On October 19, 2021 MASORI Therapeutics, a company focused on the pharmaceutical industry is applying artificial intelligence to achieve competitive advantage through the creation of innovative market solutions and Vyant Bio, Inc. ("Vyant Bio") (Nasdaq: VYNT), an emerging global drug discovery company that identifies small and large molecule therapeutics to treat central nervous system ("CNS") and oncology-related diseases, reported they entered into an agreement to pursue co-development and out-licensing partnerships with pharmaceutical and biotechnology companies (Press release, Vyant Bio, OCT 19, 2021, View Source [SID1234591546]). The MASORI Therapeutics team has decades of experience in all areas of drug discovery and development, including building biopharmaceutical commercial infrastructures and partnerships from concept to consummation.

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MASORI Therapeutics combines healthcare and best-in-class digital expertise that enables life sciences companies to leverage artificial intelligence, machine-learning, and virtual reality to achieve brand growth and better analysis, targeting, and execution. The company’s work with Vyant Bio will initially focus in Japan and will center on providing key insights into the application and intersection of their technologies to accelerate partnership-based therapeutic discovery and development.

"I am inspired by Vyant Bio’s commitment to innovation and the discovery of cures for intractable diseases," said Dane Hallberg, founder, executive chairman and chief executive officer of MASORI Therapeutics. "Vyant Bio embodies the tenets of MASORI Therapeutics, and we look forward to helping both companies drive and advance the development of new therapies that have the potential to make the greatest impact on patients."

Vyant Bio couples highly functional, complex in vitro human-based organoid platforms with advanced analytics and in vivo preclinical and regulatory expertise to bring the most promising compounds through the discovery pipeline. The company incorporates patient biology early in the discovery process to identify, validate, and de-risk new targets and compounds prior to clinical trials.

"Partnerships are central to scientific advancement, and for patients with CNS and oncology diseases, time is of the essence to uncover new treatments as quickly as possible," said Jay Roberts, president and chief executive officer of Vyant Bio. "Our relationship with MASORI Therapeutics will identify and drive drug development partnerships that leverage our capabilities to accelerate the discovery and delivery of such treatments."

On October 19, 2021 Aadi Bioscience, Inc. ("Aadi"), a privately-held clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported that Founder, Chief Executive Officer and President, Neil Desai, Ph.D., will present at H.C. Wainwright’s 2nd Annual Precision Oncology Conference, which will be held virtually (Press release, Aadi Bioscience, OCT 19, 2021, View Source [SID1234592016]).

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Presentation Information:

Date: Wednesday, October 20, 2021

Time: 1 pm ET

To Listen to the Presentation:

The live webcast can be accessed here: View Source A replay will also be available at this link for 90 days and posted on Aadi’s website within the Investors & News/Events & Presentations section.

On October 19, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported that it has submitted an Investigational New Drug application (IND) and an accompanying application for Fast Track status with the U.S. Food and Drug Administration (FDA) for a planned Phase 2 study of the company’s drug Ampligen as a therapy for locally advanced or metastatic late-stage pancreatic cancer (Press release, AIM ImmunoTech, OCT 19, 2021, View Source [SID1234591508]).

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The planned AMP-270 clinical trial of approximately 250 subjects will be a Phase 2, randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen when added to SOC (standard of care) versus SOC alone for subjects with advanced pancreatic carcinoma recently treated with FOLFIRINOX chemotherapy regimen. Secondary objectives include comparing safety and tolerability.

Amarex Clinical Research will manage the AIM-sponsored study. The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC) and Erasmus MC in The Netherlands are expected to be the primary study sites, although additional sites are anticipated.

Key support for both the study and the application for Fast Track status includes statistically significant clinical data in an Erasmus MC early-access program of 27 subjects where the overall survival of the Ampligen-treated cohort was 19.2 months from the start of FOLFIRINOX, compared to 12.5 months in the historical control group, for an increase in survival of 6.7 months. Additionally, several subjects are still alive more than three years later.

AIM believes that the clinical significance of these data as a treatment for pancreatic cancer provide Ampligen with a strong case for FDA Fast Track designation, which is designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill unmet medical needs. A drug that has been granted FDA Fast Track status is eligible for some or all of the following:

More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
AIM Chief Scientific Officer David Strayer, MD, commented, "Given the extensive work to date, we are well positioned to move aggressively and launch the Phase 2 trial of Ampligen upon approval of the IND. We could not be more enthusiastic about the outlook for this program given the compelling prior clinical data from Erasmus MC, which demonstrated a significant improvement in median overall survival, compared to a matched historical control group. Ampligen has also demonstrated a strong safety profile in numerous trials. At the same time, we are excited to have submitted our Fast Track application, which would confer a number of important benefits and potentially help accelerate approval."

AIM CEO Thomas K. Equels further commented, "Submission of our IND and Fast Track application are very significant milestones for the company and I would like to thank our entire team, as well as our clinical and regulatory advisors, for their tremendous efforts in preparing these carefully planned submissions. The rapid progress we have made is especially important given the devastating nature of pancreatic cancer. Further, both the FDA and the EMA have granted Ampligen orphan drug status in pancreatic cancer. This creates the potential for several years of market exclusivity. There is a significant unmet need for a safe and effective therapy for these patients, and we believe Ampligen holds enormous promise."

See:

AIM ImmunoTech Inc.’s Drug Ampligen Awarded FDA’s Orphan Drug Designation Status for the Treatment of Pancreatic Cancer
AIM ImmunoTech’s Subsidiary Receives Orphan Medicinal Product Designation by the European Medicines Agency for Ampligen to Treat Pancreatic Cancer

On October 19, 2021 Targovax ASA, reported that members of its executive management team are invited to present and participate in upcoming conferences (Press release, Targovax, OCT 19, 2021, View Source [SID1234591525]).

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Økonomisk Ugebrev’s Life Science Investor conference
Date: 20 October 2021
Presenter: Lone Ottesen (CDO)
Time: 14:35 CET

Next Gen Immuno-Oncology Virtual Conference-UK/EU Edition
Date: 26 October 2021
Presenter: Victor Levitsky (CSO)
Time: 17:45 CET

Oncolytic Virotherapy Summit
Date: 28 October 2021
Presenter: Erik Digman Wiklund (CBO)
Time: 09:30 EDT / 15:30 CET

On October 18, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision oncology biopharmaceutical company, reported an agreement with Takeda Pharmaceutical Company Limited ("Takeda") to acquire two clinical-stage compounds, both of which have demonstrated single-agent clinical activity with the greatest potential in biomarker-defined cancer-patient populations (Press release, Calithera Biosciences, OCT 18, 2021, View Source [SID1234591450]). The compounds, sapanisertib (CB-228, formerly TAK-228) and mivavotinib (CB-659, formerly TAK-659), further strengthen Calithera’s pipeline of clinical-stage targeted therapies.

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"We believe that these clinical-stage compounds are an excellent complement to our internally-developed pipeline programs, and fit well with our current strategic focus on biomarker-driven therapeutic approaches. We are encouraged by the promising single-agent clinical data that suggest these investigational therapies could help transform treatment for multiple cancer patient populations with high unmet need," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "Specifically, sapanisertib has the potential to be the first targeted treatment for patients with NRF2-mutated squamous non-small cell lung cancer. We have learned a great deal about the unmet medical need of patients with KEAP1/NRF2 mutations, as well as how to identify and recruit these patients, during the conduct of our KEAPSAKE trial evaluating telaglenastat. This complementary approach in KEAP1/NRF2-mutant squamous NSCLC demonstrates our commitment to these patients and the pathway.

"Additionally, mivavotinib has the potential to be a best-in-class SYK inhibitor in non-Hodgkin’s lymphoma, as well as a first-to-market approach for patients with diffuse large B-cell lymphoma whose tumors harbor MyD88 and/or CD79 mutations.

"We plan to start a clinical trial in squamous NSCLC with sapanisertib and a clinical trial in DLBCL with mivavotinib, both in biomarker specific populations, and generate data in the next 12 to 18 months that will define the clinical development and potential regulatory approval paths for both of these compounds."

The terms of the transaction include a total upfront cash payment to Takeda of $10 million and $35 million issued to Takeda in Calithera Series A preferred stock. Additionally, Takeda will be eligible to receive from Calithera clinical development, regulatory and sales milestone payments across both programs. Calithera will pay tiered royalties of high single-digits to low teens on future net sales should these candidates achieve regulatory approvals and subsequent commercial availability.

"Collaboration is an important aspect of our R&D strategy and at the center of our efforts to deliver new treatment options to patients. We are confident that Calithera, with their highly capable and experienced team, is the ideal partner to resume the development of sapanisertib and mivavotinib, and to maximize their potential to address underserved patient populations," said Christopher Arendt, Ph.D., head of Oncology Cell Therapy and Therapeutic Area Unit of Takeda. "We look forward to seeing how these programs advance under Calithera’s leadership."

Sapanisertib is a dual TORC 1/2 inhibitor that targets a key survival mechanism in KEAP1/NRF2-mutated tumor cells. These mutations are found in a considerable sub-population of patients across multiple solid tumor types. Sapanisertib has demonstrated promising single-agent activity in patients with relapsed/refractory NRF2-mutated squamous non-small cell lung cancer (NSCLC) and exhibits differential anti-tumor activity compared to rapalog inhibitors of TORC1 in NRF2-mutant squamous NSCLC in vivo models. A Phase 2 study planned to begin in the first quarter of 2022 will further evaluate sapanisertib as a monotherapy in patients with squamous NSCLC harboring a NRF2 mutation.

Mivavotinib is a SYK inhibitor that targets the constitutively active BCR pathway in many non-Hodgkin’s lymphoma (NHL) cases as well as the constitutively active inflammatory signaling pathway in MyD88-mutated NHL. In early phase studies, mivavotinib showed promising single-agent responses in relapsed/refractory diffuse large B-cell lymphoma (DLBCL). In addition, recent preclinical studies have shown enhanced SYK activity and sensitivity to SYK inhibition in DLBCL and other NHLs harboring mutations in MyD88 and/or CD79, which comprise a distinct genetic subset of DLBCL known to have poor outcomes with standard-of-care therapy. Accordingly, Calithera plans to initiate a Phase 2 study of mivavotinib in 2022 for the treatment of patients with DLBCL with and without mutations in MyD88 and CD79. Beyond DLBCL, both preclinical and clinical data support expansion across additional NHL subtypes and other hematologic malignancies as part of long-term plans.

More information about sapanisertib and mivavotinib can be found at calithera.com/pipeline.

Webcast and Conference Call Information

Calithera will hold a webcast today, Monday, October 18 at 5:30 p.m. Eastern Time / 2:30 p.m. Pacific Time. To access the link to the webcast, which will be broadcast live in listen-only mode, or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. Alternatively, the call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and referring to conference ID 6946687. The webcast will be recorded and available for replay on Calithera’s website for 30 days.