On August 24, 2022 LumaBridge (formerly known as Cancer Insight), a clinical research organization (CRO) dedicated to discovering, developing, and testing emerging biotechnologies related to cancer therapies, and the Parker Institute for Cancer Immunotherapy (PICI), the largest network of immuno-oncology expertise in the world, have reported a new strategic partnership aimed at accelerating breakthrough immunotherapies from bench to bedside with greater ease (Press release, Cancer Insight, AUG 24, 2022, View Source [SID1234618825]). The new collaboration offers affiliated scientists and organizations a one-stop shop to advance research studies.

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The two organizations are collaborating to provide PICI Affiliated Partners—PICI Network institutions and investigators, affiliated companies, and nonprofit collaborators—direct access to the full suite of clinical trial services from LumaBridge. Offerings range from clinical trial design through regulatory strategy support, including patient accrual, clinical operations, quality assurance, data management, medical writing and biostatistics, pharmacovigilance, and beyond.

Patients awaiting new therapies deserve an effective, efficient process.

"PICI was founded to clear the path from scientific idea to best possible clinical outcomes," said Ute Dugan, MD, PhD, chief medical officer of PICI, based in San Francisco. "By combining our focus with additional expertise in clinical trial design and oversight, we aim to streamline the development process and ultimately accelerate novel immunotherapies to patients."

PICI’s first valued CRO partner, LumaBridge also is focused on accelerating the development of immunological cures for cancer through innovative science, advanced technologies, and new modes of research collaboration. Through this mission-focused alliance, PICI Affiliated Partners gain preferred access to and pricing for an array of clinical trial services and expertise, including early consulting on clinical trial design and development, protocol development, regulatory support, and full-service clinical trial support.

"Patients awaiting new therapies deserve an effective, efficient process," said George E. Peoples, MD, FACS, founder and chief medical officer of San Antonio-based LumaBridge. "Through this partnership, we will harness our pioneering experience in immuno-oncology research alongside the expertise of academic, clinical, and industry partners to reduce turnaround time and safely test the most promising novel therapies for our cancer patients."

More specifically, available LumaBridge services include:

Regulatory support for pre-investigational new drug meetings and investigational new drug (IND) preparation, publishing, filing, and maintenance
Clinical trial design, execution, and support such as medical monitoring, clinical operations, data management, and quality assurance
Medical writing and biostatistics support such as statistical analysis, US Food and Drug Administration (FDA) application writing, and abstract or journal publication preparation
Guidance in navigating government/military contracts and funding
Clinical development and commercialization strategies for Cancer Prevention and Research Institute of Texas (CPRIT) applicants
The partnership advances PICI’s focus on bringing together top researchers, nonprofits and industry collaborators, providing resources and eliminating barriers to get treatments to patients faster.

"Collaboration is critical to achieving our mission," said Tarak Mody, PhD, chief business officer of PICI. "By offering access to LumaBridge’s services and expertise to our PICI Affiliated Partners, we intend to accelerate breakthrough scientific discoveries, moving them into the clinic sooner to deliver patient impact."

On August 24, 2022 GT Biopharma reported the Registrant entered into a Settlement and Investment Agreement (the "Agreement") with Cytovance Biologics, Inc. ("Cytovance") pursuant to which the Registrant and Cytovance agreed to modify the payment terms under certain Scopes of Work (the "SOWs") issued under that certain Master Services Agreement with an effective date of October 5, 2020 between the Registrant and Cytovance (Filing, 8-K, GT Biopharma, AUG 24, 2022, View Source [SID1234618769]). In consideration for the foregoing modification, Cytovance will undertake the work under the SOWs, Change Orders with respect thereto and all other documentation relevant thereto (including to be negotiated Change Orders) required to facilitate the Registrant filing its investigational new drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for to its GTB-3650 product no later than March 31, 2023, and the filing of its IND application with the FDA for its GTB-5550 product no later than June 30, 2023, in each case provided that all materials are available and there are no supply chain disruptions, delays attributable to the Registrant or other delays outside of Cytovance’s control. The parties also agreed to release each other from claims for acts or omissions arising prior to the effectiveness of the Agreement.

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The Registrant will issue 1,222,281 shares of its common stock in satisfaction of $3,251,267.75 of outstanding invoices, and will pay $3,251,267.75 of outstanding invoices in cash over a period of three months. The Registrant will pay future invoices 50% in cash and 50% through the issuance of shares of its common stock (at a per share price based on the closing price of the Registrant’s common stock on the date of issuance), except that the Registrant will pay all materials invoices in cash, and will pay stability milestone invoices in cash up to an aggregate amount of $100,000.00, with the difference paid through the issuance of shares of the Registrant’s common stock. The Registrant may increase (by 5% per week for a total of 90% (inclusive of the 50% payable through the issuance of shares of the Registrant’s common stock)) the portion of future invoices paid through the issuance of shares of the Registrant’s common stock in the event that Cytovance fails to deliver products, components and/or materials as required by the delivery schedules set forth in applicable Change Orders contemplated under the Agreement, provided that all raw materials are available as targeted and there are no supply chain disruptions, delays attributable to the Registrant or other delays outside of Cytovance’s control.

The Agreement limits Cytovance’s ownership of shares of the Registrant’s common stock to 4.9% of the outstanding shares of the Registrant’s common stock. In the event any shares of the Registrant’s common stock issuable to Cytovance would exceed the foregoing beneficial ownership limitation, the Registrant will issue such shares on a quarterly basis to the extent it may issue such shares without exceeding the beneficial ownership limitation until all such shares are issued. The Registrant also agreed to certain covenants with a view to making available to Cytovance the benefits of Rule 144 promulgated under the Securities Act of 1933, as amended, provided that Cytovance has agreed to limit its daily resale of eligible shares to the lesser of 50,000 shares or one-third of the average daily trading volume for the week preceding the proposed sale.

On August 24, 2022 Privo Technologies, Inc. ("Privo"), a phase 3 clinical stage biopharmaceutical company that has designed and developed a nanoengineered drug delivery platform to safely deliver highly potent drugs locoregionally, reported that Nature Communications published the results of the evaluation of efficacy and safety data collected using PRV111 on animal models of oral cancer and clinical trial in patients with oral cavity squamous cell carcinoma (OCSCC) (Press release, Privo Technologies, AUG 24, 2022, View Source;utm_medium=rss&utm_campaign=privo-technologies-inc-announces-publication-in-nature-communications [SID1234618715]).

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The article titled, "A nanoengineered topical transmucosal cisplatin delivery system induces anti-tumor response in animal models and patients with oral cancer" details the observed therapeutic benefit from topical delivery, via the PRV Platform, of high concentrations of cisplatin to the tumor and regional lymph nodes while avoiding systemic circulation. "We are very pleased to publish our work in a high-ranking peer-reviewed journal such as Nature Communications. This data highlights the promise of targeted and local chemotherapy treatment and validates the superior mechanism and design of the PRV Platform and its lead derivative PRV111. This data serves as a critical milestone for entering into a Phase 3 clinical trial for patients with Carcinoma in Situ of the oral cavity as well as a springboard for exploring the use of the platform in other mucosal cancers such as lung, cervical, vaginal, rectal, and anal cancers" said Manijeh Goldberg, PhD, founder and CEO of Privo. Dr. Goldberg is the first author of the article, which was published in collaboration with Dr. Nishant Agrawal, MD FACS, and Dr. Evgeny Izumchenko, PhD, at the University of Chicago, Dept of Surgery and Dept of Medicine, respectively. Dr. Goldberg, Dr. Agrawal, and Dr. Izumchenko are the corresponding authors.

"The data from this paper provides validation of our platform for nano-encapsulating highly potent drugs while providing controlled delivery and release. Privo is excited to add to the growing body of scientific evidence demonstrating that encapsulation for local delivery of highly toxic chemotherapies and other drug classes can unlock therapeutic benefits, disrupting the targeted drug delivery industry both topically and intraoperatively" said Dr. Goldberg. "We are grateful to our clinical sites and their investigative teams for their participation in this study, and of course indebted to our patients and the oral cancer community for their support of our technology." Enrollment sites included UT Health Science Center School of Dentistry and Baylor College of Medicine in Houston, TX; University of Cincinnati Cancer Institute in Cincinnati, OH; Advanced ENT and Allergy in Louisville, KY; Ben Taub Hospital and Memorial Hermann Hospital in Houston, TX.

"The treatment for oral cancer may involve life-transforming surgery which can impact function. The data presented on Privo’s PRV111 is an important step in the approval process of what will be a transformative product that has the potential to change standard of care," said Dr. Nishant Agrawal. Dr. Agrawal is the Chief of Otolaryngology-Head and Neck Surgery and Co-Director of Head and Neck Surgical Oncology at the University of Chicago.

The complete article is available in print and in digital format which can be viewed via the following link: (View Source).

Nature Communications is a peer-reviewed, open access, multidisciplinary journal dedicated to publishing high-quality research in all areas of biological, health, physical, chemical and Earth sciences.

On August 24, 2022 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the European Commission (EC) has granted conditional marketing authorisation (CMA) of TECVAYLI▼ (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) (Press release, Johnson & Johnson, AUG 24, 2022, View Source [SID1234618675]). Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.1 Today’s milestone marks the first approval worldwide for teclistamab, a first-in-class bispecific antibody that redirects CD3-positive T-cells to B-cell maturation antigen (BCMA)-expressing myeloma cells to induce the killing of tumour cells.1

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Multiple myeloma remains an incurable blood cancer, with nearly all patients relapsing and requiring subsequent therapy.2,3 As the disease progresses, relapses for patients become more aggressive with each new line of therapy, and remissions become progressively shorter.4

"Despite important scientific progress, patients who develop relapsed and refractory disease after having been exposed to the three major drug classes have limited therapeutic options and generally face poor outcomes," said Maria-Victoria Mateos, M.D., Ph.D., Consultant Physician in Haematology, University Hospital of Salamanca.* "Teclistamab has the potential to provide substantial clinical benefit and new hope to these patients, with high rates of deep and durable responses, and the added convenience of being off-the-shelf."

"The approval of teclistamab followed an accelerated approval pathway, supported via the EMA’s PRIME scheme," said Edmond Chan, MBChB M.D. (Res), Senior Director EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. "We would like to thank the medical community for recognising the promise of teclistamab. Multiple myeloma is a complex disease that requires a complex set of solutions. Only by working together can we ensure that patients are able to benefit from innovation, such as teclistamab, as early as possible."

CMA is the approval of a medicine that addresses unmet medical needs of patients based on less comprehensive data than normally required, where the benefit of immediate availability of the medicine outweighs the risk, and the applicant is able to provide comprehensive clinical data in the future.5

The CMA was supported by positive results from the multicohort, open-label Phase 1/2 MajesTEC-1 study (NCT03145181 and NCT04557098), evaluating the safety and efficacy of teclistamab in adults with RRMM (n =165).1,6,7 Patients received a weekly subcutaneous injection of teclistamab at a dose of 1.5 mg/kg, after receiving step-up doses of 0.06 mg/kg and 0.3 mg/kg.1 In the study, 104 out of 165 patients achieved an overall response rate (ORR) of 63 percent (95 percent Confidence Interval [CI]; range, 55.2–70.4) after a median of five prior lines of therapy.1 Notably, 58.8 percent of patients receiving teclistamab achieved a very good partial response (VGPR) or better and 39.4 percent achieved a complete response (CR) or better.1 The median time to the first confirmed response was 1.2 months (range, 0.2–5.5 months) and the median duration of response was 18.4 months (95 percent CI; range, 14.9–not estimable).1

Results from the MajesTEC-1 study were also published in The New England Journal of Medicine and showed that treatment with teclistamab resulted in deep and durable responses.8 The median duration of progression-free survival was 11.3 months (95 percent CI; range, 8.8–17.1) and the median duration of overall survival was 18.3 months (95 percent CI; range, 15.1–not estimable).8

Adverse events (AEs) were consistent with this patient population. The most common AEs were cytokine release syndrome (72 percent; 0.6 percent Grade 3, no Grade 4), neutropenia (71 percent; 64 percent Grade 3 or 4) and anaemia (55 percent; 37 percent Grade 3 or 4).1 Infections were frequent with the most common being upper respiratory tract infections (37 percent; 2.4 percent Grade 3 or 4) and pneumonia (28 percent; 19 percent Grade 3 or 4).1 Hypogammaglobinaemia occurred in 123 patients (75 percent) and 39 percent of patients received intravenous or subcutaneous immunoglobulin therapy.1 Neurotoxic events were low grade (15 percent; 14 percent Grade 1 or 2) and five patients (three percent) had immune effector cell-associated neurotoxicity syndrome.1

"With nearly 20 years of dedicated leadership in this area, our ambition to advance the best science to deliver novel therapies and regimens for the treatment of multiple myeloma is as strong today as it has ever been. We now look forward to collaborating with health authorities worldwide to make this treatment available to patients," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC.

"This first approval for teclistamab worldwide marks significant progress for patients with relapsed and refractory multiple myeloma," said William N. Hait, M.D., Ph.D., Executive Vice President, Chief External Innovation, Medical Safety and Global Public Health Officer, Johnson & Johnson. "Teclistamab is an important addition to our multiple myeloma portfolio. We are continuing to invest in clinical development to expand its potential and offer novel options for patients and physicians."

#ENDS#

About Teclistamab

Teclistamab is a first-in-class, off-the-shelf (ready to use) bispecific antibody.1 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight the cancer.1

The application for conditional marketing authorisation was reviewed by the Committee for Medicinal Products for Human Use (CHMP) under an accelerated timetable to enable faster patient access to this medicine.9 This was also supported though the European Medicines Agency’s (EMA) PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients’ unmet medical needs.10

Teclistamab is currently being evaluated in several monotherapy and combination studies.7,11,12,13,14

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.15 In multiple myeloma, cancerous plasma cells change and grow out of control.15 In Europe, more than 50,900 people were diagnosed with multiple myeloma in 2020, and more than 32,400 patients died.16 While some patients with multiple myeloma initially have no symptoms, others can have common symptoms of the disease which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels or kidney failure.17

On August 24, 2022 EDAP TMS SA (Nasdaq: EDAP) (the "Company"), a global leader in robotic energy-based therapies, reported that unaudited financial results for the second quarter 2022 (Press release, EDAP TMS, AUG 24, 2022, View Source [SID1234618666]).

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Marc Oczachowski, EDAP’s Chairman and Chief Executive Officer, said: "For the second quarter 2022, we generated strong year-over-year revenue growth of nearly 37% driven by contribution from all three business segments, including our core HIFU business, which grew nearly 50% over the prior year period. The measured investments that we continue to make in our US team and infrastructure continue to bear fruit as HIFU, and specifically Focal One, becomes integral to the modern prostate cancer treatment paradigm."

"Our pipeline of sales prospects continues to grow, driven by a combination of new world-renowned healthcare institutions that have adopted Focal One, and champion this technology, and our growing presence at important medical meetings such as the annual meeting of the American Urological Association this past May. These trends, together with the proposed increase in reimbursement for CY23 indicated in the preliminary CMS Outpatient Prospective Payment System (OPPS) rule, give me great optimism for the future adoption of our Focal One platform." Mr. Oczachowski concluded.

Ryan Rhodes, Chief Executive Officer of EDAP US, stated, "Following the close of the second quarter, we learned that the Centers for Medicare and Medicaid Services, in its proposed OPPS rule for calendar year 2023, raised Focal One HIFU reimbursement to APC Level 6 from Level 5 currently. It is difficult to overstate the positive impact such a change would have on expanding patient procedure access should the increase stand in the final rule, which we expect to be published in November. We are very pleased with this proposed increase to hospital reimbursement and believe it more accurately reflects the significant clinical value that HIFU brings to the urology suite."

"We also will be hosting an in-person Focal One Expert User Panel Event in New York City in September, to coincide with Prostate Cancer Awareness Month. The event will feature presentations from several renowned thought leaders and will also include a demonstration of the Focal One procedure."

Year-to-Date Results

Total revenue for the six months ended June 30, 2022, was EUR 27.1 million (USD 29.5 million), an increase of 31.5% from total revenue of was EUR 20.7 million (USD 24.8 million) for the same period in 2021.

Total revenue in the HIFU business for the six months ended June 30, 2022, was EUR 6.8 million (USD 7.4 million), an increase of 78.8% as compared to EUR 3.8 million (USD 4.6 million) for the six months ended June 30, 2021.

Total revenue in the LITHO business for the six months ended June 30, 2022, was EUR 5.8 million (USD 6.3 million), an increase of 11.6% from EUR 5.2 million (USD 6.2 million) for the six months ended June 30, 2021.

Total revenue in the Distribution business for the six months ended June 30, 2022, was EUR 14.6 million (USD 15.9 million), a 24.8% increase compared to EUR 11.7 million (USD 14.0 million) for the six months ended June 30, 2021.

Gross profit for the six months ended June 30, 2022, was EUR 12.0 million (USD 13.0 million), compared to EUR 8.6 million (USD 10.3 million) for the year-ago period. Gross profit margin on net sales was 44.0% for the six months ended June 30, 2022, compared to 41.6% for the comparable period in 2021. The increase in gross profit year-over-year was due to higher sales effect on fixed costs, particularly in the HIFU business.

Operating expenses were EUR 12.5 million (USD 13.6 million) for the six months ended June 30, 2022, compared to EUR 8.8 million (USD 10.5 million) for the same period in 2021.

Operating loss for the six months ended June 30, 2022, was EUR 0.5 million (USD 0.6 million), compared to an operating loss of EUR 0.2 million (USD 0.2 million) for the six months ended June 30, 2021.

Net income for the six months ended June 30, 2022, was EUR 2.2 million (USD 2.4 million), or EUR 0.06 per diluted share, as compared to a net income of EUR 0.4 million (USD 0.4 million), or EUR 0.01 per diluted share in the year-ago period.

As of June 30, 2022, the company held cash and cash equivalents of EUR 46.3 million (USD 48.5 million), as compared to EUR 47.2 million (USD 53.4 million) as of December 31, 2021.

Second Quarter 2022 Results

Total revenue for the second quarter 2022 was EUR 14.2 million (USD 15.0 million), a 36.7% increase as compared to total revenue of EUR 10.4 million (USD 12.4 million) for the same period in 2021.

Total revenue in the HIFU business for the second quarter 2022 was EUR 3.0 million (USD 3.2 million), an increase of 49.3% as compared to EUR 2.0 million (USD 2.4 million) for the second quarter of 2021.

Total revenue in the LITHO business for the second quarter 2022 was EUR 3.6 million (USD 3.8 million), an increase of 55.7% from was EUR 2.3 million (USD 2.7 million) for the second quarter of 2021.

Total revenue in the Distribution business for the second quarter 2022 was EUR 7.6 million (USD 8.1 million), a 25.5% increase compared to EUR 6.1 million (USD 7.3 million) for the second quarter of 2021.

Gross profit for the second quarter 2022 was EUR 6.2 million (USD 6.6 million), compared to EUR 4.2 million (USD 5.1 million) for the year-ago period. Gross profit margin on net sales was 43.8% in the second quarter of 2022, compared to 40.7% in the year-ago period. The increase in gross profit year-over-year was driven by the higher sales effect on fixed costs.

Operating expenses were EUR 6.6 million (USD 7.0 million) for the second quarter of 2022, compared to EUR 4.6 million (USD 5.6 million) for the same period in 2021.

Operating loss for the second quarter of 2022 was EUR 0.4 million (USD 0.5 million), compared to an operating loss of EUR 0.4 million (USD 0.5 million) in the second quarter of 2021.

Net income for the second quarter of 2022 was EUR 1.8 million (USD 1.9 million), or EUR 0.05 per diluted share, as compared to a net loss of EUR 0.4 million (USD 0.5 million), or EUR 0.01 per diluted share in the year-ago period.

In-person Focal One Expert User Panel Event
The management team of EDAP will host a In-person Focal One Expert User Panel Event in New York City on Thursday, September 29. View Source

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT tomorrow, August 25, 2022. Please refer to the information below for conference call dial-in information and webcast registration.