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 Nascent Biotech Inc (OTCMKTS: NBIO) reported that it is making a steady run northbound off its base at a nickel and saw some of its biggest gains while the overall markets saw steep declines (Press release, Nascent Biotech, JUN 14, 2022, View Source [SID1234615968]). NBIO is a low float biotech whose lead product Pritumumab (PTB) targeting Glioblastoma is being studied in Phase I clinical trials. On Friday the Company announced the completion of the Third cohort in dosing patients for its Phase I trial for Brain Cancer. After reviewing the data gathered from the first three cohorts, this milestone will allow the trial to advance to the fourth and possibly final cohort.

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Pritumumab works by binding to a target on the surface of cancer cells called ectodomain vimentin (also referred to as cell-surface vimentin). The target, generally referred to as an antigen, is prevalent in many different tumor types and is not being targeted by any other biopharmaceutical companies. By binding to this target, Pritumumab is able to make the tumor cells "known" to the body’s immune system, resulting in potentially several types of immune responses, including anti-idiotype, apoptosis, antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity, leading to death of the cancer cells and overall depletion of the tumor.

Nascent Biotech Inc (OTCMKTS: NBIO) operating out of Vero Beach, Florida is a clinical-stage biotech company pioneering the development of monoclonal antibodies to be used in the treatment of various cancers and viral infections, helping people worldwide. Its products are not yet commercially available. The Company’s lead candidate, Pritumumab (PTB), is a monoclonal Antibody (Mab) that the Company is developing as a treatment for epithelial cancers (which includes lung, breast, colon, brain, and pancreas). Currently Pritumumab (PTB) has received FDA orphan drug status and is being studied in Phase I clinical trials for the treatment of Brain Cancer. The Company is led by CEO Sean Carrick who has an extensive track record of success with a career that spans more than 30 years of building and leading successful Life Science Companies in large, mid-cap and venture-backed stages

Current brain cancer therapeutic strategies include chemotherapy drug Temodar, surgery, and/or radiation. Even when removed, most brain tumors come back within one-year post-surgery. With current standards of care, only 58% of brain cancer patients live past the first year after diagnosis with certain types, anaplastic astrocytoma and glioblastoma, the five-year survival rates are 27% and 5%, respectively

Based on pre-clinical and clinical studies, the Company believes Pritumumab may offer an advantage over existing treatments. Nascent has addressed manufacturing questions by re-engineering antibody production into the commonly used CHO cell expression system. Pritumumab works by binding to a target on the surface of cancer cells called ectodomain vimentin (also referred to as cell-surface vimentin). The target, generally referred to as an antigen, is prevalent in many different tumor types and is not being targeted by any other biopharmaceutical companies. By binding to this target, Pritumumab is able to make the tumor cells "known" to the body’s immune system, resulting in potentially several types of immune responses, including anti-idiotype, apoptosis, antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity, leading to death of the cancer cells and overall depletion of the tumor.

Nascent expects to amplify on the past clinical development strategy during the next 12 months plan to: complete Phase I clinical trials in the United States, establishing safety and the optimal dose of Pritumumab for treatment of patients with brain cancers. Commence Phase 2 clinical trials in the United States and China with Pritumumab for the treatment of lung cancer and breast cancer that has metastasized to the brain and continue to evaluate the application of Pritumumab in the treatment of other ectodomain vimentin positive cancer types (pancreatic, lung and colon) where there may be unmet medical needs.

On December 7, 2018, Nascent received FDA clearance to begin clinical trials with its first drug product lot but left the Company on partial clinical hold for the bulk substance lot. On December 1, 2020, the Company received FDA clearance to begin clinical trials with the second lot. The Company commenced the Phase I trial. In March 2021, the Company enrolled its initial patient. In May 2021, the first three patient cohort was enrolled.

On June 7 NBIO announced the completion of the Third cohort in dosing patients for its Phase I trial for Brain Cancer. After reviewing the data gathered from the first three cohorts, this milestone will allow the trial to advance to the fourth and possibly final cohort. As the fourth cohort is underway, Nascent will also be performing PK studies to help determine if a fifth cohort is needed. Patient enrollment will continue for Phase I. Anyone interested may review trial requirements at www.clinicaltrials.gov, then search Pritumumab.

Nascent CEO Sean Carrick announced "Having completed the first three cohorts, we are excited to move to our fourth and possibly final cohort in the Phase I trial. The third cohort took longer than expected but the data received is very useful moving forward," noted Nascent CEO, Sean Carrick, further stating that,

According to a recent ResearchAndMarkets report the global brain tumor drugs market is expected to grow from $3.17 billion in 2021 to $3.49 billion in 2022 at a compound annual growth rate (CAGR) of 10.2%. The growth is mainly due to the companies rearranging their operations and recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $4.84 billion in 2026 at a CAGR of 8.5%.

Currently trading at an $18 million market valuation, NBIO has 113,063,175 shares outstanding, 57,804,675 of which are restricted leaving 55,258,500 free trading NBIO shares worth $9 million. NBIO is fully reporting OTCQB and recent filings show the entire NBIO management team acquiring and exercising stock options at $0.05 in April. Since than the stock has been rising steadily as the Pritumumab (PTB) Phase I trials progress. Pritumumab targets the Glioblastoma market worth $3.5 billion globally. On Friday the Company announced the completion of the Third cohort in dosing patients for its Phase I trial. After reviewing the data gathered from the first three cohorts, this milestone will allow the trial to advance to the fourth and possibly final cohort. The Company hopes to progress to Phase 2 clinical trials in the United States and China with Pritumumab for the treatment of lung cancer and breast cancer that has metastasized to the brain and continue to evaluate the application of Pritumumab in the treatment of other ectodomain vimentin positive cancer types (pancreatic, lung and colon).

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 Pascal Biosciences Inc. ("Pascal" or "the Company") (TSXV:PAS) (OTC:PSCBF) (FSE: 6PB-FF) reported a renewed and expanded emphasis on the consulting and contract research component of the business. Pascal has previously had success by providing resources to other biotech companies (Press release, Pascal Biosciences, JUN 14, 2022, View Source [SID1234615969]). In particular, the Company worked with SoRSE Technology last year, bringing over $600,000 into the company. Pascal scientists have, combined, over 80 years of experience in biotechnology projects and have been involved in the discovery, preclinical, and clinical development of drugs approved by the FDA. Our intent is to leverage this expertise to provide consulting and research services to customers with projects primarily in the post-discovery to Phase I period of development.

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"Drug development has long timelines and, unless new drug candidates are forthcoming, preclinical teams tend to become redundant once a drug enters clinical studies." stated CEO Dr. Brian Bapty. "By providing virtual preclinical services, Pascal can provide the direction, experience, and facilities to efficiently support multiple preclinical programs." As with the SoRSE contract, Pascal will provide shared expertise and infrastructure so Biotech clients benefit from economies of scale while limiting fixed costs.

Pascal is in process of updating the website to reflect these changes. Pascal will continue development of internal programs notably, for Acute Lymphoblastic Leukemia which is funded by an NIH Grant, and glioblastoma which will be supported by funds from operations.

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.