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Incyte Provides Regulatory Update on Retifanlimab for the Treatment of Certain Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)

On July 23, 2021 Incyte Corporation (Nasdaq:INCY) reported that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy (Press release, Incyte, JUL 23, 2021, View Source [SID1234585141]).

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The complete response letter states that the FDA cannot approve the application in its present form. Consistent with the Oncologic Drugs Advisory Committee recommendation on June 24, 2021, the FDA determined that additional data are needed to demonstrate the clinical benefit of retifanlimab for the treatment of patients with advanced or metastatic SCAC. Incyte is reviewing the letter and will discuss next steps with the FDA.

"Patients with SCAC who have progressed after first-line chemotherapy currently do not have approved treatment options," said Hervé Hoppenot, Chief Executive Officer, Incyte. "While we are not surprised with the FDA decision given the ODAC recommendation, we are disappointed. We remain committed to advancing science to find solutions for patients with unmet medical needs, and we will ensure close coordination with the FDA in order to address feedback and determine next steps for the review of retifanlimab."

The BLA submission was based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with locally advanced or metastatic SCAC who have progressed on, or were ineligible for or intolerant of, platinum-based chemotherapy.

About Retifanlimab

Retifanlimab (formerly INCMGA0012), an investigational intravenous PD-1 inhibitor, is currently under evaluation in registration-directed trials as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell carcinoma of the anal canal (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer and SCAC.

Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of anal cancer.

In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. In 2019, Incyte and Zai Lab announced a collaboration and license agreement for the development and commercialization of retifanlimab in Greater China.

PerkinElmer Board Declares Quarterly Dividend

On July 23, 2021 The Board of Directors of PerkinElmer, Inc. (NYSE: PKI), reported a regular quarterly dividend of $0.07 per share of common stock July 23, 2021 (Press release, PerkinElmer, JUL 23, 2021, View Source [SID1234585140]). This dividend is payable on November 12, 2021 to all shareholders of record at the close of business on October 22, 2021.

Lee’s Pharmaceutical Announces First Patient Dosed With its Anti-PD-L1 Antibody Socazolimab, Licensed From Sorrento Therapeutics, as a First-Line Treatment of Extensive-Stage Small-Cell Lung Cancer

On July 23, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") and Lee’s Pharmaceutical Holdings Limited (HKEX: 950, "Lee’s Pharm") reported that, on July 15, 2021, China Oncology Focus Limited ("COF"), a subsidiary of Lee’s Pharm, has enrolled the first patient in China in the Phase 3, multicenter, randomized, double blinded, placebo controlled clinical trial of Socazolimab (anti-PD-L1 monoclonal antibody, formerly known as ZKAB001) combined with chemotherapy in the first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC) (Press release, Sorrento Therapeutics, JUL 23, 2021, View Source [SID1234585139]). The clinical trial clearance was granted by China’s National Medical Products Administration ("NMPA") in March 2021.

The initiation of this Phase 3 trial is based on the very encouraging results from an earlier Phase Ib trial in which Socazolimab combined with carboplatin and etoposide showed a promising efficacy and safety profile in patients with extensive-stage small-cell lung cancer. This clinical trial involves 56 centers and is led by Prof. Shun Lu from Shanghai Chest Hospital.

About Socazolimab

Socazolimab is a fully human anti-PD-L1 monoclonal antibody identified by Sorrento using its proprietary G-MAB library platform. COF received exclusive rights to develop and commercialize the antibody for Greater China, which includes Mainland China, Hong Kong, Macau, and Taiwan. Socazolimab has the following potential advantages over its competitors:

Fully human antibody potentially allows it to have minimal immunogenicity; demonstrated by its negative antigen-derived antibody (ADA) generation in humans in studies to date.
Potentially lower dose required to achieve efficacy compared to other anti-PD-L1 antibodies.
Dual mechanism of action observed with both immune-checkpoint inhibition and antibody-dependent cellular cytotoxicity (ADCC) effect.
The antibody has been tested or is being tested in various cancer indications including recurrent or metastatic cervical cancer, maintenance therapy for high-grade osteosarcoma after adjuvant chemotherapy, locally advanced and metastatic urothelial carcinoma, extensive small cell lung cancer in combination with carboplatin and etoposide, and advanced urothelial carcinoma in combination with albumin-bound paclitaxel and esophageal carcinoma.

ImmixBio Announces Confidential Submission of Draft Registration Statement for Proposed Initial Public Offering

On July 23, 2021 Immix Biopharma, Inc. reported that it has confidentially submitted a draft registration statement on Form S-1 with the Securities and Exchange Commission (the "SEC") relating to the proposed initial public offering ("IPO") of its common stock (Press release, Immix Biopharma, JUL 23, 2021, View Source [SID1234585138]). The number of shares to be offered and the price range for the proposed offering have not yet been determined. The IPO is expected to commence after the SEC completes its review process, subject to market and other conditions.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended ("Securities Act"). This announcement is being issued in accordance with Rule 135 under the Securities Act.

Novel degrader of cancer-driving protein AKT slows prostate, breast tumors in mice

On July 23, 2021 Mount Sinai Hospital reported that Several biopharma companies are working on compounds to inhibit AKT, a protein kinase that has been implicated in many cancers (Press release, Mount Sinai Hospital, JUL 23, 2021, View Source [SID1234585130]). Researchers at Mount Sinai Hospital in New York are pursuing a different tact against the oncogenic protein, seeking to degrade it rather than just blocking it.

Now they have early evidence that a drug they developed to do just that could become a new weapon against some forms of breast cancer, prostate cancer and other tumor types. The drug, called MS21, inhibited the growth of some cancer cells with mutations in the PI3K/PTEN pathway and slowed tumor growth in mouse models of breast and prostate cancer, they reported in the journal Cancer Discovery.

MS21 binds to AKT much like drugs that have been designed to inhibit the protein do, but it has been engineered to bind to a second protein called VHL E3 ligase, also known as the von Hippel–Lindau E3 ubiquitin ligase. VHL E3 is well known for its ability to suppress tumors by degrading toxic proteins.

The drug, "simply by bringing VHL in close proximity to AKT, allows the targeting of the ubiquitin ligase to AKT," resulting in its degradation, said Ramon Parsons, M.D., Ph.D., director of the Tisch Cancer Institute at Mount Sinai’s Icahn School of Medicine, in an interview.

The researchers tested MS21 in mice with active prostate and breast tumors, comparing them to mice that were either untreated or that received capivasertib (AZD5363), an experimental AKT inhibitor from AstraZeneca.

Administering MS21 once daily for 21 days resulted in 90% inhibition of tumor growth in the prostate cancer models and 80% in the breast cancer models as compared to untreated mice. A low dose of capivasertib, by contrast, inhibited tumor growth by 50% in both models, the researchers reported.

RELATED: ESMO (Free ESMO Whitepaper): Roche’s Akt inhibitor scores slight win over J&J’s Zytiga

Why shoot for degradation of AKT rather than settling for inhibition? Oncology researchers haven’t yet answered that question definitively, Parsons said, but preclinical research suggests there are benefits to wiping out the protein.

"When you inhibit AKT kinase, you really only inhibit it temporarily," he said. "The cell has a way to bypass the inhibition. So it only lasts for a matter of hours. When you degrade it, there’s nothing there. So we see the inhibition of AKT’s ability to function lasts for days, and we think that’s a real benefit."

AstraZeneca is testing AKT inhibitor capivasertib in breast and prostate cancer, setting up a potential showdown with Roche, which is also in phase 3 with its own AKT blocker, ipatasertib. But the true efficacy of these compounds remains controversial.

Last September, Roche said that in a trial of ipatasertib with Zytiga in a subset of patients with PTEN-loss prostate tumors, the combination improved progression-free survival by only two months over Zytiga alone. Another study revealed that adding ipatasertib to paclitaxel in a subset of breast cancer patients had no effect—a result that analysts at Jefferies called "disappointing."

The Mount Sinai team suspected that MS21 might also work well as part of combination therapies, so they combined it with a MEK inhibitor in cancer cells with BRAF and KRAS mutations. The combination inhibited the growth of cells more effectively than either drug alone did, they reported.

The researchers are planning additional animal trials to further assess the toxicology and ideal dosing profile for MS21, Parsons said. Mount Sinai is in discussions with several companies, in the hopes of finding a partner to take the drug into clinical trials, he added.