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.

On October 13, 2020 IONTAS Limited (IONTAS), an innovative biotechnology company focused on antibody discovery and cutting-edge technology development, reported that it has entered into a licensing agreement with Bristol Myers Squibb Company regarding the Company’s proprietary mammalian display (Press release, Iontas, OCT 13, 2020, View Source [SID1234568378]).

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Under the terms of this agreement, IONTAS will receive an upfront payment for accessing the technology platform and will work with Bristol Myers Squibb in establishing the platform within its facilities. Additional near-term payments include maintenance fees, the achievement of development milestones, and eventual royalty payments on all antibodies derived from the platform.

IONTAS’ proprietary mammalian display technology enables large libraries of full-length antibodies to be expressed on the surface of mammalian cells, in a way that allows selection for optimal binding properties and optimal biophysical properties. These benefits can significantly reduce the risk of antibodies failing during the expensive manufacturing stages. Effectively the platform allows the right lead antibodies to be selected early in the discovery process, reducing the requirement for any potential costly re-engineering to correct developability issues.

John McCafferty, Chief Scientific Officer of IONTAS and inventor of the platform, commented: "We are excited to have Bristol Myers Squibb, one of the global leading biopharmaceutical companies, as our licensing partner. Our mammalian display system not only allows the screening of tens of millions of clones directly for binding but also has a unique advantage to detect developability issues. This allows us to ’fix’ problematic antibodies and identify them during early drug discovery. This can save the industry significant time and money by generating developable products faster."

On October 13, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, reported that the colorectal cancer cohort in part 1 of the ONCOS-102 and durvalumab trial in colorectal and platinum-resistant ovarian cancer that has spread to the peritoneum has met the pre-defined efficacy threshold of patients without progression at the end of week 24 (Press release, Targovax, OCT 13, 2020, View Source [SID1234568350]). The second part of the colorectal expansion cohort is now open for recruitment.

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The study is an open label, exploratory phase I/II trial assessing the combination of intra-peritoneally delivered ONCOS-102 in combination with systemically administered durvalumab, an anti-PD-L1 checkpoint inhibitor, in patients with colorectal (CRC) or platinum-resistant ovarian (OC) cancers that have metastasized to the peritoneal cavity. The trial is designed with a dose-escalation phase assessing three different dosing levels, followed by an expansion phase split into separate CRC and OC cohorts. The expansion phase is divided into two parts, where the second part is opened only if a pre-defined efficacy threshold is met in the first part. The efficacy threshold in the CRC cohort is 1 out of 13 patients and 5 out of 18 patients in the OC cohort without progression at week 24.

Ludwig Cancer Research, the trial sponsor, and the investigators have reviewed the available data in part 1 of the expansion phase and concluded that the threshold has been met in the CRC cohort. The second part of the CRC cohort has therefore been opened for recruitment with the aim of enrolling 14 additional patients. For OC, threshold was not met, and this cohort has been closed for further recruitment.

Dr. Dmitriy Zamarin, Medical Oncologist at Memorial Sloan Kettering Cancer Center (MSK), Investigator at the Ludwig Center at MSK and Principal Investigator of the study, said: "Chemotherapy-resistant microsatellite-stable colorectal cancer is a challenging disease to treat, with a response rate to immune checkpoint inhibitor monotherapy of less than 5%. We are hopeful that the immune activation by ONCOS-102 in peritoneal cavity may sensitize these tumors to immune checkpoint inhibition and improve this response rate."

Dr. Magnus Jäderberg, Chief Medical Officer of Targovax, said: "The first part of the trial has allowed us to determine which primary cancer holds most promise for future development of ONCOS-102 in the intra-peritoneal setting. We are very pleased to see that the efficacy threshold has been met for the CRC cohort, and will now focus exclusively on this patient population of primary, platinum-resistant CRC with peritoneal metastases for the second part of the trial. This is a large patient group with no effective available treatment alternatives today, and we are hopeful that this novel combination of immunotherapies can deliver benefit in this disease with very high unmet medical need."

The trial is a collaboration between Targovax, AstraZeneca (LSE/STO/Nasdaq: AZN), Cancer Research Institute (CRI) and Ludwig Cancer Research.