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Almac Sciences and Queen’s University Belfast Collaboration Successfully Flows Through Mid-point

On September 22, 2021 Almac Sciences, a member of the Almac Group, reported that it has successfully reached the midway point of its continuous flow technology project made possible through an Innovate UK funded Knowledge Transfer Partnership (KTP) in partnership with Queen’s University Belfast (Press release, Almac, SEP 22, 2021, https://www.almacgroup.com/news/almac-sciences-and-queens-university-belfast-collaboration-successfully-flows-through-mid-point/ [SID1234590114]).

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The aim of the Innovate UK funded KTP is to further enhance established flow technologies platforms at Almac Sciences. The technology will be used for development and manufacture of key raw materials and unlock capacity to perform challenging chemical transformations. The KTP scheme supports business growth through identification of new skills and transfer of the latest academic concepts to deliver a strategic innovation programme.

Modular flow technology for continuous manufacture of chemicals is one of the most exciting technologies in the international pharmaceutical and fine chemical industries. There have been significant efforts in the design of flow equipment and processes globally which includes multi-phase flow reactors, gas/liquid mixers and structured catalysts to offer manufacturing flexibility and robustness in continuous production of chemicals.

The Almac team is now delighted to report its KTP project has passed the mid-point with multiple successful outcomes including dissemination through peer-reviewed publication and several conference presentations detailing the development of a continuous flow packed bed catalytic process for hydrogenation of aromatic nitrobenzoic acids to produce corresponding anilines.

Academic Supervisor, Dr Haresh Manyar, Senior Lecturer in Chemical Engineering at QUB, commented "The hydrogenations under investigation are more efficient, less consumptive and safer than the corresponding batch process. Various industrially important aromatic anilines were produced in excellent yields with high throughputs. A continuous flow approach meant no evidence of genotoxic intermediates and, with the modular reactor design, it can be scaled to produce several kilos without extensive redesign.’ He added ‘This unique collaboration with Almac Sciences is a key milestone for Catalysis research at QUB and we are delighted to work together to advance flow technology within an industrial setting."

For Almac Sciences, the KTP has a positive reach through increasing competitiveness and productivity with a recent investment of £325,000 in continuous flow, including flow hydrogenation capabilities of up to 100 bar pressure and 300°C. Dr Megan Smyth, Technical Leader, Almac Sciences discussed the positive impact the KTP project has had on the expansion of service offerings within the Technology Group adding, "the ongoing successful knowledge transfer has allowed Almac to deliver kilogram manufacture of product for our customers."

Dr Scott Wharry, Custom and Flow Chemistry Manager and Company Supervisor, Almac Sciences said "Research and innovation are at the heart of what we do on a daily basis within our Technology group. This KTP project has not only increased capacity but has allowed in-depth understanding on which we can build a platform capability which will underpin future process development and further innovation. I wish the team continued success and look forward to seeing the final outcome of the project."

Selvita Group reports over 109% increase in revenues for H1 2021

On September 22, 2021 Selvita (WSE: SLV) – one of the largest preclinical contract research organizations in Europe, reported that continues its dynamic development in Poland and abroad (Press release, Selvita, SEP 22, 2021, View Source;utm_medium=rss&utm_campaign=selvita-group-reports-over-109-increase-in-revenues-for-h1-2021 [SID1234590113]).

Following the acquisition of Fidelta, Selvita Group achieved in the first half of 2021 over a two-fold increase in sales revenue comparing to the corresponding period of the previous year. The increase in EBITDA and net profit was even higher, significantly influenced by the high profitability of the services executed by Fidelta.

Dynamic increase in all business segments

Selvita, along with its subsidiaries, has continued its dynamic growth in all business aspects.

Revenues from services executed in Poland amounted to EUR 14.4 million and were higher by 17% compared to the first half of 2020, when they amounted to EUR 12.5 million. This increase in revenues was achieved with a very high base from the first half of 2020, when a record, almost 50% revenue dynamics were noted. EBITDA of services executed in Poland (adjusted to the impact of the stock grant program) amounted to EUR 3.2 million (margin: 21.0%).

The bioinformatics segment, represented by Selvita’s subsidiary Ardigen, closed the first half of 2021 with EUR 2.9 million in commercial revenues (EUR 3.2 million including grants), while in the corresponding period of 2020, this value amounted to EUR 1.6 million (EUR 2.0 million), which indicates an increase of 84%. Ardigen’s EBITDA amounted to EUR 0.6 million (margin: 19.1%) and was 56% higher than in the corresponding period in 2020.

Fidelta, representing the segment of services executed in Croatia, recorded EUR 13.1 million in commercial revenues with EBITDA of EUR 3.9 million (margin: 30.1%). Fidelta has been part of the Selvita Group since January 2021.

The first half of 2021 saw a dynamic increase in the sales of services on global markets. With the acquisition of Fidelta, sales in the E.U. countries and Switzerland have significantly increased, as this is where the Croatian Company generates most of its revenues. On another note, it is the organic growth of Selvita and Ardigen which resulted in a significant growth of sales in the U.S.

Group revenues from the U.S. market, the most competitive market globally, amounted to EUR 8.4 million, which indicates an increase of 81.4% y/y, emphasizing the high quality of services provided by the Company.

The first half of 2021 constituted another two very good quarters for Selvita. We recorded growth in every segment of our activity, both in Poland and globally. We are satisfied with the 17% growth in the services executed by our labs in Poland, as it is worth noting that we compare this period to the record-breaking H1 2020 when in the first months of the pandemic we recorded increases of 40-50%. The revenues generated by our Croatian company, Fidelta, which joined the Group at the turn of the year, are also growing, and what is more, it is happening along with high margins. Our other company, Ardigen also continues to strengthen its position on the AI market, maintaining the highest growth dynamics in the Group.

We have no intention of slowing down, which is why we continue to invest in the development of our teams and infrastructure. Construction of the Selvita Research Center in Krakow has begun in July this year, and the adaptation of additional over 2 000 sq m of space in Zagreb is near completion.

To ensure continued revenue growth from the North American market, the largest market for research outsourcing, we have decided to expand our sales structure in the United States. We have appointed Dean Bornilla, an extensively experienced manager, for the position of VP Sales, Head of North America. Dean will be responsible for the Company’s continued development and revenue growth in the North American market. On top of that, experienced, new members joined our European sales team, and will help build our position in this region.

We are convinced that a strong sales team, along with the best scientists working in our laboratories, are the most crucial factor supporting our further development – comments Bogusław Sieczkowski, co-founder, significant shareholder and Chief Executive Officer at Selvita.

We are optimistic about the second half of the year, as the dynamic increase in the portfolio of contracts shows that we have a busy end of the year ahead of us. What is important, this portfolio has grown in all business segments, which shows that after the covid turmoil, stabilization is returning also to the regulatory research market – adds Sieczkowski.

Selvita Group’s backlog for 2021 currently amounts to EUR 59.8 million, showing an increase of 122% y/y, including organic backlog which has increased by 30% as compared to the corresponding period last year.

The path for further growth

Selvita has been consistently implementing the assumptions of the strategy adopted for 2020-2023, according to which the Group intends to develop through organic growth, as well as acquisitions. A significant milestone in the strategy was the acquisition of Fidelta, which contributed to a rapid improvement in the financial results of the entire Group. In the first half of 2021, the dynamics of the Group’s revenues amounted to over 100% y/y, which clearly shows how effectively the goals of the strategy are being implemented.

The organic development of the Group is also supported with investments in its own research area. The company has already started the construction of a new facility – Selvita Research Center in Krakow and has secured EUR 9.3 million of a grant funding and EUR 14.3 million of a bank loan, for that purpose. The future headquarters of Selvita will be able to provide workspace for over 250 people. The investment when completed will increase Selvita’s space by an additional 10 000 sq m, including approximately 4 000 sq m of laboratory and office space.

Significant events before the publication date

On July 12, the Group announced that it was initiating the construction of a new research center in Krakow. The company has signed an agreement with PORR S.A., which will act as the general contractor. Additional, state-of-the-art laboratory space will allow Selvita to increase its scale of operations and expand its services offer.

On September 6, Selvita received a grant funding of EUR 1 million to create a novel technological platform which will accelerate the drug discovery process. The grant came from the National Centre of Research and Development with a total of EUR 1.7 million dedicated to the project.

On September 20, Selvita received EUR 0.7 million to create technology allowing to develop new drugs against diseases caused by coronaviruses. The grant comes from the National Center of Research and Development with a total value of EUR 1.4 million dedicated to the project.

Both projects which were awarded the funding, will enable Selvita to develop innovative technological platforms allowing for a faster and more efficient drug discovery process, expanding the portfolio of drug discovery services offered by the Group.

Sirnaomics, Inc. to Present at TIDES USA 2021

On September 22, 2021 Sirnaomics, Inc., a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, reported that it will be presenting positive results from a Phase 2a clinical study of the company’s lead drug candidate, STP705, for treatment of squamous cell skin cancer in situ (Nonmelanoma Skin Cancer) at the 2021 TIDES USA event (Press release, Sirnaomics, SEP 22, 2021, View Source [SID1234590112]). The hybrid conference is taking place in person at the Boston Convention and Exhibition Center, and digitally on-demand, September 20-30.

Title: Novel Dual Targeting siRNA Therapeutic Offers Innovative Solution for Derm-Oncology Treatment
Presenter: Michael Molyneaux, MD, MBA, Chief Medical Officer at Sirnaomics, Inc.
Presentation Overview: Clinical trial results showing STP705, used to target TGF-β1 and COX-2 siRNAs for the treatment of nonmelanoma skin cancer, has demonstrated rates of histological clearance that rival surgical excision combined with improved cosmetic appearance.
Time/Date: 11:45am ET, Thursday, September 23, 2021. The session will be available to watch on demand for attendees starting on September 28 for a 30-day period.
Location: Room 205A, Boston Convention and Exhibition Center
Tides 2021
About STP705
Sirnaomics’ product candidate, STP705, is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. The product candidate has received multiple IND approvals from both the US FDA and Chinese NMPA, including for the treatment treatments of cholangiocarcinoma and other solid liver tumors, nonmelanoma skin cancer and hypertrophic scar, and Keloid scarring. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma, primary sclerosing cholangitis, and hepatocellular carcinoma. A Phase 2a study of STP705 for treatment of squamous cell skin cancer (isSCC) in adult patients demonstrated positive efficacy and safety results, with 76% of all patients (19/25) achieving complete histologically clearance and the two optimal dosing ranges achieving 90% histological clearance of tumor cell in the lesion. No significant or serious adverse events, including no significant cutaneous skin reactions, were reported in the study, and the company was able to define a clear therapeutic window in advance of later-stage studies.

Cue Biopharma Granted U.S. Patents on Lead Clinical Program Novel Drug Product Candidate CUE-101

On September 21 2021 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the body, reported the issuance of two new United States Patents Nos. 11,117,945 and 11,104,712 from the United States Patent and Trademark Office (Press release, Cue Biopharma, SEP 21, 2021, View Source [SID1234608271]).

U.S. Patent No. 11,117,945 covers Cue Biopharma’s first clinical drug candidate, CUE-101, and its use in treating HPV16-associated cancers such as head and neck, cervical, and genitoanal cancers. CUE-101 is currently in a Phase 1b clinical trial in which second line and beyond patients are receiving CUE-101 as a monotherapy for HPV16+ recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). To date, CUE-101 has demonstrated monotherapy clinical activity by selective activation of targeted CD8+ T cells specific for HPV+ cancer cells with a 40% clinical benefit in the first 10 evaluable patients at the recommended Phase 2 dose of 4mg/kg. CUE-101 is also in a dose escalation study in combination with pembrolizumab in front-line patients with HPV16+ recurrent/metastatic HNSCC. A Phase 2 exploratory clinical trial in which CUE-101 will be administered in the neoadjuvant phase before standard of care (SOC) therapy in treatment-naïve, HLA-A*0201 positive patients with locally advanced, HPV-positive oropharyngeal squamous-cell carcinoma, is expected to begin enrolling patients this fall.

The second U.S. Patent, No. 11,104,712, covers the use of CUE-101 in combination with KEYTRUDA (pembrolizumab) for treating HPV16-associated cancers such as head and neck, cervical, and genitoanal cancers. The combination of CUE-101 and pembrolizumab is being evaluated by Cue Biopharma in collaboration with Merck Sharp & Dohme Corp.

"The issuance of these patents represents an important development as we continue to build-up our IP portfolio and bolster patent protection for the novel protein engineering platforms we have enabled, particularly as we begin demonstrating clinical activity in what we believe will be a disruptive and transformational breakthrough in immunotherapy for addressing cancer and other debilitating and life-threatening diseases," said Daniel Passeri, chief executive officer of Cue Biopharma. "Furthermore, obtaining these patents early in the clinical development of CUE-101 enhances our ability to receive a Patent Term Extension from the United States Patent and Trademark Office if CUE-101 is approved by the FDA. We continue to make a substantial investment in protecting our intellectual property, and we look forward to the issuance of additional patents that cover our important platforms and pipeline products."

Cue Biopharma’s IP portfolio includes approximately 300 pending applications and issued patents that are either owned by Cue Biopharma or exclusively licensed from the Albert Einstein College of Medicine.

Zenith Epigenetics and Newsoara Announce Initiation of a Randomized Phase 2b Metastatic Castration-Resistant Prostate Cancer (mCRPC) Study

On September 21, 2021 Zenith Epigenetics Ltd. ("Zenith" or the "Company") and Newsoara BioPharma Co., Ltd. ("Newsoara") reported the initiation of a multi-national, randomized Phase 2b clinical trial testing the combination of ZEN-3694, a leading BET bromodomain inhibitor (BETi), with Astellas Pharma Inc. ("Astellas") and Pfizer’s androgen receptor signaling inhibitor (ARSI), enzalutamide, in patients with mCRPC who had a poor response to prior abiraterone treatment (Press release, Zenith Epigenetics, SEP 21, 2021, View Source [SID1234590199]). The study will evaluate the efficacy of ZEN-3694 + enzalutamide vs. single agent enzalutamide as measured by its primary endpoint, radiographic free progression.

Abiraterone, also an ARSI, is frequently prescribed as a first line therapy for patients with metastatic prostate cancer. A significant fraction of these patients, whose tumors have low androgen receptor (AR) signaling activity, have a sub optimal response to abiraterone and their subsequent treatment options are limited to cytotoxic therapies. The rationale for this study design is supported by a recent publication in Clinical Cancer Research whose authors uncovered a potential mechanism explaining the role of BETi in sensitizing tumors with low AR signaling to ARSI by blocking a treatment-emergent neuroendocrine differentiation program. This mechanistic study built on a previous clinical trial conducted by Zenith where results suggested that ZEN-3694 + enzalutamide was most active in mCRPC patient tumors who had the lowest AR activity. Furthermore, patients in that trial that had a poor response to prior abiraterone therapy had the most durable response with ZEN-3694 + enzalutamide.

"We are delighted to initiate this study in collaboration with our partners Newsoara and Astellas to continue the development of ZEN-3694 in mCRPC patients," said Donald McCaffrey, President and Chief Executive Officer of Zenith. "We are pursuing a novel approach of treating mCRPC patients whose tumors are resistant to ARSI. Other therapies, either approved or in development, are either cytotoxic or mainly target AR signaling which resistant tumors are no longer dependent on," Mr. McCaffrey further commented.

Dr. Benny Li, Chief Executive Officer of Newsoara added, "with promising data from the completed Phase 1b/2a trial, the initiation of the multi-national, randomized Phase 2b clinical study in patients with mCRPC is a significant milestone for us to pursue a novel treatment through our partnership with Zenith."

About Prostate Cancer

Prostate cancer is the second-most commonly diagnosed cancer among men and the fifth most common cause of male cancer death worldwide. Adenocarcinoma of the prostate is dependent on androgen for tumor progression and depleting or blocking androgen action has been a mainstay for over six decades. Although tumors are often initially sensitive to medical or surgical therapies that decrease levels of testosterone and to ARSIs that block AR signaling, disease progression ultimately occurs leading to mCRPC. The treatment of prostate cancer patients has evolved rapidly over the past ten years with second generation ARSIs. Despite these advances, many patients with mCRPC fail or develop resistance to existing treatments, leading to continued disease progression and limited survival rates.