On June 23, 2021 ImmuneID, Inc., a precision immunology company employing a proprietary platform to identify and therapeutically target antibody interactions that drive immune diseases, reported that it has raised $50 million in Series A financing (Press release, ImmuneID, JUN 23, 2021, View Source [SID1234584298]). This Series A financing brings the total amount raised by ImmuneID since its December 2020 launch to over $70 million. Proceeds from the financing will be used to advance the development of therapeutic candidates to treat autoimmune diseases, severe allergies, cancer and infectious diseases.

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"ImmuneID’s advanced platform leverages technologies such as next-generation sequencing, robotic automation and artificial intelligence to provide insights that can be used to develop precision immunology therapeutics," said Stephen Elledge, Ph.D., ImmuneID co-founder and SAB chair, Lasker Award winner and The Gregor Mendel Professor of Genetics and Medicine at Harvard Medical School. The platform was first featured in Science and additional applications of the platform in multiple disease areas have been published in leading journals such as Science, Cell, PNAS and Nature Communications.

"ImmuneID’s unique and powerful immunological target identification platform unlocks the complexity of human immune responses to guide the development of precision immunology therapeutics in areas where there remains significant unmet patient need," said Longwood Fund’s Christoph Westphal, M.D., Ph.D., ImmuneID co-founder and Executive Chair.

This Series A round was led by new investor Alta Partners and included new investors Alexandria Venture Investments, Redwood Capital Investments, Section 32 and Tekla Capital Management. All existing investors participated in the financing, including Arch Venture Partners, Longwood Fund, Pitango HealthTech, In-Q-Tel, Xfund and others. This Series A financing follows a $22 million seed financing round that was led by founding investor Longwood Fund.

"This financing from an exceptional group of investors positions us to execute on our ambitious plans to develop a new generation of precision immunology therapeutics," said ImmuneID CEO David Donabedian, Ph.D., who brings more than 20 years of experience in biotech company formation and business development to ImmuneID. Dr. Donabedian previously has held various leadership roles at biopharmaceutical companies including AbbVie (NASDAQ: ABBV) and GlaxoSmithKline (NYSE: GSK).

Dan Janney, Managing Partner of Alta Partners, said, "We are excited to lead the Series A financing and join the current syndicate to further support ImmuneID and their promising approach to developing highly targeted therapeutics to treat diseases related to the immune system."

As part of the Series A Financing, Mr. Janney and Dr. Steve Kafka, Managing Partner, Section 32, will join ImmuneID’s board of directors.

About ImmuneID’s Platform and Technology

ImmuneID’s technology platform and the underlying technology is designed to provide insights into human immune response throughout the course of disease progression for the identification of high-quality therapeutic targets. The technology was originally developed in the lab of Stephen Elledge, Ph.D., ImmuneID co-founder and Chair of ImmuneID SAB, Lasker Award winner and The Gregor Mendel Professor of Genetics and Medicine, Harvard Medical School.

On June 23, 2021 Rubius Therapeutics, Inc. (Nasdaq:RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics, reported that the first patient has been dosed in a new Phase 1 arm of the ongoing Phase 1/2 clinical trial of RTX-240 in combination with KEYTRUDA (pembrolizumab)1 for the treatment of patients with relapsed/refractory or locally advanced solid tumors (Press release, Rubius Therapeutics, JUN 23, 2021, View Source [SID1234584708]). To be eligible for the trial, patients must have disease that is relapsed or refractory to an anti-PD-1 or PD-L1 therapy.

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"RTX-240 is designed to activate and expand a patient’s own immune cells to mount a broad and potent anti-tumor response. Combining an immune agonist with a PD-1 checkpoint inhibitor has the potential to prevent the cancer from evading the immune response. The RTX-240 and pembrolizumab combination is anticipated to drive activated T cells and NK cells into the tumor microenvironment with the potential to overcome resistance to PD-1 inhibition," said Christina Coughlin, M.D., Ph.D., chief medical officer at Rubius Therapeutics. "Given the favorable emerging safety profile and promising initial clinical activity reported as part of our initial clinical results from the ongoing Phase 1 monotherapy trial of RTX-240 in advanced solid tumors, we believe that the combination with pembrolizumab has the potential to provide significant benefit to patients with disease that is relapsed or refractory to prior anti-PD-1 or PD-L1 therapy."

"Despite recent advances in cancer immunotherapy, there remains a need for new combination approaches that broaden the benefits of immunotherapy in patients with solid tumors following treatment with checkpoint inhibition," said Omid Hamid, M.D., Chief of Translational Research and Immunotherapy, Director of the Phase 1 Immuno-Oncology Program of The Angeles Clinic and Research Institute, a Cedars-Sinai Affiliate, and RTX-240 investigator. "The exciting initial safety and efficacy data from the ongoing monotherapy Phase 1 clinical trial make RTX-240 a potentially promising candidate for the treatment of cancer, and we are excited to work with Rubius to evaluate RTX-240 in combination with pembrolizumab."

RTX-240 is engineered to express a co-stimulatory molecule, 4-1BB ligand, and a cytokine, IL-15TP, on the cell’s surface, and is designed to broadly stimulate the immune system by activating and expanding both natural killer (NK) cells and T cells to generate a potent anti-tumor response. Pembrolizumab is a humanized monoclonal immunoglobulin G4 antibody (IgG4 mAb) with high specificity of binding to the programmed cell death protein-1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). Based on in vitro data, pembrolizumab has high affinity and potent receptor blocking activity for PD-1. Pembrolizumab is indicated for the treatment of patients across several indications as monotherapy and in combination with numerous therapies.

About the RTX-240 Phase 1/2 Clinical Trial
This is a Phase 1/2 open label, multicenter, multidose, first-in-human dose-escalation and expansion study designed to determine the safety and tolerability, pharmacokinetics, maximum tolerated dose and a recommended Phase 2 dose and dosing regimen of RTX-240. The trial will also assess the pharmacodynamics of RTX-240 measured by changes in T and NK cell number and function relative to baseline and anti-tumor activity. The trial has three separate Phase 1 arms: an ongoing monotherapy dose escalation arm in adults with relapsed/refractory or locally advanced solid tumors, an ongoing monotherapy dose escalation arm in adults with relapsed/refractory acute myeloid leukemia, and a combination therapy dose escalation arm with pembrolizumab in adults with relapsed/refractory or locally advanced solid tumors. The monotherapy arm of the trial in advanced solid tumors includes a Phase 2 expansion in specified tumor types.

On June 23, 2021 Kite, a Gilead Company, reported that Fosun Kite Biotechnology Co., Ltd., a joint venture between Kite and Shanghai Fosun Pharmaceutical (Group) Co., Ltd, has received approval from the China National Medical Products Administration (NMPA) for axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma (Press release, Kite Pharma, JUN 23, 2021, View Source [SID1234584284]).

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Axicabtagene ciloleucel is the first and only commercially available chimeric antigen receptor (CAR) T-cell therapy approved in China.

"In relapsed or refractory LBCL, current standard-of-care is associated with poor long-term outcomes, so we are pleased to offer this new hope of survival for patients in China who are in need of new therapeutic options," said Terence O’Sullivan, Vice President, International Region at Kite. "Thank you to the dedicated healthcare professionals, patients and caregivers who worked with the team at Fosun Kite to make this treatment option available in China."

Axicabtagene Ciloleucel, FKC876, is an autologous CD19-directed CAR T-cell therapy manufactured in China under a license to YESCARTA (Axicabtagene Ciloleucel) from Kite.

The approval is based on results of a single-arm, open label, multi-center bridging trial (FKC876-2018-001) which has evaluated the efficacy and safety of FKC876 in the treatment of Chinese patients with refractory intermediate invasive non-Hodgkin’s lymphoma (NHL)/ large B-cell lymphoma in China.

About YESCARTA (Axicabtagene Ciloleucel)

YESCARTA is the world’s first approved CAR T-cell therapy for adult patients with certain types of non-Hodgkin lymphoma (NHL). It was approved for the US market on October 18, 2017 by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, and high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. On August 27, 2018 YESCARTA was also approved by the European Medicines Agency’s (EMA) Committee for EU markets as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.

On June 23, 2021 Children’s Cancer Research Fund (CCRF) reported the support of OS Therapies, a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat and cure Osteosarcoma (OS) and other deadly cancers in kids and adults (Press release, Children’s Cancer Research Fund, JUN 23, 2021, View Source [SID1234584299]). The investment, made possible by the Zach Sobiech Osteosarcoma Fund at CCRF, will help OS Therapies initiate a much-anticipated trial in Osteosarcoma: a deadly cancer of the bone that usually targets teenagers.

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"Children’s Cancer Research Fund and Zach’s Fund are excited to join other non-profits, investors and OS Therapies to do something about this horrible disease," said Daniel Gumnit, CEO of CCRF. "OS Therapies is working to achieve the goals of CCRF, particularly to give every survivor of childhood cancer a long, healthy life after treatment."

Funding will support a national Phase IIb trial of 39 patients with Osteosarcoma that has returned (recurred) after initial treatment with failed chemotherapy and radiation. OST-HER2 (OST31-164 Listeria monocytogenes) stimulates the patient’s immune system to target the micro-metastasis seeking out soft tissue and oxygen so readily found in the lungs and brain.

"We are thrilled that CCRF would join us in this battle against Osteosarcoma. They are a leader in the research, advocacy and support of families and patients with childhood cancer," said Paul Romness, CEO of OS Therapies. "Fortunately, we have a technology that has shown great success in treating Osteosarcoma in dogs – now we need to see if it will work as well in our kids with OS."

On June 22, 2021 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, reported that it has entered into a definitive purchase agreement with Deep Track Capital for the issuance and sale of an aggregate of 2,380,953 shares of its common stock at a purchase price of $21.00 per share of common stock a registered direct offering (Press release, Anavex Life Sciences, JUN 22, 2021, View Source [SID1234584212]). The registered direct offering is expected to close on or about June 24, 2021, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds from the offering are expected to be approximately $50 million before deducting placement agent fees and other offering expenses. Anavex currently intends to use the net proceeds from the offering for advancing its pipeline and for working capital and general corporate purposes.

The shares of common stock described above are being offered pursuant to Anavex’s shelf registration statement on Form S-3 (File No. 333-232550) filed with the Securities and Exchange Commission (the "SEC") on July 3, 2019 and declared effective on July 15, 2019. Such shares of common stock may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the shares of common stock being offered in the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail: [email protected] or by telephone: (212) 856-5711.

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