On July 22, 2020 GT Biopharma, Inc. (OTCQB:GTBP)(GTBP.PA) (the "Company or GT Biopharma") an immuno-oncology company focused on innovative therapies based on the Company’s proprietary natural killer (NK) cell engager (TriKE) technology reported that it had completed a private offering resulting in aggregate gross proceeds of approximately $5.6 million (Press release, GT Biopharma, JUL 22, 2020, View Source [SID1234562236]).

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GT Biopharma is conducting its FDA Phase I/II Clinical Trial for GTB-3550 at the Masonic Cancer Center, University of Minnesota under the direction of Dr. Erica Warlick. GTB-3550 is a tri-specific recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The NK cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their cytotoxic activity.

Acute myeloid leukemia (AML) is a heterogeneous hematologic stem cell malignancy in adults with incidence rate of 3% to 5% per 100,000 people. The median age at the time of diagnosis is 65 to 69 years. AML is an aggressive cancer that is fatal on the absence of treatment. The five-year expected overall survival rate for AML is 27.4%, according to the National Cancer Institute (NCI). The monies raised by the financing will be used to fund the further clinical development of the Company’s TriKE product candidates, including GTB-3350.

Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma, commented "we are pleased to have completed our bridge financing which allows us to continue to fund our FDA clinical trial and helps to position the Company to seek approval for listing on a national securities exchange ." Mr. Cataldo also stated "we are pleased with the progress our clinical development team is making with the evaluation of GTB-3550 in AML advanced cancer patients and will be providing further clinical updates to our stakeholders in the coming weeks."

About GTB-3550 Trispecific NK cell Engager (TriKE)

GTB-3550 is the Company’s first TriKE product candidate being initially developed for the treatment of AML. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The NK cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. We intend to study GTB-3550 in CD33 positive leukemias such as AML, myelodysplastic syndrome and other CD33+ hematopoietic malignancies.

On July 22, 2020 Cullinan Oncology, LLC reported the launch of Cullinan Amber, a company focused on developing a next generation immuno-oncology platform to enhance the therapeutic window of immune-stimulatory cytokine combinations for the treatment of cancer (Press release, Cullinan Oncology, JUL 22, 2020, View Source [SID1234562254]). Cullinan Amber has acquired an exclusive license from the Massachusetts Institute of Technology for technology based on the seminal work of K. Dane Wittrup, the C. P. Dubbs Professor in Chemical Engineering and Biological Engineering, to develop novel multifunctional constructs that are retained in the tumor microenvironment via collagen binding, which enables prolonged local activity of immunostimulatory cytokine combinations. Cullinan Amber’s lead program is a single agent comprised of two potent antitumor cytokines, interleukin-12 (IL-12) and interleukin-2 (IL-2), along with a collagen-binding domain. IND-enabling studies are expected to commence in 2H20.

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"We are delighted to have the opportunity to work with Dane and his team," stated Patrick Baeuerle, Chief Scientific Officer, Biologics and co-founder of Cullinan Oncology. "The Wittrup lab has developed a pioneering approach that we believe has the potential to combine and finally enable pro-inflammatory cytokines to realize their full potential as effective, safe and well-controlled cancer therapeutics."

"Historically, numerous studies have shown that cytokine combinations, including IL-12 and IL-2, can synergistically enhance both innate and adaptive immunity, and mediate impressive antitumor activity across a range of preclinical tumor models," stated Jon Wigginton, Chief Medical Officer of Cullinan Oncology. "Clinically, however, many cytokines have been limited by systemic toxicity, and were developed without the benefit of key learnings regarding dosing, supportive care and patient selection that have emerged in the field of immuno-oncology."

To address this challenge, the Wittrup Lab, as described in a groundbreaking publication in the June 2019 issue of Science Translational Medicine (Momin et al., 26 June 2019), fused various cytokines to a collagen-binding protein and injected them directly into the tumor, which effectively retained the cytokines locally, minimized their systemic dissemination and toxicities, and prolonged their anti-tumor activity. Most importantly, non-injected tumors likewise shrank in response to therapy due to the induction of a systemic immune response.

On July 22, 2020 Replimune Group, Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported the strengthening of its executive team with the appointment of Andrea Pirzkall, M.D. as Replimune’s Chief Medical Officer effective August 31st, 2020 (Press release, Replimune, JUL 22, 2020, View Source [SID1234562237]).

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"We are very excited to have Andrea join the Replimune team as we aggressively advance our pipeline," said Philip Astley-Sparke, Chief Executive Officer of Replimune. "Andrea brings a unique profile and skill set in oncology with a track record of success in advancing cancer drugs through all stages of development, including in immuno-oncology, combined with a multi-disciplinary clinical background prior to moving to industry."

Dr. Pirzkall commented, "It is a privilege to be joining Replimune at this very exciting period in the Company’s growth. The data presented for RP1 in Replimune’s lead indications of cutaneous squamous cell carcinoma and anti-PD-1 relapsed/refractory melanoma and emerging data in other solid tumors are very promising. With initial RP2 data expected later this year and with the initiation of clinical development of RP3, it is a transformational time for Replimune and I am very excited to be joining the team. The Replimune team has built a great platform of HSV-based oncolytic immune-gene therapies with a growing pipeline of assets and I look forward to helping advance them to potentially becoming a next corner stone of immuno-oncology treatment regimens."

As Chief Medical Officer, Dr. Pirzkall will lead clinical development of Replimune’s pipeline of next-generation oncolytic immuno-gene therapies for the treatment of cancer. Dr. Pirzkall brings to Replimune over 13 years of biotechnology and pharmaceutical industry experience. Prior to joining Replimune, Dr. Pirzkall served as Executive Director of Clinical Development at BeiGene, Ltd., a publicly traded commercial-stage biotechnology company where she provided strategic oversight of, and worked closely with cross-functional teams in the US, China and Europe, on the development of tislelizumab (anti-PD1) and other pipeline agents, with a focus on thoracic indications, and including several pivotal studies of which an initial two in non-small cell lung cancer achieved positive outcomes earlier this year. She served also as the global clinical development lead on the BeiGene/Celgene joint development committee. Prior to BeiGene, Dr. Pirzkall was a Principal Medical Director at Genentech, a member of the Roche Group. During her 10-year tenure, she held increasing roles of responsibility and, as a Clinical Development Team Leader, worked with multiple cross-functional teams on the development of novel biologic agents (signaling pathway inhibitors, anti-angiogenesis, immunotherapy) in early to late stage development in oncology. Prior to her career in the biotechnology and pharmaceutical industry, Dr. Pirzkall trained in radiation oncology and completed her dissertation at the University Heidelberg and the German Cancer Research Center (dkfz). Following a fellowship in Medical Physics/Radiation Oncology at the University San Francisco (USCF), Andrea held academic positions at UCSF, including Associate Adjunct Professorships in Radiation Oncology, in Radiology, and in Neurosurgery, where she helped pioneer the use of advanced imaging modalities to guide focal therapeutic interventions and to assess responses to standard of care and novel targeted therapies. Dr. Pirzkall holds a Doctor of Medicine from Friedrich-Schiller University Jena, Germany.

On July 22, 2020 T3 Pharmaceuticals AG ("T3 Pharma"), a Swiss biotech advancing immuno-oncology with its bacteria-based protein delivery platform, reported the closing of its third financing round, raising over 25M CHF (Press release, T3 Pharmaceuticals, JUL 22, 2020, View Source [SID1234562255]).

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The financing was co-led by existing investors, including the Boehringer Ingelheim Venture Fund (BIVF), Reference Capital SA, Wille Finance AG and private investors, who all participated in the round. This latest financing brings T3 Pharma’s total funding since the launch of the Company in 2015 to 40 million CHF.

T3 Pharma will use the funds primarily to progress its lead candidate, T3P-Y058-739, through clinical studies. The Phase 1/2 clinical study in solid tumors is planned to start in early 2021.

T3P-Y058-739 is the first therapeutic candidate developed using T3 Pharma’s proprietary protein delivery platform. The technology is built on the discovery that the bacterial type III secretion (T3S) system can be repurposed to deliver chosen proteins into eukaryotic cells.1 T3 Pharma’s live bacteria vehicles have been optimised to accumulate and grow selectively at solid tumors, where they produce and deliver the therapeutic protein.

Dr. Simon Ittig, T3 Pharma’s CEO, commented: "This significant financing round comes at a pivotal moment for our company as we leverage the full potential of our proprietary platform and enter the clinic with our lead candidate. We are grateful to our investors for their continued support."

"Our novel approach to deliver bioactive proteins selectively to cancerous cells using live bacteria has the potential to revolutionize treatment of solid tumors," added Dr. Olivier Valdenaire, Chairman of the Board.

Dr. Frank Kalkbrenner, Global Head of BIVF, commented: "Since I joined the Board last year, I have been impressed not only by the technology, but also by the team and the approach they have taken to building T3 Pharma’s innovative, differentiated platform and progressing its lead candidate. It is an endorsement of the quality of the science and the team that another financing round has been completed with an exceptional group of investors, which share our vision of improving the lives of cancer patients."

On July 22, 2020 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, reported that it has commenced a registered underwritten public offering of its common shares (the "Offering") (Press release, Aurinia Pharmaceuticals, JUL 22, 2020, View Source [SID1234562239]).

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Jefferies and SVB Leerink are acting as joint book-running managers for the Offering.

The Company will grant the underwriters an option exercisable, in whole or in part, in the sole discretion of the underwriters, to purchase up to an additional 15% of common shares, for a period of up to 30 days. The Offering is subject to market 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 Company intends to use the net proceeds of the Offering for pre-commercialization and launch activities, research and development, as well as working capital and general corporate purposes.

The Offering is subject to customary closing conditions, including NASDAQ and TSX approvals. For the purposes of the TSX approval, the Company intends to rely on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as NASDAQ.

The Offering is being made pursuant to a U.S. registration statement on Form F-10, declared effective by the United States Securities and Exchange Commission (the "SEC") on June 19, 2020 (the "Registration Statement"), and the Company’s existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated June 17, 2020. The prospectus supplements relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the "Offering Documents") will be filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States. The Offering Documents will contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the Offering Documents will be available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov, as applicable. Alternatively, copies of the prospectus supplement will be available upon request in the United States by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by e-mail at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6218, or by email at [email protected]; and in Canada by contacting Jefferies Securities, Inc., attention: Steven Latimer, 161 Bay Street, Suite 2700 Toronto, Ontario M5J 2S1, by telephone at 416-572-2215.

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