On October 21, 2020 GT Biopharma, Inc. (OTCQB:GTBP) (GTBP.PA) an immuno-oncology company focused on innovative therapies based on the Company’s proprietary NK cell engager (TriKE) technology reported the publication of "NK-Cell-Mediated Targeting of Various Solid Tumors Using a B7-H3 Tri-Specific Killer Engager In Vitro and In Vivo" in the journal Cancers, volume 12, issue 9, page 2659; (View Source) (Press release, GT Biopharma, OCT 21, 2020, View Source [SID1234568724]). The research effort was conducted by researchers at the University of Minnesota and at Massachusetts General Hospital/Harvard Medical School.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

B7H3 (CD276) is a costimulatory membrane protein, and a member of the B7 family of costimulatory membrane proteins which include PD-1, PD-L1 and CTLA-4. B7 family members such as PD-1/PD-L1 and CTLA-4 play important roles in the checkpoint blockade of immune cells by cancer cells. B7H3 is highly expressed on the surface of several types of cancer, and exhibits low expression on normal tissues. The findings presented indicate that a B7H3-targeted TriKE has the potential to enhance natural killer (NK) cell immunotherapy in solid tumor settings, and supports its further clinical development.

Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma, commented "we are pleased with the results of the research, and expect to advance a B7H3 TriKE product candidate to clinical development."

On October 21, 2020 Abbott (NYSE: ABT) reported financial results for the third quarter ended Sept. 30, 2020 (Press release, Abbott, OCT 21, 2020, View Source [SID1234568723]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Third-quarter worldwide sales of $8.9 billion increased 9.6 percent on a reported basis and 10.6 percent on an organic basis, which excludes the impact of foreign exchange.
Reported diluted EPS from continuing operations under GAAP was $0.69 and adjusted diluted EPS from continuing operations, which excludes specified items, was $0.98, reflecting 16.7 percent growth versus the prior year.1
Abbott projects full-year 2020 diluted EPS from continuing operations on a GAAP basis of at least $2.35 and full-year adjusted diluted EPS from continuing operations of at least $3.55.
In August, Abbott received FDA Emergency Use Authorization for its BinaxNOW COVID-19 Ag Card rapid test for the detection of COVID-19 infection. The test delivers results in just 15 minutes with no instrumentation required. Abbott is selling the test for $5 and offers a complementary mobile phone app, called NAVICA, that allows people who test negative to display their result.
During the quarter, Abbott launched FreeStyle Libre 2 and obtained CE Mark for FreeStyle Libre 3, which automatically delivers up-to-the-minute glucose readings, unsurpassed 14-day accuracy2 and real-time glucose alarms in the world’s smallest and thinnest3 wearable sensor at the same affordable price4 as previous versions. Abbott also announced CE Mark for its Libre Sense Glucose Sport Biosensor, which helps athletes better understand the efficacy of their nutritional choices on training and athletic performance.
In September, Abbott obtained CE Mark for MitraClip G4, its next-generation MitraClip heart device, the leading minimally invasive mitral valve repair device in the world.
"Our strong results and increased guidance are a direct reflection of our ability to innovate and deliver despite challenging conditions," said Robert B. Ford, president and chief executive officer, Abbott. "Our new product pipeline continues to be highly productive, and we’re well-positioned to finish the year with a lot of momentum."

THIRD-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business. Organic sales growth excludes the impact of foreign exchange.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Third-quarter 2020 worldwide sales of $8.9 billion increased 9.6 percent on a reported basis and 10.6 percent on an organic basis.

Worldwide Nutrition sales increased 2.6 percent on a reported basis and 4.1 percent on an organic basis in the third quarter. Strong U.S. and international sales performance of Ensure, Abbott’s market-leading complete and balanced nutrition brand, led to global Adult Nutrition sales growth of 10.6 percent on a reported basis and 12.4 percent on an organic basis. In Pediatric Nutrition, U.S. sales were led by growth of Pedialyte, Abbott’s oral rehydration brand, and PediaSure. Internationally, Pediatric Nutrition growth in Southeast Asia was offset by challenging conditions in Greater China.

Worldwide Diagnostics sales increased 38.2 percent on a reported basis in the third quarter and increased 38.8 percent on an organic basis. Strong growth in the quarter was driven by demand for Abbott’s portfolio of COVID-19 diagnostics tests on its lab-based immunoassay and molecular diagnostics systems and point-of-care rapid testing platforms. Global COVID-19 testing-related sales were $881 million in the quarter.

Established Pharmaceuticals sales decreased 9.3 percent on a reported basis in the third quarter and decreased 3.3 percent on an organic basis.

Key Emerging Markets include India, Brazil, Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies decreased 10.3 percent on a reported basis in the quarter and decreased 1.8 percent on an organic basis primarily due to market softness across several countries as a result of the spread of COVID-19.

a) Includes drug-eluting stents, balloon catheters, guidewires, vascular imaging/diagnostics products, vessel closure, carotid and other coronary and peripheral products.

Worldwide Medical Devices sales increased 3.4 percent on a reported basis in the third quarter and increased 2.6 percent on an organic basis. Sales growth and procedure volume trends across Abbott’s cardiovascular and neuromodulation business areas improved significantly versus the prior quarter as demand continues to return to more normalized levels.

In Diabetes Care, strong growth was led by FreeStyle Libre, which grew 37.9 percent on a reported basis and 35.6 percent on an organic basis. In September, Abbott obtained CE Mark for its FreeStyle Libre 3 system, which automatically delivers real-time, up-to-the-minute glucose readings, unsurpassed 14-day accuracy2 and real-time glucose alarms in the world’s smallest and thinnest3 wearable sensor at the same affordable price4 as previous versions. Abbott also obtained CE Mark for its Libre Sense Glucose Sport Biosensor in Europe. Libre Sense is a consumer over-the-counter product that provides continuous glucose monitoring for athletes to better understand the efficacy of their nutrition choices on training and athletic performance.

ABBOTT’S GUIDANCE FOR 2020
Abbott projects full-year 2020 diluted earnings per share from continuing operations under GAAP of at least $2.35. Abbott forecasts specified items for the full-year 2020 of $1.20 primarily related to intangible amortization, acquisition-related expenses, restructuring and cost reduction initiatives and other net expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be at least $3.55 for full-year 2020.

ABBOTT DECLARES 387TH CONSECUTIVE QUARTERLY DIVIDEND
On Sept. 17, 2020, the board of directors of Abbott declared the company’s quarterly dividend of $0.36 per share. Abbott’s cash dividend is payable Nov. 16, 2020, to shareholders of record at the close of business on Oct. 15, 2020.

Abbott has increased its dividend payout for 48 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On October 21, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the combination of ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, and umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, for the treatment of adult patients with chronic lymphocytic leukemia (CLL) (Press release, TG Therapeutics, OCT 21, 2020, View Source [SID1234568722]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "We are extremely pleased to have received Fast Track designation for the ublituximab plus umbralisib regimen, or the U2 combination, to treat adult patients with CLL. The application for Fast Track was based on data from the UNITY-CLL Phase 3 study that we announced earlier this year had met its primary endpoint of progression free survival. This designation holds several important advantages to potentially expedite the development and regulatory review of U2 and underscores the significant unmet medical need that still exists for patients with CLL." Mr. Weiss continued, "We look forward to presenting data from the UNITY-CLL Phase 3 trial later this year, which we plan to use as the basis of a U2 regulatory submission for CLL."

ABOUT FAST TRACK
Fast Track is a program designed to expedite the development and review of drugs that treat serious conditions and that demonstrate the potential to address an unmet medical need. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy that may be potentially better than available therapy.

A drug that receives Fast Track designation is eligible for more frequent interactions with the FDA, priority review if relevant criteria are met, and rolling submission of the Biologic License Application or New Drug Application.

ABOUT UNITY-CLL PHASE 3 TRIAL
UNITY-CLL is a global Phase 3 randomized controlled clinical trial comparing the combination of ublituximab plus umbralisib, or U2, to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment-naïve and relapsed or refractory chronic lymphocytic leukemia (CLL). The trial randomized patients into four treatment arms: ublituximab single agent, umbralisib single agent, ublituximab plus umbralisib and an active control arm of obinutuzumab plus chlorambucil. A prespecified analysis was conducted to assess the contribution of ublituximab and umbralisib in the U2 combination arm and allowed for the termination of the single agent arms. Accordingly, the UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil. Full enrollment into the UNITY-CLL Phase 3 trial completed in October of 2017 with approximately 420 subjects enrolled to the two combinations arms. This trial enrolled approximately 60% treatment-naïve CLL patients and 40% relapsed or refractory CLL patients. The primary endpoint for this study was superior Progression Free Survival (PFS) for the U2 combination compared to the control arm to support the submission for full approval of the U2 combination in CLL. Positive topline results from this trial were announced in May 2020. The UNITY-CLL Phase 3 trial is being conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

ABOUT CHRONIC LYMPHOCYTIC LEUKEMIA
Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia, and in 2020 it is estimated there will be more than 20,000 new cases of CLL diagnosed in the United States1. Although signs of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of malignant cells.

On October 21, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting significant unmet needs in the treatment of tumors and viruses, reported results from an independent laboratory validating internal animal studies showing the ability of Annamycin to target lung localized tumors (Press release, Moleculin, OCT 21, 2020, View Source [SID1234568721]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Walter Klemp, Chairman and CEO of Moleculin, stated, "This is some of the most compelling data we have seen yet to support our plans for a clinical trial evaluating the potential for Annamycin to treat lung metastatic tumors. There is an extreme unmet need for a more effective treatment of sarcomas that have metastasized to the lungs, and we intend for this to be a primary focus of our next IND for Annamycin. The timing of this new information is particularly encouraging, considering the progress we reported from our recent Pre-IND meeting with the FDA. We are hopeful we can submit this IND before year-end."

The relevance of targeting lung localized tumors is that it could provide a means to address a significant unmet need in cancer therapy. Specifically, there are limited treatment options for lung metastases resulting from a primary tumor, even though the primary tumor may have been treatable. For example, a primary soft tissue sarcoma can often be initially successfully treated (most often by removal), but if it has spread to the lungs, the anthracycline Adriamycin (doxorubicin), the approved treatment for patients whose lung-localized metastases cannot be surgically removed, has only limited efficacy. Research sponsored by Moleculin and recently presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting held from June 22nd-24th, 2020 suggested a possible reason for this limited efficacy may be the inability of doxorubicin to sufficiently accumulate in the lungs in concentrations required to kill tumor cells. That presentation included findings from preliminary animal studies demonstrating that Moleculin’s drug candidate Annamycin, a more potent and non-cardiotoxic anthracycline, was capable of accumulating in the lungs of mice at up to 6-fold higher concentrations than doxorubicin.

The latest studies conducted in rats validated the previous animal studies presented at AACR (Free AACR Whitepaper). Additionally, these experiments compared both Free Annamycin (F-Anna) and Liposomal Annamycin (L-Anna) with doxorubicin (Dox), which is the current standard of care for sarcomas and other human malignancies including some that have metastasized to the lungs. The purpose of testing F-Anna (the non-liposomal form of Annamycin) was to determine whether the observed uniquely high accumulation of Annamycin in the lungs was due to its liposomal formulation (L-Anna) or whether it is an inherent property of Annamycin itself. The preliminary results show that F-Anna accumulates in the lungs of rats to a concentration 9-fold higher than Dox, demonstrating that the differences in molecular structure of Annamycin when compared to doxorubicin are responsible for Annamycin’s comparatively high accumulation in lungs and, we believe, consequently should enable an ability to target tumor cells in the lungs. In addition to the unique properties of the free drug Annamycin, the liposomal formulation further increased accumulation in the lungs and the noted concentration was more than 30-fold higher than Dox. In summary, we believe the apparent ability of the liposomal formulation of Annamycin to further enhance the natural ability of free Annamycin to accumulate in lungs without any observed toxic side effects creates a highly promising anticancer agent that may be uniquely capable of targeting lung localized tumors.

Mr. Klemp concluded, "Although our focus has been on the potential to treat sarcoma lung metastases with Annamycin, we should also point out that the indications for Annamycin might be expanded and could include lung metastatic breast cancer, colon cancer, prostate cancer, bladder cancer, and neuroblastoma. Our animal studies have already demonstrated the ability of Annamycin to significantly increase survival of mice in lung localized triple negative breast cancer and colon cancer models.

As a part of our general approach to anticancer drug design, we are currently also exploring the possibility of targeting other organs that can be considered ‘sanctuary sites of cancer’. In our opinion, our additional data continues to point to the potential for Annamycin to become an important drug in a wide range of cancers, especially in light of its lack of cardiotoxicity, which is being demonstrated in our ongoing clinical trials for AML."

On October 21, 2020 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported positive top-line results from the Company’s ongoing Phase 1 CARBON trial evaluating the safety and efficacy of CTX110, its wholly-owned allogeneic CAR-T cell therapy targeting CD19+ B-cell malignancies (Press release, CRISPR Therapeutics, OCT 21, 2020, View Source [SID1234568720]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are highly encouraged by today’s data, which demonstrate the promise of allogeneic therapies in treating hematological malignancies," said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. "Over time, we believe CRISPR-edited allogeneic CAR-T has the potential to leapfrog autologous CAR-T and benefit much broader patient populations. We continue to enroll patients and look forward to additional data read-outs for this program as well as our other allogeneic CAR-T programs, CTX120 and CTX130, next year. We are grateful to the patients and investigators who have made this important research possible."

"From this early data read-out, CTX110 has shown dose-dependent efficacy and response rates that are comparable to the early autologous CAR-T trials. Furthermore, CTX110 had an acceptable safety profile, which could make CAR-Ts more widely accessible," said Joseph McGuirk, D.O., Professor of Medicine and Division Director of Hematologic Malignancies and Cellular Therapeutics at the University of Kansas Medical Center and investigator in the Phase 1 CARBON trial of CTX110. "While longer follow-up is required, these early data support the potential for CTX110 to become an effective off-the-shelf CAR-T therapy for patients with relapsed or refractory B-cell malignancies."

CARBON Trial Overview
The Phase 1 CARBON trial is an open-label, multicenter study evaluating the safety and efficacy of CTX110 in adult patients with relapsed or refractory non-Hodgkin lymphoma, who have received at least two prior lines of therapy. As of the September 28, 2020, data cutoff, 12 patients were enrolled and infused with CTX110. Data are reported for the 11 patients who had at least completed their one-month assessment as of the data cutoff date.

Patients were infused with CTX110 following three days of lymphodepletion using fludarabine (30mg/m2/day) and cyclophosphamide (500mg/m2/day). The primary endpoints include safety as measured by the incidence of dose limiting toxicities (DLTs) and overall response rate. Key secondary endpoints include duration of response, progression-free survival and overall survival.

Additional details may be found at clinicaltrials.gov, using identifier: NCT04035434.

Safety Data Overview
Dose Levels 1 – 3 (n=10)
No DLTs were observed. There were no cases of Graft-vs-Host Disease (GvHD) despite high HLA-mismatch between allogeneic CAR-T donors and patients. No infusion reactions to either lymphodepleting chemotherapy or CTX110 were observed. Cytokine Release Syndrome (CRS) occurred in three patients (30%) and in each case was Grade 2 or below and resolved with tocilizumab administration. One patient (10%) had Grade 2 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) that improved within 24 hours with standard interventions. Two additional serious adverse events (periorbital cellulitis and febrile neutropenia) occurred after CTX110 infusion, both of which resolved and were determined to be unrelated to disease progression or CTX110.

Dose Level 4 (n=1)
One patient received Dose Level 4 of CTX110. On Day 5, the patient experienced Grade 2 CRS which resolved in 5 days. The PET/CT assessment at Day 25 showed the patient had achieved a complete response. The following day, the patient was hospitalized with febrile neutropenia and developed symptoms of short-term memory loss and confusion. The symptoms eventually progressed to significant obtundation that required intubation. He was initially treated for ICANS with steroids, anakinra and intrathecal chemotherapy without improvement. The patient was later found to have reactivation of HHV-6 and HHV-6 encephalitis and treated with antiviral therapy. The decision was made to withdraw supportive care and the patient died 52 days after CTX110 infusion.

Clinical Activity (n=11)
Early evidence of dose-dependent anti-tumor activity was seen with CTX110. Disease assessment was performed by centralized independent radiological review according to the 2014 Lugano response criteria.

Cell dose
(CAR+ T cells) DL1
30×106
N=3 DL2
100×106
N=3 DL3
300×106
N=4 DL4
600×106
N=1
Overall response rate (ORR), N (%) 0 (0%) 1 (33%) 2 (50%) 1 (100%)
Complete response
(CR) rate, N (%) 0 (0%) 1 (33%) 2 (50%) 1 (100%)
Complete response (CR) was achieved at Dose Levels 2, 3, and 4. At DL3, two out of four patients had a complete response. These two patients remain in CR.
The four patients with CR had deep responses including the complete resolution of extranodal disease, normalization of all nodal disease to 1.5 cm or smaller, and a Deauville score of 2 or lower. Additionally, one of these patients who had 30% lymphoblasts in the bone marrow achieved complete clearance after CTX110 infusion.
CR was achieved both in patients with diffuse large B-cell lymphoma and with transformed follicular lymphoma, as well as in patients who were primary refractory and who had relapsed after autologous stem cell transplant.
At DL2 and above, CTX110 was detected at multiple time points in all patients, with peak expansion occurring at 1-2 weeks and cells detected as late as 180 days post-infusion​.
Conference Call and Webcast
CRISPR Therapeutics will host a conference call and webcast today at 8:30 a.m. ET. The webcast will be made available on the CRISPR Therapeutics website at View Source in the Investors section under Events and Presentations. Following the live audio webcast, the presentation and replay will be available on the Company’s website for approximately 30 days.

Dial-In Information
Live (U.S. / Canada): +1 (866) 342‑8588
Live (International): +1 (203) 518‑9865
Conference ID: 80521

About CTX110
CTX110, a wholly owned program of CRISPR Therapeutics, is a healthy donor-derived gene-edited allogeneic CAR-T investigative therapy targeting cluster of differentiation 19, or CD19. CTX110 is being investigated in the CARBON trial.

About CARBON
The ongoing Phase 1 single-arm, multi-center, open label clinical trial, CARBON, is designed to assess the safety and efficacy of several dose levels of CTX110 for the treatment of relapsed or refractory B-cell malignancies. CRISPR Therapeutics is the sponsor of the CARBON trial.