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Fourth Indication for Boan Biotech’s Boyounuo (Bevacizumab Injection) Approved in China

On August 26, 2021 Boan Biotech reported that Boyounuo (Bevacizumab Injection), an self-developed anticancer biologic, has been approved by China’s National Medical Products Administration for the treatment of hepatocellular carcinoma (HCC) (Press release, Boan Biotech, AUG 26, 2021, View Source [SID1234595077]). It is the fourth indication approved for Boyounuo, with the first three indications being for advanced, metastatic or recurrent non-small-cell lung cancer, metastatic colorectal cancer, and recurrent glioblastoma. The latest approval gives liver cancer patients a new treatment option and will enable Boyounuo to serve a broader patient population.

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Liver cancer is a common malignancy in China, and the disease has a high morbidity and a high mortality rate. HCC is the most common form of liver cancer, accounting for around 90% of all cases . According to data from the World Health Organization’s International Agency for Research, 910,000 new cases of liver cancer were reported worldwide in 2020, of which 410,000 occurred in China, accounting for over 45% of the world total. In China, liver cancer has become the second most deadly form of cancer: 390,000 deaths were reported in 2020, close to the number of new cases the same year . The 5-year survival rate for liver cancer patients in China was only 12.1% , indicating high incidence and low survival. The disease severely affects life and health of China’s population and places a significant healthcare burden on society and patient’s families.

Due to its insidious onset, most liver cancer patients have already reached the middle to late stage of the disease at the time of initial diagnosis, when radical surgery is no longer a treatment option. The prognosis, especially for patients with unresectable HCC, is poor: patients have few options for systemic treatment and the 1-year survival rate after diagnosis is less than 50% . Bevacizumab in combination with atezolizumab is the first first-line treatment for advanced HCC to achieve positive results in more than a decade. The combination therapy overcomes common factors which lead to poor prognosis of HCC by leveraging a unique mechanism of immunotherapy together with the regulatory effects of anti-angiogenic therapy on the immune microenvironment. Compared to first-line therapies for HCC prior to this combination, patients with advanced unresectable HCC who receive the combination therapy are able to live longer and enjoy better quality of life. Bevacizumab in combination with atezolizumab is also the first approved first-line immune combination therapy for unresectable HCC and has been listed as a first-line treatment option for liver cancer by several authoritative guidelines in China and around the world with the best level of evidence and the highest level of recommendation.

Boyounuo is an anti-VEGF humanized monoclonal antibody injection developed by Boan Biotech. It is a biosimilar to Avastin. Comparative clinical studies have shown that Boyounuo is highly similar to Avastin in terms of PK characteristics, efficacy, safety and immunogenicity.

Dr. Dou Changlin, R&D President and COO of Boan Biotech, said, "We are delighted to see the approval of another indication for Boyounuo. Bevacizumab is one of the standard therapies used in the treatment of malignant tumors. We anticipate that Boyounuo will help serve more patients and contribute to the better management of cancers in China."

New Studies Published on SDH Models and GIST Research

On August 26, 2021 The Life Raft Group reported that Two new studies were published in July and August 2021 focusing on SDH-deficient tumor models and how location can affect GIST tumor profiles and drug sensitivity (Press release, The Life Raft Group, AUG 26, 2021, View Source [SID1234594778]). Establishment of Patient-derived Succinate Dehydrogenase-deficient Gastrointestinal Stromal Tumor models for predicting therapeutic response was published this week detailing an ongoing study of mutant SDH GIST tumor models focusing on molecular characterization and drug discovery. These patient-derived mSDH GIST models showed recapitulation of the transcriptional and metabolic hallmarks of parent tumors and SDH-deficiency. The study further demonstrated that temozolomide (ClinicalTrials.gov Identifier: NCT03556384), a drug currently in trial, elicits DNA damage and apoptosis in the models. They have successfully translated these discoveries to a cohort of SDH-mutant GIST patients and seen promising results.

"One of the major impediments to treating GIST is the misbelief that this disease is easily curable," said Jason Sicklick, MD, professor of surgery in the Division of Surgical Oncology at University of California San Diego School of Medicine, and a GIST specialist. But in reality, we know this is not the case. Even patients with tumors predicted to be sensitive to certain drugs rarely have complete responses to therapy. There is more to the biology that needs to be discovered."

Among the esteemed team of co-authors are Pediatric & SDH-Deficient Consortium & LRG Medical Advisory Board members Dr. Jason Sicklick, and Dr. Michael Heinrich of the OHSU Knight Cancer Institute, and a frequent speaker at LRG webinars on pathology Christopher Corless (OHSU).

UC San Diego Health published an article with more details about this study and Location of Gastrointestinal Stromal Tumor (GIST) in the Stomach Predicts Tumor Mutation Profile and Drug Sensitivity, published in July 2021.

In this earlier paper, published July 29, 2021, Sicklick and colleagues analyzed where GIST tumors arise in the stomach (the most common site) and their underlying mutations, suggesting that location may be an early clue to mutational type to guide optimal treatment.

Among the co-authors on this study are Dr. Sicklick, Dr. Heinrich, and Dr. Andrew Blakely from National Cancer Institute, who has participated in many LRG Virtual Tumor Boards and written articles for the LRG.

UC San Diego included many details about the scope of the studies and the funding sources in this article.

Cardinal Health™ Nuclear & Precision Health Solutions and IRE ELiT support the growing demand for Ga-68 labeled radiopharmaceuticals

On August 26, 2021 Cardinal Health (NYSE: CAH) and IRE ELiT (the radiopharmaceutical subsidiary of IRE Group) reported that are working to expand patient access to novel radiopharmaceuticals for Positron Emission Tomography (PET) imaging as demand in the United States (U.S.) continues to grow (Press release, Cardinal Health, AUG 26, 2021, View Source [SID1234591440]). Cardinal Health is the preferred U.S. distributor of the IRE ELiT 100 mCi Germanium-68/Gallium-68 radionuclide generator (Ge-68/Ga-68 Galli Eo generator) in support of clinical investigational trials, pre-commercial research and post-approval commercial sales in the U.S. and its territories, including Puerto Rico.

Designed for the on-site preparation of Ga-68 radiolabeled pharmaceuticals, IRE ELiT modified its Ge-68/Ga-68 Galli Eo generator to double its activity from 50 mCi to 100 mCi. This activity enhancement will enable the Nuclear & Precision Health Solutions business of Cardinal Health to increase preparation of Ga-68 radiolabeled pharmaceuticals, which are approved and under investigation for many cancers.

The new, higher-activity 100 mCi generator provides users with more flexibility by increasing the number of daily elutions and the activity in each elution, ultimately increasing the number of patients that can be served. "As a leading U.S. provider of Ga-68 radiopharmaceuticals, Cardinal Health commends IRE ELiT for their efforts to increase the activity of Ge-68/Ga-68 Galli Eo generators," said Mike Pintek, president of Cardinal Health Nuclear & Precision Health Solutions. "Ultimately, this will allow us to better supply medical providers, and their patients, with current and future novel Ga-68 diagnostics."

"Increasing the activity of our Galli Eo generator is a critical part of our plan to meet the exponential demand for Ga-68 radiolabeled pharmaceuticals in the U.S.," said Erich Kollegger, chief executive officer of IRE ELiT. "Combining the expertise of our R&D department with the experience of our production team, IRE ELiT is prepared to produce and supply Cardinal Health with these high-activity generators."

While the activity of the Ge-68/Ga-68 Galli Eo generator has increased, the footprint of each unit will remain the same to ensure Cardinal Health can seamlessly transition to the new 100 mCi Ge-68/Ga-68 Galli Eo generators without impact to the pharmacy.

Cardinal Health currently has the majority of its more than 130 nuclear pharmacies licensed for Gallium-68 and plans to license them all to expand patient access to PET imaging.

Amid Ethics Allegations, Sesen Pulls Bladder Cancer Drug Application from Europe

On August 26, 2021 Sesen Bio reported that bladder cancer drug with a Complete Response Letter, the company has withdrawn its Marketing Application Authorization from the European Union (Press release, Sesen Bio, AUG 26, 2021, View Source [SID1234586964]).

In a filing with the U.S. Securities and Exchange Commission, Sesen Bio said its decision to pull the MAA was based on the FDA’s CRL. The company acknowledged that certain components in the European Medicines Agency review are "interrelated" with some of the elements that forced the FDA to issues the CRL for Viceneum (oportuzumab monatox-qqrs) as a treatment for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Sesen is pausing its plans to pursue approval in Europe until there is more clarity from the FDA on the next steps it must take to win approval.

The company has also requested a Type A meeting with the FDA to discuss those necessary steps. Additionally, Sesen made a curious comment that noted it is "committed to the highest standards of ethics and integrity and continues to believe in the safety and efficacy data of Vicineum."

That comment points back to a STAT News report alleging that Sesen’s entire clinical program for Viceneum was allegedly marked by multiple instances of unethical behavior. According to the report, the company’s clinical program saw "thousands of violations of study rules" and "damning investigator misconduct." It also added that Sesen’s drug had much poorer safety data than was reported.

The news also revealed that the company did not disclose "worrying signs of toxicity" and that it was backed by hundreds of pages of internal documents from Sesen, as well as confirmation by "three people familiar with the matter." Sesen has yet to comment against the allegations raised by the report.

Vicenium, the drug Sesen is hoping to gain approval for, is a recombinant fusion protein. Vicenium targets epithelial cell adhesion molecule (EpCAM) antigens located on the surface of tumor cells. It aims to deliver what has been described as a potent protein payload of Pseudomonas Exotoxin A to the tumor.

When the FDA rejected Vicenium, the regulatory agency recommended that Sesen conduct additional clinical and statistical data analyses. The FDA also recommended addressing issues related to the company’s Chemistry, Manufacturing, and Controls (CMC). In the CRL, the FDA expressed concern about drug substance and drug product manufacturing, cell bank, characterization, resin reuse, reference standards, methods, specifications, stability, and microbiology.

Shares of Sesen Bio are down nearly 2% in premarket trading to $1.05, losing the gains it made on Wednesday. Since the CRL was issued, Sesen’s stock has fallen from a 2021 high of $4.91 per share.

Heat Biologics Unveils Skunkworx Bio, New Drug Discovery Subsidiary

On August 26, 2021 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported the launch of its wholly-owned subsidiary, Skunkworx Bio, Inc. ("Skunkworx"), focused on the development of a drug discovery paradigm to enable rapid drug development (Press release, Heat Biologics, AUG 26, 2021, View Source [SID1234586963]).

Skunkworx’s unique, highly diverse, proprietary libraries of "Pocket Biologics" are used to identify miniature proteins which bind to critical domains of druggable targets. The Skunkworx approach aims to enable rapid drug discovery and validation of new innovative therapeutics utilizing advanced computational methods and bioinformatics to further enhance target precision. Skunkworx has successfully identified agonists and antagonists for a number of targets and is in the process of progressing several of these assets through preclinical studies.

Matt Seavey, Ph.D., Skunkworx’s Executive Director of Scientific Operations, commented, "Our unique process flips the paradigm of drug discovery, as it enables us to rapidly identify novel drug targets to determine if a target is druggable. By utilizing this approach, we have been able to identify lead targets and already have several promising programs underway."

Jeff Wolf, Chief Executive Officer of Heat, commented, "We are extremely proud to launch Skunkworx, an innovative platform to accelerate the path from discovery to preclinical development. Skunkworx augments Heat’s emerging drug development ecosystem designed to efficiently move new biologic programs from discovery into the clinic. New programs will be discovered through Skunkworx, developed at Heat and manufactured at Scorpion Biological Services, Heat’s wholly owned manufacturing subsidiary. This integrated platform is focused on driving innovation by rapidly accelerating the drug development process. We look forward to working with Skunkworx to advance a wide repertoire of drugs across a wide variety of indications, including biosecurity applications, an area of growing importance."