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.

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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.

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.

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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.

On May 18, 2022 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceuticals company primarily focussed on the development of novel immune-oncology vaccines and drug delivery technologies, is pleased to reported the development of novel dual-acting AccumTM-linked protein vaccine, AccuVAC-PTE7, dedicated to protect from cervical cancer (prophylactic vaccine) or to treat (therapeutic vaccine) patients with pre-established cervical tumors (Press release, Defence Therapeutics, MAY 18, 2022, View Source [SID1234626249]).

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The protection from cervical cancer can currently only be achieved with the use of Gardasil-9 or Cervarix, two vaccines directed against the L1 proteins of HPV. However, there is currently no cure for patients with established cervical cancer and the clinical trials conducted previously with other companies with both the E6 and E7 proteins were highly disappointing.

Since the AccumTM molecule was previously shown to significantly enhance the immunogenicity of various proteins, the Defence team engineered a novel protein-based vaccine targeting the oncogenic protein E7 normally used by HPV to transform healthy cells into an outgrowing tumor. Pre-clinical studies conducted on this new vaccine, AccuVAC-PTE7, not only provide a 100% protection from cervical cancer if delivered prophylactically (e.g. before tumor growth), but also show potent anti-tumoral effects against established tumors when combined with various immunecheckpoint blockers such as anti-PD-1, anti-CTLA4 or anti-CD47.

"The idea of having a dual-acting vaccine targeting cervical cancer capable of both protecting and treating patients from cervical cancer is a giant step in the field of cancer vaccines. In addition, this vaccine contains a single protein, the E7, which makes it easier to manufacture and use compared to a mix of 9 proteins as provided by the Gardasil-9 product", says Mr. Plouffe, the CEO of Defence Therapeutics.

According to Fortune Business Insights, the global HPV vaccine market size was valued at $3.80 Bn in 2019 & is projected to reach $12.69 Bn by 2027, with a CAGR of 16.3%

On May 18, 2022 Accelerating Cancer Immunotherapy Research (ACIR) has featured Immunetune’s presentation during the Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper) Annual Meeting 2022 held May 10-12 in Mainz, Germany (Press release, ImmuneTune, MAY 18, 2022, View Source [SID1234614789]). At CIMT (Free CIMT Whitepaper), our CSO Jeroen van Bergen presented new preclinical results on our neoantigen cancer vaccine in combination with checkpoint inhibitors.

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ACIR’s mission is to accelerate the advancement of cancer immunotherapy by providing, free-of-charge and readily accessible on the internet, a weekly synopsis of the key advances in this fast moving and multifaceted field.

On May 18, 2022 Bavarian Nordic A/S (OMX: BAVA) reported that the share buy-back program, which was announced and initiated on May 9, 2022, has now been terminated, as the intended number of shares under the program has been repurchased (Press release, Bavarian Nordic, MAY 18, 2022, View Source [SID1234614823]). The program was executed in accordance with the provisions of Regulation (EU) No. 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse and supplementing Regulation (EU) 2016/1052 of 8 March 2016, which together constitute the Safe Harbour Regulation. The purpose of the program was to meet the Company’s obligations arising from the share-based incentive program for the Board of Directors and Executive Management.

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Under the program Bavarian Nordic A/S has bought back 71,562 shares, cf. the table below:

Transaction date Number of shares Average purchase price, DKK Transaction Value, DKK

The details for each transaction made under the share repurchase program have been attached to this announcement.

With the transactions stated above, Bavarian Nordic A/S owns a total of 146,330 own shares, corresponding to 0.21% of the share capital. The total amount of shares in the company is 70,472,935 including treasury shares.