On June 1, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patient’s body, reported that it will present at the Jefferies Healthcare Conference being held June 8–10, 2022 (Press release, Cue Biopharma, JUN 1, 2022, View Source [SID1234615363]).

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The Company will provide a corporate update highlighting the most recent clinical progress for CUE-101, its lead interleukin 2 (IL-2)-based CUE-100 series clinical drug candidate, being evaluated in a Phase 1b monotherapy trial and dose escalation trial in combination with KEYTRUDA for the treatment of patients with recurrent/metastatic HPV16+ head and neck cancer. The presentation will also focus on the Company’s second IL-2 based CUE-100 series clinical drug candidate, CUE-102, which recently received approval of an Investigational New Drug (IND) Application from the U.S. Food and Drug Administration (FDA). CUE-102 will be evaluated in a Phase 1 monotherapy dose escalation and expansion trial at a starting dose of 1mg/kg in patients with Wilms Tumor 1 (WT1)-positive recurrent/metastatic cancers.

Presentation Details
Jefferies Virtual Healthcare Conference
Date and Time: Friday, June 10 at 1:45–2:10 p.m. EDT in TRACK 2
Webcast Link: View Source

A live and archived webcast of the presentation will be available in the Investor and Media section of the Company’s website at www.cuebiopharma.com. The webcast will be archived for 30 days.

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.

On June 1, 2022 AVM Biotechnology, reported that its abstract, "The effects of AVM0703 mobilization of endogenous gamma delta invariant TCR+ bi-specific Natural Killer T-like cells against solid tumors and blood cancers" has been accepted for a poster presentation at the 2022 ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology) Annual Meeting in Chicago (Press release, AVM Biotechnology, JUN 1, 2022, View Source [SID1234615379]). Founder and CSO, Dr. Theresa Deisher, will present this research on Sunday, June 5th, 2022, in the Developmental Therapeutics – Immunotherapy tract.

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The ASCO (Free ASCO Whitepaper) Annual Meeting showcases cutting-edge research in clinical oncology and is the most influential and prominent scientific gathering of the clinical oncology community.

The chosen abstract concluded that AVM0703 led to:

i) complete response in 27% of immune-resistant mouse A20 tumors as monotherapy and complete response in 60% when combined with 2 doses of cyclophosphamide/fludarabine (CyFlu);

ii) tumor eradication and long-term memory against xenografted human T-cell Acute Lymphoblastic Leukemia (T-ALL);

iii) enhancement of Adoptive Cell Therapy equivalent to CyFlu preconditioning in mouse melanoma; and

iv) preliminary 95% complete response against mouse multiple myeloma.

A second abstract, "Acute supra-pharmacologic weight-based dexamethasone (AVM0703), 18 mgs/kg body weight, mobilizes endogenous bi-specific Natural Killer T-like cells independent of glucocorticoid receptor activation", was chosen for print and online publication.

The acceptance of both abstracts further validates the potential of AVM0703 which is the subject of an ongoing adaptive design expansion cohort clinical trial treating relapsed refractory "no-option" Non-Hodgkin’s Lymphoma/Leukemia. The company is finalizing the dose escalation portion of the trial with positive results including 80% of dosed patients experiencing clinical benefit/immune status improvement and 60% of patients achieving a durable response. Notably, a Peripheral T-cell Lymphoma (PTCL) patient has experienced a durable response with stable disease for 9 months, demonstrating enormous potential for peripheral T-cell lymphoma. The efficacy portion of the trial is anticipated to begin next month.

AVM0703 mobilizes endogenous bi-specific gamma delta TCR+ invariant TCR+ Natural Killer T-like cells resulting in cancer death within hours of administration. The small molecule offers key advantages in the crowded gamma delta field in that these cells are mobilized in vivo avoiding the manufacturing expense and risks of other cell therapies. AVM0703 may be offered as a monotherapy or in combination with chemotherapy or CAR-T and has indications in autoimmune diseases as well as cancer.

Links to the complete abstracts are as follows:

The effects of AVM0703 mobilization of endogenous gamma delta invariant TCR+ bi-specific Natural Killer T-like cells against solid tumors and blood cancers

Acute supra-pharmacologic weight-based dexamethasone (AVM0703), 18 mgs/kg body weight, mobilizes endogenous bi-specific Natural Killer T-like cells independent of glucocorticoid receptor activation

On June 1, 2022 Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported that its management team will present at the Jefferies Healthcare Conference on June 8, 2022 at 1:00 pm ET in New York City (Press release, Savara, JUN 1, 2022, View Source [SID1234615446]). A live webcast of the presentation will be available on Savara’s website at www.savarapharma.com/investors/events-presentations/ and will be archived for 90 days.

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On June 1, 2022 Ipsen (Euronext: IPN; ADR: IPSEY) reported that it has appointed an investment-services provider to purchase 125,000 Ipsen S.A. shares, or about 0.15% of the share capital, over a maximum period of three months (Press release, Ipsen, JUN 1, 2022, View Source [SID1234615290]). The shares purchased under this agreement will be allocated mainly to cover its employee free share-allocation plan.

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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

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This program is made pursuant to the authorization granted by the Combined Shareholders’ meeting, held on May 24th, 2022.

On June 1, 2022 Sichuan Kelun-Biotech Biopharmaceutical Co, Ltd. ("Kelun-Biotech") and Levena Biopharma ("Levena"), a subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), reported the planned presentation of A166 data (Abstract #1037 and Poster #415) in patients with HER2-expressing locally advanced or metastatic solid tumors at the 2022 Annual Meeting of ASCO (Free ASCO Whitepaper), the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held on June 3-7 in Chicago, IL (Press release, Sorrento Therapeutics, JUN 1, 2022, View Source [SID1234615311]). A166 is a HER2 antibody-drug conjugate (ADC) developed by Kelun-Biotech in a partnership with Levena Biopharma, which provided the patent-protected technologies for the generation and production of A166 in relation to (1) Duostatin-5, a proprietary tubulin inhibitor, (2) K-Lock, a site-specific conjugation technology, and (3) an enzymatically cleavable linker.

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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

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As previously reported, in Phase 1 of the study, A166 demonstrated a safety profile that compared favorably to its commercial competitors and potentially superior efficacy as shown by the overall response rate (ORR) of 59.1% and 71.4% in the 4.8 mg/kg cohort and 6.0 mg/kg cohort, respectively, in heavily pretreated patients with HER2-positive breast cancer (data presented at the 2021 ASCO (Free ASCO Whitepaper) meeting [NCT05311397; J Clin Oncol 39, 2021 (suppl 15; abstr 1024)].

At the upcoming 2022 ASCO (Free ASCO Whitepaper) meeting, Kelun-Biotech will report updated data from this Phase 1 trial (Abstract #1037 and Poster #415). The Phase 1 dose expansion of the study was conducted in several sites in China and enrolled a total of 58 female patients (n=23 at 4.8 mg/kg and n=35 at 6.0 mg/kg) treated with A166 in 3-week cycles.

The best ORR was 73.9% (17/23; 95% CI, 51.59 to 89.77) in the 4.8 mg/kg cohort and 68.6% (24/35; 95% CI, 50.71 to 83.15) in the 6.0 mg/kg cohort.
Median progression free survival (PFS) was 12.3 months (95% CI, 6.00-not reached) in the 4.8 mg/kg cohort and 9.4 months (95% CI, 4.00 to 10.40) in the 6.0 mg/kg cohort.
Of 23 patients treated in the 4.8 mg/kg cohort, one had a confirmed and sustained CR lasting 7+ months.
Next generation sequencing was performed on tissue-derived DNA and blood-derived circulating tumor DNA.
The detailed safety data, RECIST 1.1 response rate, and biomarker analyses will be presented in a poster (#415) at the 2022 ASCO (Free ASCO Whitepaper) meeting