Evotec enters a drug discovery collaboration with Janssen

On June 13, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that the Company has entered a drug discovery collaboration with Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson ("Janssen") (Press release, Evotec, JUN 13, 2022, View Source [SID1234615954]). Evotec’s innovative TargetAlloMod platforms will be evaluated to discover first-in-class novel mode of action therapeutic candidates. The agreement was facilitated by Johnson & Johnson Innovation.

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Under the agreement, Evotec and Janssen will jointly conduct screens on the identified targets and collaborate with hit identification and lead optimisation of the most promising chemical assets, leveraging Evotec’s end-to-end integrated drug discovery and development platform.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "We are very proud to enter into this collaboration to explore unique approaches to high potential cell surface drug targets with novel therapeutic modalities and to deliver and make innovative therapeutic options available to patients."

Besides research funding, Evotec is entitled to success-based research and commercial milestones up to approximately € 210 m per project as well as tiered royalties on products resulting from this collaboration.

About TargetAlloMod
Scientists at Evotec have discovered that for certain extracellular receptors, small molecules can bind allosterically and induce a natural proteolytic cleavage process to shed the ectodomain. This results in the disruption of cell signalling and the shed ectodomain can, in many cases, further act as a sink for the native ligand of the targeted receptor. The TargetAlloMod platform comprises a suite of proprietary assay principles and computational tools to assess and screen extracellular receptor targets for shedding and the induction of shedding by small molecule allosteric modulators. This platform has broad applicability across many therapeutic areas.

Pfizer, MorphoSys and Incyte Enter into Clinical Trial Collaboration for Monjuvi® (tafasitamab-cxix) in Combination with TTI-622, a Fusion Protein Directed Against CD47

On June 13, 2022 Pfizer Inc. (NASDAQ:PFE), MorphoSys U.S. Inc., a fully owned subsidiary of MorphoSys AG (FSE: MOR; NASDAQ:MOR), and Incyte (NASDAQ:INCY) reported that a clinical trial collaboration and supply agreement to investigate the immunotherapeutic combination of Pfizer’s TTI-622, a novel SIRPα-Fc fusion protein, and Monjuvi (tafasitamab-cxix) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT) (Press release, MorphoSys, JUN 13, 2022, View Source [SID1234615926]).

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"TTI-622 blocks the signal-regulatory protein (SIRP)α–CD47 axis, which is a key checkpoint expected to become an important backbone immunotherapy across multiple tumors, especially hematological cancers," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. "The early results for TTI-622 in late-line advanced lymphoid malignancies reflect the potential for class-leading monotherapy activity, and preclinical evidence with a diverse set of therapeutic agents provide a strong rationale for testing combination therapies. We are pleased to collaborate with MorphoSys and Incyte, generating additional evidence on the potential of TTI-622 to improve outcomes for patients with DLBCL."

‟Monjuvi in combination with lenalidomide is an important treatment option for patients with relapsed or refractory diffuse large B-cell lymphoma, and its mechanism of action, efficacy and safety profile make it an attractive combination partner," said Malte Peters, M.D., MorphoSys Chief Research and Development Officer. "We believe that the addition of novel immunotherapies, such as the investigational anti-CD47 blocking agent TTI-622, to the backbone of Monjuvi plus lenalidomide have the potential to provide new meaningful combination treatment options for patients with relapsed or refractory diffuse large B-cell lymphoma."

‟This collaboration has the potential to advance patient care in an area where there continues to be significant unmet medical need," said Lance Leopold, M.D., Group Vice President, Clinical Development Hematology and Oncology at Incyte. "We are proud to support this research effort to evaluate the potential of a new chemotherapy-free combination for these patients."

Pfizer’s TTI-622 is currently in Phase 1b/2 development across several indications, with a focus on hematological malignancies. CD47 is an innate immune checkpoint that binds SIRPα and delivers a "don’t eat me" signal to suppress macrophage phagocytosis. Overexpression of CD47 in solid and hematological malignancies, including in DLBCL, is associated with poor prognosis.
Monjuvi (marketed ex-U.S. as Minjuvi), a CD19-directed immunotherapy, in combination with lenalidomide is a treatment for adult patients with relapsed or refractory DLBCL not otherwise specified, and who are not eligible for ASCT. In this indication, accelerated or conditional approvals were granted by the U.S. Food and Drug Administration, the European Medicines Agency and other regulatory authorities. Monjuvi is being co-commercialized by MorphoSys and Incyte in the United States. Incyte has exclusive commercialization rights outside the United States.

Preclinical data by Morphosys have shown a strong synergy of Monjuvi and anti-CD47 antibodies in in vitro and in vivo lymphoma models, providing scientific rationale for investigating this combination in clinical trials. This preclinical data was presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in 2020.
Under the terms of the agreement, Pfizer will initiate a multicenter, international Phase 1b/2 study of TTI-622 with Monjuvi and lenalidomide for patients with relapsed or refractory DLBCL who are not eligible for ASCT. MorphoSys and Incyte will provide Monjuvi for the study, which will be sponsored and funded by Pfizer and is planned to be conducted in North America, Europe and Asia-Pacific.
The collaboration is effective immediately upon the execution of the agreement.

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 United States, 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 marketing authorization 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 a therapeutic 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.

Oxford BioTherapeutics Announces Research Collaboration with ImmunoGen to Develop Novel Antibody-Drug Conjugates

On June 13, 2022 Oxford BioTherapeutics (OBT), a clinical stage oncology company with a pipeline of immuno-oncology and Antibody Drug Conjugate (ADC)-based therapies, reported a multi-year collaboration to research, develop and commercialize novel, first-in-class ADCs with ImmunoGen (IMGN), a leader in the expanding field of ADCs for the treatment of cancer (Press release, Oxford BioTherapeutics, JUN 13, 2022, View Source [SID1234615951]). The companies will utilize ImmunoGen’s linker-payload technology directed to novel targets identified via OBT’s proprietary OGAP discovery platform. The companies will support these R&D efforts through joint funding and by combining their respective proprietary technologies.

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"I am very enthusiastic about our new partnership with ImmunoGen, a leader in the development of ADCs," said Christian Rohlff, PhD, Chief Executive Officer (CEO) of Oxford BioTherapeutics. "The company’s expertise, in combination with the unique targets from our OGAP database, provides potential to strengthen our respective drug pipelines with novel and highly differentiated ADCs for cancer patients in need of novel therapeutic options."

As part of the agreement, OBT will receive an upfront payment from ImmunoGen, reflecting OBT’s preclinical programs to be included in the partnership.

In addition, once antibodies generated by OBT have been coupled with ImmunoGen’s proprietary linker-payload technology, each company will have the opportunity to select one or more development programs to further develop on its own.

Each company is eligible to receive milestone payments based on the achievement of pre-specified development, regulatory, and commercial milestones, as well as tiered royalties as a percentage of worldwide commercial sales, with respect to each program selected by the other company. Once a company has chosen a given program, it will be solely responsible for all R&D costs associated with the specific program.

"OBT has demonstrated expertise in identifying novel targets for the development of specific antibodies – two key components to generating successful ADCs," said Stacy Coen, ImmunoGen’s Senior Vice President and Chief Business Officer. "This expertise, combined with ImmunoGen’s portfolio of cancer-killing payloads and linkers, will be instrumental as both companies work to develop novel ADCs designed to address cancers with high unmet need. We look forward to working with OBT as we expand and diversify our investment in ADC research capabilities, deepen our pipeline, and transition to a fully-integrated oncology company."

ImmunoGen’s portfolio is comprised of next-generation maytansinoid, DNA-acting, and novel camptothecin toxins and proprietary linkers. This collaboration will utilize novel targets identified by OBT combined with ImmunoGen’s proprietary toxins and associated linkers. OBT has clinical experience with ImmunoGen’s ADC platform and DM4 payload, which is utilized in OBT’s lead program OBT076, an ADC currently in clinical trials as a monotherapy, as well as in combination with checkpoint inhibitors, in patients with advanced or refractory solid tumors, including gastric, bladder, ovarian, and lung cancer.

NeoImmuneTech to Present at Upcoming BIO International Convention

On June 13, 2022 NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), a clinical-stage T cell-focused biopharmaceutical company, reported that its Chief Business Officer, Sam Zhang, Ph.D., MBA, will present a company update at the upcoming BIO International Convention, to be held June 13-16 in San Diego, CA (Press release, NeoImmuneTech, JUN 13, 2022, View Source [SID1234615950]).

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Sam Zhang, Ph.D., MBA, NeoImmuneTech Chief Business Officer said: "One week after NeoImmuneTech presented new promising data at ASCO (Free ASCO Whitepaper) 2022 congress, the BIO International Convention is a perfect opportunity to remind the scientific and industry community about the momentum of our broad development program with NT-I7, our long-acting human IL-7, in combination with checkpoint inhibitors and CAR-Ts".

The details of the company’s presentation are as follows:

BIO International Convention

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.

Jubilant Radiopharma Joins Illuccix® Pharmacy Partner Network

On June 13, 2022 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported that its prostate cancer imaging agent, Illuccix (kit for preparation of gallium Ga 68 gozetotide), is now available at selected pharmacies in the Jubilant Radiopharma network (Press release, Telix Pharmaceuticals, JUN 13, 2022, View Source [SID1234615949]). Illuccix is now available to order from 139 pharmacy sites across the United States, ensuring scheduling flexibility and patient access to advanced prostate cancer imaging.

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The expansion of the distribution network facilitates broader patient access to Illuccix across the country, expanding availability into new regional markets that to date have had limited access to PSMA PET imaging.

Dr. Christian Behrenbruch, Telix Group CEO and Managing Director said, "A key feature of Illuccix is its flexibility and availability for physicians and patients alike. Our goal is to ensure broad access to PSMA PET imaging from the largest metropolitan cities to regional areas and the expansion of the distribution network to include Jubilant Radiopharma puts an Illuccix scan within reach of even more patients in need."

"We are pleased to be able to expand our range and service to include Illuccix, and offer our customers the added convenience of PSMA PET imaging with Illuccix," says Renato Leite, President, Jubilant Radiopharmacies Division.