On September 11, 2020 AstraZeneca reported that Despite Tagrisso rapidly establishing itself as the new standard of care for EGFR-mutated non-small cell lung cancer, its maker has had a hard time convincing England’s drug cost watchdog of its worth (Press release, AstraZeneca, SEP 11, 2020, View Source [SID1234565003]. As of Friday, though, it’s made some progress in that department, convincing the The National Institute for Health and Care Excellence (NICE) to reverse a negative decision.

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England’s cost-effectiveness gatekeeper now recommends Tagrisso for routine NHS coverage in previously untreated EGFR-mutated NSCLC and as a second-line treatment for the T790M mutation subtype, it said.

The approval in newly diagnosed patients marks a U-turn from a previous outright rejection, while the second-line nod marks an improvement in coverage, getting Tagrisso off the Cancer Drugs Fund—which comes with a more onerous funding process—and into routine use.

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The reason for the change of mind? AstraZeneca offered up an "updated commercial arrangement"—translation, price cut—that now makes it a cost-effective use of NHS resources, NICE said.

In trials, Tagrisso topped Roche’s Tarceva and AZ’s own Iressa at stalling cancer growth in new NSCLC patients with EGFR mutations. But NICE previously picked on the fact that AZ has no direct data pitting Tagrisso against Boehringer Ingelheim’s Gilotrif, another earlier-generation tyrosine kinase inhibitor that the NHS already covers.

But AZ has managed to convince NICE with a confidential discount off its list price of £5,770 ($7,395) per 30-tablet bottle.

As for the upgrade of Tagrisso from the Cancer Drugs Fund to routine coverage in previously treated EGFR T790M-mutated NSCLC, NICE said it based the decision on new data from the AURA3 trial as well as those collected from real-world use of Tagrisso under the conditional pathway.

In the AURA3 trial, Tagrisso significantly stalled the time to cancer progression or death compared with standard platinum-based doublet chemotherapy. However, on the key life extension marker, Tagrisso missed the statistical significance mark by cutting the risk of death by just 13% over chemo.

NICE, though, acknowledged that the data should take into account a 71% rate of switching from chemo to Tagrisso after disease progression, which likely tilted the survival benefit in chemo’s favor. So after adopting a model provided by AZ, the organization decided Tagrisso’s life-extension benefits were worthy of routine coverage—after the discount.

Tagrisso is now AZ’s top-selling med, in Q2 crossing the quarterly blockbuster threshold for the first time. Sales hit $1.03 billion after 35% year-over-year growth at constant currencies.

RELATED: ASCO (Free ASCO Whitepaper): AstraZeneca’s Tagrisso, headed for big sales boost, cuts lung cancer recurrence by 83%

As the drug becomes the new EGFR-TKI of choice, AZ is aiming to push its use even earlier in the treatment. As an adjuvant therapy used after surgery, Tagrisso cut the risk of disease recurrence or death by 83% in stage II and stage IIIA EGFR-mutated NSCLC, the company unveiled at this year’s American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) virtual meeting.

Upon seeing the data, SVB Leerink analyst Andrew Berens predicted that Tagrisso could hit $5.6 billion in peak sales in the adjuvant setting alone, and about $16 billion in total worldwide sales across its indications.

Meanwhile, NICE also this week turned down Celgene’s Revlimid as a maintenance treatment after autologous stem cell transplant for newly diagnosed multiple myeloma patients even though the dug showed in clinical trials that it could extend patients’ lives compared with simple monitoring, which is current common practice.

And Pfizer’s Eucrisa, sold under the brand Staquis in Europe, got the cold shoulder as second-line treatment for mild to moderate atopic dermatitis. NICE argued that the drug’s U.S. data don’t accurately reflect U.K. clinical practice.

On September 11, 2020 The board of directors of AbbVie Inc. (NYSE: ABBV) reported a quarterly cash dividend of $1.18 per share (Press release, AbbVie, SEP 11, 2020, View Source [SID1234565001]).

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The cash dividend is payable November 16, 2020 to stockholders of record at the close of business on October 15, 2020.

Since the company’s inception in 2013, AbbVie has increased its dividend by 195 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On September 11, 2020 C4 Therapeutics reported that it is gunning for an initial public offering (Press release, C4 Therapeutics, SEP 11, 2020, View Source [SID1234564991]).

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The Watertown, Massachusetts-based preclinical biotech has been pretty secretive on the specifics of its programs, but its filing with the Securities and Exchange Commission as it preps for a potential IPO has seen it open up.

One of its leading product candidates is CFT7455, an orally bioavailable degrader targeting IKZF1/3 for multiple myeloma (MM), peripheral T-cell lymphoma (PTCL) and mantle cell lymphoma (MCL).

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The biotech is planning an IND with the FDA in the fourth quarter and expects to kick-start a phase 1/2 test next year, according to its S-1 filing.

"We believe CFT7455 could eventually replace therapies based in the class of molecules known as IMiDs as the standard of care in multiple indications, including MM. IMiD therapies have been estimated to represent worldwide sales of approximately $15 billion in 2020, including MM as well as MCL, marginal zone lymphona [sic], and follicular lymphona [sic]," said C4 in its filing.

This test will run as an open-label dose escalation study of CFT7455 in around 18 to 30 subjects with MM or NHL. The trial will focus on safety and tolerability of CFT7455, and key secondary endpoints will be to characterize CFT7455’s PK/PD profile and anti-tumor activity.

"We expect the results from this clinical trial will help us better understand the disease characteristics of those patients who may derive benefit from CFT7455, which will enable us to more effectively design future clinical trials for this product candidate."

RELATED: After Bind bankruptcy, Hirsch once again helms a biotech, landing at C4

It’s also working on another early candidate, CFT8634, an orally bioavailable degrader of a protein target called BRD9, for synovial sarcoma and SMARCB1-deleted solid tumors. An IND for this is slated for the second half of 2021 with a clinical trial projected by the end of 2021.

"We expect to design our first-in-human phase 1/2 clinical trial for this product candidate to be an open-label dose escalation/expansion study in both synovial sarcoma and solid tumors with SMARCB1 loss," the company said.

Further back in the pipeline, it is also developing degraders specifically targeting V600E mutant BRAF to treat melanoma, non-small cell lung cancer, colorectal cancer and other solid malignancies that harbor this mutation, as well as degraders targeting RET to treat lung cancer, sporadic medullary thyroid cancers and other solid malignancies that harbor oncogenic RET lesions.

"We expect to have our lead product candidates, CFT7455 and CFT8634, in the clinic by the end of 2021, and product candidates from our two other lead programs, BRAF V600E and RET, in the clinic by the end of 2022," it added.

The biotech will also assess whether its platform can help against certain neurodegenerative disorders, after engineering degraders in preclinical models that "have successfully achieved blood-brain barrier penetration," a key step in developing drugs in this tough to treat area.

C4’s so-called TORPEDO (Target ORiented ProtEin Degrader Optimizer) platform aims to develop small-molecule treatments that harness the body’s naturally occurring pathways for dismantling and eliminating proteins within the cell.

By tagging disease-causing proteins for demolition by the cell’s own proteasomes, the company aims to reach classes of targets that have been difficult to reach with traditional means.

The former Fierce 15 winner has formed collaborations with Roche, Calico and most recently Biogen—with a deal inked last January totaling up to $415 million for research into neurodegenerative diseases such as Alzheimer’s and Parkinson’s.

Last year, it hired Adam Crystal, M.D., Ph.D., a senior director at the Novartis Institutes for BioMedical Research, to be its new chief medical officer and help carry its targeted protein degraders closer to the clinic.

And, three months back, it nabbed $150 million in a series B equity round co-led by existing investor Cobro Ventures and new investor Perceptive Advisors, while also getting $20 million in venture debt from Perceptive Advisors.

Just this week, it hired former Bind Therapeutics CEO Hirsch as its new chief, who is clearly wasting no time in moving the biotech into its next phase of becoming a publicly traded, clinical biotech.

C4 follows a long line of early-stage biotechs marching toward the public markets this year, fueled by COVID-19 woes that have hit every other industry but kept life science companies largely in the green. Many have started off asking for $100 million but gone on to raise much more.

In one of the more interesting and clever ticker symbols, C4 is planning to list on the Nasdaq under the symbol "CCCC."

On September 10, 2020 Incurix reported that it made an agreement with National OncoVenture (NOV) of the National Cancer Center (NCC) for cooperation in research and development of c-myc inhibitor ‘ICX-101’ (Press release, Incurix, SEP 10, 2020, View Source;idx=69&page=1&code=news [SID1234643570]). ICX-101, the program on which the joint research agreement was made, is a candidate substance Incurix in-licensed from the National Cancer Center (NCC) and the Korea Research Institute of Chemical Technology (KRICT) in April. The c-myc protein, the target of ICX-101, is cell proliferation- and death-mediated transcription factor. The c-myc protein is key to the occurrence, growth and metastasis of cancer, and is over-expressed in various cancers, such as hematologic malignancy, lung cancer, breast cancer and central nervous system tumor.

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"Although the c-myc is an important target in anti-cancer drug development, no drug of c-myc target has been developed yet because of technological problems," Incurix CEO Kyung-Chae Jeong said. He added, "We will develop ICX-101 in partnership with National OncoVenture."

On September 10, 2020 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer, reported the pricing of a public offering of 10,000,000 shares of its common stock at a public offering price of $11.00 per share (Press release, Athenex, SEP 10, 2020, View Source [SID1234573872]). The gross proceeds to Athenex from the offering, before underwriting discounts and commissions and estimated offering expenses, are expected to be $110 million. In addition, Athenex has granted the underwriters a 30-day option to purchase up to an additional 1,500,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on September 14, 2020, subject to customary closing conditions.

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Athenex intends to use the net proceeds from the proposed offering to continue to expand and strengthen its commercial infrastructure, execute label expansion strategies for Oral Paclitaxel, advance the development of its product candidates, invest in its CMC development for its product candidates and manufacturing infrastructure, and fund working capital and other general corporate purposes.

SVB Leerink, RBC Capital Markets and Evercore ISI are acting as joint book-running managers and Oppenheimer & Co. is acting as lead manager for the offering.

The securities described above are being offered by Athenex pursuant to a shelf registration statement on Form S-3 (File No. 333-227492) that was filed with the Securities and Exchange Commission (the "SEC") on September 24, 2018 and became effective upon filing. The offering will be made only by means of a written prospectus and a prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. A final prospectus supplement and the accompanying prospectus relating to this offering will be filed with the SEC and will be available at www.sec.gov. When available, copies of the final prospectus supplement and accompanying prospectus may also be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6218, or by email at [email protected]; RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281, by telephone at (877) 822-4089, or by email at [email protected]; and Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, New York 10055, or by telephone at (888) 474-0200, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there by any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.