On February 28, 2023 2seventy bio, Inc. ("2seventy bio") (Nasdaq: TSVT), a cell and gene therapy company focused on the research, development, and commercialization of transformative treatments for cancer, reported that it has commenced an underwritten public offering of $100 million of shares of its common stock (Press release, 2seventy bio, FEB 28, 2023, View Source [SID1234627797]). All of the shares in the proposed offering are being offered by 2seventy bio. In addition, 2seventy bio intends to grant the underwriters a 30-day option to purchase up to an additional $15 million of shares of its common stock at the public offering price, less underwriting discounts and commissions. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Goldman Sachs & Co. LLC, Cowen and Company, LLC and SVB Securities LLC are acting as joint book-running managers for the offering.

The securities are being offered by 2seventy bio pursuant to 2seventy bio’s registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission (SEC) on November 7, 2022 and became effective on November 18, 2022. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the proposed offering will be filed with the SEC and may be obtained, when available, from: Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, NY 10282, telephone: (866) 471-2526, facsimile: (212) 902-9316, email: [email protected]; Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by email at [email protected] or by telephone at (833) 297-2926; or SVB Securities LLC, Attn: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at 1-800-808-7525, ext. 6105, or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 28, 2023 Clinical-stage oncology entity Prescient Therapeutics (ASX: PTX) focused on the development of novel and personalised cancer-related therapies reported its half-year report for the period ended 31 December 2022 (Press release, Prescient Therapeutics, FEB 28, 2023, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-asxptx-reports-progress-in-cancer-studies-during-h1-fy23-kalkine-media [SID1234627785]).

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The company has highlighted an increase in net assets for the period, besides the "strong financial position" of PTX following a capital raise of AU$11.3 million through a Share Purchase Plan (SPP) and a top-up placement. In November last year, the company also received a tax refund of AU$1.6 million by the Australian government for its research & development activities.

Below are the other major operational highlights of Prescient Therapeutics during the reported report.

Targeted Therapies
PTX-100

Prescient reports that its PTX-100 received the Orphan Drug Designation from the US Food and Drug Administration (FDA) during the half year ended December 2022. This pertained to PTX-100’s use in treatment for peripheral T cell lymphomas (PTCL). The FDA designation is a special status for drugs that are designed to treat rare diseases, Prescient says.

PTX-100 also continued to demonstrate encouraging efficacy and safety profile during the half year with respect to patients with relapsed and refractory TCL. The drug trial has advanced to an expansion cohort of 12 patients, with Professor H. Miles Prince, AM leading this endeavour.

PTX-200

PTX 200 — Prescient’s novel PH domain inhibitor — is undergoing trial at the Moffitt Cancer Centre. PTX says that the study so far on four patients exhibited complete responses and on one patient reflected a partial response. The drug is being studied to treat relapse and refractory acute leukaemia.

Cell Therapies
OmniCAR

A major development was Prescient’s collaboration during the reported period with the US-based The University Texas MD Anderson Cancer Centre. This effort is targeted to provide adaptable CAR-T cell therapies for the treatment of haematological malignancies.

PTX also entered into a manufacturing services agreement for OmniCAR with Q-Gen Cell

Therapeutics. The latter is a specialised cell therapy manufacturer. Q-Gen is related to the QIMR

Berghofer Medical Research Institute, which is one of Australia’s biggest manufacturers of cell-based drugs. It is stated by PTX that Q-Gen would incorporate the former’s CellPryme-M enhancement in the production process of OmniCAR T cells.

A material transfer agreement was also signed with a large international entity, targeted at manufacturing of OmniCAR T cells using non-viral methods..

CellPryme

Unveiled at the annual CAR-TCR Summit, Boston, the CellPryme-A cell therapy enhancement platform is administered in combination with cellular immunotherapy, PTX says. CellPryme-A has the capability to enhance CAR-T therapies’ tumor killing ability. PTX further says that the benefits of CellPryme-A increase when combined with CAR-T cells that used CellPryme-M in the production process.

PTX has said that its CellPryme technologies, cited above, are all set for clinical trials.

The half-year report for period ended 31 December 2022 also includes a mention of business outlook, with PTX seeking to "maintain the positive momentum" and build further on previous achievements.

PTX shares were trading at AU$0.089 in the early hours of 28 February 2023.

BeiGene has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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On February 27, 2023 The National Comprehensive Cancer Network (NCCN)—a not-for-profit alliance of leading United States cancer centers—reported a new collaboration with the Institute of Hematology and Transfusion Medicine in Poland (IHIT), and the Alliance For Innovation—Polish-American Foundation (AFI) (Press release, NCCN, FEB 27, 2023, View Source [SID1234627788]). The three organizations have signed an agreement enabling clinicians to share their established expertise and international experience in order to improve quality of care and outcomes for patients with hematologic malignancies in Poland and around the world.

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"This new agreement highlights our commitment to continue advancing our ongoing collaboration with Polish colleagues to standardize and improve how cancers are managed," said Robert W. Carlson, MD, Chief Executive Officer, NCCN. "The Institute of Hematology and Transfusion Medicine in Poland is the leading medical and research hospital in Poland for hematology; it serves as a national clinical and diagnostic reference center. Together, we can make sure more people with blood cancers receive region-appropriate treatment based on the latest evidence and expert consensus."

This new agreement builds on a multi-year collaboration between NCCN, the Marie Curie-Sklodowska National Research Institute of Oncology, Republic of Poland Ministry of Health, and AFI to improve country-specific guidelines for solid tumor diagnostic and therapeutic procedures in Poland, based on the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) —as called for in Poland’s National Cancer Strategy. NCCN Guidelines are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently-updated clinical practice guidelines available in any area of medicine. They have been translated, adapted, and harmonized in collaboration with local and regional experts, advocates, and policymakers across Sub-Saharan Africa, the Middle East and North Africa (MENA), the Caribbean, Asia, South America, and Europe, in order to make them more relevant and accessible to patients and care providers worldwide. The initial work with Poland launched in 2021; to date, the groups have co-developed Polish NCCN Guidelines Adaptations for:

Central Nervous System Cancers,
Cervical Cancer,
Colon Cancer,
Head and Neck Cancers, and
Ovarian Cancer
"Our main goal is to improve the quality of care and outcomes for hematologic patients in Poland," said Prof. Ewa Lech-Marańda, Director of the IHIT. "The cooperation between our institutions will include the development of adapted clinical guidelines based on NCCN’s knowledge, experience, and expertise, as well as longstanding procedures for continuous updates."

"The signing of an agreement between such important cancer control institutions is of great importance for patients and the oncological community, as well as for the further development of Polish-American cooperation," said Marcin Hańczaruk, Co-Chairman of AFI.

NCCN’s resources for cancer patients and providers are widely accessed and utilized free-of-charge around the world. Nearly half of the 1.7 million registered users who view NCCN Guidelines at NCCN.org or via the Virtual Library of NCCN Guidelines app are located outside of the U.S. Learn more about NCCN’s collaborative work to define and advance high-quality, high-value, patient-centered cancer care globally at NCCN.org/global.

On February 27, 2023 Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound mocravimod, reported that it has received clearance from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan for the pivotal global MO-TRANS Phase 3 study evaluating mocravimod in Acute Myeloid Leukemia (AML) patients undergoing allogeneic hematopoietic cell transplant (HCT) (Press release, Priothera, FEB 27, 2023, View Source [SID1234627787]).

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Elisabeth Kueenburg, M.D., Chief Medical Officer at Priothera, said: "We are grateful for the clearance from the PMDA to start our MO-TRANS Phase 3 study in Japan as we believe mocravimod has the potential to address a significant unmet need for Japanese patients with AML undergoing allogeneic HCT. We look forward to enrolling the first patients in several sites across Japan in the coming months."

Priothera is conducting the pivotal MO-TRANS study – now classified as a global Phase 3 trial following acceptance by regulatory authorities – in 15 countries, including the US, Japan, Israel, France, and in additional European, Asian and Latin American countries, to assess the efficacy and safety of mocravimod as an adjunctive and maintenance therapy in AML patients undergoing allogeneic HCT. The double-blind, placebo-controlled study assesses relapse-free and overall survival of two dose levels of mocravimod in comparison to placebo. Topline data from this study are expected in 2025.

Dr. Takanori Teshima, M.D., is the Principal Investigator in Japan for the MO-TRANS global Phase 3 trial. Dr. Teshima is Professor of Medicine in the Division of Hematology and Deputy-director of Hokkaido University Hospital. He serves as a president of the Japanese Society of Hematopoietic Cell Transplantation (JSHCT), an executive director of Japanese Society of Hematology (JSH) and Japan Society of Transfusion Medicine and Cell Therapy (JSTMCT).

Dr. Teshima, M.D., commented: "AML is the most common acute leukemia in Japan accounting for approximately 70% of all myeloid leukemias. Despite advances in the use of HCT in Japan, patients are still at risk of relapse with resulting poor prognosis. Any new treatment that can enhance the curative potential of this approach would offer a significant benefit to patients. I am therefore delighted that Japan will be part of the MO-TRANS global Phase 3 study investigating mocravimod as an innovative potential new adjunctive and maintenance therapy for patients with AML undergoing allogeneic Hematopoietic Cell Transplant."

Mocravimod, a sphingosine 1 phosphate (S1P) receptor modulator which has been previously tested in multiple autoimmune indications, is being developed to enhance the curative potential of allogeneic HCT. Mocravimod has shown a clinically relevant benefit in an early clinical study in patients with hematologic malignancies undergoing allogeneic HCT.

Florent Gros, Co-Founder and CEO of Priothera, added: "Japan represents an important potential market for us and one we see as a priority as we advance the development of mocravimod in AML patients undergoing allogeneic HCT globally. With this clearance we anticipate a further uptake in patient enrollment in our MO-TRANS trial. We look forward to seeing topline results from MO-TRANS in 2025."