On June 23, 2021 Oncoinvent AS, a clinical stage company advancing a pipeline of radiopharmaceutical products across a variety of solid cancers, reported plans to raise a private round of financing (Press release, Oncoinvent, JUN 23, 2021, View Source [SID1234584285]). The company has engaged Arctic Securities AS and DNB Markets, a part of DNB Bank ASA, as Joint Global Coordinators and Joint Bookrunners (together, the "Managers") to advise on and carry out a private placement (the "Private Placement") estimated to raise gross proceeds to the Company of approximately NOK 150 – 200 million. The net proceeds from the Private Placement are expected to ensure financing past end of 2023, including financing of two clinical phase 2A studies (in ovarian cancer and colorectal cancer).

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!

The price per share in the Private Placement has been set to NOK 52, implying a total pre-money market capitalisation of NOK 744 million.

The Managers have received non-binding indications of interest from existing shareholders and new investors for a substantial part of the offering size, including pre-commitments of NOK 114 million from large existing shareholders Hadean Ventures, Geveran, RADFORSK Investeringsstiftelse, Sundt, Must Invest, Canica, MP Pensjon and Watrium.

"We are extremely satisfied to be finishing off a successful year of clinical trials with Radspherin, during which we have been able to navigate the COVID-19 pandemic and execute the phase 1 trials with solid recruitment rate. This enables us to move fast into phase 2A studies after having demonstrated that Radspherin can be administered safely and effectively. The safety profile of Radspherin is very good and we have determined the clinically relevant dose for the product," said Jan A. Alfheim, Oncoinvent CEO. "We are now looking to move forward with the clinical development of Radspherin and to focus on measuring the efficacy of the product in the upcoming phase 2A clinical trials."

Alfheim continued by saying, "We are pleased that our current investors continue to believe in the company and our technology, and we welcome their strong participation in this current round of financing."

"It has been a very busy year for Oncoinvent running two clinical trials and manufacturing of radionuclides, microparticles, and finished product as well as performing quality controls for clinical supplies at the same time as working on developing pipeline candidates. This has been performed in a cost efficient and reliable way and we thank all the employees, and collaborators, as well as the staff at the clinical trial sites, for their efforts. We will hereby thank existing and new investors for their current and future financial support of Oncoinvent," says Roy H. Larsen, Chairman of the Board.

Ingrid Teigland Akay, Oncoinvent board member and Managing Partner of Hadean Ventures which together with Geveran are the largest anchor investors in the upcoming financing round, commented: "We have been impressed by the company’s ability to run two parallel clinical trials in a very difficult year where so many trials have been impacted by the pandemic. The results we have seen so far from these trials are promising in regard to the future development of Radspherin and we are very pleased to continue to support Oncoinvent on this journey."

About RAD-18-001 and RAD-18-002

The Phase 1 open-label, dose-escalation clinical trials are designed to assess the dose, safety and tolerability of Radspherin, an α-emitting radionuclide therapy, administered into the intraperitoneal cavity in subjects with peritoneal carcinomatosis from ovarian cancer and colorectal carcinoma respectively. The trials include a dose escalation phase followed by repeated injection and expansion cohort phases at the recommended clinical dose. Key objectives in the studies include determining maximum tolerated dose, abdominal biodistribution, and preliminary anti-tumor activity. Please refer to www.clinicaltrials.gov for additional clinical trial details.

About Radspherin

Radspherin is a novel alpha-emitting radioactive microsphere suspension designed for treatment of metastatic cancers in body cavities. The radium-224 based therapeutic, Radspherin has shown strong and consistent anticancer activity at doses being essentially non-toxic in preclinical studies. It is anticipated that the product can potentially be used to treat several forms of metastatic cancer.

On June 23, 2021 Kite, a Gilead Company, reported that Fosun Kite Biotechnology Co., Ltd., a joint venture between Kite and Shanghai Fosun Pharmaceutical (Group) Co., Ltd, has received approval from the China National Medical Products Administration (NMPA) for axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma (Press release, Kite Pharma, JUN 23, 2021, View Source [SID1234584284]).

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!

Axicabtagene ciloleucel is the first and only commercially available chimeric antigen receptor (CAR) T-cell therapy approved in China.

"In relapsed or refractory LBCL, current standard-of-care is associated with poor long-term outcomes, so we are pleased to offer this new hope of survival for patients in China who are in need of new therapeutic options," said Terence O’Sullivan, Vice President, International Region at Kite. "Thank you to the dedicated healthcare professionals, patients and caregivers who worked with the team at Fosun Kite to make this treatment option available in China."

Axicabtagene Ciloleucel, FKC876, is an autologous CD19-directed CAR T-cell therapy manufactured in China under a license to YESCARTA (Axicabtagene Ciloleucel) from Kite.

The approval is based on results of a single-arm, open label, multi-center bridging trial (FKC876-2018-001) which has evaluated the efficacy and safety of FKC876 in the treatment of Chinese patients with refractory intermediate invasive non-Hodgkin’s lymphoma (NHL)/ large B-cell lymphoma in China.

About YESCARTA (Axicabtagene Ciloleucel)

YESCARTA is the world’s first approved CAR T-cell therapy for adult patients with certain types of non-Hodgkin lymphoma (NHL). It was approved for the US market on October 18, 2017 by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, and high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. On August 27, 2018 YESCARTA was also approved by the European Medicines Agency’s (EMA) Committee for EU markets as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.

On June 23, 2021 Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, reported that its new wholly owned subsidiary, Celsion GmbH, will manage all current and future investigator-sponsored development of ThermoDox, the Company’s proprietary heat-activated liposomal encapsulation of doxorubicin (Press release, Celsion, JUN 23, 2021, View Source [SID1234584283]). Andreas Voss, M.D., a leading oncology researcher, has been named Managing Director of Celsion GmbH and will step down from Celsion’s board of directors later this year to head the subsidiary, which is based in Zug, Switzerland.

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!

Establishing Celsion GmbH allows Celsion’s management to focus solely on GEN-1, its DNA-mediated IL-12 immunotherapy currently in Phase I/II development for the treatment of advanced ovarian cancer, and PLACCINE, its nucleic acid vaccine platform. In addition to clinical and regulatory advice, Celsion’s ongoing investment in ThermoDox will be limited to providing clinical drug supply and modest financial support.

ThermoDox is currently under investigator-sponsored development for several cancer indications, including:

A Phase I study led by the University Medical Center Utrecht in the Netherlands to determine the safety, tolerability and feasibility of ThermoDox in combination with Magnetic Resonance Guided High Intensity Focused Ultrasound hyperthermia and cyclophosphamide therapy for the local treatment of the primary tumor in metastatic breast cancer.
A Phase I study led by Oxford University in the UK to assess intravenous delivery of ThermoDox in combination with High Intensity Focused Ultrasound in pancreatic cancer.
A clinical project at the National Institutes of Health to evaluate ThermoDox plus the chemotherapy drug mitomycin in bladder cancer.
Commenting on his new role in leading Celsion GmbH, Dr. Voss said, "I am excited to spearhead this effort and to work with investigators around the world who are interested in pursuing further clinical development of ThermoDox. Building upon encouraging preclinical results in several cancer indications, we have been fielding numerous requests from investigators to conduct their own studies. We know that doxorubicin is one of the most active cytotoxic drugs with no known specific resistance mechanism. Furthermore, the ability of ThermoDox to deliver high doses into tumor tissue is proven and its mechanism of action is well understood. Celsion GmbH’s long-term objective is to seek partnerships that will maximize the potential of ThermoDox, ultimately providing value to the parent company."

Michael H. Tardugno, Celsion’s chairman, president and chief executive officer, said, "Despite the bitter disappointment and surprise with our Phase III OPTIMA study of ThermoDox in primary liver cancer, many investigators are undaunted by various anomalies related to that data and see value in the drug’s continued study. We owe patients and the scientific community the opportunity to investigate ThermoDox while removing the financial obligation from our stockholders. Celsion is now solely focused on the significant opportunity we face with GEN-1 and PLACCINE in advanced ovarian cancer and SARS-CoV-2 vaccines, respectively. I am delighted that Celsion GmbH is in the experienced hands of Dr. Voss, who will pursue other collaborations and partnerships with the intent to monetize this asset."

Andreas Voss, M.D. joined Celsion’s board of directors in 2015. Dr. Voss has more than 25 years of research and drug development expertise. He previously served as Vice President of Clinical Affairs for Europe at Caris Life Sciences, a biotechnology company focused on implementing personalized medicine in oncology through its liquid biopsy technology. Prior to joining Caris in 2010, he was responsible for the global clinical development of Avastin and was a member of the Corporate Drug Safety Board at F. Hoffmann-La Roche. Before joining Roche in 2006, he was Medical Director for the Lung Cancer Disease Area at AstraZeneca, and from 2000 to 2003 he was Medical Director for Anti-infectives and Oncology at Bayer GmbH. From 1996 to 2000, Dr. Voss was Head of Medical Research, Oncology at Asta Medica AG. Dr. Voss received his M.D. from the University of Hamburg Medical School and was a postdoctoral fellow at the University of California San Diego.

On June 23, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that it has recently concluded a Type B meeting with the U.S. Food and Drug Administration ("FDA") regarding omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma (Press release, Y-mAbs Therapeutics, JUN 23, 2021, View Source [SID1234584281]).

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!

At the Type B meeting with the FDA, available data from external historical control groups and plans for statistical analyses to compare such data with the data from Study 03-133 were discussed. Based on our discussions with the FDA, we believe we now have a clearer path towards the resubmission of the omburtamab BLA to the FDA. Y-mAbs agreed to provide the agency with additional detailed data and the statistical analysis plan ("SAP") and anticipates being able to do so during the third quarter of 2021. Upon receiving the FDA’s feedback on these items, we expect to move forward and request a Type B pre-BLA meeting. Pending a positive Type B pre-BLA meeting, we aim to initiate rolling resubmission of the omburtamab BLA by the end of the year.

"Although we are moving the timeline into the fourth quarter, we believe we now have a clearer path towards the resubmission of the BLA for omburtamab, which, if approved, would address an important unmet medical need," stated Thomas Gad, founder, Chairman and President.

Dr. Claus Moller, Chief Executive Officer, continued, "We are very pleased to be aligned with the FDA on the next step towards the resubmission of the omburtamab BLA, and believe that, if approved, omburtamab can be of significant benefit to children with CNS/leptomeningeal metastasis from neuroblastoma."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound.

On June 23, 2021 Seven and Eight Biopharmaceuticals Inc., a clinical stage biotechnology company focused on developing proprietary novel immuno-oncology therapies to activate the immune system against cancer, reported that the first patient was treated in a First-in-Human Phase 1 clinical trial evaluating BDB018 in advanced solid tumors at Florida Cancer Specialists & Research Institute in Sarasota, FL (Press release, Seven and Eight Biopharmaceuticals, JUN 23, 2021, View Source [SID1234584279]).

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!

BDB018 is a next-generation intravenously administered Toll-Like Receptor 7 and 8 (TLR 7/8) dual agonist specifically designed to further enhance immune activation against cancer, while maintaining a favorable safety profile similar to its analogue, BDB001. BDB001 has shown to be well tolerated as monotherapy and in combination with an anti-PD-1 mAb, with responses seen in multiple advanced solid tumor types (SITC, 20201; ASCO (Free ASCO Whitepaper), 20212).

BDB018-101 (NCT04840394) is an open-label, dose escalation Phase I clinical trial evaluating the safety and tolerability of BDB018 in patients with advanced solid tumors that have relapsed or are refractory to standard treatments.

"We are excited to bring our next generation program with an intravenously administered TLR 7/8 dual agonist to the clinic, building on our success with BDB001," said Dr. Robert H.I. Andtbacka, Chief Medical Officer, Seven and Eight Biopharma, "The dosing of the first patient with BDB018 will begin to provide us with essential safety information needed to guide the future development of BDB018."

"Initiation of the BDB018-101 Phase I trial is another important milestone for Seven and Eight Biopharma in our mission to develop novel treatments for cancer and expand immuno-oncology treatments beyond targeting PD-1, PD-L1, and CTLA-4." said Dr. Walter Lau, Chief Executive Officer, Seven and Eight Biopharma.