On October 19, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a U.S. clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for Rhenium-186 NanoLiposome (186RNL) for the treatment of leptomeningeal metastases (LM) (Press release, Cytori Therapeutics, OCT 19, 2021, View Source [SID1234591523]). The Company expects to initiate patient accrual in a Phase 1 dose escalation trial of 186RNL (ReSPECT-LM) in the fourth quarter of 2021.

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"LM is an increasingly common secondary cancer complication, occurring as a result of increasing observed survival rates for a variety of primary solid and hematologic tumors," said Andrew J. Brenner, M.D., Ph.D., Professor of Medicine, Neurology, and Neurosurgery at The University of Texas and ReSPECT-LM Principal Investigator. "Given the excellent safety data thus far using 186RNL in recurrent glioblastoma, and the preclinical efficacy data when used in animal models of LM, we are optimistic about the potential safety and efficacy of 186RNL as a novel treatment option for LM."

The ReSPECT-LM trial is a multicenter, sequential cohort, open-label, single dose, dose escalation Phase 1 study. It will evaluate the maximum tolerated dose, maximum feasible dose, safety, and efficacy of a single administration of 186RNL via intraventricular catheter for LM following standard surgical, radiation, and/or chemotherapy treatment. The primary endpoint of the study is the incidence and severity of adverse events/serious adverse events and dose limiting toxicities. Secondary endpoints include overall response rate, duration or response, progression free survival, and overall survival.

"Leptomeningeal metastasis is a neurologically devastating and fatal complication of cancer," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "Our latest approved IND application is part of a multifaceted plan to expand our radiotherapeutic pipeline with promising, innovative drugs to treat a variety of rare and difficult to treat cancers."

The ReSPECT-LM Phase 1 clinical trial follows preclinical studies in which tolerance to doses of 186RNL as high as 1,075 Gy was shown in animal models with LM with no observed significant toxicity. Treatment led to marked reduction in tumor burden in both C6 and MDA-231 LM models.

About Leptomeningeal Metastases (LM)

LM is a rare complication of cancer in which the disease spreads to the membranes (meninges) surrounding the brain and spinal cord. LM occurs in approximately 5% of people with cancer, or 110,000 people in the U.S. each year, and is usually terminal with a median survival of approximately 2-3 months following treatment. LM occurs with cancers that are most likely to spread to the central nervous system. The most common cancers to include the leptomeninges are breast cancer, lung cancer, and melanomas.

On October 19, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), applying innovative diagnostics to transform disease management and improve patient outcomes, reported it has signed a definitive agreement to acquire Cernostics, Inc. (Cernostics), an Illumina Ventures company (Press release, Castle Biosciences, OCT 19, 2021, View Source [SID1234591522]). Cernostics specializes in spatial biology and artificial intelligence-driven image analysis of tissue biopsies. Its TissueCypher Barrett’s Esophagus Assay is the first precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE).

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"We are pleased to welcome Cernostics into the Castle family," said Derek Maetzold, president and CEO of Castle Biosciences. "Acquiring the TissueCypher platform is aligned with our commitment to utilizing innovative technology to provide clinically actionable information that guides disease management and improves patient outcomes. The TissueCypher Barrett’s Esophagus Assay addresses an unmet need in BE, as it is designed to objectively and accurately predict progression from non-dysplastic, indefinite for dysplasia and low-grade dysplasia BE to HGD or esophageal adenocarcinoma (EAC). This is critical, as EAC is highly lethal, with five-year survival rates under 20%1, and intervention (ablation) in patients with BE has been proven to reduce progression to EAC. Unfortunately, the incidence of esophageal cancer is increasing at one of the fastest rates of all cancers in the U.S., so we need new clinical tools to reverse this growth trend in the diagnosis of EAC.
"We believe the combined strengths of Castle and Cernostics will position us for continued growth and success as a leader in the diagnostics space, complementing our first-to-market dermatologic franchise. Beginning with a common patient-centric mind-set, our companies are strategically aligned with compatible company cultures and business models that include a strong, ongoing emphasis on growing the body of clinical evidence backing our tests. Together, we have the opportunity to accelerate our impact on patient care and thus drive value creation for shareholders."

"We are excited about joining forces with Castle, a leader in the precision diagnostics space with a strong history of commercial success," said Mike Hoerres, chief executive officer of Cernostics. "With our innovative TissueCypher platform, we have the potential to address unmet clinical needs in the gastrointestinal space, starting with BE. We believe the TissueCypher Barrett’s Esophagus Assay is a valuable tool for improving prevention of esophageal cancer, particularly, to help physicians and patients make more informed management decisions based on the unique biology of an individual patient’s esophageal biopsy."
1 Esophageal Cancer Action Network, View Source

There are approximately 4 million patients in the U.S. diagnosed with BE, and annually, approximately 400,000 endoscopies are performed on BE patients. TissueCypher Barrett’s Esophagus Assay is listed in Group 1 of Novitas’ Billing and Coding Article "Molecular Pathology and Genetic Testing" (A58917). The article becomes effective on November 8, 2021.

Transaction Terms and Other Information

Under the terms of the definitive agreement, Cernostics will become a wholly owned subsidiary of Castle Biosciences. At closing, Castle will pay $30 million in initial consideration to Cernostics security holders, which may consist entirely of cash or $20 million in cash and $10 million in common stock of Castle, at Castle’s sole discretion. The purchase price is subject to customary working capital and other adjustments. Further, up to an additional $50 million in cash and/or common stock, at Castle’s sole discretion, is payable in connection with the achievement of certain milestones based on 2022 performance. The transaction is expected to close prior to year-end 2021, subject to the delivery of certain financial statements to the Company, continued employment of certain Cernostics personnel and satisfaction of other customary conditions to closing.

Upon finalization of the transaction, Hoerres and Cernostics’ executive management team and other staff based in Pittsburgh are expected to stay with the Company. Cernostics’ laboratory and operations will remain in Pittsburgh.

Company management will host a conference call and webcast to discuss this transaction at 7:30 a.m. Eastern time today.

Conference Call and Webcast Details

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website: View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until Nov. 9, 2021.

To access the live conference call via phone, please dial 1 844 200 6205 from the United States and Canada, or +1 929 526 1599 internationally, at least 10 minutes prior to the start of the call, using the conference ID 781408.

There will be a brief Question & Answer session following management commentary.

About Cernostics and TissueCypher Barrett’s Esophagus Assay

Cernostics applies spatial biology and biologically-aware AI and machine learning to tissue diagnostics, delivering precision diagnostic testing to patients and gastroenterologists. This technology and platform are the core of the TissueCypher Barrett’s Esophagus Assay, the world’s first precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE). The

TissueCypher Barrett’s Esophagus Assay is indicated for patients with endoscopic biopsy confirmed BE that is graded non-dysplastic, indefinite for dysplasia or low-grade dysplasia. The TissueCypher Barrett’s Esophagus Assay is a proprietary Laboratory Developed Test (LDT) with its own unique CPT PLA code (0108U), available only from Cernostics’ CLIA-certified pathology laboratory. The TissueCypher Barrett’s Esophagus Assay has been on the Medicare Clinical Laboratory Fee Schedule since January 2021.

On October 19, 2021 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported the final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules, in 2.5 mg and 20 mg strengths, and tentative approval for 5 mg, 10 mg, 15 mg, and 25 mg strengths, a therapeutic equivalent generic version of REVLIMID (lenalidomide) Capsules, from the U.S. Food and Drug Administration (USFDA) (Press release, Dr Reddy’s, OCT 19, 2021, View Source [SID1234591521]). With this approval, Dr. Reddy’s is eligible for 180 days of generic drug exclusivity for Lenalidomide Capsules, 2.5 mg and 20 mg.

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In September 2020, Dr. Reddy’s announced a settlement agreement of their litigation with Celgene, the maker of REVLIMID (lenalidomide) Capsules and a wholly-owned subsidiary of Bristol Myers Squibb (NYSE: BMY), relating to patents for the branded drug.

In settlement of all outstanding claims in the litigation, Celgene agreed to provide Dr. Reddy’s with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S. beginning on a confidential date after March 2022 subject to regulatory approval. The agreed-upon percentages remain confidential. As part of the settlement, Dr. Reddy’s is also licensed to sell generic lenalidomide capsules in the U.S. without volume limitation beginning on January 31, 2026.

"We are pleased with the Agency’s approval of Lenalidomide Capsules, 2.5 mg and 20 mg and being eligible for 180-day market exclusivity," says Marc Kikuchi, CEO, North America Generics, Dr. Reddy’s Laboratories. "We look forward to bringing a more affordable generic version of this drug to market for the benefit of patients."

On October 19, 2021 Exelixis, Inc. (Nasdaq: EXEL) reported that its third quarter 2021 financial results will be released on Tuesday, November 2, 2021 after the markets close (Press release, Exelixis, OCT 19, 2021, View Source [SID1234591520]). At 5:00 p.m. EDT / 2:00 p.m. PDT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update . Access to the event is available via the Internet from the company’s website.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 9563879 to join by phone.

A telephone replay will be available until 8:00 p.m. EDT on November 4, 2021. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 9563879. A webcast replay will also be archived on www.exelixis.com for one year.

On October 19, 2021 HUYABIO International (HUYABIO), the leader in accelerating global development of China’s pharmaceutical innovations, reported the product launch in Japan for Hiyasta tablets to treat relapsed and/or refractory (R/R) adult T-cell leukemia/lymphoma (ATLL) (Press release, HUYA Bioscience, OCT 19, 2021, View Source [SID1234591519]).

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Japanese patients with relapsed and/or refractory R/R ATLL have very poor prognosis. The effectiveness of available treatments, such as chemotherapy, diminishes with each relapse. Results from the HBI-8000 study in these patients have demonstrated clinically meaningful tumor response despite the advanced stage of disease. The treatment was safe and side effects could be managed with routine care. "In my opinion, this treatment is expected to address an important unmet medical need," said Dr. Kensei Tobinai, Visiting Scientist of the National Cancer Center Hospital in Japan and medical expert of the HBI-8000 Phase 2 study.

HUYABIO recently announced the approval of Hiyasta by the Japanese Minister of Health, Labor and Welfare based on the results of a clinical trial conducted in Japan in patients with R/R ATLL. Meiji Seika Pharmaceuticals, HUYABIO’s partner, will market the product in Japan. HUYABIO retains worldwide rights to the drug ex-Asia. Development of HBI-8000 is ongoing globally.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "This first product launch for our lead oncology drug, HBI-8000, is a major milestone for HUYABIO as we transition into a revenue generating Company. It demonstrates our global reach and ability to develop and commercialize products licensed from China for debilitating diseases and make a major public health contribution."

About HBI-8000
HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylases (HDAC) and suppresses the expression of the viral oncogene HTLV-I bZIP factor, nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and the inflammasome in ATLL cells. Furthermore, HBI-8000 may induce latent viral antigen expression making ATLL cells more sensitive to immune cytotoxicity targeting.