On June 7, 2023 Neomabs Biotechnologies reported that developing new generations of immunotherapies to treat still incurable pediatric leukemias: this is the objective of Neomabs Biotechnologies, a new Montreal biotechnology company specializing in the discovery and development of innovative therapies in oncology (Press release, Neomabs Biothechnologies, JUN 7, 2023, View Source [SID1234636476]).

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The result of a strategic and innovative partnership between key players in the life sciences ecosystem, the creation of Neomabs was made possible thanks to pre-seed financing of $2M led by Theodorus, with the participation of Eureka Investment Fund. Neomabs also counts CQDM, Immune Biosolutions and the CHU Sainte-Justine Research Center among its partners.

Neomabs is working to develop therapeutic antibodies directed against new targets – neo-antigens – against acute pediatric leukemia, of which 20% to 30% of affected children still die today. The discovery of these targets is made possible thanks to the expertise of researcher Étienne Caron, his associate Isabelle Sirois and Dr. Sonia Cellot at CHU Sainte-Justine. Indeed, Étienne Caron, also an assistant professor in the pathology department of the University of Montreal, uses high-performance methods of proteomics, immunopeptidomics and computational mass spectrometry which he pairs with a unique biobank of leukemic specimens, xenografts derived from patients and artificial human leukemia models led by Dr. Sonia Cellot , hemato-oncologist and clinician-researcher at CHU Sainte-Justine. It is this combination of expertise which is the source of the antibodies developed by Neomabs.

The company has thus concluded an exclusive worldwide licensing agreement on the neo-antigens identified at the CHU Sainte-Justine Research Center, through Axelys, partner of CHU Sainte-Justine for the management and marketing of its active ingredients. intellectual property.

"We are delighted with the launch of this new company in Montreal. This is the culmination of a unique partnership between Theodorus and CQDM, launched in 2021, which aimed to identify innovative research programs in the development of new therapies and to accelerate their commercialization through the creation of new companies. in life sciences in Quebec, declared Patricia Escoffier , Director at Theodorus. We are proud to be able to lead this round of financing and to participate in this unique partnership which will promote the creation of a real commercial opportunity for this promising technology."

"The Eureka Fund was set up with the objective of supporting the development of new innovative technology companies at the pre-seed stage such as Neomabs. We are proud to support promising young companies operating in key sectors of our economy, such as life sciences, and which develop technologies through close collaboration with the community. », Underlines Benoit Leroux , president of the Eureka Investment Fund.

"The Eureka Fund propels young innovative technological companies like Neomabs Biotechnologies, which work to improve the well-being of the Quebec population. By supporting their creation, we enable the emergence of new therapies from public research centers which will have a real effect on people’s health," says Pierre Fitzgibbon , Minister of the Economy, Innovation and Energy. , Minister responsible for Regional Economic Development and Minister responsible for the Metropolis and the Montreal region.

"The CHU Sainte-Justine Research Center is pleased to actively contribute, through its academic and clinical excellence, to the emergence of this new partnership model dedicated to transforming the care pathway for children with cancer," says Dr. Jacques L. Michaud , director of research at CHU Sainte-Justine.

"We are proud to join this unique group of partners to support the growth of Neomabs and accelerate the development of new treatments to fight pediatric cancers," said Jesse Paterson, Senior Director of Business Development at CQDM. This is a perfect example of how CQDM contributes to the development of a solid Quebec ecosystem in the field of life sciences by bringing together the right partners and the most promising innovations.

"This strategic partnership with NeoMabs will help identify the next generation of therapeutic antibodies to treat pediatric leukemias. Thanks to our common passion and our shared resources, we are convinced that we can improve the quality of life of young patients as well as their families," underlines Luc Paquet , President and CEO of Immune Biosolutions and Chairman of the Board of Immune Biosolutions. administration of Neomabs.

"Neomabs fully illustrates the quality of the Quebec biotechnology ecosystem that Axelys wishes to support in its growth and maturation, in order to create, grow and shine leaders offering therapies for patients suffering from serious illnesses and often without a therapeutic alternative," explains Catherine Gagnon , vice-president, business development and investments at Axelys.

On June 7, 2023 ITabMed Ltd., a clinical-stage biotech company in China, reported the IND approval from China National Medical Products Administration (NMPA) for A-337, a CD3-activating bi-specific antibody targeting EpCAM. This is a "Phase I, Open-label, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of A-337 in patients with advanced solid tumors" (Press release, ITabMed, JUN 7, 2023, View Source [SID1234632575]). EpCAM is one of the earliest identified tumor-associated antigens (TAA) and up-regulated and over-expressed in many solid tumors.

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A-337 is the second immune oncology product generated by the immunotherapy antibody (iTab) platform to enter clinical development in China. iTab is a T cell engager (TCE) platform for human CD3-activating bi- and tri-specific antibodies targeting tumor associated antigens (TAA). A-337 was designed with two EpCAM targeting fragments (EpCAM x EpCAM x CD3) with significantly enhanced biological properties and improved safety profile compared to the competitor’s products including EpCAM x CD3 TCE, EpCAM x CD3 bispecific antibodies. In preclinical studies, A-337 demonstrated potent anti-tumor activity, favorable pharmacokinetics, and a significantly improved safety window.

Dr. Xiao Qiang Yan, Chairman and CEO of ITabMed Ltd commented "A-337 is our second immunotherapeutic antibody entering clinical development in China. A-337 has the similar structural design as A-319 which is in phase I development to treat liquid tumors. Two phase I studies of A-319 are being conducted in patients with relapsed and refractory B cell acute lymphoblastic leukemia (r/r-B-ALL) and in patients with relapsed and refractory non-Hodgkin’s lymphoma (r/r-NHL). The preliminary results of the two phase I studies have demonstrated an excellent safety profile and promising anti-tumor responses of A-319 during dose-escalation. Likewise, we believe that A-337 has enormous potential to treat metastatic solid tumors due to its improved safety profile and its unique format design. The IND approval demonstrates our continued effort in "innovating for life" and to cure many cancer patients with our innovative medicines".

About iTab platform

ITabMed has been developing the iTAb (immunotherapy antibody) platform for more than a decade. iTAb generates bi- and tri-specific antibodies that bind to the CD3 molecule on human T cells, and simultaneously bind to TAAs or TSA on a tumor cell. The formation of a synapse between the tumor cell and the T cell linked by the antibody leads to the activation of the T cells, and the release of mediators lysing the tumor cells. These T cell engaging bi- and tri-specific antibodies can drive the expansion of T cells, rendering T cells as serial killers of tumor cells. The iTAb antibodies are very potent and are manufactured in CHO cells in serum-free conditions. The iTAb drug products are very stable in liquid formulation with extra-long stability profile.

On June 7, 2023 Real-world data and expert perspectives on state-of-the-art clinical practice for the management of infection in patients with CLL will be showcased during the Octapharma Update-in-Hematology session at the EHA (Free EHA Whitepaper) Hybrid Congress on June 9, 2023, in Frankfurt, Germany (Press release, Octapharma, JUN 7, 2023, View Source [SID1234632574]).

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Secondary immunodeficiency (SID) is a common complication in patients with haematological malignancies such as CLL. Up to 85% of patients with CLL develop hypogammaglobulinemia, either due to the underlying disease or as a side effect of treatment.1 Patients with hypogammaglobulinemia are more likely to develop infections, which are a major cause of morbidity and account for up to 60% of deaths in patients with CLL.2 The use of immunoglobulin therapy (intravenous and subcutaneous) is well established as secondary prophylaxis once patients experience a severe/repeated infection. Furthermore, primary prophylaxis with immunoglobulin therapy has been suggested to decrease infection rates but more robust data are needed to evaluate the safety and efficacy of this strategy.3-5

Octapharma’s interactive Update-in-Hematology session "Chronic Lymphocytic Leukemia (CLL) and Beyond: Management of the Infection Burden" will begin with a spotlight on the risk of infections in patients with CLL using a data-driven and machine learning approach by Dr Caspar da Cunha-Bang, Rigshospitalet, Copenhagen, Denmark. This will be followed by a discussion on the risk factors for infections and the importance of guideline recommendations in choosing the right treatment to reduce the severity of these infections by Professor Hartmut Link, Haematology Oncology Kaiserslautern, Kaiserslautern, Germany. Finally, Professor Livio Trentin, University of Padua, Italy, will speak about his experience using subcutaneous immunoglobulin therapy for infection prophylaxis in patients with CLL. In addition, he will share his first-hand experience with ongoing research into this area, including the PRO-SID clinical trial and its potential for primary infection prophylaxis. The session will round off with an exciting panel discussion bringing together the audience and experts to exchange views on challenging cases of infections associated with CLL.

Stephan Stilgenbauer, Professor of Medicine and Medical Director of the Comprehensive Cancer Centre in Ulm, Germany, will chair the session. He stated, "The COVID-19 pandemic has vividly reminded us about the impact of infections on patients. Therefore, novel perspectives in approaching prophylaxis in CLL are highly valued – I am very much looking forward to discussing some of these exciting advances in the field with the international panel of speakers and audience at this session."

Octapharma has a longstanding commitment to improving the management of patients with SID, and in 2020 launched PRO-SID (NCT04502030), a Phase III clinical trial investigating primary infection prophylaxis with panzyga, a human immunoglobulin for intravenous administration, in patients with CLL and SID. Over 240 adult patients with CLL and hypogammaglobulinemia (IgG levels < 5 g/L) who are receiving antineoplastic treatment will be enrolled to investigate the efficacy and safety of panzyga compared with placebo. The primary outcome is the occurrence of at least one major infection over 52 weeks. With this trial, Octapharma aims to gather robust clinical data on the efficacy of primary prophylaxis in managing infection risk in patients with SID and expand the treatment options in these patients.

Livio Trentin, Professor of Haematology and Director of the Haematology Unit at Padua University, is supervising one site of the PRO-SID trial. He commented: "There remains a significant need to establish the most effective approach to managing patients with haematological malignancies and secondary immunodeficiency. Proactive management of infections in these patients using primary prophylaxis with intravenous immunoglobulin has great potential but it is important that we gather robust evidence on the efficacy and safety of this treatment option through trials such as PRO-SID."

Olaf Walter, Board Member at Octapharma, added: "Octapharma is delighted to support this Update-in-Hematology session, and we look forward to facilitating expert perspectives and audience interaction to improve the care of patients with CLL. We are also proud to support the PRO-SID study which will provide important data to understand how to improve and potentially save the lives of these patients."

In addition to this Update-in-Hematology session, the strong commitment of Octapharma to the field of SID will be illustrated by the presentation of a subgroup analysis of patients with SID in a non-interventional safety study conducted in Germany. The results of this analysis on 3,846 SID patients will be displayed and commented during the poster session of the Congress on June 9, 2023:

P1505: "Tolerability and safety of intravenous immunoglobulins (5% and 10%) for the treatment of patients with secondary immunodeficiencies – Final subgroup results of a non-interventional safety study," presented by Octapharma.
We look forward to seeing you soon at EHA (Free EHA Whitepaper) 2023 – drop by the Octapharma booth on-site in Frankfurt for more information.

About panzyga

Panzyga is a 10% human normal immunoglobulin solution ready for intravenous administration. Panzyga is approved for use in treatment of primary immunodeficiency, idiopathic thrombocytopenic purpura (ITP) and chronic inflammatory demyelinating polyneuropathy (CIDP) in the USA, Europe and Canada. It is also approved for secondary immunodeficiencies and Guillain Barré syndrome in Europe and Canada and for Kawasaki disease, and multifocal motor neuropathy (MMN) in Europe.

On June 7, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA) reported its second broad provisional patent application covering the composition of matter for a new telomere-targeting molecule (Press release, MAIA Biotechnology, JUN 7, 2023, View Source [SID1234632573]). MAIA is creating and evaluating multiple telomere-targeting compounds designed to modify the telomeric structure through the cancer cell – intrinsic telomerase activity – and thus cause the death of these cells. The studies, conducted in vitro in multiple cancer cell lines and in vivo in several pre-clinical cancer models, demonstrated the intended mechanism of action and high-level anti-cancer activity for these new molecules.

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MAIA has nominated a new molecular entity candidate (designated as MAIA-2021- 029) for further advancement into preclinical GLP-toxicity and other studies, and may advance this candidate into human clinical trials upon completion of the required preclinical evaluations. The patent titled "TUMOR REDOX-ACTIVATED 6-THIOPURINE CONTAINING DIMER COMPOUNDS" further adds to MAIA’s Telomere-Targeting Molecule Program, which includes THIO, the lead therapeutic candidate currently being evaluated in a Phase 2 clinical trial, and follow-on compounds MAIA-2021-020 and MAIA-2022-012, patented in the fourth quarter of 2022.

"The discovery and preclinical advancements of these new telomere-targeting compounds represent another significant chapter for MAIA. We have observed impressive single-agent activity in several different tumor types for the new candidates, as well as in combination with immune checkpoint inhibitors," said Sergei Gryaznov, Ph.D., MAIA Chief Scientific Officer. "The observed anti-cancer activity in vitro and in vivo is quite remarkable, often leading to complete tumor eliminations. We are working diligently to advance these candidates toward clinical development."

"The development of proprietary new molecular entity candidates is a key component to MAIA’s strategy and greatly increases the chances to bring a highly efficacious telomere-targeting therapy to market. Our molecules can be used in the treatment of multiple cancer indications, and with the excellent preliminary results observed in our ongoing Phase II trial evaluating THIO in patients with Non-Small Cell Lung Cancer, we look forward to announcing further developments of MAIA’s proprietary new molecular entity candidates," said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is an 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. THIO is being 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.

On June 7, 2023 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported initial proof of concept monotherapy data from its Phase 1 MYTHIC clinical trial evaluating lunresertib (RP-6306), a first-in-class, oral PKMYT1 inhibitor in molecularly selected advanced solid tumors (Press release, Repare Therapeutics, JUN 7, 2023, View Source [SID1234632572]).

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"These initial proof of concept results for lunresertib monotherapy show a favorable and distinct tolerability profile and preliminary antitumor activity that support our development plans for this program," said Maria Koehler, MD, PhD, Chief Medical Officer of Repare. "The data demonstrate that lunresertib effectively inhibits PKMYT1 and offers a synthetic lethal combination with CCNE1 amplification or inactivating mutations in FBXW7 and PPP2R1a. These genetic alterations have previously been considered undruggable and represent a significant unmet medical need. These findings, along with the continued advancement of the lunresertib program across multiple ongoing combination clinical trials, validate our proprietary STEP2 platform and precision medicine approach."

"While early, these promising proof-of-concept data continue to support our belief in the potential transformative role that lunresertib could play, either alone or in combination with other therapies, in patients with molecularly selected advanced solid tumors," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "We look forward to reporting initial combination data of lunresertib with camonsertib, as well as lunresertib with gemcitabine, in the fourth quarter of this year, while also advancing multiple other trials to further our understanding of our first-in-class PKMYT1 inhibitor program."

Key Initial Findings from the Phase 1 MYTHIC Clinical Trial:

MYTHIC (NCT04855656) Module 1 is a first-in-human, global, open-label Phase 1 dose-escalation study to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of a novel and potent small molecule PKMYT1 inhibitor, lunresertib. MYTHIC Module 2 will investigate lunresertib in combination with camonsertib (RP-3500/RG6526), a potent and selective oral inhibitor of ATR developed by Repare and now partnered with Roche (excluding the lunresertib combination), in molecularly selected advanced solid tumors. As of the data cutoff date of April 28, 2023, 63 patients were enrolled in lunresertib monotherapy Module 1 of the MYTHIC study, which is ongoing and accruing patients.

Tolerability profile of lunresertib monotherapy appears favorable and differentiated from other clinical cell cycle inhibitors, which have been characterized with myelotoxicity and diarrhea. No grade 4 toxicity was observed with lunresertib, where grade 3 treatment emergent adverse events of interest included rash (7.9%), anemia (6.3%) and nausea or vomiting (1.6%) The only dose limiting toxicity was reversible rash, alleviated with dose modifications and simple supportive measures.
Two recommended dose/schedules were identified – 240mg daily continuously and 80-100mg BID intermittent weekly – to offer maximum flexibility in combination studies.
Pharmacodynamic analysis confirmed lunresertib treatment results in PKMYT1 target inhibition at active doses and increases DNA damage.
Preliminary anti-tumor activity was observed, including moderate tumor shrinkages and a confirmed partial response per RECIST 1.1 criteria. Several patients demonstrated long stable disease and remain on treatment for greater than 11 months and ongoing.
Early clinical combination insights demonstrated greater anti-tumor activity in patients treated with the combination of lunresertib and camonsertib than lunresertib alone, based on higher molecular response rates and RECIST 1.1 responses. Examples of confirmed partial responses are provided for the three tested sensitivity genotypes in endometrial adenocarcinoma, cholangiocarcinoma and colorectal cancer, with more details planned for the Q4 scientific presentation.
Encouraging early responses observed across gemcitabine, camonsertib, and FOLFIRI clinical combinations in multiple tumor types and genotypes.
Favorable and distinct tolerability profile and preliminary antitumor activity demonstrated thus far support potential development plans that may include further trials of lunresertib in various combination and maintenance approaches.
Repare is also currently evaluating lunresertib in combination with gemcitabine in the Phase 1 MAGNETIC study and in combination with FOLFIRI in the Phase 1 MINOTAUR study. Repare is working with Princess Margaret Cancer Center to initiate clinical testing, as part of an investigator-sponsored trial (IST), of a fourth lunresertib combination with carboplatin and paclitaxel for the treatment of recurrent TP53 mutated ovarian and uterine cancer, with first patient dosing expected this year. The Company is also collaborating with the Canadian Cancer Trials Group in an ongoing basket Phase 2 IST that is enrolling patients with selected, advanced cancers receiving lunresertib as combination (NCT05605509), and in a second active study that will evaluate lunresertib in combination with gemcitabine in patients with CDK4/6 inhibitor treated ER+/HER2- metastatic breast cancer (NCT05601440). These studies aim to expand the treatment opportunities for lunresertib to earlier stages of cancer treatment or additional tumor types.

Company Virtual Webcast Event:

The Company will host a virtual investor webcast with accompanying slides for analysts and investors today at 4:30 p.m. Eastern Time to further discuss the lunresertib program, including initial proof-of-concept monotherapy data from MYTHIC and an update on ongoing combination clinical trials.

To access the call, please dial (877) 870-4263 (U.S. and Canada) or (412) 317-0790 (international) at least 10 minutes prior to the start time and ask to be joined to the Repare Therapeutics call. A live video webcast will be available in the Investor section of the Company’s website at View Source A webcast replay will also be archived for at least 30 days.