Entry into a Material Definitive Agreement.

On September 16, 2021, Gritstone bio, Inc. (the "Company") reported that it entered into a Securities Purchase Agreement (the "Purchase Agreement") with certain purchasers identified on the signature pages thereto (the "Purchasers"), pursuant to which the Company issued and sold to the Purchasers, in an unregistered offering, an aggregate of 5,000,000 shares of common stock, par value $0.0001 per share (the "Common Stock") at a per share purchase price of $11.00 per share, for aggregate gross proceeds to the Company of $55.0 million (the "Private Placement"). The closing of the Private Placement occurred on September 17, 2021 (the "Closing") (Filing, 8-K, Gritstone Oncology, SEP 16, 2021, View Source [SID1234587887]).

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Pursuant to the Purchase Agreement, the Company has agreed to file a resale registration statement with the Securities and Exchange Commission as soon as practicable, and in all events within 30 days after the Closing, to register the resale of the Securities issued at the time of the Closing.

Cowen & Company LLC acted as sole placement agent for the Private Placement.

The foregoing summaries of the Private Placement, the Shares to be issued in connection therewith, and the Purchase Agreement are qualified in their entirety by reference to the definitive transaction documents. A copy of the Purchase Agreement is attached hereto as Exhibit 10.1 and is incorporated herein by reference.

FairJourney Biologics announces THE ANTIBODY SERIES 2022

On September 16, 2021 FairJourney Biologics S.A. , leader in the discovery and optimization of antibodies, reported , after the overwhelming success of the 2021 ANTIBODY SERIES conference, planning for a larger scale 2022 ANTIBODY SERIES are underway (Press release, FairJourney Biologics, SEP 16, 2021, View Source [SID1234587884]).

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This year’s conference attracted over 800 online participants and a select group of 150 in-person attendees. Nobel Prize Laureate Sir Gregory Winter opened the inaugural event with a keynote presentation and Q&A, followed by a diverse panel of pioneers and leaders in industry and academia. THE ANTIBODY SERIES provided a platform for the exchanging of innovative ideas, approaches and solutions in the field of antibody discovery and development, and additional opportunities for panel Q&A, discussion, and networking.

Ton Logtenberg, who presented at this year’s conference has been announced as Chairman of THE ANTIBODY SERIES 2022.

Ton Logtenberg, Founder of MERUS N.V. commented: "A wonderful event combining superb presentations, excellent networking opportunities and festivities. The success of the meeting inspired the decision to organize THE ANTIBODY SERIES again in 2022. As the Chairman of that event, I invite you to join us for updates on progress in the exciting antibody field while greeting old friends and making new ones."

Gritstone Announces Private Placement Financing of $55.0 Million

On September 16, 2021 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies and vaccines, reported a $55.0 million private investment in public equity (PIPE) financing from the sale of 5,000,000 shares of its common stock at a price per share of $11.00 (Press release, Gritstone Oncology, SEP 16, 2021, View Source [SID1234592013]). Gross proceeds from the PIPE financings total $55.0 million, before deducting placement agent fees and offering expenses. The PIPE is being led by Frazier Life Sciences Public Fund, with additional participation from Redmile Group and Gilead Sciences.

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"As long-term backers of Gritstone, we continue to be impressed by the company’s progress and emergence as a leader in development of next generation immunotherapies and vaccines for cancer and infectious diseases," said Jamie Brush, M.D., General Partner and Portfolio Manager of the Frazier Life Sciences Public Fund. "We believe Gritstone’s EDGE platform and integrated vaccine manufacturing capabilities uniquely position the company to rapidly expand into infectious disease vaccine development with a potentially refrigerator stable self-amplifying mRNA vaccine platform. This financing will help ensure Gritstone has the resources to move quickly in this exciting new area, and we are excited to support the company in its next phase of growth."

The closing of the PIPE financing is subject to customary closing conditions and is expected to close by September 17, 2021. Cowen served as the sole placement agent for the PIPE financing.

The securities sold in this private placement have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the U.S. except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Gritstone bio has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in this private placement.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.

Targovax ASA: Poster at European Society for Medical Oncology (ESMO)

On September 16, 2021 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that the poster "A pilot study of Engineered Adenovirus ONCOS-102 in combination with pembrolizumab (pembro) in checkpoint inhibitor refractory advanced or unresectable melanoma" is now available at the ESMO (Free ESMO Whitepaper) congress website and on the Company’s website (Press release, Targovax, SEP 16, 2021, View Source [SID1234587806]). The poster will be presented as an e-poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress by Dr Alexander N. Shoushtari, Memorial Sloan Kettering Cancer Center.

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The poster presents the pilot study of ONCOS-102 in combination with pembrolizumab (pembro) in checkpoint inhibitor refractory advanced or unresectable melanoma. The poster concludes that co-administration of ONCOS-102 and pembrolizumab is safe and feasible for patients with melanomas progressing on PD-1 blockade. Rapid clinical objective responses were seen in patients treated both sequentially and in combination, and immune markers demonstrating induction of beneficial tumor microenvironment changes support the role of ONCOS-102 as a complementary treatment with aPD1 and other IO modalities.

E-poster title: A pilot study of Engineered Adenovirus ONCOS-102 in combination with pembrolizumab (pembro) in checkpoint inhibitor refractory advanced or unresectable melanoma
E-poster number: 1083P
Presenter: Dr Alexander N. Shoushtari, Memorial Sloan Kettering Cancer Center

clinical-collaboration-with-Amgen

On September 16, 2021 Boehringer Ingelheim reported a clinical phase I collaboration with Amgen to evaluate the combination of BI 1701963, the first and most advanced SOS1::pan-KRAS inhibitor exhibiting activity against a broad spectrum of KRAS alleles, and LUMAKRAS (sotorasib), the first US Food and Drug Administration (FDA) approved KRASG12C inhibitor for adult patients with locally advanced or metastatic non-small cell lung cancer (Press release, Boehringer Ingelheim, SEP 16, 2021, View Source [SID1234587821]). The trial will investigate potential synergistic effects of this combination, possibly improving therapeutic outcomes beyond those of KRASG12C inhibitor therapy alone, specifically for people living with lung and colorectal cancers.

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Preclinical data suggest that the combination of a KRASG12C inhibitor with a SOS1::pan-KRAS inhibitor may result in increased anti-tumor activity in KRAS G12C-driven cancers based on the complementary mechanisms of these targeted oncology agents.1,2 By shifting the equilibrium from active KRAS towards the inactive form, SOS1::pan-KRAS inhibitors have the potential to sensitize KRAS G12C-mutant tumors to covalent KRASG12C inhibitors that bind to inactive KRAS. In addition, SOS1 inhibitors block feedback reactivation which occurs upon pathway inhibition.

"We are excited to partner with Amgen, who have pioneered KRAS G12C inhibition, and to further expand our program to make a difference for people living with KRAS-driven cancers," said Francesco Di Marco, Ph.D., Corporate Senior Vice President, Global Therapy Area Head Oncology at Boehringer Ingelheim. "Boehringer Ingelheim follows an ‘all-in’ research approach to taking cancer on, including the first and most advanced SOS1::pan-KRAS inhibitor which we investigate in several combinations and cancer types to realize even more opportunities to deliver potential therapeutic benefits to cancer patients."

Under the terms of the non-exclusive collaboration, Amgen will be the sponsor of the trial and Boehringer Ingelheim and Amgen will jointly share the costs of and oversee clinical development for the combined therapy.

About BI 1701963
BI 1701963 is an investigational, orally available small molecule, that binds to the catalytic domain of SOS1 preventing the interaction with inactive KRAS. This reduces the formation of active KRAS and in consequence inhibits MAPK pathway signaling in KRAS-dependent cancers. SOS1 inhibition also simultaneously blocks feedback driven reactivation of the MAPK pathway. The selective inhibition of SOS1 is a therapeutic concept that could allow KRAS blockade irrespective of KRAS mutation type (pan-KRAS approach). SOS1::KRAS inhibitors exhibit activity on a broad spectrum of KRAS alleles, including all major G12D/V/C and G13D oncoproteins, as published by Hofmann MH, et al. in Cancer Discovery, a journal of the American Association of Cancer Research (AACR) (Free AACR Whitepaper). BI 1701963 is currently being evaluated in phase I clinical trials in patients with advanced KRAS-mutated cancers to evaluate safety, tolerability, pharmacokinetic and pharmacodynamic properties, and preliminary efficacy of BI 1701963 alone and in combination with MEK inhibitors, KRASG12C inhibitors or irinotecan.