On March 30, 2022 Accutar Biotechnology, Inc., a clinical stage biotechnology company focusing on artificial intelligence (AI)-enabled drug discovery, reported the dosing of the first patient in a Phase 1 study of AC0176, an orally bioavailable, chimeric degrader molecule designed to target the androgen receptor (AR) with high potency and selectivity (Press release, Accutar Biotechnology, MAR 30, 2022, View Source [SID1234611205]).

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"The initiation of this study marks the second program from our AI-enabled drug discovery platform and our chimeric degrader portfolio to enter the clinic," said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. "AC0176 was designed to potently degrade both AR wildtype and prevalent AR mutants which confer drug resistance to current AR-targeted therapies, including but not limited to L702H, T878A, H875Y, W742C. We are excited about the differentiated therapeutic profile of AC0176 and its broad potential to treat prostate cancer patients."

The purpose of the Phase 1 multi-center, open-label study is to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0176 treatment in patients with mCRPC. Additional information on this clinical trial can be found on www.clinicaltrials.gov (NCT05241613).

About AC0176

AC0176 is an investigational orally bioavailable, chimeric degrader of AR for the potential treatment of prostate cancers. In preclinical studies, AC0176 demonstrated potent and selective AR protein degradation with broad coverage of AR mutants, favorable pharmacological properties, as well as promising anti-tumor activity in animal models.

On March 30, 2022 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported that financial results and a business update for the full fiscal year ended December 31, 2021 (Press release, VolitionRX, MAR 30, 2022, View Source [SID1234611226]). Volition management will host a conference call tomorrow, March 31 at 8:00 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.

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"I could not be prouder of the team’s achievement in securing a global licensing and supply agreement for our Nu.Q Vet Cancer Screening Test with Heska Corporation, one of the industry’s leading companies," commented Cameron Reynolds, President and Group Chief Executive Officer of Volition. "Volition Veterinary is an exciting, fast-moving part of our business with clear potential to generate significant revenue for the company, initially under our agreements with Heska and SAGE Healthcare, through both milestone payments and ongoing sales of kits and key components. We have also made good progress in other key areas including our Nu.Q NETs and Nu.Q Capture programs as we shift gears towards our goal of becoming a commercial company with products."

An interview with Cameron Reynolds, President and Group Chief Executive Officer of Volition, Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, and Terig Hughes, Group Chief Financial Officer of Volition: View Source

Company Highlights

Financial

Cash and cash equivalents as of December 31, 2021, totaled approximately $20.6 million compared with $19.4 million as of December 31, 2020.
Subsequent to year end, Volition is due to receive a $10 million upfront payment as a result of the execution of the agreement with Heska Corporation.
Cash burn rate averaged approximately $2 million per month.
Net loss for the full year of 2021 was $27 million versus $20.4 million for 2020 with this increase primarily due to non-cash items in addition to new hire staffing costs.
Signed our first Nu.Q Discover agreement in 2021 and subsequent to year end have signed an additional five agreements worth an aggregate of approximately $200,000 on a full-year basis.
Made strong progress in improving internal controls and processes and anticipate the remaining weakness regarding segregation of duties in finance will be resolved in 2022.
Commercial Opportunity

We estimate our annual total addressable market ("TAM") to be approximately $70 billion worldwide including Nu.Q Vet, Nu.Q Discover, Nu.Q NETs and Nu.Q Cancer.
All estimates are global and on an annualized basis using key assumptions as follows:
We estimate the Nu.Q Vet TAM to be approximately $11 billion based on global canine and feline populations that are eligible for screening and monitoring and a price assumption of $50 per test to the consumer.
For Nu.Q Discover we estimate the TAM to be over $200 million using drug pipeline data of registered clinical trial programs for relevant epigenetic targets.
We estimate the Nu.Q NETs TAM to be approximately $22 billion calculated using estimated hospital admissions and discharges for sepsis and the associated average length of stay.
We estimate our Nu.Q Cancer TAM to be approximately $37 billion calculated based on eligible populations for annual screening, target participation rates and incidence/prevalence of specific cancers, and risk stratification use cases.
Price per test assumptions for Nu.Q and Nu.Q NETs range from $120 for the U.S., $50 for Europe and $25 for the rest of the world.
Personnel/ Operational

To support our commercial expansion, we welcomed Terig Hughes as our Chief Financial Officer, Gael Forterre as our Chief Commercial Officer, Dr. Tom Butera as the Chief Executive Officer of our veterinary subsidiary, and Mr. Nick Plummer as Group General Counsel.
In addition, Gaetan Michel was promoted to Chief Operating Officer and has relocated to the U.S. to accelerate the development of Volition America.
Dr. Terry Kelly was promoted to Chief Innovation Officer and is building a team focused on cutting-edge, discovery research at our new innovation hub which opened in California in March 2022.
Volition Veterinary

Executed a global licensing and supply agreement with one of the industry’s leading companies, Heska Corporation.
In exchange for granting Heska exclusive worldwide rights to sell the Nu.Q Vet Cancer Screening Test for companion animals at the Point of Care, Volition will receive:
a $10 million upfront payment on signing,
up to $18 million based upon the achievement of near/mid-term milestones, and
ongoing additional revenue for key components.
In addition, Volition has granted Heska non-exclusive rights to sell the Nu.Q Vet Cancer Screening Test in kit format for companion animals, through Heska’s network of central reference laboratories for which Volition will receive ongoing additional revenue for such kit sales.
Appointed SAGE Healthcare as a non-exclusive licensee and distributor of our Nu.Q Vet Cancer Screening Test for the Asian market.
We remain in advanced negotiations with other potential licensing partners in our efforts to make Nu.Q Vet as accessible as possible worldwide and anticipate further announcements in 2022.
Published two peer-reviewed clinical papers and two abstracts at the Veterinary Cancer Society Annual Conference including the first data demonstrating the use of Nu.Q Vet as a disease monitoring tool.
Clinical – NETosis including COVID-19

Volition believes the Nu.Q NETs assay will have wide applicability for monitoring diseases with a NETs component (such as COVID-19, influenza, sepsis, autoimmune diseases, and cancer) and potentially to risk-stratify patients for treatment selection.
Volition expects to register CE marks on its first NETs product, across multiple platforms including ELISA plate, automated beads, and a proof of concept on a very high throughput platform by the summer of 2022.
Volition intends to register the Nu.Q NETs product with a broad almost C-reactive protein (CRP) style claim "for the detection and evaluation of infection, tissue injury, inflammatory disorders and diseases associated with NETosis."
Posters published during 2021 (at the International Society on Thrombosis and Haemostasis Congress) showed that results on admission using the same Nu.Q NETs assay could predict future COVID-19 disease severity and that serial results correlate with disease progression including 28-day mortality.
Further larger studies have been completed in COVID-19 and sepsis which are now awaiting publication, as well as studies in other diseases in progress, with results expected in the coming quarters.
Clinical – Cancer

Published data at ASCO (Free ASCO Whitepaper) GI 2022 for two colorectal cancer studies (asymptomatic and symptomatic populations) conducted with the National Taiwan University.
Results demonstrated that using Nu.Q assays in conjunction with FIT could potentially reduce unnecessary colonoscopies by up to 28% in patients with gastrointestinal symptoms and that this dual approach could also improve the effectiveness of FIT-based screening programs for asymptomatic patients.
The Lung Cancer team at the National Taiwan University has completed collection and preliminary analysis and submitted abstracts to upcoming conferences.
Volition has also undertaken active and continuing negotiations in Asia, in addition to platform development on its first human cancer launch in China.
Collection for the U.S. Early Detection Research Network ("EDRN") study restarted in June 2021 and enrollment has been slow but steady. The EDRN has diverted some efforts to drive recruitment and it still anticipates study completion in the fourth quarter of 2022.
With regards to Volition’s U.S. blood cancer studies, the timing of expected completion for each has been impacted by the COVID-19 pandemic due to sample collection and protocol issues.
Given the pandemic, and resultant delays in the larger Non-Hodgkin Lymphoma ("NHL") study (of 1500 subjects), the Company has taken the opportunity to upgrade the platform to a high-throughput platform which will help facilitate an FDA compliant product. Consequently, Volition now expects this study to initiate recruitment in the second quarter of 2022 with study completion anticipated in 2023.
A smaller, proof of concept NHL monitoring study is ongoing. However, due to missing serial samples as a result of pandemic collection issues, we are not in a position to publish yet. Collection continues and we anticipate analyzing a more complete data set in 2022.
Nu.Q Capture

The Nu.Q Capture program now has several strands of technology which:
essentially remove background noise, thereby amplifying the signal,
look to identify the signal in a novel way including through mass spectrometry, or
isolate various chromatin fragments, including nucleosomes and transcription factors.
Nu.Q Capture, when used in combination with either sequencing, mass spectrometry and/or Volition’s Nu.Q assays could potentially aid diagnosis, treatment selection, and both treatment and disease monitoring in addition to aiding biomarker discovery.
Further to the publication in 2021 of a novel method utilizing Nu.Q Capture and mass spectrometry, Volition is developing a large 1000-plus patient study in lung cancer and colorectal cancer with further announcements expected in 2022.
Intellectual Property

29 patent families (plus three in-licensed families) covering both human and animal use of Volition’s Nucleosomics platform.
84 granted patents (12 in the U.S., 14 in Europe, and 58 rest of world).
93 patents pending worldwide.
Continued focus on filings and expect portfolio to grow in the quarters and years ahead.
Publications

In 2021, data for the Nu.Q platform was presented at five international conferences and Volition has collaborated on four clinical papers.
In 2022, to date, two posters were presented at the ASCO (Free ASCO Whitepaper) GI 2022 conference.
These publications are another very important step forward for the Company.
Upcoming Milestones

Drive near term revenue in the following key areas:
Licensing of its technology, with a particular but not exclusive focus on Nu.Q Vet.
Complete Heska Corporation agreement milestones in order to receive further milestone payments.
Sales of key components of Point of Care test with Heska.
Sales of kits from non-exclusive agreements for the use of Nu.Q Vet via central reference labs.
Ongoing and new Nu.Q Discover agreements.
Sales of its disease monitoring tests (e.g. COVID-19, sepsis).
Continue to progress the research program for the use of Nu.Q in NETosis, in monitoring disease progression of COVID-19, sepsis, and potentially other diseases and as a possible companion diagnostic for a treatment for sepsis.
Continue to advance its previously announced large-scale blood, lung, and colorectal cancer trials in Europe, Asia, and the U.S.
Publish several abstracts and peer-reviewed scientific papers with clinical results showing the robustness and utility of its Nu.Q platform.
Advance the development of Nu.Q Capture.
Continue to file patents to expand and extend its intellectual property portfolio.
VolitionRx Limited Full Fiscal 2021 Financial Results and Business Update

Cameron Reynolds, President and Group Chief Executive Officer of Volition, will host the call along with Terig Hughes, Group Chief Financial Officer of Volition, Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, and Scott Powell, Executive Vice President, Investor Relations of Volition.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source

In addition, a telephone replay of the call will be available until April 14, 2022. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13728406.

On March 30, 2022 Cipla Medpro and the wholly owned subsidiary of Cipla Limited reported that have finalised a partnership agreement with the global biotechnology company mAbxience, to get oncology and respiratory-related biosimilars to South Africa (Press release, mAbxience, MAR 30, 2022, View Source [SID1234611165]).

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These medicine products for the treatment of cancer are on the WHO Model List of Essential Medicines.

The mAbxience partnership will enable Cipla to continue its ethos of ensuring equitable access to affordable, life-saving medication. Most other biosimilar treatments, particularly in oncology, create a high-cost burden on the payer or patient and often are inaccessible to patients in need of this critical treatment.

A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing approved reference biologic product, and is produced from living cells using biotechnology. Biosimilars, while being more affordable, are developed with equivalent efficacy, safety and quality of the reference biologic.

In 2018, Cipla paved the way for more affordable treatments in the fight against dreaded diseases with the launch of the first biosimilar drug, Filgrastim Teva, for oncology and haematology patients in South Africa. Cipla also recently launched a biosimilar for the treatment of immune-mediated inflammatory disease.

According to the Cancer Alliance report CA03/2021, South Africa faces a crisis in terms of affordable access to medicines, particularly in the treatment of cancer. Fatima Hassan of the Health Justice Initiative says most patients cannot afford the medicines and treatment because they are priced for first-world markets.

"Some also enjoy extended periods of exclusivity, which means they have little or no competition", Hassan added.

Challenging treatment pricing and accessibility

Cipla changed the face of the HIV/Aids pandemic during its most severe phase more than 20 years ago, by dramatically slashing the prices of antiretrovirals to less than $1 a day, in comparison to the prevailing yearly treatment cost of $12,000 per patient. This revolutionised HIV/Aids from being a perceived death sentence to a disease managed like any other chronic medical condition.

CEO of Cipla South Africa, Paul Miller, said: "Cipla is built on the foundation of ensuring affordable and accessible drugs to patients in need. Cipla has focused on oncology to help make an equally profound difference in patients’ lives. We want people to live a long and healthy life, and quality medication is not just the privilege for a few, but a right for everyone."

Recently, Cipla also received regulating approval for lenalidomide – a lifesaving drug proven to enhance the immune-system cells that identify and attack cancer cells – a development that addresses the disparity with regards to access to and affordability of this medication.

On March 30, 2022 Nextera AS, a drug and target discovery company built on the unique and novel NextCore protein engineering and discovery platform, reported a strategic collaboration with Zelluna Immunotherapy AS on optimizing T cell receptors (TCRs) for subsequent implementation into the "off-the-shelf" TCR based Natural Killer (TCR-NK) cell approach of Zelluna Immunotherapy AS for the treatment of cancer (Press release, Nextera, MAR 30, 2022, View Source [SID1234611188]).

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Nextera’s aim is to engage into strategic commercial partnerships focused on the huge unmet medical demand in autoimmunity and immuno-oncology by leveraging its NextCore platform. This partnership represents the first collaboration on engineering TCRs, which will complement the company’s focus on TCR-Like antibodies and HLA peptidome target deconvolution.

TCR-NK products are a novel and proprietary class of allogeneic cellular therapies that combine the inherent pan cancer killing mechanism, efficiency, and the allogeneic nature of NK cells with the targeting capabilities of TCRs. Arming NK cells with TCRs may unlock the potential to treat a wide range of currently untreatable cancers.

"We are delighted to engage into this collaboration with Zelluna, which is pioneering the TCR-NK field with its innovative and proprietary allogenic "off-the-shelf" approach. Engineered TCR therapy has very recently entered the mature clinical pipeline and further expansion of this field has the outlook to make a transformational difference for patients across multiple cancer indications. Our differentiated NextCore platform is uniquely well situated to harness the new generation of TCR targeting modules in these approaches to maximize efficacy and safety" said Dr. Geir Åge Løset, co-founder and CEO/CSO of Nextera.

On March 30, 2022 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, reported its financial results for the year ended December 31, 2021 (Press release, Renovorx, MAR 30, 2022, View Source [SID1234611206]).

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"2021 was a transformative year for RenovoRx. We successfully closed on our initial public offering and listed on the NASDAQ under ‘RNXT,’" said Shaun Bagai, CEO of RenovoRx. "Importantly, despite challenges created by the COVID-19 pandemic, we maintained steady enrollment in our Phase 3 clinical trial in locally advanced pancreatic cancer. We recently achieved approximately 50% of the target enrollment under the current statistical analysis plan. One of the issues with systemic chemotherapy is the significant side effects to the entire body. RenovoRx is addressing this problem by localizing therapy to treat tumors via our proprietary RenovoTAMP (RenovoRx Trans-Arterial Micro-Perfusion) therapeutic platform. Today, we have the strategy and team to build on our progress in treating pancreatic cancer with the opportunity to extend the RenovoTAMP platform to other cancers. We are challenging the bounds typically associated with treating solid tumors to improve survival and quality of life for patients undergoing chemotherapy."

2021 Operational Highlights:

Issuance of seventh U.S. patent extending the intellectual property coverage of the RenovoTAMP therapy platform.
Closed on IPO and listed on the Nasdaq Capital Market under the ticker symbol, "RNXT."
Received new 510(k) clearance for the RenovoCath delivery system (the device component of the Company’s initial product, RenovoGem). RenovoRx received its initial 510(k) for the RenovoCath delivery system in 2014.
Announced final data from RR2 observational registry study. Phase 1/2 trials demonstrated that prior radiation treatment, together with targeted chemotherapy delivered via RenovoTAMP, reduced the tolerability issues typically associated with systemic chemotherapy and improved survival.
2022 Operational Highlights and Upcoming Targeted Milestones:

Began enrolling patients at Columbia University’s New York-Presbyterian Hospital Irving Medical Center in ongoing TIGeR-PaC Phase 3 Clinical Trial.
TIGeR-PaC achieved approximately 50 percent of the target enrollment under the current statistical analysis plan.
Plans to meet with the FDA to discuss trial design for a second indication, extrahepatic (or outside the liver) cholangiocarcinoma (bile duct cancer), or eCCA. Pending the outcome of that meeting and protocol submission, Phase 2 trial in eCCA may be launched in 2H 2022.
Expects to conduct TIGeR-PaC interim analysis.
Financial Highlights for the Fiscal Year Ended December 31, 2021

Cash and cash equivalents as of December 31, 2021, were $15.2 million.
Research and development expenses were $3.0 million for the year ended December 31, 2021, compared to $2.4 million for the year ended December 31, 2020. The increase was primarily due to higher clinical development employee-related costs.
General and administrative expenses were $2.6 million for the year ended December 31, 2021, compared to $0.8 million for the year ended December 31, 2020. The increase was primarily due to higher professional and consulting expenses related to preparing for our IPO in August 2021, including employee-related costs and insurance costs for Directors and Officers Liability Insurance.
Net loss was $6.3 million for the ended December 31, 2021, compared to net loss of $3.8 million for year ended December 31, 2020.
As of March 25, 2022 the Company had 9,029,305 common shares outstanding.
About the Phase 3 TIGeR-PaC Clinical Trial

TIGeR-PaC is a randomized multi-center Phase 3 study using RenovoRx’s innovative therapy platform, RenovoTAMP (RenovoRx Trans-arterial Micro-perfusion). The study is evaluating the Company’s first product candidate, RenovoGem, to treat locally advanced pancreatic cancer (LAPC) through the intra-arterial delivery of gemcitabine (an FDA-approved chemotherapy). The study has a primary endpoint of overall survival and several secondary endpoints, including quality of life.

TIGeR-PaC is currently enrolling unresectable LAPC patients at several sites across the U.S. To learn more about the study and the participating clinical trial sites, visit View Source