On December 2, 2021 ITM Isotope Technologies Munich SE, a leading radiopharmaceutical biotech company and Navigo Proteins GmbH, a premier protein engineering company developing optimized scaffold protein-based affinity ligands called Affilin molecules from its Precision Targeting toolbox, reported a research collaboration for the development of a fibroblast activation protein (FAP)-targeted radiopharmaceutical program for the treatment of solid tumors (Press release, ITM Isotopen Technologien Munchen, DEC 2, 2021, View Source [SID1234596411]). The program is planned to be added to ITM’s growing proprietary pipeline of Targeted Radionuclide Therapies spanning multiple radioisotopes and targeting molecules for optimal therapeutic effect. FAP-Targeted Radionuclide Therapy is a promising new approach to treating cancer within the precision oncology field.

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Under the terms of the agreement, Navigo’s proprietary protein engineering platform will be used to develop and select a FAP-targeting Affilin molecule which will then be coupled with a therapeutic radioisotope provided by ITM. Following candidate selection, ITM will have the exclusive rights to further advance the radiolabeled FAP-specific Affilin through clinical testing in potentially multiple cancer indications. The agreement also includes a non-exclusive license for diagnostic use in radio-imaging. Further details of the agreement were not disclosed.

"FAP-targeting approaches have received heightened attention for good reason. We believe this approach holds the potential to treat a wide range of cancer indications. As such, we look forward to exploring this innovative targeted radiopharmaceutical approach for our growing precision oncology pipeline, further expanding its reach and breadth. We believe that developing a new candidate by combining our radioisotopes with an Affilin ligand targeting FAP has the opportunity to make a difference in the lives of patients," commented Steffen Schuster, CEO of ITM.

FAP is a highly attractive tumor target for Targeted Radionuclide Therapy that is preferentially expressed on cancer cells and in particular on cancer associated fibroblasts (CAFs). It is detectable in most epithelial cancers, including over 90% of breast, lung, colorectal and pancreatic carcinomas. High expression levels are associated with poor prognosis, and therefore warrant additional medical research and focus. ITM and Navigo are addressing this urgent need through their research collaboration and combined efforts to develop a promising FAP-targeted radiopharmaceutical.

"We welcome the opportunity to extend our productive partnership with ITM with yet another promising project. We strongly believe in the potential of our technology to generate high-quality Affilin ligands targeting FAP and capable of breaking the tumor microenvironment. By joining forces with ITM, we are fully equipped to build a strong FAP-targeting candidate, that ITM will then advance through clinical development," said Henning Afflerbach, CEO of Navigo Proteins.

The therapeutic candidate developed together by ITM and Navigo will enable a direct attack against tumor cells by irradiating them via crossfire effects in a highly precise manner. Through the direct depletion of CAFs it additionally provides a new access point to modify the tumor microenvironment in which CAFs play a central role in upholding the barrier for effective immune cell infiltration.

This agreement further strengthens the existing partnership between the two organizations, combining ITM’s deep expertise in developing promising Targeted Radionuclide Therapies for cancer patients with Navigo’s proprietary Affilin molecules and protein engineering proficiency.

On December 2, 2021 Omeros Corporation (Nasdaq: OMER) reported that it has entered into a definitive agreement for the sale of OMIDRIA to Rayner Surgical Group Limited (Press release, Omeros, DEC 2, 2021, View Source [SID1234596430]). Expected to close on or before December 31, 2021, the transaction includes an upfront payment of $125 million with an additional $200 million in a commercial milestone payment . Omeros will also retain its accounts receivable balance at the closing, which was $34 million at the end of last quarter. Together with substantial royalties to be paid by Rayner to Omeros on net sales of OMIDRIA, the transaction is valued in excess of $1 billion.

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Rayner will pay Omeros royalties on both U.S. and ex-U.S. net sales of OMIDRIA. In the U.S., the royalty rate will be 50 percent of U.S. net sales until the earlier of either January 1, 2025 or payment of the $200-million commercial milestone, after which Omeros will receive royalties of 30 percent of U.S. net sales for the life of OMIDRIA’s U.S. patent estate. The commercial milestone payment is triggered if separate payment for OMIDRIA is secured for a continuous period of at least four years. Outside of the U.S., Omeros will receive a 15-percent royalty rate on OMIDRIA net sales throughout the applicable patent life on a country-by-country basis.

OMIDRIA will become a key product in Rayner’s ophthalmology franchise, which includes intraocular lenses, ophthalmic viscoelastic devices and dry eye treatments. As part of the agreement, Rayner will acquire the OMIDRIA commercial organization, including the OMIDRIA sales force. In addition, Rayner plans to expand the sales force in both the U.S. and ex-U.S., further strengthening its commercial presence internationally and further accelerating U.S. market growth of OMIDRIA.

"OMIDRIA will be an important part of our ophthalmic product portfolio internationally and a key strategic focus for Rayner," said Tim Clover, chief executive officer of Rayner. "Our new OMIDRIA business and commercial team of seasoned industry professionals are an ideal fit for Rayner as we focus on broadly serving ophthalmic surgeons with our pipeline of innovative products, including the recently FDA-approved RayOne EMV intraocular lens. We look forward to continue growing U.S. sales of OMIDRIA and the rest of our portfolio and to launching EMA-approved OMIDRIA throughout Europe and other regions of the world, consistent with our mission of offering superior products and outcomes for surgeons and their patients."

The transaction is subject to customary closing conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

"We are immensely proud of our OMIDRIA team and its achievements over the last seven years," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "OMIDRIA has become an important part of cataract surgery, de-risking the procedure for surgeons and improving patient outcomes. This transaction recognizes both the current and future value that OMIDRIA brings to cataract surgery, affording Omeros a significant ongoing economic interest in the expected growth of OMIDRIA, while allowing us to focus our efforts primarily on our complement franchise of large- and small-molecule MASP-2 and MASP-3 inhibitors as well as on the rest of our innovative pipeline. We believe that Rayner, with its expertise and increasingly strong international presence in ophthalmology, represents a great home for OMIDRIA and the product’s commercial team, and Omeros is committed to assist Rayner, throughout the transition and beyond, to maximize OMIDRIA utilization and revenues."

Conference Call Details

Omeros’ management will host a conference call to discuss today’s announcement. The call will be held today at 8:30 a.m. Eastern Time; 5:30 a.m. Pacific Time. To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 9080996. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 9080996.

To access the live or subsequently archived webcast of the conference call on the internet, go to the company’s website at View Source

About OMIDRIA

Omeros’ OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is the first and only FDA-approved product of its kind and is marketed in the U.S. for use during cataract surgery or intraocular lens replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. OMIDRIA also is the only NSAID-containing product FDA-approved for intraocular use. In post-launch studies across conventional and femtosecond laser-assisted cataract surgery, OMIDRIA has been shown to (1) prevent intraoperative floppy iris syndrome (IFIS) and iris prolapse, (2) significantly reduce complication rates (including sight-threatening cystoid macular edema and breakthrough iritis), use of pupil-expansion devices, and surgical times, (3) significantly reduce intraoperative use of the opioid fentanyl and postoperative prescription opioids, (4) enable performance of surgery and postoperative care without the use of steroids, and (5) significantly improve uncorrected visual acuity on the first day following cataract surgery. While OMIDRIA is broadly indicated for use in cataract surgery, the post-launch outcomes cited above are not in its currently approved labeling.

Important Safety Information for OMIDRIA Systemic exposure of phenylephrine may cause elevations in blood pressure. In clinical trials, the most common reported ocular adverse reactions at two percent or greater are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation; incidence of adverse events was similar between placebo-treated and OMIDRIA-treated patients. OMIDRIA must be added to irrigation solution prior to intraocular use.

On December 2, 2021, Delcath Systems, Inc. Presented the Corporate Presentation (Presentation, Delcath Systems, DEC 2, 2021, View Source [SID1234596394]).

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On December 2, 2021 InteRNA Technologies, a clinical-stage biotech company developing microRNA (miRNA)-based therapeutics with a focus on cancer, reported it received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for the company’s Phase I clinical trial evaluating lead miRNA candidate, INT-1B3, in patients with advanced solid tumors (Press release, InteRNA Technologies, DEC 2, 2021, View Source [SID1234596412]). INT-1B3 is a lipid nanoparticle (LNP) formulated, chemically modified mimic of the endogenous tumor suppressor, miR-193a-3p, and represents a promising novel therapeutic approach that is designed to simultaneously address multiple hallmarks of cancer.

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The IND approval enables InteRNA to expand the number of clinical sites and to facilitate the enrollment of patients for the dose expansion (Phase Ib) part of the trial in the United States. The first part of the Phase I trial was initiated in Europe at the beginning of 2021, with the dosing of the first patient in the dose escalation (Phase Ia) part in February. The treatment of the first patient in the Phase Ib cohort is planned for the second half of 2022.

"Receiving such a positive outcome from the FDA shortly after submitting a full IND application is a major achievement for us," commented Laurens van Pinxteren, Chief Operating Officer of InteRNA. "It underlines the high potential of our novel miRNA-based approach that enables us to address the multi-facetted disease cancer from different angles with one drug providing a novel therapeutic entity to patients with hard-to-treat solid tumors, such as advanced breast cancer or hepatocellular carcinoma."

Roel Schaapveld, CEO of InteRNA, added: "The IND approval enables us to enroll an international, diversified patient population, marking significant progress in the clinical evaluation of our novel therapeutic modality. The rapid, positive feedback by the FDA is highly encouraging and we look forward to start patient recruitment in the United States next year."

The multicentric, open-label, multiple ascending dose Phase I/Ib trial (NCT04675996) will investigate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of INT-1B3 in patients with advanced solid tumors. The study is expected to enroll a total of up to 80 patients at up to 15 clinical centers in the United States and Europe. The Phase Ia part of the trial is currently ongoing in the Netherlands and Belgium and will enroll approximately 30 patients with advanced solid tumors. In the second part (Phase Ib) of the trial, approximately 50 patients with hepatocellular carcinoma or triple negative breast cancer will be enrolled in the United States and Europe. Topline results from the Phase Ia part of the study are expected in the first half of 2022.

About INT-1B3

INT-1B3’s unique mechanism of action addresses multiple hallmarks of cancer simultaneously. It directly targets tumor cells and the tumor microenvironment by specific modulation of multiple signaling pathway components across the PTEN tumor suppressor pathway and the oncogenic PI3K/Akt and Ras/MAPK pathways resulting in inhibition of proliferation and migration and induction of cell cycle arrest and apoptosis. The triggering of the immunogenic tumor cell death (ICD) process as well as downregulation of the adenosine-A2A receptor pathway through inhibition of CD39/CD73 leads to a decrease in immunosuppressive FoxP3/Lag3 regulatory T cells and monocytic myeloid-derived suppressor cells (mMDSCs), and maturation of dendritic cells. As a result, the immune system is activated, and long-term immunity is triggered by recruitment of CD8+ effector T cells leading to decreased metastasis development and improved animal survival compared to anti-PD1 treatment.

On December 1, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported it has completed its share purchase agreement to acquire 100 percent of the outstanding shares of TIB Molbiol Group (Press release, Hoffmann-La Roche, DEC 1, 2021, View Source [SID1234596316]). TIB Molbiol will continue to operate as a subsidiary within the Diagnostics division. Roche and TIB Molbiol will build on their capabilities for the rapid development of assays for emerging pathogens and potential health threats, such as infectious diseases.

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With over 45 CE-IVD assays and more than a 100 research-use-only assays joining the Roche family, the companies will jointly accelerate access for patients around the world to even more clinically important diagnostic tests. TIB Molbiol will further expand Roche’s molecular diagnostics solutions, especially for the flexible open platforms LightCycler PCR and MagNA Pure sample preparation systems.

The two companies have collaborated for more than 20 years to rapidly address critical healthcare needs including biological threats, such as SARS, anthrax, avian influenza virus H5N1, MERS, the novel influenza virus H1N1 swine, Ebola virus, Zika virus and most recently, SARS-CoV-2 virus and its variants. For example, in 2001 with anthrax and 2003 with SARS-CoV1, TIB Molbiol demonstrated their ability to develop PCR assays for the detection of new pathogens within days.

"I am very pleased that together with TIB Molbiol, we can significantly improve access for patients to a broader spectrum of diagnostic tests – from high volume routine tests to the diagnosis of rare diseases. TIB Molbiol will continue to be an innovation engine and frontrunner in our common fight against infectious diseases, such as SARS-CoV-2", said Thomas Schinecker, CEO Roche Diagnostics. "TIB Molbiol has helped to shape the future of PCR infectious disease testing, and will continue to drive cutting-edge research so we can bring better healthcare outcomes to patients faster."