Entry into a Material Definitive Agreement

On June 23, 2022 Turning Point Therapeutics, Inc. (the "Company") reported that it entered into a strategic collaboration agreement (the "Agreement") with The University of Texas M.D. Anderson Cancer Center ("MD Anderson") (Filing, 8-K, Turning Point Therapeutics, JUN 24, 2022, View Source [SID1234616249]). Under the terms of the Agreement, the Company will provide funding and support for preclinical and clinical studies to be conducted by MD Anderson in several solid tumors, including non-small cell lung cancers, gastrointestinal malignancies and endocrine cancers (the "Studies").

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The initial focus of the Studies will be the Company’s lead drug candidate, repotrectinib, a next-generation kinase inhibitor targeting the ROS1 and NTRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors that is currently being studied in a registrational Phase 1/2 study (TRIDENT-1). The Studies will also include two additional drug candidates, elzovantinib (TPX-0022), a kinase inhibitor targeting MET, CSF1R and SRC, which is being studied in a Phase 1 trial of patients with advanced solid tumors harboring genetic alterations in MET (SHIELD-1), and TPX-0131, a next-generation ALK inhibitor, which is being studied in a Phase 1/2 trial of previously treated patients with ALK-positive advanced or metastatic non-small cell lung cancer (FORGE-1).

Pursuant to the Agreement, the Company has agreed to provide total funding in an amount of $10.0 million for the performance of the Studies, such funding to be provided in increments of $1.0 million on a twice-yearly basis. The Studies will be overseen by a joint steering committee, which will provide technical, scientific, clinical and regulatory guidance, discuss and approve study budgets, and monitor the progress of the Studies.

Under the terms of the Agreement, all Inventions will be solely owned by the Company, except with respect to the use of Proprietary Materials of MD Anderson that does not involve the use of the Company’s Study Drug or Proprietary Materials (each as defined in the Agreement).

The term of the Agreement runs five years or until the Studies are completed, whichever is later, unless terminated earlier in accordance with the terms set forth in the Agreement.

The foregoing description of the material terms of the Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Agreement, a copy of which the Company intends to file, with confidential terms redacted, with the Securities and Exchange Commission as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022.

TOLREMO Announces Appointment of Dr. Karl Schumacher as Chief Medical Officer

On June 24, 2022 TOLREMO therapeutics AG reported that Dr. Karl Schumacher, MD, MHBA, has joined the company as Chief Medical Officer (CMO). Dr. Schumacher will lead the clinical and medical programs of TOLREMO in support of the company’s lead asset TT125-802, that is expected to enter the clinic in early 2023 (Press release, TOLREMO, JUN 24, 2022, View Source [SID1234616248]). He will help in the further advancement of TOLREMO’s platform, addressing the unmet medical need of non-genetic cancer drug resistance.

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«We are delighted to have Karl join TOLREMO’s executive management team in this exciting phase for the company. With more than 10 years of clinical development experience in oncology focusing on combination therapies and drug resistance, he will add tremendous value to our drug development programs» said Dr. Stefanie Flückiger-Mangual, CEO and co-founder of TOLREMO.

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Dr. Schumacher practiced surgical oncology for several years before joining the life sciences industry. Prior to joining TOLREMO, he held various roles in the pharmaceutical industry focusing on drug combinations to prevent resistance to targeted therapies in multiple cancer types. He has been instrumental to the clinical development of targeted and innovative anti-cancer therapies for NSCLC, breast cancer and melanoma. He joins TOLREMO from Merck KGaA where he was Vice President Clinical Development for the MET inhibitor tepotinib (Tepmetkoâ) and the DNA damage response (DDR) inhibitor portfolio.

«I am excited to join TOLREMO at this pivotal phase of the company’s development. I am looking forward to applying my clinical expertise with drug combinations and cancer drug resistance to the company’s clinical development. I am convinced that TT125-802 has a high potential to be developed as a versatile combination partner to a number of targeted therapies» said Dr. Karl Schumacher.

Quest Diagnostics to Release Second Quarter 2022 Financial Results on July 21, 2022

On June 24, 2022 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report second quarter 2022 financial results on Thursday, July 21, 2022, before the market opens (Press release, Quest Diagnostics, JUN 24, 2022, View Source,-2022 [SID1234616247]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "7895081." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 888-566-0439 for domestic callers or 203-369-3045 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on July 21, 2022 until midnight Eastern Time on August 4, 2022.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

Priothera – Clinical Mocravimod Data in Hematological Malignancies Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (aHSCT) Presented at the 2022 European Hematology Association (EHA) Congress

On June 24, 2022 Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound, mocravimod, reported that first clinical data on mocravimod (also known as KRP203) in hematological malignancies patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Congress, which was held in Vienna, Austria, June 9-12th, 2022 (Press release, Priothera, JUN 24, 2022, View Source [SID1234616246]).

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The oral presentation, which took place on 12th June, was entitled A two-part, single- and two-arm randomized, open-label study to evaluate the safety, tolerability and pharmacokinetics of KRP203 in subjects with hematological malignancies undergoing allogeneic hematopoietic stem cell transplantation. The study showed that in the Phase 1b/2a study mocravimod was safe and well tolerated with promising overall survival.

Key take aways from the data presentation were:

The study provided first ever human data of a S1P receptor modulator administered to patients undergoing allogeneic HSCT
S1PR modulator class effects, such as bradycardia, were of no clinical concern
Promising overall survival (OS) data
Limited number of relapses, acute and chronic graft-versus-host disease (GVHD)
Data supportive for conducting the planned MO-TRANS pivotal study to investigate efficacy (Relapse-free survival and OS) and GVHD in AML patients undergoing allogeneic HSCT
Priothera is initiating the pivotal MO-TRANS global Phase 2b/3 study in Europe, US and Japan, to assess the efficacy and safety of mocravimod as an adjunctive and maintenance therapy in adult AML patients undergoing allogeneic HSCT. The study is expected to start in the second half of 2022 and preliminary data from this study are expected by the end of 2024.

Florent Gros, Co-Founder and CEO of Priothera, said: "We are delighted to have been given the opportunity to present the full first human clinical data on mocravimod at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress this year. Based on these results mocravimod has the potential to be a first-in-class therapy in maintaining graft-versus-leukemia responses while preventing graft-versus-host disease. This novel approach would provide a tremendous benefit to AML patients undergoing an allogeneic hematopoietic stem cell transplant. We are excited about mocravimod which leverages a well-described mode of action in a hematology/oncology setting and has been successfully used in autoimmune indications. Pre-clinical and clinical proof of concept studies have herewith demonstrated mocravimod’s ability to improve survival outcomes for this devastating disease. We look forward to advancing the global pivotal Phase 2/3 trial which is due to start in the second half of 2022."

Priothera’s abstract is available on EHA (Free EHA Whitepaper)2022 Congress Abstract Book, here: View Source

About Mocravimod
Mocravimod (also known as KRP203) is a synthetic, sphingosine 1-phosphate receptor (S1PR) modulator. This novel investigational drug has been assessed in Phase 1 and Phase 2 trials for safety and tolerability, as well as for efficacy in several autoimmune indications. Promising data from a Phase 1b/2a clinical study in patients with hematological malignancies led Priothera to further develop mocravimod for the treatment of blood cancers and the improvement of CART cell therapy.

Mocravimod will be investigated as an adjunctive and maintenance treatment in a Phase 2b/3 study as a potential treatment for patients with Acute Myeloid Leukemia (AML) receiving allogeneic hematopoietic stem cell transplantation (HSCT). Allogeneic HSCT is the only potentially curative approach for AML patients, but current treatments have unacceptably high mortality and morbidity rates.

Priothera leverages S1PR modulator’s unique mode of action to maintain anti-leukemia activity – graft-versus leukemia (GVL) while reducing tissue damage resulting from graft-versus-host disease (GVHD), a consequence of allogeneic HSCT. This novel treatment approach – mocravimod being the only S1PR modulator treating blood cancers – tackles a high unmet medical need and intends to add quality life to patients.

Novel pre-clinical results regarding OncoSec’s intratumoral electroporation platform were highlighted as Editor’s Pick in Molecular Cancer Research

On June 24, 2022 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec"), a clinical-stage biotechnology company focused on developing intratumoral immunotherapies to stimulate the patient’s own immune system to target and eradicate cancer, reported that their recent publication in Molecular Cancer Research is being featured as the June 2022 "Editor’s Pick (Press release, OncoSec Medical, JUN 24, 2022, View Source [SID1234616244])." The manuscript, titled "Intratumoral Electroporation of Plasmid Encoded IL-12 and Membrane-Anchored Anti-CD3 Increases Systemic Tumor Immunity," summarizes pre-clinical results regarding OncoSec’s next-generation anti-cancer treatment approach, IL-12 combined with a polyclonal T cell stimulator.

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"Our previous preclinical and clinical studies have demonstrated that intratumoral electroporation of solid tumors with plasmid IL-12 (TAVO) can provide clinical benefit due to the ability of TAVO to deliver durable anti-tumor immune responses. This recently published manuscript further advances these findings and highlights the potential of our intralesional delivery of expression plasmids as molecular platform and innovative therapeutic approach for solid tumors," said Robert H. Arch, Ph.D., OncoSec’s Chief Executive Officer.

"The incorporation of a polyclonal T cell stimulator coupled with an enhanced plasmid IL-12 results in potent stimulation of T cells by membrane-bound anti-CD3 monoclonal antibody. This results in an effective anti-tumor immune response by enhancing proliferation and interferon-γ (IFN-γ) secretion of CD8+ cytotoxic T-cells and reducing suppressive effects of CD4+ T regulatory (Treg) cells. We believe these data provide a strong rationale to further evaluate this approach for potential clinical development," said David Canton, Ph.D., OncoSec’s Vice President of R&D.