On September 28, 2022 MorphoSys U.S. Inc., a fully owned subsidiary of MorphoSys AG (FSE: MOR; NASDAQ: MOR), reported data from the ongoing L-MIND study showing that Monjuvi (tafasitamab-cxix) plus lenalidomide followed by Monjuvi monotherapy provided long-term efficacy in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) treated for at least 2 years, including six patients on treatment for 5 years or more (Press release, MorphoSys, SEP 28, 2022, View Source [SID1234621527]). Additionally, the frequency of adverse events declined after patients transitioned from combination therapy to monotherapy. The data will be presented during a poster session at the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO 2022) in Houston, Texas.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The body of data presented at SOHO shows the long-term duration of response to tafasitamab in some patients with relapsed or refractory diffuse large B-cell lymphoma not eligible for autologous stem-cell transplant," said Malte Peters, M.D., MorphoSys Chief Research and Development Officer. "These long-term follow-up results for L-MIND reaffirm our belief that tafasitamab plus lenalidomide remains the in-practice, outpatient targeted immunotherapy of choice for this group of patients."

At data cutoff (February 15, 2022), 27 of 80 patients (34%) had undergone treatment for at least 2 years, with a median duration of treatment of 4.3 years. Of those 27, 23 patients were alive at data cutoff, and 13 remained on treatment, including six who were on treatment for at least 5 years.

A complete response was observed in 23 of the 27 patients, including four who were refractory to their primary therapy. A partial response was seen in four patients, two of whom were still on treatment at data cutoff.

The majority of adverse events were grade 1 or 2 during both combination and monotherapy treatment. Patients experienced a lower frequency of all-grade and grade 3 or higher adverse events during monotherapy. The most common adverse events with combination therapy were neutropenia (incidence per person per year, all-grade/Grade ≥3: 3.87/1.91) and diarrhea (1.04/0.04), which declined after patients switched to monotherapy (all-grade/Grade ≥3: 0.87/0.45 and 0.32/0.00, respectively, in the first year of monotherapy). Neutropenia and diarrhea remained the most common adverse events in the first two years of monotherapy.

"The new long-term follow-up results from L-MIND at SOHO 2022 highlight the potential of tafasitamab in providing long-term efficacy in patients with relapsed or refractory diffuse large B-cell lymphoma," said Johannes Duell, M.D., University Hospital Wuerzburg Medical Clinic and Polyclinic. "The fact that six of the 27 patients who responded received treatment for 5 or more years – with another seven patients nearing the 5-year mark – points to the durable response induced by tafasitamab. This response durability represents the type of data that offers oncologists confidence when recommending therapies to their patients."

On September 28, 2022 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, reported an update to its existing collaboration agreement with Pierre Fabre for the commercialization of tabelecleucel (tab-cel) for Epstein-Barr virus (EBV)-positive cancers (Press release, Atara Biotherapeutics, SEP 28, 2022, View Source [SID1234621526]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the amended terms, Atara will receive an additional USD 30 million milestone payment upon tab-cel EC approval and subsequent filing of the Marketing Authorization Application (MAA) transfer to Pierre Fabre in exchange for reduced tab-cel royalties and supply price mark-up for Pierre Fabre. Tiered royalties on sales remain at a significant double-digit rate following this amendment.

"With an anticipated European approval in Q4 2022, tab-cel is positioned to become the first ever allogeneic off-the-shelf T-cell therapy available for patients with significant need," said Pascal Touchon, President and CEO of Atara. "This update to our agreement with Pierre Fabre reaffirms our strong partnership and shared belief in the transformative potential of tab-cel, while enabling Atara to further extend our cash runway."

In October 2021, Atara entered into an exclusive commercialization agreement with Pierre Fabre for tab-cel in Europe, Middle East, Africa and other select emerging markets for EBV-positive cancers, receiving an upfront payment of USD 45 million, and up to approximately USD 320 million in additional regulatory and sales milestone payments. In addition to responsibility for the pivotal ALLELE study in EBV+ post-transplant lymphoproliferative disease (EBV+ PTLD) and securing European Commission approval, Atara also remains responsible for the Phase 2 multi-cohort study, which is evaluating tab-cel in six additional patient populations with the goal of label expansion in other EBV-driven cancers. Pierre Fabre will lead all commercialization and distribution activities in the territories, as well as medical and regulatory activities after the anticipated MAA approval in Europe. Atara retains full commercialization rights to tab-cel in the United States and other major markets.

"Tab-cel has the potential to be a transformational product for EBV-positive cancers and is eagerly awaited by physicians and patients in Europe with limited treatment options," said Eric Ducournau, CEO of Pierre Fabre. "This update to our agreement with Atara confirms our confidence and commitment to tab-cel in Europe, where the Pierre Fabre team is excited to bring the first allogeneic T-cell therapy to European patients in a rare oncology condition."

Atara is leveraging its first-in-kind allogeneic off-the-shelf EBV T-cell platform to develop transformative therapies for patients including tab-cel, which is the Company’s lead candidate in development for EBV-positive cancers, including EBV+ PTLD, where it is currently being investigated in adults and children in the Phase 3 ALLELE study. Tab-cel has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) designation by the European Medicines Agency (EMA).

On September Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T cell therapies to treat cancer, reported the publication of a study in the New England Journal of Medicine entitled "GPRC5D-Targeted CAR T Cells for Myeloma (Press release, Eureka Therapeutics, SEP 28, 2022, View Source [SID1234621525])." The study was led by Dr. Eric Smith of the Dana-Farber Cancer Institute, Dr. Renier Brentjens of the Roswell Park Comprehensive Cancer Center, and Dr. Sham Mailankody of the Memorial Sloan Kettering Cancer Center (MSK).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The GPRC5D binder used in the study was developed by Eureka using its proprietary E-ALPHA platform in collaboration with MSK. Eureka and MSK licensed the binder to Juno Therapeutics/Bristol Myers Squib in 2016 for CAR use, and to Sanofi in 2021 for non-CAR use.

While B cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell therapies have generated responses in patients with multiple myeloma, relapses associated with low-to-negative expression of BCMA are common. Preclinical studies have shown the efficacy of G protein-coupled receptor, class C, group 5, member D (GPRC5D)-targeted CAR T-cell therapy in multiple myeloma, including in BCMA antigen escape models (Smith EL et al. Science Trans Med 2019).

In this study, 17 patients were enrolled and received GPRC5D CAR T-cell therapy (MCARH109), including patients who had previously received BCMA therapies. At the highest dose level (450 million CAR T cells), 1 patient had grade 4 cytokine release syndrome and neurotoxicity and 2 patients had delayed cerebellar-like toxicities; there were no treatment associated deaths. The maximum tolerated dose was identified at 150 million CAR T cells. A response was reported in 71% of the patients in the entire cohort, and in 58% of those who received the lower doses of 25 million to 150 million cells. Patients that previously relapsed after BCMA-targeted CAR T cell therapy responded similarly to those that were CAR naïve.

"The data confirms GPRC5D as an active immunotherapeutic target in multiple myeloma," said Eric Smith, M.D., Ph.D., and co-inventor of CARs for the targeting of multiple myeloma. "We look forward to advancing this program either as a stand-alone therapy or as a combination therapy with BCMA-targeting CARs."

"We are thrilled that the positive GPRC5D-directed CD28/4-1BB CAR study results were published in such a prestigious journal," said Dr. Cheng Liu, President and Chief Executive Officer at Eureka Therapeutics. "The results reaffirm our commitment to developing the next generation of safer and more effective T-cell therapies to treat patients with cancer."

On September 28, 2022 Eczacıbaşı-Monrol Nuclear Products Co. (Monrol) reported that it has decided to establish a legal entity and manufacturing facility in Germany (Press release, Eczacıbaşı-Monrol Nuclear Products, SEP 28, 2022, View Source [SID1234621524]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The new facility will focus on the manufacture of SPECT products and radiopharmaceutical products for radioligand therapy(*) such as Gallium-68 generator and n.c.a Lutetium-177. Developed by Monrol R&D teams, these products are widely used in the production of radiopharmaceuticals for cancer patients. The facility will also have a dedicated division for state-of-the art cGMP Contract Development and Manufacturing Organization (CDMO) services.

Monrol plans to make the site a center of excellence for both radiopharmaceutical production and scientific and industry collaborative efforts to create innovations. The facility is expected to be up and running by 2026 at an estimated cost of around 30 million euros.

(*) Targeted radioligand therapy is an innovative approach to cancer treatment that is considered to be one of the most remarkable and advanced therapies currently under study. Multiple clinical development programs and clinical trials around the world are testing this approach for various cancer types.

About Lutetium-177 n.c.a
Lutetium-177 n.c.a is a radioisotope of choice for targeted radionuclide therapy. Lu-177 n.c.a production process enables treatment options that have the potential to improve treatment outcomes for certain cancer patients. Unique properties of Lutetium-177 n.c.a make it a theranostically desirable radioisotope for peptide receptor radionuclide therapy (PRRT) to treat certain cancers like neuro endocrine tumors (NET) and prostate cancer; many clinical development programs are also testing the therapy for other cancers like ccRCC.

About Gallium-68
A gallium-68 generator is a device used to extract the positron-emitting isotope 68Ga of gallium from decaying germanium-68. The parent isotope 68Ge is easily utilized for in-hospital production of generator-produced 68Ga. Its decay product gallium-68 is extracted and employed in certain positron emission tomography nuclear medicine diagnostic procedures used for the diagnosis of cancer patients and direct tumor imaging.

On September 28, 2022 RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of difficult-to-treat solid tumors through its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMPTM) therapy platform, reported Ripal Gandhi, M.D., FSIR, FSVM presented, "Trans-Arterial Micro-Perfusion Therapy for Pancreatic Cancer," at the recent Symposium on Clinical Interventional Oncology (CIO) (Press release, Renovorx, SEP 28, 2022, View Source [SID1234621522]). Dr. Gandhi is a course director for the symposium recently held September 23-25, 2022 at the Loews Hotel in Miami Beach, Florida. View Dr. Gandhi’s full presentation.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Gandhi is a professor of Interventional Radiology at the Miami Cancer Institute and Miami Cardiac and Vascular Institute, Florida International University Herbert Wertheim College of Medicine. Since 2018, Dr. Gandhi has been instrumental in the multi-center Phase 3 TIGeR-PaC clinical trial as a principal investigator for the Miami Cancer Institute.

Dr. Gandhi’s presentation, "Trans-Arterial Micro-Perfusion Therapy for Pancreatic Cancer," provides an overview of the clinical challenges of the standard-of-care treatment, available to locally advanced pancreatic cancer (LAPC) patients. Systemic (intravenous) chemotherapy is considered the standard of care for LAPC and is often associated with debilitating side effects. It may be ineffective in treating this type of cancer due to tumors lacking dedicated blood vessels critical for delivering chemotherapy.

Dr. Gandhi highlighted the RenovoTAMP therapy platform’s potential as a targeted oncology option for LAPC patients. The presentation showcased RenovoRx’s RR1 Phase I/II and RR2 Observational Registry studies suggesting when RenovoTAMP is used in combination with radiation therapy, arterial microvasculature may be reduced, minimizing chemotherapy leakage during delivery. Increasing chemotherapy directly to the tumor could reduce systemic side effects. Dr. Gandhi also presented about the mission and protocol behind the TIGeR-PaC study.

The TIGeR-PaC study is evaluating RenovoRx’s first product candidate, RenovoGem, to treat LAPC through RenovoTAMP’s intra-arterial delivery of gemcitabine, an FDA-approved chemotherapy. Study goals include extension of patient survival, reduction of side-effects associated with systemic chemotherapy, and improved quality of life for pancreatic cancer patients.

"The CIO symposium aims to educate on the most viable and sought-after treatments in the rapidly growing practice of interventional oncology management," said Ramtin Agah, M.D., Chief Medical Officer and Founder of RenovoRx. "As a recognized expert in this field, we appreciate Dr. Gandhi highlighting our therapy platform as a potential option for difficult-to-treat cancers, like LAPC."

"Over the past decade, our team has refined RenovoTAMP. Results of Phase 1/2 and observational registry studies suggest RenovoTAMP may enhance patient survival while countering chemotherapy tolerability issues. The result could be improved quality of life for patients and their loved ones. Our team continues making progress enrolling the TIGeR-PaC study. We look forward to reporting the first prospective interim analysis for the study, which is expected in the fourth quarter of this year."