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Mersana Therapeutics Announces FDA Grant of Orphan Drug Designation to XMT-2056 for the Treatment of Gastric Cancer

On May 19, 2022 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to XMT-2056, the company’s lead Immunosynthen STING-agonist ADC, for the treatment of gastric cancer (Press release, Mersana Therapeutics, MAY 19, 2022, View Source [SID1234614864]).

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According to the American Cancer Society, gastric cancer (also referred to as stomach cancer) accounts for approximately 1.5 percent of all new cancers diagnosed in the United States each year, with an estimated 26,560 new cases reported in 2021. The FDA grants orphan drug designation to a drug or biologic intended to treat a rare disease or condition impacting fewer than 200,000 individuals in the United States. This designation qualifies Mersana for potential incentives, including tax credits for certain trials, exemption from user fees and the potential for seven years of market exclusivity following approval (if granted).

"The FDA’s decision to grant orphan drug designation to XMT-2056 for the treatment of gastric cancer is an important recognition of its potential in this area of high unmet medical need," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "We are eager to bring XMT-2056 and its unique mechanism of action into the clinic mid-year to investigate its safety, tolerability and anti-tumor activity in gastric and other cancers."

XMT-2056 is designed to offer a differentiated and complementary therapeutic approach to existing and emerging solid tumor treatments. The company developed XMT-2056 leveraging a differentiated antibody that binds to a novel HER2 epitope, providing the opportunity, as demonstrated in preclinical studies, for treatment both as monotherapy and in combination with a variety of agents, including other anti-HER2 therapies. Mersana plans to initiate a Phase 1 trial of XMT-2056 in a range of HER2 expressing tumors, such as breast, gastric and non-small-cell lung cancers, in mid-2022.

Genprex to Present at Upcoming Investor Conference in May 2022

On May 19, 2022 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its President and Chief Executive Officer, Rodney Varner, will be providing a virtual overview of the Company’s gene therapies for cancer and diabetes to investors at the following conference in May 2022 (Press release, Genprex, MAY 19, 2022, View Source [SID1234614863]).

Event: H.C. Wainwright Global Investment Conference (Virtual and In-Person)

Conference Dates: May 23-26, 2022

Virtual Presentation Date: Available on-demand within the virtual platform for all delegates beginning May 24 at 7 a.m. ET

Presenter: Rodney Varner, Genprex’s President and Chief Executive Officer

Mr. Varner will deliver an overview of the Company’s pioneering gene therapies for cancer and diabetes and will be available for virtual one-on-one meetings with investors through the H.C. Wainwright conference platform

INCEPTOR BIO ANNOUNCES $37 MILLION SERIES A FINANCING

On May 19, 2022 Inceptor Bio, a biotechnology company advancing cell therapies for difficult-to-treat cancers, reported the closing of a $37 million Series A financing led by Kineticos Ventures (Press release, Inceptor Bio, MAY 19, 2022, View Source [SID1234614862]).

Proceeds from the Series A financing will be used to advance Inceptor Bio’s CAR-T lead program to a Phase I clinical trial and continue development of its CAR-M and CAR-NK platforms. Additionally, proceeds will support completion of Inceptor Bio’s Advanced Manufacturing Platform (AMP+) facility, a 29,000 square foot, state-of-the-art cell and gene therapy GMP manufacturing site located in Gainesville, Florida.

Inceptor Bio’s CAR-T, CAR-M, and CAR-NK platforms are at the center of a diversified portfolio of cell therapies focused on novel mechanisms that enhance cell performance in the tumor microenvironment. Novel technologies include a co-stimulatory domain M83, proprietary TMax manufacturing process, the K62 platform, which increases the phagocytic capabilities of macrophages and supports a M1 anti-tumor phenotype, and a differentiated iPSC technology.

"We are grateful for the continued support of Kineticos Ventures and our life sciences investors," said Shailesh Maingi, Founder and CEO of Inceptor Bio. "We have a simple strategy at Inceptor Bio. We’re advancing novel CAR-T, CAR-M and CAR-NK platforms into the clinic, securing our supply through AMP+, and building a leading team of scientists and engineers in order to improve treatment options for patients with difficult-to-cancers."

"This Series A funding allows us to focus on advancing our lead CAR-T program into the clinic while continuing to advance our other exciting cell therapy platforms," said Mike Nicholson, Ph.D., President and Chief Operating Officer of Inceptor Bio. "Our programs address serious challenges in the cell therapy arena, and fully realizing the potential of these therapies requires significant capital. We are grateful for the support of this incredible group of investors."

"Investing in early life sciences companies with promising pipelines like Inceptor Bio is at the heart of what we do," said Frank Lis, President of Kineticos Ventures. "With an expert team and a scalable manufacturing facility, Inceptor Bio is well positioned to advance next-generation cell therapy technologies to address difficult-to-treat cancers."

EORTC and Alliance Healthcare’s continued partnership in support of SPECTA clinical research infrastructure

On May 19, 2022 The European Organisation for Research and Treatment of Cancer (EORTC) reported its continued partnership with Alliance Healthcare, one of the largest pharmaceutical wholesalers in Europe (Press release, EORTC, MAY 19, 2022, View Source [SID1234614861]). Specifically, the collaboration supports the organisation’s SPECTA platform, a pan-European translational research infrastructure for all tumour types including rare cancers.

The EORTC SPECTA platform allows for the rapid implementation of new clinical trials and robust translational cancer research aimed at increasing our understanding of cancers in order to guide a more targeted clinical research and treat patients effectively.

Alliance Healthcare was previously owned by Walgreens Boots Alliance (WBA) until June 2021. Since then, Alliance Healthcare is a wholly owned subsidiary of AmerisourceBergen and the EORTC is delighted that its support and commitment to SPECTA is to continue under this new ownership. The fantastic support that Alliance Healthcare as part of WBA has provided over the past 10 years (since 2011) will persist to further reinforce and strengthen recognition of the SPECTA platform as the leading pan-European translational research infrastructure. The partnership with Alliance Healthcare under the umbrella of AmerisourceBergen will ensure the continuation of SPECTA’s work in personalised cancer medicine, helping guide patients’ treatments, but also advance our understanding of cancer biology to help treat more patients effectively.

Through the growth of SPECTA’s translational clinical research, it provides hope to thousands of patients. One patient with papillary thyroid cancer said that their "current treatment was defined after [their] inclusion in SPECTA" and after previous treatments didn’t work.

Treating oncologists also benefit from SPECTA. Pr. Jean-Yves Blay has said "the SPECTA study enables [the opportunity] to gain more understanding on the nature of the disease and to guide the treatment of many patients with rare cancer, which is quite unique."

Today, SPECTA’s ever-growing cancer clinical research platform includes 128 authorized research doctors in 17 countries. More than 1330 patients have participated in 3 clinical research projects with over 1200 individual result reports provided to patients and providing guidance for their treatment.

EORTC CEO, Dr Denis Lacombe commented "EORTC looks forward to continue working with Alliance Healthcare and AmerisourceBergen, pushing the boundaries of understanding cancer and furthering the standard of care for cancer patients in the European continent, through SPECTA."

Juan Guerra, SVP Managing Director at Alliance Healthcare said "I am extremely proud of the efforts of Alliance Healthcare colleagues Europe-wide over the last decade. The work the EORTC does, and advancements in cancer therapies and treatment SPECTA brings about, is critical in the fight against this disease. I am extremely happy that under our new AmerisourceBergen ownership we are continuing to help and support through a range of fund-raising initiatives and a donation from the AmerisourceBergen Foundation as together we aim to improve the health and wellbeing of patient populations."

EpiAxis Therapeutics presents at Bioshares Biotech Summit

On May 19, 2022 EpiAxis Therapeutics reported to attend and present at the 16th Bioshares Biotech Summit this month in Albury, NSW (Press release, EpiAxis Therapeutics, MAY 19, 2022, View Source;utm_medium=rss&utm_campaign=epiaxis-therapeutics-presents-bioshares-biotech-summit [SID1234614860]).

BioShares is a life science conference mainly targeting ASX-listed Australian biotech companies, biotech investors, fund managers and brokers and entrepreneurs. The conference was organised by Bioshares, Australia’s leading independent biotech investment publication.

The event featured an intense two-day program, with approximately 25 speakers and excellent networking opportunities within the biotech industry and investment sectors. It was a valuable opportunity to access to investors who support the Australian life science sector.

EpiAxis was represented at Bioshares by Chairman Dr David Fuller, Director Rob McInnes and CEO Dr Jeremy Chrisp. Dr Chrisp gave a presentation during the "New Kids on the Block" session on day two of the conference.

Dr Fuller said: "It was great to see Bioshares return and be face-to-face with industry colleagues and friends again after the COVID-19 pandemic. The EpiAxis presentation was well received and marked the start of our next fundraising effort, with discussions held with many of the investors and funds present."