On September 7, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx) targeting oncology and immuno-dysregulated diseases, reported that it has completed Good Manufacturing Practice ("GMP") manufacturing of a scaled-up batch of IMX-110 for clinical trials. IMX-110 was produced using our proprietary, scaled-up manufacturing process that will provide drug supply for 2 ImmixBio clinical trials planned to start in 2022: first, planned monotherapy IMX-110 clinical trial in soft tissue sarcoma ("STS"); second, planned combination IMX-110 + BeiGene anti-PD-1 tislelizumab clinical trial in advanced solid tumors (Press release, Immix Biopharma, SEP 7, 2022, View Source [SID1234619143]).

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"Completing the first batch of GMP IMX-110 using our proprietary, scaled-up GMP manufacturing process just 7 months after our manufacturing kick-off is a testament to the efficiency and dedication of our stellar team," said Ilya Rachman, MD PhD, CEO of ImmixBio. "Building on promising clinical and animal data for IMX-110 as a monotherapy and in combination with PD-1, we are excited to kick off 2 clinical trials soon in 2022 – IMX-110 monotherapy, and IMX-110 combined with BeiGene anti-PD-1 tislelizumab."

About IMX-110

The U.S. Food and Drug Administration ("FDA") has approved orphan drug designation ("ODD") for IMX-110 for the treatment of soft tissue sarcoma. Additionally, the FDA has approved rare pediatric disease designation ("RPDD") for IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma. RPDD qualifies ImmixBio to receive fast track review and a priority review voucher (PRV) at the time of marketing approval of IMX-110. IMX-110 is currently being evaluated in a phase 1b/2a clinical trial in patients with advanced solid tumors. Learn more at www.immixbio.com/iMX-110.

On September 7, 2022 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported that management will be presenting a corporate overview at the H.C. Wainwright Annual Global Investment Conference being held in New Yok on September 12 – 14, 2022 (Press release, CorMedix, SEP 7, 2022, https://www.cormedix.com/cormedix-inc-to-present-at-the-h-c-wainwright-annual-global-investment-conference/ [SID1234619142]).

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On September 7, 2022 Monteris Medical reported that the first patient has been enrolled in its REMASTer (Recurrent Brain Metastases After Stereotactic Radiosurgery [SRS] Trial) clinical trial (Press release, Monteris Medical, SEP 7, 2022, View Source [SID1234619141]). This randomized controlled study is designed to investigate laser interstitial thermal therapy (LITT) using the NeuroBlate System as an early intervention for radiographically progressive brain metastases and to provide Level I evidence to guide treatment for this complex patient population.

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Treatment of recurrent brain metastases is challenging as no standardized care currently exists within the clinical community for patients with disease progression following SRS. This is primarily attributed to the uncertainty of the underlying cause being either recurrence or radiation necrosis. In recent years, LITT has proved to be an effective tool for both causes of progression after SRS and can be performed during the same procedure as needle biopsy. Recent published studies suggest that LITT plus SRS may be superior to LITT alone or repeat SRS alone for treatment of biopsy-proven brain metastasis recurrence after SRS failure, even after controlling for variables known to predict progression. Recent literature also has revealed LITT to be effective for the treatment of radiation necrosis, with a superior time to steroid independence compared to medical management alone.

The REMASTer trial is designed to determine the superior treatment algorithm for both the recurrent tumor and radiation necrosis populations. The study will enroll 154 patients at up to 12 sites. Primary endpoints for the study include time to local intracranial progression or death and time to steroid cessation. Additional endpoints include comparison of treatment approaches with respect to overall survival, quality of life, and cognitive changes over time.

"The REMASTer trial will be vital in providing Level I evidence that establishes a critically needed standard of care in patients who have radiographically progressive metastatic disease, be it radiation necrosis or true disease recurrence," said Dr. Peter Fecci, director of the Brain Tumor Immunotherapy Program and the Center for Brain and Spine Metastasis at Duke University School of Medicine in Durham, N.C. and REMASTer principal investigator. "Rapidly establishing steroid independence in the radiation necrosis population in the era of immunotherapy is crucial, as is optimizing freedom from local progression in patients with truly recurrent brain metastatic disease. This study will help to solidify the role for LITT in both scenarios."

It is estimated that up to 300,000 patients in the United States are diagnosed annually with metastatic brain tumors. The incidence of metastatic brain tumors has risen in recent years due to patients living longer with systemic cancers as a result of treatment advances, increased imaging procedures and early detection, and improvements in imaging technology. Metastatic tumor progression and radiation necrosis are therefore increasing in prevalence as well, necessitating the need for standard of care approaches to patient treatment.

"While the data supporting the use of LITT in radiation necrosis and recurrent metastatic disease is already strong enough to warrant inclusion in National Comprehensive Cancer Network guidelines, evidence is lacking to advise the best time for LITT in the treatment algorithm for patients with radiographic progression," said Jennifer Englund, vice president of clinical and regulatory affairs of Monteris. "We believe the study Dr. Fecci has designed is poised to deliver meaningful results that will standardize treatment for this growing population of patients."

On September 7, 2022 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that it has entered into a securities purchase agreement with a select group of institutional investors to issue and sell an aggregate of 8,625,520 shares of its common stock at a price per share of $26.01 in a private placement transaction (the "Financing") (Press release, SpringWorks Therapeutics, SEP 7, 2022, View Source [SID1234619140]). SpringWorks anticipates gross proceeds from the Financing to be approximately $225 million, before deducting offering expenses. The closing of the financing is expected to occur on September 9, 2022, subject to customary closing conditions.

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The Financing includes participation from new and existing institutional investors, including EcoR1 Capital, Boxer Capital, Invus, Deerfield Management, Perceptive Advisors, and another large institutional investor. Goldman Sachs & Co. LLC acted as placement agent and J.P. Morgan Securities LLC acted as structuring agent in the Financing.

"We are very pleased by the support from this high-quality group of investors as we work towards the first of our expected drug launches next year and continue to advance our diversified pipeline," said Saqib Islam, Chief Executive Officer of SpringWorks. "These additional funds will support our mission to make a profound impact on the lives of patients with devastating cancers."

SpringWorks intends to use the net proceeds from the Financing to support the anticipated U.S. launch of nirogacestat in patients with desmoid tumors, the advancement of the Company’s ongoing research and development programs, and for working capital and general corporate purposes. SpringWorks expects its cash, cash equivalents and marketable securities, inclusive of the equity investment pursuant to the Company’s recently announced expanded collaboration with GSK plc, to exceed $600 million upon closing of the Financing, which is expected to be sufficient to fund operating and capital expenditures into 2026. This cash estimate is a preliminary estimate based on net proceeds and information available to management as of the date of this release; actual cash on-hand may vary from this estimate.

The securities sold in the Financing are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Concurrently with the execution of the securities purchase agreement, SpringWorks and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the securities sold in the Financing.

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

On September 7, 2022 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that it has entered into an expanded global, non-exclusive license and collaboration agreement with GSK plc (LSE/NYSE: GSK) for nirogacestat, SpringWorks’ investigational oral gamma secretase inhibitor, in combination with Blenrep (belantamab mafodotin-blmf), GSK’s antibody-drug conjugate targeting B-cell maturation antigen (BCMA) (Press release, SpringWorks Therapeutics, SEP 7, 2022, View Source [SID1234619139]).

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Under the terms of the expanded agreement, SpringWorks will receive a $75 million equity investment from GSK, with shares of common stock priced at a premium to the 30-day volume-weighted average share price on September 2, 2022. SpringWorks will also be eligible to receive up to $550 million in additional payments based on reaching certain development and commercial milestones. SpringWorks will retain full commercial rights to nirogacestat and will be responsible for global commercialization of nirogacestat.

"We are very pleased to expand our relationship with GSK to enable potential additional studies of Blenrep and nirogacestat," said Saqib Islam, Chief Executive Officer of SpringWorks. "Our goal is to maximize the clinical impact of nirogacestat as a potentiator of BCMA targeted therapies and today’s announcement advances our opportunity to serve patients with multiple myeloma across lines of therapy."

"We look forward to continuing our relationship with SpringWorks for the potential expanded development of Blenrep with nirogacestat and are encouraged by the early clinical data emerging from the combination," said Hesham A. Abdullah, M.D., M.Sc., Senior Vice President, Global Head of Oncology Development at GSK. "Blenrep in combination with novel therapies, such as nirogacestat, could prove to be an impactful therapeutic option for patients with multiple myeloma, as these combination regimens may further optimize the benefit-risk profile of Blenrep, especially in earlier lines of therapy."

SpringWorks and GSK first entered into a clinical trial collaboration and supply agreement in June 2019, later amended in October 2021, to cover the initial clinical development of nirogacestat in combination with Blenrep in patients with relapsed or refractory multiple myeloma. The new agreement expands the original collaboration to include the potential for continued development and commercialization of the combination of nirogacestat and Blenrep in earlier lines of treatment, including newly diagnosed multiple myeloma. SpringWorks and GSK will expand their previously established governance structures to add a new Joint Steering Committee and Joint Commercialization Committee to their existing Joint Development Committee. GSK will continue funding all development costs, except for those related to the supply of nirogacestat and certain expenses related to intellectual property rights.