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.

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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.

On June 13, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported it will present positive data on its lead investigational drug, Rhenium-186 NanoLiposome (186RNL), from the Phase 1/2a ReSPECT-GBM dose escalation clinical trial in patients with recurrent glioblastoma (GBM) during an oral presentation at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2022 Annual Meeting, on June 14 at 10:20 AM PT in Vancouver, British Columbia, Canada (Press release, Cytori Therapeutics, JUN 13, 2022, View Source [SID1234615931]).

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According to the interim data, 186RNL delivered via convection enhanced delivery (CED) provides direct therapy with high radiation absorbed doses for local tumor control with minimal brain and whole-body radiation exposure. 186RNL’s tumor-killing effects were observed when greater than 100 Gy doses are delivered to greater than 80% of a tumor without dose-limiting toxicity.

The presentation, titled "Rhenium-186-NanoLiposome (186RNL) in the treatment of relapse/recurrent glioblastoma (rGBM): a novel approach to cancer therapy," outlines data from the ReSPECT-GBM trial, substantially funded by the U.S. National Institutes of Health/National Cancer Institute, which has thus far evaluated 24 adult patients with recurrent GBM across seven cohorts of increasing dose. To date, there have been no significant adverse events during the dose escalation.

"186RNL’s novel localized radio-nanotherapeutic approach has significant potential to translate into treatment for a broad range of tumors where local tumor control is difficult or all other therapies are exhausted, ineffective or toxic," said William Phillips, M.D., Nuclear Medicine Physician at UT Health-San Antonio, and primary presenter. "To treat glioblastoma, the targeted and controlled use of 186RNL is critical for patients as we aim to mitigate brain and whole-body exposure. The novel administration via localized radio-nanotherapeutic enables high doses of radiation to be absorbed while protecting patients from the harsh effects of unnecessary radiation exposure."

The Company expects to initiate a Phase 2/registrational trial of 186RNL in patients with recurrent GBM by the end of 2022. In addition, the Company is continuing to evaluate 186RNL in leptomeningeal metastases as part of the ReSPECT-LM Phase 1/2a dose escalation clinical trial and is in late-stage planning for the treatment of pediatric ependymoma and high-grade GBM.

Upcoming Company Presentation at BIO International Convention

Additionally, Russ Havranek, Vice President of Corporate Strategy and New Product Planning of Plus Therapeutics will present a corporate update in person at the BIO International Convention 2022 on June 15 at 10:30 AM PT in San Diego, California.

Copies of both presentations will be made available under the Presentations tab of the For Investors section of the Company’s website following the meetings at www.plustherapeutics.com.

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.

On June 13, 2022 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies for autoimmune diseases, enhance gene therapies and mitigate unwanted immune responses to biologics, reported several pipeline advancements and partnership updates (Press release, Selecta Biosciences, JUN 13, 2022, View Source [SID1234615932]).

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Extension of Sarepta’s Research License and Option Agreement

Sarepta Therapeutics (NASDAQ: SRPT) has extended the options under the Research License and Option Agreement to license the rights to develop and commercialize Selecta’s immune tolerance platform, ImmTOR, for use in Duchenne Muscular Dystrophy (DMD) and certain Limb-Girdle Muscular Dystrophies (LGMD). Selecta will receive a $2 million payment for the nine-month extension to both options. Additionally, Selecta is eligible to receive an additional $4 million payment upon the achievement of certain near-term preclinical milestones by Sarepta. If Sarepta exercises its option to enter a commercial license agreement for DMD or LGMD Selecta will be eligible for additional development, regulatory, and commercial milestone payments, as well as tiered royalties on net product sales.

Clinical Pipeline Updates

DISSOLVE II, the second of two Phase 3 clinical studies evaluating SEL-212 for chronic refractory gout, continues to progress. SEL-212 is a combination of Selecta’s ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase).

"As a result of Selecta’s proactive addition of 11 trial sites in the United States and the commitment of our clinical team, investigators and study participants around the world, DISSOLVE II is on track to successfully enroll approximately 140 study participants by the end of Q2 2022," said Carsten Brunn, Ph.D., President and Chief Executive Officer of Selecta. "We expect to complete the study in Q4 2022 and announce joint topline data from DISSOLVE I and II in Q1 2023. The upcoming completion of enrollment for DISSOLVE II brings us one step closer to our ultimate goal of providing a differentiated and more convenient treatment option for patients suffering from chronic refractory gout."

Swedish Orphan Biovitrum AB, (Sobi) has in-licensed SEL-212 from Selecta and is responsible for development, regulatory and commercial activities in all markets outside of China. The Phase 3 program for SEL-212 is being run by Selecta and funded by Sobi. The completion of enrollment in DISSOLVE I & II will result in a $10 million milestone payment obligation from Sobi to Selecta.

Additionally, Selecta continues to progress its wholly owned gene therapy program, SEL-302 for the treatment of patients with methylmalonic acidemia (MMA), toward the clinic. Selecta expects to start a Phase 1 clinical trial in Q4 2022.

DISSOLVE clinical program

The DISSOLVE Phase 3 clinical program consists of two double-blind, placebo-controlled studies of SEL-212, titled "A Randomized Double-Blind, Placebo-Controlled Study of SEL-212 in Patients with Gout Refractory to Conventional Therapy," in which SEL-212 will be evaluated at two doses of ImmTOR (0.1 mg/kg and 0.15 mg/kg), and one dose of pegadricase (0.2 mg/kg) in both studies. In DISSOLVE I, safety and efficacy will be evaluated in 112 patients at six months and will have a six-month extension to evaluate safety. DISSOLVE II will assess safety and efficacy in approximately 140 patients at only the six-month time point, with no extension. The primary endpoint in both studies is serum uric acid (SUA) control during month six, a well-validated measure of disease severity in chronic refractory gout. Secondary endpoints include tender and swollen joint counts, tophus burden, patient-reported outcomes of activity limitation and quality of life and gout flare incidence. For more details about the study, visit clinicaltrials.gov (NCT04513366).

SEL-212

SEL-212 is a novel combination medicine designed to sustain SUA levels in people with chronic refractory gout, potentially reducing harmful tissue urate deposits which when left untreated can lead to debilitating gout flares and joint deformity.1 SEL-212 consists of pegadricase, Selecta’s proprietary pegylated uricase, co-administered with ImmTOR, designed to mitigate the formation of anti-drug antibodies (ADAs). ADAs develop due to unwanted immune responses to biologic medicines, reducing their efficacy and tolerability, which remains an issue across multiple therapeutic modalities and disease states including chronic refractory gout.

Chronic refractory gout

Gout is the most common form of inflammatory arthritis with more than 8.3 million people in the United States having been diagnosed with gout, which is caused by high levels of uric acid in the body that accumulate around the joints and other tissues and can result in flares that cause intense pain. Approximately 160,000 people in the United States suffer from chronic gout refractory to conventional medicines, a painful and debilitating condition in which people SUA levels below 6 mg/dL and therefore have several flares per year and can develop nodular masses of uric acid crystals known as tophi.1 Elevated SUA levels have been associated with diseases of the heart, vascular system, metabolism, kidney and joints.2

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.