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 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 Tempus, a leader in artificial intelligence and precision medicine, reported a new collaboration sponsored by Eli Lilly and Company designed to provide broader access to genomic testing to patients with advanced/metastatic non-small cell lung cancer (NSCLC) (Press release, Tempus, JUN 9, 2022, View Source [SID1234615820]). Leveraging Tempus tests, this collaboration is intended to help physicians understand the benefits of broad-panel genomic sequencing through clinical practice guidelines.

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In advanced metastatic NSCLC, 47% of patients harbor an actionable biomarker that cannot fully be detected by single analyte testing.1 Tempus and Eli Lilly aim to expand access to genomic testing by removing cost as a barrier for patients to receive molecular profiling.

"This collaboration aims to provide eligible NSCLC patients access to our genomic tests, to help reduce disparities in biomarker testing and assist physicians in making data-driven treatment decisions," said Mike Yasiejko, Executive Vice President, Oncology at Tempus. "We look forward to working with Lilly in supporting physicians in identifying the optimal therapeutic path for each of their patients."

Physicians will have the option of using the Tempus xT broad-panel genomic sequencing assay, designed to detect actionable alterations by sequencing tumor samples with matched normal saliva or blood samples, for their NSCLC patients. For patients where tissue is unavailable or is not sufficient to conduct broad-based tissue testing, Tempus’ xF liquid biopsy is available as an alternative. Physicians also will be able to order select immunohistochemistry (IHC) staining. To learn more, visit here.

"Genomic testing allows oncologists to more accurately select effective treatments for patients," said Anthony (Nino) Sireci, M.D. vice president, clinical biomarker and diagnostics development, Loxo Oncology at Lilly. "We look forward to supporting these efforts alongside Tempus to increase accessibility to biomarker testing and potentially create better outcomes for patients."

On June 9, 2022 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic for the two indications of Rozlytrek (entrectinib), a targeted therapy developed by Genentech, a member of the Roche Group (Press release, Foundation Medicine, JUN 9, 2022, View Source [SID1234615819]). As a companion diagnostic, FoundationOne CDx can be used to identify patients with ROS1-positive non-small cell lung cancer (NSCLC), or patients with Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion-positive solid tumors who may be appropriate for treatment with Rozlytrek (entrectinib).

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"Comprehensive and validated genomic testing is critical to identify patients with ROS1 or NTRK gene fusions as they are rare and can be missed when more limited or unvalidated testing panels are used to profile a patient’s tumor," said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. "We’re proud that this companion diagnostic will enable broader access to genomic testing and this breakthrough therapy, ultimately allowing more patients to benefit from precision medicine."

As a condition of this approval, Foundation Medicine will conduct a post-approval study powered by the Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB) to further demonstrate FoundationOne CDx’s ability to identify NSCLC patients with ROS1 fusions who may respond to Rozlytrek (entrectinib). The CGDB is a de-identified, HIPAA-compliant database that links outcomes data from Flatiron’s network of oncology clinics and genomic data from Foundation Medicine’s CGP assays. The database currently contains more than 100,000 linked genomic profiles.

"We look forward to our ongoing partnership with Genentech and Flatiron Health as we implement this novel approach to post-approval evidence generation through our CGDB," said Sanket Agrawal, chief biopharma business officer at Foundation Medicine. "This database is an invaluable asset for cancer research, especially in rare patient populations, like ROS1-mutated NSCLC. We are well-positioned to support our biopharma partners with this unique resource as we continue accelerating access to new precision medicines."

NSCLC is the most common type of lung cancer, accounting for 80 to 85 percent of all lung cancer diagnoses.1 When ROS1 gene fusions occur, generally in 1-2 percent of NSCLC diagnoses, 2 cancer cells grow and proliferate in an uncontrolled manner. NTRK gene fusions occur when NTRK1/2/3 genes fuse with other genes, resulting in altered TRK proteins, which can activate signaling pathways involved in proliferation of certain types of cancer. Though rare, occurring in roughly .3 percent of all solid tumors,3 these fusions can be found in many tumor types, including breast, cholangiocarcinoma, colorectal, gynecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers.4 CGP is an important tool for identifying these rare mutations.

Using a tissue sample, FoundationOne CDx analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor. The test is FDA-approved as a companion diagnostic for 25 CDx indications, and 3 group claims across 30 targeted therapies, demonstrating Foundation Medicine’s deep regulatory expertise. FoundationOne CDx is also the first and only companion diagnostic approved for Rozlytrek (entrectinib).

On June 9, 2022 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported that it will participate in a fireside chat at The JMP Securities Life Sciences Conference on June 16, 2022 at 1:00 p.m. ET in New York, NY (Press release, Concert Pharmaceuticals, JUN 9, 2022, View Source [SID1234615818]).

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A webcast of the JMP fireside chat may be accessed in the Investors section of the Company’s website at www.concertpharma.com. A replay of the webcast will be available on Concert’s website for two weeks following the presentation.