On August 18, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that Swissmedic has accepted the marketing authorization application (MAA) for BRUKINSA, a treatment option for adult patients with Waldenström’s macroglobulinaemia (WM) (Press release, BeiGene, AUG 18, 2021, View Source [SID1234586728]). Swissmedic has started the formal review of the MAA. BRUKINSA has already been granted orphan drug status by Swissmedic.

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"The acceptance of the marketing authorization application of BRUKINSA by Swissmedic is a crucial step in the development of BRUKINSA for Swiss patients with WM. We are looking forward to continuing our work with the health authorities to bring BRUKINSA to patients living with this rare, incurable blood cancer."

Swissmedic, the Swiss Agency for Therapeutic Products, reviews new products for market authorization. Within this process, Swissmedic evaluates a product’s quality, safety, and effectiveness through clinical trial data.

Gerwin Winter, Senior Vice President, Head of Commercial, Europe, at BeiGene said: "The acceptance of the marketing authorization application of BRUKINSA by Swissmedic is a crucial step in the development of BRUKINSA for Swiss patients with WM. We are looking forward to continuing our work with the health authorities to bring BRUKINSA to patients living with this rare, incurable blood cancer."

The MAA is supported by data from the randomized Phase 3 ASPEN clinical trial (NCT03734016), evaluating zanubrutinib compared to ibrutinib in adult patients with WM.1

The approval by Swissmedic would grant marketing authorization for BRUKINSA in WM within Switzerland.

About Waldenström’s Macroglobulinemia

WM is a rare lymphoma representing approximately 1% of all non-Hodgkin lymphomas and typically progresses slowly after diagnosis.2 The disease usually affects older adults and is primarily found in the bone marrow, although lymph nodes and the spleen may be involved.3 Throughout Europe, the estimated incidence rate of WM is approximately 7 for every 1 million men and 4 for every 1 million women.4

About BRUKINSA (zanubrutinib)

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is currently approved in several regions for various indications.1 To date, more than 30 marketing authorization applications in multiple indications have been submitted covering the United States, the European Union, and more than 20 other countries or regions.

On August 18, 2021 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that it will announce its 2021 first half results on Wednesday, August 25, 2021 (Press release, Bavarian Nordic, AUG 18, 2021, View Source [SID1234586727]).

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The management of Bavarian Nordic will host a conference call at 2:00 pm CEST (8:00 am EDT) on the same day to present the interim results followed by a Q&A session. A live and replay version of the call and relevant slides will be available at https://bit.ly/3xzOiQo.

To join the Q&A session dial one of the following numbers and state the participant code 8569159: Denmark: +45 32 72 80 42, UK: +44 (0) 844 571 8892, USA: +1 631-510-7495.

On August 18, 2021 The National Cancer Institute reported that it has awarded Van Andel Institute a five-year, $1.7 million grant to establish a cutting-edge training program for postdoctoral fellows in cancer epigenetics, a growing field with untold potential to impact human health (Press release, Van Andel Institute, AUG 18, 2021, View Source;utm_medium=rss&utm_campaign=t32-award-cancer-epigenetics-training-program [SID1234586725]).

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The new Cancer Epigenetics Training Program combines extensive professional development with comprehensive, interdisciplinary research training by VAI’s internationally recognized cadre of experts. Postdoctoral trainees also will have access to the Institute’s state-of-the-art shared scientific resources and technologies as well as opportunities to participate in established translational research programs and partnerships led by VAI investigators.

Epigenetic abnormalities are universally found across cancers and serve as major drivers for malignancy, making them promising new targets for the development of novel cancer therapies. As such, the field — and its capacity for producing breakthroughs — is rapidly expanding.

"In the past few years, VAI has become a global destination for groundbreaking, collaborative cancer epigenetics research," said VAI Chief Scientific Officer Peter A. Jones, Ph.D., D.Sc. (hon). "Postdoctoral trainees will emerge from our Cancer Epigenetics Training Program with extensive, rigorous training and a solid foundation from which to launch their independent research careers."

Jones and VAI Associate Professor Scott Rothbart, Ph.D., will lead the program in collaboration with Erica Gobrogge, Ph.D., program director of VAI’s Office of Postdoctoral Affairs. The program also benefits from the guidance of its advisory committee, which includes renowned scientists from across the U.S.

VAI’s Cancer Epigenetics Training Program is now accepting applications from candidates who are near completion of a Ph.D., M.D. or other appropriate terminal degree. For a full list of eligibility criteria, please visit vari.vai.org/cancer-epigenetics-training-program.

The Cancer Epigenetics Training program is supported by a National Cancer Institute T32 training grant (no. T32CA251066). The content is solely the responsibility of VAI and does not necessarily represent the official views of the National Institutes of Health.

On August 18, 2021 ProMIS Neurosciences Inc. ("ProMIS" or the "Company") (TSX: PMN), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported it has upsized its public offering (the "Offering") of units ("Units") to US$17.5M from US$15M at a price of US$0.16 per Unit. If the Agent’s Option (as defined below) is exercised in full, the aggregate gross proceeds of the Offering will be approximately US$20.1M (Press release, ProMIS Neurosciences, AUG 18, 2021, View Source [SID1234586724]).

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Each Unit consists of one common share of the Company (a "Common Share") and one quarter of one Common Share purchase warrant (each whole purchase warrant, a "Warrant"). Each Warrant will entitle the holder thereof to purchase one Common Share (each, a "Warrant Share") at a price of US$0.21 per Warrant Share at any time up to 60 months following the issuance date thereof, subject to acceleration.

The Offering will be conducted on a commercially reasonable efforts basis pursuant to the terms and conditions of an agency agreement to be entered into between the Company and Leede Jones Gable Inc. (the "Agent"). The Company will also grant the Agent an option (the "Agent’s Option"), exercisable, in whole or in part, at the sole discretion of the Agent, to increase the size of the Offering by up to 15%. The Agent’s Option is exercisable, in whole or in part, at any time until the date that is two business days prior to the Closing Date (as defined herein).

The Offering is expected to close on or about August 24, 2021, or such other date as may be mutually agreed to by the Company and the Agent (the "Closing Date"), subject to satisfaction of customary closing conditions, including the approval of the Toronto Stock Exchange (the "TSX").

The Offering is being made pursuant to a prospectus supplement to the Company’s short form base shelf prospectus dated June 30, 2021 (the "Base Prospectus"), which the Company will file with the securities commissions or other security regulatory authorities in each of the provinces and territories of Canada (other than Québec). Additionally, the Offering is expected to be conducted by way of private placement in other jurisdictions where the Offering can lawfully be made.

The Company intends to use the net proceeds from the Offering (including additional proceeds from the possible exercise of the Agent’s Option) to advance its lead Alzheimer’s therapy PMN310 to the filing of an Investigational New Drug application to enable a first clinical trial, expanding the ProMIS portfolio of antibodies and patents, and general corporate purposes, as more fully described in the preliminary prospectus supplement of the Company dated August 17, 2021 (the "Preliminary Prospectus Supplement").

The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or applicable state securities laws, and such securities may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as such terms are defined in Regulation S under the U.S. Securities Act) absent registration or an applicable exemption from such registration requirements. This news release does not constitute an offer for sale of securities nor a solicitation for offers to buy any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

On August 18, 2021 Prescient Therapeutics and University of Pennsylvania (Penn) reported that thay are developing a new way for cancer-fighting CAR-T cells to overcome the resistance present in some types of B-cell driven cancers (Press release, Prescient Therapeutics, AUG 18, 2021, View Source;utm_medium=rss&utm_campaign=university-of-pennsylvania-finds-solution-for-war-weary-car-t-cells [SID1234586723]).

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Although CAR-T treatments have proven effective against numerous cancer types, chronic lymphocytic leukemia (CLL) has so far proven difficult to treat.

But new research from researchers at Penn – who pioneered CAR-T technology – could provide a solution.

Penn researchers found that by inhibiting ‘bromodomain and extra terminal’ (BET) proteins, they could improve CAR-T cell function by fighting ‘T-cell exhaustion’ – a phenomenon that hinders genetically-engineered T-cells from fully fighting certain cancers.

It’s a significant finding, as many CLL patients undergo aggressive chemotherapy before receiving CAR-T treatments, and this chemotherapy process can leave many T cells exhausted.

Using a small-molecule drug called JQ1 to inhibit BET proteins during the cell engineering process, Penn researchers were able to lessen T-cell exhaustion and increase the production of CAR-T cells.

"Treating these ‘war weary’ T cells during the CAR T cell engineering process has the potential to boost responses, we’ve shown here," senior author and assistant professor of microbiology at Penn Joseph A. Fraietta said.

"It’s setting the stage for a very promising set of next steps that rationalize further studies, including clinical trials, to prove this approach is safe and feasible."

Prescient Therapeutics advances separate Penn technology
While the Penn research team have been fighting T-cell exhaustion, ASX-listed biotechnology company Prescient Therapeutics has partnered with the Peter MacCallum Cancer Centre to advance OmniCAR – a next generation CAR-T platform built using technology licensed from Penn.

OmniCAR is designed to give medical practitioners greater control over traditional CAR-T treatments – which genetically re-engineer a patients’ own immune system to identify and attack cancerous cells.

The platform is also designed to make treatment safer for patients and to be able to direct the CAR-T cells against a variety of cancer targets.

In July, immunogenicity testing on OmniCAR provided positive safety results. The in-silico tests (meaning they were conducted by complex computer algorithms) found two binding components used in OmniCAR treatments, SpyTag and SpyCatcher, are unlikely to trigger adverse immune responses in patients.

Join Prescient Therapeutics CEO Steven Yatomi-Clarke for a special investor briefing next Wednesday, 25th August at 11am (AEST), where he will discuss the encouraging progress through clinical trials of Prescient’s foundational assets PTX-100 and PTX-200, provide an introduction into the amazing field of CAR-T, and how Prescient’s next gen CAR-T platform, OmniCAR, is seeking to take this burgeoning cancer field to the next level. Click here to book in.

Reach Markets have been engaged by PTX to help manage their investor communications

Sources:

Fierce Biotech: Novartis-backed Penn study proposes boosting CAR-T responses in CLL by waking up ‘war weary’ T cells
Penn Medicine: Existing Drug May Help Improve Responses to Cellular Therapies in Advanced Leukemias
ASX: PTX announcement 5 July 2021
PTX: Technology