On July 26, 2022 Blueprint Medicines Corporation (NASDAQ: BPMC) reported that it will host a live conference call and webcast at 8:00 a.m. ET on Tuesday, August 2, 2022 to report its second quarter 2022 financial results and provide a corporate update (Press release, Blueprint Medicines, JUL 26, 2022, View Source [SID1234616958]).

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To access the live conference call, please dial 844-200-6205 (domestic) or 929-526-1599 (international), and refer to conference ID 694684. A webcast of the call will also be available under "Events and Presentations" in the Investors & Media section of the Blueprint Medicines website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

On July 26, 2022 Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries and/or associate companies) and Cassiopea, a subsidiary of Cosmo Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) ("Cosmo") reported the signing of addendums to the License and Supply Agreements for WINLEVI (clascoterone) cream 1% expanding the territory to include Japan, Australia, New Zealand, Brazil, Mexico and Russia (Press release, Sun Pharma, JUL 26, 2022, View Source [SID1234616957]). In 2021, Sun Pharma and Cassiopea had signed License and Supply Agreements for the United States and Canada markets. Sun Pharma launched WINLEVI in the US market in November 2021.

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Under the terms of the above referred agreements, Sun Pharma will receive from Cassiopea the exclusive right to develop and commercialize WINLEVI in Japan, Australia, New Zealand, Brazil, Mexico and Russia. Cosmo will be the exclusive supplier of the product. Cassiopea will receive an upfront payment of US$ 7 million, potential regulatory and sales milestones and customary double-digit royalties on net sales.

Aalok Shanghvi, EVP & Head – Generic R&D, Generic Global BD and Emerging Markets, Sun Pharma said, "WINLEVI is a new class of topical medication and it continues to generate significant interest amongst dermatologists in the US. The expansion of our agreement with Cosmo will enable us to make this new acne treatment available to patients in many more countries and is in line with our strategy to build a global portfolio of specialty products."

Diana Harbort, President of Cosmo Dermatology Division, said: "We are very pleased to expand our agreement with Sun Pharma making WINLEVI available to more patients around the world. Sun Pharma’s early success with WINLEVI in the US makes us highly confident of their ability to maximize the opportunity in the expanded territory."

A first-in-class topical androgen receptor inhibitor, WINLEVI was approved by the U.S. Food and Drug Administration (FDA) in August 2020 for the topical treatment of acne vulgaris in patients 12 years of age and older. Although its exact mechanism of action is unknown, laboratory studies suggest that WINLEVI works by inhibiting the effects of androgen receptors in cells of the sebaceous glands (oil-producing glands in the skin) to help reduce sebum (oil) production and inflammation.3 It is suitable for use in both males and females.1 WINLEVI is the first FDA-approved acne drug with a first-in-class mechanism of action in nearly 40 years.1,2

On July 26, 2022 Oxford Biomedica plc (LSE:OXB) ("Oxford Biomedica" or "the Company"), a leading gene and cell therapy group, reported that it has signed a new Licence and Supply Agreement ("LSA") with an undisclosed US-based private biotechnology company advancing a new generation of adoptive cell therapies (Press release, Oxford BioMedica, JUL 26, 2022, View Source [SID1234616956]). The LSA grants the new partner a non-exclusive licence to utilise Oxford Biomedica’s LentiVector platform for its application in their lead CAR-T programme, and puts in place a three-year Clinical Supply Agreement.

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Under the terms of the LSA, Oxford Biomedica will receive an undisclosed upfront payment, as well as additional payments related to the development and manufacturing of lentiviral vectors for use in clinical trials. The Company will also receive certain development and regulatory milestone payments and an undisclosed royalty on the net sales of products sold that utilise the Company’s LentiVector platform.

Stuart Paynter, Chief Financial Officer of Oxford Biomedica, commented: "This new partnership further demonstrates the strength of our LentiVector platform. This is another example of our important role in supporting the development of potentially life-saving CAR-T therapies and has been made possible by the fact we’ve been able to offer strategically re-acquired targets to our customers. As a leading viral vector specialist, we look forward to continuing to build upon our position as a partner of choice in cell and gene therapy."

On July 26, 2022 Oxford Biomedica plc (LSE:OXB) ("Oxford Biomedica" or "the Company"), a leading gene and cell therapy group, reported that it has initiated a new project with Orchard Therapeutics utilising the Company’s proprietary LentiStable technology (Press release, Oxford BioMedica, JUL 26, 2022, View Source [SID1234616955]).

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As part of the project, Oxford Biomedica’s LentiStable technology platform will be used to develop a producer cell line capable of stably expressing lentiviral vectors. Using this technology, the project will be focused on developing high-performing candidate clones for Orchard Therapeutics’ OTL-203, an investigational hemopoietic stem cell (HSC) gene therapy in development for the potential treatment of mucopolysaccharidosis type I Hurler’s syndrome (MPS-IH). As part of an existing collaboration, established in November 2016, Orchard Therapeutics will explore the technology to increase the manufacturing efficiency and scalability of HSC gene therapy.

Oxford Biomedica’s cutting edge LentiStable technology platform, which is the result of more than 10 years of optimisation work, allows the development of a mammalian cell line which can use a chemical inducer to generate viral vector production without the need for transient transfection. This technology has the potential to deliver highly efficient producer cell lines to enable streamlined, scalable and cost-effective manufacturing.

Dr. Kyriacos Mitrophanous, Chief Scientific Officer of Oxford Biomedica, commented: "We are pleased to enter into a new project with Orchard Therapeutics, a global gene therapy leader. We are committed to innovation and to the ongoing development of our platform, which is key to our goal of widening access to gene therapy by lowering the cost of viral vector manufacturing. Our proprietary LentiStable technology shows great promise in support of this goal and underlines our overall position as a leader in cell and gene therapy and our ambition to remain at the forefront of this important work for patients globally."

Nicoletta Loggia, Ph.D., Chief Technical Officer of Orchard Therapeutics, added: "This project underscores Orchard’s commitment to continued innovation in all aspects of our operations, including manufacturing. The evaluation of stable cell producer lines is part of our focus on establishing a sustainable lentiviral vector manufacturing platform. We look forward to working with Oxford Biomedica to further explore this technology for the HSC gene therapy field."

On July 26, 2022 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported the enrollment of the 36th patient in the ENVASARC pivotal trial at the 600 mg dose of envafolimab, which enables the initial independent data monitoring committee (IDMC) interim efficacy analysis to proceed (Press release, Tracon Pharmaceuticals, JUL 26, 2022, View Source [SID1234616954]). The interim analysis is expected to occur in the fourth quarter of this year.

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The initial IDMC interim efficacy analysis proceeds after the 36th patient has been enrolled for at least three months to permit two on study scans to determine the preliminary objective response rate. One objective response is required in each of the trial’s two cohorts to continue accrual in that cohort. The first cohort includes the initial 18 patients who receive single agent envafolimab and the second cohort includes 18 patients who receive envafolimab with ipilimumab. A second IDMC interim efficacy analysis is expected in 2023 following enrollment of the 92nd patient.

"We are pleased at the pace of enrollment in ENVASARC and have accrued more than 36 patients in fewer than six months since the FDA approved the amended protocol. As a result, we are currently ahead of the enrollment projection that would allow for full accrual of the 160 planned patients dosed with 600 mg of envafolimab before the end of 2023," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We look forward to reporting the IDMC recommendations following the two interim safety analyses and interim efficacy analysis expected this year."

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.