On May 21, 2021 MorphoSys AG (FSE & NASDAQ: MOR) reported that Jean-Paul Kress, M.D., the company’s Chief Executive Officer, will participate in a fireside chat at the UBS Global Healthcare Conference on Tuesday May 25, 2021 at 7:00 a.m. Eastern Time (Press release, MorphoSys, MAY 21, 2021, View Source [SID1234580432]).

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Live audio of the fireside chat can be accessed from the Media and Investors section under Conferences on MorphoSys’ website, www.morphosys.com. A replay of the webcast will also be available on MorphoSys’ website.

On May 21, 2021 XOMA Corporation (Nasdaq: XOMA) reported that learned its licensees are presenting at the upcoming 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held June 4-8, 2021, in a virtual setting (Press release, Xoma, MAY 21, 2021, View Source [SID1234580448]).

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"We congratulate Novartis and AVEO on their recent announcements regarding NIS793 and ficlatuzumab, respectively. We were particularly excited to see the statements each company made in their May 19th press releases regarding the potential for advancing these drug candidates to Phase 3 clinical programs. We look forward to each company’s data presentations at ASCO (Free ASCO Whitepaper) early next month," stated Jim Neal, Chief Executive Officer at XOMA. "We wish both companies continued success with their development activities."

Novartis1

Title: Phase Ib study of the anti-TGF-β monoclonal antibody (mAb) NIS793 combined with spartalizumab (PDR001), a PD-1 inhibitor, in patients (pts) with advanced solid tumors
Abstract: 2509; poster session
Date and Time: June 4, 2021, at 9:00 a.m. Eastern Time

Title: Phase II study of the anti-TGF-β monoclonal antibody (mAb) NIS793 with and without the PD-1 inhibitor spartalizumab in combination with nab-paclitaxel/gemcitabine (NG) versus NG alone in patients (pts) with first-line metastatic pancreatic ductal adenocarcinoma (mPDAC)2.
Abstract: TPS4173

AVEO Oncology3

Title: Randomized Phase II trial of ficlatuzumab with or without cetuximab in pan-refractory, advanced head and neck squamous cell carcinoma (HNSCC).
Presenter: Julie E. Bauman, M.D., MPH, Professor of Medicine, Chief, Division of Hematology/Oncology, Associate Director of Translational Research, University of Arizona Cancer Center
Abstract: 6015
Date and Time: June 4, 2021 at 9:00 a.m. Eastern Time

NIS793 and ficlatuzumab are investigational compounds. Efficacy and safety have not been established in either drug candidate. There is no guarantee that NIS793 and/or ficlatuzumab will become commercially available.

On May 21, 2021 Genmab A/S (Nasdaq: GMAB) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization for the daratumumab subcutaneous (SC) formulation (daratumumab and hyaluronidase-fihj), known as DARZALEX SC in the European Union, in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) for the treatment of adult patients with newly diagnosed systemic light-chain (AL) amyloidosis (Press release, Genmab, MAY 21, 2021, View Source [SID1234580433]). The CHMP also issued a positive opinion recommending DARZALEX SC in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor (PI) and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a PI and have demonstrated disease progression on or after the last therapy. Janssen Pharmaceutica NV submitted Type II variation applications to the EMA for these indications in November 2020. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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"We are extremely pleased about the positive CHMP opinions for DARZALEX SC and hopeful that the positive opinion in AL amyloidosis will lead to the first approved treatment option for European patients with this devastating disease," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About the ANDROMEDA (AMY3001) study
The Phase 3 study (NCT03201965) included 416 patients newly diagnosed with AL amyloidosis. Patients were randomized to receive treatment with either daratumumab and hyaluronidase-fihj in combination with bortezomib (a proteasome inhibitor), cyclophosphamide (a chemotherapy), and dexamethasone (a corticosteroid) or treatment with VCd alone. The primary endpoint of the study was the percentage of patients who achieve hematologic complete response.

About the APOLLO (MMY3013) study
The Phase 3 (NCT03180736), randomized, open-label, multicenter study included 304 patients with multiple myeloma who have previously been treated with lenalidomide and a PI. Patients were randomized 1:1 to either receive daratumumab in combination with Pd or Pd alone. In the original design of the study, patients in the daratumumab plus Pd arm were treated with the intravenous (IV) formulation of daratumumab. As of Amendment 1 to the study protocol, all new subjects in the experimental arm were dosed with the SC formulation of daratumumab and patients who had already begun treatment with IV daratumumab had the option to switch to the SC formulation. The primary endpoint of the study was progression free survival (PFS). The study was conducted in Europe under an agreement between Janssen, the European Myeloma Network (EMN) and Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON).

About AL Amyloidosis
Amyloidosis is a disease that occurs when amyloid proteins, which are abnormal proteins, accumulate in tissues and organs. When the amyloid proteins cluster together, they form deposits that damage the tissues and organs. AL amyloidosis most frequently affects the heart, kidneys, liver, nervous system and digestive tract. There is currently no cure for AL amyloidosis or existing approved therapies for AL amyloidosis patients in Europe, though it can be treated with chemotherapy, dexamethasone, stem cell transplants and supportive therapies.1 It is estimated that in 2019 there were 4,388 diagnosed incident cases of AL amyloidosis in the five major European markets.2

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.3 Approximately 18,114 new patients were diagnosed with multiple myeloma and approximately 11,063 people died from the disease in the Western Europe in 2020.4 Globally, it was estimated that 176,404 people were diagnosed and 117,077 died from the disease in 2020.5 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.6

About DARZALEXSC (daratumumab and hyaluronidase-fihj)
Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. DARZALEX SC (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved in the Europe 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). 7,8, 9, 10, 11

On May 21, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that the first patient has been dosed in the U.S. Phase 1 clinical trial of ON 123300, the Company’s proprietary, novel multi-kinase inhibitor (Press release, Onconova, MAY 21, 2021, View Source [SID1234580449]). The trial is expected to include three U.S. sites that will enroll patients with advanced cancer including, but not limited to, HR+ HER 2- metastatic breast cancer patients who are refractory to, or progressing on, currently approved CDK 4/6 inhibitors.

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The Phase 1 trial is designed to assess the safety, tolerability, and pharmacokinetics of ON 123300 administered orally as monotherapy at increasing doses starting at 40 mg daily for consecutive 28-day cycles. Following completion of the dose-escalation phase of the trial and once the recommended Phase 2 dose (RP2D) is established, additional patients with HR+ HER 2- metastatic breast cancer with at least one prior line of therapy, which are expected to include approved CDK 4/6 inhibitors, will be enrolled into the trial with the intent to identify signals of efficacy. Additional cancer indications are also under consideration for study, and will be chosen based on preclinical and developing data.

"We are excited to begin dosing patients in this Phase 1 study and are pleased to be advancing ON 123300’s clinical development in the United States," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova Therapeutics. "Our goal is to provide an innovative treatment option for patients with advanced breast cancer who have become resistant to the commercial CDK 4/6 inhibitors, and other refractory solid tumors driven by the overexpression of tyrosine kinases targeted by ON 123300. Notably, ON 123300’s ability to target multiple kinase pathways that are overexpressed in cancer may allow for single-agent efficacy and better tolerability compared to existing treatment regimens."

Dr. Fruchtman added, "We are also pleased by the progress our partner HanX Biopharmaceuticals is making with their ongoing Phase 1 trial with ON 123300 in China. While the administration schedule differs between these two Phase 1 trials, the maximum tolerated dose has not yet been reached in the first two dose-escalation cohorts of this trial, which is a promising sign for ON 123300’s safety profile. Collectively, we expect these two complementary Phase 1 studies to provide important insights that will inform the design of subsequent trials."

For more information on the U.S. Phase 1 clinical trial of ON 123300 see ClinicalTrials.gov identifier: NCT04739293.

On May 21, 2021 Janux Therapeutics reported that it has filed to raise up to $100 million in an IPO (Press release, Janux Therapeutics, MAY 21, 2021, View Source [SID1234580465]). The Merck-partnered biotech wants the money to take a clutch of T-cell engager drug candidates into phase 1 clinical trials.

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San Diego-based Janux has raised $201 million from investors including Avalon Ventures and RA Capital since setting up shop in 2017. Using the money, Janux has established a preclinical pipeline based on its TRACTr platform. The platform is designed to overcome the limitations of existing T-cell engagers and, in doing so, realize the potential of the modality in solid tumors.

Now, with candidates against PSMA, EGFR and TROP2 going through IND-enabling studies on route to clinical development, Janux is turning to public investors to finance the next stage of its evolution.

Using the IPO haul, Janux plans to submit four INDs, starting in the first half of next year. The PSMA candidate is leading the way, trailed by the EGFR and TROP2 assets and an early-stage PD-L1xCD28 costimulatory bispecific.

The areas of focus put Janux up against bigger companies with more advanced assets. Regeneron, for example, took a PSMA bispecific into the clinic in 2019. Bayer, in collaboration with Amgen, moved a candidate into human testing back in 2012, although Janux sees the difficulties that program ran into as evidence of the differentiation of its asset. Amgen now has a different PSMA drug in the clinic.

Janux is asking public investors to back it on the strength of early-stage evidence. The IPO paperwork features the findings of an initial proof-of-technology study that showed its EGFR prospect did not lead to cytokine release syndrome in nonhuman primates and drove tumor shrinkage in a mouse model. Janux has preclinical data on its other candidates, too.

In addition to the early evidence, Janux has the validation of its investor syndicate and Merck, which teamed up with the biotech late last year to work on TRACTr candidates against two cancer targets.

The Merck collaboration, which is currently Janux’s sole source of revenue, generated $380,000 for the biotech over the first three months of the year. Merck paid $8 million upfront to kick off work on the first collaboration and will pay the same amount when the second target is selected.

Janux could ultimately receive almost $500 million in success-based fees per target, but the payments are heavily backloaded, with $350 million tied to sales milestones. The development and regulatory milestones are worth up to $142.5 million per target.