On January 21, 2021 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease, reported that it has entered into securities purchase agreements with certain institutional and accredited investors to raise $25.0 million through the issuance of an aggregate 12,500,000 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 6,250,000 shares of common stock, at a purchase price of $2.00 per share of common stock (or common stock equivalent in lieu thereof) and associated warrant in a private placement priced at-the-market under Nasdaq rules (Press release, Caladrius Biosciences, JAN 21, 2021, View Source [SID1234574258]). The closing of the private placement is expected to occur on or about January 25, 2021, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price of $2.90 per share, are exercisable immediately and have a term of five and one-half years.

The Company currently intends to use the net proceeds from the offering for working capital and general corporate purposes, including the advancement of its CD34+ technology-based clinical programs.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

Under an agreement with the investors, the Company is required to file an initial registration statement with the Securities and Exchange Commission covering the resale of the shares of common stock to be issued to the investors within ten calendar days and to use its best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 90 days after today in the event of a "full review" by the Securities and Exchange Commission.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

On January 21, 2021 Merck KGaA reported that it will discontinue a Phase III clinical trial studying its cancer drug hopeful bintrafusp alfa (Press release, Merck KGaA, JAN 21, 2021, View Source [SID1234574230]). The decision was made based on an Independent Data Monitoring Committee recommendation which indicated the study was unlikely to meet its specified primary efficacy endpoint of progression-free survival.

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Bintrafusp alfa (anti-PD-L1/TGF-beta trap) is an investigational bifunctional immunotherapy co-designed with GlaxoSmithKline (GSK) to manage hard-to-treat cancers. Merck KGaA was studying the therapy in the ongoing INTR@PID Lung 037 clinical trial as a first-line therapy for patients with stage IV non-small cell lung cancer (NSCLC) and high expression of PD-L1.

"We have pioneered the science behind bintrafusp alfa, and now through a strategic alliance, multiple non-correlated parallel hypotheses are being evaluated across numerous indications in our extensive INTR@PID clinical program," said Merck KGaA’s Global Head of Development for the Healthcare business Danny Bar-Zohar, M.D., in a statement. "We remain committed to further evaluation of bintrafusp alfa, and these data from INTR@PID Lung 037 will provide important insights that may be applied to future studies."

The discontinuation of the trial threatens the cancer drug development goals of GSK, which is developing bintrafusp alfa with Merck under a 2019 collaboration agreement. The partnership agreement held the potential of paying the German company up to $4.5 billion.

Following the news of the trial’s failure, American depositary receipts (ADRs) in Merck KGaA fell 1.7%, while ADRs in GSK fell 1.6%. Merck shares remained unchanged at $83.19.

Despite this setback, Merck KGaA is still investigating the utility of bintrafusp alfa in other clinical trials for other indications. The therapy is being investigating in biliary tract cancer in the INTR@PID BTC 047 study as well as another planned Phase II/III study. In addition, the company is investigating the efficacy of bintrafusp alfa in a Phase II study focused on cervical cancer and two studies focused on non-small cell lung cancer (INTR@PID LUNG 005 and INTR@PID LUNG 024).

Meanwhile, Merck KGaA recently announced it had acquired Hamburg-based AmpTec, a deal that Merck says will increase its ability to produce mRNA for vaccines, diagnostics and treatments focused on COVID-19, among other diseases. This may place Merck in the running toward developing another mRNA-based COVID-19 vaccine, aside from approved vaccines from Pfizer/BioNTech and Moderna.

"By combining AmpTec’s PCR-based mRNA technology with Merck’s extensive expertise in lipids manufacturing, we are able to provide a truly differentiated and integrated offering across the mRNA value chain, which will significantly decrease supply chain complexity and enhance speed-to-market," said CEO Stefan Oschmann. "This transaction is another important step to support the constant growth of our Life Science business through tailored, small-scale acquisitions with high impact."

AmpTec offers Merck a differentiated PCR-based technology for mRNA manufacturing. The company suggests its technology has significant advantages over technologies from other companies, boasting benefits such as greater purity and flexibility, increased quality and higher performance.

Last month, Merck also announced a partnership with Artios to produce several precision cancer drugs over a three-year period. Under terms of the collaboration deal, Artios will receive an upfront $30 million payout and will be eligible for future payments of $860 million per treatment target.

On January 21, 2021 NexImmune reported that hiring of Gilead Sciences and Kite Pharma alum Robert Knight, M.D., the T-cell biotech is now gunning for an $86 million IPO (Press release, NexImmune, JAN 21, 2021, View Source [SID1234574228]).

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The startup wants the cash to boost its work on immunotherapy, with its platform designed to employ the body’s own T cells to generate a potent and durable immune response that mimics natural biology.

"Our mission is to create therapies with curative potential for patients with cancer and other life-threatening immune-mediated diseases," the Maryland biotech said in its Securities and Exchange Commission filing.

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It’s early-stage but in the clinic, unusually for a lot of biotech IPO attempts these days, with two candidates in human trials: NEXI-001 in acute myeloid leukemia (AML) and NEXI-002 in multiple myeloma (MM). Early data for these should be out by year-end.

NEXI-001 is a donor-derived, or allogeneic, ACT in a phase 1/2 test for treatment of patients with relapsed AML after allogeneic stem cell transplantation. NEXI-002, meanwhile, is a patient-derived, or autologous, ACT in a phase 1/2 for MM patients that have failed at least three prior lines of therapy.

"The backbone of our approach is our proprietary Artificial Immune Modulation, or AIM, nanoparticle technology platform. The AIM technology enables us to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. Like natural dendritic cells, the AIM nanoparticles employ natural signaling proteins to deliver specific instructions to specific T cells directing a desired immune response," the company said in the filing.

It said what sets it apart is, unlike other cell therapy approaches, it’s is accomplished "without any genetic manipulation of the T cell," thereby creating T-cell products designed to maintain natural target identification, engagement and killing mechanisms.

It now has Knight on board to help with the approach and can tap his vast experience in immunotherapy, which includes work on cell therapy Yescarta with Gilead-Kite as well as stints at Celgene and Sorrento.

The decade-old company, which licensed its core AIM tech from Johns Hopkins University, plans to list on the Nasdaq under the symbol "NEXI."

On January 21, 2021 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that its partner BioInvent International AB ("BioInvent") (OMXS: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy today announces that it will host a Key Opinion Leader call on BI-1206 for relapsed or refractory Non-Hodgkin’s Lymphoma on Thursday, January 28, 2021 at 11:30 a.m. Eastern Time (5:30 p.m. CET) (Press release, CASI Pharmaceuticals, JAN 21, 2021, View Source [SID1234574188]).

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The event will feature a presentation by renowned lymphoma expert Mats Jerkeman, MD, Lund University, who will discuss the current treatment landscape, and unmet medical need for patients with relapsed or refractory Non-Hodgkin’s Lymphoma for whom current treatment options are very limited. Dr Jerkeman will also discuss his experience in treating these patients with BioInvent’s anti-FcγRIIB antibody, BI-1206, a novel monoclonal antibody that specifically targets the antibody "brakes" to help overcome resistance to rituximab.

BioInvent’s management team will also provide an update on the ongoing Phase I/IIa trial of BI-1206 in combination with rituximab and CASI Pharmaceuticals Chairman and CEO, Dr. Wei-Wu He, will provide an update on the development plan and potential for BI-1206 in China. Dr. Jerkeman and senior members of the BioInvent and CASI management teams will be available to answer questions following the formal presentations.

To register for the call, please click here.

Dr. Mats Jerkeman is Professor in Clinical Oncology at Lund University, Sweden. His research focus is all possible aspects of malignant lymphomas, aiming for the improvement of the quality of life and survival of these patients.

Dr. Jerkeman is the coordinator of several ongoing clinical trials in diffuse large B-cell lymphoma and mantle cell lymphoma. He also serves as Chairman of the Nordic Lymphoma Group, Editor of ESMO (Free ESMO Whitepaper) Guidelines/Lymphoma and as coordinator of the Swedish Lymphoma Register for many years.

On January 21, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported the dosing of the first patient in the dose-expansion cohort of the Phase 1 STRO-002 study. STRO-002 is an internally developed, folate receptor alpha (FolRα) targeting antibody-drug conjugate (ADC) for the potential treatment of ovarian cancer (Press release, Sutro Biopharma, JAN 21, 2021, View Source [SID1234574187]). The dose-expansion cohort will assess the efficacy, safety and tolerability of STRO-002 at 4.3 and 5.2 mg/kg, given every 3 weeks in patients with ovarian cancer. The dose-expansion cohort for FolRα-selected endometrial cancer is planned for later this year.

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"We are pleased to advance the clinical development of STRO-002 into dose-expansion studies. Results from our STRO-002 dose escalation in a heavily pre-treated ovarian cancer patient population demonstrated improved outcomes in RECIST response and duration of response," said Dr. Arturo Molina, Chief Medical Officer of Sutro Biopharma. "Sutro plans to expand the study to approximately 35 clinical sites in the U.S. and Europe. We are hopeful that the dose-expansion study will validate the preliminary signs of efficacy we have seen in dose-escalation and provide valuable data on the treatment paradigm and patient population that will benefit from treatment, bringing us one step closer to offering an important new potential treatment option to ovarian cancer patients."

Dr. Lainie Martin, Leader of Gynecology/Oncology Program at Hospital of the University of Pennsylvania and an investigator on the STRO-002-GM1 study, said, "STRO-002 continues to be well-tolerated and we have observed encouraging preliminary activity in patients with advanced platinum-resistant and refractory ovarian cancer. We are excited to be part of the STRO-002-GM1 dose-expansion study and to provide additional clinical data to show the potential of this therapeutic for ovarian patients with limited treatment options."

The dose-expansion study includes two patient cohorts, advanced epithelial ovarian cancer and endometrial cancer. The ovarian cancer cohort currently enrolling includes patients with platinum resistant disease and have received 1-3 prior regimens or platinum sensitive patients that have received 2-3 prior treatment regimens. Patients in the dose-expansion cohort of the STRO-002-GM1 Phase 1 study will be randomized 1:1 and treated with either 4.3 or 5.2 mg/kg STRO-002 intravenously once every three-weeks. Patients will not be pre-selected for FolRα expression and fresh or archival tumor tissue sample is required for immunohistochemistry (IHC) analysis of FolRα expression.

Additional information on the study can be found at: View Source

About the Phase 1 Trial of STRO-002 in Ovarian Cancer
STRO-002-GM1, the Phase 1 open-label, multicenter, dose escalation trial with dose expansion of STRO–002, has completed enrollment. Follow-up is ongoing and will continue to evaluate the safety, tolerability, and preliminary anti-tumor activity of STRO-002 in adults with advanced epithelial ovarian cancer, including fallopian and primary peritoneal cancer. The trial is registered with clinicaltrials.gov identifier NCT03748186. Sutro discovered, developed and manufactures STRO-002 using its proprietary XpressCF cell-free protein synthesis and XpressCF+ site-specific conjugation technologies.