Biofrontera AG announces subscription price for 1.00 % qualified subordinated mandatory convertible bond 2020/2021

On August 10, 2020 The Executive Board of Biofrontera AG (shares of Biofrontera AG ISIN: DE0006046113) reported that has decided on 27 July 2020, with the approval of the Supervisory Board, to issue a 1.00 % qualified subordinated mandatory convertible bond 2020/2021 (ISIN: DE000A3E4548 / WKN: A3E454). It is divided into up to 2,638,150 qualified subordinated mandatory convertible bearer bonds ("Bonds") with a nominal value of EUR 3.00 each and a total nominal value of up to EUR 7,914,450 (Press release, Biofrontera, AUG 10, 2020, View Source [SID1234568548]). The shareholders or holders of subscription rights were invited by an announcement in the Federal Gazette (Bundesanzeiger) of 29 July 2020 to exercise their subscription rights to the Bonds during normal business hours in the period from 30 July 2020 up to 13 August 2020 (included) to avoid exclusion. It was also provided that the subscription price would be published in the Federal Gazette (Bundesanzeiger) and via an electronic information medium no later than three days before the end of the subscription period.

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The subscription price for each of the Bonds was set at

100 % of their nominal value of EUR 3,00.

Thus, the cash payment for each bond subscribed is EUR 3.00.

Sysmex Corporation received Insurance Coverage in Japan for Liquid Biopsy RAS Gene Mutation Testing  for CRC Using High-Sensitivity Digital PCR

On August 10, 2020 Sysmex Corporation (Chairman and CEO: Hisashi letsugu) reported that it has received approval for insurance coverage for blood-based RAS gene mutation testing for colorectal cancer using the OncoBEAM RAS CRC Kit (Press release, Sysmex Inostics, AUG 10, 2020, View Source [SID1234568252]). The coverage went into effect on August 1, 2020.
With this regulatory approval, even when it is difficult to obtain in vivo diagnostics (biopsy) on a sample taken from tumor tissue, RAS gene mutation testing using the kit may be performed with a minimal physical and mental burden on patients when it is necessary, owing to the fact that it uses the patient’s blood as a sample. This will have the effect of optimizing decisions on the administration of anti-EGFR monoclonal antibody drugs. Receipt of insurance coverage will also make it possible for us to provide more patients with testing to allow physicians to select an appropriate treatment method.

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Currently, at the beginning of therapy, colorectal cancer patients treated with medication undergo RAS gene mutation testing using tumor tissue, the results of which inform a decision on whether or not to administer anti-EGFR monoclonal antibody drugs. Several studies have reported that re-challenge of anti-EGFR monoclonal antibody drugs is an effective treatment method for patients with recurrent colorectal cancer after treatment by anti-EGFR monoclonal antibody drugs, and that the RAS gene mutation status may change by the time of re-challenge from what it was in initial therapy. The relevant guidance published by the Japanese Society of Medical Oncology indicates that it is desirable to assess the gene mutation status several times over time to make appropriate re-challenge decisions based on the state at the time of relapse. As such, much has been expected from a practical application of liquid biopsy, which checks the RAS gene mutation status using the patient’s blood samples when biopsy may not be performed easily.
The OncoBEAM RAS CRC Kit is used to test samples of tumor-derived DNA (circulating tumor DNA, or ctDNA) suspended in the blood of colorectal cancer patients. Using BEAMing technology, the kit detects RAS gene mutations with a high degree of sensitivity (mutant allele frequency of no more than 1% in approximately 30% of mutation cases thus detected). As the first colorectal cancer liquid biopsy testing in Japan that provides auxiliary test data to determine the appropriateness of anti-EGFR monoclonal antibody drugs – Cetuximab and Panitumumab (gene recombination) – for patients with colorectal cancer, this product was approved as an in vitro diagnostic reagent in July 2019 and was covered under health insurance from August 1, 2020. Please note that an insurance-covered assay service for colorectal cancer using this product is also due to start in August 2020.
Performance of RAS gene mutation testing when it is necessary and with a minimal physical and mental burden on patients for whom biopsy is challenging to perform is expected to optimize the administration of anti-EGFR monoclonal antibody drugs. On the other hand, there is a possibility that this testing may deem patients whose ctDNA is not sufficiently leaked into the blood to have wild-type RAS, even though RAS gene mutation exists in tumor tissue. For patients with lung metastasis only, it is particularly necessary to prioritize testing using tumor tissue. Sysmex will remain committed to the provision of scientific information so that medical institutions may perform testing properly.
Going forward, Sysmex will continue to contribute to the advancement of personalized medicine by working on expanding testing opportunities for patients and providing testing and diagnostic technologies with high diagnostic value.

Prescient gears up for growth with $6.5m raise as the race to cure cancer heats up

On August 10, 2020 Prescient Therapeutics reported that it is advancing to next-stage trials for its personalised treatments for cancer and COVID-19 and has launched a capital raising for up to $6.5m via a Share Purchase Plan (SPP) (Press release, Prescient Therapeutics, AUG 10, 2020, View Source;utm_medium=rss&utm_campaign=prescient-gears-up-for-growth-with-6-5m-raise-as-the-race-to-cure-cancer-heats-up [SID1234565483]).

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The cash raised will see Prescient Therapeutics’ (ASX:PTX) well-funded to progress its expanded pipeline of exciting cancer treatments, including clinical trials of PTX 100 and 200 products, and its cutting edge programs in cell therapy including the new OmniCAR platform for next-generation CAR-T therapies.

At the same time, the company has attracted leading cancer researcher Professor Phillip Darcy to its Scientific Advisory Board.

The SPP share issue is priced at 5.5c, a 15 per cent discount to its volume-weighted average share price prior to the SPP announcement, and it closes August 17.

"We have a diversified pipeline of targeted therapies of medicines that are in clinical stage trials. And, we have a number of cell therapy programs, including CAR-T," chief executive and managing director Steven Yatomi-Clarke said.

"Not only is Prescient the only ASX company undertaking CAR-T programs, we are have an enabling platform from the pioneer of this technology to create next-gen CAR-T therapies."

Prescient’s personalised cancer therapies focus on genetically modifying the proteins or antigens on the T-Cells of patients so they can better fight and defeat cancer.

"T-cells might normally be able to detect cancer cells by recognising certain proteins on their surface. However, cancers evolve and can evade the immune system by changing these proteins. Without these, the T-cells in our immune system can no longer recognise them. And that’s when we come in to fix that, " Yatomi-Clarke said.

CAR-T is a new generation cell therapy for treating cancer that turbo-charges the body’s immune system’s T-Cells to attack and destroy cancer cells. It does so by training these T-cells to recognise the cancer cells.

A sample of a patient’s T-Cells are collected and grown in a laboratory where they are genetically modified, adding a cancer antigen or protein, to create a hybrid T-Cell called a Chimeric Antigen Receptor (CAR).

"We can reprogram these T-Cells to recognise cancer once again because we add our receptor of choice called a CAR-T cell," Yatomi-Clarke said.

"It is a chimera between the patient’s own T-Cells plus a brand new, introduced receptor so the result is a hybrid; a turbo-charged version of the patient’s T-Cells."

The CAR-T field received a boost at the world’s largest cancer conference, when pharma company Johnson & Johnson reported a 100 per cent response rate among patients in a trial for CAR-T therapy for multiple myeloma.

Globally renowned expertise
Prescient has also just announced a well-timed appointment, naming internationally renowned cancer and CAR-T expert Professor Phillip Darcy as a new member of its Scientific Advisory Board.

Professor Darcy is currently National Health and Medical Research Council (NHMRC) senior research fellow and group leader of cancer immunotherapy at the Peter MacCallum Cancer Centre in Melbourne.

"Prescient is pursuing a number of promising approaches in cell therapy, including cell therapy enhancements, that have the potential to significantly broaden and improve existing approaches to CAR-T therapy," Professor Darcy said.

"Another exciting development involves the OmniCAR platform. This approach may pave the way for a new generation of CAR-T cells that are capable of being controllable, targeting multiple antigens, and potentially used as an off-the-shelf product. I am excited to be able to participate in this important work for cancer patients."

Treating multiple cancers
As exciting and groundbreaking as CAR-T is, the current generation of therapies face challenges that limit its application, including safety, cost and flexibility to treat a range of cancers.

OmniCAR is Prescient’s new platform that seeks to address these challenges – creating the next generation of CAR-T therapies that are safer, controllable and flexible.

OmniCAR aims to improve the safety profile of CAR-T and enhance dosage control and T-Cell activity by making CAR-T more flexible and adaptable to treat multiple cancers including tumours.

The therapy is designed to overcome challenges of CAR-T such as time and cost — the treatment can cost $500,000 per patient — as well as safety concerns, and antigen loss that can lead to a patient’s relapse.

OmniCAR can overcome some of the clinical challenges of CAR-T treatments by allowing on-demand activation of CAR-T cells, increased control over side effects, and reduced cost of treatment.

The OmniCAR platform works by creating a modular CAR-T therapy. The solution is elegant in its simplicity, and effective.

The T-cells and the portion that binds to the cancer (the "binder") are administered separately, where they form a fully functional CAR-T inside the patient. The modularity gives control and enables the CAR-T to be re0directed at-will by the clinician.

"Inside the patient they attach like Lego. That simple elegant capability is what enables you to overcome the challenges of conventional CAR-T," Yatomi-Clarke said.

Dosage control is an important feature of OmniCAR, potentially allowing clinicians to have control of CAR-T activity post infusion.

"With OmniCAR, by administering the binder separately you can add increasing amounts and it switches on progressively. For the very first time after infusion the doctor has control which is important," Yatomi-Clarke said.

"This feature alone would be a game-changer because it makes it more accessible and safer to give to patients."

Quality pipeline of cancer treatments
Prescient Therapeutics has other cancer treatments in its PTX 100 and PTX 200 targeted cell therapies.

"They address particular switches that drive cancer. They are targeted therapies that go inside cancer cells and switch off aberrant proteins," Yatomi-Clarke said.

PTX 100 is the only RhoA inhibitor in clinical development that targets RhoA mutations in cancer cells.

A "Basket trial" is underway for PTX 100 to examine the treatment’s effect on different types of solid and blood cancers after the treatment was deemed safe in a previous Phase 1 trial.

"Rarher than focus on the location of the cancer, we focus on the genetic driver of that cancer," he said.

Results from the basket trials are expected in late 2020 and includes research on PTX 100’s impact on gastric, pancreatic, colorectal cancers and T-Cell lymphomas.

PTX 200 is a personalised treatment for breast cancer that selectively kills tumours, and the company is exploring new combinations of the treatment for breast and ovarian cancers.

A trial is underway to examine the application of PTX 200 in acute myeloid leukemia.

COVID-19 treatment trial
Prescient has also partnered with The Doherty Institute in Melbourne, which is researching the application of two of the company’s drugs as a potential treatment for COVID-19.

"We are in the business of cancer [treatment] and that remains our focus. It just so happens that some of the mechanisms that drive cancer also happen to be important for viral infection and replication and we are looking to exploit that," Yatomi-Clarke said.

Both treatments have priority status and results from the Doherty trials are expected in September.

Prescient has filed patents to protect all intellectual property generated in the trials.

Turning Point Therapeutics Reports Second-Quarter Financial Results, Provides Operational Updates

On August 10, 2020 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported financial results and operational updates for the second quarter ended June 30 (Press release, Turning Point Therapeutics, AUG 10, 2020, View Source [SID1234564368]).

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"We achieved many important milestones since our first quarter update in May, including advancing our pipeline of four drug candidates, sharing our preclinical combination data for repotrectinib in KRAS cancer models, raising gross proceeds of $374 million through our May stock offering, completing a strategic agreement with Zai Lab to develop repotrectinib in Greater China and strengthening our team with the hiring of our chief commercial officer, Andy Partridge," said Athena Countouriotis, M.D., president and chief executive officer.

"Turning to the second half of 2020, we remain focused on advancing our pipeline, as we continue to navigate the COVID-19 pandemic and monitor its impact to our timelines. For the TRIDENT-1 Phase 2 registrational study of repotrectinib, site activations and enrollment have improved since our last update in May, and we are planning to report early interim data from the study in the third quarter. Our goal is to achieve full global site activation in the TRIDENT-1 study in early 2021.

"Overall, I am pleased with how our team has adapted and advanced our clinical development during these challenging times and I want to again thank the dedicated health care providers worldwide who continue to treat patients suffering from COVID-19."

Second quarter and recent highlights include:

Progress in the TRIDENT-1 Phase 2 registrational study of repotrectinib, where the company anticipates reporting early interim data in the third quarter. The preliminary efficacy and safety data by physician assessment are expected to be from 30 to 40 patients across multiple Phase 2 cohorts, including registrational and exploratory cohorts. The company’s goal is to achieve full site activation in the study in early 2021.

Three additional trials ongoing, including the Phase 1/2 open-label study to assess repotrectinib in pediatric patients with ALK-, NTRK- or ROS1-positive advanced solid tumors; the Phase 1 study of TPX-0022, Turning Point’s MET/CSF1R/SRC inhibitor; and the Phase 1/2 study of TPX-0046, Turning Point’s RET/SRC inhibitor.

Completing an exclusive license agreement with Zai Lab for the development and commercialization of repotrectinib in Greater China, which includes mainland China, Hong Kong, Macau and Taiwan. Under the terms of the agreement, Zai Lab obtained exclusive rights to develop and commercialize repotrectinib in Greater China and Turning Point Therapeutics will receive a $25 million upfront payment, with the potential to receive up to an additional $151 million in development, regulatory and sales-based milestone payments. Turning Point will also be eligible to receive mid-to-high teen royalties based on annual net sales of repotrectinib in Greater China.

Appointing Andrew Partridge as executive vice president and chief commercial officer. Mr. Partridge has more than 20 years of global pharmaceutical sales and marketing experience leading more than 20 commercial launches across multiple indications, including oncology, hematology and rare diseases.
Second Quarter Financial Update
Operating expenses for the second quarter totaled $32.7 million compared to $18.5 million in the second quarter of 2019. Primary drivers of the year-over-year increase were investments made to develop repotrectinib, TPX-0022 and TPX-0046, as well as personnel expenses.

Excluding a one-time non-cash stock-based compensation charge in the first quarter of $31.4 million, non-GAAP operating expenses for the first half totaled $64 million compared to $32.5 million in the first half of 2019. Year-to-date net cash used in operating activities was $51.2 million.

Cash, cash equivalents and marketable securities at June 30 totaled $710.4 million, an increase of $329.6 million from Mar. 31 driven by proceeds from the company’s May stock offering. Turning Point Therapeutics projects its cash position funds current operations into 2023.

Upcoming Milestones
Key milestones anticipated into early 2021 include:

Early interim data from approximately 30 to 40 patients across multiple TRIDENT-1 Phase 2 cohorts in the third quarter.

Additional preclinical data highlighting the potential for repotrectinib to increase the effectiveness of KRAS-G12C inhibitors in the fourth quarter.

Early interim data from initial patients treated with TPX-0022 in the fourth quarter.

Submitting the IND for TPX-0131 by early 2021.

Early interim data from initial patients treated with TPX-0046 in early 2021

Kite, a Gilead Company, Looks to Expand Its Cell Therapy Maryland Operations

On August 10, 2020 Maryland has become a key part of the strategy for Kite, a Gilead company, and its mission to find a cure for cancer (Press release, Kite Pharma, AUG 10, 2020, View Source [SID1234563629]). As the California-based company focuses more and more on cutting-edge cell therapy research and manufacturing, Kite is expanding its toehold in the BioSpace Hotbed region known as BioCapital.

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Kite first moved into Maryland in 2018 following the forging of a cell therapy-focused partnership with the National Cancer Institute to develop adoptive cell therapies targeting patient-specific tumor neoantigens, which are mutations found on the surface of cancer cells that are unique to each person and tumor.

Kite announced it leased a 26,000 square-foot facility in Gaithersburg, Maryland, which is just miles away from Bethesda, Maryland, home of the NCI. The Gaithersburg site is focused on research and clinical manufacturing of TCR-based, adoptive t-cell therapies for solid tumor cancers.

After two years, Kite has more than 60 employees in its Gaithersburg facility. More employees will be needed at the facility as Kite invests more money to expand the facility to support the solid tumor research.

Matthew Levy, Associate Director, Talent Acquisition with Kite told BioSpace in an interview that the work being accomplished at the Gaithersburg facility is exciting due to the cutting-edge technology. As the facility expands, Levy said Kite will continue to hire the best and brightest to help the company in its mission of curing cancer.

With Maryland’s rich life sciences ecosystem, one that includes multiple government agencies like NCI, the National Institutes of Health and the U.S. Food and Drug Administration, Levy said Kite will be able to draw on a highly skilled talent pool as it expands its headcount in Gaithersburg. Not only does Maryland have a strong pool of talent already in place, Levy said the state is a nice place to live and offers residents a lot of cultural and recreational amenities. Although Kite has not identified a target number of employees it will hire for the Gaithersburg site, Levy said the company is already hiring for a number of positions there and will be expanding further next year.

Gaithersburg isn’t the only site Kite has in the state of Maryland. In 2019, the company announced it will build a third cell therapy manufacturing facility to support the company’s CAR-T manufacturing needs. Kite selected Frederick, Maryland in addition to its two other facilities in California and The Netherlands. "This will enable us to meet the future needs for cell therapies," Levy said.

Following the FDA-approval of Yescarta, its CAR-T treatment for some blood cancers, Levy said the company realized that having additional capacity in manufacturing would be beneficial for the cutting-edge treatment. Logistically, Levy said it was beneficial to have a manufacturing facility on the East Coast of the United States. He noted that the individualized CAR-T treatment cannot be stockpiled like some other medications can and having the third facility better serves Kite’s patients.

In addition to the manufacture of Yescarta, which was approved in 2017 two months after Kite was acquired by Gilead Sciences for $12 billion, the Maryland facility will also be ready to produce future commercial cell therapies.

"We’re sparing no expense to bring the best science to bear for patients," Levy said.

The 280,000 square-foot Frederick facility is expected to come online in 2022. The site is expected to employ a few hundred people over the next several years and Levy said the company is actively recruiting for positions there. Types of positions the company is recruiting for include manufacturing, facilities and engineering, supply chain and quality.

When it comes to potential candidates, Levy said the company is looking for candidates who are patient-centric in their work. Ideal candidates will be passionate about using their technical skills to benefit cancer patients. Levy stressed a strong sense of connectivity between the work performed at Kite and the patients the company serves. For example, Cell Therapy Specialists – Kite’s manufacturing technicians – literally hold patients’ cells in their hands; that personalized approach drives home the point that patients are at the center of everything the company does, Levy noted.

"If someone is looking for an opportunity to positively impact cancer patients through cutting-edge work in cell therapy, Kite is a great place to be," Levy said. "We really mean it when we say that cancer is personal to us."