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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.

Nammi Therapeutics Granted FDA Orphan Drug Designation For QXL138AM for the Treatment of Multiple Myeloma

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]).

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.

Innovent and Etana Jointly Announce the Approval of Bevagen® (Bevacizumab Biosimilar) by the Indonesian Food and Drugs Authority (BPOM)

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.

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.

Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta® (Pertuzumab) and Prolia®/Xgeva® (Denosumab) Biosimilar Candidates

On June 13, 2022 Organon (NYSE: OGN), a global women’s health company with deep expertise in biosimilar commercialization, reported that it has entered into an agreement with Shanghai Henlius Biotech, Inc. (2696.HK), whereby Organon will license commercialization rights for biosimilar candidates referencing Perjeta (pertuzumab, HLX11) and Prolia/Xgeva (denosumab, HLX14) (Press release, Organon, JUN 13, 2022, View Source [SID1234615946]). Organon will acquire exclusive global commercialization rights except for China; including Hong Kong, Macau and Taiwan.

Pertuzumab is used for the treatment of certain patients with HER2+ breast cancer in combinations with trastuzumab and chemotherapy. In the US, 20% of people with breast cancer are HER2+. Denosumab is used for the treatment of certain patients with osteoporosis with high risk of fracture and for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastasis from solid tumors. Osteoporosis affects over 20% of women over the age of 50 globally.

"Biosimilars are a key growth pillar for Organon, and this collaboration represents the successful execution of our strategy to expand our biosimilars portfolio leveraging our strong global footprint and deep commercial expertise," said Kevin Ali, CEO of Organon. "With our experience in biosimilars and women’s health, our goal is to help more patients gain access to treatments for breast cancer and osteoporosis, two areas that significantly impact the health of women."

The agreement also includes an option to negotiate an exclusive license for global commercialization rights for a biosimilar candidate referencing Yervoy (ipilimumab, HLX13). Ipilimumab is used for the treatment of certain patients with unresectable or metastatic melanoma, as adjuvant treatment of certain patients with cutaneous melanoma, certain patients with Renal Cell Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Non-Small Cell Lung Cancer, Malignant Pleural Mesothelioma and Esophageal Cancer.

Consideration for the transaction includes an upfront payment of $73 million as well as additional payments upon the achievement of certain development, regulatory and commercial milestones. Henlius will be responsible for development and, if approved, will supply the products to Organon.

As stated on Organon’s first quarter conference call, to align with views expressed by the US Securities and Exchange Commission, beginning in 2022 Organon will no longer exclude expenses for upfront and milestone payments related to collaborations and licensing agreements, or charges related to pre-approval assets obtained in transactions accounted for as asset acquisitions, from its non-GAAP results. Organon’s financial guidance does not assume an estimate for these expenses associated with business development not yet executed, and accordingly, the $73 million upfront payment and an approximate $30 million for milestones expected to be achieved in 2022 were not included in the full year 2022 guidance the company provided on May 5, 2022. The company does not plan to update its guidance inter-quarter based solely on these items.

About HLX11 (pertuzumab biosimilar candidate)

HLX11 (anti-HER2 domain II humanized monoclonal antibody injection) is a biosimilar candidate of pertuzumab and is independently developed by Henlius. Pertuzumab is used in combination with trastuzumab and chemotherapy as neoadjuvant or adjuvant treatment for HER2 positive early breast cancer and in combination with trastuzumab and docetaxel in certain patients with HER2 positive metastatic or unresectable locally recurrent breast cancer. To date, HLX11 has met the primary endpoint in a Phase 1 clinical trial, showing similar pharmacokinetic and safety profiles to the reference drugs from different sources.

About HLX14 (denosumab biosimilar candidate)

HLX14 (recombinant anti-RANKL human monoclonal antibody injection) is a biosimilar candidate of denosumab and is independently developed by Henlius. Denosumab is used for a range of indications including for the treatment of postmenopausal women with osteoporosis at high risk for fracture, certain patients with giant cell tumor of bone, and skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.

BWXT Medical and TRIUMF Execute Agreement for Manufacture of High Purity Ac-225 Based Products

On June 13, 2022 BWX Technologies, Inc. (NYSE: BWXT) reported that subsidiary BWXT Medical Ltd. and TRIUMF, Canada’s particle accelerator centre, have executed a licensing and services agreement that strengthens their existing partnership for the production of medical isotopes (Press release, BWX Technologies, JUN 13, 2022, View Source [SID1234615945]). This agreement will enable BWXT Medical to manufacture high purity Actinium-225 (Ac-225) based products for pharmaceutical companies as it continues to build on its medical isotope production operations on the TRIUMF site.

Ac-225 is an alpha-emitting isotope used in targeted alpha therapies that combine Ac-225 with specific tumor-seeking targeting vectors to kill metastatic cancer while leaving healthy cells unaffected.

Leveraging existing infrastructure, TRIUMF will irradiate thorium-232 targets for BWXT Medical. From this irradiated thorium, BWXT Medical will process and produce high purity Ac-225, sometimes referred to as non-carrier-added Ac-225, for commercial sale, strengthening BWXT Medical’s position as a leading global manufacturer and supplier of critical medical isotopes and radiopharmaceuticals.

BWXT Medical intends to partner with pharmaceutical and biotechnology companies who intend to develop targeted alpha therapeutics.

"We are very pleased to announce this significant deal with our partner TRIUMF, whose capabilities are truly unique in the world," said Martyn Coombs, president, BWXT Medical. "There is much excitement around targeted alpha therapeutics, which may in the future offer hope to patients where previously no hope remained. We anticipate being the first company to produce non-Russian sourced high purity Ac-225 at semi-scale, starting this summer (2022). Our intention is to partner with a small number of leading pharmaceutical companies, initially supplying the isotope, and with line-of-sight to a deeper relationship including contract development and manufacturing of the finished products."

"TRIUMF and BWXT have been producing isotopes at TRIUMF since 1978; our first therapeutic isotope produced at the Vancouver facility was palladium-103 for prostate brachytherapy. This agreement represents a key and complementary initiative to our strategy to increase the supply of Ac-225, commonly known as ‘the rarest drug on earth,’ to researchers and patients around the world," said Kathryn Hayashi, CEO of TRIUMF Innovations.

Executive Director and CEO for TRIUMF, Dr. Nigel Smith, added, "Working together to increase the supply of cancer-fighting isotopes shows the impact that TRIUMF’s cyclotron infrastructure and expertise can have on the world."