On May 19, 2021 Targovax ASA’s ("Targovax" or the "Company") stock exchange reported that Published on 18 May 2021, regarding the board of directors’ resolution to increase the Company’s share capital with NOK 2,129.90 by the issuance of 21,299 new shares, each with a nominal value of NOK 0.10, in order to facilitate an exercise of 21,299 RSUs pursuant to the Company’s RSU program for Board members (Press release, Targovax, MAY 19, 2021, View Source [SID1234580281]).

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Primary insider, Bente-Lill Romøren, member of the board of directors, has exercised

15,250 restrictive stock units ("RSUs") under her RSU agreement and subscribed for 15,250 new shares in the Company following the exercise of RSUs. The exercise price for the options was NOK 0.10 per new share.

Following the RSU exercise and subscription of new shares and the registration of the share capital increase pertaining to the new shares with the Norwegian Register of Business Enterprises (Nw. Foretaksregisteret), Bente-Lilll Romøren holds 35,577 shares, 11,361 RSUs and nil options in Targovax.

On May 19, 2021 MAIA Biotechnology, Inc., a targeted therapy, immuno-oncology company focused on developing first-in-class oncology drugs, reported that it has raised $8.0 million financing in a convertible note offering led by new investor Checkmate Capital Group with participation from other strategic and existing investors (Press release, MAIA Biotechnology, MAY 19, 2021, View Source [SID1234580297]). The proceeds of the financing will advance the company’s targeted immuno-oncology programs and will support the initiation of a Phase 1/2 clinical trial evaluating THIO followed by Libtayo (cemiplimab) in patients with advanced Non-Small Cell Lung Cancer (NSCLC). The Phase 1/2 clinical trial is expected to begin later this year.

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"We are excited to expand MAIA’s investor base and welcome several new investors who have extensive expertise in immuno-oncology and biotechnology investing. This funding round brings MAIA the necessary capital to accelerate development of the THIO program," stated Vlad Vitoc, MD, MAIA’s Chief Executive Officer and President. "We appreciate the investors’ recognition of THIO’s well-demonstrated clinical safety profile and promising efficacy potential in a variety of advanced tumors."

Lead investors in this financing included a diverse group of strategic investors, including Checkmate Capital Group, BRK Financial Group, and MDL Investments.

"As experienced investors in successful immuno-oncology companies, we have been deeply impressed with the THIO pre-clinical results in multiple difficult-to-treat tumor types. The data from sequential administration of THIO followed by Libtayo raise the prospect of a groundbreaking advancement in cancer treatment," commented Alex Monsef, Managing Director from Checkmate Capital Group. "We see the THIO program as having the potential to transform the immuno-oncology landscape. We are thrilled to invest in this exciting technology platform led by a world class oncology team at MAIA."

About the Phase 1/2 Clinical Trial in Advanced Non-Small Cell Lung Cancer (NSCLC)

This trial (THIO-101) will be the first to test THIO’s immune system activation followed by administration of the checkpoint inhibitor Libtayo (co-developed by Regeneron and Sanofi), allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to checkpoint inhibitor treatment will enhance and prolong immune response in patients with advanced NSCLC who did not respond or progressed after first-line treatment regimen containing a checkpoint inhibitor.

The trial will assess the safety, mechanistic activity and immune system activation of four THIO dose levels, each in separate arms. Each dosing arm will then be evaluated further for efficacy based on Overall Response Rate (ORR), Duration of Response (DoR), Progression Free Survival (PFS) and Overall Survival (OS). Additional patients may be recruited for further clinical evaluation in any of the THIO arms based on safety and clinical benefit. Each arm of the trial will enroll up to 40 evaluable patients.

About THIO

THIO (aka 6-thio-dG, 6-thio-2’-deoxyguanosine) is a first-in-class small molecule that is the only cancer telomere targeting agent currently in development. THIO selectively kills telomerase-positive cancer cells, which account for more than 85% of human cancers. THIO’s activity was shown to be specific to tumor types with active telomerase, an enzyme that is silent in most healthy cells. Telomerase recognizes THIO and selectively incorporates it into the telomeres in tumor cells. Once incorporated, THIO compromises the telomere structure and function, leading to ‘uncapping’ of the chromosome ends, which results in rapid tumor cell death. Low doses of THIO, followed by anti-PD-L1 or anti-PD1 therapy, completely eliminated advanced tumors in pre-clinical models and produced cancer cell-specific immune memory, where the immune system continued to be active against the cancer cells after extended periods of time, with no additional treatment. These results demonstrate how the THIO-produced telomere stress increases innate sensing and adaptive anti-tumor immunity, which provides a strong rationale for sequentially combining telomere-targeted therapy with immunotherapy. THIO is investigational and has not been approved yet for any use by regulatory authorities.

About Non-Small Cell Lung Cancer

Lung cancer is the leading cause of cancer death worldwide. It is estimated that, in 2020, more than 2.2 million new cases were diagnosed globally, including 228,000 new cases in the U.S. Approximately 85% of all lung cancers are NSCLC and an estimated 80% of these cases are telomerase positive. While immunotherapies have transformed advanced NSCLC treatment in recent years, there remains a significant unmet need to optimize treatment of patients and offer additional clinical options.

On May 19, 2021 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, reported initial efficacy and safety data from one of the cohorts in ARC-6, a randomized Phase 1b/2 platform study, evaluating the novel combination of etrumadenant (dual adenosine A2a/A2b receptor antagonist) plus zimberelimab (anti-PD1 antibody) and docetaxel in people with taxane-naïve mCRPC who progressed following treatment with one or more new hormonal agents and were checkpoint inhibitor-naïve (Press release, Arcus Biosciences, MAY 19, 2021, View Source [SID1234580313]). In this Phase 1b cohort of the etrumadenant-based combination, a composite ORR (radiographic and/or PSA [prostate-specific antigen] response) of 41% and a PSA response of 35% were observed. The safety profile was consistent with the known profiles of each individual agent, and no significant additive toxicity was observed with the addition of etrumadenant. These data will be presented in a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 4-8.

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"We are encouraged by these early data that indicate the etrumadenant-based combination is well tolerated and demonstrates promising clinical activity in people with advanced disease who progressed on prior treatments," said Bill Grossman, M.D., Ph.D., Chief Medical Officer of Arcus. "Based on these data, we have initiated enrollment into the randomized Phase 2 portion of this arm in the ARC-6 platform study, which compares the etrumadenant-based regimen to standard of care."

"Prostate tumors produce high levels of adenosine, which is believed to be immunosuppressive," said Sumit K. Subudhi, M.D., Ph.D., Department of Genitourinary Medical Oncology, Division of Cancer Medicine at the University of Texas, M.D. Anderson Cancer Center. "I am encouraged by the early evidence of clinical response and composite ORR of 41% observed in this study cohort, indicating adenosine receptor blockade with an etrumadenant-based combination may have a role in the treatment of prostate cancer."

ARC-6: A Phase 1b/2, Open-Label, Randomized Platform Study to Evaluate Efficacy and Safety of Etrumadenant (AB928)-Based Treatment Combinations in Patients with Metastatic Castrate-Resistant Prostate Cancer (Abstract 5039)

As of the data cut-off (DCO) of April 9, 2021, 17 people (n=17) had received the etrumadenant-based combination in this cohort of the Phase 1b portion of the study. Median time on treatment was 4.2 months (range: 2.1-8.3+ months), and 11 people remained on study treatment at time of DCO. For this cohort, all people had received prior systemic therapy but were taxane naive; most (13/17; 76%) had received ≥1 prior anti-androgen, and 11/17 people (65%) had received prior abiraterone.

Safety Analyses:

People in this cohort of the study were administered 150 mg of etrumadenant orally once daily plus 360 mg of zimberelimab and 75mg/m2 of docetaxel intravenously every three weeks.
All people experienced treatment emergent adverse events (TEAE), and the most common TEAEs were alopecia (53%), lymphocyte count decreases (53%) and fatigue (47%).
Grade 3 or 4 related TEAEs were reported for 6/17 (35%) people; all of these events were related to etrumadenant and may also be attributed to zimberelimab and/or docetaxel.
No treatment emergent serious adverse events (TESAEs) were considered related to etrumadenant.
Clinical Activity:

The composite ORR (radiographic and/or PSA response) was 41% (7/17) per the Prostate Cancer Working Group 3 (PCWG3) criteria.
Six people (35%) had a >50% decrease in PSA level, and seven people (41%) had non-response/non-progression.
All 11 people with RECIST measurable or non-measurable disease experienced clinical benefit (stable disease or better).
One unconfirmed complete response (CR) was observed in a person with only non-target disease remaining.
Two confirmed partial responses (PRs) were observed; one person with PR also had improvement in bone disease burden.
The safety and clinical activity data from this cohort of ARC-6 add to the emerging body of evidence that adenosine receptor blockade with an etrumadenant-based combination may have a role in the treatment of certain cancers. Based on these results, Arcus has initiated the randomized portion of this cohort which is evaluating this etrumadenant-based combination compared to docetaxel, the current standard of care for this setting.

Additional information about this poster presentation may be found on the Arcus website at Arcus Publications on June 4.

In addition to ARC-6, etrumadenant is currently being evaluated in three randomized Phase 2 studies:

ARC-7 is evaluating domvanalimab (anti-TIGIT antibody) plus zimberelimab vs. zimberelimab alone vs. domvanalimab plus zimberelimab and etrumadenant in first-line metastatic, PD-L1>50%, locally advanced or metastatic non-small cell lung cancer (NSCLC), with an interim analysis planned for this quarter.
ARC-4 is evaluating etrumadenant plus chemotherapy and zimberelimab vs. chemotherapy plus zimberelimab in second-line (2L) or third-line (3L) EGFR-positive NSCLC. Data from this study are expected in the second half of 2021.
ARC-9 is evaluating etrumadenant-based combinations in 2L and 3L metastatic colorectal cancer (mCRC). These data build on the results of ARC-3, a Phase 1/1b open-label study of etrumadenant plus chemotherapy in people with mCRC, which showed encouraging tolerability and efficacy in the 3L setting compared to standard of care. Data from this study are expected in the first half of 2022.
About Etrumadenant

Etrumadenant (AB928), the first dual A2a/A2b adenosine receptor antagonist in the clinic, is designed to maximally inhibit the adenosine-driven impairment of tumor-infiltrating lymphocytes (mainly CD8+ T cells and NK cells) and myeloid cells (dendritic cells, macrophages), mediated by A2aR and A2bR, respectively. A2bR is also upregulated by certain cancer cells, such as in prostate cancer and KRAS-mutated cancers. As a result, etrumadenant may uniquely block adenosine’s immunosuppressive and cancer cell-intrinsic effects. Developed specifically for the oncology setting, etrumadenant achieves high penetration of tumor tissue, robust potency in the presence of high adenosine concentrations, and minimal shift in potency from non-specific protein binding. Etrumadenant has demonstrated a favorable safety profile with a variety of combination regimens and exhibits pharmacokinetics / pharmacodynamics consistent with once-daily oral dosing. AB928 is currently being evaluated in several Phase 1b/2 studies across multiple indications.

On May 19, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported additional data from the Company’s dose-escalation cohort of the Phase 1 study of STRO-002, a folate receptor alpha (FolRα) targeting antibody-drug conjugate (ADC) for patients with advanced, progressive ovarian cancer; the data will also be presented as a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting to be held on June 4-8, 2021 (Press release, Sutro Biopharma, MAY 19, 2021, View Source [SID1234580329]).

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"We are pleased to share today the maturing dose-escalation data on STRO-002 that will be presented by principal investigator Dr. R. Wendel Naumann during the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting," said Bill Newell, Chief Executive Officer of Sutro Biopharma. "The 39 patients with advanced, progressive ovarian cancer on the study achieved a median progression-free survival of 7.2 months. Median duration of response was 5.8 months in the five confirmed responders. The dose-escalation data positions STRO-002 as a potentially important treatment option providing durable clinical benefit, especially when compared to standard of care and other agents in clinical development."

Summary of STRO-002-GM1 Phase 1 Dose-Escalation Cohort Update
The dose-escalation cohort enrolled patients with advanced, progressive epithelial ovarian cancer, not pre-selected based on FolRα-expression levels. Patient enrolled were heavily pre-treated and had received a median of six prior lines of therapy – including at least one platinum-based regimen in 100% of patients, and at least three prior lines of platinum regimens in 46%, bevacizumab in 82%, PARP inhibitors in 59%, checkpoint inhibitors in 21%, and other investigational agents in 36% of patients.

The cohort enrolled 39 patients and included 34 patients treated with clinically active dose levels at 2.9 mg/kg or higher, of which 31 patients had at least one post-baseline scan and were evaluable for RECIST responses. The cohort completed enrollment in August 2020 and the data in the ASCO (Free ASCO Whitepaper) 2021 abstract was based on an earlier cut-off date of January 30, 2021. The data that will be presented in a poster at ASCO (Free ASCO Whitepaper) 2021 had a cut-off date of April 23, 2021 and is summarized below.

Of the 31 patients evaluable for RECIST, 10 patients met criteria for response. One patient achieved a complete response (CR) and nine patients achieved a partial response (PR). Of the nine PRs, four were confirmed PRs (cPRs) and five were unconfirmed PRs (uPRs).
For the five confirmed responders (1 CR and 4 cPRs), the median duration of response (DOR) was 5.8 months (95% CI: 2.0, not evaluable).
Median study follow-up was 8.4 months and median progression-free survival (PFS) was 7.2 months (95% CI: 4.5, 10.8).
86% of treatment-emergent adverse events (AEs) were Grade 1 or 2. The most common Grade 3 and 4 AEs were neutropenia (64%), arthralgia (13%), fatigue (10%), neuropathy (8%), and abdominal pain (8%), all of which were managed with standard medical treatment, dose reductions, or dose delays.
Dose limiting toxicities (DLTs) were observed at higher dose levels in two patients – at 6.0 mg/kg (Grade 2 neuropathy/Grade 3 arthralgia) and at 6.4 mg/kg (Grade 3 bone pain).
Tissue samples for FolRα-expression analysis were provided by clinical sites retrospectively and were available in 18 patients treated at ≥ 2.9 mg/kg in the dose-escalation cohort. Antitumor activity was observed across a broad range of FolRα-expression levels.

Dr. Arturo Molina, Chief Medical Officer of Sutro commented, "It is encouraging to see the durable clinical benefit in our dose-escalation cohort, including in patients with lower levels of FolRα-expression who are being excluded from other ovarian cancer clinical trials. The need for new treatment options for this community drives our efforts to potentially bring STRO-002 to the broadest patient population that may benefit from the therapy. In consideration of a potential FolRα biomarker enrichment strategy, we plan to take a data-driven approach through balancing an efficient path forward, while serving the high unmet medical needs for ovarian cancer patients."

The Phase 1 dose-escalation data with a data cut-off date of April 23, 2021 will be available today as part of the Company’s Corporate Presentation, which can be accessed through the Company’s website at www.sutrobio.com. Additionally, the data will be presented virtually as a poster at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting from June 4-8, 2021, with details as follows:

Abstract: #5550
Session: Gynecologic Cancer
Time: Friday, June 4, 2021 at 9 a.m. ET
Title: Phase 1 Dose-Escalation Study of STRO-002, an anti-Folate Receptor alpha (FRα) Antibody Drug Conjugate (ADC), in Patients with Advanced, Progressive Platinum-Resistant/Refractory Epithelial Ovarian Cancer (EOC)
Presenter: R. Wendel Naumann, M.D., Professor & Director of Gynecologic Oncology Research at Levine Cancer Institute, Atrium Health

About the STRO-002-GM1 Phase 1 Study
STRO-002-GM1 is an open-label, multi-center, and two-part single-arm monotherapy Phase 1 study for STRO-002 in patients with advanced, progressive epithelial ovarian cancer, not pre-selected based on FolRα-expression levels. The Phase 1 is intended to study the safety, pharmacokinetics and preliminary efficacy of STRO-002, a folate receptor alpha (FolRα)-targeting ADC. The dose-escalation cohort has enrolled 39 patients and completed enrollment as of August 2020. The dose-expansion cohort is open for enrollment and requires tissue from patients for biomarker analysis prior to enrollment.

On May 19, 2021 Scenic Biotech BV ("Scenic"), a pioneer in the discovery of genetic modifiers to enable the development of disease modifying therapeutics for rare genetic disorders and other devastating illnesses, reported that it has entered into a multi-year strategic collaboration with Genentech, a member of the Roche Group, to discover, develop and commercialize novel therapeutics that target genetic modifiers (Press release, Scenic Biotech, MAY 19, 2021, View Source [SID1234580249]).

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Genetic modifiers are genes that counteract the effect of a disease-causing gene. They may explain why some people with genetic mutations linked to severe disease end up having only mild or no symptoms. Also known as disease suppressors, genetic modifiers therefore positively influence the severity of disease and act as a ‘natural form of protection’. Their discovery is leading to a completely new class of drug targets.

Under the terms of the agreement, Scenic will utilize its Cell-Seq platform and its data warehouse of genetic modifiers to identify drug targets in multiple therapeutic areas. The collaboration enables Genentech to select multiple targets for further development with an option to extend the collaboration. Scenic will receive an undisclosed upfront payment and is eligible to receive additional target selection fees for drug targets taken forward by Genentech. In addition, Scenic is eligible for success-based payments for each target based on achievement of certain predetermined milestones, as well as royalties on sales of certain products resulting from the collaboration. Total deal value could exceed US $375M.

Scenic has built an extensive proprietary data warehouse of genetic modifiers and its Cell-Seq platform enables the development of potential disease modifying therapeutics for devastating diseases with an in-house focus on inherited rare diseases and immuno-oncology/inflammation.
The Company was founded in 2017 as a spin-out of the Netherlands Cancer Institute, and Oxford University and recently appointed Oscar Izeboud, PhD as its Chief Executive Officer.

Dr Sebastian Nijman, Co-founder and CSO of Scenic Biotech said:
"Genentech is the pioneer in innovative biotech and has world leading research and development capabilities. Scenic is a science-driven company and having Genentech as our first major industry partner is a great validation of our technology and by working together it will extend the utility of our platform beyond our current therapeutic areas of interest. The collaboration also brings significant strategic value for Scenic as it enables us to realise the potential of our genetic modifier expertise alongside independently advancing our own programs towards clinical development."