On April 11, 2023 Independent biopharmaceutical company Specialised Therapeutics Asia Pte Ltd (ST) reported that it will partner with CTTQ-Akeso (Shanghai) Biomed. Tech. Co., Ltd. (CTTQ-Akeso)（jointly established by Akeso, Inc. (9926.HK, Akeso) and Chia Tai Tianqing Pharmaceutical Group Co., Ltd. to commercialise a new immuno-oncology therapy in Australia, Singapore and across Southeast Asia (Press release, Specialised Therapeutics Asia, APR 11, 2023, View Source [SID1234629963]).

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The therapy ANNIKO (penpulimab) is an anti-PD1 monoclonal antibody currently under regulatory review by the US FDA for nasopharyngeal carcinoma – a difficult to treat form of head and neck cancer.

This follows the FDA granting ANNIKO orphan drug and fast track designations in 2020, as well as a further "breakthrough therapy" designation in March 2021. In addition, ANNIKO was granted a FDA Real-Time Oncology Review (RTOR) in 2021, to accelerate the drug approval process.[1,2]

ANNIKO has been approved in China for the treatment of adult patients with relapsed or refractory classical Hodgkin’s lymphoma (advanced r/r cHL) who have undergone at least second-line chemotherapy, as well as first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC) in combination with chemotherapy.[3]

Under the terms of the arrangement, ST will be responsible for all marketing, regulatory and distribution activities in its key regions of Australia, Singapore and across Southeast Asia.

CTTQ-Akeso retains the rights of conducting any development work in relation to ANNIKO and Akeso retains all rights to product manufacture and supply.

Announcing the partnership, ST Chief Executive Officer Carlo Montagner said ANNIKO was the first immuno-oncology drug to be included in the company’s therapeutic portfolio and the arrangement was further endorsement of ST’s regional capabilities.

"ANNIKO will provide a new opportunity for patients in our regions with nasopharyngeal carcinoma – a very difficult to treat cancer – to be treated with an immune-based therapy," he said.

"Nasopharyngeal carcinoma is native to Southeast Asia, affecting between 15 and 50 people in every 100,000[4] and with almost 37,000 new cases diagnosed annually in this region.[5] Making ANNIKO available for this disease is a high priority."

Akeso CEO Michelle Xia said the company looked forward to collaborating with ST and providing eligible cancer patients with world-class therapy.

"We trust that ST’s expertise in these regions, navigating complex regulatory channels will ensure our therapy reaches as many eligible patients as possible," she said.

"We look forward to a successful and mutually beneficial partnership, working together with a shared goal of improving patient outcomes."

Regulatory activities are currently in progress.

On April 11, 2023 GC Genome Corporation, a leading genomic diagnostics company, reported the publication of a new study in Nature Communications, showcasing the company’s novel AI-based liquid biopsy technology (Press release, Korea Institute of Science and Technology Information, APR 11, 2023, View Source [SID1234629962]). The study highlights the unprecedented accuracy of the technology for cancer early detection and tissue-of-origin localization utilizing advanced AI algorithms to analyze mutation density and patterns of cell-free DNA (cfDNA) and epigenomes in collaboration with the Korea Advanced Institute of Science and Technology (KAIST).

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Noninvasive screening by cfDNA holds great promise for multi-cancer early detection. The cancer early detection of various types is an important part of cancer treatment since cancer has a better prognosis and survival rate when diagnosed and treated earlier[1].[2]. However, de novo detection of cancer, especially at early stages, remains challenging and the solution for this urgent need is being actively pursued by using cfDNA-based noninvasive cancer screening for Multi-Cancer Early Detection (MCED) and localization of cancer[3].

"Since cancer screening technologies are limited or premature, diagnostic tests are usually performed after symptoms arise, and early intervention opportunities are often missed, leaving few treatment options," said Dr. Jung Kyoon Choi, Department of Bio and Brain Engineering, KAIST. "We hope that our methods leveraging large-scale tumor genomes and epigenomes as reference data lay the groundwork for accurate cfDNA-based cancer diagnosis at early stages."

The Nature Communication study includes a total of 2,543 cancer patient samples and 1,241 normal control samples and describes an ensemble algorithm that incorporates genomic and epigenomic profiles of tumor tissues into a deep learning model. This model analyzes mutation distribution and chromatin organization in reference tumor tissues and uses them as model features to detect the existence of cancer and determine the type of cancer in cfDNA samples.

The technology has demonstrated promising results in detecting multiple types of cancer at an early stage. The technology has shown exceptional sensitivity, achieving a 91.1% performance rate based on a 95% specificity and a high level of accuracy, with an 81.7% success rate in predicting both the presence and type of cancer.

"These results suggest that the GC Genome AI-based cancer early detection technology could help reduce cancer deaths by offering a convenient, high-performing test to people," said Dr. Eun-Hae Cho, MD, Chief Technical Officer at GC Genome. "We will continue our research to improve accuracy and sensitivity and look forward to making our technology accessible to all cancer patients worldwide."

On April 11, 2023 Pharmaxis Ltd (ASX: PXS) reported it will add a combination treatment arm to the current Phase 2 clinical trial of PXS‐5505 in myelofibrosis (MF). Following helpful feedback from the U.S. Food and Drug Administration (FDA), the trial will be widened to include myelofibrosis patients already receiving a JAK inhibitor as standard of care in combination with PXS‐5505 (Press release, Pharmaxis, APR 11, 2023, View Source;utm_campaign=Following%20FDA%20Review%20Pharmaxis%20to%20Accelerate%20Plans%20for%20PXS-5505%20Combination%20Study&utm_content=Following%20FDA%20Review%20Pharmaxis%20to%20Accelerate%20Plans%20for%20PXS-5505%20Combination%20Study+CID_03240385beb62faf2fb8d4378d022ac5&utm_source=Campaign%20Monitor&utm_term=View%20Full%20Media%20Release [SID1234629961]).

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Pharmaxis has previously reported interim data from MF‐101 in a monotherapy setting demonstrating a well‐tolerated drug that leads to stable or improved symptoms, haematological cell counts and fibrosis grades. In a Type C Meeting review, the FDA examined a package of safety and efficacy information from the monotherapy trial and provided guidance on the number of patients, treatment dosage, study duration and endpoints for a study in combination with a JAK inhibitor.

Recruitment for the current study has reached 21 out of a targeted 24 patients on monotherapy with 20 sites active worldwide. Pharmaxis now plans to submit a protocol amendment to global regulators, including the FDA, that will add an arm to the existing MF study MF‐101 and utilise its existing trial sites. Based on the FDA feedback, it is anticipated that the trial design can be streamlined to initiate the combination arm at the same dose currently used in the monotherapy arm and commence later this year.

Pharmaxis CEO, Gary Phillips said, "The agreement with the FDA to expand the patient population in the ongoing phase 2 study to include those patients currently on a JAK inhibitor is an important step forward in realising the benefits of lysyl oxidase inhibition for all myelofibrosis patients and in maximising the commercial opportunity for PXS‐5505. We are already in discussion with the existing trial site investigators who have welcomed the opportunity to extend the patient population for the study and anticipate significantly accelerated recruitment."

In recent months Pharmaxis has reported interim data from MF‐101, two poster presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) and the publication of ground breaking pre‐clinical data in myelodysplastic syndrome (MDS) in Nature Communications for the Company’s lead asset, PXS‐5505. Following a review of its development strategy Pharmaxis has decided to focus its resources on these haematological malignancies and will not at this point be progressing the previously planned study in hepatocellular carcinoma (HCC) patients in an investigator initiated clinical trial by the University of Rochester.

Pharmaxis CEO Gary Phillips said, "Our collaboration with the research team at University of Rochester remains highly valued and their work is continuing with further pre‐clinical evaluation of our pipeline assets but for now we have decided not to pursue HCC given the timelines for recruitment and the need to focus our resources."

Pharmaxis will provide further details of study design, timelines and costs for the PXS‐5505 / JAK Inhibitor combination arm of the MF‐101 study after it receives feedback from regulators on the amended protocol, expected in Q2 2023.

On April 11, 2023 Biogen Inc. (Nasdaq:BIIB) reported it will announce first quarter 2023 financial results Tuesday, April 25, 2023, before the financial markets open (Press release, Biogen, APR 11, 2023, View Source [SID1234629960]).

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Following the release of the financials, the Company will host a live webcast with Biogen management at 8:00 a.m. ET. To access the live webcast, please go to the investors section of Biogen’s website at investors.biogen.com. An archived version of the webcast will be available for at least 90 days following the presentation.

On April 11, 2023 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec"), a clinical-stage biotechnology company developing intratumoral immunotherapies to stimulate the patient’s immune system to target cancer cells and eradicate disease, reported the closing of its previously announced registered direct offering of 1,582,932 shares of its common stock, at a purchase price of $1.25 per share, priced at-the-market under Nasdaq rules (Press release, OncoSec Medical, APR 11, 2023, View Source [SID1234629959]). The Company also issued in a concurrent private placement unregistered warrants to purchase up to an aggregate of 1,582,932 shares of common stock. The warrants have an exercise price of $1.12 per share, are immediately exercisable upon issuance, and will expire five and one-half years from the date of issuance.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering were approximately $2 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering as working capital for general corporate purposes.

The securities described above (excluding the warrants and the shares of common stock underlying the warrants) were offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333-260850) that was originally filed with the Securities and Exchange Commission (the "SEC") on November 8, 2021, and declared effective on November 15, 2021. The offering of such securities in the registered direct offering was made only by means of a prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying such warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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