On July 20, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported it has completed the development of a biological cell-based in vitro assay which can identify clinically active cannabis derived compounds that bind to and activate the A3 adenosine receptor (A3AR), thus enabling the development of pharmaceuticals that use a specific cannabis derived compound to treat a variety of diseases (Press release, Can-Fite BioPharma, JUL 20, 2020, View Source [SID1234562134]). Numerous studies published in peer reviewed scientific journals demonstrate that cannabis derived compounds bind to the Gi protein-coupled A3AR, which is over-expressed in pathological cells and tissues.

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As a global leader in discovering and developing drugs which target A3AR, Can-Fite is utilizing its platform technology to develop cannabis derived compounds for the treatment of unmet medical needs. Can-Fite has a strategic partnership with Univo Pharmaceuticals, a medical cannabis company.

In addition to using its assay in the development of its own cannabis derived compound-based therapeutics, Can-Fite plans to market the assay on a ‘fee for service’ basis to researchers and other cannabis companies worldwide.

"This new assay, combined with our unparalleled expertise in the development of therapeutics that target A3AR, enable Can-Fite to contribute to unlocking the vast potential of cannabis derived compounds for the effective treatment of specific diseases," stated Can-Fite CEO Dr. Pnina Fishman.

According to Adroit Market Research, the medical cannabis market is projected to grow at a CAGR of 29% to $56.7 billion by 2026.

On July 20, 2020 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," "MTEM" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery and development of the Company’s proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported that it has raised gross proceeds of approximately $43 million through its At-the-Market facility ("ATM") with participation based on interest received from Consonance Capital Management (Press release, Molecular Templates, JUL 20, 2020, View Source [SID1234562130]). The Company sold approximately 3.6 million shares of the Company’s common stock at a purchase price of $12.00, the market price at the time of sale. Cantor Fitzgerald & Co. is acting as the sales agent for the ATM.

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The additional funds raised through the ATM will be used to advance the Company’s pipeline, including the development of MT-3724, MT-5111, TAK-169, MT-6402, as well as for working capital and other general corporate purposes.

The shares of common stock described above were sold by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-228975) previously filed and effective on February 13, 2019.

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

On July 20, 2020 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported that its phase 1 studies of PRS-343 have been placed on partial clinical hold by the U.S. Food and Drug Administration (FDA) while Pieris conducts an additional in-use and compatibility study requested by the Agency (Press release, Pieris Pharmaceuticals, JUL 20, 2020, View Source [SID1234562128]). Currently-enrolled patients may continue to receive treatment, although no new patients can be enrolled until resolution of this partial hold.

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The partial hold follows discussions with FDA regarding the Company’s in-use study supporting the technical setup for clinical administration of PRS-343. Specifically, FDA has requested that Pieris conduct an additional in-use and compatibility study of PRS-343 with various infusion materials under specific conditions to confirm suitability of PRS-343 for administration in clinical settings. In its telephonic communication, the Agency did not cite any adverse events in connection with its request. In-use and compatibility studies are laboratory-based studies typically conducted to evaluate the impact of product handling on a drug candidate’s behavior, including effects of dilution media, hold times, and adsorption to materials such as tubing and infusion bags before administration to patients. As part of the development of PRS-343, Pieris conducted in-use and compatibility studies prior to phase 1 and thereafter, the results of which were shared with the Agency.

Separately, the Company has received a written response from the Agency to its Type C meeting request related to the planned phase 2 proof of concept study of PRS-343 in combination with ramucirumab and paclitaxel. Based on this response, Pieris continues to believe it can initiate this clinical study later this year, pending successful completion of the requested in-use and compatibility study.

"We share FDA’s commitment to product quality and will continue to engage with the Agency to initiate and complete the requested in-use and compatibility study with the highest priority," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "Pending satisfactory completion of this laboratory study, we remain committed to continuing the development of PRS-343, including the initiation of a phase 2 study in second-line gastric cancer in combination with the standard of care this year, as previously communicated. We also remain on track to present comprehensive data from both the monotherapy and atezolizumab combination phase 1 studies at a medical conference later this year."

About PRS-343:

PRS-343 is a 4-1BB/HER2 fusion protein comprising a 4-1BB-targeting Anticalin protein and a HER2-targeting antibody. The drug candidate is currently in development for the treatment of HER2-positive solid tumors. Ongoing phase 1 studies of PRS-343 include a monotherapy study and a combination study with atezolizumab. Based on encouraging initial results from both studies, which demonstrated clinical benefit and biomarker data indicative of a 4-1BB-driven mechanism of action, the Company is actively working towards initiating a phase 2 study of PRS-343 in combination with ramucirumab and paclitaxel for the treatment of HER2-positive gastric cancer in a second line setting later this year.

On July 20, 2020 INmune Bio, Inc. (NASDAQ: INMB) (the "Company" or "INmune"), a clinical-stage immunology company focused on developing treatments that harness a patient’s innate immune system to fight disease, reported the closing of its previously announced underwritten public offering of an aggregate of 2,173,914 shares of its common stock at a public offering price of $10.00 per share and the exercise in full of the underwriters’ option to purchase an additional 326,086 shares of common stock (Press release, INmune Bio, JUL 20, 2020, View Source [SID1234562121]).

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A total of 2,500,000 shares of common stock were issued in the offering, including the full exercise of the over-allotment option.

The gross proceeds to INmune from this offering are approximately $23.1 million, before deducting underwriting discounts and commissions and other offering expenses payable by INmune. INmune intends to use the net proceeds from the offering for general corporate purposes, including to support research and development, including clinical trials.

BTIG, LLC acted as sole book-running manager of the offering, and National Securities Corporation acted as a co-manager.

The offering was made pursuant to the shelf registration statement on Form S-3 (File No. 333-237368) that was filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020 and became effective on April 2, 2020, including the related base shelf prospectus, as supplemented by the prospectus supplement dated July 16, 2020. The final prospectus supplement and accompanying base shelf prospectus are available on the SEC’s website at www.sec.gov.

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 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 jurisdiction.

On July 20, 2020 Lantern Pharma (NASDAQ: LTRN), 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 that entering into agreements with leading contract manufacturing companies for process development and manufacturing for two of Lantern’s oncology drug candidates, LP-300 and LP184 (Press release, Lantern Pharma, JUL 20, 2020, View Source [SID1234562120]). Lantern Pharma filed an 8-K on Thursday, July 16 describing a recent agreement for GMP manufacturing.

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Lantern’s LP-300 is a small molecule drug candidate currently in preparation to enter phase 2 clinical trials in a growing, but unaddressed, type of non-small cell lung cancer (NSCLC) among never-smokers. Lantern is focused on developing LP-300 as a potential first-in-class combination therapy for never smoking (or non-smoking) NSCLC patients with histologically defined adenocarcinoma. NSCLC among never and non-smokers has a distinct molecular profile and according to the American Cancer Society, as many as 20% of people who die from lung cancer in the United States every year have never smoked or used any other form of tobacco. Leading researchers have started to classify lung cancer in never and non-smokers as having unique and distinct clinical, biological and pathological characteristics that have the potential to be impacted by new therapeutic options. According to market research, and data analytics firm, GlobalData, approximately $10 billion USD will be spent annually on NSCLC therapies in 2020 in the leading eight markets (by annual drug sales), with approximately $4 billion in the US.

Lantern’s LP-184 is a small molecule drug candidate currently in preclinical development for certain genomically defined solid tumors that overexpress certain RNA, as well as for glioblastoma multiforme (GBM). Lantern is currently planning to enter a Phase 1 clinical trial with this drug candidate in late 2021 or early 2022, after finalizing further biomarker studies with leading researchers, and after completing IND-enabling studies. Lantern estimates that, by 2025, potential annual sales for therapies in the genomically defined solid tumors targeted by LP-184 will be over $2.5 billion USD globally, and that potential annual sales for therapies to treat GBM will be nearly $1 billion globally. Both molecules have been advanced using Lantern’s proprietary RADR A.I. platform. With nearly 500 million data points, the RADR A.I. platform uses machine learning techniques, genomics, and computational biology methods to accelerate drug development by accelerating the discovery of potential mechanisms of action and developing genomic and biomarker signatures that correlate to drug UNDER EMBARGO UNTIL 8:00 AM EASTERN MONDAY, 07/20/20 response in cancer patients.

Both molecules, LP-300 and LP-184, are being developed with the vision of pairing them with companion diagnostics generated, in-part by RADR, to enable precision medicine trials and selection of patients with the highest probability of benefiting from the drug and offering the potential for best-in-class outcomes.

Panna Sharma, CEO and President of Lantern Pharma, stated, "the launch of manufacturing activities with our partners represents key steps in establishing a specialized global manufacturing network that can provide Lantern with critical scalability, flexibility and innovation to help maximize the impact of our capital resources and efficiently prepare our drug supply for our clinical trials and studies." Sharma continued, "These key capabilities are especially important now as we advance LP-300 and LP-184 towards commencement of clinical trials that can likely shape the timing and terms of potential future partnering discussions."