On June 13, 2022 Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) ("Sirona") reported it has entered into a global exclusive licensing agreement with Allergan Aesthetics, an AbbVie company (NYSE: ABBV), pursuant to which Allergan Aesthetics will develop and commercialize topical skin care treatments based on active ingredients derived from certain of Sirona’s patents for TFC-1067 and related family of compounds (Press release, Sirona Biochem, JUN 13, 2022, View Source [SID1234615935]).

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"We are very pleased to have finalized terms with a global leader in medical aesthetics and the innovator behind SkinMedica, a leader in the science of skin rejuvenation," said Dr. Howard Verrico, CEO of Sirona Biochem. "Our most recent clinical trial of TFC-1067 was a collaborative effort with Allergan Aesthetics to demonstrate the clinical potential in topical skin care treatments. This further validates our platform technology as viable for additional commercial products which we are actively pursuing. We would like to thank Dr. Linda Pullan of Pullan Consulting who assisted with our current success."

"Allergan Aesthetics’ global presence in the aesthetic space and goal to further enhance aesthetic medicine combined with Sirona’s disruptive technology made this all possible," reports Dr. Linda Pullan, of Pullan Consulting.

Under the license agreement, Sirona will a receive an upfront payment and further payments on achievement of milestones and royalties on product sales and has also agreed to financial terms as a supplier of its compounds.

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.

On June 13, 2022 Hamlet Pharma reported that signed a joint development agreement with Neurochase Limited, founded by Professor Steven Gill, a world leading expert in the area of neurosurgery, to develop novel technology and methods to treat Central Nervous System (CNS) tumors with Alpha1H (Press release, HAMLET Pharma, JUN 13, 2022, View Source;utm_medium=rss&utm_campaign=brain-tumor-therapy-a-new-indication-for-hamlet-pharma [SID1234615967]).

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Alpha1H is effective against a range of solid and haematological tumor cells that commonly metastasize to the CNS. Early studies in rats have shown that infusion of HAMLET into the brain markedly delayed the progression of glioblastomas. Glioblastomas are highly invasive and malignant brain tumours with a poor prognosis, accounting for about 60% of all primary brain tumors. At the time of diagnosis, the tumors are mostly inaccessible to complete surgical removal due to spread of tumor cells from the primary tumor site and there is a lack if efficient, alternative treatments.

As a pioneer in this field, Professor Gill has invented new technologies for drug delivery into the brain and used them successfully in the treatment of neurological diseases and cancers. In this collaboration between Neurochase and Hamlet Pharma, new technology will be developed for delivery of Alpha1H to the leptomeninges for treatment of primary and secondary CNS tumors. The collaboration will primarily explore infusion of Alpha1H in an animal model in preparation for clinical trials.

Steven Gill said "We are delighted to be collaborating with Hamlet Pharma on this programme. Alpha 1H has shown very promising results to date as a potential treatment for CNS tumors. I am hopeful that by working together we can improve the otherwise poor outcome for patients with CNS tumors".

" Combining this novel technology with Alpha1H to explore the treatment of brain tumors is a very exiting prospect", says Catharina Svanborg, Professor and Chairman of Hamlet Pharma AB.

On June 13, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patient’s body, reported that it will take part in a fireside chat at the JMP Securities Life Sciences Conference being held June 15–16, 2022 (Press release, Cue Biopharma, JUN 13, 2022, View Source [SID1234615936]).

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During the fireside chat, Cue Biopharma will provide an overview highlighting its ongoing clinical trials and an update on its Corporate Development initiatives.

Presentation Details
JMP Securities Life Sciences Conference
Date and Time: Thursday, June 16 at 1:00 p.m.–1:25 p.m. EDT
Webcast Link: View Source

A live and archived webcast of the presentation will be available on the Events page in the Investors and Media section of the Company’s website at www.cuebiopharma.com. The webcast will be archived for 30 days.

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

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.