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Abstract for MIV-818 phase 1b monotherapy for ESMO Congress published

On September 13, 2021 Medivir AB (Nasdaq Stockholm: MVIR) reported that the Abstract entitled "Phase 1 study of the novel prodrug MIV-818 in patients with hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (iCCA) or liver metastases (LM)" has been released on the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) website (View Source) (Press release, Medivir, SEP 13, 2021, View Source [SID1234587651]).

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The results from the completed phase 1b monotherapy dose escalation part of the study will be presented by

Dr Debashis Sarker, King´s College, London, as an e-poster (number 527P) at ESMO (Free ESMO Whitepaper) on Thursday September 16. Medivir will host a conference call to update on the progress and plans for the MIV-818 program at 15.00 CET on September 16.

About MIV-818
MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC and other forms of liver cancer. MIV-818 has completed a phase 1b monotherapy study, and a combination study in HCC is now planned to be initiated during the second half of 2021.

About primary liver cancer
Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are 42,000 patients diagnosed with primary liver cancer per year in the US and current five-year survival is 11 percent. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

Hummingbird Bioscience Announces US FDA Clearance of IND for First-in-Human Phase 1 Trial of HMBD-002 in Patients with Advanced Solid Tumors

On September 13, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets, reported that the U.S. Food and Drug Administration (FDA) has approved the initiation of a Phase 1 clinical trial of HMBD-002, Hummingbird’s anti-VISTA neutralizing antibody (Press release, Hummingbird Bioscience, SEP 13, 2021, View Source [SID1234587650]). HMBD-002 is being developed for the treatment of cancers with VISTA-mediated immune suppression, including triple negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC).

HMBD-002 is an IgG4 monoclonal antibody, rationally engineered with high affinity and specificity to bind and block the activation of VISTA, a protein that enables tumors to suppress and escape the immune system. HMBD-002 accomplishes this without depleting VISTA expressing immune cells that play important roles in the immune response. In pre-clinical cancer models, treatment with HMBD-002 could counteract immune suppression, as indicated by the decreased infiltration of immune-suppressing myeloid cells into the local tumor environment and the increased activity of T cells. Pre-clinical studies also show that HMBD-002 as a monotherapy, and in combination with pembrolizumab (an immune checkpoint inhibitor), significantly inhibited tumor growth, with no observed toxicity.

The Phase 1, multi-center, open-label trial will evaluate HMBD-002, as a monotherapy and in combination with pembrolizumab. Safety and tolerability will initially be assessed in a dose escalation study in patients with advanced solid malignancies, where the maximum tolerated or tested dose (MTD) and recommended Phase 2 dose (RP2D) will be identified. The anti-cancer activity of HMBD-002 will then be evaluated in a dose expansion study examining HMBD-002 as a monotherapy in patients with previously treated TNBC and NSCLC, or in combination with pembrolizumab in patients with TNBC, NSCLC, and other VISTA-expressing malignancies.

Correlative studies will assess pre- and post-treatment markers of immune activity in the periphery and the tumor microenvironment. The development of HMBD-002 into the clinic is supported by a grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

"VISTA is an exciting but complex new immune checkpoint protein. With Hummingbird’s proprietary Rational Antibody Discovery platform, we used machine learning and computational biology to predict the optimal drug binding site on VISTA in order to develop an antibody therapy that could effectively block and neutralize its activity. As such, HMBD-002’s mechanism of action is highly differentiated from other anti-VISTA drug candidates. We look forward to advancing the clinical development of HMBD-002 for cancer patients where VISTA is involved in suppressing immune response," said Jerome Boyd-Kirkup, Chief Scientific Officer and co-founder of Hummingbird Bioscience.

About HMBD-002

HMBD-002 represents a unique first-in-class anti-VISTA neutralizing antibody, and the only IgG4 isotype anti-VISTA antibody currently in development. It was engineered to bind to VISTA at a specific site that was predicted to be essential for ligand-binding and function, thus inhibiting VISTA and neutralizing its immunosuppressive activity without depleting VISTA expressing cells that play many important roles in the immune system.

Pre-clinical models have shown that HMBD-002 as a monotherapy inhibits tumor growth and significantly prolongs progression-free survival, with no observed toxicity. It has also shown synergy when used in combination with anti-PD-1 therapy.

HMBD-002 is being developed for the treatment of multiple cancers that have strong evidence of VISTA mediated suppression, both as a monotherapy and in combination with PD-1 inhibitor.

HMBD-002 advanced to clinical trials with a grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

Immunovia enters licensing agreement with JW BioScience for pancreatic cancer biomarkers

On September 13, 2021 Immunovia AB (publ) ("Immunovia"), a diagnostic company that develops and sells highly accurate blood tests for the early detection of cancer, reported that Immunovia has strengthened its patent protection for pancreatic cancer biomarkers by obtaining a global license from the South Korean company JW BioScience’s IP portfolio (Press release, JW Pharmaceutical, SEP 13, 2021, View Source [SID1234587649]).

The license agreement gives Immunovia global commercial rights for two biomarkers for early detection of pancreatic cancer. The biomarkers are also part of Immunovia, Inc.’s IMMray PanCan-d biomarker signature. Immunovia discovered these pancreatic cancer biomarkers independently of JW BioScience and have now fully secured intellectual property rights.

The details and deal size of this contract are not disclosed as agreed by both parties.

Patrik Dahlen, CEO of Immunovia, said, "We are delighted to enter into this agreement that further secures relevant IP and validates our biomarker discovery approach. By entering into this agreement, Immunovia and JW BioScience will also evaluate possibilities for commercial collaboration to enable early detection of pancreatic cancer in the Korean market."

Eun-Kyung Hahm, CEO of JW Bioscience, said, "This contract is an important milestone for JW’s unique IP position and a recognition of the excellence of JW technology in the global market." She also added that, "JW will be able to further strengthen its commercial and technological competitiveness through the collaboration with Immunovia."

Immunovia has a strong and extensive IP portfolio consisting of seven patent families, covering biomarkers in pancreatic cancer.

GT Biopharma Advances GTB-3650, a Second-Generation Tri-Specific Killer Engager -TriKE®, Into IND-Enabling Studies

On September 13, 2021 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE protein biologic technology platform, reported the advancement of GTB-3650 into IND-enabling studies, with which it plans to supplant the ongoing Phase 1 program with GTB-3550 (Press release, GT Biopharma, SEP 13, 2021, View Source;trike-into-ind-enabling-studies-301374947.html [SID1234587648]).

Therapeutic and commercial advantages of GTB-3650 compared to GTB-3550 include:

Based on second generation camelid single-domain antibody technology that holds several advantages over traditional IgG monoclonal antibodies
Improved potency and enhanced binding affinity
Similar preclinical safety profile
Commercial manufacturing capabilities through arrangement with Cytovance
Proprietary patented molecule, which unlike GTB-3550, is wholly owned by GT Biopharma
"We look forward to advancing GTB-3650 toward the clinic" noted Greg Berk, M.D., GT Biopharma’s President of R&D and Chief Medical Officer. "This transition marks the next logical evolution of our TriKE platform. As the company focuses its resources on the most promising pipeline candidates, GTB-3650 will now be able to take advantage of the strong evidence gathered from our first-generation pilot TriKE program. Complementing this development advance, has been the transition of all manufacturing processes to Cytovance Biologics, a leading specialty cGMP contract manufacturing organization. We have now achieved another strategic milestone consistent with our mission to advance novel immuno-oncology drugs to patients with advanced cancers", commented Dr. Berk.

About Camelid Antibodies

Camelid antibodies are single domain antibodies (sdAbs) from the Camelidae family of mammals that include llamas, camels, and alpacas. These animals produce 2 main types of antibodies. One type of antibody camelids produce is the conventional antibody that is made up of 2 heavy chains and 2 light chains. They also produce another type of antibody that is made up of only 2 heavy chains and no light chain. This is known as heavy chain IgG (hcIgG). While these antibodies do not contain the CH1 region, they retain an antigen binding domain called the VHH region. VHH antibodies, also known as single domain antibodies, contain only the VHH region from the camelid antibody. Camelid antibodies have key characteristics, which include high affinity and specificity (equivalent to conventional antibodies), high thermostability, good solubility and strictly monomeric behavior, small size, relatively low production cost, ease of genetic engineering, format flexibility or modularity, low immunogenicity, and a higher penetration rate into tissues.

About GTB-3650

GTB-3650 is the Company’s lead second-generation Tri-Specific Killer Engager TriKE program currently in preclinical development for the treatment of relapsed/refractory acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS).

Palatin to Participate in H.C. Wainwright 23rd Annual Global Investment Virtual Conference

On September 13, 2021 Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor systems, reported that Carl Spana, Ph.D., President and Chief Executive Officer, will participate in the H.C. Wainwright 23rd Annual Global Investment Virtual Conference on September 13-15, 2021 (Press release, Palatin Technologies, SEP 13, 2021, View Source [SID1234587647]).