On June 15, 2020 Thermo Fisher Scientific reported that The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Oncomine Precision Assay to identify low-grade glioma (LGG) patients with isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations who may be eligible for vorasidenib (AG-881) (Press release, Thermo Fisher Scientific, JUN 15, 2020, View Source [SID1234561115]). The assay, first introduced to the market as a research product in November 2019, is designed to run on the new Ion Torrent Genexus System, the first fully automated next-generation sequencing (NGS) platform with a specimen-to-report workflow that delivers comprehensive genomic profiling results in a single day.

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Thermo Fisher recently announced it had expanded its strategic partnership agreement with Agios Pharmaceuticals to co-develop the companion diagnostic (CDx) for vorasidenib, an investigational, oral, brain-penetrant, dual inhibitor of mutant IDH1 and IDH2 enzymes currently under evaluation in the Phase 3 INDIGO study for IDH mutant LGG. Over time, Thermo Fisher seeks to receive premarket approval (PMA) for the Oncomine Precision Assay as a companion diagnostic for multiple therapies, as well as approval for liquid biopsy tumor profiling in lung cancer and solid tissue tumor profiling in multiple cancer types.

"Access to timely, comprehensive genomic profiling data that supports well-informed treatment decisions can be challenging under the current cancer-testing paradigm," said Dr. Alain Mita, Associate Professor of Medicine, Co-Director of the Experimental Therapeutics Program at Cedars-Sinai Medical Center. "The possibility of having multi-biomarker profiling that is generated onsite and available in about a day is game-changing for the manner and speed in which oncologists are able to determine and prescribe the most appropriate treatment for their patients."

The goal of the FDA’s Breakthrough Device Program is to provide patients and health care providers with timely access to medical devices by speeding up their assessment and review, while preserving the agency’s statutory standards. Once cleared under PMA, the Oncomine Precision Assay will maximize detection of guideline-recommended biomarkers, such as EGFR, ALK, KRAS, BRAF, ROS1, NTRK, RET, HER2 and others.

When combined with the Genexus System, molecular testing laboratories can generate comprehensive NGS results within the same timeframe as single-gene tests. Additionally, these features set the stage for molecular pathologists in the future to analyze NGS information in parallel with first-line testing modalities, such as immunohistochemistry (IHC).

"Breakthrough designation for the companion diagnostic is a big step forward in our endeavor to ensure that more clinicians can have quicker access to comprehensive genomic information," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "Receiving this insight at the speed that the Genexus System enables can help expedite patient therapy selection, which is a critical need in the clinic today."

With its unprecedented speed to results, the Genexus System is positioned to accelerate a broad range of application areas, including oncology, infectious disease, inherited disease and reproductive health, among others. Since its launch in November 2019 as a research only solution, the integrated sequencer has also been enabled to analyze SARS-CoV-2 samples to support epidemiology or contact tracing studies.

On June 15, 2020 Constellation Pharmaceuticals, Inc., (Nasdaq: CNST) a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that it has commenced an underwritten public offering of 4,000,000 shares of its common stock (Press release, Constellation Pharmaceuticals, JUN 15, 2020, View Source [SID1234561100]). All of the shares are being offered by Constellation. In addition, Constellation expects to grant the underwriters a 30-day option to purchase up to an additional 600,000 shares of its common stock sold in the public offering.

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J.P. Morgan, Jefferies, Cowen and RBC Capital Markets are acting as joint book-running managers for the offering. SunTrust Robinson Humphrey is acting as lead manager and Baird is acting as co-manager for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The shares are being offered by Constellation pursuant to an automatically effective shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on December 9, 2019.

This offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering is expected to be filed with the SEC and, if and when filed, copies of the preliminary prospectus supplement relating to the offering may be obtained for free by visiting the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 877-821-7388 or by email at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; or RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, New York, New York 10281, by telephone at (877) 822-4089 or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

On June 15, 2020 Medison Pharma Trading AG, a fully owned subsidiary of Medison Pharma Ltd., and Alpha Tau Medical Ltd., the developer of a breakthrough alpha-radiation cancer therapy "Alpha DaRT," reported an exploratory collaboration in the oncology field in Central and Eastern Europe (Press release, Medison Pharma, JUN 15, 2020, View Source [SID1234561116]). Medison is a specialized pharmaceutical and biotech company focused on licensing highly innovative, cutting edge therapeutics for patients in need of life-saving therapies in various international markets. According to the new arrangement, Medison will take advantage of its deep familiarity and extensive local infrastructure in CEE in order to evaluate the market opportunity towards the launch of the cutting-edge technology in the region.

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Meir Jakobsohn, CEO of Medison Pharma, commented: "After licensing Alpha DaRT for the Canadian and Israeli markets, the collaboration with Alpha Tau for the Central and Eastern European region is a natural development that demonstrates our commitment to save and improve lives of patients in need in the CEE region. We continue to seek opportunities that will deliver innovative and valuable solutions in all the regions in which we operate."

On June 15, 2020 Lantern Pharma Inc. (LTRN) (the "Company"), a clinical stage biotechnology company, focused on leveraging artificial intelligence ("A.I."), machine learning and genomic data to streamline the drug development process and to identify the patients that will benefit from its targeted oncology therapies, reported the closing of its initial public offering of 1,750,000 shares of its common stock at a public offering price of $15.00 per share, for gross proceeds of $26,250,000, before deducting underwriting discounts, commissions and offering expenses (Press release, Lantern Pharma, JUN 15, 2020, View Source;utm_medium=rss&utm_campaign=lantern-pharma-announces-closing-of-initial-public-offering [SID1234561215]). In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 262,500 shares of common stock at the initial public offering price, less the underwriting discount, to cover over-allotments.

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ThinkEquity, a division of Fordham Financial Management, Inc. acted as sole book-running manager for the offering. Colliers Securities LLC and Paulson Investment Company, LLC acted as co-managers for the offering.

Registration statements on Form S-1 (Files No. 333-237714 and 333-239112) relating to the shares were filed with the Securities and Exchange Commission ("SEC") and became effective on June 10, 2020, or automatically became effective, as applicable. This offering is being made only by means of a prospectus. Copies of the final prospectus may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, by email at [email protected].

On June 15, 2020 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported that the Medicines and Healthcare products Regulatory Agency (MHRA; the UK equivalent of the FDA) has given approval to initiate a Phase I clinical trial of INKmune, a novel therapy to prime the patient’s own NK cells to attack their cancer, in patients with high-risk Myelodysplastic Syndrome (MDS) (EUDRACT 2019-004820-40) (Press release, INmune Bio, JUN 15, 2020, View Source [SID1234561101]). This single center Phase I trial will be the first-in-man study using INKmune. Based on the current environment and timetable of its clinical site, INmune Bio is targeting the study initiation in the 2nd half of this year.

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"Patients with MDS are mostly elderly; in this population high-dose chemotherapy or bone marrow transplant are usually too toxic," said Dr. Marion Wood, consultant hematologist and the medical director for this INKmune program. "With this clinical trial, we hope to show that INKmune will provide an effective and better tolerated therapeutic option for those patients who are poorly served by current therapies." Patients with high-risk MDS will be enrolled to receive at least 3 doses of INKmune therapy via intravenous infusion, without the need for any type of conditioning therapy or pretreatment. The Phase I trial, called Laurel, will include at least 9 patients enrolled at a single center in the UK and has the capacity for an extension cohort.

"Recent research has shown that MDS patients who survive beyond two years are those with good NK cell activity (Tsirogianni et al 2019). INKmune has been shown to boost the function of NK cells from MDS patients in laboratory experiments. We will target those patients whose NK cells demonstrate a response to INKmune in the laboratory. This is part of our precision approach to immunotherapy," said Dr. Mark Lowdell, CSO of INmune Bio and discoverer of the science behind INKmune. "We are excited to be able to test it as a treatment in this group of patients facing an unmet therapeutic need."

"Professor Lowdell and his team in the UK have worked closely with the MHRA to get this trial through regulatory approval, despite the challenges of the COVID-19 pandemic," said RJ Tesi MD, CEO of INmune. "The INKmune program is the second oncology platform entering the clinic for INmune Bio."