On July 8, 2021 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported it has completed preparatory work ahead of the anticipated initiation of patient enrollment for its pivotal Phase III registration trial of Namodenoson in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer (Press release, Can-Fite BioPharma, JUL 8, 2021, View Source [SID1234584691]).

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Can-Fite has received agreement from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on the protocol and plans to submit it for Institutional Review Board (IRB) approvals in the coming weeks. Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel.

The double blind, placebo-controlled trial will enroll 450 patients diagnosed with HCC and underlying Child Pugh B7 (CPB7) through clinical sites worldwide. Patients will be randomized to oral treatment with either 25 mg Namodenoson or matching placebo given twice daily. The primary efficacy endpoint of the trial is overall survival. Other oncology trial efficacy outcomes such as tumor radiographic response rates and median progression-free survival, as well as standard safety parameters, will be assessed.

The Company plans to conduct an interim analysis by an Independent Data Monitoring Committee (IDMC) after 50% of enrolled patients are treated. Namodenoson will be evaluated as a 2nd or 3rd line treatment for CPB7 patients in whom other approved therapies have not been or are no longer effective.

"We are eager to commence this study, as there is a dire need for a safe and effective treatment for patients with advanced liver disease, defined as CPB7, where Namodenoson has an advantage with its liver protective effect," stated Can-Fite CEO Dr. Pnina Fishman.

According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. As new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $3.8 billion by 2027 for the G8 countries

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On July 7, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported a clinical supply agreement with Regeneron for Libtayo (cemiplimab) (Press release, Silverback Therapeutics, JUL 7, 2021, View Source [SID1234590284]). The supply agreement supports the evaluation of Libtayo, a PD-1 inhibitor, in combination with SBT6050, the first of a new class of targeted immuno-oncology agents designed to direct a TLR8 agonist linker-payload to activate myeloid cells in tumors expressing moderate to high levels of HER2.

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"SBT6050’s unique ability to activate both innate and adaptive immune responses has the potential to enhance and expand the effectiveness of a PD-1 inhibitor in HER2-expressing solid tumors," said Naomi Hunder, M.D., Chief Medical Officer of Silverback. "We are eager to complete the ongoing dose escalation of SBT6050 combined with a PD-1 inhibitor, and look forward to working with Regeneron as we begin tumor-specific expansion cohorts."

In the first quarter of 2021, Silverback initiated treatment in Part 3 of the Phase 1/1b study to evaluate the activity of SBT6050 in combination with a PD-1 inhibitor in dose escalation. Under the terms of the agreement, Silverback will expand the ongoing Phase 1/1b trial to evaluate the combination of SBT6050 and Libtayo in tumor-specific dose expansion cohorts, initially in HER2-expressing non small cell lung cancer ("NSCLC") and gastric cancer.

Libtayo is a PD-1 blocking antibody being jointly developed and commercialized by Regeneron and Sanofi. Libtayo is approved for the first-line treatment of patients with advanced NSCLC whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined by an FDA-approved test, with no EGFR, ALK, or ROS1 aberrations, for adults with metastatic cutaneous squamous cell carcinoma ("CSCC") or locally advanced CSCC who are not candidates for curative surgery or curative radiation, and for patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor ("HHI") or for whom an HHI is not appropriate that is either locally advanced (full approval) or metastatic (accelerated approval).

On July 7, 2021 Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) ("Takeda") reported that the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA) has accepted the company’s New Drug Application (NDA) for mobocertinib (TAK-788) and granted priority review for this Class-1 innovative drug, for the treatment of adult patients with non-small cell lung cancer(NSCLC) with epidermal growth factor receptor (EGFR) Exon20 insertion mutations (Press release, Takeda, JUL 7, 2021, View Source [SID1234586735]). Mobocertinib is the first oral therapy specifically designed to target EGFR Exon20 insertion mutations. The U.S. Food and Drug Administration (FDA) recently granted priority review for the company’s New Drug Application for mobocertinib with a Prescription Drug User Fee Act (PDUFA) target action date set for October 26, 2021.

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"Patients with EGFR Exon20 insertion+ mNSCLC face critical unmet needs in China," said Sean Shan, president of Takeda in China. "The acceptance by CDE marks an important step to accelerate the delivery of innovative treatments to patients with limited therapeutic options. The Chinese government’s healthcare reforms are rewarding innovation which also present an opportunity for Takeda’s current portfolio and pipeline of innovative and life transforming medicines."

The EGFR Exon20 insertion mutation is a rare mutation in non-small cell lung cancer (NSCLC). In China, the incidence of NSCLC with the EGFR Exon20 insertion mutations accounts for about 2.3 percent of all NSCLC cases[1]. Currently, there are no approved therapies targeting EGFR Exon20 insertion mutations, and the current EGFR TKIs and chemotherapy provide limited benefits for these patients whose clinical needs are very urgent[2].

"Takeda is committed to bringing established innovative products as well as exciting, new molecular entities like mobocertinib to patients in China. And, when possible, ensuring submission and approval occurs in a similar timeframe as in other regions," said Lin Wang, Head of the Takeda Development Center Asia. "We’re preparing for an exciting period of growth and expansion in fiscal year 2021, with the potential for up to 12 submissions and six approvals, which will contribute significantly toward our goal of delivering more than 15 innovative medicines to patients in China by fiscal year 2024."

The NDA for mobocertinib is primarily based on results from the Phase 1/2 trial, which is evaluating the safety and efficacy of oral mobocertinib in patients with mNSCLC.

On July 7, 2021 Viewpoint Molecular Targeting, Inc. ("Viewpoint" or the "Company"), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported it has entered into a collaborative partnership with Netherlands-based Pepscan Therapeutics B.V. ("Pepscan"), the all-in-one peptide service provider with proprietary peptide constraining technologies (Press release, Viewpoint Molecular Targeting, JUL 7, 2021, https://viewpointmt.com/viewpoint-molecular-targetingr-partners-with-industry-leader-pepscan-to-accelerate-peptide-discovery-program/ [SID1234585493]).

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"Pepscan is clearly a world leader in peptide discovery and lead optimization, and we are delighted to have taken the first step on this journey," commented Michael K. Schultz, PhD, Chief Science Officer and Co-Founder of Viewpoint. "In our diligence, the Pepscan team is technically and professionally the strongest we’ve had the pleasure to work with. We are particularly excited to see how their CLIPS innovative scaffold technology results in superior synthetic peptide candidates for us to develop."

Peptide-based radiopharmaceuticals have recently emerged as an exciting therapeutic and diagnostic platform in the areas of neuroendocrine tumors, prostate cancer, and other solid tumors. Pepscan’s world-leading libraries of CLIPS (Chemical Linkage of Peptides onto Scaffolds) constrained peptides combined with its screening technologies and deep knowledge of the discovery process will result in optimal ligands which bind cancer-specific cellular targets with high affinity and selectivity. In post-discovery the candidates can be modified with Viewpoint’s proprietary linker and chelator technology which is specific for the lead-212 therapeutic isotope and lead-203 imaging isotope. This allows Viewpoint’s in-house scientists to optimize the pharmacokinetic "tuning" of the peptides to ensure high tumor uptake and reduced healthy organ uptake.

"We are excited to join Viewpoint’s journey and enable them to develop life-improving breakthroughs. Ultimately, the success of our peptide discovery and optimization for radiopharmaceuticals lies in the technical strength, expertise, and understanding of the team that transitions our candidates into clinically relevant radiopharmaceutical drugs," added Pepscan’s Director of Peptide Discovery, Michael Goldflam. "Given Viewpoint’s track-record in translating its two lead products through development to clinic-ready status, we have great confidence that the Viewpoint team will achieve success based on our discovery results."

This collaborative partnership agreement provides an avenue for both Viewpoint and Pepscan to focus on their world-leading expertise and technologies in order to accelerate the process from discovery phase to clinic-ready radiopharmaceuticals. The terms of the agreement are to remain confidential.

On July 7, 2021 Nuvalent reported that it has brought in $185 million through two funding rounds since launching in January, but the precision cancer biotech wants more: an IPO (Press release, Nuvalent, JUL 7, 2021, View Source [SID1234584749]).

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Cambridge, Massachusetts-based Nuvalent filed Wednesday for a $100 million IPO, but that customary initial sticker price is likely short of what will actually be raised when the biotech lists on the Nasdaq under the symbol "NUVL."

Nuvalent snapped up a $135 million series B in May and a $50 million series A in January when it emerged from stealth. The company is looking to cash in on the biotech IPO frenzy, which just this week has caught Rallybio and Caribou Biosciences.

With positive preclinical data on two lead programs already and plans to enter the clinic by the end of this year, Nuvalent is going public to fuel its ambitions of competing against existing kinase inhibitors.

RELATED: Nuvalent bags $135M to trial resistance-beating kinase inhibitors in lung cancer

These drugs block an enzyme called kinase that controls important functions in human cells. Some kinases can be more active in certain types of cancer cells, so inhibiting them can prevent the cancer cells from growing.

Led by CEO James Porter, formerly of Infinity Pharmaceuticals, Nuvalent has high hopes that its parallel lead programs, NVL-520 and NVL-655, will rival similar kinase inhibitors from Roche and Pfizer. Both target a kinase called tyrosine.

Nuvalent is positioning NVL-520 to become the next generation for the treatment of ROS1-positive non-small cell lung cancer (NSCLC). The therapy could offer a solution that avoids resistance and adverse events that have plagued approved treatments in the class like Pfizer’s Lorbrena and Xalkori along with Genentech’s Rozlytrek.

NVL-655 will also combat tumor resistance in ALK-positive NSCLC, going up against Roche’s Alecensa, Takeda’s Alunbrig and Novartis’ Zykadia.

RELATED: Nuvalent nets $50M to create better targeted meds for cancer resistance

Proceeds from the stock market debut will give Nuvalent a boost in taking on Big Pharma. The funds will cover phase 1 trials of NVL-520 and NVL-655 and initiate phase 2 studies for those programs. NVL-520 should land in the clinic for patients with NSCLC and other advanced solid tumors in the second half of this year, and NVL-655 is slated to get there in the first half of 2022.

Nuvalent isn’t a household name just yet, but the seven-month-old biotech is backed by some key life sciences investors. Deerfield Management owns slightly more than 65% of shares, Bain Capital Life Sciences has about 7% and Fidelity Management and Research has a 6% stake.

The IPO proceeds will also give life to Nuvalent’s discovery programs, with a goal of nominating drug candidates for two programs next year, including another ALK NSCLC lead indication.

RELATED: Icosavax raises $100M to take RSV, COVID-19 vaccines into clinic

Nuvalent has an IPO filing buddy: RSV and COVID-19 vaccine hopeful Icosavax also submitted its S-1 Wednesday. The filing comes three months after the company raised $100 million in a series B to take two viruslike particle vaccine assets into clinical trials this year, including one against respiratory syncytial virus.