On June 14, 2022 J INTS BIO reported that it will be presenting the preclinical results of its NSCLC candidate ‘JIN-A02’ at the upcoming 2022 IASLC World Conference on Lung Cancer, to be held in Vienna, Austria from 6th to 9th August (Press release, J INTS BIO, JUN 14, 2022, View Source [SID1234615986]).

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‘JIN-A02’ is a novel orally administered 4th generation EGFR TKI that targets NSCLC cancers harboring C797S mutation. C797S is a mutation that occurs after the use of 3rd generation EGFR TKIs such as Osimertinib and Lazertinib, resulting in tumor resistance and disease progression.

According to J INTS BIO, ‘JIN-A02’ showed strong inhibitory activities against NSCLC cancer cell-lines harboring double and triple mutations with C797S mutations in in-vitro studies. In particular, ‘JIN-A02" showed robust inhibition against double mutations (Ex19Del/C797S or L858R/C797S), which with the increasing use of 3rd generation EGFR-TKIs as First Line therapy worldwide, will soon become the dominant mutations leading to resistance and disease progression.

In addition, ‘JIN-A02’ also effectively reduced tumor volume in a dose-dependent manner, compared to Osimertinib, in mouse model harboring EGFR Ex19Del/T790M/C797S triple mutation cancers and exhibited high brain penetrance with efficacy.

A company official added that ‘JIN-A02’ demonstrated a favorable safety profile with a low propensity for cardiotoxicity and did not show significant toxic effects such as weight loss and cytotoxicity in animal models at therapeutic dose levels. It is therefore expected to be a highly valued new drug in the armamentarium for the treatment of NSCLC.

Dr Anna Jo, CEO J INTS BIO, said: "We are determined to rapidly advance our novel NSCLC pipeline program, and to overcome the limitations of developing or approved treatments through rigorous R&D, so as to improve the outcomes of patients around the world who suffered from NSCLC with limited or no viable alternative treatments."

On June 14, 2022 NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), a clinical-stage T cell-focused therapeutics company, reported that Nature Communications (Impact Factor: 14.92) published the results of an in vivo study combining the long-acting human IL-7, NT-I7, with chimeric antigen receptor (CAR) T cells directed against CD19+ B cell lymphoma and acute myeloid leukemia (Press release, NeoImmuneTech, JUN 14, 2022, View Source [SID1234615985]).

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The study led by Dr. DiPersio and his team at Washington University investigated the impact of NT-I7 on in vivo CAR-T cell expansion and anti-tumor response employing sophisticated models of B cell lymphoma or acute myeloid leukemia and an immune competent syngeneic model of acute promyelocytic leukemia. Utilizing these tools, the group tested whether NT-I7 could expand a less differentiated CAR-T product with improved durability and tumor killing abilities in multiple models of hematological cancer.

Over the past 10 years, CAR-T cell therapy has become routinely used to treat patients with refractory hematologic malignancies. Despite progress, long-lived memory responses and long-term in vivo persistence of CAR-T cells have yet to be consistently achieved to prevent tumor cell escape and clinical relapse.

In the study reported in Nature Communications, NT-I7 protected CD19-targeting CAR-T cells from cell death, enhancing their viability while promoting their expansion in the presence of CD19+ tumor cells. CAR-T cells expanded in the presence of NT-I7 were less differentiated but with equivalent effector cytokine secreting abilities. Treatment of tumor bearing mice with NT-I7 enhanced in vivo expansion and subsequent anti-tumor effects of CAR-T cells targeting CD19+ B cell lymphoma or CD33+ acute-myeloid leukemia. The combination of NT-I7 and CAR-T cells dramatically extended survival. Impressively, co-treatment of tumor bearing mice with NT-I7 reduced the minimum number of CAR-T cells needed to achieve a survival benefit by imparting increased tumor killing abilities to CAR-T cells on a per cell basis and expanding CAR-T cells in vivo. These studies provide compelling evidence that NT-I7 has the potential to enhance CAR-T therapy for the treatment of hematological diseases by promoting CAR-T anti-tumor activity, expansion and persistence.

Dr. Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech, Inc. said: "This Nature Communications article highlights the exciting properties of NT-I7 that can increase CAR T cells’ functionality and cytotoxicity. Those results demonstrate the broad applicability of NT-I7 for cellular therapy, in addition to its well-documented benefits as a long-acting human IL-7 that has the potential to amplify T cells across the subsets, boost the immune system, and enhance the anti-tumor response in people with hematologic malignancies and solid tumors."

This study presented in Nature Communications demonstrates the potential for NT-I7 to support impactful clinical use of multiple CAR-T therapies with improved safety and tolerability. Strategic combination of NT-I7 with CD19-targeting CAR-T cells is currently being tested as part of a multi-site clinical trial (NCT05075603) for the treatment of relapsed/refractory large B-cell lymphoma. At ASCO (Free ASCO Whitepaper) 2022, poster #239b presented the most advanced updates on this study (NIT-112) that aims to show if NT-I7 may increase expansion and persistence of CAR-T, leading to increased tumor response rate and improved clinical outcomes without safety concerns.

Reference: Kim, M.Y., Jayasinghe, R., Devenport, J.M. et al. A long-acting interleukin-7, rhIL-7-hyFc, enhances CAR T cell expansion, persistence, and anti-tumor activity. Nat Commun 13, 3296 (2022). View Source

About chimeric antigen receptor (CAR-T) cells therapies

CAR-T cell therapy is a type of treatment in which a patient’s T cells (a type of immune system cell) are changed in the laboratory so they will attack specific cancer cells. T cells are taken from a patient’s blood. Then the gene for a special receptor that binds to a certain protein on the patient’s cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion. Chimeric antigen receptor T-cell therapy is used to treat certain blood cancers, and it is being studied in the treatment of other types of cancer.

About NT-I7 (efineptakin alfa) (rhIL-7-hyFc)

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On June 14, 2022 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported the presentation of imaging data from the "cold antibody sub-study" evaluating pre-administration of cold antibody (naked antibody without the isotope) prior to administration of the imaging agent (antibody with the isotope) in the Phase 1 study of FPI-1434 for the treatment of solid tumors expressing IGF-1R (Press release, Fusion Pharmaceuticals, JUN 14, 2022, View Source [SID1234615984]). Data were presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2022 Annual Meeting in a presentation titled "Impact of Pre-Administration of Anti-IGF-1R Antibody FPI-1175 on the Dosimetry, Tumor Uptake, and Pharmacokinetics of the IGF-1R Targeted Theranostic Imaging Agent [111In]-FPI-1547 in Patients with Solid Tumors".

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"Pre-administration of cold antibody has the potential to increase the therapeutic index of radiopharmaceuticals through multiple avenues, including adjusting the pharmacokinetics to increase drug circulation and drive increased binding to tumor targets, saturating natural sinks for antibodies and blocking endogenous antibody binding," said Chief Executive Officer John Valliant, Ph.D. "The positive trends observed in tumor lesion uptake when cold antibody is pre-administered validate our ongoing evaluation of additional cohorts using this dosing regimen in the Phase 1 trial of FPI-1434."

The cold antibody sub-study was conducted concurrently with the dose escalation portion of the Phase 1 study of FPI-1434 for the treatment of solid tumors. The sub-study was designed to determine the safety, tolerability, and effect of administration of varying doses of FPI-1175, the naked antibody without the isotope, or "cold antibody", on the biodistribution, dosimetry and tumor uptake of [111In]-FPI-1547, the investigational imaging agent.

Imaging data from the study demonstrate a favorable gain in [111In]-FPI-1547 tumor lesion uptake versus normal tissue when FPI-1175 was pre-administered and compared to dosing with FPI-1547 alone. Importantly, sites of improved tumor lesion uptake were independent of anatomic location of disease and included bone, lung, liver, and lymph nodes.

Administration of FPI-1547 with and without pre-administration of FPI-1175 was safe without any drug-related Serious Adverse Events or Dose Limiting Toxicities.

Dr. Valliant continued, "These data from the cold antibody sub-study strengthen our understanding of this dosing regimen and support further evaluation. In our ongoing Phase 1 study of FPI-1434, we are evaluating two dosing regimens, one with FPI-1434 alone, and one in which cold antibody is administered prior to FPI-1434, demonstrating our commitment to develop and potentially deliver the safest, most clinically meaningful treatment regimen possible to patients with solid tumors expressing IGF-1R."

Pre-administration of FPI-1175 at 0.5 mg/kg is currently being evaluated with increasing dose levels of FPI-1434 in the ongoing Phase 1 study.

Following the conclusion of the SNMMI Annual Meeting, copies of the presentations can be found at View Source

About FPI-1434
FPI-1434 is a radioimmunoconjugate designed to target and deliver alpha emitting medical isotopes to cancer cells expressing IGF-1R, a receptor that is overexpressed on many tumor types. FPI-1434 utilizes Fusion’s Fast-Clear linker to connect a human monoclonal antibody that targets IGF-1R with actinium-225, a powerful alpha-emitting isotope with desirable half-life and decay chain properties.

On June 14, 2022 MorphoSys AG (FSE: MOR; NASDAQ: MOR) and Human Immunology Biosciences, Inc. (HIBio), a South San Francisco-based biotechnology company focused on discovering and developing precision medicines for autoimmune and inflammatory diseases, reported that the companies entered into an equity participation agreement and license agreements to allow HIBio to develop and commercialize MorphoSys’ felzartamab, an anti-CD38 antibody, and MOR210, an anti-C5aR1 antibody (Press release, MorphoSys, JUN 14, 2022, View Source [SID1234615983]).

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"Under the leadership of experienced drug developers, HIBio is backed by two world-class venture capital firms with demonstrated track records of building successful companies. Its management, coupled with deep scientific expertise in autoimmune diseases, makes HIBio exceptionally well positioned to successfully advance felzartamab and MOR210 into new medicines for patients in need of better treatment options," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "At MorphoSys, we will continue to focus our resources on driving our late- and mid-stage oncology pipeline forward. This includes pelabresib, our potential best-in-class BET inhibitor, and tafasitamab, our CD19 targeting immunotherapy – two medicines that have the potential to enhance the standard and quality of care in difficult-to-treat and debilitating types of blood cancers."

"At HIBio, we are discovering and developing transformative precision therapies for patients with autoimmune and inflammatory diseases. We are excited that we’ve reached this deal with MorphoSys, which will allow us to realize the potential of felzartamab and MOR210 across multiple autoimmune diseases," said Travis Murdoch, M.D., CEO of HIBio. "These programs are foundational to our broader strategy of developing targeted therapies for patients with autoimmune diseases, where unmet need remains high."

"We recognize there is a tremendous unmet need and opportunity to develop more precise and effective therapies for patients with autoimmune and inflammatory diseases," said Paul Berns, Managing Director at ARCH Venture Partners and HIBio Chairman, "HIBio is poised to become a leader in precision immunology, and we are pleased to add these potential best-in-class programs to our portfolio."

Under the terms of the agreements, HIBio will obtain exclusive rights to develop and commercialize felzartamab and MOR210 across all indications worldwide, with the exception of Greater China for felzartamab and Greater China and South Korea for MOR210. As part of the agreements, MorphoSys will receive a 15% equity stake in HIBio, along with certain equity earn-in provisions and standard investment rights. MorphoSys will also be represented as a member of HIBio’s Board of Directors. On achievement of development, regulatory and commercial milestones, MorphoSys will be eligible to receive payments from HIBio of up to $1 billion across both programs, in addition to tiered, single- to low double-digit royalties on net sales of felzartamab and MOR210 and will be compensated for ongoing program expenses. HIBio will assume full responsibility for future development and commercialization expenses. Upon signing, MorphoSys also receives an upfront payment of $15 million for MOR210.

Felzartamab, a novel therapeutic human monoclonal antibody derived from MorphoSys’ HuCAL antibody library and directed against CD38, is being evaluated as a potential treatment for two kidney diseases, anti-PLA2R antibody-positive Membranous Nephropathy (aMN), and Immunoglobulin A Nephropathy (IgAN), where limited treatment options are available. There are two Phase 2 trials in aMN fully enrolled and underway, M-PLACE and NewPLACE, and a Phase 2 trial being conducted in IgAN, IGNAZ. First interim data from the M-PLACE study, presented in November 2021, demonstrated that felzartamab has the potential to rapidly and substantially reduce anti-PLA2R auto-antibody titers (a serological marker for aMN) in difficult to treat patients with aMN. MOR210 is a novel human antibody directed against C5aR1, the receptor of the complement factor C5a.

BofA Securities acted as the financial advisor to HIBio, and Goodwin Procter is serving as legal counsel to HIBio for this agreement.

About Felzartamab

Felzartamab (MOR202) is a therapeutic human monoclonal antibody derived from MorphoSys’ HuCAL antibody library and directed against CD38. In Membranous Nephropathy, long-lived plasma cells drive pathogenic antibody production, contributing to functional damage to the glomeruli in the kidney. By targeting CD38, felzartamab has the potential to deplete the CD38 positive plasma cells, which may ultimately improve clinical outcomes in a broad range of autoantibody driven diseases.

MorphoSys is currently evaluating the safety and efficacy of investigational felzartamab for patients with anti-PLA2R antibody-positive membranous nephropathy (M-PLACE and NewPLACE trial) and Immunoglobulin A Nephropathy (IGNAZ trial).

In 2017, MorphoSys entered into an exclusive regional licensing agreement with I-Mab Biopharma to develop and commercialize felzartamab in Greater China which encompasses Mainland China, Hong Kong, Macau, and Taiwan. I-Mab is evaluating felzartamab in relapsed/refractory multiple myeloma and Systemic Lupus Erythematosus.

Felzartamab is an investigational drug that has not yet been approved by any regulatory authorities.

About MOR210

MOR210 is a novel human antibody directed against C5aR1 derived from MorphoSys’s HuCAL technology. C5aR1, the receptor of the complement factor C5a, is investigated as a potential new drug target in the field of autoimmune diseases and immuno-oncology. MOR210 has also been sublicensed to I-Mab Biopharma in Greater China and South Korea. I-Mab is investigating MOR210 as a treatment for relapsed or refractory advanced solid tumors. MOR210 is an investigational drug that has not yet been approved by any regulatory authorities.

About Pelabresib

Pelabresib (CPI-0610) is an investigational selective small molecule designed to promote anti-tumor activity by inhibiting the function of bromodomain and extra-terminal domain (BET) proteins to decrease the expression of abnormally expressed genes in cancer. Pelabresib is being investigated as a treatment for myelofibrosis and has not yet been evaluated or approved by any regulatory authorities.

About Tafasitamab

Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the U.S., Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as an immunotherapeutic option in B-cell malignancies in several ongoing combination trials.

Monjuvi and Minjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S. and marketed by Incyte under the brand name Minjuvi in Europe, the UK and Canada.

XmAb is a registered trademark of Xencor, Inc.

On June 14, 2022 Boehringer Ingelheim reported the signing of an option to acquire Trutino Biosciences Inc. (the "Transaction"), a San Diego-based biotech company (Press release, Boehringer Ingelheim, JUN 14, 2022, View Source [SID1234615982]).

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Trutino Biosciences is a pre-clinical stage biotech company dedicated to the discovery and development of next-generation cytokine therapies to treat immuno-oncology and autoimmune diseases. Boehringer Ingelheim is dedicated to a two-pronged research strategy to fight cancers: through cancer cell-directed and immune cell-targeting compounds. The ongoing research partnership between Boehringer Ingelheim and Trutino is part of an overarching effort to mobilize a patient’s immune system to fight cancer.

"Boehringer Ingelheim is excited to extend our partnership with Dr. Kim and his outstanding team at Trutino Biosciences. Our existing collaboration has made rapid and impressive progress in a short time frame, and we expect this field to have potential combination benefits with our existing immune-targeting assets," said Clive R. Wood, Ph.D., Corporate Senior Vice President and Global Head of Discovery Research, Boehringer Ingelheim. "The selective activation of specific cytokines localized in the tumor microenvironment holds enormous promise and has the potential to be a key element in fully harnessing the power of the immune system to fight cancer."

"It’s been two years since our initial strategic alliance began and we are very excited to further strengthen our partnership with Boehringer Ingelheim, a leader in cancer immunology, to advance potential cytokine therapeutic options that will transform the lives of cancer patients worldwide," said Phillip Kim, Ph.D., MBA, Founder and CEO of Trutino Biosciences. "Boehringer Ingelheim has a deep commitment to our innovative scientific approaches and to bringing novel cancer therapies to patients. This global partnership validates the broad potential of our proprietary ‘On Demand Cytokine’ platform. As part of this expanded collaborative framework, we aim to rapidly develop a new generation of cytokine therapies as single agent and in combination with Boehringer Ingelheim’s pipeline portfolio of cancer vaccines, oncolytic viruses, T cell engagers and other therapeutic modalities."

Under the agreement, Boehringer Ingelheim reserves the right to purchase all shares of Trutino Biosciences once specified program milestones have been achieved within a given timeframe. Until that time, Trutino will continue to operate as an independent company, with the existing fruitful strategic partnership and collaboration agreement between the companies continuing uninterrupted.

The transaction consideration consists of an option fee, the issuance of a convertible note and fixed purchase price terms to acquire Trutino Biosciences once pre-defined milestones are achieved. The option fee and principal amount of the convertible note funded by Boehringer Ingelheim at the signing of the option will collectively fully finance Trutino Biosciences through the next major development milestones of Trutino Biosciences.

Boehringer Ingelheim and Trutino Biosciences were introduced in 2019 during one of Boehringer Ingelheim’s "Grass Roots Innovation" events in San Diego. From there, in 2020 the companies forged a multi-target strategic partnership on conditionally masked cytokines. Boehringer Ingelheim’s Grass Roots programs provide biotech entrepreneurs mentoring and access to expertise and possible funding. To learn more, visit Grass Roots Innovation.