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.

On June 14, 2022 City of Hope, one of the largest cancer research and treatment organizations in the United States, reported that Philip Okala, chief operating officer at the University of Pennsylvania Health System, will join the organization as system president (Press release, City of Hope, JUN 14, 2022, View Source [SID1234615981]). In his role, Okala will be responsible for City of Hope’s portfolio of clinical care and research entities, which include City of Hope Los Angeles, City of Hope Orange County, Translational Genomics Research Institute (TGen), Beckman Research Institute of City of Hope and the recently acquired Cancer Treatment Centers of America. He will also have executive oversight of City of Hope’s medical foundation and clinical and research operations. Okala will report to Robert Stone, City of Hope’s chief executive officer, and join the organization in September of this year.

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Okala joins City of Hope after serving for the past five years as chief operating officer at the University of Pennsylvania Health System, which represents six acute care hospitals/health systems and the expansive Penn Medicine at Home enterprise, in addition to more than 43,000 employees, 8,900 credentialed physicians on staff across the system and approximately $9 billion in annual revenue. In his role, Okala had executive oversight of the health system’s hospitals, clinical service line operations, corporate emergency management and overall system integration. Prior to this role, Okala served for five years as senior vice president for business development at Penn Medicine, overseeing strategy and business development initiatives. He has previously held leadership roles at the Geisinger Health System, Roswell Park Cancer Institute, MD Anderson Cancer Center and the Michael E. DeBakey VA Medical Center.

"As we set the stage for City of Hope’s next 100 years of service to cancer patients and their families, I could not imagine a better leader to accelerate our mission than Phil Okala," said Robert Stone, the Helen and Morgan Chu Chief Executive Officer Distinguished Chair. "Phil has an extraordinary set of leadership skills and experience, managing operations and executive teams across a complex health system and research organization. His expertise will be immensely valuable as we further our goal to democratize cancer care and create a system that develops the next generation of research discoveries, treatment and care and makes them accessible to more patients, families and communities across the country."

Today’s leadership announcement is the latest milestone in City of Hope’s transformation into a national cancer research and treatment system. In recent years, City of Hope has grown substantially with the expansion of its clinical network in Southern California, addition of genomics leader TGen, launch of its employer cancer care benefits offering AccessHopeTM, the acquisition of Cancer Treatment Centers of America and a new cancer center in Orange County, California, scheduled to open in 2022.

"City of Hope’s vision to make cancer care more accessible to more people across the country is part of what really attracted me and got me excited about the opportunity," said Okala, incoming City of Hope system president. "When you talk to people who work at City of Hope or walk through the campus, you feel the culture, values and absolute commitment to the patient that comes through in each and everything they do. It’s a special place, and the system we’re building will allow even more people to experience the unique power and talent this organization has to offer patients in their moments of need."

City of Hope’s system of provider and research entities serves approximately 115,000 patients each year, with more than 11,000 team members, 575 physicians and more than 1,000 scientists and researchers across a network of locations in California, Arizona, Illinois and Georgia.

On June 14, 2022 Immunicom, Inc., a privately held clinical-stage biotechnology company with a transformative immuno-oncology platform, reported that it has been awarded $2 million by the National Cancer Institute (NCI) and National Institutes of Health (NIH) to initiate its first US-based clinical trial at the Baylor College of Medicine in Houston, Texas (Press release, Immunicom, JUN 14, 2022, View Source;Breast-Cancer [SID1234615980]). The trial [NIH/NCI Grant 1R44CA261565-01A1], to be conducted in collaboration with Dr. Mothaffar F. Rimawi, Professor of Medicine/Oncology and Executive Medical Director, Dan L. Duncan Cancer Comprehensive Center, Baylor College of Medicine, will evaluate the safety, tolerability, and efficacy of the FDA Breakthrough Immunopheresis LW-02 Molecular Ligand-Capture Column for treating refractory, hormone-resistant breast cancers.

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"We are honored to receive this grant from the NCI/NIH recognizing the potential of Immunopheresis therapy. This clinical trial is a monumental step for Immunicom to address unmet needs for patients with difficult-to-treat cancers," said Principal Investigator Dr. Robert Segal, Immunicom’s Chief Medical Officer. "We feel confident that further evaluation of Immunopheresis, both alone and as an adjunct to chemotherapy, will demonstrate that this is an essential new modality for immuno-oncology. Through this US-based trial, we will seek further evidence that Immunopheresis safely and effectively treats cancer and has a positive effect on the quality of patients’ lives, as has been observed in the Company’s three ongoing global trials conducted in 67 patients, with over 2,000 treatments completed to date."

The Company’s LW-02 Molecular Ligand-Capture technology, which received FDA Breakthrough designation in 2018, is designed to remove specific factors (sTNF-R1/2) shed by cancer cells that inhibit endogenous tumor necrosis factor alpha (TNF-α), a cytokine widely recognized for its tumoricidal behavior. In a process like dialysis, Immunopheresis therapy removes sTNF-R1/2 from plasma, helping kickstart endogenous TNF-α response to cancer without toxicities that increase the risk of side effects.

The exploratory study of 12 subjects will evaluate Immunopheresis therapy in metastatic, hormone-refractory ER+/HER2- breast cancer patients who have failed at least two lines of hormone therapy, and one to two lines of chemotherapy. These patients will be recruited to receive Immunopheresis LW-02 Column induction monotherapy over a two-week period, then in combination with low-dose chemotherapy for an additional 14 weeks. Throughout treatment, patients will be monitored for reduction of circulating sTNF-R1/2 and adverse events. Objective response and clinical benefit will be exploratory; quality-of-life/clinical function, circulating CT-DNA and tumor cells, and markers of an immunologic response (including in tissue) will also be evaluated. Clinical response to treatment and tumor burden will be monitored by standard RECIST v1.1/iRECIST criteria (MRI/CT), and follow-up for up to one year will include evaluating subjects for progression free survival (PFS), best overall response (BOR), overall response rate (ORR), and overall survival (OS).

Subtractive Therapy – Immunopheresis and the LW-02 Column

Immunicom employs a proprietary, high-affinity, molecular capture-ligand binding matrix within the LW-02 Column to remove specific cytokine receptors, soluble TNF-Receptors 1 and 2 (sTNFR-1/2), that are shed by cancer cells into the extracellular tumor microenvironment. sTNF-Rs serve as decoys, binding to tumor necrosis factor alpha (TNF-α) before it can bind to its membrane-embedded sTNF-R receptors to trigger several cell death pathways, as well as modulate antitumor cytotoxic T-cells and macrophage activity. The selective removal of decoy sTNF-Rs by the LW-02 Column allows the patient’s immune system to identify and aggressively attack the cancer.

Immunopheresis, like dialysis, is a subtractive therapy that occurs outside the body, in contrast to conventional drugs and biologics that are infused into the patient. Immunopheresis is thus intended to be much better tolerated than chemo- and immunotherapies, allowing for its use as an adjunct with these therapies, possibly in lower doses to reduce their toxicity. The Immunopheresis platform is a targeted removal therapy that can selectively remove any soluble factor. Immunicom has multiple cytokine and soluble targets under development, including IL-6, VEGF, IL-1 beta, and soluble PD-L1, with others to follow.

On June 14, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported a poster presentation on DecisionDx-Melanoma at the recent 2022 Fall Clinical Dermatology Conference for PAs & NPs (Press release, Castle Biosciences, JUN 14, 2022, View Source [SID1234615979]). The poster, titled "Attitudes of Patients with Cutaneous Melanoma Towards Prognostic Testing Using Gene Expression Profiling," shares results from a survey of 120 melanoma patients regarding prognostic testing with DecisionDx-Melanoma. The poster can be viewed here.

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"The number of invasive melanoma diagnoses has risen by 31% over the last decade,1 and in 2022 alone, it is estimated that melanoma will claim over 7,000 lives.2 For this reason, a diagnosis of malignant, invasive melanoma can be terrifying for patients," said Kyleigh LiPira, M.B.A., study author and chief executive officer of the Melanoma Research Foundation (MRF). "In the survey, a significant majority of patients desired testing with DecisionDx-Melanoma after receiving a melanoma diagnosis and appreciated the in-depth information provided by the results, regardless of whether they received low or high-risk scores."

Highlights from survey results:

90% of patients wanted prognostic information about their tumors at diagnosis.
Patients wanted DecisionDx-Melanoma testing to increase their knowledge about their disease (76.9%) and inform treatment decisions (46.2%).
More than 90% of patients felt the testing was useful and that they gained understanding (60.7%) and relief from uncertainty (39.3%).
Patients receiving results from their DecisionDx-Melanoma test did not experience decision regret, even among patients who received a DecisionDx-Melanoma Class 2 (high-risk) test result.
DecisionDx-Melanoma provides personalized information based on a patient’s biological risk of metastasis and recurrence that can aid clinicians and patients in making more informed and risk-aligned decisions about the management of their melanoma.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma (CM) metastasis or recurrence, as well as the risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 6,300 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. Additionally, Castle has an ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on CM cases. This collaboration has resulted in Castle’s analysis of 5,226 samples (clinically tested through December 31, 2018) in a study to evaluate melanoma-specific survival and overall survival; in this study, patients tested with DecisionDx-Melanoma had better survival rates than untested patients, and the data suggested that DecisionDx-Melanoma can accurately risk-stratify for disease progression to aid in risk-aligned treatment plans for improved patient outcomes and survival. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Additionally, impact on patient management plans for one of every two patients tested has been shown in five multi-center/single-center studies including more than 800 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Through March 31, 2022, DecisionDx-Melanoma has been ordered 97,288 times for patients with cutaneous melanoma.