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Agenus to Manufacture Clinical Supply of GS-1423 for Gilead

On August 21, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, adoptive cell therapies1 and cancer vaccines, reported a manufacturing agreement with Gilead for the supply of GS-1423, a bi-functional molecule licensed to Gilead (Press release, Agenus, AUG 21, 2019, View Source [SID1234538899]). This supply represents a second clinical batch for an ongoing Phase 1 clinical trial of GS-1423. Agenus is providing clinical supply at standard industry rates.

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"Our state-of-the-art facility in Berkeley, California and experienced staff have delivered more than 50 antibodies into the clinic2," said Al Dadson, Chief Manufacturing Officer of Agenus. "In the last 18-20 months, we have set path-breaking records with the development and manufacture of 8 compounds including two bi-specific compounds with 7 accepted INDs and one pending acceptance."

The collaboration between the two companies was announced in December 2018. Under the terms of the agreement, Agenus received $150 million in an upfront cash payment and equity investment and is eligible for approximately $1.7 billion in potential future fees and milestones.

GS-1423 is an investigational agent that has not been approved for any uses. Efficacy and safety have not been established.

Araris Biotech AG closes seed financing round of CHF 2.5 million

On August 20, 2019 Araris Biotech AG reported the closing of an oversubscribed seed financing round of CHF 2.5 million with participation of Swiss investors Redalpine, Schroder Adveq and VI Partners (Press release, Araris Biotech, AUG 20, 2019, View Source [SID1234651277]). The proceeds will be used to develop a pipeline of proprietary antibody-drug conjugates (ADCs).

Araris’ co-founder and Chief Executive Officer, Dr. Philipp Spycher, commented: "We are very pleased to announce that three renowned Swiss investors with a very strong track record have invested in Araris." Dr. Dragan Grabulovski, co-founder and chairman of the board, added: "Obtaining a seed financing from VCs just six months after incorporation of Araris validates the strong interest in our novel linker ADC technology. The funding will allow Araris to progress quickly towards generating key proof of principle data."

STORM Therapeutics to Host First RNA Epigenetics Conference in Cambridge UK

On August 20, 2019 STORM Therapeutics, the drug discovery company focused on the discovery of small molecule therapeutics modulating RNA epigenetics, reported that it will be hosting an international conference focused on the emerging field of "RNA epigenetics" (Press release, STORM Therapeutics, AUG 20, 2019, View Source [SID1234561041]). The Conference, entitled RNA epigenetics in human disease is the first of its kind and will take place on 17-20 September 2019 at St Catharine’s College, Cambridge, UK.

RNA epigenetics is an exciting, emerging, innovative area of biology and STORM is the first company to explore the therapeutic potential of the field.

Founded in 2015, STORM is a University of Cambridge spin-out translating the ground-breaking work of Professors Tony Kouzarides and Eric Miska in RNA epigenetics into the discovery of first-in-class drugs in oncology and other diseases. STORM is tackling disease through modulating RNA modifying enzymes and is developing a unique platform to address these enzyme classes, including RNA methyltransferases.

The conference will host an incredible line up of international speakers and experts covering aspects of RNA epigenetics. Speakers include:

Robert Copeland – President, Chief Scientific Officer & Co-founder – Accent Therapeutics
Richard Gregory – Principal Investigator – Boston Children’s Hospital
Chuan He – Professor – The University of Chicago
Samie Jaffrey – Professor – Weill Medical College, Cornell University
Tony Kouzarides – Gurdon Institute and STORM Therapeutics
Eric Miska – Gurdon Institute and STORM Therapeutics
Gerhard Müller – Chief Scientific Officer – Gotham Therapeutics
Oliver Rausch – Chief Scientific Officer – STORM Therapeutics
For the full programme and to register for the event, please visit the conference website http://stormtxconference2019.com/

Follow the conference on Twitter using #STORMtxRNA2019

Sponsors of the event include: eurofins discovery, WuXi AppTec, evotec, Reaction Biology Corp, Altemis Lab, CrownBio, Lexogen, Formulatrix and AstraZeneca

Media Partner: BioCentury

Entry into a Material Definitive Agreement.

On August 20, 2019, GT Biopharma, Inc. (the "Company") reported that it has entered into a Securities Purchase Agreement with seven purchasers (individually, a "Purchaser," and collectively, the "Purchasers") pursuant to which the Company has issued to the Purchasers Convertible Debentures in an aggregate principal amount of $650,000 (the "Debentures"), which Debentures are convertible into the Company’s common stock (the "Common Stock") at a price of $0.20 per share (Filing, 8-K, GT Biopharma, AUG 20, 2019, View Source [SID1234551114]). The Company and each Purchaser also entered into a Registration Rights Agreement.

The issuance of the Debentures was made in reliance on the exemption provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), for the offer and sale of securities not involving a public offering and Regulation D promulgated under the Securities Act.

The foregoing summaries of the Securities Purchase Agreement, the Registration Rights Agreement and the Debentures are qualified in their entirety by reference to the full text of the agreements, which are attached hereto as Exhibits 10.1, 10.2 and 4.1, respectively, and are incorporated herein by reference.

GT BIOPHARMA HIRES CHIEF MEDICAL OFFICER JEFFERY MILLER, M.D.

On August 20, 2019 GT Biopharma, Inc. (OTCQB:GTBP) (GTBP.PA) an immuno-oncology company focused on innovative treatments based on the Company’s proprietary NK cell engager (TriKE) platform and Multi-Target Directed Bispecific Drug Conjugate platform, reported that Jeffrey Miller, M.D. has been hired by the Company as its Consulting Chief Medical Officer (Press release, GT Biopharma , AUG 20, 2019, View Source [SID1234539510]).

Dr. Miller is currently Professor of Medicine at the University of Minnesota, and is the Deputy Director of the University of Minnesota’s Masonic Comprehensive Cancer Center. Dr. Miller has more than 20 years of experience studying the biology of NK cells, and other immune effector cells and their use in clinical immunotherapy with over 170 peer-reviewed publications. Dr. Miller is a board certified physician specializing in hematological oncology. Dr. Miller is a member of numerous societies such as the American Society of Hematology (ASH) (Free ASH Whitepaper), the American Association of Immunologists, and has been a member of the American Society of Clinical Investigation since 1999. Dr. Miller serves on the editorial board for Blood, and is a reviewer for a number of journals and NIH grants.

Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma commented "we are pleased Jeff has agreed to become our Consulting Chief Medical Officer". Mr. Cataldo further stated "Jeff is an outstanding physician and scientist, and is the inventor of our highly sought after TriKE platform technology".

About GTB-3550 Trispecific NK cell Engager (TriKE)

GTB-3550 (OXS-3550) is the Company’s first Tri-specific NK cell Engager (TriKE) product candidate being initially developed for the treatment 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 natural killer (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 acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies.

About GTB-1550 Multi-Target Directed Bispecific Drug Conjugate

GTB-1550 targets cancer cells expressing the CD19 receptor or CD22 receptor or both receptors thereby maximizing cancer cell recognition by binding to CD19+, CD22+ and CD19+/CD22+ cancer cells. When GTB-1550 binds to cancer cells, the cancer cells internalize GTB-1550, and are killed due to the action of drug’s cytotoxic diphtheria toxin payload.