On August 10, 2020 Saniona (OMX: SANION) ("Saniona" or the "Company"), a clinical-stage biopharmaceutical company focused on rare diseases, reported that its Board of Directors has resolved on a directed issue of 30,660,374 shares to a number of U.S. and international institutional investors and sector specialists based on the authorization granted by the Annual General Meeting held on 6 May 2020 (the "Directed Issue") (Press release, Saniona, AUG 10, 2020, View Source [SID1234563249]).

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The new shares were issued at a subscription price of USD 2.12 per share (SEK18.50), and represents a discount of approximately 45 per cent compared to the volume weighted average price (VWAP) on Nasdaq Stockholm for the period of the last 45 days up to and including 7 August 2020.
Through the Directed Issue, the Company will receive gross proceeds of USD 65 million (approximately SEK 567 million).
The Directed Issue was led by RA Capital Management with participation from Pontifax Venture Capital and New Leaf Venture Partners among other U.S. and international healthcare investors as well as the Second Swedish National Pension Fund (AP2), the Third Swedish National Pension Fund (AP3) and the Fourth Swedish National Pension Fund (AP4).
The net proceeds will be used to continue Saniona’s advancement of its late-stage clinical trials with Tesomet in two rare eating disorders, hypothalamic obesity (HO) and Prader Willi Syndrome (PWS), as well as to build its U.S.-based organization in support of these programs.
Comment from Rami Levin, President & CEO of Saniona

"The participation of multiple well-respected U.S. and International institutional healthcare investors in this financing led by RA Capital Management demonstrates the significant potential of Saniona’s rare disease pipeline. With this financing, we will be able to further increase shareholder value by advancing Tesomet to registration for approval, moving our early-stage pipeline into the clinic, and building our U.S. organization. We believe achieving these milestones will position us as potentially the first treatment for two rare diseases, hypothalamic obesity and Prader-Willi Syndrome" said Rami Levin, President and CEO of Saniona.

The Directed Issue

The Board of Directors of Saniona has, in accordance with the issue authorization granted by the Annual General Meeting on May 6, 2020, resolved on a directed issue of 30,660,374 shares at a subscription price of USD 2.12 per share (SEK 18.50), consequently raising gross proceeds of USD 65 million (approximately SEK 567 million) before deduction of costs related to the transaction.

The net proceeds will be used to continue Saniona’s advancement of its late-stage clinical trials with Tesomet in two rare eating disorders, hypothalamic obesity (HO) and Prader Willi Syndrome (PWS), as well as to build its U.S.-based organization in support of these programs.

The Directed Issue was led by RA Capital Management with participation from Pontifax Venture Capital and New Leaf Venture Partners among other U.S. and international healthcare investors as well the Second Swedish National Pension Fund (AP2), the Third Swedish National Pension Fund (AP3) and the Fourth Swedish National Pension Fund (AP4). The subscription price per share of USD 2.12 (SEK 18.50) has been established through arms’ length negotiations with a number of institutional investors over a period of time. The Company’s Board of Directors is therefore of the opinion that the subscription price has been set at market terms and accurately reflects current market conditions and demand. The reasons for the deviation from the shareholders’ preferential right were mainly to diversify the shareholder base with financially strong and well reputable U.S. and Swedish institutional investors and sector specialists and to enable a capital raise in a time and cost-efficient manner. It is the assessment of the Board of Directors that the Directed Issue is beneficial to the Company and hence for all existing shareholders.

Through the Directed Issue, the number of shares in the Company will increase by 30,660,374 to 61,043,690, and the share capital will increase by SEK 1,533,018.70 to SEK 3,052,184.50. The Directed Issue entails a dilution of approximately 50 per cent for existing shareholders, based on the number of shares in the Company after the Directed Issue.

In connection with the Directed Issue, the Company has agreed pursuant to a lock-up undertaking, subject to customary exceptions, not to issue additional shares or other securities for a period of 90 days following settlement of the Directed Issue. In addition, in connection with the Directed Issue, members of the Board of Directors and management of Saniona have agreed not to sell any shares or other securities in the Company for a period of 90 days following the settlement of the Directed Issue, subject to customary exceptions and furthermore subject to that warrants of series TO2 (where the exercise period runs between 7 September 2020 – 21 September 2020) or shares subscribed through exercise of such warrants are not covered by the lock-up undertaking.

A prospectus relating to the listing of the shares in the Directed Issue on Nasdaq Stockholm is expected to be approved and registered by the Swedish Financial Supervisory Authority ("SFSA") on or about 13 August, 2020, i.e. before the new shares are subject to trading on Nasdaq Stockholm.

The completion of the Directed Issue is subject to certain customary conditions of the investment agreement entered into by the Company with the investors in connection with the Directed Issue, whereby the investors may for customary reasons terminate the placing in full if it occurs before settlement of the placing.

Financial and legal advisors

Oppenheimer & Co. Inc. and ABG Sundal Collier AB acted as Joint Bookrunners ("Joint Bookrunners") while Setterwalls Advokatbyrå AB acted as legal advisor to Saniona in relation to Swedish law and Goodwin Procter LLP acted as legal advisor to Saniona in relation to US law.

On August 10, 2020 Vycellix, Inc., an immuno-centric discovery life science company with a focus on natural killer cell-based (NK cell) therapeutics, reported that its Chairman & CEO, Evren Alici, M.D., Ph.D., will present at the upcoming Innate Killer Summit (Press release, Vycellix, AUG 10, 2020, View Source;utm_medium=rss&utm_campaign=vycellix-ceo-to-present-next-generation-universal-cell-platform-to-optimize-allogeneic-cell-therapies-at-innate-killer-summit [SID1234563248]). The Conference, which will be held as a virtual event on August 25-26, is the largest industry-focused meeting concentrating on all aspects of innate immunity and NK cell therapy breakthroughs.

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Vycellix Presentation Details:

Event: Innate Killer Summit (virtual conference)
Presenter: Evren Alici, M.D., Ph.D., Chairman & CEO, Vycellix, Inc.
Day/Time: Wednesday, August 26 at 9:30am ET
Title: Strategies to Generate Potent NK Cells as Universal Source
Link: View Source

Dr. Alici’s presentation will include discussion reporting on Vycellix’s VY-UC platform, designed to generate immune-privileged universal cells without altering the components that control self-recognition (HLA). Cells modified by VY-UC avoid immune recognition of grafted cells without impacting HLA while conserving viability, functionality, and persistence.

According to Dr. Alici, "We developed VY-UC to abrogate cellular immune response while obviating the need for immune-suppressive drugs in contexts of allogeneic cell therapies, hence redefining ‘off-the-shelf’ treatment strategies for a broad range of uses and indications, including for the development of next-generation NK cells." Dr. Alici is group leader in Hematology at Karolinska Institutet (KI), Department of Medicine, Stockholm, Sweden. He also serves as co-director of NextGenNK, an international Competence Center for the development of next-generation NK cell-based cancer immunotherapies based at KI.

On August 8, 2020 MonTa Biosciences reported that have completed our regulatory meeting with the Danish Medicines Agency to align views on development strategy and interpretation of ICH guidelines (Press release, MonTa Biosciences, AUG 8, 2020, View Source [SID1234618678]). MonTas plan for moving our lead candidate MBS8 into the clinic was well supported, securing a clear path forward toward, and a smooth process for our Clinical Trial Application filed in the near future. Thanks to our consultants Ozack and Ingrid Bøgh for great help in the process.

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On August 8, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported with Eli Lilly and Company ("Lilly",NYSE: LLY) that interim analysis data from ORIENT-11 were released today in an oral presentation at the IASLC World Conference on Lung Cancer (WCLC) 2020 Virtual Presidential Symposium. On the same day, the data was published online by the Journal of Thoracic Oncology. This trial was conducted to assess the efficacy of TYVYT (sintilimab injection) in combination with ALIMTA (pemetrexed) and platinum chemotherapy as a first-line treatment in people with nonsquamous non-small cell lung cancer (nsqNSCLC) without sensitive EGFR mutation or ALK rearrangement.

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ORIENT-11 is a randomized, double-blind, Phase 3 clinical trial evaluating TYVYT (sintilimab injection) or placebo in combination with ALIMTA (pemetrexed) and platinum chemotherapy as a first-line treatment for advanced or recurrent nsqNSCLC without sensitizing EGFR mutations or ALK rearrangements. Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), TYVYT (sintilimab injection) in combination with ALIMTA (pemetrexed) and platinum chemotherapy demonstrated a statistically significant improvement in progression-free survival (PFS) compared with placebo in combination with ALIMTA (pemetrexed) and platinum chemotherapy, which met the pre-defined efficacy criteria. After a median follow up of 8.9 months, the median PFS of the sintilimab combination and the placebo combination assessed by the Independent Radiographic Review Committee (IRRC) was 8.9 months and 5.0 months, respectively [HR (95%CI) = 0.482 (0.362, 0.643), P < 0.00001]. The median overall survival (OS) was not reached in both groups, but OS showed an improvement favoring the sintilimab combination (HR=0.609, 95%CI: 0.400-0.926). Confirmed objective response rate (assessed by IRRC) was improved from 29.8% to 51.9%, and the sintilimab combination showed a shorter time to response (median time to response: 1.51 months in the sintilimab combination versus 2.63 months in the placebo combination). The safety profile was consistent with previously reported sintilimab studies, and no new safety signals were identified. National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for this indication.

Professor Li ZHANG, Head of Department of Internal Medicine, Sun Yat-sen University Cancer Center, the primary investigator of the ORIENT-11 trial, stated: "According to data released by the National Cancer Centre in 2019, lung cancer currently has the highest incidence and mortality of all cancers. Immunotherapy combined with chemotherapy has become one of the standard first-line treatments for patients with negative driver genes. The ORIENT-11 trial has demonstrated a significant delay of disease progression with sintilimab in combination with chemotherapy in this patient population. We are honored to be selected as one of the oral presentations in the Presidential Symposium to share this clinical data."

Dr. Hui ZHOU, Vice President of Medical Science and Strategy Oncology of Innovent, stated: "ORIENT-11 showed a significant improvement in progression-free survival in patients who received sintilimab combined with conventional chemotherapy as a first-line treatment compared with those who received chemotherapy alone. We would like to thank the patients and investigators involved in ORIENT-11 for their important contributions to this landmark trial."

Dr. Li WANG, Senior VP of Lilly China and Head of Lilly China Drug Development and Medical Affairs Center, stated: "Being able to present the results of ORIENT-11 at the WCLC 2020 Presidential Symposium is a major recognition. With these encouraging results of ORIENT-11, sintilimab may soon be able to expand its indication to the first-line treatment of non-squamous NSCLC. We look forward to its potential approval in China, with the goal of helping more patients with lung cancer and giving these patients and their families hope of a longer life."

About ORIENT-11 Trial

ORIENT-11 is a randomized, double-blind, Phase 3 clinical trial evaluating the efficacy and safety of TYVYT (sintilimab injection) or placebo in combination with ALIMTA (pemetrexed) and platinum chemotherapy as a first-line treatment for advanced or recurrent non-squamous non-small cell lung cancer (nsqNSCLC) without sensitizing EGFR mutations or ALK rearrangements (ClinicalTrials.gov, NCT03607539). The primary endpoint is progression-free survival (PFS) assessed by Independent Radiographic Review Committee based on RECIST v1.1. The key secondary endpoints include overall survival (OS) and safety profile.

A total of 397 subjects have been enrolled in the ORIENT-11 trial and randomized in a 2:1 ratio to receive either sintilimab 200mg or placebo in combination with ALIMTA (pemetrexed) and platinum chemotherapy every 3 weeks for up to 4 cycles, followed by either sintilimab or placebo plus ALIMTA (pemetrexed) maintenance therapy. The subjects will receive treatment until radiographic disease progression, unacceptable toxicity or any other conditions that require treatment discontinuation. Conditional crossover is permitted.

About nsqNSCLC

Lung cancer is a malignancy with the highest morbidity and mortality in China. NSCLC accounts for about 80 to 85 percent of lung cancer. Approximately 70 percent of NSCLC is locally advanced or metastatic at initial diagnosis, rendering those patients with no chance of radical resection. Meanwhile, even after radical surgery, patients still have a high chance of recurrence and eventually die from disease progression. About 70 percent of NSCLC in China is the nonsquamous subtype and 50 percent of nsqNSCLC is without sensitizing EGFR mutations or ALK rearrangements. These patients do not respond well to targeted therapy and there are limited treatment options available to them.

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection), an innovative drug with global quality standards jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after at least two lines of systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT (sintilimab injection) is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL) in November 2019. In April 2020, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with ALIMTA (pemetrexed) and platinum as first-line therapy in non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT (sintilimab injection) combined with Gemzar (gemcitabine for injection) and platinum chemotherapy met the predefined primary endpoint in the Phase 3 ORIENT-12 study as first-line therapy in patients with locally advanced or metastatic squamous NSCLC, and TYVYT (sintilimab injection) monotherapy met the primary endpoint in the ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma as well.

TYVYT (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies for sintilimab injection to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. Meanwhile, we are actively developing it globally.

On August 8, 2020 The Netherlands Cancer Institute reported that the combination of first-line nivolumab and ipilimumab demonstrated an improvement of overall survival for patients with unresectable malignant pleural mesothelioma compared to platinum-based chemotherapy (Press release, Checkmate Pharmaceuticals, AUG 8, 2020, View Source [SID1234563246]).

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The study is presented by Paul Baas, M.D., from The Netherlands Cancer Institute and The University of Leiden, in Amsterdam. Watch a video of Dr. Baas explaining his research here: View Source

Nivolumab is an immunotherapy that works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Ipilimumab is a monoclonal antibody that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system. When administered in combination, this dual immunotherapy has shown clinical benefit in 6 different tumor types, including mesothelioma.

In this large phase III study, Dr. Baas and the global study investigators randomly assigned more than 600 patients: 303 to the nivolumab + ipilimumab arm and 302 to the chemotherapy arm. The study had a minimal follow up of close to two years. Two-year overall survival rates were 40.8% for the patients in the experimental treatment arm vs 27.0% in chemotherapy arm. Of the 30.3% of patients in the study-combination group who experienced grade 3-4 adverse events, 15% discontinued therapy compared with 7.4% of the 32.0% of patients in chemotherapy group.

"CheckMate 743 met its primary endpoint of statistically improved OS with nivolumab + ipilimumab vs standard of care chemotherapy in first-line treatment of patients with mesothelioma," said Dr. Baas. "These clinically meaningful data represent the first positive phase 3 trial of immunotherapy in first-line MPM and should be considered as a new standard of care."

Phase 3 eXalt3 Study Shows Significantly Longer Progression-Free Survival in Patients with ALK+ Lung Cancer with Ensartinib Versus Crizotinib

Patients with non-small cell lung cancer (NSCLC) carrying anaplastic lymphoma kinase (ALK) gene alterations who received ensartinib experienced substantially longer progression-free survival than a matched group of patients who received crizotinib.

The results were presented today by Leora Horn, MD, Ingram Associate Professor of Cancer Research in the Division of Hematology/Oncology and director of the Thoracic Oncology Program at Vanderbilt-Ingram Cancer Center, Nashville, Tenn. View a video interview of Dr. Horn discussing the trial here: View Source

Ensartinib (X-396) is a novel next-generation ALK tyrosine kinase inhibitor (TKI). According to Dr. Horn, in Phase 1 and 2 studies, ensartinib showed promising activity in patients with ALK+ NSCLC who were ALK TKI treatment naive or received prior crizotinib or second-generation ALK TKIs, including strong activity in patients with brain metastases.

Crizotinib is an anti-cancer drug acting as an ALK, MET, and ROS1 inhibitor, approved for treatment of some subtypes of patients with NSCLC (including ALK+) in the United States and other countries worldwide.

Dr. Horn and her colleagues at the participating cancer centers randomized 290 patients with ALK+ NSCLC to either ensartinib or crizotinib—the prespecified intent to treat (ITT) population with locally determined ALK+ NSCLC. Patients were stratified by prior chemotherapy, Eastern Cooperative Oncology Group performance status, brain metastases, and geographic region. Baseline characteristics were well balanced between the two groups: median age was 54.1; 26% of patients had prior chemotherapy, and 36% of patients had baseline brain metastases (5% had prior brain radiotherapy). The modified ITT population (the prespecified patient population that was ALK+ as confirmed by central Abbott FISH test) included 247 patients, of which 121 received ensartinib and 126 received crizotinib.

At the July 1, 2020 data cutoff, based on a pre-planned interim analysis design (at 75% of progression-free survival events) treatment was ongoing in 64 ensartinib-treated patients (45%) and 25 crizotinib-treated patients (17%). There were 139 patients who experienced disease progression (as assessed by blinded independent review committee, BIRC) or death, which represented 73% of progression events in the ITT population and 119 BIRC-events or deaths (63%) in the mITT population.

According to Dr. Horn, the trial’s analysis demonstrated a statistically significant difference between patients who received ensartinib, with a median progression-free survival of 25.8 months compared with 12.7 months with crizotinib, with a median follow-up of 23.8 and 20.2 months, respectively (HR, 0.52; 95% CI, 0.36-0.75; P=.0003 by log-rank test). In the mITT population, the median progression-free survival has not been reached yet for the ensartinib arm vs. 12.7 months for the crizotinib arm (HR, 0.48; 95% CI, 0.32-0.71; P=.0002 by log-rank test).

The overall response rate was 75% versus 67% with crizotinib; among patients with measurable brain metastases, the BIRC-assessed intracranial overall response rate was 64% with ensartinib versus 21% with crizotinib.

The time-to-treatment-failure rate in the brain in patients with no baseline brain metastases was also significantly lower with ensartinib compared to crizotinib (4% vs 24% at 12 months).

"In patients with ALK-positive NSCLC, ensartinib significantly prolonged progression-free survival over crizotinib with a favorable safety profile, representing a new option in the first-line setting," Dr. Horn concluded.

Addition of Sintilimab to Pemetrexed and Platinum Improved Progression-Free Survival in Patients with Nonsquamous Non-Small Cell Lung Cancer—Results of ORIENT-11 Presented at IASLC Virtual Presidential Symposium

The interim analysis of ORIENT-11, a phase III double-blind randomized trial has shown a nearly two-fold increase in progression-free survival with addition of sintilimab to chemotherapy in patients with advanced or metastatic non-squamous non-small cell lung cancer without EGFR or ALK genomic aberrations, according to research data presented today at the International Association for the Study of Lung Cancer Virtual Presidential Symposium.

The research findings are also published simultaneously in the Journal of Thoracic Oncology, the journal of the International Association for the Study of Lung Cancer.

Previously, sintilimab in combination with pemetrexed and a platinum-based chemotherapy had shown promising activity for nonsquamous non small cell lung cancer in a phase 1b study, according to Li Zhang, M.D., of Sun Yat-sen University Cancer Center, Guangzhou, China.

Dr. Zhang and investigators from centers in China enrolled 397 patients in the study. Of these, 266 and 131 patients were randomly assigned to the sintilimab combination and to placebo combination, respectively. Patients with all ranges of PD-L1 expression (by tumor proportion score, TPS) were included. The median progression free survival per was significantly improved in sintilimab-combination group compared to placebo combination group (8.9 vs. 5.0 months).

Dr. Zhang reported that sintilimab-combination group showed a nominally significant improvement of overall survival The overall response rate also was improved for the sintilimab-combination group (51.9% versus 29%). The safety signal for the sintilimab combination was similar to that found in other studies, but rates of occurrence of grade > 3 adverse events were slightly higher in the sintilimab-combination group (61.7% versus 58.8%).

"This study demonstrated that the addition of sintilimab to chemotherapy significantly improved progression-free survival and a nominally improved overall survival, with an acceptable safety profile in [patients with] first-line non-squamous non small cell lung cancer," said Dr. Zhang. "In this study, we collected tumor samples at baseline of treatment. So, our next work will focus on biomarker exploration. By RNA sequencing of tumor samples, we look forward to searching a potential biomarker which can predict the survival benefit from PD-1 combination with chemotherapy."