On October 13, 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 additional preliminary data from the Phase 1 clinical trial of its immuno-stimulating STAT3 inhibitor, WP1066, in patients with glioblastoma (GBM) (Press release, Moleculin, OCT 13, 2020, View Source [SID1234568385]). This supports the progression of the trial to the fourth and final dose escalation cohort. Three patients have completed treatment in the third cohort at a dose level of 8 mg/kg with no adverse events related to WP1066 and the study will now proceed to the next higher dose of 16 mg/kg.

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Walter Klemp, Chairman and CEO of Moleculin, stated, "On the heels of our recent positive announcement regarding the progress of the pediatric brain tumor trial of WP1066, we are pleased to also report on the progress of the adult GBM clinical trial for the same drug candidate. The trial in adults has been important in leading the way to establishing a safe and tolerable human dose level for what we believe is a first-in-class compound that crosses the blood-brain barrier and is being developed for the treatment of central nervous system malignancies. In animal models, WP1066 has been shown to stimulate immune responses that successfully modulate oncogenic transcriptional activity in tumor cells and repress their ability to drive tumor growth.

Mr. Klemp continued: "In addition to providing valuable pharmacokinetic data, this trial also creates the foundation for future studies in WP1066, including another investigator-initiated study, which is currently being proposed to examine the combination of WP1066 with radiation for the treatment of GBM. This next clinical trial is being proposed as a result of recent discoveries presented in a peer-reviewed article published in Clinical Cancer Research (Clin Cancer Res June 30 2020 DOI:10.1158/1078-0432.CCR-19-4092), which reported findings that Moleculin’s STAT3 inhibitor, WP1066, used in combination with traditional whole brain radiation therapy, resulted in long-term survivors and enhanced median survival time relative to monotherapy in mice with implanted human brain tumors."

Mr. Klemp concluded, "In keeping with our established clinical trial reporting policies, we look forward to updating investors on the continued progress of this trial once this final cohort is completed."

On October 13, 2020 Biomica, an emerging biopharmaceutical company developing innovative microbiome-based therapeutics, and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), reported the advancement to large-scale production of BMC128, its Live Bacterial Product (LBP) candidate consortium (Press release, Evogene, OCT 13, 2020, View Source [SID1234568384]). The microbes, which will be produced in large-scale are expected to support Biomica’s first-in-man proof-of-concept clinical trials for its immuno-oncology program, anticipated to begin in 2021. BMC128 is advancing to the GMP production stage following the successful completion of the initial R&D stage of drug product development and manufacturing, conducted by Biose Industrie (Aurillac, France).

Biomica’s immuno-oncology program is focused on its leading 4-strain candidate consortium BMC128. Biomica recently announced positive results in the program, demonstrating the efficacy of BMC128 in potentiating the response to immune-checkpoint inhibitors (ICI) in preclinical studies. In these studies, BMC128 was administered to mice bearing cancer tumors prior to and during ICI therapy, and the results showed that treatment with BMC128 significantly improved anti-tumor activity.

Biose Industrie is a drug-GMP certified manufacturer of bacteria-based APIs and clinical and commercial products. As previously announced earlier this year, Biomica engaged Biose for the scale-up development and GMP production of a clinical batch of its drug candidates.

Elran Haber, CEO of Biomica stated: "We are pleased with the continual advancements achieved with the production of our leading drug candidate, BMC128. The success seen in the R&D phase indicates that the production of these microbes is not only feasible but can be done efficiently in large scale. We will now be able to produce these microbes, which have demonstrated efficacy in pre-clinical trials, in large quantities in preparation for our proof-of-concept clinical trials in 2021."

Ofer Haviv, Chairman of Biomica and President & CEO of Evogene stated: "This is an additional important developmental milestone for Biomica. I am very proud of the progress that Biomica has achieved in 2020, and particularly that of its advancing immune-oncology program. We see significant opportunity in this program which has the potential to bring new solutions for patients currently uncurable under available therapies."

About BMC128

Developed as a Live Bacterial Product (LBPs), BMC128 is a rationally-designed LBP consortium comprised of four unique bacterial strains, natural inhabitants of the human intestinal tract, that harbor specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity through multiple biological processes.

Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a host’s microbial community with individually selected, cultured bacteria.

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On October 13, 2020 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, and Neogene Therapeutics, Inc., a biotechnology company pioneering a new class of fully personalized T cell therapies to treat cancer, reported a broad strategic partnership (Press release, Neogene Therapeutics, OCT 13, 2020, View Source [SID1234568383]). The companies will leverage Neogene’s proprietary expertise in targeting tumor neo-antigens, mutated proteins found in cancer cells due to cancer-associated DNA mutations, together with Twist’s DNA synthesis platform and product lines to develop personalized chimeric antigen receptor (CAR) T cell therapies and T cell receptor (TCR) therapies for patients with cancer.

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"Engineered T cell therapies have demonstrated benefit to patients with difficult-to-treat cancers. We are delighted to partner with Neogene, a company pioneering fully personalized T cell therapies for solid tumors," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "Putting our platforms together, we believe we will be able to expedite the identification and genetic engineering of TCR genes to create personalized T cell therapies for cancer, bringing new hope to address the current limitations of treatments available today."

"Neogene is committed to changing the treatment paradigm for solid cancers using our novel technology to provide access to tumor-specific TCRs for engineered T cell therapy on an individualized patient basis. Twist’s proven ability to make synthetic DNA products at scale provides a tremendous engine to power innovative, precise cancer therapeutics," said Carsten Linnemann, Ph.D., CEO and co-founder of Neogene Therapeutics. "We are confident that our proprietary platform for the development of personalized T cell therapies, combined with Twist’s diversified platform of synthetic DNA based tools, will allow us to expedite development of revolutionary treatment options for solid cancers."

Under the terms of the collaboration, Neogene and Twist will work together to develop novel tools for T cell therapies. Twist Biopharma, a division of Twist Bioscience, will create a specialized T cell receptor (TCR) library for Neogene with the goal of discovering engineered TCRs against two specified T cell targets in cancer for future Neogene personalized T cell therapies. Using its "Library of Libraries", Twist Biopharma also will discover antibodies with specific function, affinity and specificity to two oncology targets for future Neogene CAR-T therapies. These antibodies will have very fine (single point) specificity to their target providing the potential for novel CAR-T therapies against such targets.

Twist will receive technology access fees as well as milestones and royalties based on key preclinical, clinical and commercial milestones for any antibodies and T cell receptors resulting from the collaboration. Neogene will have exclusive rights to the synthetic TCR library for targeting viral and neo-antigens in the field of oncology.

On October 13, 2020 Bio-Techne Corporation (NASDAQ: TECH) reported that management will host a conference call and webcast on Thursday, November 5, 2020, at 8:00 a.m. CST to review first quarter 2021 financial results (Press release, Bio-Techne, OCT 13, 2020, https://investors.bio-techne.com/news/detail/215/bio-techne-to-host-conference-call-on-november-5-2020-to-announce-first-quarter-2021-financial-results [SID1234568382]).

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Access to the discussion may be obtained as follows:

Time:

8:00 a.m. CST

Date:

November 5, 2020

Dial-in:

1-855-327-6837 or 1-631-891-4304 (for international callers)

Conference ID:

10011451

Webcast:

View Source

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512-2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 10011451.

The replay will be available from 11:00 a.m. CST on Thursday, November 5, 2020 until 11:00 p.m. CST on Saturday, December 5, 2020.

On October 13, 2020 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous formulation (sold under the tradename DARZALEX FASPROTM in the U.S.), as reported by Johnson & Johnson were USD 1,099 million in the third quarter of 2020 (Press release, Genmab, OCT 13, 2020, View Source [SID1234568381]). Net trade sales were USD 585 million in the U.S. and USD 514 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX and DARZALEX FASPRO under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize daratumumab. As previously announced, Janssen has started reducing its royalty payments to Genmab by what it claims to be Genmab’s share of Janssen’s royalty payments to Halozyme, cf. company announcement No. 39 of September 22, 2020.

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About DARZALEX(daratumumab)
DARZALEX (daratumumab) has become a backbone therapy in the treatment of multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy; in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy2. Daratumumab is the first subcutaneous CD38 antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.

In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.3 DARZALEX FASPRO is the first subcutaneous CD38 antibody approved in the U.S. for the treatment of multiple myeloma.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,4,5,6,7

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.