On May 26, 2021 Nordic Nanovector ASA (OSE: NANOV) reported its results for the first quarter 2021 (Press release, Nordic Nanovector, MAY 26, 2021, View Source [SID1234580658]). A live webcast presentation by Nordic Nanovector’s management team will take place today at 08.30 CEST. A link to the webcast is available on www.nordicnanovector.com.

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The results report and the presentation are also available on the company’s website in the section: Investors & Media/Reports and Presentation/Interim Reports/2021. A replay of the webcast will be made available at the same location after the event.

Peter L. Braun, Chief Executive Officer of Nordic Nanovector, commented: "Nordic Nanovector has made important progress so far in 2021, including raising the money needed to deliver the preliminary top-line three-month data from the PARADIGME study and to prepare for a subsequent potential BLA filing for Betalutin. The company has also implemented a range of initiatives aimed at improving patient recruitment into PARADIGME, and which we believe will further improve patient enrolment when the impact of COVID-19 recedes. I am convinced that effective and well-tolerated, targeted radiopharmaceuticals, such as Betalutin, a one-time treatment, can make a real difference to NHL patients worldwide."

Operational Highlights

Peter L. Braun was appointed Chief Executive Officer in March
Mr Braun is an experienced and entrepreneurial pharmaceutical leader with extensive commercialisation and innovative oncology experience from a career spanning nearly 30 years at Roche
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
Operational improvements and protocol changes have improved PARADIGME recruitment rate in recent months, despite impact from the on-going COVID-19 pandemic
83 patients enrolled as of 25 May 2021 (73 enrolled as of 17 February 2020)
Company remains on track to report preliminary three-month top-line data by the end of 2021
Promising Phase 1b data from the Archer-1 study evaluating Betalutin in combination with rituximab in 2L FL
Board changes
Hilde Hermansen Steineger, PhD, decided not to stand for re-election at AGM
Solveig Hellebust, PhD, appointed Non-executive Director at the AGM on 28 April 2021
Financial Highlights Q1 2021

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

Revenues for the first quarter amounted to NOK 0.0 million (NOK 0.0 million).
Total operating expenses for the first quarter were NOK 101.2 million (NOK 125.9 million).
Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 85.9 % of total operating expenses year to date 2021 (80.8 %).
Comprehensive loss for the first quarter amounted to NOK 102.1 million (loss of NOK 91.7 million).
Cash and cash equivalents at the end of March 2021 amounted to NOK 497.9 million, compared to NOK 294.0 million at the end of December 2020.
Outlook

Nordic Nanovector’s current focus is to complete patient enrolment into PARADIGME and the target is to announce the preliminary readout of three-month top line data from PARADIGME by end 2021.

Following the recent successful Private Placement and Repair Offering, the company has extended its cash runway into H2’2022, which in addition to allowing it to deliver the top line data from PARADIGME, will enable further preparatory work on the potential Betalutin BLA filing 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.

On May 26, 2021 KAHR, a clinical-stage cancer immunotherapy company developing novel bi-functional fusion proteins, and Cancer Focus Fund, LP, a unique venture capital fund established in collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) to provide funding and clinical expertise to advance promising cancer therapies, reported that Cancer Focus Fund is investing $5 million to finance a clinical trial of KAHR’s lead anti-CD47 candidate, DSP107, in blood cancers (Press release, KAHR Medical, MAY 26, 2021, View Source [SID1234580657]).

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The Cancer Focus Fund investment will support a Phase 1/2 clinical study assessing KAHR’s first-in-class CD47x41BB targeting agent in the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and T-cell lymphoproliferative diseases. Cancer Focus Fund is receiving a combination of equity and future payments from KAHR based on DSP107 achieving certain milestones.

"KAHR’s multi-functional immuno-recruitment fusion proteins exemplify the innovative approach to cancer we seek to support," said Ross Barrett, a founder and Managing Partner of Cancer Focus Fund. "DSP107 uniquely delivers a multilayered attack by binding cancer cells and T-cells to produce a targeted synergistic effect, combining immune checkpoint inhibition with selective T-cell activation. It has demonstrated encouraging activity in preclinical models, and we welcome the opportunity to support its clinical assessment in blood cancers."

"We are honored to collaborate with Cancer Focus Fund, which has invested in KAHR and through its partnership with MD Anderson, contributed expertise in the planning of this Phase 1/2 clinical trial," said Yaron Pereg, PhD, CEO of KAHR. "This marks our second clinical study for DSP107, which is currently being investigated in a Phase 1/2 trial as monotherapy and in combination with Roche’s PD-L1-blocking checkpoint inhibitor atezolizumab (Tecentriq) in solid tumors. We look forward to expanding the clinical development program for our lead product and initiating this study in hematological malignancies in collaboration with MD Anderson."

The study will be conducted at MD Anderson under the direction of Naval Daver, MD, Associate Professor in the Department of Leukemia. The two-part open label, dose escalation and expansion study is expected to enroll up to 112 patients. The first part will evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of DSP107 as monotherapy and in combination with azacytidine in patients with relapsed/refractory AML, MDS or chronic myelomonocytic leukemia (CMML). In the second part, the trial will assess the efficacy of DSP107 as monotherapy and in combination with azacytidine or with azacytidine plus venetoclax in patients with previously untreated AML or MDS, and in patients with relapsed/refractory MDS, CMML and T-cell lymphoproliferative diseases.

About DSP107
DSP107 is a first-in-class CD47x41BB targeting compound that simultaneously targets cancer cells, weakens their innate defenses and activates an effective, local response of both innate and adaptive immunity. DSP107 targets CD47-overexpressing tumors, simultaneously blocking macrophage inhibitory signals and delivering an immune costimulatory signal to tumor antigen-specific, activated T-cells. CD47 is overexpressed on many cancer cells and binds SIRPα on immune phagocytic cells to produce a "don’t eat me" signal. DSP107 binds CD47 on cancer cells, blocking interaction with SIRPα and thus, blocking the "don’t eat me signal". Simultaneously, DSP107 binds 41BB on T-cells, stimulating their activation. These activities lead to targeted immune activation through both macrophage and T-cell mediated tumor destruction.

On May 26, 2021 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported for the first quarter 2021 (Press release, Oncopeptides, MAY 26, 2021, View Source [SID1234580656]).

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"Oncopeptides now stands proudly among the few companies that have successfully navigated the long and difficult path from discovery to commercialization" says CEO, Marty J Duvall.

Financial overview January-March

Net sales amounted to SEK 19.4 M (0.0)
Operating loss amounted to SEK 347.3 M (loss: 296.9)
Loss for the period was SEK 234.7 M (loss: 297.3)
Loss per share, before and after dilution, was SEK 3.45 (loss: 5.37)
Cash and cash equivalents amounted to SEK 372.5 M (617.8) on March 31
Significant events January-March

PEPAXTO was granted accelerated approval by the FDA for the treatment of adult patients with relapsed or refractory multiple myeloma on 26 February
The US commercial launch of PEPAXTO was successfully initiated in mid-March
PEPAXTO was included in the in the new Multiple Myeloma Clinical Practice Guidelines of the National Comprehensive Cancer Network (NCCN) in Oncology in March
The leadership in Europe was in the beginning of March strengthened with two new significant recruitments to build up European commercial organization
Oncopeptides strengthened the balance sheet through a directed share issue of SEK 1,106 M (USD 130 M). The share issue was completed in April
Significant events after the reporting period

PEPAXTO April net sales amounted to SEK 28.0 M (USD 3.3 M)
An application for conditional marketing authorization of melflufen in the EU submitted in mid- April
Patient enrollment in the phase 2 PORT study was completed in May
Top-line results from the phase 3 OCEAN study was announced on May 25
New dates for publication of the interim reports for Q2 and Q3 2021

Conference call for investors, analysts and the media

Investors, financial analysts and media are invited to participate in a webcast with a Q&A session at 12:00 CEST. The event will be hosted by CEO, Marty J Duvall, CMO, Klaas Bakker and CFO, Anders Martin-Löf.

The webcast will be streamed via this ink which can also be found on the website: www.oncopeptides.com.

On May 26, 2021 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that Andrew Robbins, Chief Executive Officer and President, will present at Jefferies Virtual Healthcare Conference on Thursday, June 3rd, from 11:30-11:55am ET (Press release, Cogent Biosciences, MAY 26, 2021, View Source [SID1234580655]).

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Access to the webcast of this event, as well as an archived recording, will be available under the "Events" tab on the investor relations section of the Cogent Biosciences website at: View Source

On May 26, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, and Addario Lung Cancer Medical Institute (ALCMI) reported they will present on the progress of "Biomarker Analysis in High PD-L1 Expressing NSCLC Patients Treated With PD-1/PD-L1 Based Therapy With or Without the Addition of Platinum Based Chemotherapy (BEACON-Lung) (Press release, Biodesix, MAY 26, 2021, View Source [SID1234580654])." The BEACON-Lung study aims to evaluate biomarkers to predict overall survival and early progression outcomes in treatment-naïve advanced stage non-small cell lung cancer (NSCLC) patients with high PD-L1 expression. The first patient participant enrolled in the study this week.

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"The BEACON-Lung study furthers ALCMI’s mission to work with partners like Biodesix to overcome barriers to treatment in lung cancer," said Tony Addario, chair and CEO of ALCMI. "This study will enable us to develop a better understanding of how biomarkers can unlock treatment options for patients with NSCLC and improve survivorship."

The study, being conducted through ALCMI’s prestigious research consortium of leading US academic centers, launched early this year. Nearly half of the targeted 10 sites are actively enrolling with a target enrollment of 390 patients. BEACON-Lung will use Biodesix’s Primary Immune Response (PIR) test to classify patients receiving PD-1/PD-L1 therapy or PD-1/PD-L1 plus carboplatin-based chemotherapy and identify those who may benefit from more aggressive treatment regimens.

"As an oncologist, I am excited by the progress we have made for patients who are now diagnosed with non-small cell lung cancer," said Dr. Mary Jo Fidler, principal investigator for the BEACON trial and associate professor in the Department of Internal Medicine, Division of Hematology, Oncology and Cell Therapy at Rush Medical College. "However, to identify the best treatment course for an individual patient still requires the development of biomarkers, especially in the field of immunotherapy. BEACON-Lung is a study that aims address this current gap in biomarker development and treatment selection for advanced non-small cell lung cancer."

The BEACON-Lung study is designed to generate key data to further the development of immunotherapy biomarkers for treatment naïve NSCLC patients. Currently, PDL1 expression is the only clinically validated biomarker predicting patient response to front line PD-1/L1 directed immunotherapy. However, PD-L1 expression remains an imperfect marker, and this study will also help determine if patients should pursue other treatment regimens.

"We are thrilled that the BEACON-Lung study is now launched," said Dr. James Jett, CMO of Biodesix. "This study will allow us to evaluate performance of Biodesix’s PIR test in the treatment naïve NSCLC patient population receiving immunotherapy. We are committed to the advancement of biomarker research and to fulfill an unmet need in the NSCLC treatment landscape."

Presentation Title: Biomarker Analysis in High PD-L1 Expressing NSCLC Patients Treated With PD-1/PD-L1 Based Therapy With or Without the Addition of Platinum Based Chemotherapy (BEACON-Lung)
Authors: Mary J. Fidler, Victoria Meucci Villaflor, Amol Rao, Balazs Halmos, Erin Marie Bertino, Raymond U. Osarogiagbon, David Paul Carbone; Rush University Medical Center, Chicago, IL; Northwestern University Feinberg School of Medicine and Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Memorial Care, Laguna Hills, CA; Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY; The Ohio State University Comprehensive Cancer Center, Columbus, OH; Baptist Cancer Center, Multidisciplinary Thoracic Oncology Department, Memphis, TN
Abstract Number: TPS9126
Session Date/Time: June 4, 2021 / After 9am E.T.

About ALCMI
The Addario Lung Cancer Medical Institute (ALCMI, voiced as "Alchemy"), founded in 2008 as a 501c(3) non-profit organization by lung cancer survivor Bonnie J Addario, is a patient-centric, international research consortium driving research otherwise not possible. Working in tandem with its "partner" foundation, GO2 Foundation for Lung Cancer, ALCMI powers collaborative initiatives in genetic (molecular) testing, therapeutic discoveries, targeted treatments, and early detection. ALCMI combines scientific expertise found at its network of 26 member academic institutions through its network of community cancer centers to accelerate patient access to research.