On July 2, 2020 Cardinal Health (NYSE: CAH) reported fourth-quarter and year-end financial results for its fiscal year 2020 on August 6 prior to the opening of trading on the New York Stock Exchange (Press release, Cardinal Health, JUL 2, 2020, View Source [SID1234561647]). The company will webcast a discussion of these results beginning at 8:30 a.m. Eastern.

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To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required. Presentation slides and a webcast replay will be available until August 5, 2021.

On July 2, 2020 Vaccibody AS, a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported First Patient Dosed in its VB C-02 trial; a multi-centre, open-label Phase II clinical trial testing a combination of Vaccibody’s VB10.16, a targeted DNA vaccine, and Roche’s PD-L1-blocking immune-checkpoint inhibitor atezolizumab (Tecentriq) in patients with advanced or recurrent, non-resectable HPV16 positive cervical cancer (Press release, Vaccibody, JUL 2, 2020, View Source [SID1234561646]).

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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

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Siri Torhaug, Chief Medical Officer of Vaccibody, said: "We are excited to have the first patient dosed with VB10.16 at our Norwegian site at Oslo University Hospital, and to initiate the clinical collaboration with Roche. Today, advanced cervical cancer patients have limited treatment options. The trial addresses the high unmet medical need in this patient population, as well as the need for novel treatment options."

Agnete B. Fredriksen, President & Chief Scientific Officer of Vaccibody, added: "VB10.16 is the frontrunner in the Vaccibody cancer vaccine portfolio. The rationale for this trial is supported by the positive data from the Phase I/IIa clinical trial with VB10.16 as monotherapy in patients with precancerous cervical lesions and data supporting a scientific rationale for synergistic effect of combining VB10.16 with checkpoint inhibitors. We believe the combination of VB10.16 and atezolizumab can enhance the anti-tumor efficacy in advanced cervical cancer patients."

The planned open-label Phase II clinical trial is designed to evaluate the safety and efficacy of multiple dosing with VB10.16 immunotherapy in combination with atezolizumab in patients with advanced or recurrent non-resectable HPV16 positive cervical cancer, who failed or are not eligible for current standard of care. The VB C-02 clinical trial is a multi-centre, open-label clinical trial and will enroll up to 50 patients in six European countries. The clinical trial has the ClinicalTrials.gov Identifier: NCT04405349. 2

About VB10.16
VB10.16 is an investigational therapeutic DNA vaccine developed to treat human papillomavirus type 16 (HPV16) induced malignancies and pre-malignancies. The drug candidate has demonstrated favorable 12M clinical data in a Phase I/IIa clinical trial in precancerous HPV16 induced high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3).

About cervical cancer
Cervical cancer is the most common cancer among women in developing countries and is the second most common cancer amongst women worldwide. An estimated 45 thousand cases of cervical cancer will be diagnosed in the US and EU in 2020 and similarly an estimated 18 thousand deaths from cervical cancer will occur in 2020. Cervical cancer is caused by high risk HPV. HPV16 is the virus type that most frequently causes cancer. It has been reported to be the most common genotype in high grade cervical intraepithelial neoplasia. It is detected in up to 60% of all cervical cancers, especially in younger women and it has also been found to play an essential role in the development of several other cancer types (approximately 90% of anal cancers; 70% of oropharyngeal cancers, 40% of penile-, vaginal-, and vulvar cancers; and 25% of oral cavity cancers). Gardasil and Cervarix are preventive HPV vaccines which prevent infection of HPV, but these do not have an effect in already infected patients. A high percentage of the eligible population for the preventive vaccines does not get vaccinated, thus HPV infection and HPV+ cancer still requires effective therapeutic interventions. There is currently no available therapy treating HPV specifically.

On July 2, 2020 Cardinal Health (NYSE: CAH) reported to release fourth-quarter and year-end financial results for its fiscal year 2020 on August 6 prior to the opening of trading on the New York Stock Exchange (Press release, Cardinal Health, JUL 2, 2020, View Source [SID1234561645]). The company will webcast a discussion of these results beginning at 8:30 a.m. Eastern.

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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

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Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required. Presentation slides and a webcast replay will be available until August 5, 2021.

On July 2, 2020 Ipsen (Euronext: IPN; ADR: IPSEY), reported it will join the Exelixis and Roche clinical collaboration and participate in the funding of the recently initiated CONTACT-01 and CONTACT-02 global Phase III pivotal trials (Press release, Ipsen, JUL 2, 2020, View Source [SID1234561643]). CONTACT-01 is evaluating the safety and efficacy of cabozantinib (CABOMETYX) in combination with atezolizumab (TECENTRIQ) in patients with metastatic non-small cell lung cancer (NSCLC) who have been previously treated with an immune checkpoint inhibitor and platinum-containing chemotherapy. CONTACT-02 is evaluating the safety and efficacy of cabozantinib given in combination with atezolizumab versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant prostate cancer (CRPC) who have previously been treated with one NHT.

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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

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"There is a growing body of preclinical and clinical evidence that cabozantinib may positively impact treatment when paired with immunotherapy," said Dr. Howard Mayer, Executive Vice President and Head of Research and Development at Ipsen. "We are pleased to enter into this collaboration with Exelixis and Roche to build on the promising data from COSMIC-021 and further examine the potential of cabozantinib in combination with atezolizumab to treat metastatic non-small cell lung cancer and for men with metastatic castration-resistant prostate cancer."

"Ipsen has built its strength in oncology through solid long-term partnerships which are evaluating new approaches to target difficult-to-treat cancers. This marks an important milestone in our partnership with Exelixis to further develop cabozantinib and our shared vision to progress the treatment for cancers and indications with high unmet need, ensuring no patient is left behind," said Bartek Bednarz, Senior Vice President, Global Product & Portfolio Strategy at Ipsen.

Ipsen has an exclusive collaboration agreement with Exelixis for the further development and commercialization of cabozantinib outside of the United States and Japan. Under this agreement, following its decision to opt-in to pivotal studies exploring cabozantinib’s potential in new potential indications, Ipsen gains access to the results of those studies, which if positive, may support potential future regulatory submissions in its territory.

Tecentriq (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About CONTACT-01

CONTACT-01 is a global, multicenter, randomized, Phase III, open-label study that aims to enroll approximately 350 patients. Patients will be randomized 1:1 to the experimental arm of cabozantinib in combination with atezolizumab and the control arm of docetaxel. The primary endpoint of the trial is overall survival. Secondary endpoints include progression-free survival, objective response rate and duration of response. The trial was initiated on June 11, 2020 and is sponsored by Roche and co-funded by Exelixis, Ipsen and Takeda Pharmaceutical Company Limited.

About NSCLC

Lung cancer is the most commonly occurring cancer in men and the third most commonly occurring cancer in women.1 There were over two million new cases in 2018.2 Non-small-cell lung carcinoma (NSCLC) is any type of epithelial lung cancer other than small cell lung carcinoma (SCLC). NSCLC accounts for about 85% of all lung cancers.3,4

About CONTACT-02

CONTACT-02 is a global, multicenter, randomized, Phase III, open-label study that plans to enroll approximately 580 patients at 250 sites. Patients will be randomized 1:1 to the experimental arm of cabozantinib in combination with atezolizumab and the control arm of a second novel hormonal therapy (either abiraterone and prednisone or enzalutamide). The co-primary endpoints of the trial are progression-free survival and overall survival. Additional endpoints include objective response rate, prostate-specific antigen response rate and duration of response. The trial was initiated on June 30, 2020 and is sponsored by Exelixis and co-funded by Roche, Ipsen and Takeda Pharmaceutical Company Limited.

About CRPC

Prostate cancer is the second most commonly occurring cancer in men and the fourth most commonly occurring cancer overall.5 There were 1.27 million new cases in 2018.6 Approximately 10-20 percent of prostate cancer cases are castration-resistant, and up to 16% of these patients show no evidence that the cancer has spread at the time of the castration-resistant diagnosis.

Metastatic castration-resistant prostate cancer is when the cancer has spread to parts of the body other than the prostate, and it is able to grow and spread even though drugs or other treatments to lower the amount of male sex hormones are being used to manage the cancer.

About Ipsen products

This press release mentions investigational uses of Ipsen products. Product indications and approvals for use vary by jurisdiction; please see SmPC/PI for full indications and safety information.

About CABOMETYX (cabozantinib)

CABOMETYX is not marketed by Ipsen in the U.S.

CABOMETYX 20mg, 40mg and 60mg film-coated unscored tablets

Active ingredient: Cabozantinib (S)-malate 20mg, 40mg and 60mg

Other components: Lactose

Indications: CABOMETYX is currently approved in 51 countries, including in the European Union, the U.K., Norway, Iceland, Australia, Switzerland, South Korea, Canada, Brazil, Taiwan, Hong-Kong, Singapore, Macau, Jordan, Lebanon, Russian Federation, Ukraine, Turkey, United Arab Emirates, Saudi Arabia, Serbia, Israel, Mexico, Chile and Panama for the treatment of advanced RCC in adults who have received prior VEGF-targeted therapy; in the European Union, the U.K., Norway, Iceland, Canada, Australia, Brazil, Taiwan, Hong Kong, Singapore, Jordan, Russian Federation, Turkey, United Arab Emirates, Saudi Arabia, Servia, Israel, Mexico, Chile and Panama for previously untreated intermediate- or poor-risk advanced RCC; and in the European Union, the U.K., Norway, Iceland, Canada, Australia, Switzerland, Saudi Arabia, Serbia, Israel , Taiwan, Hong Kong, South Korea, Singapore, Jordan, Russian Federation, Turkey, United Arab Emirates, and Panama for HCC in adults who have previously been treated with sorafenib.

For more information, see the regularly updated registered product information on the European Medicine Agency www.ema.europa.eu

CABOMETYX is marketed by Exelixis, Inc. in the United States. Ipsen has exclusive rights for the commercialization and further clinical development of CABOMETYX outside of the United States and Japan.

U.S. Indications and Important Safety Information

Indications:

CABOMETYX (cabozantinib) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

CABOMETYX (cabozantinib) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

On July 1, 2020 Bolt Biotherapeutics, Inc., a clinical-stage biotechnology company developing its Immune-Stimulating Antibody Conjugate (ISAC) platform technology to harness the power of the innate immune system to treat cancer, reported the closing of an oversubscribed $93.5 million Series C financing (Press release, Bolt Biotherapeutics, JUL 1, 2020, View Source [SID1234618699]). Led by Sofinnova Investments, the Series C financing included participation from new investors RA Capital Management, Surveyor Capital (a Citadel Company), Rock Springs Capital, Samsara BioCapital and Pfizer Ventures as well as existing investors Novo Holdings, Vivo Capital, Pivotal bioVenture Partners and others.

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Bolt is pioneering a new category of immunotherapies that combine the precision of antibody targeting with the power of the innate immune system via activating myeloid cells and reprogramming the tumor microenvironment. Bolt has raised more than $170 million since its founding in 2015, and this new round of funding will support the continued clinical development of its lead ISAC, BDC-1001, which is delivered systemically as monotherapy for HER2-expressing cancers. The financing will also support the expansion of the company’s pipeline of Boltbody therapeutics. Bolt’s expertise in myeloid biology lays the foundation for its innovative work developing proprietary innate immune stimulants for use in ISACs.

"The support from this marquee group of biotech investors is a testament to what we have recently accomplished, in particular the start of our first clinical trial for BDC-1001," said Randall Schatzman, Ph.D., the company’s chief executive officer. "We have built a strong team with expertise in key drug development areas, and this financing round will enable us to drive our ongoing clinical study and pipeline development work forward expeditiously. The Bolt technology has potential to significantly improve how we treat certain cancers and promises durable responses for patients.

In addition to BDC1001, we are currently on track to nominate our next clinical candidates later this year." In conjunction with the financing, Jason Pitts Ph.D., principal at Sofinnova Investments, will join the company’s board of directors. He states, "We believe Bolt is well-positioned to execute on its vision of developing immuno-oncology therapies with the potential to generate systemic immunological memory and provide durable clinical benefit. I look forward to helping the company realize their goal of developing the ISAC platform across a range of solid tumor targets."

Bolt is developing BDC-1001 as a monotherapy for patients with HER2-expressing solid tumors. The drug candidate is an ISAC comprised of trastuzumab conjugated to a Bolt proprietary TLR7/8 agonist payload. In preclinical models, systemic administration of HER2-ISACs demonstrate localized immune activation that results in robust single agent activity, generation of host immunological memory against cancer and epitope spreading. Preclinical data, which were presented at SITC (Free SITC Whitepaper) 2019, demonstrated complete, durable regression of established tumors resistant to trastuzumab and immunological memory providing protection against tumor cells that no longer express the HER2 antigen in syngeneic mouse cancer models. This offers the potential for durable and meaningful responses for HER2-expressing cancers.

About Bolt Biotherapeutics’ Immune-Stimulating Antibody Conjugate (ISAC) Platform Technology
The Boltbody platform consists of Immune-Stimulating Antibody Conjugates (ISAC) that harness the ability of innate immune stimulants to convert cold tumors into immunologically hot tumors, thereby illuminating tumors to the immune system and allowing them to be invaded by tumor-killing cells. Boltbody ISACs have demonstrated the ability to eliminate tumors following systemic administration in preclinical models and have also led to the development of immunological memory, which is predicted to translate into more durable clinical responses for patients. The company’s first Boltbody to enter clinical development, BDC-1001, is currently being evaluated in patients with HER2-expressing solid tumors.