On February 23, 2022 Immunetune, a preclinical-stage biotech developing next-generation DNA vaccines against cancer and infectious diseases, reported the publication of preclinical data on its novel adjuvant in the scientific journal Vaccine (Press release, ImmuneTune, FEB 23, 2022, View Source [SID1234608861]). The published findings underline the ability of Immunetune’s proprietary adjuvant PyroVant to increase the immune response against its neoantigen cancer vaccine and the resulting profound impact on tumor growth and survival.

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The publication on PyroVant in the journal Vaccine describes the development of a novel, first-in-class genetic adjuvant that greatly improves immune responses elicited by DNA cancer vaccines. Unlike other adjuvants, this DNA-encoded adjuvant induces pyroptosis, a form of inflammatory cell death that results in the release of a plethora of inflammatory molecules that together attract and stimulate immune cells crucial for the generation of an anti-tumor T cell response. When given simultaneously with a DNA vaccine encoding tumor antigens, PyroVant increases tumor-specific T cell numbers up to 8-fold, in a dose-dependent fashion. Subsequently, in a preclinical model of melanoma, the addition of PyroVant to this DNA vaccine significantly delayed tumor growth and increased survival.

"It is important to have these results peer-reviewed by the scientific community and share our mechanistic insights into this first-in-class genetic adjuvant to increase the potential impact of cancer vaccines," said Jeroen van Bergen, Chief Scientific Officer of Immunetune. "We are especially excited to have incorporated PyroVant in our neoantigen cancer vaccine NeoVAC, which is currently moving towards clinical development."

The experiments were performed in close collaboration with the Tumor Immunology group (Prof. Ossendorp) of the Department of Immunology at the Leiden University Medical Center (LUMC) in the Netherlands. Immunetune has submitted a patent application on PyroVant and has recently completed GLP toxicity studies of its DNA-based cancer vaccines in combination with PyroVant. These studies showed that both vaccine and PyroVant were well tolerated with no test article-related observations on survival, body weight and clinical pathology across the toxicity and biodistribution studies. Immunetune is now moving its lead cancer vaccine NeoVAC towards clinical studies.

The full publication is titled ‘Pyroptosis-inducing active caspase-1 as a genetic adjuvant in anti-cancer DNA vaccination’ and can be accessed on the website of the journal Vaccine here.

On February 23, 2022 Nichi-Iko Pharmaceutical Co., Ltd. has recently reported that it received approval for a biosimilar of bevacizumab BS intravenous infusion 100 mg/400 mg, whose marketing authorization application was filed based on the clinical pharmacokinetic (PK) study data conducted in Japan in addition to the global Phase 3 study data conducted by mAbxience (Press release, mAbxience, FEB 23, 2022, View Source [SID1234608885]).

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Bevacizumab BS is highly similar to the reference medicinal product and data has shown a comparable quality, safety and efficacy to Avastin. Bevacizumab BS is indicated for the treatment of advanced or recurrent colorectal cancer that is not curatively resectable and advanced or recurrent non-small cell lung cancer that is not resectable except for squamous cell carcinoma.

On February 23, 2022 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs), reported the appointment of Steve Hughes, M.D. as chief medical officer (Press release, Avidity Biosciences, FEB 23, 2022, View Source [SID1234608919]). Dr. Hughes has over 20 years of experience building and leading clinical development and medical affairs teams at prominent biopharmaceutical companies.

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"Steve brings a unique combination of extensive experience in the RNA field as well as a deep understanding of rare disease drug development," said Sarah Boyce, president and chief executive officer. "Steve’s unparalleled leadership in developing RNA-based treatments across therapeutic areas will be invaluable as we expand our AOC platform and execute on our goal of having three programs in the clinic by the end of this year."

Dr. Hughes has contributed to over 50 clinical trials for more than 25 drugs across multiple therapeutic areas including cardiovascular, neurology and several rare diseases. He has been closely involved in multiple registrational regulatory filings, including playing a key role in the approval of three rare disease products in the last six years.

"I’m thrilled to be joining the talented team at Avidity. The AOC platform is a ground-breaking technology that significantly broadens the potential for RNA therapies," said Steve Hughes, M.D., chief medical officer at Avidity. "I look forward to contributing to Avidity’s progress in the clinic during this pivotal time as we work to advance our clinical programs and deliver potentially transformative medicines to people living with rare diseases that have limited or no therapeutic options."

Dr. Hughes joins Avidity from Arcturus Therapeutics where he continues to be a strategic clinical advisor. Prior to that, he held the position of CMO where he provided leadership and direction to clinical operations, clinical development, clinical sciences, data management, biometrics, and drug safety. Prior to Arcturus, he served as the Chief Medical Officer of Organovo where he led the non-clinical and clinical development teams developing bioprinted tissues for the treatment of hepatic and renal diseases. Dr. Hughes’s previous positions include the Chief Clinical Development Officer at Ionis Pharmaceuticals and positions at Biogen, CSL Behring and Sanofi. Dr. Hughes is board certified in pharmaceutical medicine and received his medical degree from Imperial College, London. He also has an MBA from Imperial College Business School.

On February 23, 2022 InDex Pharmaceuticals Holding AB reported that year-end report 2021 (Press release, InDex Pharmaceuticals, FEB 23, 2022, View Source [SID1234608862])

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Period October – December 2021
Net sales amounted to SEK 0.0 (0.0) million
Operating loss amounted to SEK –22.7 (–10.1) million
Result after tax amounted to SEK –22.8 (–10.1) million, corresponding to SEK –0.04 per share (–0.04) before and after dilution
Cash flow from operating activities amounted to SEK –43.9 (–8.1) million
Period January – December 2021
Net sales amounted to SEK 0.0 (0.0) million
Operating loss amounted to SEK –102.9 (–57.3) million
Result after tax amounted to SEK –103.0 (–57.4) million, corresponding to SEK –0.21 per share (–0.24) before and after dilution
Cash flow from operating activities amounted to SEK –124.1 (–70.7) million
Cash and cash equivalents at the end of the period amounted to SEK 428.4 (53.8) million
Number of employees at the end of the period was 9 (7)
Number of shares at the end of the period was 532,687,650
All comparative amounts in brackets refer to the outcome during the corresponding period 2020.

Significant events during the quarter
InDex enrolled the first patient in the phase III study CONCLUDE with cobitolimod in ulcerative colitis
InDex got new patent for cobitolimod granted in the US
InDex got new patent for cobitolimod granted in Canada
Other events
InDex enrolled the first patient in the PK study with cobitolimod
CEO statement
At the end of November, the first patient was enrolled in the phase III study CONCLUDE and I am proud that we have achieved this important milestone on the way towards market approval. The study evaluates the drug candidate cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis. With cobitolimod, we want to give new hope to the patients suffering from this severe disease. Given cobitolimod’s outstanding combination of efficacy and safety, the annual global peak sales at a successful commercialisation are estimated to have the potential to reach more than USD 1 billion.

The induction study will include approximately 440 patients and be conducted at several hundred clinics in over 30 countries including Europe, the Americas and the Asia-Pacific region. The contract research organisation (CRO) Parexel, contracted by InDex to conduct the phase III study, was recently ranked by clinics around the world as the best CRO to work with for clinical trials in the "WCG CenterWatch Global Site Relationship Benchmark Survey".

We estimate that the study will take 18 to 24 months to complete. In the current start-up phase our focus is on obtaining approval to start the study in each country and activating the clinics there. The study is currently approved in 16 countries, and we expect several additional approvals in the coming weeks. The pandemic has continued to affect the start-up of new clinical studies, but we now see that it is easing up and that many clinics are eager to get started.

We have initiated the application process for a scientific advice meeting with the Japanese regulatory authority in 2022. The goal is to be able to include Japanese patients in the next induction study in the phase III program. An established regulatory development plan for the Japanese market will also be important in discussions with potential regional partners.

The first patient has also been enrolled in a smaller clinical pharmacokinetic study (PK study) with cobitolimod. The PK study will include at least 6 patients with moderate to severe ulcerative colitis and is conducted in parallel with the phase III study CONCLUDE. With the PK study, we aim to confirm the limited systemic uptake of cobitolimod shown in previous studies. This is a significant advantage compared to competing drugs for ulcerative colitis that act on the whole body and can cause severe side effects outside the inflamed colon.

Tomorrow we have a virtual investor presentation at HC Andersen Capital, and on March 14 we invite you to a Capital Markets Day. The focus of the Capital Markets Day will be on the phase III study CONCLUDE, cobitolimod’s market potential and InDex’s long-term strategies for commercialisation of cobitolimod. Hope to see you there now that the Swedish pandemic restrictions are gone!

The full report is attached as a PDF and is available on the company’s website View Source

Publication
This information is information that InDex Pharmaceuticals Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (MAR). The information was submitted for publication through the agency of the contact person set out above at 8:00 CET on February 23, 2022.

On February 23, 2022 Nascent Biotech, Inc. (OTCQB: NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company pioneering the development of monoclonal antibodies targeting treatment of various cancers and viral infections, reported that the Company has received a payment totaling USD $750,000 from BioRay Pharmaceutical, Ltd. ("BioRay") in association with the Licensing Agreement established between the two companies in May 2021 (Press release, Nascent Biotech, FEB 23, 2022, View Source [SID1234608886]). This payment represents the Second Payment stipulated in the Licensing Agreement (the "Agreement").

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The Agreement grants to BioRay exclusive rights to commercialize Nascent’s monoclonal antibody, Pritumumab, in international markets, excluding North America and Central America. Under terms of the Agreement, Nascent will receive a total of USD $5,000,000 to be paid out at various stipulated milestones. The initial payment of USD $1,000,000 was received by Nascent on April 20, 2021.

This second payment of USD $750,000 was received by Nascent for entering the third cohort in Nascent’s first Phase 1 clinical trial of Pritumumab.

A third payment of USD $2,500,000 will be received by Nascent upon approval from the FDA to conduct a Phase 2 clinical trial of Pritumumab. The final USD $750,000 payment will be received by Nascent upon the commencement of the Phase 2 clinical trial.

"There continue to be significant unmet medical needs across a variety of cancers," remarked Sean Carrick, CEO of Nascent Biotech. "We are highly encouraged by Pritumumab’s potential as an innovative, first-in-class treatment candidate, and we are delighted to be working closely with BioRay in this collaboration."