Galapagos to present at 39th Annual J.P. Morgan Healthcare Conference

On January 6, 2021 Galapagos NV (Euronext & NASDAQ: GLPG) reported that it will participate in the 39th Annual J.P. Morgan Healthcare Conference on January 11-14, 2021 (Press release, Galapagos, JAN 6, 2021, View Source [SID1234577410]).

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Onno van de Stolpe, CEO, will present on Thursday, January 14 at 15.10 CET (09:10 am EST). The presentation will be a live audio webcast and can be accessed via the following link. A replay of the webcast will be available on the Galapagos’ website at www.glpg.com.

Myeloid Therapeutics Launches with Over $50 Million in Financing and Two Clinical Trials

On January 6, 2021 Myeloid Therapeutics, Inc., a company harnessing and reprogramming myeloid cells for treating cancers, reported with over $50 million in financing to initiate multiple clinical trials in 2021 (Press release, Myeloid Therapeutics, JAN 6, 2021, View Source [SID1234575243]). The Company combines advanced gene and cell engineering capabilities with substantial biologics knowledge to elucidate and redirect the power of myeloid cells to treat cancers, particularly solid tumors and those that are poorly served by existing therapies. Myeloid has advanced its lead development candidates through preclinical studies, implemented its manufacturing platform and plans to dose patients in the first half of this year.

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The Company’s scientific founders include Ronald Vale, Ph.D., a world-renowned biochemist and cell biologist, and executive director of the Howard Hughes Medical Institute (HHMI) Janelia Research campus; and hematologist, oncologist and Pulitzer-Prize winning author Siddhartha Mukherjee, M.D., D.Phil. Newpath Partners led the financing round with participation from 8VC, Hatteras Venture Partners and Alexandria Venture Investments.

With this funding, Myeloid will initiate clinical trials for the Company’s programs, which target T cell lymphoma, glioblastoma and other solid tumors. The team will also continue to design and advance a broad pipeline of targeted myeloid cell therapies, including primed myeloid cells, myeloid multi-specific engagers and other development candidates created with Myeloid’s novel mRNA delivery technologies. The Company expects to enter the clinic with its two lead programs in glioblastoma and T cell lymphoma in 2021.

"I believe Myeloid is best positioned to leverage the unique power of myeloid cells to help patients fighting cancers that until now, have been very difficult to treat," said Dr. Mukherjee. "Despite the promise of current cell therapies, many challenges remain when it comes to targeting specific types of cancers, including solid tumors, and in efficiently manufacturing treatments. I’m thrilled to help develop Myeloid’s transformative treatment modality, which has the potential to overcome many of these challenges."

"Myeloid cells play a critical role in orchestrating the body’s immune responses, including by directly killing cells, bacteria and viruses through a number of disease-fighting mechanisms," said Michael Dee Gunn, M.D., Professor of Medicine and Immunology at Duke University, and a pioneer in the research of molecular mechanisms of innate immunity and inflammation and a member of Myeloid’s Scientific Advisory Board. "This novel class of cell therapies has strong potential to benefit patients with the highest unmet medical needs."

ATAKTM Cell Platform

The Company’s ATAK platform was inspired by Drs. Vale and Mukherjee, who envisioned the disease-fighting power of myeloid cells – versatile cells with effector functions capable of targeting and eliminating cancerous cells, along with other harmful cells in the body. Within the oncolytic setting, the ATAK platform is being applied to harness the innate abilities of myeloid cells, to specifically recognize and engulf cancer cells, to produce anti-tumor agents, promote anti-tumor adaptive immunity, alter the tumor microenvironment – and ultimately to kill cancer. In addition to reprogramming monocytes to target difficult-to-treat cancers, the platform offers Myeloid and its partners many additional advantages, including novel mRNA-based protein and gene delivery, a library of intermixed cell receptors, and chimeric antigen receptors (CARs) that may be applied to enhance treatment effects or to engineer novel tri- and bi-specific cell engagers.

Myeloid is currently focused on advancing two categories of novel ATAK therapies: ATAK CAR monocytes and ATAK primed monocytes. ATAK CAR monocytes are myeloid cells with innate immune receptor-inspired CARs to recognize and kill cancer. ATAK primed monocytes function like cell vaccines, programmed to trigger T cells to kill cancer cells.

Manufacturing candidates from the ATAK platform benefit from speed and scalability in manufacturing process development. The Myeloid team can scale manufacturing rapidly, from product concept to clinical use. In addition, current products derived from the ATAK platform have a single-day cell manufacturing process. Given the observed strengths of the manufacturing process, Myeloid reasonably envisions same-day ATAK platform treatment, especially relevant upon clinical presentation of aggressive tumors.

The Company is also in the process of developing "off the shelf" approaches in order to advance the full range of clinical delivery options.

Myeloid Leadership and Scientific Advisory Board

As co-founder and Chief Executive Officer of Myeloid, Daniel Getts, Ph.D., MBA, oversees the Company’s portfolio and growth strategies. Dr. Getts is a repeat biotech entrepreneur, having led research at TCR2 through its IPO and the development of the first cell therapy to show clinical responses in ovarian cancer. Before that, he co-founded Cour Pharmaceuticals Development Company.

The Company’s Scientific Advisory Board includes world-renowned scientists whose expertise span oncology, immunology, cell therapy, synthetic biology and genetic engineering:

"Our mission is to apply our energy and significant research capabilities to design and develop truly transformative treatments," said Dr. Getts. "We built Myeloid’s ATAKTM platform to overcome many limitations of existing cell therapies, in part by embracing the natural tendencies of monocytes to penetrate solid tumors and catalyze immune reactions. By harnessing the power of monocytes, which are the cells that comprise the largest population of immune cells in the tumor microenvironment, we are working to bring new therapies to patients. We have also designed and successfully implemented an efficient, flexible manufacturing process that sets a new threshold for cell therapies. We are very pleased to have the support of this strong group of investors, who enable us to further develop the ATAK platform, to advance multiple solid tumor programs into the clinic, and to bring forward new transformative programs as we broaden Myeloid’s pipeline."

"Myeloid cells are the body’s front-line-disease-fighting tools, and they are critical in the orchestration of adaptive immune responses. These myeloid cells are overrepresented in solid cancers and I have been fascinated with their therapeutic potential since researching them during my medical training," said Thomas Cahill, M.D., Ph.D., Myeloid co-founder and Managing Partner of Newpath Partners. "Most other cell therapies focus on reprogramming the adaptive immune system and they have truly improved patient outcomes, especially with respect to liquid tumors. To expand on this promise, the next logical step was to empower the cells at the front lines of solid tumors. By engineering myeloid cells, the Company is developing an extremely versatile and potent class of new therapeutic agents. I look forward to continuing to support this team through their first wave of clinical trials and beyond."

Mersana Therapeutics to Present at the 39th Annual J.P. Morgan Healthcare Conference

On January 6, 2021 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that Anna Protopapas, President and Chief Executive Officer, will present a company overview at the 39th Annual J.P. Morgan Conference being held virtually on Wednesday, January 13, 2021 at 5:20 p.m. ET (Press release, Mersana Therapeutics, JAN 6, 2021, View Source [SID1234575008]).

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A live webcast of the presentation will be available on the Investors & Media section of Mersana’s website at www.mersana.com. An archived replay will be available for approximately 90-days following the presentation.

Scandion Oncology’s rights issue registered with the Danish Business Authority – BTAs are converted to shares

On January 6, 2021 Scandion Oncology A/S ("Scandion" or the "Company") reported it has carried out a rights issue of approximately SEK 236 million (Press release, Scandion Oncology, JAN 6, 2021, View Source;btas-are-converted-,c3264644 [SID1234574545]). Today, on 6 January 2021, the share capital increase and updated articles of association have been registered with the Danish Business Authority.

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The last day of trading in paid subscribed shares (BTAs) is 12 January 2021. BTAs will be converted to shares on 18 January 2021 and the ISIN code for the BTAs will be merged with the permanent ISIN code on 18 January 2021. The newly issued shares are expected to be delivered to the shareholders’ securities accounts on 18 January 2021.

Following registration of the new shares with the Danish Business Authority, the Company’s share capital has increased by DKK 787,320.8280 to a total of DKK 2,361,962.4840. The number of shares and voting rights in the Company has increased by 10,711,848 shares and voting rights to a total of 32,135,544 shares and voting rights.

Autolus Therapeutics provides business outlook for 2021 & 2022

On January 6, 2021 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, updated its business outlook, strengthening its focus on its potentially transformational CAR T cell therapy candidate, AUTO1, which is being investigated in relapsed / refractory adult B-Acute Lymphoblastic Leukemia (ALL) (Press release, Autolus, JAN 6, 2021, View Source [SID1234573697]).

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"We are very excited about the unique characteristics of AUTO1 that we reported at ASH (Free ASH Whitepaper) in December 2020, with some patients continuing in molecular complete remission at 24 months without a subsequent transplant, an event-free survival of 52% at 12 months and a well-tolerated safety profile. Taking into consideration the high unmet need in adult ALL and the commercial opportunity this represents, we are prioritizing this program with potential pivotal data expected in 2022," said Dr. Christian Itin, chairman and chief executive officer of Autolus. "We also plan to capitalize on the differentiated profile of AUTO1 by exploring activity in additional B-cell malignancies, including Primary CNS Lymphoma (PCNSL) where no adequate standard of care currently exists. We expect to see first data from these additional indications in 2021."

Additional clinical data points in 2021 are expected from AUTO1/22, a novel dual targeting CAR T cell based therapy candidate based on AUTO1, with the first pediatric ALL patient dosed in December 2020, and AUTO4 in Peripheral T Cell Lymphoma (PTCL), which will continue in 2021 through a dose escalation phase. Furthermore, the company continues to progress its pipeline of next generation programs, including for solid tumor indications, in collaboration with its academic partners.

With the prioritization of the AUTO1 program, the company plans to seek a partner for the AUTO3 program, its CD19 and CD22 dual targeting CAR T product candidate being investigated in relapsed/refractory diffuse large B cell lymphoma (DLBCL), before progressing the program into the next phase of development. In addition, through Q1 2021, the company will adjust its workforce and infrastructure footprint, which will involve an overall reduction in headcount of approximately 20%. The company expects to realize cash savings, on an annualized basis, of approximately $15 million per annum once the operational changes are fully implemented. Additionally, the company announced a reorganization of its management team. David Brochu was promoted to Chief Technical Officer (CTO) with expanded responsibilities from Senior Vice President, Product Delivery. Senior Vice Presidents Dr. Adam Hacker and Dr. Nushmia Khokhar will be leaving the company in Q1 2021. A search for a new Chief Medical Officer is ongoing.

"Building on its differentiated clinical profile, we believe AUTO1 is well positioned to deliver fundamental value for patients and shareholders. Our organizational focus will position us well to realize the potential of AUTO1 and lay the foundation for the next opportunities in our pipeline with several clinical proof of concepts targeted during 2021 and 2022," said Dr. Christian Itin, chairman and chief executive officer of Autolus.