On December 15, 2020 Scandion Oncology A/S ("Scandion" or the "Company") reported that the result of its rights issue (the "Rights Issue"), where the subscription period ended on December 10, 2020, shows that 3,600,363 shares, corresponding to approximately 34 percent of the shares offered, were subscribed for by exercise of subscription rights (Press release, Scandion Oncology, DEC 15, 2020, View Source,c3254864 [SID1234574542]). Additionally, 1,634,048 shares, corresponding to approximately 15 percent of the Right Issue, were subscribed for without use of subscription rights, of which 1,318,505 shares, corresponding to 12 percent of the Rights Issue, were subscribed for by external professional investors. The remaining part of the Rights Issue, corresponding to 5,477,437 shares or approximately 51 percent, were subscribed for by the guarantors. The Rights Issue is therefore fully subscribed and provides Scandion with proceeds amounting to approximately SEK 236 million before issue costs.

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Not for publication, distribution or announcement, directly or indirectly, in or into the United States, Australia, Hong Kong, Japan, Canada, New Zealand, Switzerland, Singapore, South Africa or any other jurisdiction in which publication, distribution or announcement of this press release is unlawful or is subject to legal restrictions other than those required by Swedish law.

3,600,363 shares, corresponding to 34 percent of the Rights Issue, were subscribed for using subscription rights.
1,318,505 shares, corresponding to approximately 12 percent of the Rights Issue, were subscribed for by external professional investors.
315,543 shares, corresponding to approximately 3 percent of the Rights Issue, were subscribed for by existing shareholders and others without subscription rights.
The remaining part of the Rights Issue, corresponding to 5,477,437 shares or approximately 51 percent, were subscribed for by the guarantors.
Approximately 1.3 percent of the Rights Issue, corresponding to approximately SEK 3 million, were subscribed for by certain members of the board of directors and the management.
"I am extremely pleased to embrace the capitalization of Scandion Oncology and the strong support from our existing and new shareholders. This capital raise is a defining moment for us in our journey to make a difference for the many patients with drug resistant cancers. With this amount of new funding we are poised to deliver strong validating data for our first in class lead candidate SCO-101 and it gives Scandion Oncology the opportunity to implement our strategy to become the cancer drug resistance company" says Bo Rode Hansen, President & CEO of Scandion Oncology A/S.

Allocation of shares subscribed for without using subscription rights has been done in accordance with the principles stated in the prospectus published on 24 November 2020. Notice of allotment is made through a settlement note sent to the respective subscribers. Payment for allotted shares must be made in accordance with the instructions in the settlement note.

Following settlement and registration of the new shares with the Danish Business Authority, the Company’s share capital will increase by DKK 787,320.8280 to a total of DKK 2,361,962.4840. The number of shares in the Company will increase by 10,711,848 shares to a total of 32,135,544 shares.

Following settlement, trading in paid subscribed shares (BTA) takes place on the Spotlight Stock Market until the BTAs have been converted to ordinary shares, following registration of the new shares with the Danish Business Authority, which is expected to take place during week 52, 2020, at which point the temporary ISIN code for the BTAs will be merged with the permanent ISIN code for the Company’s shares.

Advisors

Vator Securities is financial adviser and Advokatfirman Schjødt (as to Swedish law) and Plesner Advokatpartnerselskab (as to Danish law) are legal advisers to the Company in connection with the Rights Issue.

On December 15, 2020 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, and Overland Pharmaceuticals ("Overland"), a premier biopharmaceutical company backed by Hillhouse Capital, reported the formation of Allogene Overland Biopharm (Allogene Overland) (Press release, Allogene, DEC 15, 2020, View Source [SID1234572962]). The joint venture will focus on the development, manufacturing and commercialization of AlloCAR T therapies for patients in greater China, Taiwan, South Korea and Singapore. Allogene Overland will have an exclusive license to develop, manufacture and commercialize specific Allogene candidates targeting BCMA, CD70, FLT3, and DLL3 in the licensed territories. The joint venture will also seek opportunities to advance the global development of AlloCAR T therapies against these targets.

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"We are excited to be the first allogeneic cell therapy company to establish a joint venture in China dedicated to making the potential benefits of an off-the-shelf cell therapy available to patients in China and other Asian Pacific markets," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "We’re looking forward to joining forces with Overland to build a leading cell therapy company focused on helping to accelerate the development of AlloCAR T therapies for blood cancers and solid tumors."

"Overland has a strong operational presence in China backed by the Hillhouse Capital global biopharmaceutical ecosystem. Combined with Allogene’s domain expertise, this positions Allogene Overland Biopharm to bring these important new therapies to patients and physicians fighting cancer across Asia and around the world," said Hua Mu, M.D., Ph.D., Co-Founder, Interim Chief Executive Officer and Chief Medical Officer of Overland Pharmaceuticals.

"Allogene has an established track record of success in the design, manufacture and development of innovative cell therapies," added Ed Zhang, M.B.A., Co-Founder, Chief Operating Officer and Chief Business Officer of Overland Pharmaceuticals. "Together, we establish a broad strategic partnership and will jointly move forward the development and global expansion of this cutting-edge technology platform."

Under the terms of the agreement, Allogene Overland will receive an exclusive license to AlloCAR T candidates directed at four targets, BCMA, CD70, FLT3, and DLL3, in the licensed territories. Overland will invest $117 million in capital, which includes an upfront payment of $40 million to Allogene and $77 million in capital to support joint venture operations. Overland and Allogene are the sole equity holders in Allogene Overland. Allogene will be eligible to receive a milestone payment per product for each first regulatory approval in China, as well as tiered royalties on net sales. Overland will provide development and operational support while Allogene will provide technical and manufacturing expertise. Allogene Overland will be governed by a Board of Directors with equal representation from Overland and Allogene.

Allogene has an exclusive license to the Cellectis technology for its allogeneic products and holds all global development and commercial rights for these investigational candidates.

On December 15, 2020 Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, reported that it has signed an exclusive agreement in China to license DetermaRx, its proprietary test to identify high-risk, early-stage lung cancer patients who need treatment to improve their five-year survival, to Burning Rock Biotech Limited, a $2.5 billion market cap NASDAQ-listed (BNR) company (Press release, Oncocyte, DEC 15, 2020, View Source [SID1234572942]). Burning Rock is one of the fastest growing and largest companies in China’s next-generation sequencing (NGS) based cancer therapy selection market.

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Under the agreement, Oncocyte will receive upfront cash payments after transferring and installing DetermaRx technologies, and for a fixed number of tests performed when DetermaRx achieves inclusion in the United States National Comprehensive Cancer Network (NCCN) Guidelines. Oncocyte will also receive ongoing royalties per patient tested with DetermaRx. The transfer of the testing technology is scheduled to occur in the first quarter of 2021, and the technology installation is expected to be completed by the third quarter of 2021.

China represents the largest patient population in the world for DetermaRx. This agreement marks Oncocyte’s fifth global licensing agreement and completes the Company’s stated goal of reaching all the major world markets within the first year of launch.

DetermaRx is a treatment stratification test that identifies stage I-IIA non-small cell lung cancer (NSCLC) patients at high-risk of recurrence despite ostensibly curative surgery, who may benefit from the addition of chemotherapy. The test is reimbursed by Medicare. In a 250-patient prospective cohort, test-identified, low-risk patients had a five year freedom from recurrence (FFR) rate of 94.6%; test-identified high-risk or intermediate-risk patients who were treated with adjuvant platinum chemotherapy had 96.7% five year FFR compared to 71.7% five-year disease-free survival (DFS) for high-risk patients who did not receive chemotherapy. Recurrence rate in molecular high-risk stage IA patients was 25%, compared to only 3% in molecular low-risk stage IA patients.1

"This agreement with Burning Rock accelerates the ongoing expansion of our DetermaRx test to patients and physicians outside the U.S., and exemplifies our global growth strategy," said Ron Andrews, Chief Executive Officer and President of Oncocyte. "We believe aligning with one of the largest and fastest growing companies in China’s NGS-based cancer therapy selection market speaks to the strength of DetermaRx as a valuable treatment stratification tool to help clarify this critical treatment decision point in early stage tumors. We continue to see strong growth in all of our commercial metrics thus far in the fourth quarter, and this agreement helps us achieve our goal of completing distribution agreements for DetermaRx in all major rest-of-world markets within one year of the U.S. product launch. We are honored to partner with Burning Rock whose comprehensive portfolio of molecular tests for the oncology market allows us access to the largest eligible patient population in the world as well as China’s major cancer centers. In addition to expanding our available market, this important milestone also provides us with non-dilutive capital and an ongoing revenue stream to strengthen our growth trajectory as well as help reduce our operational cash burn."

Yusheng Han, Founder and Chief Executive Officer of Burning Rock added, "We are excited to be entering into this agreement with Oncocyte. As the leader of NGS application in oncology in China, we are committed to providing the best diagnostic solutions to Chinese patients and oncologists. China’s stage I-IIA non-squamous NSCLC incidence is estimated at over 100,000 per annum2. We believe Oncocyte’s risk stratification test fills a clear unmet need in identifying those patients who are at high risk and may benefit from adjuvant chemotherapy, versus low risk patients who do not have to undergo unnecessary chemo treatments, in a convenient and affordable manner. Combining DetermaRx with our products for genetic testing and MRD detection (currently under R&D), we can provide a comprehensive testing strategy for oncologists to ultimately benefit Chinese early-stage NSCLC patients by improving their survival and quality of life. We look forward to expanding this much-needed and promising test to the Chinese market and continuing to collaborate with Oncocyte in the future."

For a more complete description of the terms of the agreement, please read the Exclusive Sublicense Agreement that will be filed as an exhibit to Oncocyte’s Form 8-K on or about December 14, 2020.

On December 15, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, reported that it provides an update on efti clinical programs (Press release, Immutep, DEC 15, 2020, View Source [SID1234572933]).

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Eftilagimod alpha ("efti") Update

AIPAC – Phase IIb clinical trial

The Company presented in a spotlight presentation at the San Antonio Breast Cancer Symposium 2020, first Overall Survival (OS) data and is on track to report final overall survival data and overall response rate by mid calendar year 2021. Currently there are more than 66% of events compared to approx. 60% which were the basis of the OS data presented at the San Antonio Breast Cancer Conference.

TACTI-002 – Phase II clinical trial

The 3rd stage of 1st line NSCLC with an additional 74 patients in the US, Australia and Europe is now open for recruitment. The TACTI-002 Phase II study, which is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada), has been expanded by 74 additional patients, following the results presented at SITC (Free SITC Whitepaper) in November 2020.

Recruitment is ongoing for stage 2 of Part C (second line head and neck squamous cell carcinoma) and it is expected to open recruitment of stage 2 of Part B (second line non-small cell lung cancer) in the next year.

Phase II Clinical Trial in Head and Neck Cancer

Immutep continues to prepare for a new randomised, controlled Phase II clinical study in approximately 160 1st line HNSCC patients. Patients will be 1:1 randomised to receive efti in combination with an anti-PD-1 treatment, or anti-PD-1 monotherapy. The trial is intended to take place across clinical trial sites in the United States, Australia and Europe.

TACTI-mel – Phase I clinical trial

The results of Immutep’s Phase I TACTI-mel trial were recently published in the Journal for ImmunoTherapy of Cancer. The trial was conducted in Australia and evaluated efti in combination with pembrolizumab in metastatic melanoma.

INSIGHT-004 – Phase I clinical trial

INSIGHT-004, the fourth arm of the INSIGHT trial (INSIGHT-004 is also known as Stratum D of INSIGHT) which is being conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. is expected to deliver final data in 2021. First data from the study were presented at ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) 2020.

EOC Pharma – Phase II clinical trial

Preparations are ongoing for a new Phase II clinical study in China (152 patients) evaluating efti in combination with chemotherapy for the treatment of metastatic breast cancer.

Financial Update

In the current quarter, Immutep completed an equity financing and raised approximately A$29.6 million in a placement supported by high quality institutional investors from Australia and offshore.

In addition, given the recent exercise of warrants over American Depository Shares, which generated proceeds of approximately US$7.7 million (approx. AU$10.1 million), the Company is in an excellent financial position with a cash runway beyond end of calendar year 2022.

On December 15, 2020 Peptomyc S.L., a biotech company specialized in the development of protein and peptide therapeutics for cancer treatment, reported the completion of an equity financing round of EUR 11.4 million (Press release, Peptomyc, DEC 15, 2020, View Source [SID1234572929]). The company is focused on the development of a new generation of cell penetrating peptides (CPPs) targeting the Myc oncoprotein for cancer treatment.

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Peptomyc is relying on a strong syndicate of life sciences investors. This investment was led by AurorA Science and substantially supported by existing investors including Alta Life Sciences, HealthEquity, Business Angels and the CDTI. Also, Peptomyc’s employees had the opportunity to invest in the company.

This financing will enable Peptomyc to advance OMO103 until preliminary results of phase I clinical trial. OMO103 has already demonstrated its safety and anti-tumor activity in multiple types of experimental models of cancer and it is now ready to be tested in clinical studies. The treatment of the first patient with the lead candidate, OMO103, is expected to start in Q1, 2021.

"We are delighted to have attracted such high-profile investors to our company," said Laura Soucek, CEO of Peptomyc. "I am confident that their industrial background and extensive experience in bio-pharma and translational medicine will significantly contribute to the success of our product."

"We were excited to have the opportunity to participate in this financing" said Guido Guidi, chairman of AurorA Science. "Peptomyc is a promising company matching our industrial criteria, following a rigorous selection process managed by AurorA Science’s three partners, AurorA-TT, Rottapharm Biotech and Italfarmaco. We are glad to support a company with front edge science and outstanding potential to bring benefits to patients."

Of note: Peptomyc is already preparing for a new financing round for 2021 to ensure the swift execution of its ongoing and planned clinical development programs until completion of successful clinical Phase II studies.