On June 9, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that the company will participate in investor meetings at the JMP Securities Life Sciences Conference being held in New York City, June 15 – 16, 2022 (Press release, Hookipa Biotech, JUN 9, 2022, View Source [SID1234615805]).

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On June 9, 2022 Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, reported the close of a US$126 million Series A financing round (Press release, Tessa Therapeutics, JUN 9, 2022, View Source [SID1234615822]). Polaris Partners led the financing with participation from existing investors, including Temasek, EDBI, Heliconia Capital and Heritas Capital. In conjunction with the financing, Amy Schulman and Darren Carroll, Managing Partners at Polaris Partners, have joined Tessa’s Board of Directors.

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Tessa plans to use the proceeds from the financing to advance the ongoing clinical development of the company’s autologous CD30-CAR-T therapy (TT11) and allogeneic CD30.CAR EBVST therapy (TT11X) programs. The CD30-CAR-T clinical trial supplies will be manufactured in Tessa’s newly qualified state of the art commercial cGMP facility.

"Completion of this financing with leading global healthcare investors is an important inflection point in the growth of Tessa and adds to the momentum surrounding the company following the presentation of clinical data from our TT11 and TT11X programs at the 63rd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper)," stated John Ng, CTO and Acting CEO of Tessa Therapeutics. "As we look to 2022 and beyond, Tessa is poised to emerge as a true leader in the cell therapy industry given the significant potential of our autologous and allogeneic cell therapy platforms combined with the scale and sophistication of our technical operations. This financing will be instrumental to helping us achieve several key near-term milestones, including the initiation of a pivotal clinical trial of our TT11 program and advancement of our TT11X program."

"We are very pleased to have secured this significant round of financing from such a highly regarded syndicate of global healthcare investors, including Temasek and Polaris Partners," said Göran Ando, M.D., Chairman of the Board of Tessa Therapeutics. "Additionally, we are excited to welcome Amy Schulman and Darren Carroll of Polaris to our Board of Directors and look forward to benefitting from their substantial industry experience and business acumen as Tessa enters an important period of growth as we advance our pipeline of revolutionary cell therapies through the clinic to patients in need."

"We are delighted to lead this financing in Tessa Therapeutics to enable the acceleration of the company’s corporate and clinical development activities," said Ms. Schulman. "Tessa is at an exciting point with two differentiated clinical-stage programs pursuing novel approaches for the treatment of CD30-positive lymphomas. We look forward to working with the Tessa team and the Board of Directors in developing the next generation of cancer cell therapies."

Tessa’s lead program TT11, is an autologous CD30 chimeric antigen receptor T-cell (CAR-T) therapy that harvests the patient’s own T-cells and modifies them to target cancer cells expressing the CD30 protein, a well-validated lymphoma target. Clinical data from the pilot stage of the ongoing Phase 2 CHARIOT trial of TT11 presented at ASH (Free ASH Whitepaper) demonstrated a favorable safety profile and promising efficacy in relapsed or refractory CD30-positive classical Hodgkin lymphoma (cHL) patients, with a complete response (CR) rate of 57.1 percent and an overall response rate (ORR) of 71.4 percent. Tessa expects to advance to the pivotal Phase 2 CHARIOT trial later this year.

A second program TT11X, is based on Tessa’s proprietary allogeneic CD30.CAR EBVST platform. The platform overcomes toxicity challenges common to "off the shelf" cell therapies such as Graft vs Host Disease (GVHD) by using allogeneic Virus specific T-cells (VSTs) augmented with CD30-CAR.

Allogeneic VSTs have demonstrated strong safety profile and efficacy in early trials. Clinical data from an ongoing Phase 1 study (NCT04288726) of TT11X also presented at ASH (Free ASH Whitepaper) demonstrated a favorable safety profile and encouraging signs of efficacy with clinical responses observed in seven out of nine patients, including a complete disappearance of tumor reported in four patients.

Mr. Ng continued, "The data presented at ASH (Free ASH Whitepaper) demonstrate the potential of our autologous and allogeneic cell therapy platforms and provide a strong foundation for Tessa to build on as we advance these clinical programs. We believe that Tessa’s CD30-CAR-T therapy, TT11, with its promising efficacy and excellent safety profile, may addresses current gaps in the treatment of relapsed or refractory cHL. Meanwhile, our allogeneic platform appears to overcome toxicity challenges common to ‘off the shelf’ cell therapies by using allogeneic VSTs. Our long-term goal is to develop this platform to tackle a broad range of cancers."

On June 9, 2022 Curia, formerly AMRI, a leading contract research, development and manufacturing organization, and Replicate Bioscience, a company pioneering ways to prevent drug resistance in cancer and to treat autoimmune and inflammatory disorders and other diseases using self-replicating RNA (srRNA), reported that they will collaborate on a robust development platform for Replicate’s srRNA therapeutics (Press release, Replicate Bioscience, JUN 9, 2022, View Source [SID1234615838]). The strategic collaboration unites two RNA therapeutics industry leaders.

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As part of the collaboration, Curia’s experienced process development team will support the GMP production of Replicate Bioscience’s srRNA vectors up to eight-liter scale (8L), which can be used in Phase 1 through pivotal clinical trials. Curia’s global mRNA development and manufacturing facility is ISO-13485 certified and located near Boston, Massachusetts. This facility also supports innovators engaged in vaccine and other mRNA therapy development and manufacture through Phase 2 and 3, including GMP assays. Additional Curia facilities support manufacture of srRNA through commercial production scales.

"Replicate’s approach to srRNA is unique, in that we create our own virally-derived synthetic vectors to customize srRNAs to deliver specific proteins," said Replicate Co-founder and Chief Development Officer Andrew Geall, Ph.D., who previously has set up srRNA CMC frameworks for companies including Novartis, Synthetic Genomics, and Precision Nanosystems. "This customization has important therapeutic advantages—versatility of application, lower dosing, and longer duration of therapeutic effect compared to other RNA modalities—but requires built-for-purpose processes to solve the challenges of manufacturing longer RNAs. Curia’s unprecedented expertise in process development and end-to-end integration of longer RNAs makes them a perfect partner for us as we transition from research into clinical development and the production of our srRNA for trials in patients."

"The manufacture of these longer mRNAs is more technically challenging than non-replicating mRNAs and to date we have succeeded with mRNAs up to 16,000 bases," said Norman Garceau, Ph.D., Vice President, Global R&D Technology, Curia. "Curia’s platform offers versatility and streamlined manufacturing times that can handle such complex molecules. Our collaboration with Replicate Bioscience is enabling us to create entirely new methods of manufacturing longer RNAs. We have built our platform from the ground up, using our combined experience in biologics and chemistry to create end-to-end solutions covering mRNA synthesis, lipid synthesis, formulation, and liquid nanoparticle fill-finish. We are proud to apply our capabilities and expertise to support the Replicate Bioscience team and its innovative approach."

On June 9, 2022 Genmab A/S (Nasdaq: GMAB) reported that it has commenced a new arbitration under its license agreement with Janssen Biotech, Inc. (Janssen) for daratumumab (Press release, Genmab, JUN 9, 2022, View Source [SID1234615823]).

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This new arbitration follows from the award in the prior arbitration, where the tribunal ruled in favor of Janssen on the question as to whether Genmab is required to share in Janssen’s royalty payments to Halozyme Therapeutics, Inc. for its technology used in the subcutaneous formulation of daratumumab (marketed as DARZALEX FASPRO in the United States), cf. Company Announcement No 14. The tribunal based its ruling on the finding that DARZALEX FASPRO constitutes a new licensed product under the license agreement.

In this new arbitration, Genmab is consequently seeking an award of $405 million plus interest in accrued milestone payments for DARZALEX FASPRO and a declaration that it is entitled to a new 13-year royalty term from the date of DARZALEX FASPRO’s first commercial sale.

Under the agreement, the arbitration will be conducted in New York pursuant to the rules of the CPR Institute for Dispute Resolution for Non-Administered Arbitration before a panel of three arbitrators. While Genmab intends to vigorously enforce its rights, the outcome of any arbitration proceeding, as well as its duration, is inherently uncertain. The arbitration will be confidential, subject to the parties’ disclosure obligations under applicable law. Other than pursuant to these obligations, Genmab does not intend to comment or provide additional information regarding the arbitration until an award on the merits or other material order is issued in the arbitration or the arbitration is otherwise concluded. While the arbitration is pending, Genmab’s various collaborations with Janssen will continue.

On June 9, 2022 Molecular Targeting Technologies, Inc. (MTTI), a clinical stage oncology company, reported that it will highlight advances on its EvaTheraTM radiotheranostics platform at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) meeting in Vancouver, BC, on June 11-15, 2022 (Exhibit booth #1715) (Press release, Molecular Targeting Technologies, JUN 9, 2022, View Source [SID1234615839]). The EvaThera platform includes EBTATETM (177Lu-DOTA-EB-TATE) for Neuroendocrine Neoplasms (NENs), Hürthle cell thyroid and nasopharyngeal cancers and EBRGDTM (177Lu-DOTA-EB-RGD) for glioblastoma multiforme and non-small cell lung cancer

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A video featuring the EBTATE story (see link below) will be released at the meeting.

View Source

In addition, two abstracts highlighting MTTI’s EBTATE & our PET imaging agent,18F-glucarate, were selected for oral and poster presentations:

(i) Evaluation of Safety, Biodistribution and Dosimetry of a long-Acting Radiolabeled Somatostatin Analogue 177Lu-DOTA-EB-TATE with and without Amino Acid Infusion by Qingxing Liu, Yuanyuan Jiang, Koon Pak, Guochang Wang, Jingjing Zhang, Xiaoyuan Chen and Zhaohui Zhu (oral presentation)

EBTATE treatment without amino acid infusion, normally used in current treatments to block drug impact on non-target organs, has acceptable, minor effects on the kidneys and does no harm to kidney function. EBTATE may significantly improve patient comfort vs. current treatments.

(ii) Assessment of 18F-glucarate as a potential PET tracer for cancer imaging by Junling Li, Huaiyu Zheng, Levi Beverly, Brian Gray, Koon Pak and Chin K. Ng (poster presentation)

18F-glucarate uptake in both in vitro and in vivo correlated well with the degree of cell death and shows early tumor response to chemotherapy, enabling faster assessment of treatment efficacy.