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.

On May 21, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that Janssen Pharmaceutica N.V. (Janssen) received two positive opinions from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending to broaden the existing marketing authorization for the DARZALEX (daratumumab) subcutaneous (SC) formulation, which uses ENHANZE technology, in two new indications (Press release, Halozyme, MAY 21, 2021, View Source [SID1234580434]). One recommendation is for the use in combination with cyclophosphamide, bortezomib and dexamethasone (D-VCd), for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis. The second recommendation is for the use of daratumumab SC in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy. These two positive opinions will next be reviewed by the European Commission (EC), which has the authority to grant final approval of the indications.

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"Janssen’s obtaining positive CHMP opinions is an important step forward in the EU and we are delighted subcutaneous DARZALEX may soon be available in these important new indications," said Helen Torley, president and chief executive officer at Halozyme. "This would be the first approval in Europe for the treatment of AL amyloidosis and also introduces a new treatment option for certain patients with multiple myeloma."

The Positive CHMP Opinion for the AL amyloidosis indication is supported by data from Janssen’s Phase 3 ANDROMEDA study.1 Janssen reported that the study met the primary endpoint of percentage of patients with hematologic complete response.

The Positive CHMP Opinion for daratumumab SC in combination with Pd in the treatment of relapsed or refractory multiple myeloma is supported by data from the Phase 3 APOLLO study conducted in collaboration with the European Myeloma Network. 2 Janssen reported that the study met its primary endpoint of improved progression-free survival (PFS).

On May 21, 2021 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that management will participate in a fireside chat at the Jefferies Healthcare Conference on Friday, June 4th at 11am Eastern Time (Press release, Sangamo Therapeutics, MAY 21, 2021, View Source [SID1234580450]).

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The virtual session will be webcast live and may be accessed on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. The presentations will also be available on the Sangamo Therapeutics website after the event.

On May 21, 2021 Targovax ASA, reported that members of its executive management team is invited to present at upcoming conferences (Press release, Targovax, MAY 21, 2021, View Source [SID1234580435]).

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ABGSC Life Science Summit, virtual
Date: 25 May 2021
Presenter: Øystein Soug (CEO)
Time: 16:30 CET

Oncolytic Viruses Virtual Symposium
Date: 25 May 2021
Presenter: Magnus Jäderberg (CMO)
Time: 10:45 CET