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MARKER THERAPEUTICS ANNOUNCES ENTRY INTO SERVICES AGREEMENT WITH WILSON WOLF

On April 26, 2022 Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported it has entered into a services agreement with Wilson Wolf Manufacturing Corporation (Press release, Marker Therapeutics, APR 26, 2022, View Source [SID1234612965]). The agreement includes an $8.0 million upfront cash payment by Wilson Wolf to Marker in exchange for services relating to Marker’s expertise in the manufacture of cell therapies. Wilson Wolf has agreed to pay Marker an additional $1.0 million if the certain work, as defined in the services agreement, is completed within one year from the onset of the services agreement.

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"Marker Therapeutics has created its own cGMP manufacturing capacity that allows us to service our clinical trials with full control and lower costs when compared to use of contract manufacturing organizations," said Peter Hoang, CEO of Marker Therapeutics. "Our process utilizes Wilson Wolf products and we think our knowledge is highly aligned with Wilson Wolf’s mission to advance the cell and gene therapy field through simplified manufacturing. Wilson Wolf’s payment of $8 million in non-dilutive funding, with potential for another $1 million, for a portion of Marker’s knowledge will be used by Marker to advance its mission to fundamentally improve the way liquid and solid tumors are eliminated. Given how entrenched Wilson Wolf’s technology is in the cell and gene therapy field, we see this as an endorsement of Marker’s manufacturing expertise."

"Marker’s therapies have demonstrated in clinical trials to date the potential to activate the patient’s own immune system while eliminating tumors. This $8 million upfront payment provides Marker with added wherewithal to treat and assess patients," said Mr. Hoang.

"Wilson Wolf’s mission is to create hope for cancer patients, one G-Rex device at a time. We have hundreds of customers using our G-Rex technology for the manufacture of cell and gene therapies that range from early-stage R&D all the way to an FDA approved therapy," said John Wilson, CEO of Wilson Wolf. "Nearly every CAGT organization relies on contract manufacturers to make their therapies for clinical trials. The revolutionary nature of these lifesaving therapies has caused explosive growth in demand on contract manufacturing capacity. As a result, cell and gene therapy companies are incurring skyrocketing costs and long wait times to get their clinical drugs made."

"Marker found a unique way to avoid this problem and created their own FDA registered drug manufacturing facility which integrates a G-Rex based manufacturing process that we believe is extremely simple, cost effective, and easily scaled," said John Wilson. "The way that Marker freed itself of reliance on CMOs inspired Wilson Wolf to enter into a service agreement that we believe will enhance our effort to de-risk the cell and gene therapy industry as a whole."

BioNTech to Report First Quarter 2022 Financial Results and Operational Update on May 9, 2022

On April 26, 2022 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that it will announce its financial results for the first quarter 2022 on Monday, May 9th, 2022 (Press release, BioNTech, APR 26, 2022, View Source [SID1234612964]). BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the first quarter 2022.

The slide presentation and audio of the webcast will be available via this link.

To participate in the conference call, please dial the following numbers ten minutes prior to the start and provide the Conference ID:

Participants may also access the slides and the webcast of the conference call via the "Events & Presentations" page of the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

Plus Therapeutics to Present at the 2022 Q2 Investor Summit

On April 26, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported that Marc Hedrick, M.D., President and Chief Executive Officer, will present at the 2022 Q2 Investor Summit on Tuesday, May 3, 2022, at 12:30 p.m. ET at the Westin New York Grand Central, New York, N.Y (Press release, Cytori Therapeutics, APR 26, 2022, View Source [SID1234612963]).

Investors interested in arranging a meeting with the Company’s management during the conference should contact the Investor Summit conference coordinator. A webcast of the presentation will be available under the For Investors tab of the Plus website at www.plustherapeutics.com. A webcast replay will also be accessible for 90 days following the event.

Treadwell Therapeutics Announces Fast Track Designation Granted by the FDA to CFI-400945 for the Treatment of Acute Myeloid Leukemia

On April 26, 2022 Treadwell Therapeutics, a clinical-stage biotechnology company developing novel medicines for unmet needs in cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to CFI-400945, a first in class inhibitor of Polo-like kinase 4 (PLK4), for the treatment of adult patients with relapsed or refractory Acute Myeloid Leukemia (AML) (Press release, Treadwell Therapeutics, APR 26, 2022, View Source [SID1234612962]).

"Although several exciting new classes of medicines have emerged in the past decade for patients with AML, there still remains an unmet need for certain patient segments, where survival rates remain low," said Dr. Michael Tusche, Treadwell co-CEO. "CFI-400945, has shown encouraging signs of monotherapy activity in AML patients with adverse cytogenetics. We are grateful for the Fast Track Designation for this exciting program, and look forward to frequent interactions with the FDA to chart our regulatory path forward, as we continue the development of ‘945 in leukemia."

Fast Track designation seeks to streamline the development and accelerate the review of new agents with potential to treat serious or life-threatening diseases and that potentially address an unmet medical need. Drugs that are granted this designation can have more frequent interactions with the FDA, as well as potential pathways for expedited approval.

About AML
AML is a disease characterized by uncontrolled proliferation of malignant clonal hematopoietic stem cells which can lead to anemia, neutropenia, and thrombocytopenia. If left untreated, AML can lead to death within weeks. In the US, an estimated 19,940 new cases of AML were expected to be diagnosed and approximately 11,180 deaths attributed to AML, nearly all in adults. AML is generally a disease of the elderly with an average age of 68 years at the time of diagnosis and is more common in men than women. For adults <65 years of age, the 5-year survival is approximately 33%, but drops dramatically to 4% in adults >65 years of age.

Cellectar Biosciences Announces Positive DMC Review of Pivotal Trial of
Iopofosine in Waldenstrom’s Macroglobulinemia

On April 26, 2022 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, reported an independent Data Monitoring Committee (DMC) has completed its planned futility/efficacy assessment of the company’s pivotal Phase 2b study of iopofosine in Waldenstrom’s macroglobulinemia (WM) and unanimously recommended continuation of the trial as planned (Press release, Cellectar Biosciences, APR 26, 2022, View Source [SID1234612961]).

"We remain highly encouraged with the consistent performance of iopofosine I-131 in this difficult-to-treat refractory patient population," said James Caruso, president and chief executive officer of Cellectar. "We have alignment with the FDA on a 20% major response rate hurdle as the primary endpoint of our pivotal study. In a poster presented at ASCO (Free ASCO Whitepaper) 2021, we showed an 83.3% major response rate with one complete response in six WM patients, which served as the basis for our pursuing this indication."

The pivotal trial is a global, non-comparator, single-arm, open-label expansion cohort of the currently ongoing Phase 2 CLOVER-1 study of CLR 131. The study will enroll 50 WM patients. Patients in the trial will receive up to four doses of iopofosine over two cycles (cycle one on days 1, 15, and cycle two on days 57 and 71). The primary endpoint of the trial is major response rate as defined as a partial response (a minimum of a 50% reduction in the biological marker IgM) or better in patients that receive a minimum total body dose of 60 mCi with secondary endpoints of treatment free survival, duration of response and progression free survival.

The DMC is an independent committee of clinical research experts who review data in ongoing clinical trials. The DMC assessment was based on a pre-specified futility analysis within the first 10 patients as defined in the study protocol.

About Waldenstrom’s macroglobulinemia
Waldenstrom’s macroglobulinemia (WM) is a rare and incurable disease defined by specific genotypic subtypes that defines patient responses and long-term outcomes. The U.S. annual incidence is 3,000 (anticipated annual growth rate of approximately 30% through 2025) with a current U.S. prevalence of approximately 45,000 patients. The U.S. represents approximately 43% of the global market. WM is a lymphoma, or cancer of the lymphatic system. The disease occurs in a type of white blood cell called a B-lymphocyte or B-cell, which normally matures into a plasma cell whose job is to manufacture immunoglobulins (antibodies) to help the body fight infection. In WM, there is a malignant change to the B-cell in the late stages of maturing, and it continues to proliferate into a clone of identical cells, primarily in the bone marrow but also in the lymph nodes and other tissues and organs of the lymphatic system. These clonal cells over-produce an antibody of a specific class called IgM.

WM cells have characteristics of both cancerous B-lymphocytes (NHL) and plasma cells (multiple myeloma), and they are called lymphoplasmacytic cells. For that reason, WM is classified as a type of non-Hodgkin’s lymphoma called lymphoplasmacytic lymphoma (LPL). About 95% of LPL cases are WM; the remaining 5% do not secrete IgM and consequently are not classified as WM.

There is no standard treatment for WM. Several drugs have demonstrated activity either alone or in combinations, but only a single drug has received regulatory approval. Treatment is mainly focused on the control of symptoms and the prevention of organ damage. Front-line treatments for WM include rituximab alone or in combination with other agents. In the salvage therapy (second line or later) setting, ibrutinib, combinations of proteosome inhibitors and immunomodulatory drugs and stem cell transplantation are considered. Ibrutinib is the only drug to receive regulatory approval (2015) as a salvage therapy; in late 2019, it was approved for front-line treatment in combination with rituximab. Factors such as long-term cytopenias, age, hyper viscosity, the need for quick disease control, lymphadenopathy, co-morbidities, and IgM-related end-organ damage are key considerations in the choice of treatment.