On February 16, 2022 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported its results for the fourth quarter and full year 2021 (Press release, BerGenBio, FEB 16, 2022, View Source [SID1234608161]).

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A briefing by BerGenBio’s senior management team will take place at 10:00am CET today via a webcast presentation, followed by a Q&A session. Please see below for details.

Operational Highlights – fourth quarter 2021 (including post-period end)• Post-period end, BerGenBio announced its participation in the EU-SolidAct trial, part of EU-RESPONSE, a pan-European research project involved with the rapid and coordinated investigation of medications to treat COVID-19 during the ongoing pandemic allowingBerGenBio to potentially confirm encouraging clinical data at significantly reduced cost​. • Licensed key exclusive intellectual property rights from UT Southwestern Medical Center, which strengthen the intellectual property estate for the potential treatment of Non-Small Cell Cancer (NSCLC) patients with STK11 mutations.• Granted Fast Track designation by the FDA for bemcentinib in combination with an anti-PD-(L)1 agents as treatment for patients with STK11 altered advanced/metastatic NSCLC patients without actionable mutations.• Presented pre-clinical and clinical data on bemcentinib in STK11 mutated NSCLC at SITC (Free SITC Whitepaper) Annual Meeting 2021, indication that bemcentinib restores response to anti-PD-1 treatments in NSCLC patients with STK11 mutations.• Presented updated data from Phase II trial(BGBC003) of bemcentinib in combination with low dose cytarabine (LDAC) in older, relapsedand refractory AML patients at the 63rd Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting.• Anders Tullgren appointed as Chairman of the Board, bringing over 35 years of global experience in both large pharmaceutical and small/mid-size biotech environments.

Financial Highlights – fourth quarter and full year 2021(Figures in brackets = same period 2020 unless otherwise stated) • Revenue amounted to NOK 0.8 million (NOK 0.6million) for the fourth quarter and NOK 0.8million (NOK 0.6 million) for the full year 2021• Total operating expenses for the fourth quarter were NOK 68.1 million (NOK 72.4 million) and total operating expenses for the full year 2021amounted to 315.2 million (NOK 261.7 million)• The operating loss for the quarter came to NOK 67.3 million (NOK 71.8 million) and NOK 314.5 million (NOK 261.1 million) for the full year2021• Cash and cash equivalents amounted to NOK 436.4 million at the end of December 2021 (NOK 721.6 million by end of December 2020)

Martin Olin, Chief Executive Officer of BerGenBio, commented: "In the fourth quarter of 2021 we continued to make significant progress in defining our strategy and priorities to advance our two AXL development candidates. Our lead development candidate, bemcentinib, a potentially first-in-class selective AXL inhibitor currently undergoing Phase II clinical trials in NSCLC, AMLand respiratory infections (COVID-19), is well positioned for further advancement.

"Our strategy and priorities going forward will be anchored within a rigorous data-driven framework, where the scientific rationale, pre-clinical and clinical data define a compelling rationale for advancing our development candidates towards potential treatment modalities addressing high unmet medical needs.

"With a clear strategy in place, I believe BerGenBio is well positioned to progress and deliver on its potential. I look forward to providing you with further updates on our progress."

Presentation and Webcast Details

The live webcast link is available at www.bergenbio.com in the Investors/Financial Reports section. A recording will be available shortly after the webcast has finished.

The fourth quarter and full year report and presentation will be made available on the Company’s website in the Investors/Financial Reports section and a recording of the webcast will be made available shortly after the webcast has finished.

On February 15, 2022 ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (hereinafter referred to as "ImmuneOnco", the company) reported that the first bispecific antibody-receptor recombinant protein (project number: IMM2902) targeting human CD47 x HER2 has completed the first patient enrollment and dosing, and administration process was smooth and successful (Press release, ImmuneOnco Biopharma, FEB 15, 2022, View Source [SID1234655630]).

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IMM2902, a CD47xHER2 bispecific fusion protein designed for solid tumors, is at the forefront of global research. The project has previously been approved by the National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA) for clinical trials on June 29, 2021 and August 21, 2021. It is the third new drug project in the clinical research stage of the company based on targeting CD47/SIRPa. The completion of the first subject enrollment and dosing in the IMM2902 project is another major milestone for the company.

Dr. Wenzhi Tian, Founder and CEO of the company, is very confident in the clinical trial research of IMM2902.

"We are very pleased that our IMM2902 project has completed the first patient in. IMM2902 is a bispecific molecule developed on our mAb-Trap technique platform for CD47 and HER2. The molecule preferentially binds to tumor cells through the high affinity to HER2 and CD47, at the same time, it doesn’t bind to human red blood cells and other off-target cells, so as to avoid the "Antigen sink" effect, thereby greatly enhance the synergistic effect based on both targets against tumors. IMM2902 will have great potential in clinical development and commercial value."

On February 15, 2022 Intellia Therapeutics Inc is to out-license rights to its ex vivo Crispr/Cas9 genome editing platform to ONK Therapeutics Ltd enabling the Irish company to develop engineered natural killer (NK) cell therapies for cancer (Press release, ONK Therapeutics, FEB 15, 2022, View Source [SID1234613904]). ONK is developing off-the-shelf NK cell therapies. In addition to the genome editing platform, ONK will also have access to the US company’s lipid nanoparticle delivery technologies. The agreement will enable the development of up to five allogeneic NK cell therapies.

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On February 15, 2022 (the "Effective Date"), Cue Biopharma, Inc. (the "Company") reported that entered into a loan and security agreement (the "SVB Loan Agreement") with Silicon Valley Bank, as lender ("SVB"), pursuant to which SVB has agreed to provide term loans to the Company in an aggregate principal amount of up to $20.0 million (the "SVB Term Loans"), consisting of (i) a tranche A term loan in the aggregate principal amount of $10.0 million, available to the Company on or around the Effective Date, and (ii) two contingent tranche B term loans in amounts of at least $5.0 million each and in an aggregate principal amount not to exceed $10.0 million, available to the Company at any time on or prior to December 31, 2022, following the Company having received both (x) positive data for the CUE-101 Phase 1 Part B monotherapy sufficient to begin a Phase 2 clinical trial and (y) unrestricted and unencumbered net cash proceeds in a specified amount from the issuance and sale by the Company of its equity securities to investors acceptable to SVB (Filing, 8-K, Cue Biopharma, FEB 15, 2022, View Source [SID1234608316]).

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The SVB Term Loans bear interest at a floating rate per annum equal to the greater of (A) the prime rate (as published in the money rates section of The Wall Street Journal) plus 2.25% and (B) 5.50%. On the first calendar day of each month, the Company will be required to make monthly interest payments and commencing on June 30, 2023 (extended to December 31, 2023 if the tranche B term loans are advanced), the Company will be required to repay the SVB Term Loans in (i) 30 consecutive installments of principal plus monthly payments of accrued interest if the tranche B term loans are not advanced and (ii) 24 months if the tranche B term loans are advanced. All outstanding principal and accrued and unpaid interest under the SVB Term Loans and all other outstanding obligations with respect to the SVB Term Loans are due and payable in full on December 1, 2025.

The SVB Loan Agreement permits voluntary prepayment of all, but not less than all, of the SVB Term Loans, subject to a prepayment premium except if the facility is refinanced with another SVB facility. Such prepayment premium would be 3.00% of the principal amount of the SVB Term Loans if prepaid prior to the first anniversary of the Effective Date, 2.00% of the principal amount of the SVB Term Loan if prepaid on or after the first anniversary of the Effective Date but prior to the second anniversary of the Effective Date, and 1.00% of the principal amount of the SVB Term Loan if prepaid on or after the second anniversary of the Effective Date. Upon repayment in full of the SVB Term Loans, the Company will be required to pay a final payment fee equal to 5.00% of the original principal amount of any funded term loan being repaid.

The SVB Term Loans and related obligations under the SVB Loan Agreement are secured by substantially all of the Company’s properties, rights and assets, except for its intellectual property (which is subject to a negative pledge under the SVB Loan Agreement). The SVB Loan Agreement contains customary representations, warranties, events of default and covenants, including a requirement that the Company maintain in accounts of the Company at SVB unrestricted and unencumbered cash equal to the lesser of all of the Company’s cash and 110% of the obligations to SVB. The occurrence and continuation of an event of default could cause interest to be charged at the rate that is otherwise applicable plus 3.00% (unless SVB elects to impose a smaller increase) and would provide SVB with the right to accelerate all obligations under the SVB Loan Agreement and exercise remedies against the Company and the collateral securing the SVB Term Loan and other obligations under the SVB Loan Agreement, including foreclosure against assets securing the SVB Term Loan and other obligations under the SVB Loan Agreement, including the Company’s cash.

On February 15, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patient’s body, reported that the company’s therapeutic Immuno-STAT (Selective Targeting and Alteration of T cells) biologics are scheduled to be featured in an Oxford University poster presentation at the Biophysical Society Annual Meeting taking place on February 19-23, 2022 at the Moscone Center in San Francisco, California (Press release, Cue Biopharma, FEB 15, 2022, View Source [SID1234608264]). Cue Biopharma entered into a strategic research collaboration with Dr. Michael Dustin and the University of Oxford in May 2020 to determine the molecular mechanisms underlying the activity of its IL-2 based CUE-100 series biologics.

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Presentation Details
Title: Integration of IL-2 Signaling at the Immunological Synapse
Presenter: Dr. Jesusa Capera Aragones of the Kennedy Institute at the University of Oxford
Poster Session: Membrane Receptors and Signal Transduction
Poster #: 414/B238
Poster Location: Exhibit Hall ABC
Date & Time: February 20, 2022 at 1:45 p.m. PST or 4:45 p.m. EST

"It has traditionally been the view that cytokine signaling follows T cell receptor signaling, however this study demonstrates that antigen-T cell receptor signaling and cytokine signaling can work side-by-side to impact T cell responses through the immunological synapse," said Dr. Dustin, professor of immunology and Wellcome Trust Principal Research Fellow, director of research of the Kennedy Institute at the University of Oxford.

Dr. Anish Suri, president and chief scientific officer of Cue Biopharma commented, "The mechanistic insights provided by the elegant work conducted by Dr. Aragones and Dr. Dustin supports the central hypothesis of Immuno-STATs specifically – that concurrent delivery of antigen and interleukin 2 (IL-2) signals results in robust synapse formation, providing for selective T cell activation, a supposition now being clinically validated through the development of CUE-101, our lead and representative IL-2 based drug product candidate from the CUE-100 series."

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About Immuno-STAT
The company’s Immuno-STAT (Selective Targeting and Alteration of T cells) biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a pMHC to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in selective T cell modulation. Because our drug candidates are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo), and reinfused.