTXR3 activated by radiotherapy as a primer of immune response in combination with checkpoint inhibitors. The Company has launched a phase I clinical trial of NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors in patients with locoregional recurrent (LRR) or recurrent and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) amenable to re-irradiation or with lung or liver metastasis (mets) from any primary cancer eligible for anti-PD-1 therapy.

Other ongoing NBTXR3 trials are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and pancreatic cancer. The Company has a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center (initially expected to support nine new clinical trials in the United States) to evaluate NBTXR3 across several cancer types.

On June 17, 2020 Median Technologies (Paris:ALMDT) (ALMDT), The Imaging Phenomics Company, reported the results of a preliminary retrospective study on the evaluation of the risk of recurrence for patients with primary liver cancer (HCC – hepatocellular carcinoma) based on a non-invasive biomarker (Press release, MEDIAN Technologies, JUN 17, 2020, View Source [SID1234561194]). The iBiopsy imaging biomarker discovery platform, which integrates advanced technologies in artificial intelligence has produced these results on one of the three indications on which it is positioned. Bearing in mind, the various clinical development plans for iBiopsy were communicated on April 20, and relate to (1) the evaluation of severity of hepatic fibrosis in non-alcoholic fatty liver disease (NASH – Non Alcoholic Steatohepatitis), (2) the identification of responders/non-responders to certain immunotherapies in oncology, and finally (3) the detection, characterization and prognosis of primary liver cancer (HCC).

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The level of hepatic fibrosis1 is of great prognostic value and helps inform therapeutic intervention with regard to liver disease. The diagnosis of fibrosis is classically based on the anatomo-pathological examination of a fragment of liver collected by a hepatic puncture, a painful invasive act, presenting risks for the patient and which turns out to be expensive.

There was a two-fold objective for the preliminary retrospective study: first, to accurately quantify liver fibrosis on CT images, and second, to correlate the score of fibrosis with the risk of recurrence in post-operative patients with HCC.

Therefore, a learning algorithm was used on the pre-operative CT scans of 94 patients that were separated in two sets (training and validation) in order to model the relationship between image features of liver, spleen and hepatic fibrosis characterized by histological METAVIR scoring system (F0-F4). The performance of iBiopsy testing characterized by the area under the curve (AUROC) is 0.91 with a specificity of 1 for the diagnosis of severe fibrosis (F3-F4). Using this quantification methodology, iBiopsy non-invasive fibrosis biomarker permits the stratification of pre-operative patients at high-risk of tumor recurrence (HR = 4.1 (CI: [1.2,13.9], p-value<0.01). Such knowledge can positively impact the therapeutic approach in patients to undergo hepatic resection.

Based solely on the threshold values ​​of advanced fibrosis, the iBiopsy fibrosis test would avoid biopsy in 100% of cases, unlike other imaging techniques such as ultrasonic elastography and elasto-MR which have lower specificity and sensitivity values. These very encouraging first results need to be confirmed in larger independent patient cohorts. This will be one of the objectives of the Liver iBiopsy study, conducted in collaboration with the AP-HP, as part of the AP-HP Median partnership announced on March 2.

"These initial results are exciting and show the relevance of our approach. With the integration of the AI technologies, cloud computing and our data science expertise, we are positioning iBiopsy as a platform for the discovery of imaging biomarkers, on which we will deploy our entire non-invasive biomarkers portfolio, " said Fredrik Bragg, CEO and co-founder of Median.

"In this first study, the success of the quantification of HCC-related fibrosis via routine scanner imaging opens the prospective to the evaluation of the severity of fibrosis on NASH patients using the same modality. Our objective is to exploit the information content of the images widely used in clinical routine and clinical trials. iBiopsy allows for the comprehensive analysis of features of images on whole organ, which permits a true evaluation of the entire tumoral landscape and increases the amount of information that we can extract from images, and thus the performance of the biomarkers we calculate," he added.

About iBiopsy: Based on the most advanced AI technologies and with expertise in data science, Median’s iBiopsy proprietary imaging platform allows for the extraction of non-invasive imaging biomarkers, which are the disease "signatures". These biomarkers, obtained from standard medical imaging modalities are used both in the field of clinical development and clinical routine in which medical needs regarding disease detection, treatment options and follow-up of patients are still unmet and have yet to foster the promise of predictive and precision medicine.
Median’s iBiopsy development program is supported by the European Investment Bank (EIB) through a financial loan of €35 million under the Juncker Plan, the European Fund for Strategic Investments, which aims to support research and innovation projects developed by companies with high growth potential.

On June 17, 2020 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported a change to its presentation time at the upcoming JMP Securities Hematology and Oncology Forum. Updated details are as follows (Press release, Syros Pharmaceuticals, JUN 17, 2020, View Source [SID1234561193]):

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JMP Securities Hematology and Oncology Forum
Date: Thursday, June 18
Presentation Time: 3:20 p.m. ET

A live webcast of the presentation will be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay will be available for approximately 30 days following the fireside chat.

On June 17, 2020 Foundation Medicine, Inc., reported that the U.S. Food and Drug Administration (FDA) approved FoundationOneCDx as a companion diagnostic for KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, which was also approved under accelerated approval for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options (Press release, Foundation Medicine, JUN 17, 2020, View Source [SID1234561192]). FoundationOne CDx is the first and only FDA-approved companion diagnostic to measure TMB and help identify patients who may be appropriate for treatment with KEYTRUDA, regardless of solid tumor type.

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TMB is a measure of the number of somatic mutations per coding region within a tumor’s genome.1 This genomic signature can help determine a patient’s likelihood to respond to immunotherapies. FoundationOne CDx, Foundation Medicine’s comprehensive genomic profiling (CGP) assay approved for all solid tumors, enables oncologists to identify TMB-H patients (≥ 10 mutations/megabase) with unresectable or metastatic solid tumors across all tumor types who could potentially benefit from KEYTRUDA.

"Immunotherapy is revolutionizing cancer treatment. Not only does this approval mean that clinicians will be able to identify more patients who could benefit from this treatment option, but it’s an important milestone in the shift toward making biomarker-driven, tumor agnostic therapies available to patients, which is possible through an FDA-approved companion diagnostic," said Brian Alexander, M.D., M.P.H., chief medical officer at Foundation Medicine. "We’re proud to have been at the forefront of efforts to bring TMB from research into clinical practice in partnership with the oncology community. It’s exciting to see this breakthrough translate into advanced care for patients."

FoundationOne CDx is the first FDA-approved CGP test that is clinically and analytically validated for all solid tumors and incorporates multiple companion diagnostic claims. It is currently approved as the companion diagnostic test for more than 20 therapies across multiple cancer types.

"This approval represents a paradigm shift toward biomarker-driven cancer treatment. It’s made possible in part by an unparalleled collaboration to better understand how TMB levels are measured and reported," said Jeff Allen, President and CEO of Friends of Cancer Research. "TMB provides an additional tool to inform clinical care, especially for cancer patients previously ineligible for immunotherapy based on existing biomarkers."

Merck also announced today that the FDA approved its supplemental Biologics License Application (sBLA) for KEYTRUDA, for adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. The accelerated approval was based on a prospectively planned and retrospective analysis of the KEYNOTE-158 open-label trial, which used a clinical trial assay (CTA) based on FoundationOne CDx to determine TMB status in patients’ tumor tissue. The results showed that patients with TMB-H in solid tumors (≥ 10 mutations/megabase) who were treated with KEYTRUDA had a higher overall response rate (29%) compared to patients with TMB <10 mut/Mb (6%).2

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is now approved for two pan-tumor indications. In 2017, KEYTRUDA was granted FDA approval as the first cancer treatment based on a genomic signature, regardless of cancer type, in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. More information about KEYTRUDA can be found at www.keytruda.com.

About FoundationOne CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit View Source

About TMB

Tumor mutational burden (TMB) is a measure of the total number of mutations per coding area of a tumor genome.3 TMB is an additional genomic signature, similar to a biomarker, that can help identify more candidates likely to benefit from immunotherapy across a range of tumor types. Levels are measured by the number of non-inherited mutations occurring per megabase (1 million DNA base pairs) of the tumor genome.4 TMB-H tumors may be more likely to respond to certain immunotherapies because their high number of mutations make them easier for the immune system to identify. Higher TMB levels are correlated with higher levels of neoantigens, which help the immune system recognize and attack cancer cells.5 TMB can be measured with both tissue and blood-based comprehensive genomic tests.