On February 16, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at Citi’s 2021 Healthcare Services, Medtech, Tools & HCIT Virtual Conference on Thursday, February 25, 2021 at 9:50 a.m. EST (Press release, Bio-Techne, FEB 16, 2021, View Source [SID1234575092]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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On February 16, 2021 GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage biopharmaceutical company focused on the development and commercialization of its disruptive, target-directed Natural Killer (NK) cell engager immunotherapy protein biologic platform technology: TriKE for cancer and infectious diseases, reported the closing of an underwritten public offering of 4,300,000 Units (Press release, GT Biopharma, FEB 16, 2021, View Source [SID1234575091]). Each Unit consisted of one share of GT Biopharma’s common stock and one warrant to purchase one share of common stock at a public offering price of $5.50 per share, per Unit. In addition, the Company has granted the underwriters a 45-day over-allotment option to purchase up to an additional 645,000 Units, less underwriting discounts and commissions.

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Gross proceeds from the offering are approximately $23.6M, before deducting underwriting discounts and commissions and offering expenses, but excluding any exercise of the underwriters’ over-allotment option. Following the offering, the Company’s cash position is approximately $30M, extending GT Biopharma’s cash runway through 2022. The transaction successfully extinguished over $25M in debt, which converted into equity, without the need to exercise a downward reset and consolidated the Company’s capital structure to 20,637,000 shares issued and outstanding.

Anthony J. Cataldo, GT Biopharma’s Chairman and CEO, commented: "Completing our financing and uplisting to NASDAQ was a major milestone for us and a significant move to increase GT’s corporate reach. We have long been recognized to have a disruptive platform NK technology, TriKE, as demonstrated with the ongoing results of our FDA-approved expanded GTB-3550 TriKE Phase 1/2 clinical trial. This was evidenced by the very positive response to our oral data presentation at the ASH (Free ASH Whitepaper) (American Society of Hematology) conference in December. Now, as a repositioned biotech NASDAQ trading company, institutional funds and analysts are no longer restricted from participating with GT Biopharma, Inc. With this infusion of capital set to advance both liquid and solid cancer TriKEs in the clinic, and partnership opportunities on the horizon for targeted TriKE licensing programs, this is a most auspicious time for the Company. We are very excited to have our corporate structure on par with the quality of human data, which thus far has shown no signs of toxicity or side effects; but has shown clinical benefit in our GTB-3550 TriKE Phase 1/2 expansion trial for Acute Myeloid Leukemia (AML) and Myelodysplastic syndromes (MDS). This is the first of our several planned cancer trials later this year."

Roth Capital Partners and Dawson James Securities, Inc. acted as joint book-running managers for the offering.

On February 16, 2021 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported that Selecta’s Chief Executive Officer, Carsten Brunn, Ph.D., will provide a corporate update and participate in one-on-one investor meetings at the SVB Leerink 10th Annual Global Healthcare Conference taking place February 24 – 26, 2021 (Press release, Selecta Biosciences, FEB 16, 2021, View Source [SID1234575090]).

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The presentation on Friday, February 26 at 10 a.m. ET will be available through the SVB Leerink Conference portal and an archived webcast will also be accessible in the Investors & Media section of the company’s website at www.selectabio.com.

On February 16, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for the use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic (CDx) for the fibroblast growth factor receptor (FGFR) inhibitor pemigatinib, for patients with FGFR2 fusion positive locally advanced or metastatic biliary tract cancer on February 15, 2021 (Press release, Chugai, FEB 16, 2021, View Source [SID1234575086]).

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"We are very pleased that FoundationOne CDx Cancer Genomic Profile has been approved as a companion diagnostic for pemigatinib in patients with biliary tract cancer. The expanded use of FoundationOne CDx Cancer Genomic Profile for this new cancer type with high unmet medical needs underscores the value of comprehensive genomic profiling in cancer treatment," said Dr. Osamu Okuda, Chugai’s President and COO. "We are committed to preparing for the use of the genomic profiling to identify those who may benefit from pemigatinib."

The approval allows the use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic to identify patients with FGFR2 fusion positive locally advanced or metastatic biliary tract cancer who could benefit from treatment with pemigatinib. Incyte Biosciences Japan submitted a Japanese New Drug Application for pemigatinib for the treatment of FGFR2 fusion positive locally advanced or metastatic cholangiocarcinoma with the MHLW on September 14, 2020 which is currently under review. The MHLW granted orphan drug designation to pemigatinib for this indication.

As a leading company in the field of oncology, Chugai is committed to realizing advanced personalized oncology care and contributing to patients and healthcare professionals through improving access to comprehensive genomic profiling of cancers.

Approval information The underlined part has been newly added.

Intended uses or indications

The Product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesylate
EGFR exon 20 T790M alterations osimertinib mesylate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib hydrochloride hydrate
BRAF V600E and V600K alterations Malignant melanoma dabrafenib mesylate, trametinib dimethyl sulfoxide, vemurafenib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab (genetical recombination)
KRAS/NRAS wild-type Colorectal cancer cetuximab (genetical recombination), panitumumab (genetical recombination)
NTRK1/2/3 fusion gene Solid tumors entrectinib, larotrectinib sulfate
BRCA1/2 alterations Ovarian cancer olaparib
BRCA1/2 alterations Prostate cancer olaparib
FGFR2 fusion genes Biliary tract cancer pemigatinib

On February 16, 2021 Onward Therapeutics SA (Onward) reported the execution of a worldwide exclusive license and co-development agreement with Biomunex Pharmaceuticals SAS (Biomunex), Paris, France, of a bispecific antibody targeting two immune checkpoints (Press release, BIOMUNEX Pharmaceuticals, FEB 16, 2021, View Source [SID1234575077]).

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Biomunex grants the rights for Onward to pursue development, manufacture and commercialization of this first-in-class bispecific antibody. Onward and Biomunex will jointly develop the antibody during the preclinical and early clinical program. Biomunex is responsible for early preclinical development, while Onward will complete the IND-enabling studies, and will be responsible for GMP manufacture, clinical development, and commercialization.

Under the terms of the agreement, Onward will pay upfront, development, regulatory and sales milestones, as well as tiered royalties on net sales. In addition, Onward will make an equity investment in Biomunex, and Dr. C. Grace Yeh, Chairman and CEO of Onward will join the board of Biomunex. The details of the financial terms were not disclosed.

"Based on our ‘Buy and Build’ business model, this deal enables Onward to get a head start of developing an innovative bispecific antibody in the field of immuno-oncology," said Dr. C. Grace Yeh. "We saw a great opportunity to collaborate with an immunotherapy player who has an array of bi-specific and multi-specific antibody projects built from their BiXAb technology platform. The two companies having complementary expertise, we believe that this synergy has the potential to further our partnership in developing other antibody immuno-therapeutics."

"This license and co-development agreement for one of our proprietary antibodies based on our ‘Plug-and-Play’ BiXAb technology, enables a step forward for Biomunex development, said Dr. Pierre-Emmanuel Gerard, founder and CEO of Biomunex. It demonstrates once again, following the 2019 deal with Sanofi, the value of our disruptive BiXAb technology to rapidly and efficiently generate new drugs in immuno-oncology, bringing new hope for cancer patients. It also confirms the relevance of our business model combining partnerships on BiXAb technology and collaborations and licenses on our proprietary products."