On August 27, 2021 TILT Biotherapeutics, a clinical-stage biotechnology company developing cancer immunotherapeutics, reported that new preclinical data relating to the use of its oncolytic immunotherapy platform for expressing a human IL-2 variant protein has been published in Frontiers in Immunology (1) (Press release, TILT Biotherapeutics, AUG 27, 2021, View Source [SID1234586975]). The paper was independently authored by researchers at the University of Helsinki (Finland) and other leading institutions, together with TILT Biotherapeutics.

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 paper, entitled: "Oncolytic Adenovirus Coding for a Variant Interleukin 2 (vIL-2) Cytokine Re-Programs the Tumor Microenvironment and Confers Enhanced Tumor Control," describes a study with TILT-452 (in the paper referred to as Ad5/3-E2F-d24-vIL2), which is a novel tumor-selective oncolytic adenovirus encoding for an improved variant of IL-2. TILT-452 was used in vitro and in vivo in a model of immunosuppressive pancreatic cancer leading to substantial intratumoral immune modulation and potent antitumor responses.

TILT-452 is constructed using the same platform as TILT’s lead asset, TILT-123, which is a 5/3 chimeric serotype adenovirus armed with two human cytokines; TNF alpha and IL-2. TILT-123 has demonstrated a 100% response rate in pre-clinical cancer models in vivo, and it is currently in multiple Phase 1 clinical trials (2,3) with interim data expected later this year.

The platform (Ad5/3-E2F-d24-) features unique double tumor specificity by restricting viral replication with trans-complemented mutations and a tumor-specific promoter, with transgene expression controlled by tumor-specific virus replication, allowing local and systemic administration. Moreover, the chimeric capsid from adenovirus serotype 5 that carries a knob from serotype 3 is used for increased entry into cancer cells through desmoglein 2, which is highly expressed by most malignant cells. Another advantage of using a vectored system for the protein delivery is the prolonged and spatially restricted high production in tumor lesions with minimum leakage to healthy tissues.

TILT Biotherapeutics’ CEO, Akseli Hemminki, a biotech entrepreneur and oncologist who has personally treated 300 patients with eleven different oncolytic viruses, said, "TILT-452 is a promising candidate for translation into clinical trials in human immunosuppressive solid tumors, such as pancreatic cancer and other difficult malignancies with unmet clinical need. We continue to progress this as part of our portfolio of next generation oncolytic viruses."

The heart of TILT’s approach revolves around the use of armed oncolytic adenoviruses, using cytokines and other molecules to boost the patient’s immune response to better enable it to find and destroy cancer cells. The company is advancing its preclinical pipeline towards further clinical trials in 2023.

On August 27, 2021 Nordic Nanovector ASA (OSE: NANOV) reported its results for the second quarter and first half 2021 (Press release, Nordic Nanovector, AUG 27, 2021, View Source [SID1234586974]). A presentation by Nordic Nanovector’s senior management team will be webcasted live today beginning at 8:30am CEST. The webcast can be accessed from www.nordicnanovector.com in the section: Investors & Media and a recording will also be available on this page after the event.

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 results report and the presentation are available on the company’s website in the section: Investors & Media/Reports and Presentation/Interim Reports/2021.

Malene Brondberg, interim CEO of Nordic Nanovector, said: "Nordic Nanovector continues to make important progress towards completing patient enrolment into the pivotal PARADIGME trial despite ongoing disruption from the COVID-19 pandemic. This disruption has reduced the acceleration in recruitment that we anticipated as a result of the amendments we made to the trial protocol and the multiple recruitment initiatives we have implemented. We now expect to report the preliminary readout from PARADIGME in H1’2022 and are focused on delivering this crucial milestone. The Company remains convinced that Betalutin is uniquely positioned to meet the need for a chemo-free, effective yet tolerable treatment for NHL patients, coupled with its convenient administration schedule, with potential quality of life advantages for elderly and frail patients."

Operational Highlights

PARADIGME timelines revised following review of patient recruitment rate and expected impact of continuing COVID-19 pandemic caused by the spread of the more infectious SARS-CoV-2 delta variant
Preliminary three-month data readout now expected during H1’2022
94 of a targeted 120 patients have been enrolled into PARADIGME as of 26 August 2021 (83 patients enrolled as of 25 May 2021)
Successful Private Placement and oversubscribed Repair Offering completed in February and April, respectively, raised approximately NOK 422 million (USD 49.7 million) in gross proceeds
Extends the company’s cash runway into H2’2022
Promising Phase 1b data reported from the Phase 1 Archer-1 study evaluating Betalutin in combination with rituximab in 2L follicular lymphoma (FL)
The combination showed a very good safety profile comparable to that of single agent Betalutin, and early signs of efficacy, with all seven patients responding to treatment, with 6 out of 7 patients still in remission
On 3 August 2021, the Company announced that the findings from Archer-1 will be important to inform the future development strategy for Betalutin in 2L FL and that it will invest no further funds in Archer-1.
Betalutin was found to be well tolerated, with a good safety profile consistent with all previous studies, in the LYMRIT 37-05 Phase 1 trial in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Clinical activity of Betalutin was seen in the six evaluable patients receiving the highest dosing regimen
Next steps for development of Betalutin in DLBCL are under consideration
The Company has committed to hosting an R&D Day in Q4’2021 to discuss the positioning and next steps for Betalutin development and commercialisation, as well as further pipeline opportunities
Malene Brondberg was appointed interim Chief Executive Officer in July
Ms Brondberg replaces Peter Braun, who left Nordic Nanovector for personal reasons. Ms Brondberg will continue in her role as CFO. The Board has initiated a search for a new CEO
Board changes
Hilde Hermansen Steineger, PhD, decided not to stand for re-election at the AGM on 28 April 2021
Solveig Hellebust, PhD, was appointed Non-executive Director at the AGM
Financial Highlights

(Figures in brackets = same period 2020 unless otherwise stated)

Revenues for the second quarter 2021 amounted to NOK 0.0 million (NOK 0.0 million)
Total operating expenses for the second quarter 2021 were NOK 103.9 million (NOK 113.4 million)
Comprehensive loss for the second quarter 2021 amounted to NOK 101.8 million (loss of NOK 125.6 million)
Revenues for the first half 2021 amounted to NOK 0.0 million (NOK 0.0 million)
Total operating expenses for the first half 2021 decreased to NOK 205.1 million (NOK 239.3 million)
Comprehensive loss for the first half 2021 was NOK 204.0 (NOK 217.2 million)
Cash and cash equivalents amounted to NOK 450.1 million at the end of June 2021, compared to NOK 497.9 million at the end of March 2021, and NOK 294.0 million at the end of December 2020
Outlook

Nordic Nanovector’s current focus is to complete patient enrolment into PARADIGME and is targeting the readout of preliminary three-month top line data during H1’2022.

The company’s current cash position will support its operations into H2’2022 and will enable further preparatory work on the potential Betalutin BLA filing and planning for commercialisation to be undertaken.

The company believes that, if positive, the PARADIGME trial data could represent a significant value inflection point for the company and its shareholders, confirming Betalutin as a highly promising new targeted radioimmunotherapy that can address the unmet needs of R/R FL patients.

The company intends to discuss the development plan and opportunities for expanding the market for Betalutin into other NHL indications, together with other potential areas for pipeline expansion based on CD37-targeting immunotherapies, at its R&D Day, which is planned to take place in Q4’2021.

On August 27, 2021 Shenzhen IONOVA Life Science Co., Ltd. ("IONOVA" or "the company"), a clinical-stage biotechnology company located in the Guangdong-Hong Kong-Macao Greater Bay Area of China, reported that completion of a new financing round of USD $100 million, jointly led by Tsing Song Capital, Shenzhen Capital Group Company, Ltd. ("SCGC"), and Greater Bay Area Homeland Development Fund, with existing shareholders Dyee Capital and Lilly Asia Ventures (LAV) adding to their holdings. Life Venture served as financial advisor (Press release, Shenzhen Ionova Life Sciences, AUG 27, 2021, View Source [SID1234586973]).

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!

IONOVA was founded in November 2016 by Dr. Yongkui Sun, a former veteran from Merck Research Laboratories for over 20 years in R&D and business development, and a member of the US National Academy of Engineering. IONOVA’s thrust is to develop a new generation of innovative targeted and immuno therapies for more effective cancer treatment.

IONOVA leadership consists of a team with extensive drug hunting experiences ranging from disease biology to early clinical development. The company’s unique research arm, Touchstone Translational Research Institute, enables the company to establish both internal disease biology-driven drug discovery programs, and external collaborations with academia and industry to translate discoveries in basic biomedical research into novel therapies for cancer treatment. IONOVA has a rich pipeline of drug candidates fighting cancers and cancer resistance. Among them, INV-1120 is in Ph I in the US.

"We at IONOVA are committed to translation of basic biomedical research discoveries into novel drugs with differentiated clinical benefits in cancer treatment. We are excited to complete this round of financing led by Tsing Song Capital, Shenzhen Capital Group Company, Ltd. ("SCGC"), and Greater Bay Area Homeland Development Fund, three venture firms renowned in fueling growth of biotechnology in China. We are also delighted to have continued support from our earlier investors Dyee Capital and Lilly Asia Ventures. The fund will fuel rapid advancement of a growing number of preclinical and clinical oncology candidates in IONOVA pipeline. Jointly we will use our collective creativity to bring forward IONOVA innovations from the Great Bay Area to global marketplace and to the benefits of cancer patients around the world," said Dr. Yongkui Sun, founder, Chairman and CEO of IONOVA.

"IONOVA has a well-defined R&D strategy that solidly anchors on a deep understanding of cancer biology and patient needs and focuses on creating novel cancer therapeutics that have significant clinical values and clear product differentiation. To improve success of novel drug discovery efforts, IONOVA established an innovative industry-leading translational research platform that aims to harness the collective ingenuity of scientific ecosystem. IONOVA constantly strives for scientific excellence and accelerates drug development by intense focus on projects that have strong scientific rationale, combination synergy and biomarker strategy to bring our innovations sooner to patients," said Dr. Xiang S Ye, Chief Scientific Officer of IONOVA.

"It’s our honor to support IONOVA, as well as continue to boost the company’s promising research and development pipeline. We believe there remains a variety of untapped opportunities in the global oncotherapy field. Moreover, we strongly agree with the company’s development strategy. The company has been engaged in the tumor microenvironment and immunoregulation since its founding. A synergetic pipeline of "immunotherapy + targeted therapy" has been constructed, clinical development of various drugs are being systematically and rapidly advanced, and the pipeline is also being further enriched. These all prove the strong execution capabilities of the company’s management team. We are confidently looking forward to a future where IONOVA will become the leading enterprise of innovative drugs in the oncotherapy field in China and even globally, healing patients, and fulfilling its vision," said Dr. Zhang Song, founder of Tsing Song Capital.

"IONOVA has a world-class R&D team for innovative cancer drugs. The company is equipped with experienced scientists in all areas of new drug R&D and has established a strong R&D platform for translational medicine, which continuously contributes to high-value product pipelines. All product pipelines have global interests and pay great attention to synergy; the company’s overall development strategy is highly consistent with the current policy orientation of China and development trend of the global pharmaceutical industry. We are very optimistic about the company’s future development potential, " said Dr. Xing Zhibin of SCGC.

On August 27, 2021 ViewRay, Inc. (NASDAQ: VRAY) reported that the Company will present at the Morgan Stanley 19th Annual Global Healthcare Conference. Scott Drake, President and Chief Executive Officer, and Zach Stassen, Chief Financial Officer, will participate in a fireside chat at 10:15 a.m. Eastern Time on Friday, September 10, 2021 (Press release, ViewRay, AUG 27, 2021, View Source [SID1234586972]).

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!

An audio webcast of the Company’s presentation will be available on the investor relations section of ViewRay’s website at View Source A replay of the webcast will be available for 7 days after the date of the presentation.

On August 27, 2021 Lynk Pharmaceuticals CO., LTD (hereinafter referred to as "Lynk Pharmaceuticals"), an innovative pharmaceutical R&D company, reported that it has successfully completed Series B financing of $50 million, with Lilly Asia Ventures (LAV) as lead investor, New Alliance Capital and Hangzhou HEDA Biological Medicine Venture Capital Partnership (L.L.P.) as co-investors, and its original shareholders Legend Capital and Med-Fine Capital as participating investors (Press release, Lynk Pharmaceuticals, AUG 27, 2021, View Source [SID1234586971]). The proceeds from this round of financing will mainly be used to conduct Phase I and II clinical trials for multiple programs in the R&D pipeline of Lynk Pharmaceuticals. In addition, the funding will be used to expand international business, strengthen international collaborations with leading companies and support preclinical development of new projects. CEC Capital acted as the exclusive financial advisor to Lynk Pharmaceuticals in this transaction.

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!

Founded in 2018, Lynk Pharmaceuticals is a globally leading innovative drug R&D company. Based on the team’s world-leading experience in medicinal chemistry and small molecule clinical development, it is dedicated to the development of global FIC/BIC small molecule drugs for autoimmune diseases, inflammation and cancers. In three and a half years since its establishment, Lynk has obtained IND approvals for three original products in China and the United States, launched global clinical development efforts, and completed the ex-Chinese rights out-license of LNK01001 to a US company and the in-license of the first-in-class RAS program from Japan’s Kobe University and RIKEN, both in 2020.

Dr. Zhao-Kui (ZK) Wan, Chairman and CEO of Lynk Pharmaceuticals, said, "We are very much grateful for the recognition and support from the top investors in the industry. Since the establishment of Lynk Pharmaceuticals, we have been advancing our projects with efficient execution, and we have made significant progress in just three and a half years. This round of financing will lay a solid foundation for us to further develop our pipeline and continue to advance innovative therapies. Owing to the great efforts of many scientists and investigators, I believe that we will benefit patients with innovative therapies as soon as possible."

According to Dr. Ting Feng, Vice President of Lilly Asia Ventures (LAV), "We are deeply impressed by the efficient execution and global vision of Lynk Pharmaceuticals’ management team. We are also very optimistic about the future huge market space and the unmet patient needs in the field of autoimmune disease and cancer. We are excited to partner with the Lynk team to accelerate its growth and look forward to more breakthroughs and successes in the future with our innovation capability."

Lei Cai, Managing Director at New Alliance Capital, commented："there have been huge unmet needs as well as great potential for small molecule drugs to treat autoimmune disease and cancer. Lynk’s international vision and strong team execution have left a deep impression on us; we are very happy to have the opportunity to work with Lynk. New Alliance Capital will provide full support in all aspects of capitals and industry resources to support the company to become a global leader and bring more effective solutions to benefit patients across the world."