On December 16, 2021 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported an update on the on-going clinical Phase I trial with the 4-1BB (CD137) drug candidate ATOR-1017, which is developed as a tumor-directed therapy for metastatic cancer (Press release, Alligator Bioscience, DEC 16, 2021, View Source [SID1234597275]). The early readout data corroborates previous data on biomarkers, safety and tolerability, sustaining a safety profile up to and including a dose of 360 mg with no dose limiting toxicities reported.

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The Phase I study with ATOR-1017 is a first-in-human, open-label, dose escalation study in patients with advanced solid cancer (NCT04144842). The primary objective of the study is to investigate the safety and tolerability of ATOR-1017, and to determine the recommended dose for subsequent Phase II studies. The results from the current evaluation shows that ATOR-1017 has an encouraging safety profile. Again, there was no dose-limiting toxicity or severe immune-related adverse events. The results support data from earlier read-outs that ATOR-1017 exhibits a favorable pharmacokinetic profile. Additionally, it confirms and extends previous biomarker data demonstrating proof of mechanism of ATOR-1017, including increased proliferation of circulating T-cells and dose-dependent increases in soluble 4-1BB, both biomarkers of T-cell activation. A full data read-out is expected in Q1 2022.

Earlier this year, the Company announced results that validated the therapeutic potential of ATOR-1017 demonstrating a very favorable safety profile combined with clear signs of proof of mechanism, as activation of T cells in the circulation was observed across active dose levels of ATOR-1017 in a poster presentation at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting (link to press release).

"We are extremely pleased with the confirmatory data as it strengthens the case for the safety and tolerability as well as confirming the proof of mechanism of ATOR-1017. We are excited by this outcome and are working hard on completing this study and determining the dose for a subsequent Phase II program," said Søren Bregenholt, CEO of Alligator Bioscience.

On December 16, 2021 Anaveon, a clinical-stage immuno-oncology company, reported that it has agreed a CHF 110 million Series B financing led by incoming investor Forbion, corner-stoned by founding investor Syncona, also joined by existing investor Novartis Venture Fund, as well as new investors, Cowen Healthcare Investments (a division of Cowen Investment Management), Pfizer Ventures and Pontifax (Press release, Anaveon, DEC 16, 2021, View Source [SID1234597261]). In connection with the Series B financing, Jasper Bos (Forbion), Tim Anderson (Cowen) and Denis Patrick (Pfizer Ventures) will join the Anaveon Board at closing, which is expected before year end.

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Anaveon is undertaking a Phase I/II study to evaluate the safety, dosing and clinical activity of its lead program, ANV419, a powerful and selective interleukin-2 (IL-2) agonist in patients with solid tumors. Proceeds from this financing will enable the Company to pursue multiple parallel Phase II programs in order to explore the full therapeutic potential of ANV419. In addition, it will allow Anaveon to continue its work in developing follow-on compounds to expand on the success of ANV419 by delivering the IL-2 agonist to tumor fighting cells and thus expand the therapeutic potential into less immunogenic tumors. Additionally, the Company is building on its cytokine engineering expertise with preclinical-stage programs harnessing the power of cytokines for therapeutic purposes.

"There is strong momentum behind Anaveon and we are thrilled to welcome leading EU and US investors Forbion, Cowen Healthcare Investments, Pfizer Ventures and Pontifax to the Company. I would also like to personally thank our existing founding investors for their continued guidance and support to bring the company this far," said Andreas Katopodis, Co-Founder and Chief Executive of Anaveon. "With this fundraising we have made a clear statement about the scale and nature of our ambitions to bring cancer therapies rapidly to patients with a high unmet medical need, as well as leverage the experience of our in-house cytokine engineering experts to broaden our pipeline for the benefit of patients suffering from diseases with immune dysregulation pathologies."

"We continue to be very encouraged by Anaveon’s strong progress with its lead product, ANV419, as well as its future ambitions for expanding the pipeline," added Martin Murphy, Chief Executive of Syncona Investment Management Limited and Chairman of Anaveon’s Board. "The Company is seeking to develop engineered cytokines in multiple indications and draw on the deep expertise of the experienced team in order to deliver significant benefits to patients with limited therapeutic options."

Jasper Bos, General Partner at Forbion and Anaveon’s incoming Board Director, said, "We have been very impressed by the scientific co-founders, management team, board of directors, and vision of the Company, and we are excited to support Anaveon as they progress ANV419 through the clinic and grow the pipeline into new indications."

Anaveon, founded in December 2017, is developing selective IL-2 Receptor Agonists, which have the potential to therapeutically enhance a patient’s immune system to respond to tumors. In the body, human IL-2 stimulates a type of immune cell, called a T-cell, to multiply and become activated. Activated T-cells are able to attack tumors and, consistent with this approach, human IL-2 is already approved as a therapeutic for the treatment of metastatic melanoma and renal cancer; however, due to lack of specificity, human IL-2 has severe, dose-limiting side effects and a short half-life that requires frequent infusions. The lead compound, ANV419, is designed to preferentially signal through the IL-2 beta/gamma receptor and therefore overcome known challenges of human IL-2. This novel type of therapeutic, if approved, could potentially have a wide utility in oncology, including in combination with cell therapies, vaccines, checkpoint inhibitors and radiotherapy.

On December 15, 2021 Lyell Immunopharma, Inc. (Lyell), (Nasdaq: LYEL), a T-cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors, reported that its LyFE Manufacturing Center in Bothell, Washington has been commissioned and qualified in compliance with the U.S. Food and Drug Administration’s (FDA’s) Current Good Manufacturing Practices (cGMP) (Press release, Lyell Immunopharma, DEC 15, 2021, View Source [SID1234609995]).

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The cGMP qualification confirms Lyell has the proper design, monitoring and control of its manufacturing facility. Since becoming operational in April 2021, the LyFE Center has completed successful engineering runs at scale in support of the Company’s planned upcoming clinical trials.

"We are advantageously positioned with qualified manufacturing infrastructure that we own and control to support consistent and reliable manufacture of cell products for our upcoming clinical trials," said Liz Homans, Chief Executive Officer of Lyell. "We believe that combining cGMP manufacturing with our deep understanding of T-cell biology will help us achieve our vision of curing patients with solid tumors."

With 70,000 square feet of space, the LyFE Manufacturing Center provides several key capabilities for cell therapy manufacturing. The facility utilizes electronic systems with advanced data and analytics for real-time feedback, batch monitoring and process optimization. To support its digital manufacturing capabilities, Lyell collaborates with Amazon Web Services (AWS). The LyFE Manufacturing Center is one of the first cell therapy manufacturing facilities to benefit from AWS’s extensive experience with cloud computing, Internet of Things (IoT) and advanced analytics.

"Lyell is dedicated to developing safe and effective cell therapies for patients by investing in innovative operations and technology, including our LyFE Manufacturing Center that is designed to support a broad pipeline and is now qualified to support cGMP manufacturing standards," said Stephen Hill, Chief Operating Officer of Lyell. "Integrating digital systems into our manufacturing operations means quicker access to data, leading to faster recognition and implementation of process improvements."

On December 15, 2021 Curium reported that welcomes Sakir Mutevelic MD, MSc. As Chief Medical Officer, Sakir leads Curium’s global medical strategy and clinical development for diagnostic and therapeutic radiopharmaceuticals (Press release, Curium, DEC 15, 2021, View Source [SID1234606798]).

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In this role, he develops and leads Curium`s product pipeline growth initiatives, to drive product evolution and portfolio expansion across radiopharmaceutical diagnostics, companion diagnostics and therapeutics — ensuring the Curium Group fulfils its "Life Forward" mission to transform and improve disease management and patient lives. This includes managing and coordinating strategic partnerships, clinical development planning and operational execution, managing the clinical aspects of regulatory strategies and interactions with health authorities, and supporting Curium`s strategic initiatives from medical and clinical development perspective. Sakir is a member of Curium’s Global Leadership Team.

Sakir holds a medical doctor degree and master’s degree in pharmacology and has more than 25 years of professional experience in the pharmaceutical industry, with profound clinical experience and successful clinical development of both new chemical and biological entities in oncology and hematology, from early to late-stage clinical development as well as global regulatory submissions and approvals. Prior to his time at Curium, he served in different strategic and operational functions, with increasing responsibility at country, regional and global levels at Boehringer Ingelheim, Baxter, Baxalta, Shire, Servier and AAA/Novartis.

On December 15, 2021, Syndax Pharmaceuticals, Inc. (the "Company") reported that entered into an underwriting agreement (the "Underwriting Agreement") with Goldman Sachs & Co. LLC and Cowen and Company LLC (the "Representatives"), as representatives of the several underwriters (collectively, the "Underwriters"), relating to the issuance and sale of (i) 3,157,144 shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), at a price to the public of $17.50 per share, and (ii) pre-funded warrants of the Company to purchase 1,142,856 shares of Common Stock at an exercise price equal to $0.0001 per share (the "Pre-Funded Warrants"), at a price to the public of $17.4999 per share of Common Stock underlying the Pre-Funded Warrants (equal to the public offering price per share of Common Stock, minus the exercise price of each Pre-Funded Warrant) (the "Offering") (Filing, 8-K, Syndax, DEC 15, 2021, View Source [SID1234597376]). In addition, the Company has granted to the Underwriters an option to purchase up to an additional 645,000 shares of Common Stock. The gross proceeds to the Company from the Offering are expected to be approximately $75.3 million (or approximately $86.5 million if the Underwriters exercise their option to purchase additional shares in full).

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The Pre-Funded Warrants are exercisable at any time, provided that each Pre-Funded Warrant holder will be prohibited from exercising such Pre-Funded Warrants into shares of Common Stock if, as a result of such exercise, the holder, together with its affiliates, would own more than 9.99% of the total number of shares of Common Stock then-issued and outstanding, which percentage may change at the holders’ election provided that such limitation cannot exceed 19.99%, and provided that any increase in the beneficial ownership limitation shall not be effective until 61 days after such notice is delivered.

The Offering is being made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-254661), which became effective upon filing with the Securities and Exchange Commission on March 24, 2021, a base prospectus dated March 24, 2021 and the related prospectus supplement dated December 15, 2021. The Offering is expected to close on or about December 20, 2021, subject to satisfaction of customary closing conditions.

The Underwriting Agreement contains customary representations, warranties, covenants and agreements by the Company, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions. The representations, warranties, covenants and agreements contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties. All of the Company’s directors and executive officers and certain stockholders have agreed, subject to certain exceptions, not to sell or transfer any shares of Common Stock for 90 days, and the Company has agreed not to sell or transfer any shares of the Common Stock for 90 days, in each case, after December 15, 2021, without first obtaining the written consent of the Representatives.

The foregoing description of the terms of each of the Underwriting Agreement and Pre-Funded Warrants does not purport to be complete and is each qualified in its entirety by reference to the Underwriting Agreement and Form of Pre-Funded Warrant, respectively, which are attached as Exhibit 1.1 and Exhibit 4.1 hereto, respectively, and incorporated by reference herein.