On May 3, 2022 Byondis B.V., an independent, Dutch clinical stage biopharmaceutical company creating precision medicines, reported that it has entered into a License and Collaboration Agreement and a Supply Agreement with medac GmbH, a privately owned pharmaceutical company based in Germany (Press release, Byondis, MAY 3, 2022, View Source [SID1234613449]). Byondis and medac will partner to commercialize Byondis’ lead program, anti-HER2 antibody-drug conjugate (ADC) trastuzumab duocarmazine (SYD985), pending approval by the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA), as well as other regulatory authorities in Europe.

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Under the terms of the agreement, medac receives an exclusive license to commercialize SYD985 in the EU, the UK and further European countries, in all approved indications. Byondis will receive an undisclosed upfront payment and sales royalties. Byondis will also be eligible for payments upon achievement of certain development and sales milestones.

"This collaboration with medac on SYD985 is a crucial step in ensuring that the therapy, once approved, is available to patients, who desperately need other treatment options," said Byondis Founder and Chairman Jacques Lemmens, Ph.D.

"Like Byondis, medac is committed to developing novel therapies, especially in areas of unmet medical need. We believe in the potential of Byondis and SYD985 and look forward to bringing this next generation ADC to patients who need it," said medac Managing Director, CEO Jörg Hans.

Byondis CEO Marco Timmers, Ph.D. added: "We are pleased to have found in medac a true partner who shares our passion for innovation and making a difference in the lives of patients."

SYD985 targets a range of HER2-expressing cancers such as metastatic breast and endometrial (uterine) tumors. Data from the SYD985 pivotal Phase III TULIP study (SYD985.002) in HER2-positive unresectable locally advanced or metastatic breast cancer showed statistically significant progression-free survival (PFS) results compared to physician’s choice (PC) treatment. TULIP continues to study overall survival and a Marketing Authorization Application (MAA) for this initial clinical indication will soon be submitted to the EMA. The ADC is also in a Phase II multiregional clinical trial to evaluate its safety and efficacy in patients with HER2-expressing recurrent, advanced or metastatic endometrial cancer (SYD985.003).

About trastuzumab duocarmazine (SYD985), a Next Generation Antibody-Drug Conjugate
Trastuzumab duocarmazine (SYD985) incorporates Byondis’ distinctive, proprietary duocarmazine linker-drug (LD) technology ByonZine. The ADC is comprised of the anti-HER2 monoclonal antibody trastuzumab, and a cleavable linker-drug called valine-citrulline-seco-DUocarmycin-hydroxyBenzamide-Azaindole (vc-seco-DUBA).

The antibody part of trastuzumab duocarmazine binds to HER2 on the surface of the cancer cell and the ADC is internalized by the cell. After proteolytic cleavage of the linker, the inactive cytotoxin is activated and DNA damage is induced, resulting in tumor cell death. SYD985 is considered a form of targeted chemotherapy.

On May 3, 2022 Omega Therapeutics (NASDAQ: OMGA) (Omega), a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming platform, reported that will present preclinical data on its novel Omega Epigenomic Controller (OEC) to regulate expression of the c-Myc (MYC) oncogene via epigenomic programming in models of NSCLC in a poster presentation at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting, taking place in Washington, D.C., May 16-19, 2022 (Press release, Omega Therapeutics, MAY 3, 2022, View Source [SID1234613448]).

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"These preclinical data establish epigenomic programming as a differentiated approach to correct aberrant MYC expression by control of its insulated genomic domain (IGD) in NSCLC, which accounts for almost 25% of cancer deaths worldwide," said Thomas McCauley, Ph.D., Omega’s Chief Scientific Officer. "Combined with our previously presented data demonstrating sustained MYC downregulation in preclinical models of hepatocellular carcinoma by our lead OEC, these new results further highlight the power of our approach and the capabilities of our platform, fueled by our pioneering research, to design and develop potentially transformative medicines."

Details for the poster presentation:

Title: Novel Epigenetic Targeting of the MYC Oncogene for the Treatment of NSCLC using programmable mRNA therapeutics
Abstract #: 1114
Date and Time: Wednesday, May 18, 2022, from 5:30 p.m. through 6:30 p.m. EDT

Key findings:

OEC treatment yields precise, targeted changes in the epigenetic landscape of the MYC IGD in NSCLC cell lines
Epigenetic changes drive robust downregulation of both MYC mRNA and protein in multiple NSCLC cell lines, leading to associated changes in MYC-driven genes and an increase in cell death via apoptosis
Treatment with the OEC did not strongly impact the viability of healthy primary lung epithelial and endothelial cells
Combining OEC treatment with either a MEK or EGFR inhibitor in NSCLC cells yielded greater reductions in MYC protein and cell viability, suggesting the potential for additive or synergistic effects of the OEC with standard of care therapies in patients
OEC treatment effectively reduced tumor growth in vivo and was well tolerated in murine xenograft models, further supporting the therapeutic potential of this asset

On May 3, 2022 Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported that phase 2 sarcoma data, phase 2 breast cancer data and phase 1/2 solid tumor data from its ongoing cohort studies of lead asset, INT230-6, will be presented in two oral and three poster sessions at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held live at McCormick Place in Chicago, IL, and online, from June 3-7, 2022 (Press release, Intensity Therapeutics, MAY 3, 2022, View Source [SID1234613447]).

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Abstract Title: INT230-6 monotherapy and in combination with ipilimumab (IPI) across a broad spectrum of refractory soft tissue sarcomas (STS) [Intensity IT-01; BMS#CA184-592].
Presenter/First Author: Matthew Ingham, MD
Session Type/Title: Poster Discussion Session/Sarcoma
Poster Discussion Session Date and Time: Sunday, June 5, 2022, 12:30 PM – 2:00 PM EDT
Location: In-Person & On Demand | S404
Abstract Number: 11515
Poster: 420

Abstract Title: Effect of intratumoral INT230-6 on tumor necrosis and promotion of a systemic immune response: Results from a multicenter phase 1/2 study of solid tumors with and without pembrolizumab (PEM) [Intensity IT-01; Merck KEYNOTE-A10].
Presenter/First Author: Jacob Stephen Thomas, MD
Session Type/Title: Poster Discussion Session/Developmental Therapeutics—Immunotherapy
Poster Discussion Session Date and Time: Sunday, June 5, 2022, 12:30 PM – 2:00 PM EDT
Location: In-Person & Live Stream | Hall D2
Abstract Number: 2520
Poster: 176

Abstract Title: Intratumoral (IT) INT230-6 can cause tumor necrosis In Vivo: Preliminary results of a phase II randomized presurgical window-of-opportunity study in early breast cancers (the INVINCIBLE study).
First Author: Angel Arnaout, MD, FACS
Session Type/Title: Poster Session/Breast Cancer—Local/Regional/Adjuvant
Session Date and Time: Monday, June 6, 2022, 9:00 AM – 11:00 AM EDT
Location: In-Person & On Demand
Abstract Number: 605
Poster: 376

Copies of these materials will also be available on the Intensity Therapeutics website at View Source following completion of the live presentation.

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells. In addition to local disease control, direct killing of the tumor by INT230-6 releases a bolus of neoantigens specific to the patient’s malignancy, leading to engagement of the immune system and systemic anti-tumor effects. Importantly, these effects are mediated without the immunosuppression of concomitant systemic chemotherapy.

INT230-6 is currently being evaluated in several phase 2 cohorts (NCT03058289) in patients with various advanced solid tumors as part of Study IT-01. In 2019, the Company signed a clinical collaboration agreement with Merck Sharpe & Dohme (Merck) to evaluate the combination of INT230-6 and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced pancreatic, colon, squamous cell and bile duct malignancies. In 2020, the Company executed a clinical collaboration agreement with Bristol-Myers Squibb Company to evaluate the combination of INT230-6 with Bristol-Myers Squibb’s anti-CTLA-4 antibody, Yervoy (ipilimumab), in patients with advanced liver, breast and sarcoma cancers. In 2021, the Company executed agreements with the Ottawa Hospital Research Institute and the Ontario Institute of Cancer Research to study INT230-6 in a randomized controlled neoadjuvant phase 2 study in women with early stage breast cancer (the INVINCIBLE study) (NCT04781725).

On May 3, 2022 Centene Corporation (NYSE: CNC) reported it will present at the Bank of America 2022 Healthcare Conference, to be held Monday, May 9-Friday, May 13, 2022, in Las Vegas (Press release, Centene , MAY 3, 2022, View Source [SID1234613446]).

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Centene will present on Tuesday, May 10th at 8:40 a.m. Pacific Time (PT). A simultaneous live audio webcast is available at: https://bofa.veracast.com/webcasts/bofa/hc2022/idhB56LV.cfm.

A webcast replay will be available afterwards via the Company’s website at www.centene.com, under the Investors section.

On May 3, 2022 Agastiya Biotech and Vopec Pharmaceuticals reported that the US FDA has granted Orphan Drug Designations for Pancreatic Cancer and AML for its novel small molecule, AB001 (Press release, Agastiya Biotech, MAY 3, 2022, View Source [SID1234613445]).

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AB001 is a small molecule PD-L1 checkpoint inhibitor that also targets aberrant intracellular signaling pathways in the tumor microenvironment, such as Wnt/beta-catenin, PI3K, and RAS. This dual mechanism has been shown in the animal model to work across multiple cancer types, including solid and liquid tumors and, also, on non-PDL1+ cancers. The research offers potential proof for the drug-ability of the so far undruggable beta-catenin and clear advantages of AB001 over Gemcitabine which is the standard of care for pancreatic cancer. Furthermore, AB001 exerts anti-leukemia activity in preclinical models of acute lymphoblastic leukemia, likely through inhibiting VEGFR2-mediated signaling pathways, and suggests potential benefits and clinical application of AB001 in treating Leukemia patients.

Agastiya’s founder Dr. Baskaran Pillai says, "Chemo drugs are efficient in killing tumor cells. However, due to its high toxicity, it also ends up harming normal cells, weakening the patient’s health and energy. AB001 preclinical studies have proved that it is able to kill cancer cells without harming normal cells. Additionally, AB001 targets cancer stem cells, thereby disrupting drug resistance and relapse mechanisms."

Dr. MG Dinesh, Chief Scientific Officer, states, "On the advice of Dr. Pillai, I researched the preventative efficacy of AB001 on 5 different cancer cell lines. The prophylactic studies show that AB001 prevents various oncogenes from becoming mutated into tumors and maintains the tumor suppressor genes in the active state after induction with a chemical carcinogen."

Cancer prevention is one of the important Moonshot project goals of President Biden. "Our India-US collaboration marks an important milestone in cancer therapeutics." Says Sonja Benkovich, interim-CEO.