Intensity Therapeutics Announces New Clinical Data in Solid Tumors for its Lead Asset, INT230-6, were Accepted for Two Poster Discussion Sessions and Three Poster Presentations at the Upcoming 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

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).

CENTENE TO PRESENT AT BANK OF AMERICA 2022 HEALTHCARE CONFERENCE

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.

Agastiya Biotech receives FDA Orphan Drug Designation for AB001 for Pancreatic cancer and Acute Myeloid Leukemia (AML)

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.

West to Participate in Upcoming Investor Conferences

On May 3, 2022 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it will participate in the Bank of America Securities 2022 Healthcare Conference taking place May 9-13, 2022, in Las Vegas, NV (Press release, West Pharmaceutical Services, MAY 3, 2022, View Source [SID1234613444]). Management will present on Tuesday, May 10, 2022, at 11:20 AM PDT.

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It will also present at the 42nd Annual William Blair Growth Stock Conference in Chicago, IL on Monday, June 6, 2022, as well as at the Jefferies Global Healthcare Conference in New York, NY on Thursday, June 9, 2022.

A live audio webcast will be available in the "Investors" section of the Company’s website at www.westpharma.com. Replay of the webcasts will be available for approximately 90 days after the events.

Enveric Biosciences Announces Distribution of Series C Preferred Stock to Holders of its Common Stock

On May 3, 2022 Enveric Biosciences Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, reported that its Board of Directors declared a dividend of one one-thousandth of a share of newly-designated Series C Preferred Stock, par value $0.01 per share, for each outstanding share of Enveric common stock held of record as of 5:00 p.m. Eastern Time on May 13, 2022 (Press release, Enveric Biosciences, MAY 3, 2022, View Source [SID1234613443]). The outstanding shares of Series C Preferred Stock will vote together with the outstanding shares of the Company’s common stock, as a single class, exclusively with respect to a proposal to increase the number of authorized shares of the Company’s common stock, a proposal giving the Board of Directors the authority, as it determines appropriate, to implement a reverse stock split within twelve months following the approval of such proposal by the Company’s stockholders, as well as any proposal to adjourn any meeting of stockholders called for the purpose of voting on the foregoing matters, and will not be entitled to vote on any other matter, except to the extent required under the Delaware General Corporation Law. Subject to certain limitations, each outstanding share of Series C Preferred Stock will have 1,000,000 votes per share (or 1,000 votes per one one-thousandth of a share of Series C Preferred Stock).

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All shares of Series C Preferred Stock that are not present in person or by proxy at the meeting of stockholders held to vote on the above described proposals as of immediately prior to the opening of the polls at such meeting will automatically be redeemed by the Company. Any outstanding shares of Series C Preferred Stock that have not been so redeemed will be redeemed if such redemption is ordered by Enveric’s Board of Directors or automatically upon the approval by Enveric’s stockholders of the above described proposals.

The Series C Preferred Stock will be uncertificated, and no shares of Series C Preferred Stock will be transferable by any holder thereof except in connection with a transfer by such holder of any shares of the Company’s common stock held by such holder. In that case, a number of one one-thousandths of a share of Series C Preferred Stock equal to the number of shares of Enveric’s common stock to be transferred by such holder would be transferred to the transferee of such shares of common stock.

Further details regarding the Series C Preferred Stock will be contained in a report on Form 8-K to be filed by Enveric with the Securities and Exchange Commission.