On October 24, 2023 Ankyra Therapeutics, a clinical stage biotechnology company pioneering anchored immunotherapies to treat cancer, reported approval of its investigational new drug (IND) application by the U.S. Food & Drug Administration (FDA) and clinical trial application (CTA) by Health Canada for its lead agent, ANK-101, a novel tumor-directed anchored immune medicine (Press release, Ankyra Therapeutics, OCT 24, 2023, View Source [SID1234636318]). The Company plans to initiate a first-in-human Phase I clinical trial of ANK-101 as a single agent in early 2024 at a limited number of clinical sites in the U.S. and Canada in patients with advanced solid tumors who have failed standard of care treatments.

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ANK-101, an interleukin-12 (IL-12) cytokine anchored to aluminum hydroxide, is locally delivered and retained in the tumor microenvironment for several weeks where it mediates recruitment and activation of effector immune cells. Ankyra has demonstrated single agent activity of ANK-101 in preclinical studies of various solid tumors in mice as well as in canine melanoma (cANK-101) with a tolerable safety profile.

"By anchoring to and being retained at the tumor site, ANK-101 has the ability to avoid hallmark challenges of both systemic and intratumoral therapies, namely by preventing cytokine diffusion, effectively training the body to potently destroy cancer cells," said Howard L. Kaufman, MD, CEO and President of Ankyra Therapeutics. "We are very excited about the clearance of our CTA and IND, which will allow us to bring ANK-101 to patients who may benefit from this new approach to cancer treatment."

Joe Elassal, MD, MBA, Ankyra’s Chief Medical Officer, added "ANK-101 represents potential treatment benefit without unwanted side effects. Our hope is that by anchoring the IL-12 at the site of tumor growth, we will see therapeutic activity without systemic toxicity. We look forward to advancing our first-in-class asset to realize this vision, and to paving the way for anchored immunotherapy to safely deliver other biologically active agents in the future."

About ANK-101
ANK-101 is an anchored drug complex composed of interleukin-12 (IL-12) linked to aluminum hydroxide. ANK-101 enables local delivery of functional IL-12 to the tumor microenvironment where it remains biologically active for several weeks but does not diffuse into the systemic circulation, thereby avoiding systemic toxicity. Treatment with ANK-101 in animal models has been associated with recruitment and retention of tumor-specific CD8+ T cells, NK cells and M1 macrophages activating innate and adaptive anti-tumor immunity. ANK-101 is being evaluated for the treatment of advanced solid tumors alone and in combination with anti-PD-1 agents.

On October 24, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, reported positive preliminary efficacy data from its ongoing Phase 2 clinical trial, THIO-101, evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC) in sequential combination with Regeneron’s anti-PD-1 cemiplimab (Libtayo) (Press release, MAIA Biotechnology, OCT 24, 2023, View Source [SID1234636317]).

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Key findings:

100% Preliminary DCR observed in second-line and 88% in third-line, in highly difficult-to-treat patients who already progressed through previous lines of treatment.
DCRs across all dose levels met the pre-determined statistical requirements earlier than expected to proceed to next stage of the trial.
"In NSCLC patients who received at least one line of therapy, DCRs have shown to be excellent predictors of overall survival.1 Observing 100% DCR to date in second-line treatment is unprecedented compared to DCRs for the SoC ranging from 53-64%,2" said Vlad Vitoc, M.D., MAIA’s Chief Executive Officer. "We have also observed unprecedented high DCRs in third-line, with an 88% control rate, with treatment of THIO followed by cemiplimab. The results are even more remarkable given patients in this population have previously failed treatment with a checkpoint inhibitor. Currently, there is no SoC for third-line, but previous studies have reported an approximate 30% DCR.3 These exceptional preliminary results underscore our confidence in advancing the trial to bring our novel treatment to advanced stage NSCLC patients."

1 Matsumoto H et al. Transl Lung Cancer Res. 2021 May; 10(5): 2278–2289

2 REVEL View Source

3 Journal of Thoracic Oncology (VOLUME 16, ISSUE 10, OCTOBER 2021), T. Beninato et al.

Study Disease Control Rates by Line of Treatment

Treatment Line Standard of Care Treatment DCR Treatment Line THIO + Libtayo (cemiplimab) DCR
NSCLC-1 pembrolizumab (KEYNOTE-024)
71%

NSCLC-1 TBD
NSCLC-2 ramucirumab + docetaxel (REVEL)
64%

NSCLC-2
100%

docetaxel monotherapy (REVEL)
53%

NSCLC-3 chemotherapy (RWD)
25-35%

NSCLC-3
88%

The Company presented the data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 in Madrid, Spain, on October 23, 2023. Full preliminary data is detailed in the poster available here.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to Regeneron’s anti-PD-1 cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing a checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

On October 24, 2023 Elpiscience Biopharmaceuticals, Inc. ("Elpiscience"), a clinical-stage biopharmaceutical company focused on developing next-generation immunotherapies to benefit cancer patients worldwide, reported that it will have three poster presentations at the SITC (Free SITC Whitepaper) 2023 Annual Meeting taking place November 3-5, 2023, in San Diego (Press release, Elpiscience, OCT 24, 2023, View Source [SID1234636316]). The posters will highlight its studies on three innovative molecules including a first-in-class NKG2A/NKG2C dual-targeting antibody ES015, a high affinity LILRB1 specific blocking antibody ES008-a, and the first-in-class anti-CD39/TGF-βRII bifunctional fusion protein ES014 which has been proven to be able to deliver TGFβ "trap" to CD39-expressing immune and stroma cells to reshape tumor microenvironment and rejuvenates antitumor immunity.

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Poster presentation details:

Title: Selective delivery of TGFβ "trap" to CD39-expressing immune and stroma cells reshapes tumor microenvironment and rejuvenates antitumor immunity
Abstract Number: 453
Date and time: November 3, 2023; 9 am –7 pm PDT
Location: Exhibit Halls A and B1 – San Diego Convention Center

Title: ES015, a first-in-class NKG2A and NKG2C dual-targeting antibody, demonstrated potent anti-tumor immune response
Abstract Number: 498
Date and time: November 4, 2023; 9 am –8:30 pm PDT
Location: Exhibit Halls A and B1 – San Diego Convention Center

Title: ES008-a, a high affinity LILRB1 specific blocking antibody activates multiple immune cells to fight cancers
Abstract Number: 510
Date and time: November 4, 2023; 9 am –8:30 pm PDT
Location: Exhibit Halls A and B1 – San Diego Convention Center

On October 24, 2023 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315) reported that the company will be presenting 16 posters and exhibiting at booth 223 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual conference, taking place from November 1-5, 2023 in San Diego, CA (Press release, Biocytogen, OCT 24, 2023, View Source [SID1234636315]).

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The poster presentations will highlight 9 drug assets and 7 gene-edited humanized mouse models:

Bispecific Antibody-Drug Conjugate Assets

DM001: A novel bispecific ADC targeting TROP2 and EGFR with potent anti-tumor efficacy in PDX models
Poster number: 1152
Date: November 4th, 2023

Preclinical evaluation of fully human bispecific antibody-drug candidates targeting HER3 and the juxtamembrane region of MUC1
Poster number: 1165
Date: November 3rd, 2023

DM005, an EGFR х MET bispecific antibody-drug conjugate, showed robust anti-tumor activity in PDX models
Poster number: 1150
Date: November 4th, 2023

BSA01, a bispecific antibody-drug conjugate targeting EGFR and membrane-bound MUC-1-C, exhibits anti-tumor efficacy in vivo
Poster number: 1164
Date: November 4th, 2023

BCG022: A HER3×MET bispecific antibody-drug conjugate (BsADC) targeting key mechanisms of bypass resistance in multiple tumor types
Poster number: 1153
Date: November 3rd, 2023

A novel bispecific antibody-drug conjugate targeting PTK7 and TROP2, BCG033, demonstrates preclinical efficacy against triple-negative breast cancer xenografts
Poster number: 1163
Date: November 3rd, 2023

TCR-mimic Antibody Assets

Identification of fully human TCR-mimic antibodies targeting the KRAS G12V/HLA complex generated in HLA-transgenic RenMab mice
Poster number: 1168
Date: November 4th, 2023

Preclinical application of a fully human TCR-mimic antibody developed to target NY-ESO-1/HLA-A02
Poster number: 356
Date: November 4th, 2023

Fully Human Monoclonal Antibody Asset

Fc-competent fully human anti-TIGIT blocking monoclonal antibodies demonstrated potent anti-tumor efficacy in preclinical models
Poster number: 479
Date: November 3rd, 2023

Off-the-Shelf Mouse Models – Humanized Mice

Development of a preclinical CD98HC mouse model for therapeutic studies
Poster number: 13
Date: November 3rd, 2023

Generation and validation of humanized GARP/TGFB1 mice for testing novel anti-human GARP antibodies
Poster number: 18
Date: November 4th, 2023

Humanized CD200/CD200R mice as a tool for evaluating novel therapeutics
Poster number: 12
Date: November 4th, 2023

Humanized ICOS mice as a novel tool for predicting and monitoring T-cell-mediated immunotherapy response
Poster number: 11
Date: November 3rd, 2023

Humanized NKP46 mouse models for testing novel NK cell-based immunotherapies
Poster number: 17
Date: November 3rd, 2023

Preclinical CD3-based mouse models for evaluation of bi-specific T-cell engager antibodies
Poster number: 19
Date: November 3rd, 2023

Off-the-Shelf Mouse Models – Immunodeficient Target Humanized Mice

A novel B2m-deficient immunodeficient model expressing human IL-15 for preclinical evaluation of T cell and NK cell-based therapies
Poster number: 16
Date: November 4th, 2023

To explore licensing and collaboration opportunities for drug assets, fully human antibody/TCR discovery platforms, off-the-shelf animal/cell models, or preclinical pharmacology services, please visit booth 223.

On October 24, 2023 ProfoundBio, a clinical-stage biotechnology company focused on the development of novel antibody-drug conjugate therapeutics for cancer, reported that management will be participating in one-on-one meetings with investors at the Wells Fargo 2023 Virtual Private Biotech Symposium on Wednesday, November 1, 2023 and at the Piper Sandler 35th Annual Healthcare Conference from November 28 – November 30, 2023 (Press release, ProfoundBio, OCT 24, 2023, View Source [SID1234636314]).

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"We look forward to participating in these conferences to discuss our emerging clinical data from SITC (Free SITC Whitepaper) and company growth plans with investors" said Baiteng Zhao, PhD, CEO of ProfoundBio. "This is an exciting time for ProfoundBio as we explore the potential for our innovative ADC technology platform in the clinical setting."