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BiVictriX Therapeutics Pipeline update 2022

On 11 July 2022 BiVictriX Therapeutics plc (AIM: BVX), an emerging biotechnology company applying a novel approach to develop next generation cancer therapies using insights derived from frontline clinical experience, reported an update on the Company’s recent activities (Press release, BiVictriX Therapeutics, JUL 11, 2022, View Source [SID1234626591]). The Company has made significant progress with its lead candidate, BVX001; expanded its pipeline protection with further patent applications; and broadened its profile with attendance at international conferences and awards.

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BVX001 – LEAD CANDIDATE NOMINATION IN Q4 2022

BiVictriX has made significant progress in the creation and execution of the development plan for its lead product, BVX001, since the company’s Initial Public Offering (IPO) in August 2021. By investing additional time and resources, working closely with regulatory advisors, the Company is actively creating a clear path to Investigational New Drug (IND) status, minimising development risks. Notably, the work performed to date has enabled the Company to better understand the optimum range of target binding affinities for lead declaration – a milestone eagerly anticipated later this year.

BROADENING AND FURTHER PROTECTING THE PIPELINE

BiVictriX continues to expand and strengthen its strategic industrial and academic collaborations, acquiring access to state-of-the-art technical and disease area expertise for new target discovery and product development. This has allowed for the initiation of the Company’s antibody selections and proof-of-concept studies for its two additional therapeutic programmes, BVX002 and BVX003. In addition, BiVictriX is able to progress as planned with the identification of further cancer-specific antigen fingerprints across a wide range of solid and haematological tumour indications.

The Company continues to optimise and invest in BVX001 and, on 29 June 2022, filed a further UK patent application for BVX001, further reinforcing its already robust IP position.

STRENGTHENED TEAM

In line with its planned hiring strategy, BiVictriX has completed the recruitment of a highly talented scientific team establishing a fully functional technical capability within the Company’s labs at Alderley Park to further progress the development of BVX001 and the wider pipeline.

ROBUST CASH POSITION AND PRUDENT COST CONTROL

BiVictriX has a strong cash position and sufficient cash to execute its current strategy. In addition, the Company continues to assess suitable non-dilutive funding opportunities and applies prudent cash control to its operations.

BROADENED NETWORK

BiVictriX is attending major international conferences in order to broaden its network. The Company will present at the 14th Annual PEGS Europe event in November 2022, a prestigious scientific congress well-attended by the life sciences industry and investment spectrum.

The Company has also won and been nominated for a variety of industry awards during the recent quarter including winning ‘Investment Deal of the Year Award’ at BioNow’s 20th Annual Awards. In addition, CEO Tiffany Thorn has been named regional finalist for EY’s 2022 UK ‘Entrepreneur of the Year’.

Tiffany Thorn, Chief Executive Officer of BiVictriX, commented: "We remain focused on developing our lead asset, BVX001, and are making great progress. At the same time, we are exploring the breadth of our Bi-Cygni approach across a wide array of different cancer types through our broad pipeline of anti-cancer therapeutic assets, which includes BVX002 and BVX003, and are applying our learnings to each of our programmes. I am proud of the progress we are making as a rapidly emerging biotech company and the rigour we are applying to our business. I am of course also thrilled that we are being recognised by the industry as such."

Halo Labs Completes $6M Series C Growth Financing

On July 11, 2022 Halo Labs , a leading life science instrumentation company reported it has raised $6M in series C financing (Press release, Research Corporation Tech, JUL 11, 2022, View Source [SID1234616611]). The round was led by Agilent Technologies Inc. and includes participation from existing investors Research Corporation Technologies, Broad Oak Capital Partners, BioAdvance, and members of the Board of Directors and senior management.

"We are excited to have Agilent as a partner in this journey as we scale our business in some exciting new directions."

This new funding will be used for continued commercialization of Halo Labs’ Aura platform , increasing manufacturing capacity and developing innovative new products to meet the current and new needs of pharmaceutical researchers.

"For the past two years, Halo Labs has deployed an aggressive growth strategy and has raised the bar for innovation in our market," said Rick Gordon , CEO of Halo Labs. "The fact that we were able to close on a funding round in the current economic environment demonstrates the success of that strategy. Our instruments have been adopted by virtually every major biopharmaceutical company and are now one of the leading tools in cell and gene therapy. With this capital, we will continue our current trajectory and scale our business in some exciting new directions. We are excited to have Agilent as a partner in that journey."

First launched in 2017, Aura from Halo Labs has disrupted pharmaceutical product development by combining multiple stability, quality, and safety assays into one instrument. Now available in six different models, representing tools specific for different therapeutic modalities and development stages, Aura instruments give pharmaceutical scientists access to an unprecedented amount of data in a matter of minutes, allowing for new therapies to move from the lab to the clinic faster and more safely.

Sinopharm May Bid $1 Billion for Shanghai’s BBI, a Research Products Company

On July 11, 2022 Sinopharm, China’s large state-owned biopharmaceutical company, reported that make a $1 billion bid to acquire BBI Life Sciences, a Shanghai company that offers products for research science (Press release, SINOPHARM, JUL 11, 2022, View Source [SID1234616598]). The acquisition process is in an early stage and includes several other interested bidders. BBI offers raw materials and consumables for life science research, as well as for the food and agriculture industries. BBI IPO’d in 2014 on the Hong Kong Exchange, but in 2020, its major owners, the Wang family, took the company private again. Sinopharm uses M&A and venture investments to expand its portfolio.

Ionis partner licenses rare kidney disease treatment and will advance into Phase 3 clinical study

On July 11, 2022 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS), reported that its long-standing partner, Roche, will license and advance IONIS-FB-LRx, an investigational antisense medicine, into a Phase 3 clinical study in patients with immunoglobulin A nephropathy (IgAN) (Press release, Ionis Pharmaceuticals, JUL 11, 2022, View Source [SID1234616596]). IgAN is a rare and serious condition that often leads to chronic kidney disease and renal failure. Roche’s decision to advance the program comes after positive data from a Phase 2 clinical study in which IONIS-FB-LRx met its primary endpoint of change in 24-hour urinary protein at 29 weeks compared to baseline.

In the Phase 2 study (NCT04014335), IONIS-FB-LRx demonstrated a favorable safety and tolerability profile. The study data are consistent with the clinical profile seen across Ionis’ other LICA programs, further validating how advancements in the company’s LIgand-Conjugated Antisense technology platform position Ionis to deliver potentially transformative treatments for a range of unmet medical needs. Data from the Phase 2 study of IONIS-FB-LRx in patients with IgAN has been submitted for presentation at an upcoming medical meeting.

IgAN occurs when too much IgA protein accumulates in the kidneys, causing inflammation and tissue damage, which is the root cause of the disease. IONIS-FB-LRx was designed by Ionis to reduce the production of complement factor B (FB), which is associated with the development of several complement-mediated diseases, including IgAN.

"Roche’s decision to advance the program reaffirms our shared confidence in the ability of Ionis’ antisense medicines to effectively target the root cause of difficult to treat diseases like immunoglobulin A nephropathy," said Michael McCaleb, Ph.D., vice president, clinical development at Ionis. "The results of the Phase 2 study provide initial clinical evidence that IONIS-FB-LRx reduces complement and protein levels in the urine of patients with IgAN."

Roche will lead and be responsible for the Phase 3 study of IONIS-FB-LRx in patients with IgAN and for future global development, regulatory and commercialization activities.

IONIS-FB-LRx is also being evaluated in GOLDEN (NCT03815825), a Phase 2 clinical study to determine whether the medicine can slow or halt the progression of geographic atrophy due to age-related macular degeneration, or AMD. Ionis will receive $55 million from Roche for licensing IONIS-FB-LRx for IgAN and achieving a development milestone in the GOLDEN study.

About IgA Nephropathy (IgAN)
Immunoglobulin A nephropathy (IgAN) is an important cause of chronic kidney disease and renal failure. Also known as Berger’s disease, IgAN is characterized by deposition of IgA and Complement 3 (C3) activation products in the glomerular mesangium of the kidneys, resulting in inflammation and tissue damage. Although IgAN may occur at any age, it generally presents in the second or third decade of life. The clinical presentation, disease progression and histologic findings are highly variable among affected individuals. Current therapies are aimed at reduction of protein levels in the urine with administration of angiotensin inhibitors and control of blood pressure. Sometimes immunosuppressive therapies are given; however, this practice is not universally accepted.

Athenex Announces Entry into Agreement to Sell its China API Business to TiHe Capital (Bejing) Co., Ltd.

On July 11, 2022 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that Athenex and certain affiliates have entered into an agreement to sell all of its equity interests in its China subsidiaries, which are primarily engaged in Active Pharmaceutical Ingredient (API) manufacturing operations, to TiHe Capital (Beijing) Co., Ltd. for RMB 124.4 million, or approximately $19.0 million (Press release, Athenex, JUL 11, 2022, View Source [SID1234616595]). Athenex will receive at least 70% of the proceeds at Closing, followed by 20% within three months after the Closing Date, and the remaining balance within six months after the Closing Date. Proceeds from the transaction will be used in part toward repaying existing debt and operating the business. The deal is subject to customary closing conditions, including obtaining certain regulatory approvals in China. Athenex and TiHe also plan to enter into a long-term supply agreement for the manufacture and supply of certain API products.

"Following the sale of our Dunkirk facility, as well as the sale of our U.S. and European tirbanibulin royalty and milestone interests, the Athenex team continues to execute on our strategy to monetize our non-core assets, bolster our balance sheet, extend our cash runway, and focus on our potential best-in-class NKT cell therapy program," said Dr. Johnson Lau, Chief Executive Officer of Athenex. "We continue to look to identify additional opportunities to deliver on those plans."