On November 26, 2021 3D Medicines (Beijing) Co., Ltd. (3DMed) , Alphamab Oncology (stock code: 9966.HK)，and Simcere Pharmaceutical Group Limited (Simcere) reported that Envafolimab (Enweida), the world’s first single-domain PD-L1 antibody formulated for subcutaneous injection (SC) co-developed by the three companies, has received approval from the Chinese National Medical Products Administration (NMPA) to be commercialized in China (Press release, 3D Medicines, NOV 26, 2021, View Source [SID1234596160]). The approved indication for Enweida is for adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors, including those patients with advanced colorectal cancer who have experienced disease progression following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as well as patients with other advanced solid tumors who have experienced disease progression following prior treatment and have no satisfactory alternative treatment options. This represents the first tissue-agonistic indication granted to an immune checkpoint inhibitor by NMPA.

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Currently, over a dozen of PD-1 and PD-L1 antibody drugs are being marketed as intravenous injection (IV) in China and globally. The average time to administer the drug is 0.5-2 hours.

As the world’s first SC PD-L1 antibody, Envafolimab can be administered within 30 seconds—significantly shortening treatment time, while sparing the patients from various adverse reactions arising from intravenous infusion. It has provided an alternative treatment opportunity for the cancer patients who have no access to immunotherapy due to intolerance to IV injection.. The simplified treatment process associated with envafolimab is expected to reduce the burden of care to the healthcare system, broaden the accessibility of immunotherapy to lower tier health centers, and improve the compliance and convenience of cancer patients.

A pivotal phaseⅡclinical study, led by Professor Lin Shen from Peking University Cancer Hospital and Institute，has evaluated the efficacy and safety of Envafolimab in patients with advanced dMMR/MSI-H tumors. The updated clinical data presented at CSCO 2021 showed that the Objective Response Rate (ORR) of patients who received Envafolimab as second or later-line treatment is 44.7%, including 12 (11.7%) cases of Complete Response (CR). The responses were durable, and the rates of durable response at 12 months in in patients with advanced colorectal cancer (CRC), advanced gastric cancer, other advanced solid tumors, and all patients were 89.3%, 100%, 100%, and 93.4%, respectively. The median progression-free survival (PFS) was 11.1 months, 12-month overall survival (OS) rate was 74.6%. Envafolimab was well tolerated in this study with no cases of immune-related pneumonitis, immune-related colitis, immune-related nephritis, or infusion related reactions reported.

Dr. Zhaolong GONG, Chairman and CEO of 3DMed, commented, "Envafolimab is our first product reaching commercial stage. We have built a robust pipeline based on our belief that cancer is increasingly being managed as a chronic disease. The launch of envafolimab proves our capabilities from preclinical discovery, to IND and NDA. Through strategic cooperation with our partners, we will deliver the world’s first subcutaneous PD-L1 antibody to cancer patients, and help them live longer and better."

Dr. Ting XU, Chairman and CEO of Alphamab Oncology, commented, "Since discovering Envafolimab, we have been driven by the clinical needs of patients and the differentiated advantages to develop and launch the world’s first and only subcutaneously injected PD- L1 inhibitor with our partners, and continue to develop this product that has a global competitive advantage. We will continue committing to the mission of the company, to make cancer manageable and curable, leveraging the competitive advantages of our integrated proprietary biologics platforms, and keep on developing breakthrough next generation therapies for cancers, so that more patients can benefit from biotechnology progress.

Mr. Jinsheng REN, Founder and Chairman of Simcere, commented: "Simcere’s mission is ‘Providing Today’s Patients with Medicines of the Future’, namely, new drugs with greater clinical significance, including better patient compliance. As the first subcutaneous PD-L1 antibody approved globally, Envafolimab brings to the world a brand-new method of administrating PD-L1 antibody that has the potential of changing the game in immunotherapy. Subcutaneous injection is safer and more convenient than traditional IV infusion, therefore providing a new therapy option to patients with better treatment experiences and quality of life. I wish to thank our partners and the dedicated clinical experts for their fruitful efforts. We will accelerate the commercialization of this innovative drug and make it available to patients sooner."

About Envafolimab （KN035）

Envafolimab is a fusion protein of humanized anti-PD-L1 single domain antibody and human IgG1 Fc independently invented by Alphamab Oncology. Envafolimab was in pre-clinical stage when the Co-Development Agreements were first entered into between the Company and Alphamab in February 2016. Since then, we took full responsibility for global clinical development of envafolimab, which has undergone clinical trials across for multiple tumor types in the U.S., China and Japan. On March 30, 2020, Alphamab Oncology, 3DMed, and Simcere reached a strategic cooperation, whereby Alphamab Oncology is responsible for production and quality control, and 3DMed is responsible for the clinical development in oncology field, and Simcere is responsible for the exclusive commercial promotion of products in mainland China.

At present, Envafolimab (KN035) is being studied in clinical trials in multiple tumor types in China, the United States and Japan, including registration/phase III clinical trials in multiple indications. Envafolimab (KN035) obtained orphan drug designation from the US FDA for the treatment of advanced biliary tract cancer and soft tissue sarcoma. In November 2021, Envafolimab obtained the market approval by the Chinese National Medical Products Administration for the treatment of previously treated MSI-H/dMMR advanced solid tumors.

On November 26, 2021 Melbourne biotech company Starpharma reported positive interim results from the prostate cancer cohort in its ongoing phase 2 trial of DEP cabazitaxel (Press release, Starpharma, NOV 26, 2021, View Source [SID1234596116]). The company showed that 100% of evaluable patients with (Stage IV) metastatic prostate cancer have had efficacy responses, utilising one or more standard measures of disease.

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Prostate cancer is the 2nd most common cancer in males globally with 1.4 million new prostate cancer patients diagnosed annually.

DEP cabazitaxel is a patented, detergent (polysorbate-80) free, nanoparticle version of the conventional cancer drug, Jevtana, which is a leading oncology agent used to treat advanced prostate cancer. Sales of Jevtana (conventional cabazitaxel) exceeded US$600 million in 2020. The conventional cabazitaxel formulation (Jevtana) has two US FDA-mandated ‘black box’ warnings in relation to neutropenia and severe hypersensitivity, associated with polysorbate-80 in the formulation.

Starpharma’s interim results in prostate cancer show that one or more efficacy signals[1] were observed in 100% of patients assessed following DEP cabazitaxel treatment. Responses included:

64% of patients with assessable tumour lesions saw prolonged stable disease and significant reductions in tumour size for up to 36 weeks
90% of patients with assessable PSA (Prostate Specific Antigen) tumour biomarker levels had a reduction in PSA, with more than half of these patients achieving a reduction in PSA of at least 50%
83% of patients with secondary bone disease exhibited either no progression or an improvement in these lesions
56% of patients who were evaluable for all three measures had responses to all three.
These positive interim results are particularly significant given all patients in this cohort had late-stage prostate cancer and had failed multiple anti-cancer treatments (including taxanes), in addition to surgeries and radiation, prior to entering the DEP cabazitaxel trial.

Patients treated with DEP cabazitaxel also experienced significantly less severe bone marrow toxicity (myelosuppression), significantly lower rates of severe neutropenia and no instances of neutropenic sepsis, which are all associated with conventional cabazitaxel. Further, the absence of detergent-like polysorbate 80[2] in the DEP cabazitaxel formulation eliminated the need for prophylactic corticosteroids and antihistamines, with no anaphylaxis or severe hypersensitivity reactions observed. This avoidance of long-term steroid use is attractive, particularly in prostate cancer patients where bone health can be a significant issue.

Professor Anthony Joshua, Study Investigator from the Kinghorn Cancer Centre in Sydney with a focus in prostate cancer commented:

"The trial results to date for DEP cabazitaxel in heavily pre-treated prostate cancer patients are highly encouraging and indicate the potential of the product compared to standard cabazitaxel. The anti-cancer activity, together with less myelosuppression than standard cabazitaxel and a generally well-tolerated safety profile, mean this novel form of dendrimer-enhanced cabazitaxel represents a useful option for prostate cancer patients, including in older patients in whom DEP cabazitaxel has been particularly well tolerated."

51 patients have now been recruited across all cancer types in the phase 2 DEP cabazitaxel trial, which is being conducted at multiple sites in the UK and Australia. Recruitment of a small number of additional patients in ovarian and gastro-oesophageal cancer continues following promising efficacy signals in these tumours. Full results for the trial will be reported separately in the coming months.

DEP cabazitaxel is one of Starpharma’s three clinical stage DEP assets being developed internally, alongside DEP docetaxel and DEP irinotecan. Starpharma’s intention is to licence internal DEP assets following clinical proof-of-concept/phase 2. Starpharma also has a number of partnered DEP programs including with Merck & Co., Inc., and also a multiproduct DEP licence with AstraZeneca, which includes the development and commercialisation of AZD0466, a novel Bcl2/xL inhibitor, which is in the clinic.

On November 26, 2021 Enzychem Lifesciences (KOSDAQ: 183490) and Cadila Healthcare Ltd, a part of the Zydus Group, reported that they have entered a Manufacturing License and Technology Transfer Agreement for the world’s first plasmid DNA vaccine (ZyCoV-D) (Press release, Enzychem Lifesciences, NOV 26, 2021, View Source [SID1234596115]). Following the results of a large clinical trial involving nearly 30,000 subjects, ZyCoV-D was recently granted emergency use approval (EUA) by India’s national regulatory agency for subjects 12 years and above.

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Under the terms of this agreement, Zydus shall transfer its manufacturing technology and provide technical assistance to Enzychem. Both CHL and Enzychem believe that this partnership will lead to estimated manufacturing of 80 million or more doses of the plasmid DNA vaccine in 2022. Accordingly, Enzychem shall pay Zydus license fees and royalties for the commercialization of the Plasmid DNA-based COVID-19 vaccine made in Korea and exported to a number of countries, including low-medium income countries (LMICs) in Latin America and Asian New Southern Policy member countries.

Mr. Ki Young Sohn, Chairman of Enzychem Lifesciences said: "Today marks an important milestone for our vaccine consortium as we embark on the manufacturing of the world’s first- in-class DNA vaccine for humans. This technology allows vaccines to be produced at affordable costs in record time, and DNA vaccines are considerably stable. The vaccine is administered intradermally using the PharmaJetneedle free applicator, which ensures painless intradermal vaccine delivery and can thus be deployed more readily, especially in resource-poor populations where these are urgently needed. With state-of-the-art manufacturing facilities and a qualified workforce dedicated to manufacturing high quality products, we are very eager to partner with Zydus in addressing the global demand for COVID vaccines, especially in low-medium income countries."

Speaking on the development, Dr. Sharvil Patel, Managing Director, Cadila Healthcare Ltd., said, "We are very happy to partner with Enzychem Lifesciences and provide access to the technology behind the needle-free, Plasmid DNA vaccine technology which is the first of its kind in the world. Our aim is to provide new innovations and novel technologies that can support people with better approaches to healthcare. This agreement enables people in South Korea and other key markets of Enzychem, the access to a safe, well tolerated and efficacious vaccine with a novel platform to fight COVID-19."

On November 26, 2021 Healthcare and Optellum reported that they have signed a letter of intent to collaborate to advance precision diagnosis and treatment of lung cancer. GE Healthcare is a global leader in medical imaging solutions. Optellum is the leader in AI decision support for the early diagnosis and optimal treatment of lung cancer (Press release, GE Healthcare, NOV 26, 2021, View Source [SID1234596113]).

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Together, the companies are seeking to address one of the largest challenges in the diagnosis of lung cancer, helping providers to determine the malignancy of a lung nodule: a suspicious lesion that may be benign or cancerous. The majority of incidentally detected pulmonary nodules present an indeterminate cancer risk, and are incredibly challenging for clinicians to diagnose and manage, leading to delayed treatment for cancer patients and invasive procedures on healthy people.

Optellum’s Virtual Nodule Clinic identifies and scores the probability of malignancy in a lung nodule, which is key to determining whether biopsy is necessary, and accelerating diagnosis. It is the only FDA-cleared AI-assisted diagnosis software for early-stage lung cancer1, and has been shown to improve the sensitivity and specificity of malignancy assessments of indeterminate nodules 2 — enabling pulmonologists and radiologists to make optimal clinical decisions3.

The clinician’s AI-assisted diagnosis of malignancy may enable patients whose nodules are not malignant to avoid unnecessary and aggressive procedures such as biopsy and surgical resection, while expediting the diagnostic process, and enabling the right treatment to start earlier. This has the potential to provide patients with personalized diagnosis and treatment plans, enabling lung cancer patients to be treated at the earliest possible stage when survival rates are the highest.

GE plans to collaborate with Optellum’s sales team on the distribution of the Virtual Nodule Clinic and work with Optellum to integrate the platform with AI solutions powered by GE Healthcare’s Edison platform. In addition the companies intend to bring results from Optellum’s Lung Cancer Prediction AI into the existing workflow of various GE Healthcare technological pathways, including CT and PACS.

"The precise diagnosis of lung cancer can greatly improve patient prognosis," said Ben Newton, General Manager, Oncology Solutions, at GE Healthcare. "The integration of imaging and medical device data from the Edison Platform with AI-enabled solutions like the one offered by the Optellum Virtual Nodule Clinic has the potential to streamline clinician workflows and advance our goal of making precision healthcare, taking the right action at the right time for every patient, at scale, as widely accessible as possible."

"This collaboration is a major step forward for Optellum and the field of thoracic oncology at large," commented Václav Potěšil, PhD, Founder and Chief Business Officer of Optellum. "GE’s vast clinical network can accelerate deployment of Optellum’s platform and could enable a revolutionary redefinition of early lung cancer treatment for clinicians and patients around the world."

On November 26, 2021 The Iceland based healthcare investor, Aztiq ("Aztiq"), founded by Alvogen’s Chairman and CEO, Róbert Wessman and Innobic Asia ("Innobic"), a wholly-owned Life Science arm of PTT Public Company Limited ("PTT", SET ticker: PTT), Thailand’s largest publicly traded conglomerate, reported that have signed a definitive agreement to acquire a 100% stake in Alvogen Emerging Market Holdings Limited ("AEMH") from Alvogen Lux Holdings Sarl ("Alvogen") (Press release, Lotus Pharmaceutical , NOV 26, 2021, View Source [SID1234596109]). Key shareholders in Alvogen include CVC Capital Partners ("CVC") and Temasek Holdings of Singapore ("Temasek"), as well as Aztiq. The total transaction value is estimated to be approximately US$475 million, and the deal is expected to close during the first quarter 2022.

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With this transaction the consortium becomes the leading shareholder in the global oncology pharmaceutical company Lotus Pharmaceuticals ("Lotus", TWSE ticker: 1795), and the owner of 100% shares in Alvogen Malta (Out-Licensing) Holding Ltd., shareholder of the fast-growing global business to business (B2B) pharmaceutical company Adalvo.

Alvogen Lux Holdings Sarl will remain a leading shareholder in the generics pharmaceutical company Alvogen US, including specialty pharma company Almatica, as well as being the second largest shareholder in global biosimilar company Alvotech.

Róbert Wessman, Chairman and CEO of Alvogen and Founder of Aztiq, will continue to serve as Chairman of the board of Lotus and Adalvo.

Róbert Wessman, Chairman and CEO of Alvogen/ Founder of Aztiq, commented: "I am very proud to have witnessed the maturation of both Lotus and Adalvo. I would like to take this opportunity to thank the existing shareholders for their great support in transformation and at the same time I would like to welcome our new partner as we look forward to carrying out the essential work of expanding access to medicines with strong expertise collectively by all parties. With the comprehensive geographic networks and solid market intelligence in ASEAN brought by PTT and Innobic, I believe that Lotus and Adalvo will have a compelling competitive advantage, which enables them to become global leaders in the pharma industry."

Tomas Ekman, Director of the Board, Alvogen Lux Holding Sarl commented: After seven years as the lead shareholder of Lotus and the broader Asian business, Alvogen concluded that now is the right time to monetize our investment and letting Aztiq and Innobic continue the journey Lotus is on. Both Adalvo and Lotus will continue to collaborate closely with the Alvogen group of companies. Today’s announcement is consistent with Alvogen’s strategic focus and we intend to deploy the proceeds from the transaction in line with our capital allocation priorities to maximize shareholder value.

Dr. Buranin Rattanasombat, Senior Executive Vice President, Innovation and New Ventures, PTT and Chairman of Innobic (Asia), commented: "This partnership will accelerate our goal and enable Innobic to leap into being a fully integrated pharmaceutical company. By being the major shareholder in Lotus jointly with Aztiq, Innobic will have access to the capability of operating a full suite of pharmaceutical business, ranging from research, development, and formulation to production and commercialization, with a primary focus on generic drugs covering a wide range of therapeutic areas, in particular, oncology and central nervous system. The strengthened access to high quality medicines, together with the global networks and commercialization capability of Adalvo, and Innobic’s support to further expand the pharmaceutical businesses in the ASEAN and globally, make this investment fully in line with the goals and strategies for realizing life science business in Thailand and the ASEAN."

Alvogen acquired a majority stake in Lotus in 2014 and together with its shareholders, Lotus has evolved into a next generation pharmaceuticals company focused on global oncology with direct market access in more than 10 countries in Asia and global reach of its portfolio to over 130 markets.

Alvogen has further developed Adalvo in 2018 from an in-house B2B platform into a separate business unit focusing on global markets. In a short period of time, Adalvo has achieved a remarkable growth with over 500 transactions and a world class portfolio of 60 differentiated medicines and is currently one of the fastest growing B2B pharmaceutical company globally, serving its partners and patients in over 100 markets around the world.

In April of 2021, Innobic invested approximately US$50 million into Lotus by acquiring newly-issued shares via a private placement. Both parties, Lotus and Innobic, are committed to further collaboration with the aim of expanding access to high quality medicines. Further participation by Innobic, through its investment in AEMH, demonstrates both a strong belief in the Lotus strategy as well as a commitment to drive opportunities in South East Asian pharmaceutical markets including Thailand, Vietnam, Philippines, Malaysia and other ASEAN countries.