On September 15, 2021 Herantis Pharma Plc ("Herantis" or the "Company") reported the result of the offering of new shares (the "Placing Shares") in a private placement to institutional and other qualified investors (the "Placing") (Press release, Herantis Pharma, SEP 15, 2021, View Source,c3416074 [SID1234587799]). The Company announced the launch of the Placing by way of a company release published on 15 September 2021. Herantis raises gross proceeds of EUR 4.04 million in the Placing.

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In the Placing, the Company expects to issue a total of 1,346,500 Placing Shares in a directed share issue. The Placing Shares represent approximately 13.8 per cent. of the issued shares in Herantis prior to the Placing and approximately 12.1 per cent. of the issued shares in Herantis following the Placing. The total number of issued shares in the Company after the Placing will be 11,103,568.

The subscription price of the Placing Shares is EUR 3.00 per Placing Share, corresponding to a discount of 6.5 per cent to the closing price on First North Growth Market Finland immediately before the commencement of the Placing on 15 September 2021. The subscription price shall be recorded in the invested unrestricted equity reserve.

The Placing was carried out based on offers received in an accelerated book building and based on the authorisation given to the board of directors by the Company’s extraordinary general meeting of 2 December 2020.

As previously announced, Acme Investments SPF Sarl, a company controlled by Timo Syrjälä, and Nanoform Finland Plc participated in the Placing among several other investors.

The Placing Shares (ISIN code FI4000087861) will be registered with the trade register maintained by the Finnish Patent and Registration Office on or about 16 September 2021. The Placing Shares are expected to be ready for delivery to the investors against payment through Euroclear Finland Oy or, as applicable, through Euroclear Sweden AB on or about 20 September 2021.

Herantis intends to make applications for the admission into trading of the Placing Shares on Nasdaq First North Growth Market Finland and on Nasdaq First North Growth Market Sweden. Trading in the Placing Shares is expected to commence on Nasdaq First North Growth Market Finland and Nasdaq First North Growth Market Sweden on or about 20 September 2021, subject to the respective listing applications being approved.

The CEO of Herantis, Craig Cook comments: "We are pleased with the support amongst existing as well as respected new shareholders in Herantis. The funds will clearly enable us to continue the important development activities of our novel disease-modifying CNS drugs rhCDNF and xCDNF (HER-096). These assets are the epitome of our ground-breaking science and have the potential to slow, stop or even reverse the progression of neurodegenerative diseases with high impact for patients and society. Herantis is well positioned to capitalize on this momentum and create value for our growing list of world class shareholders."

Swedbank AB (publ) is acting as the global coordinator and bookrunner of the Placing in association with Kepler Cheuvreux. Krogerus Attorneys Ltd is acting as the legal counsel to the Company as to Finnish law and Borenius Attorneys Ltd is acting as the legal counsel to the global coordinator and bookrunner of the Placing as to Finnish law.

On September 15, 2021 GenesisCare—one of the leading oncology providers in the United States, Australia, Spain, and the United Kingdom—reported that it is collaborating with Lee Health—one of the largest not-for-profit public health systems in Florida—to transform pancreatic patient survival rates (Press release, GenesisCare, SEP 15, 2021, View Source [SID1234587794]). Today the companies announced that their collaborative Florida Center for Pancreas Diseases has been designated a Pancreatic Cancer Center of Excellence (PCCoE) by the National Pancreas Foundation (NPF).

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The NPF Center designation is awarded only to institutions offering high-quality, multidisciplinary care that treat the "whole patient," focusing on the best possible outcomes and an improved quality of life.

"Our goal is to provide hope to our patients fighting this dreadful disease using the latest treatment advances available with our world-class multidisciplinary team of over 20 doctors and certified professionals," said Dr. Mark Bloomston, Surgical Oncologist, GenesisCare, and the Founder of the Florida Pancreas Center. "Over the last six years, we have been able to leverage the resources and talent that were already present in the Ft. Myers area and recruit more experts in the field to create an outstanding team. A comprehensive and personalized approach to treating this disease is the only way to truly impact survival rates. We have to be bolder in our approach to treatment if we want to change the trajectory for our patients." Dr. Bloomston was recruited to Southwest Florida in 2015 due to his expertise in gastrointestinal cancers, specifically pancreatic cancer.

"Receiving a cancer diagnosis of any kind is a scary life-altering experience," said Frank Barreiro, a five-year pancreatic cancer survivor treated at the Florida Center for Pancreas Diseases. "Because of the quick efforts of Dr. Bloomston and his team, I’m here today. I’m not just living but thriving. I’m golfing, weightlifting, and fishing again. I’ve seen my daughter graduate high school, college and get married. I was given the gift of five more years with my high school sweetheart, my wife."

In 2021, the American Cancer Society estimates 4,700 Floridians will be diagnosed with pancreatic cancer, a challenging disease to treat because it spreads rapidly and is often found close to other organs.

Physicians at the Florida Pancreas Center treat more cases of pancreatic cancer in a single day than most oncologists see in a lifetime. Patients have access to groundbreaking new treatments before they become standard through the center’s innovative clinical trial program, including oncolytic immunotherapy and irreversible electroporation. The designation as a PCCoE opens the door to new resources. One of them is an MR Linac, a technology that enables the precise targeting of pancreatic cancer cells with real-time MRI imaging to deliver more effective doses of radiation to the tumor while minimizing damage to nearby tissues.

"We now have the opportunity to further improve upon the high-quality care we are providing to hundreds of patients in our community," stated Dr. Bloomston.

"Pancreatic cancer treatment is complex, and patients want to feel confident that they are working with a highly experienced care team with the convenience of receiving that care close to home," said Dan Collins, Founder and CEO, GenesisCare. "Our collaboration with Lee Health brings together Florida’s top pancreatic cancer specialists and the latest treatment advances to meet this need."

"The fastest way to advancing progress against cancer is through collaboration. We will continue to explore partnerships such as this to ensure that no one is left behind when it comes to receiving access to the latest medical breakthroughs and the highest possible quality of care, continued Mr. Collins."

Pancreatic cancer has the highest mortality rate of all major cancers and is the third leading cause of cancer-related deaths in the U.S., surpassed only by lung and colon cancers. Of those diagnosed this year in the U.S., an estimated 80 percent (48,000) will die from the disease.

"After more than five years of planning, we’re launching a collaborative effort, dedicated to ensuring patients facing the bleakest of outcomes may benefit from a team of leading pancreatic cancer specialists," said President & CEO of Lee Health Dr. Larry Antonucci. "Pancreatic cancer is an aggressive and devastating disease that will continue its relentless grasp on our communities if we don’t act. Now is the time for partnerships that seek to overcome obstacles, offer hope, and extend lives."

The Pancreatic Center of Excellence application requires the fulfillment of numerous criteria and dedicated core personnel and specialized physicians who lead multidisciplinary teams. There are only 62 PCCoE facilities in the U.S. This designation allows patients access to evidence-based pathways, multidisciplinary care, participation in clinical trials, ongoing investment in staff training and professional development, and ongoing audits and reviews against a range of quality metrics. The Florida Pancreas Center includes collaboration with Lee Health’s Regional Cancer Center and Lee Physician Group Medical Oncology, and Florida Cancer Specialists. For more information on the Florida Center for Pancreas Diseases. visit View Source

On September 15, 2021 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported a clinical data presentation and highlights from the 2021 American Urological Association Annual Congress (AUA2021), which was held virtually September 10-13, 2021 (Press release, PhotoCure, SEP 15, 2021, View Source [SID1234587785]). During the program, new results from a study using Blue Light Cystoscopy (BLC) with Cysview in the surveillance setting were reported in a podium presentation, and separately, BLC with Cysview was discussed in an Expert Presentation on Surgical Techniques.

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The American Urological Association (AUA) meeting is one of largest international meetings in the urology calendar. This year’s event included an innovative, evidence-based, quality program for urologists and urologic health care professionals worldwide.

Podium Presentation

Title: UTILITY OF BLUE LIGHT FLEXIBLE CYSTOSCOPY FOR BLADDER CANCER SURVEILLANCE AFTER INTRAVESICAL THERAPY

Presenter: Sanam Ladi Seyedian, M.D., University of Southern California

Session and Date: PD-63: Bladder: Cancer Non-Invasive III: Sept. 13, 2021

Results were provided by two high-volume treatment facilities that perform Blue Light Flexible Cystoscopy (BLFC) and are participants in the Blue Light Cystoscopy with Cysview Registry. In this study, data was captured from 277 office based BLFC examinations in 136 patients who received intravesical BCG or chemotherapy, as part of standard of care treatment for non-muscle invasive bladder cancer (NMIBC).

From these examinations, a total of 52 office-based biopsies were taken, of which 23 (44%) were confirmed as malignant. BLFC identified all 23 malignancies, demonstrating 100% sensitivity for cancer detection in this cohort, whereas analysis by cytology identified only 3 of the 23 confirmed malignancies. Additionally, from the 277 total examinations, 23 (8%) were White Light Cystoscopy (WLC) normal and BLFC abnormal. Of these 23 discordant results, 16 had office-based biopsies and cancer was confirmed in 9 cases (56%), which would have been missed by WLC alone.

The study authors concluded that office-based BLFC helps improve early detection of recurrence in cases with normal WLC and can aid in surveillance of patients receiving intravesical therapy, enhance performance of office-based biopsy and increase early detection of BCG unresponsive disease.

"The results from this study show that use of Blue Light Cystoscopy with Cysview for patient surveillance improved the ability to detect recurrent disease in this high-risk, recently-treated patient cohort, which can significantly impact future treatment decisions," said Dr. Sia Daneshmand, one of the study authors. "Early detection of recurrent or residual cancer during initial treatment is essential for properly risk-stratifying all bladder cancer patients, and confirming response to treatment on follow-up and can have a major impact on subsequent treatment pathways and patient outcomes. As a result, Blue Light Cystoscopy can be an important tool throughout the continuum of care for patients diagnosed with bladder cancer."

Dr. Sia Daneshmand, M.D., is a Professor of Urology with Clinical Scholar designation and serves as director of clinical research as well as the urologic oncology (SUO) fellowship director at the University of Southern California (USC) in Los Angeles.

Abstract Link: View Source

Expert Presentation

Title: ADVANCES IN ENDOSCOPIC TREATMENT OF BLADDER TUMORS

Presenter: Yair Lotan, M.D., UT Southwestern Medical Center

Session and Date: Plenary Session: Surgical Techniques: Sept. 10, 2021

In this presentation, Dr. Lotan emphasized the importance of BLC with Cysview in accurately detecting NMIBC, stratifying bladder tumors, and helping to perform a complete TURBT in the operating room. He also provided an expert perspective on how biopsy and fulguration in the surveillance setting can positively impact patient outcomes using BLC with Cysview in the office-based setting.

Dr. Lotan is a Professor of the Department of Urology at UT Southwestern and Jane and John Justin Distinguished Chair in Urology, In Honor of Claus G. Roehrborn, M.D. He is Vice chair of Clinical Affairs and chief of urologic oncology.

"The study results presented at this year’s AUA meeting as well as the discussion on BLC in the Surgical Techniques presentation underscores how critically important it is for patients to receive the proper bladder cancer care whether they are having tumor resection in the hospital or follow-up procedures" said Geoffrey Coy, Vice President and General Manager of North American Operations at Photocure. "These new study results also highlight the range of opportunities made possible by Blue Light Cystoscopy for urologists, and the benefits to patients, especially when including flexible Blue Light Cystoscopy in the office setting as part of the continuum of care. We remain focused on expanding the availability of the procedure so that more physicians and patients have access to this important solution."

Note to editors: All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA

About Bladder Cancer

Bladder cancer ranks as the seventh most common cancer worldwide with 1 720 000 prevalent cases (5-year prevalence rate)1a, 573 000 new cases and more than 200 000 deaths annually in 2020.1b

Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with an average of 61% in year one and 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3

Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3, and T4, are more likely to spread and are harder to treat.4

1 Globocan. a) 5-year prevalence / b) incidence/mortality by population.
Available at: View Source, accessed [April 2021].
2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
3 Sievert KD et al. World J Urol 2009;27:295–300
4 Bladder Cancer. American Cancer Society. View Source

About Hexvix/Cysview (hexaminolevulinate HCl)

Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLC). BLC with Hexvix/Cysview improves the detection of tumors and leads to more complete resection, fewer residual tumors and better management decisions.

Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Canada, Chile, Australia, and New Zealand. Please refer to View Source for further information on our commercial partners.

On September 15, 2021 Starpharma reported that it’s DEP cabazitaxel is a proprietary nanoparticle version of leading prostate cancer drug cabazitaxel (Jevtana), which had global sales of US$536 million in 2020 (Press release, Starpharma, SEP 15, 2021, View Source [SID1234587784]). Starpharma’s DEP cabazitaxel is a water soluble, polysorbate-80 free formulation, without requirement for pre-treatment with steroids nor G-CSF to reduce the risk of severe bone marrow toxicity .

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In preclinical and clinical studies, DEP cabazitaxel has shown an improved side effect profile, notably markedly reduced bone marrow toxicity demonstrated by lower rates of severe neutropenia, thrombocytopenia, and severe anaemia, which are experienced by a significant proportion of Jevtana treated patients.

The composition of matter patent builds on Starpharma’s suite of existing international patents for DEP cabazitaxel. It specifically covers a DEP dendrimer conjugated to multiple cabazitaxel drug molecules via a particular releasable linker, with a patent term to 2039 and potential for a 5-year extension.

Starpharma CEO, Dr Jackie Fairley, commented: "The grant of this new US patent illustrates the unique and compelling benefits of Starpharma’s DEP drug delivery technology and DEP cabazitaxel. We look forward to completing the phase 2 clinical program for DEP cabazitaxel, in parallel with commercial licensing discussions."

DEP cabazitaxel is in late phase 2 clinical development, recruiting patients with solid tissue tumours, including prostate, ovarian and gastro-oesophageal cancers.

Encouraging efficacy signals have been observed in multiple tumour types, including in prostate cancer where radiological responses, significant reductions in prostate-specific antigen (PSA) and no new bone metastases were observed. These efficacy signals were observed despite patients having been heavily pre-treated with an average of 30 prior cycles of treatment, and in some cases with more than 100 cycles and up to 10 different treatment regimens. Patients treated with DEP cabazitaxel have also exhibited encouraging efficacy signals in gastro-oesophageal, ovarian, cholangiocarcinoma, lung and head and neck cancers.

DEP cabazitaxel was developed using Starpharma’s proprietary DEP drug delivery platform, used by the company and partners to create novel nanoparticle formulations of existing and new drugs to enhance their therapeutic and commercial value. DEP drug delivery is applicable to a wide range of drugs in oncology and other therapeutic areas. Starpharma has three phase 2 clinical-stage DEP assets, multiple preclinical DEP programs, and several DEP commercial partnerships with companies, including AstraZeneca, Chase Sun and Merck & Co., Inc., to develop DEP versions of their products or ADCs.

On September 15, 2021 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE protein biologic technology platform, reported that Jeffrey Miller, MD, University of Minnesota Medical School, Professor of Medicine, Division of Hematology, Oncology and Transportation will present a mini-oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 to be held virtually September 16-21 (Press release, GT Biopharma, SEP 15, 2021, View Source [SID1234587783]).

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The mini-oral presentation will present updated positive Phase 1 safety data, progress, and preclinical data going beyond hematologic malignancies to solid tumors of a Phase 1 GTB-3550 TriKE trial. The Tri-Specific Killer Engager TriKE program is currently in pre-clinical and clinical development for the treatment of relapsed/refractory acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS) with solid tumor TriKE commercial manufacturing and IND enabling studies in progress.

Mini-oral Poster Presentation Details:

Title: GTB-3550 TriKE safely activates and delivers IL-15 to NK cells, but not T cells, in immune suppressed patients with advanced myeloid malignancies, a novel paradigm exportable to solid tumors expressing Her2 or B7H3 (Abstract #4068)

Speaker: Jeffrey Miller, MD

Mini-oral Session: Investigational Immunotherapy (Channel 2)

Presentation Time: September 17 at 6:10 PM EST

Mini-oral Presentation Number: 965MO

The abstract is currently available on the ESMO (Free ESMO Whitepaper) website at www.esmo.org. At the start of the mini-oral session the presentation will be available in the "Presentations" section of the Company’s website at View Source

Recent Announcement
The Company recently announced the advancement of GTB-3650 into IND-enabling studies, with which it plans to supplant the ongoing Phase 1 program with GTB-3550. GTB-3650 is a novel molecule based on camelid single-domain camelid antibody technology with advantages that build upon the strong proof-of-concept data from the Company’s first generation TriKE program, GTB-3550.

Therapeutic and commercial advantages of GTB-3650 compared to GTB-3550 include:

Based on second generation camelid single-domain antibody technology that holds several advantages over traditional IgG monoclonal antibodies
Improved potency and enhanced binding affinity
Similar preclinical safety profile
Commercial manufacturing capabilities through arrangement with Cytovance
Proprietary patented molecule, which unlike GTB-3550, is wholly owned by GT Biopharma
About Camelid Antibodies

Camelid antibodies are single domain antibodies (sdAbs) from the Camelidae family of mammals that include llamas, camels, and alpacas. These animals produce 2 main types of antibodies. One type of antibody camelids produce is the conventional antibody that is made up of 2 heavy chains and 2 light chains. They also produce another type of antibody that is made up of only 2 heavy chains and no light chain. This is known as heavy chain IgG (hcIgG). While these antibodies do not contain the CH1 region, they retain an antigen binding domain called the VHH region. VHH antibodies, also known as single domain antibodies, contain only the VHH region from the camelid antibody. Camelid antibodies have key characteristics, which include high affinity and specificity (equivalent to conventional antibodies), high thermostability, good solubility and strictly monomeric behavior, small size, relatively low production cost, ease of genetic engineering, format flexibility or modularity, low immunogenicity, and a higher penetration rate into tissues.

About GTB-3650

GTB-3650 is the Company’s lead second-generation Tri-Specific Killer Engager TriKE program currently in preclinical development for the treatment of relapsed/refractory acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS).