On February 23, 2022 Oasmia Pharmaceutical AB (Oasmia), an oncology-focused specialty pharmaceutical company, reported that the first patient has now fully completed the study in the Investigator-Initiated Phase 1b trial of Docetaxel micellar for advanced prostate cancer (trial SAKK 67/20 of the Swiss Group for Clinical Cancer Research SAKK) (Press release, Oasmia, FEB 23, 2022, View Source [SID1234608863]). Furthermore, the first of three dosing groups in the trial has been successfully recruited and the first patient has started in the second dose group.

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Francois Martelet, MD, Chief Oasmia Officer, Oasmia, commented: "We are grateful for the significant effort of the Swiss Group for Clinical Cancer Research (SAKK), our investigators and clinics have made in progressing the study so far. SAKK has informed us that it is well-positioned to complete recruitment this year and secure data crucial for the continued development of Docetaxel micellar."

Oasmia’s Docetaxel micellar is a solvent-free formulation of docetaxel developed to avoid the need for the solubility enhancers in solvent-based docetaxel, and the mandatory high-dose steroid premedication, while providing an effective treatment option. Prostate cancer is a significant and increasingly prevalent health problem worldwide and is the leading cause of male cancer deaths.

The SAKK 67/20 trial (NCT04629781) is an open-label, multicenter, single-stage Phase 1b trial at major hospitals in Switzerland, recruiting 18 chemotherapy-naïve patients with metastatic castration resistant prostate cancer (mCRPC) with adequate bone marrow, liver, and renal function. The primary objective of this trial is to determine the maximum tolerated dose of Docetaxel micellar in patients with mCRPC and the secondary objectives are to evaluate safety, assess the preliminary anti-tumor activity, and to characterize the pharmacokinetics in this population.

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 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 22, 2022 Huahui Health reported successful completion of first patient dosing of Phase I trial of HH-101, an Fc-enhanced anti-TIGIT antibody (Press release, Huahui Health, FEB 22, 2022, View Source [SID1234642184]).

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HH-101 has demonstrated superior anti-tumor effects and a good safety profile in pre-clinical studies. The Phase I study aims to evaluate the safety, tolerability, PK and efficacy of HH-101 in patients with late-stage solid tumors.

The Leading PI, Prof. SHEN Lin at Beijing Cancer Hospital, commented on the Phase I study, "Compared with many other anti-TIGIT antibodies, HH-101 is with enhanced Fc region, which may potentially lead to more effective Treg depletion and consequently improved anti-tumor effects. Hopefully the superior pre-clinical efficacy data can be translated into improved patient outcomes through human studies. We wish to have a successful clinical development of HH-101, providing Chinese cancer patients with more therapeutic options."

"HH-101 is the first oncology pipeline asset of Huahui Health that has received IND approval and entered clinical development stage. This is a milestone for the company’s rapid growth, and a recognition of Huahui’s R&D capabilities in oncology," says Dr. Bin Chen, the CEO of Huahui Health. "We strive to innovate breakthrough therapies to transform patient lives across the globe, through our continued commitment and efforts in understanding the disease biology and translating science into medicine and improved clinical benefits."

On February 22, 2022 Hovione, the leader in spray drying and particle engineering, reported a strategic partnership with Zerion Pharma to market and commercialize Dispersome, Zerion´s proprietary solubility enhancement technology platform (Press release, Zerion, FEB 22, 2022, View Source [SID1234609347]).

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Zerion´s innovative Dispersome technology builds on a new concept of increasing drug solubility by using natural protein-based excipients to formulate APIs into amorphous solid dispersions (ASDs) by spray drying. By combining Dispersome technology with Hovione’s unique spray drying capabilities, experience in development, scale-up and GMP manufacturing, Hovione further strengthens its leadership in amorphous solid dispersions and shows its commitment to innovative solutions to overcome one of the most prevalent challenges faced by the industry: low drug solubility.

"We are extremely pleased to have entered into this partnership with Zerion whom we recognize as a very innovative company in the field of oral drug formulations. By joining forces, Zerion and Hovione will be able to bring Dispersome to the market faster. We look forward to applying the technology in collaboration with our customers and partners in our effort to develop novel drugs with strong benefits to patients.", comments Jean-Luc Herbeaux, Hovione´s Chief Operating Officer. "Hovione will continue to pursue opportunities to enhance its offering around core areas of expertise such as particle engineering and inhalation by partnering with companies and research institutions developing innovative drug formulation technologies, like Dispersome".

Zerion´s CEO, Ole Wiborg, sees a strong synergy in the partnership and expects it to generate new pharma partnerships. "We consider Hovione the global leader in the field of producing amorphous solid dispersions by spray-drying. More importantly for us, this leadership has resulted in Hovione being, over the last 5 years, the main commercial manufacturer of novel FDA-approved drugs formulated as amorphous solid dispersions. Incorporating these competencies in our offering to the pharma industry both validates the strength of our Dispersome platform and provides us and our pharma partners immediate access to the highest quality in upscaling and commercial GMP manufacturing." says Ole Wiborg.

The announcement of this partnership follows Hovione’s communication on a further expansion with an expected investment of $170 million in assets worldwide and shows the company’s commitment to also expand its technology platforms. Hovione is investing both in new assets and innovative technologies to meet customer demand for integrated and differentiated services in drug substance manufacturing, particle engineering and most recently drug product manufacturing.