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 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.

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.

On June 13, 2022 Nammi Therapeutics, Inc. (Nammi), an LA-based immunotherapy company, reported that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its lead program, QXL138AM, for the treatment of multiple myeloma (Press release, Nammi Therapeutics, JUN 13, 2022, View Source [SID1234615948]).

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QXL138AM is a Masked Immunocytokine (MIC) that targets a masked interferon alpha (IFNα) to the CD138 protein on the surface of the tumor cells. Once bound to the tumor cell, proteases on the tumor cell surface cleave the mask off the IFNα allowing it to bind its receptor. Activation of the IFNAR complex induces direct killing of myeloma cells as well as activating innate and adaptive anti-tumor immunity.

Multiple Myeloma is a relatively rare form of cancer, with the American Cancer Society estimating over 34,000 new cases and 12,000 deaths from multiple myeloma this year. While therapeutics have extended survival, it remains largely incurable. IFNα based therapeutics have demonstrated anti-tumor activity in clinical studies but are infrequently used due to significant toxicities. QXL138AM directly addresses this toxicity issue by targeting the IFNα to the myeloma cells with an anti-CD138 antibody and by masking the IFNα activity until it gets to the tumor.

About QXL138AM
QXL138AM is a first in class MIC comprised of a CD138-targeted antibody fused with Interferon alpha (IFNα) that is masked with a tumor-selectively releasable peptide. CD138 is expressed in multiple myeloma as well as many different solid tumor indications including pancreatic, breast, colon, hepatic, ovarian, urothelial, and head and neck cancers. Nammi Therapeutics is expecting to file an Investigational New Drug (IND) application with the FDA to allow initiation of clinical studies this year.

On June 13, 2022 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, and PT Etana Biotechnologies Indonesia ("Etana"), reported that the Indonesian Food and Drugs Authority (BPOM) has approved Bevagen (bevacizumab biosimilar), a recombinant humanized anti-VEGF monoclonal antibody drug, for five indications including metastatic colorectal cancer (mCRC), locally recurrent or metastatic triple negative breast cancer (mTNBC), advanced, metastatic, or recurrent non-small cell lung cancer(NSCLC), epithelial ovarian, fallopian tube, and primary peritoneal cancer (OC), and cervical cancer(CC) (Press release, Innovent Biologics, JUN 13, 2022, View Source [SID1234615947]). Etana will commercialize Bevagen in Indonesia under the current licensing agreement with Innovent. Bevagen will potentially be the first Chinese antibody drug to be marketed and locally produced in Southeast Asia.

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Dr. Michael Yu, Founder, Chairman and CEO of Innovent, said "We are pleased that under the strategic collaboration with Etana, the approval of Bevagen in Indonesia marked a meaningful step toward bringing Innovent’s innovative portfolio into the global market, benefitting patients globally. Pairing Etana’s commercial expertise in the local Indonesian market with Bevagen’s clinical profile, high-quality production and relative affordability, we are confident that Bevagen will launch to the market quickly and benefit many cancer patients."

Nathan Tirtana, President Director of Etana said, "Etana appreciates the support of BPOM for approving Bevagen for cancer patients in Indonesia. With this product, we believe we can provide better access to high quality and affordable biosimilar drug to meet the need of cancer patients in Indonesia. Our next step is to implement the technology transfer and local Bevagen production in Indonesia, via collaboration with Innovent. According to GLOBOCAN 2020 data, breast cancer (16.6%), cervical cancer (9.2%), lung cancer (8.8%), liver cancer (5.4%) and colorectal cancer (4.4%) are the most frequent cancer types in Indonesia, and Bevagen is approved for most of these indications."

The approval of Bevagen with the active ingredient Bevacizumab (humanised anti-VEGF monoclonal antibody) was granted by BPOM on 13 Jun 2022. Each single use Bevagen vial contains 100mg of bevacizumab in 4mL vial (25mg/mL). The approval in Indonesia confirms that Bevagen has complied with the drug safety and efficacy standards set by the Indonesian government, both in terms of product quality and production processes.

Since January 18, 2021, Etana has entered into strategic collaboration with Innovent Biologics. Currently, Innovent’s bevacizumab biosimilar injection known as BYVASDA in Mainland China, has been approved by the National Medical Product Administration (NMPA) for six indications including advanced non-small cell lung cancer, metastatic colorectal cancer, adult recurrent glioblastoma, advanced or unresectable hepatocellular carcinoma, advanced ovarian cancer and advanced cervical cancer.

About Bevagen (Bevacizumab Biosimilar)

Bevagen is a biosimilar of the recombinant humanized anti-VEGF monoclonal antibody bevacizumab. Vascular endothelial growth factor (VEGF) is a critical factor in promoting angiogenesis, and is highly expressed by the endothelial cells in most tumors. An anti-VEGF antibody selectively binds to VEGF , preventing their binding to VEGF receptors on the surface of vascular endothelial cells, thereby inhibiting key signaling pathways, such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK, and producing anti-tumor effects. Since its launch, bevacizumab has been approved for the treatment of patients with multiple malignant tumors globally, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. The efficacy and safety of bevacizumab have been well documented and recognized worldwide.