1stOncology™: Cancer Intelligence Service – Page 6488 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

MODERNA TO PRESENT AT THE UBS 2022 GLOBAL HEALTHCARE CONFERENCE

On May 18, 2022 Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported its participation in a fireside chat at the UBS 2022 Global Healthcare Conference on Tuesday, May 24th at 9:15 a.m. ET (Press release, Moderna Therapeutics, MAY 18, 2022, View Source [SID1234614869]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

A live webcast of the presentation will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for at least 30 days following the presentation.

BioVaxys Confirms First Clinical Site and Principal Investigators for Ovarian Cancer Vaccine Trial and Enters into Second Tumor Cell Supply Agreement

On May 18, 2022 BioVaxys Technology Corp. (CSE: BIOV; FRA: 5LB; OTCQB: BVAXF) ("BioVaxys" or "Company"), reported that Hospices Civils de Lyon, France ("HCL") has agreed to serve as a clinical study site for the Phase I study of BVX-0918, the Company’s autologous haptenized tumor cell vaccine for late-stage ovarian cancer (Press release, BioVaxys Technology, MAY 18, 2022, View Source [SID1234614858]). HCL has further agreed to supply BioVaxys with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients undergoing treatment at the hospital to permit the Company to perform manufacturing tests. BioVaxys, together with its EU partner, ProCare Health of Barcelona, Spain, is preparing for a Phase I clinical study with BVX-0918 later this year.

HCL is a public hospital and France’s second University Hospital Center, and a premier site for clinical studies in the EU. Hospices Civils de Lyon is at the heart of the healthcare ecosystem of Greater Lyon, one of the major biotechnology and healthcare markets in Europe.

BioVaxys and Procare personnel will collaborate with Dr Pierre Adrien Bolze, MD, PhD, and Pr. Benoît You, MD, PhD, of HCL who are planned Clinical Investigators for the Phase I study of BVX-0918.

BioVaxys is preparing to file a Clinical Trial Application ("CTA") with the European Medicines Agency ("EMA") later in 2022. Access to surgically removed ovarian cancer tumor cells is a critical step enabling BioVaxys to validate the manufacturing process for BVX-0918. BioVaxys recently entered a similar collaboration with Deaconess Research Institute in the United States to provide the Company with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients. Tumor samples from both hospitals are being used to validate the tumor collection protocol, cryopackaging, cryopreservation, and supply chain logistics for BVX-0918 bioproduction for prospective patients in the US and EU. Tumor samples from HCL will also be used for process testing and manufacturing "dry runs" of BVX-0918, a major step leading to the completion of Good Manufacturing Process ("GMP") production, a requirement for the planned CTA with the EMA.

HCL has pre-screened the first patient for tumor collection, with patient enrollment for surgical debulking planned for next week.

Dr. You stated, "There is an unmet medical need for innovative approaches, based on vaccines and immunotherapies drugs, in ovarian cancer, as a way of improving the prognosis of patients. It has been defined as a priority for our institution. This collaboration with Biovaxys is a great opportunity for developing a vaccine that would then be assessed in a first-in-human trial in our early phase trial unit." Professor You is a medical oncologist and head of the Phase 1 trial unit oncology group (Centre d’Investigation des Thérapeutiques en Oncologie et Hématologie de Lyon), certified by French National Cancer Institute.

"We are very happy to partner with Biovaxys to contribute to the development of innovative therapeutic strategies for our ovarian cancer patients," stated Pierre Adrien Bolze, MD, PhD, Professor of Gynecological Obstetrics at HCL. "Our department is certified by the European Society of Gynaecological Oncology for ovarian cancer surgery, and has an extensive track record in gynecology oncology studies."

"BioVaxys is honored to be working with Dr Bolze and Dr You on the Phase I study of BVX-0918. They are leaders in gynecological oncology, and have led an extensive range of clinical studies," says Kenneth Kovan, President and Chief Operating Officer of BioVaxys. Ovarian cancer ranks fifth for cancer-related death in women. About 75% of ovarian cancers are diagnosed at late stage of the disease, when the peritoneum is involved (stage III) or disease has spread to other organs (stage IV). The standard of care for late-stage ovarian cancer relies on a medical-and-surgical treatment associating a platinum-based chemotherapy and a surgical debulking of the tumor mass meant to be complete with no post-operative residual lesion.

BioVaxys’ vaccine platform is based on the established immunological concept that modifying surface proteins—whether they are viral or tumor—with haptens makes them more visible to the immune system. This process of haptenization "teaches" a patient’s immune system to recognize and make target proteins more "visible" as foreign, thereby stimulating a T-cell mediated immune response. BioVaxys’ cancer vaccines are created by extracting a patient’s own (autologous) cancer cells, chemically linking with a hapten, and re-injecting them into the patient to induce an immune response to proteins which are otherwise not immunogenic. Haptenization is a well-known and well-studied immunotherapeutic approach to cancer immunotherapy and has been clinically evaluated in both regional and disseminated metastatic tumors.

A first generation single-hapten vaccine invented by BioVaxys Co-Founder and Chief Medical Officer David Berd, MD, achieved positive immunological and clinical results in Phase I and Phase II human trials in over 600 patients with different tumor types, as well as having no observed toxicity in years of clinical study. These studies were conducted under an FDA-reviewed IND. A first generation autologous, haptenized vaccine was also tested by Dr. Berd in women with advanced ovarian cancer who had ceased to respond to conventional chemotherapy. The results were encouraging: In 24 patients, the median overall survival was 25.4 months with a range of 4.5-57.4 months; 8 patients survived for more than 2 years. BioVaxys has enhanced the first-generation approach by utilizing two haptens ("bi-haptenization"), which the Company believes will yield superior results.

Personalized medicine: cooperation agreement between Semmelweis University and Roche

On May 18, 2022 Semmelweis University reported that A strategic cooperation agreement with Roche Hungary will bring significant advances in R&D activities, particularly in the fields of oncology, haematology, immunology, neurology and ophthalmology (Press release, Semmelweis University, MAY 18, 2022, View Source [SID1234614844]). The research projects can greatly contribute to the treatment of rare and serious diseases, as well as to the value-based development and digitization of the Hungarian healthcare system.

"Semmelweis University is the leading medical and health sciences institution in Hungary and in the region, where innovation for the benefit of our patients is a priority in our daily activities. Roche Hungary is a global healthcare company at the forefront of biotechnology and diagnostics, renowned for its innovative solutions. Therefore it is no coincidence that we have a long-standing partnership, which is further strengthened by this strategic agreement," said Dr. Béla Merkely at the signing ceremony held at the university.

The Rector of Semmelweis University considers of utmost importance that all elements of the document are characterized by a patient-centered approach, aiming at efficient, high-quality care and improving the quality of life of patients.

The joint work will bring significant progress, particularly in the fields of oncology, haematology, immunology, neurology and ophthalmology. The number of clinical trials on innovative therapies could increase, with a particular focus on breast cancer, lung cancer and congenital muscular disorders,"

the rector said.

He added that increasing the volume of clinical trials will help ensure that patients get access to innovative therapies as soon as possible, and that researchers and doctors at the university are among the first to gain experience with new treatments.

One important area of clinical trials is breast cancer. More than 8,000 cases are diagnosed and more than 2,000 people die of the disease every year in Hungary, accounting for 6.7 percent of all cancer deaths. The collaboration between the University and Roche could bring significant advances in the treatment of breast cancer.

The Managing Director of Roche Hungary recalled that the company has conducted around 70 clinical trials in various disease groups in collaboration with the university over the past five years.

"To create a patient-centered and more sustainable healthcare system, leading-edge science and healthcare professionals need to work together, which is why we are building a partnership with Semmelweis University that will bring radical change for patients and healthcare providers. The aim of the agreement is to promote a personalized and value-based approach," emphasized Raffaella Claudia Bondi.

The current strategic agreement also aims to improve the organization of healthcare and the use of digitization to enable doctors to make faster, better decisions based on all available data, taking into account the whole patient journey. This will allow more time for quality interactions between doctors and patients.

Tibor Kövesi, Head of the Strategic Development and Transformation at Roche Hungary, said that Semmelweis University is testing a web application under development within each of its disease groups to support the development and operation of a digital patient journey management system. The application has been developed by the Foundation for Hungarian Personalized Healthcare Development (SzEFA), established by Roche.

Its incorporation into the university’s hospital IT systems could significantly reduce administrative burdens, while in the medium term it could make patient journeys more transparent and shorten the time needed to make a diagnosis. The digital patient journey management element of the agreement will affect first the cardiovascular care of the oncology patients and will help them to improve both length and quality of life.

The collaboration will also include the creation of a cytostatic mixture infusion laboratory at Semmelweis University, supported by a digitized system, to supply personalized therapy for cancer patients.

The host of the event, Dr. Péter Ferdinandy, Vice-Rector for Science and Innovation, expressed his hope that the agreement is the beginning of a new chapter of fruitful cooperation. The document was signed by Dr. Béla Merkely, Rector and Dr. Lívia Pavlik, Chancellor of Semmelweis University, and by Raffaella Claudia Bondi and Tibor Kövesi on behalf of Roche Hungary Ltd.

IONETIX AND ATONCO SIGN A PARTNERSHIP AGREEMENT TO FIGHT BLADDER CANCER

On May 18, 2022 The companies Atonco (Nantes-Saint Herblain, France) and IONETIX Corporation (Lansing, MI) reported that they have signed a partnership agreement to ensure the radioisotope production and supply of the radiopharmaceutical necessary for the success of Atonco’s clinical studies and commercialization in the United States (Press release, IONETIX, MAY 18, 2022, View Source [SID1234614839]).

Atonco, a radiopharmaceutical company at the clinical stage, aims to demonstrate through its clinical research program the relevance of a breakthrough therapeutic treatment, alpha immunotherapy, targeting superficial bladder cancer.

IONETIX Corporation operates a North American good manufacturing practice ("GMP") manufacturing and supply chain of positron and alpha-emitting radiopharmaceuticals. Ionetix through this agreement will produce astatine-211 and manufacture patient doses for clinical use, according to CGMP regulations. The agreement includes the supply of the radioisotope, astatine-211, the GMP manufacturing of the injectable doses and specifies the terms of the U.S. FDA agent agreement signed in August 2021.

IONETIX is leading the way by establishing the first North American commercial scale supply of astatine-211, from its new cyclotron facility in Lansing, MI that is dedicated to the production and distribution of alpha-emitting radioisotopes. "We are very excited about the partnership with Atonco which will enable us to fully support their clinical development program and commercialization in the United States, subject to FDA approval of Atonco’s drug candidates", declared David Eve, Vice President of Medical Affairs.

"This partnership agreement is a key step in the development of Atonco", declared Sylvain Fanier, President of Atonco. "We are convinced that Ionetix is the most reliable and advanced partner to ensure optimal sourcing for our clinical development and commercialization in North America. Thanks to their expertise and experience in the manufacture of radiopharmaceuticals and in discussions with the FDA, Ionetix will greatly contribute to our common success, in order to offer patients suffering from bladder cancer a very promising therapeutic alternative".

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) launches Luzsana Biotechnology™ (Luzsana)

On May 18, 2022 Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) reported that it is launching Luzsana Biotechnology (Luzsana), a global, purpose-driven innovative medicines company committed to delivering medicines that are available, accessible and affordable to more people around the world (Press release, Jiangsu Hengrui Medicine, MAY 18, 2022, View Source [SID1234614838]). Luzsana, a wholly owned subsidiary of Hengrui Pharma, is a global development and commercialization biotechnology organization. Luzsana has developed a strategic plan with Hengrui Pharma that provides the company access to a world-class pipeline of more than 250 clinical studies in areas of high unmet medical need, such as oncology, cardiovascular, metabolic/diabetes, pain management, immunology and liver and renal disease.

The origin of the Luzsana name is rooted in "la luz," which is Spanish for light, and "sana," which is Latin for heal. Luzsana is a healthcare company that aspires to become a "healing light" across the biotech sector by prioritizing the well-being of all stakeholders it encounters while operating its business. With locations in Princeton, New Jersey, Basel, Switzerland, and Tokyo, Japan, Luzsana is being led by a highly skilled team of industry veterans who average more than 25 years of experience with success delivering global execution excellence and building, leading and commercializing products at scale.

"There are more innovative medicines than ever being developed across the globe, yet many people continue to face barriers in terms of availability, accessibility and affordability. For example, while the World Health Organization notes that there are 25 essential cancer medications, only 10% of countries have made all 25 available to patients.1 We refer to this as the healthcare paradox," said Scott Filosi, chief executive officer of Luzsana.

"We believe the most effective medicines are ones that people can use. That’s why we won’t rest until we get our medicines into the hands of those who need them most—no matter their geography or socioeconomic status," said Filosi. "We’re confident the Luzsana mission can be brought to life because our unique partnership model has the potential to quantifiably reduce development costs thereby allowing us to invest in proven solutions that will drive innovative medicine availability, accessibility and affordability."

Through their unique relationship, Luzsana can partner with Hengrui Pharma to assess and hand select assets from Hengrui Pharma’s robust pipeline of more than 250 clinical studies across multiple therapeutic areas for global co-development and commercialization. Luzsana also will have access to 16 Hengrui Pharma research and development centers with more than 5,400 research staff. Luzsana has initially selected 11 high-potential oncology and non-oncology programs that span all phases of development, from preclinical to phase 3 for co-development. While the company’s initial pipeline is weighted heavily toward oncology with 8 out of 11 programs, Luzsana intends to further diversify its pipeline over time.

"Combining Hengrui Pharma’s established discovery and manufacturing capabilities with our robust global clinical trials network provides Luzsana with the potential to bring medicines to market quickly and at a competitive cost following regulatory approval without needing to make significant investments in high-risk, early discovery and infrastructure," said Jeff Crowther, president, commercial strategy and global operations at Luzsana.

Luzsana will share more details about its oncology pipeline at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 3-7 in Chicago (Exhibit Booth #27155). The company also plans to attend the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022, September 9-13 in Paris, France.