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Announcement of Series A2 financing

On November 20, 2019 Thyas reported that it has raised JPY 240 million in Series A2 financing on November 20, with participation from Kyoto University Innovation Capital Co., Ltd., Chushin Venture Capital Co., Ltd., and Future Venture Capital Co., Ltd. (Press release, Thyas , NOV 20, 2019, View Source [SID1234629210]).

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The funds will be used for accelerating the research and development including preclinical studies of iPS cell-derived T cell therapy for the treatment of solid cancers.

ONC201 and ONC206 Activity in Neuro-Oncology to be Presented at SNO Conference

On November 20, 2019 Oncoceutics, Inc. reported that new data will be presented on the efficacy and mechanism of action of imipridones ONC201 and ONC206 at the 24nd Annual Scientific Meeting of the Society of Neuro-Oncology, to be held November 20th-24th in Phoenix, Arizona (Press release, Oncoceutics, NOV 20, 2019, View Source [SID1234558320]).

These data will highlight exciting findings that have emerged over the past year, including:

Updated clinical results for ONC201 in pediatric and adult H3 K27M-mutant gliomas
Extension of ONC201 activity to other brain tumors
Synergy antitumor activity of ONC201 in combination with other treatments
Activity of ONC206 in medulloblastoma
IND-enabling studies with ONC206
Distinctions in the activity of ONC201 and ONC206
Inhibition of mitochondrial function by ONC201
The capability of the imipridone family to bind to distinct molecular targets
Oncoceutics and academic investigators will present a range of results with imipridones that will include mechanistic and efficacy findings from preclinical models that detail their unique therapeutic potential in neuro-oncology. In addition, updated safety, pharmacokinetic, pharmacodynamic, and efficacy results from clinical trials with ONC201 in high-grade glioma patients will be reported. These results are largely derived from the ongoing clinical program that is dedicated to exploring ONC201 a molecularly-defined patient population (H3 K27M-mutant glioma). The rationale for the upcoming first-in-human clinical trial of ONC206 in adult recurrent CNS tumors will also be highlighted.

Summaries and presentation information are provided below:

Date/Time Location Abstract Title Presenter

Wednesday 11/20
9:40 – 9:50 PM JW Marriott Selective targeting of dopamine receptor dysregulation in high grade gliomas with ONC201 Varun Prabhu, PhD, Oncoceutics

Thursday 11/21
5:00 – 7:00 PM Investigator Meeting

Friday 11/22
7:30 – 9:30 PM Ballroom Lawn Imipridone Structure Activity Relationship Uncovers ONC206 as the Next Bitopic DRD2 Antagonist for Oncology with Differentiated Receptor Pharmacology Varun Prabhu, PhD, Oncoceutics
7:30 – 9:30 PM Ballroom Lawn Single agent ONC201 in previously treated, progressive adult H3 K27M-mutant glioma Isabel Arrillaga-Romany, MD, PhD, MGH
7:30 – 9:30 PM Ballroom Lawn Role of ONC206 in regulating medulloblastoma tumor progression Anshu Malhotra, PhD, Emory University
7:38 – 7:42 PM Wildflower B Receptor pharmacology of ONC201: The first bitopic DRD2 antagonist for clinical neuro-oncology Josh Allen, PhD, Oncoceutics

Saturday 11/23
7:15 – 8:30 AM Grand Canyon 8-13 H3K27M glioma and ONC201 (SNO-EANO Joint session) Isabel Arrillaga-Romany, MD, PhD, MGH
3:45 – 3:55 PM Grand Canyon 1-6 Clinical efficacy of ONC201 in thalamic H3 K27M-mutant glioma Carl Koschmann, MD, Michigan Medicine
4:40 – 4:45 PM Grand Canyon 1-6 Phase I clinical trial of ONC201 in pediatric H3 K27M-mutant glioma or newly diagnosed DIPG Sharon Gardner, MD, NYU Langone Health
5:00 – 7:00 PM Ballroom Lawn Preclinical combination of ONC201 with radiotherapy or Temozolomide in GBM, DIPG and ATRT cell lines results in dopamine receptor antagonism, ATF4 induction and cell death Lanlan Zhou, MD, PhD, Brown University
5:00 – 7:00 PM Ballroom Lawn Metabolic rewiring by ONC201/TIC10 and 2-Deoxyglucose has synergistic anti-glioblastoma activity Josh Allen, PhD, Oncoceutics
5:00 – 7:00 PM Ballroom Lawn PDTM-25 Study of ONC201 in pre-clinical models of DIPG Wafik Zaky, MD, MD Anderson
5:00 – 7:00 PM Ballroom Lawn IND-enabling Characterization of ONC206 as the Next Bitopic DRD2 antagonist for Neuro-oncology Varun Prabhu, PhD, Oncoceutics

Presentation dated November 20, 2019

On November 20, 2019, Bicycle Therapeutics plc (the "Company") presented the corporate presentation (Filing, 8-K, Bicycle Therapeutics, NOV 20, 2019, View Source [SID1234553767]).

PharmAbcine’s Olinvacimb, able to manage the first recruitment of patients for phase II clinical trial

On November 20, 2019 PharmAbcine, a biotech company specialized for developing novel human antibody therapeutics, reported that the company successfully recruited the first patient for Phase II clinical trials of olinvacimab (TTAC-0001) in US/Australia as of November 13, 2019 (Press release, PharmAbcine, NOV 20, 2019, View Source;mode=VIEW&num=6&category=&findType=&findWord=&sort1=&sort2=&it_id=&shop_flag=&mobile_flag=&page=1 [SID1234553401]).

In the phase II, 36 patients with rGBM (recurrent glioblastoma multiforme), whose tumour is reported to be progressed post the bevacizumab treatment, will be treated with a gradual successive increased dosage of olinvacimab from 16mg/kg, 20mg/kg to 24mg/kg. In this study, safety is the primary endpoint, followed by the assessment of efficacy. The study will also substantiate its effectiveness on patients with respect to Quality of Life through the assessment of tumour and of their reliance on steroid usage.

Gliobloastoma multiforme (GBM) is a type of brain tumour and it represents 15% of brain tumours. Even though there appears to be rigorous attempts to remove the tumour through surgery, chemotherapy and radiotherapy as a means of primary treatments, there is a high proclivity that GBM will likely relapse within a year. Regardless of prudent attentive post-treatment that has been performed for the patients, it is reported that 5 year survival rates are found to be less than 3%

Recently, Roche’s Avastin (bevacizumab) has been able to gain its top-notch clinical value through the manifestation of remarkable effectiveness in mitigating cerebral edema and consequently it has been approved for medical use in rGBM as a standard treatment. Nevertheless, an issue that starts to arise is that there are non-responding patients to bevacizumab and patients who start to develop non-responsiveness as a consequence of repeated use of bevacizumab. For these individuals, unmet medical needs for the rGBM indication are quite high owing to the deficient availability of alternative treatments for them.

One of representatives from PharmAbcine said, "There is no current suitable treatment for rGBM patients who are progressed after the bevacizumab treatment and it is unfortunate that it will cause cerebral edema in patients and cause severe damage," and continued, "We are looking to subjugate other rare diseases that are currently medically unmet and expecting to substantiate prominent asset of olinvacimab. From there we will extend our hands to a bigger spectrum of different indications of cancers."

Even though they both can mitigate angiogenesis in the TME (tumour microenvironment), onlinvacimb is significantly thought to be a more powerful strategic treatment to impede the process of metastasis and growth of tumour. Notably, while bevacizumab particularly binds to VEGF-A and inhibits the signaling caused by the binding of VEGF-A to VEGFR2, olinvacimab specifically targets VEGFR2 and consequently interferes with the activation of VEGFR2 caused by VEGF-A, C and D.

Entry into a Material Definitive Contract

On November 20, 2019, CASI Pharmaceuticals (WUXI) Co., Ltd. ("CASI-Wuxi"), a joint venture between CASI Pharmaceuticals, Inc. (the "Company") and Wuxi Jintou Huicun Investment Enterprise (Limited Partnership) in which the Company owns 80% of the equity interests, completed the Contract for Assignment of the Right to the Use of the State-owned Construction Land (the "Land Use Contract") with the Wuxi Natural Resources and Planning Bureau (Filing, 8-K, CASI Pharmaceuticals, NOV 20, 2019, View Source [SID1234551698]). Pursuant to the Land Use Contract, CASI-Wuxi will acquire the right to use the 74,028 square meters of industrial land in Wuxi for a period of 50 years.

As consideration for the land use right, CASI-Wuxi has committed to a land use fee in the total amount of approximately RMB 44,420,000 (USD$ 6,316,524), of which RMB 8,880,000 (USD$ 1,262,736) was paid as an advance deposit. A lump sum payment of the remaining land use fee (less the deposit) is expected to be paid by CASI-Wuxi on or about November 29, 2019.

As previously reported, CASI-Wuxi intends to construct a cGMP manufacturing facility on the land parcel. Under the Land Use Contract, CASI-Wuxi has agreed to make specified fixed asset investments on the land with initial construction to begin before August 26, 2020 and be completed before August 26, 2022, unless extended. CASI-Wuxi may transfer portions of the granted land to a third party once it has invested 25 percent of the total fixed asset investments amount and completed 25 percent of the project.

The foregoing description of the Land Use Contract does not purport to be a complete description of the rights and obligations of the parties thereunder and is qualified in its entirety by reference to the full text of the Land Use Contract that will be filed as an exhibit to the Company’s Annual Report on Form 10-K. for the year ended.