On April 7, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer, infectious disease and autoimmune disease, reported the grant of patent number EP3317301 entitled "Combination therapies comprising antibody molecules to LAG-3" by the European Patent Office (Press release, Immutep, APR 7, 2021, View Source [SID1234577719]).

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The claims of EP3317301 are directed to embodiments of LAG525, a humanised form of Immutep’s IMP701 antibody which is out-licensed to Novartis AG. In particular, the claims of the patent are directed to compositions comprising LAG525 and spartalizumab, an anti-PD-1 antibody molecule, and related methods of use of the combination in the treatment of cancer.

The patent is co-owned by Novartis AG and Immutep S.A.S. and will expire on 28 July 2036.

About IMP701 and LAG525

IMP701 is a therapeutic antibody originally developed by Immutep S.A. (now Immutep S.A.S.) to target LAG-3. This antagonist antibody plays a role in controlling the signalling pathways in both effector T cells and regulatory T cells (Treg). The antibody works to both activate effector T cells (by blocking inhibitory signals that would otherwise switch them off) and at the same time inhibit Treg function that normally prevents T cells from responding to antigen stimulation. The antibody therefore removes two brakes that prevent the immune system from responding to and killing cancer cells. In contrast, some other checkpoint antibodies in development target only the effector T cell pathway.

Rights to the development and commercialisation of IMP701 are exclusively licensed to Novartis.

LAG525, a humanised form of IMP701 is being evaluated by Novartis in several Phase I and/or Phase II clinical trials in combination with Novartis’ PD-1 inhibitor spartalizumab for the treatment of certain cancer(s). Novartis has full responsibility for the continued development of the LAG-3 antibody program and Immutep is eligible to receive development-based milestone payments and sales-based royalties.

On April 7, 2021 Bridge Biotherapeutics, a research and development company for innovative new drugs, reported that the first phase of clinical trials for BBT-176, a candidate for the next-generation lung cancer target anticancer drug, began in earnest, and that it was administered to patients participating in the clinical trial on the 2nd (Press release, Bridge Biotherapeutics, APR 7, 2021, View Source;pn=6&sn=1&idx=64 [SID1234577708]).

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BBT-176 is a novel epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) targeting the C797S specific EGFR mutation. The C797S mutation is known as an acquired resistance mutation that appears after treatment with tagriso (ingredient name: osimertinib) in Non-small Cell Lung Cancer (NSCLC). Bridge Biotherapeutics has secured data related to the tumor suppression effect of brain metastasis, including the tumor suppression effect against the C797S positive triple mutation in animal models, through the preclinical development previously advanced.

This clinical trial, which is first initiated by three domestic institutions, targets patients with locally advanced or metastatic non-small cell lung cancer with an EGFR mutation. ) We plan to closely grasp patient group data by mutation by applying procedures, etc.

BBT-176 In the first phase of clinical phase 1/2, the Dose Escalation Study evaluates the safety and tolerability of the drug to be tested to determine the recommended phase 2 dose. Next, in the Dose Expansion Study, which is expected to enter Korea and the United States within this year, ▲ Objective Response Rate (ORR), ▲ Objective Response Rate (ORR) according to version 1.1 of the Solid Tumor Response Assessment (RECIST) ; Duration of Response) and ▲ Progress-free Survival (PFS). The clinical trial is planned to be conducted on about 90 patients.

Bridge Biotherapeutics CEO Jeong-gyu Lee said, "I think it is meaningful to be the first to start the clinical trial of BBT-176, a new anticancer drug candidate targeting C797S mutant non-small cell lung cancer, in Korea, which has no treatment options worldwide." Based on the development strategy, the entire development team will do their best to conduct the clinical trials with full accuracy and speed based on the development strategy. I will add it."

More detailed information related to the BBT-176 clinical trial, which was launched this time , can be found in the Clinical Trial Information menu in the Korea Food and Drug Administration’s Integrated Drug Information System website .

On the other hand, Bridge Biotherapeutics, which started to discover its own candidates this year, started to discover and develop new candidates for non-small cell lung cancer drugs that can effectively meet various unmet medical demands, including C797S double mutation.

On April 7, 2021 BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV) reported that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) for the Phase I/IIa clinical study of the immuno-modulatory anti-TNFR2 antibody BI-1808 (Press release, BioInvent, APR 7, 2021, View Source [SID1234577707]).

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"FDA approval of the Phase I/IIa study of BI-1808 is another important milestone for BioInvent as we continue to broaden our exciting pipeline of anti-cancer antibodies. TNFR2 is increasingly attracting interest as revealed by the recent deals in the field. The development of BI-1808 is supported by an impressive set of preclinical data and is one of three BioInvent lead candidates in clinical development," said Martin Welschof, CEO of BioInvent.

The Phase I/IIa study will evaluate the safety, tolerability, and potential signs of efficacy of BI-1808 as a single agent, and in combination with the anti-PD-1 therapy Keytruda in patients with ovarian cancer, non-small cell lung cancer and CTCL. It is planned to be carried out in the U.S., Denmark, Hungary, the United Kingdom and Russia and is already enrolling patients.

The anti-TNFR2 antibody BI-1808 is a first-in-class drug candidate and is part of BioInvent’s tumor-associated regulatory T cells (Treg)-targeting program. This has emerged from the F.I.R.S.T platform technology that simultaneously identifies new targets and high-quality antibodies, generating promising new drug candidates to target the tumor microenvironment (TME). TNFR2 is particularly upregulated on Tregs of the TME and has been shown to be important for tumor expansion and survival, representing a new and promising target for cancer immunotherapies.

On April 7, 2021 AVM Biotechnology reported that the first cohort has been fully enrolled in their clinical study (NCT04329728 "The WWRD Study") (Press release, AVM Biotechnology, APR 7, 2021, https://www.prnewswire.com/news-releases/avm-biotechnology-announces-full-enrollment-of-first-cohort-of-relapsedrefractory-non-hodgkins-lymphoma-patients-dosed-with-avm0703-at-major-cancer-centers-in-usa-301263637.html [SID1234577706]). All three patients had failed multiple prior therapies, and one had failed two transplants. These patients are reportedly all doing very well, and one was quoted as saying, "I feel great!" Three major US Cancer Centers are actively enrolling study participants. AVM Biotechnology is excited to advance AVM0703 to the next dose level cohort of no-option lymphoma patients. The drug has been well tolerated, without safety issues, as expected. The study is an adaptive design/expansion cohort trial such that cohort enrollment of relapsed/refractory Non-Hodgkin’s Lymphoma patients for the pivotal trial can immediately follow the dose-escalation phase.

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Since originally approving the study, the FDA has approved a reduction in the interval between patients in a cohort, from 7 days to 48-hours and between cohorts, from 21 to 7 days of dosing for the first two cohorts. This reduction was approved in response to drug tolerance data submitted from patients treated under FDA approved compassionate use applications.

AVM0703 targets lymphoma while sparing normal lymphocytes, platelets, red blood cells, and stem cells.

"Considering the delay of many clinical studies due to the pandemic, we are gratified to see enrollment occurring so rapidly," said Janet R. Rea, AVM COO. "We are pleased to see these patients tolerate the drug well after failing multiple other therapies and look forward to seeing continued positive results with dose escalation."

The administration of a single dose of AVM0703 is believed to activate the innate immune system to launch novel gamma/delta Natural Killer T cells (NKT cells), and cytotoxic T cells that possess enhanced activity. Once triggered, these cells provide rapid onset of action and response. AVM0703 targets lymphoma while sparing normal lymphocytes, platelets, red blood cells, and stem cells. AVM believes this treatment could reduce the need for transfusions, lower the costs of cancer care associated with managing treatment side-effects, and improve quality of life for lymphoma patients.

"AVM0703 represents an entirely new approach for cancer and non-cancerous diseases. It has the potential to be a true game-changer. I am encouraged by the pre-clinical data and look forward to seeing results of this pivotal trial," said Dr. William Matsui, MD, Deputy Director of Livestrong Cancer Institute.

AVM0703 is available under Expanded Access or Compassionate Use guidelines.

About Non-Hodgkin’s Lymphoma
Non-Hodgkin’s Lymphoma, a broad heterogeneous constellation of lymphoproliferative disorders, is the seventh most common cancer in both men and women, affecting an estimated 77,240 people in the US each year. The overall five-year survival rate is approximately 72%, and over half of the newly–diagnosed cases are in people over age 65 years. Remission following initial established treatment is common, but the disease typically recurs or relapses in as many as 50% of the patients within two years,1 and in some patients, their disease is "refractory," or resistant to additional treatment. Second-line or so-called salvage therapy in these patients consists of stronger chemotherapy "cocktails" or, more recently, cell therapy or hematopoietic cell transplantation. Both approaches can have significant and serious side effects, and the response rates to salvage chemotherapy range from 26%2 to 45%3, with 50% of patients proceeding to autologous stem cell transplant (ASCT). Four-year survival rates are less than 40% utilizing salvage chemotherapy and 60% for those who then undergo ASCT.3 Treatments and associated side effects, coupled with the medical fragility associated with these patients, leaves many of them no treatment options, i.e., "no-option". AVM Biotechnology is committed to providing an option to these patients.

On April 7, 2021 AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company") reported that it has been granted an exclusive sublicense to technology related to the use of novel and proprietary central nervous system (CNS) homing peptides for the therapeutic treatment of neuroinflammatory disease in cancer patients (Press release, AIkido Pharma, APR 7, 2021, View Source [SID1234577705]).

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The homing peptides covered by the sublicense can be used to facilitate the delivery of therapeutic agents to inflamed CNS tissue. Psychedelics such as psilocybin have been shown to have anti-inflammatory activity in addition to their potential efficacy for treatment of neurological disorders such as anxiety, depression and post-traumatic stress disorder (PTSD). Studies indicate that neuroinflammation of the brain and other CNS tissues in cancer patients contributes to, among other symptoms, the onset of cancer cachexia, which is characterized by loss of appetite, extreme weight loss and muscle wasting.

Anthony Hayes, CEO of AIkido Pharma, stated, "The novel homing peptides covered under this sublicense have the potential to allow the direct delivery of psilocybin to inflamed CNS tissue in cancer patients. This sublicense culminates our Letter of Intent previously announced on February 16, 2021. It complements our recently announced support of the psilocybin research for PTSD treatment at Mount Sinai Center for Psychedelic Psychotherapy and Trauma Research."