On May 12, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that China’s National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for a Phase III clinical trial designed to evaluate the safety and efficacy of selinexor (XPOVIO) in the treatment of advanced or recurrent endometrial cancer (the SIENDO trial) (Press release, Antengene, MAY 12, 2021, View Source [SID1234579828]).

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Endometrial cancer is a common gynecologic malignancy which frequently occurs in women of reproductive age. With a high incidence rate that has continued to rise in recent years, endometrial cancer has become the most prevalent malignancy of the female reproductive tract. Pregnancy, obesity, diabetes and reproductive system diseases are the main risk factors for endometrial cancer[1]. There is a lack of treatment options and curative care for patients with advanced or recurrent endometrial cancer, so effective novel treatments are increasingly important.

Selinexor (XPOVIO) is an US Food and Drug Administration (FDA) approved oral selective inhibitor of nuclear export that has been included in five regimens recommended by the National Comprehensive Cancer Network (NCCN) Guidelines and multiple regimens recommended by the Chinese Society of Clinical Oncology (CSCO) Diagnosis and Treatment Guidelines, for the treatment of multiple myeloma (MM) and diffuse large B-cell lymphoma (DLBCL). Selinexor inhibits XPO1, the only clinically proven nuclear export protein target. Based on its unique mechanism of action, selinexor can be combined with various other drugs in order to potentially enhance efficacy. The SIENDO trial is a global trial being conducted at over 80 centers across North America, Europe and Asia.

"This IND approval for selinexor in China marks a major milestone in achieving our mission to transform patients’ lives," said Dr. Jay Mei, founder, Chairman and CEO of Antengene. "The successful initiation of the SIENDO trial is a further step in helping us to explore additional solid tumor indications for the drug candidate. We believe that selinexor has the potential to play an important role in improving treatment options for patients with endometrial cancer. We look forward to working with sites and our partners to execute this trial. If data are positive, we will soon make this innovative therapy available to patients in China and around the world."

[1] Reference: Qingliang ZENG, China Maternal and Child Health,2021,36(08),1723-1725 DOI:10.19829/j.zgfybj.issn.1001-4411.2021.08.006

About Selinexor (XPOVIO)

Selinexor, a first-in-class and only-in-class oral selective inhibitor of nuclear export (SINE) compound discovered and developed by Karyopharm Therapeutics Inc. (NASDAQ: KPTI), is currently being developed by Antengene, which has the exclusive development and commercial rights in certain Asia-Pacific markets, including Greater China, South Korea, Australia, New Zealand and the ASEAN countries.

In July 2019, the US Food and Drug Administration (FDA) approved selinexor in combination with low-dose dexamethasone for the treatment of relapsed/refractory multiple myeloma (rrMM) and in June 2020 approved selinexor as a single-agent for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). In December 2020, selinexor also received FDA approval as a combination treatment for multiple myeloma after at least one prior therapy. In February 2021, selinexor was approved by the Israeli Ministry of Health for the treatment of patients with rrMM or rrDLBCL and in March 2021, the European Commission (EC) has granted conditional marketing authorization for selinexor (NEXPOVIO) for the treatment of adult patients with rrMM.

Selinexor is so far the first and only oral SINE compound approved by the FDA and is the first drug approved for the treatment of both MM and DLBCL. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene’s partner, Karyopharm, presented positive results from the Phase III randomized, double blind, placebo controlled, cross-over SEAL trial evaluating single agent, oral selinexor versus matching placebo in patients with liposarcoma. Karyopharm also announced that the ongoing Phase III SIENDO trial of selinexor in patients with endometrial cancer passed the planned interim futility analysis and the Data and Safety Monitoring Board (DSMB) recommended the trial should proceed as planned without any modifications. Top-line SIENDO trial results are expected in the second half of 2021.

Antengene is currently conducting five late-stage clinical trials of selinexor for the treatment of MM, DLBCL, non-small cell lung cancer, and peripheral T and NK/T-cell lymphoma. Furthermore, Antengene has submitted New Drug Applications (NDAs) for selinexor in multiple Asia Pacific markets including China, Australia, South Korea, and Singapore, and was granted the Priority Review status by China’s NMPA and an Orphan Drug Designation by the Ministry of Food and Drug Safety of South Korea (MFDS).

On May 12, 2021 Orion Biotech Opportunities Corp. (the "Company") reported the pricing of its initial public offering ("IPO") of 20,000,000 units at a price of $10.00 per unit (Press release, Orion Biotechnology, MAY 12, 2021, View Source [SID1234579827]). The units will be listed on The Nasdaq Capital Market LLC (the "Nasdaq") and trade under the symbol "ORIAU" beginning May 13, 2021.

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Each unit consists of one of the Company’s Class A ordinary shares and one-fifth of one redeemable warrant, with each whole warrant entitling the holder thereof to purchase one Class A ordinary share at a price of $11.50 per share. Once the securities comprising the units begin separate trading, the Class A ordinary shares and warrants are expected to be listed on the Nasdaq under the symbols "ORIA" and "ORIAW", respectively.

Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering. The Company has granted the underwriter a 45-day option to purchase up to 3,000,000 additional units to cover over-allotments, if any. The offering is expected to close on May 17, 2021, subject to customary closing conditions.

The offering is being made only by means of a prospectus. Copies of the prospectus may be obtained, when available, from Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 5th Floor New York, New York 10022; Email: [email protected].

A registration statement relating to these securities has been declared effective by the U.S. Securities and Exchange Commission (the "SEC") on May 12, 2021. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On May 12, 2021 NANOBIOTIX (Euronext : NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that Laurent Levy, chief executive officer, will present at the UBS Global Healthcare Virtual Conference on Monday, May 24, 2021 at 7:00 am Eastern Time (Press release, Nanobiotix, MAY 12, 2021, View Source [SID1234579826]).

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A live webcast of the presentation may be accessed by visiting the events section of the company’s website at www.nanobiotix.com. A replay of the webcast will be available shortly after the conclusion of the presentation and will be archived on the company’s website.

On May 12,, 2021 Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that new preclinical and clinical data will be presented at upcoming medical meetings in June (Press release, Epizyme, MAY 12, 2021, View Source [SID1234579825]).

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"We look forward to sharing our preclinical data at EHA (Free EHA Whitepaper) that provide the therapeutic rationale for targeting SETD2 in multiple myeloma and are so pleased that it has been chosen for an oral presentation. These data are the basis for moving our SETD2 inhibitor program forward and, as we have previously reported, we remain on track for our planned IND submission in mid-2021 and plan to initiate a first-in-human clinical trial by year end," said Dr. Jeffery Kutok, Epizyme’s Chief Scientific Officer. "As our SETD2 inhibitor program began to take shape, we were struck by the many parallels we saw with our EZH2 inhibitor, TAZVERIK (tazemetostat). SETD2 is a histone methyltransferase, like EHZ2, and plays multiple key roles in cellular processes and cancer. We’re excited about the potential of SETD2 inhibition in several settings, including high-risk t(4;14) myeloma, and more broadly in myeloma without the t(4;14) mutation, as well as other B-cell malignancies. We see potential as a monotherapy, as well as in combination with existing and emerging therapies in myeloma, with preclinical data also showing synergy with tazemetostat."

"We are excited to share safety and preliminary activity data related to the EZH-301 confirmatory study of tazemetostat in Epithelioid Sarcoma (ES) at ASCO (Free ASCO Whitepaper), a key milestone toward our goal of demonstrating the benefits of tazemetostat to patients in earlier lines of treatment for ES and Follicular Lymphoma by exploring combinations with standard of care therapies," said Dr. Shefali Agarwal, Executive Vice President and Chief Medical and Development Officer at Epizyme. "As we outlined during our recent Vision Call, we plan to further explore tazemetostat as both monotherapy and in combinations across multiple hematologic and solid tumor cancers in clinical studies, which are on track to initiate later this year."

Details of the presentations are listed below:

EHA Oral Presentation

Title: Discovery of a selective inhibitor of the SETD2 histone methyltransferase with potent in vitro and in vivo activity in preclinical models of multiple myeloma
Session: Basic and translational myeloma research
Presenter: Dr. Jennifer Totman
Abstract Code: S176
Live Q&A: Monday, June 14; 2021 8:45-9:30 p.m. CEST/2:45-3:30 p.m. EDT.

The EHA (Free EHA Whitepaper) abstracts are available at View Source All oral and poster presentations will be available on the EHA (Free EHA Whitepaper) website on Friday, June 11, 2021 at 9:00 a.m. CEST/3:00 a.m. EDT.

ASCO Poster Presentation

Title: Results of the phase 1b soft-tissue sarcoma (STS) portion of the global randomized, double-blind, placebo-controlled study of tazemetostat (TAZ) plus doxorubicin (DOX) as frontline therapy for advanced epithelioid sarcoma (ES)
Session: Sarcoma
Presenter: Sant P. Chawla, M.D.
Abstract No.: 11563

The ASCO (Free ASCO Whitepaper) abstracts are available at View Source All oral and poster presentations will be available on the ASCO (Free ASCO Whitepaper) website on Friday, June 4, 2021 at 9:00 a.m. EDT.

About TAZVERIK (tazemetostat)
TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

On May 12, 2021 Bluestar Genomics, an innovative company leading the development of next-generation epigenomic approaches to early cancer detection, reported the company had raised $70 million in new equity funding (Press release, Bluestar Genomics, MAY 12, 2021, View Source [SID1234579824]). Led with the increased funding by the current investor, Mattias Westman, founding partner of Prosperity Capital Management, the oversubscribed Series C round includes several existing investors and multiple new investors: Pathology Asia Holdings Pte Ltd (Pathology Asia), the largest independent medical diagnostics group in Southeast Asia, as well as a venture fund based in San Francisco, CA, and a large, diversified asset manager on the west coast, among others. VAHOCA Pte Ltd acted as a financial advisor to Bluestar Genomics.

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Separately, the company announces the expansion of its Scientific Advisory Board, with the appointment of Drs. Felix Feng, professor of radiation oncology, urology, and medicine, University of California San Francisco, and Craig Venter, Ph.D., chairman and CEO of the J. Craig Venter Institute. With the new appointment, Feng and Venter are joining Alan Ashworth, Ph.D., FRS, president, Helen Diller Comprehensive Cancer Center, University of California, San Francisco.

"As we continue to champion the development of next-generation non-invasive cancer detection, we welcome Drs. Feng and Venter to our team. Their leading scientific and clinical expertise will help accelerate our development and commercialization efforts," said Samuel Levy, Ph.D., chief executive, and chief scientific officer at Bluestar Genomics. "Collectively, these milestones will extend our ability to deliver on our promise to improve on existing cancer screening and provide a new solution where none exists."

Series C investments and scientific advisory board membership expansion are largely inspired by Bluestar Genomics’ groundbreaking technology platform that employs state-of-the-art machine learning coupled with the 5-hydroxymethylcytosine (5hmC) as a screening method to detect cancer in multiple organs in men and women. The company’s novel approach has recently demonstrated positive results in two studies published in Nature Communications and earned the FDA’s breakthrough device designation for the company’s proprietary non-invasive pancreatic cancer detection test.

"The convergence of innovative technologies has pushed the cost of multi-cancer screening down by 20-fold, allowing for continued optimization of cancer detection via routine blood draw to improve patient early treatment options," said Venter. "With the multi-cancer screening market projected to scale to more than $100 billion in the U.S. alone, Bluestar Genomics’ technology is uniquely positioned to address the needs of over 60 million patients. I am excited to become part of such a pivotal contribution to improving patient lives through completely unlocking the full potential of genomics."