On January 19, 2022 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) reported that updated analysis of the ongoing international Phase I/Ib trial of fruquintinib will be presented at the upcoming 2022 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, taking place on January 20-22, 2022 (Press release, Hutchison China MediTech, JAN 19, 2022, View Source [SID1234605536]). The meeting will be held virtually and in person at the Moscone Center in San Francisco, California, US.

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Further details of the presentation are as follows:

Title: Phase I/Ib trial of fruquintinib in patients with advanced solid tumors: preliminary results of the dose expansion cohorts in refractory metastatic colorectal cancer
Presenter: Arvind Dasari, MD, MS, MD Anderson Cancer Center
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Abstract No.: 93
Date & Time: Saturday, January 22, 2022
Location: Moscone Center – West, Level 1, West Hall and virtually

About Colorectal Cancer ("CRC")
CRC is a cancer that starts in either the colon or rectum. CRC is the third most common cancer worldwide, estimated to have caused more than 915,000 deaths in 2020.[1] In the U.S., an estimated 150,000 people were diagnosed with CRC and 53,000 people died from CRC in 2021.[2] In Europe, CRC is the second most common cancer, with an estimated 507,000 new cases and 240,000 deaths in 2020.[2] In Japan, CRC is the most common cancer, with an estimated 147,000 new cases and 59,000 deaths in 2020.[2]

About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

About Fruquintinib Approval in China
Metastatic CRC in China: Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in late November 2018 under the brand name ELUNATE. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. ELUNATE is indicated for the treatment of patients with metastatic CRC who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Results of the FRESCO study[3], a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic CRC in China, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).

About Fruquintinib Development Beyond CRC Monotherapy
The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated:

Gastric Cancer ("GC") in China: In October 2017, HUTCHMED initiated the FRUTIGA study, a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for second-line treatment of advanced gastric or esophagogastric junction ("GEJ") adenocarcinoma. The trial is designed to enroll patients who did not respond to first-line standard chemotherapy. Subjects receive either fruquintinib combined with paclitaxel or placebo combined with paclitaxel. Patients are randomized at a 1:1 ratio and stratified according to factors such as stomach vs. GEJ tumor type and performance status. The primary efficacy endpoint is overall survival (OS). Secondary efficacy endpoints include progression-free survival (as defined by RECIST 1.1), objective response rate, disease control rate, duration of response, and quality-of-life score (EORTC QLQ-C30, version 3.0). Biomarkers related to the antitumor activity of fruquintinib will also be explored (clinicaltrials.gov identifier: NCT03223376). In June 2020, HUTCHMED completed a planned interim data review. Based on the preset criteria, the Independent Data Monitoring Committee (IDMC) recommended that the trial continue.

Immunotherapy combinations: HUTCHMED has entered into collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317, developed by BeiGene, Ltd) and sintilimab (IBI308, developed by Innovent Biologics, Inc. and marketed as TYVYT in China).

Metastatic breast and endometrial cancers in the U.S.: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase Ib/II study in the U.S. to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced, refractory triple negative breast cancer ("TNBC") and endometrial cancer ("EMC"). This study is being conducted to investigate if the addition of fruquintinib can potentially induce activity to immune checkpoint inhibitor therapy in TNBC and EMC. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04577963. Safety and preliminary efficacy of fruquintinib were demonstrated in advanced solid tumors, including TNBC, in a Phase I study conducted in China (NCT01645215) and a Phase I/Ib study is ongoing in the United States (NCT03251378).

Gastric, colorectal and non-small cell lung cancers in China & Korea: BeiGene, Ltd. initiated this open-label, multi-center, Phase II study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced or metastatic, unresectable GC, CRC or non-small cell lung cancer ("NSCLC"). Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04716634.

Solid tumors in China: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase II study to assess the safety and efficacy of fruquintinib in combination with sintilimab in patients with advanced EMC, cervical cancer, CRC, GC, hepatocellular carcinoma (HCC), NSCLC or renal cell carcinoma (RCC). Additional details of the study may be found at clinicaltrials.gov, using identifier NCT03903705. Preliminary results of certain cohorts were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) and the Chinese Society of Clinical Oncology Annual Meeting (CSCO).

On January 19, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported a corporate update on its key strategic priorities for 2022 and 2023 in addition to confirming its upcoming clinical development milestones for zanidatamab and ZW49 (Press release, Zymeworks, JAN 19, 2022, View Source [SID1234605664]).

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"Upon assuming my new role effective January 15th, we have moved quickly to review and confirm key strategic priorities for the near term and to establish a renewed and smaller leadership team focused on accomplishing those priorities in a prompt, high-quality and cost-efficient manner," stated new Chair and Chief Executive Officer, Kenneth Galbraith. "We have already begun the process to reset and focus the organization on: (i) timely execution of our clinical development programs for zanidatamab and ZW49 in collaboration with our Asia-Pacific partner, BeiGene; (ii) a streamlined R&D strategy for our technology platforms and preclinical product candidates; (iii) actively seeking additional opportunities to establish further partnerships and collaborations in order to grow our business; and (iv) improving our financial position in order to properly fund our key priorities for 2022 and 2023."

Mr. Galbraith continued, "As an initial step, we have reset and focused the Company’s operations around our core activities and most promising R&D opportunities. These measures, including the reduction in our workforce announced today, provide opportunities to reduce our future planned expenditures while continuing to fund our key priorities for 2022 and 2023. I am looking forward to reporting our progress against these key priorities over the course of 2022 and 2023 as we reset, focus and build a leading biopharmaceutical company around a renewed organization, and an exciting and expanding pipeline of product candidates with the potential to make a significant difference for patients around the world with difficult-to-treat cancers."

Key Strategic Priorities for 2022 and 2023

Fully recruit the HERIZON-BTC-01 pivotal clinical study for zanidatamab by mid-2022;
Fully recruit the HERIZON-GEA-01 pivotal clinical study for zanidatamab by the end of 2023;
Complete or close out other ongoing early-stage clinical studies for zanidatamab as data become available, and use these data to identify and support strategic decisions regarding future clinical development opportunities beyond the ongoing pivotal clinical studies;
Finalize a clear clinical development path for ZW49 based on additional clinical data expected in 2022 from the ongoing Phase 1 clinical trial;
Select and advance two new antibody-drug conjugate or multispecific product candidates leveraging Zymeworks’ novel, therapeutic platforms (Azymetric, ZymeLink, EFECT and ProTECT) to IND-enabling studies to provide the ability to submit two Investigational New Drug (IND) applications by the end of 2024;
Execute on new partnerships and collaborations to support the development and commercialization of zanidatamab and Zymeworks’ early-stage R&D pipeline and technology platforms;
Continue to support and advance Zymeworks’ core technology platforms and collaborations; and
Improve Zymeworks’ financial position over 2022 and 2023 through a combination of alternatives, including forming additional partnerships and collaborations, monetizing existing assets and products and securing additional financing.
"By focusing on our key priorities, we can work towards improved operational execution in a cost-effective manner over 2022 and 2023, and position the Company for appropriate and well-managed growth of our clinical and preclinical pipeline as opportunities arise," said Mr. Galbraith.

R&D Update

"2022 will be an important year for the development of our lead clinical-stage product candidate, zanidatamab, as we continue our efforts in conjunction with our Asia-Pacific partner, BeiGene, to make this potential new therapy available to patients around the world suffering from Biliary Tract Cancer (BTC) and Gastroesophageal Adenocarcinomas (GEA). We look forward to reporting new clinical data at upcoming medical conferences throughout 2022, and announcing next steps in the months ahead for both zanidatamab and ZW49," stated Dr. Neil Josephson, Chief Medical Officer (CMO) of Zymeworks.

Biliary Tract Cancer (BTC)

HERIZON-BTC-01, a pivotal study evaluating zanidatamab in previously-treated advanced HER2-amplified BTC, continues to enroll patients in line with our expectations, including in the Asia-Pacific region with our partner BeiGene
The Company refines its guidance of completing the enrolment in the HERIZON-BTC-01 pivotal clinical study by mid-2022
Gastroesophageal Adenocarcinoma (GEA)

HERIZON-GEA-01, a pivotal study evaluating zanidatamab in 1L HER2-positive GEA, continues to enroll patients in line with our expectations, building off the encouraging clinical data in the 1L GEA setting for zanidatamab in combination with chemotherapy presented at ESMO (Free ESMO Whitepaper) in September 2021
The Company confirms its guidance of completing enrolment in the HERIZON-GEA-01 pivotal clinical study before the end of 2023
The Company confirms its guidance for providing clinical data for zanidatamab in combination with chemotherapy and tislelizumab in 1L HER2-positive GEA in H1 2022 in conjunction with its Asia-Pacific partner BeiGene
Other Clinical Development Opportunities for Zanidatamab

Early clinical studies continue to advance in important patient populations, including studies conducted in collaboration with BeiGene, ALX Oncology and Pfizer, that will play a role in determining and supporting investment in future clinical development opportunities for zanidatamab beyond the current pivotal studies for BTC and GEA
Zymeworks confirms its guidance for providing data for:
zanidatamab in combination with chemotherapy in 1L HER2-positive breast cancer in H1 2022 in conjunction with its Asia-Pacific partner BeiGene, and
zanidatamab in combination with Ibrance and fulvestrant in 3L+ HER2-positive HR‑positive breast cancer in H1 2022
ZW49

Dose escalation for the QW dosing schedule as well as expansion cohorts for the Q3W dosing schedule continue to progress
The Company confirms its guidance of providing updated clinical data in H2 2022 that will inform and support clear decisions to be made in 2022 regarding the clinical development path for ZW49 in conjunction with its Asia-Pacific partner BeiGene
Leadership Team

"In connection with our renewed focus on key strategic priorities for 2022 and 2023, Mr. Neil Klompas, our newly-promoted Chief Operating Officer (COO), Dr. Neil Josephson, our recently-promoted CMO, and I have re-established the leadership team comprised of highly qualified and experienced individuals who will work together with us to reset, focus and build our Company," stated Mr. Galbraith. "Mr. Klompas will work with me to directly manage and guide our commercial strategy for zanidatamab, our expanded outreach in business development and corporate development, our renewed early-stage R&D strategy for the technology platforms, our efforts to improve our financial position and leadership of our corporate operations. Dr. Josephson will work with me to manage our important clinical-stage development programs for zanidatamab and ZW49, and provide an important leadership function with our talented employees based in Seattle and other regions in the United States."

"I look forward to working with both of them in their new leadership positions. In addition, we will be immediately commencing a search for an experienced Head of Research and Development to lead our R&D operations and continue building our world-class technology platforms."

The leadership team is comprised of:

Neil Klompas, CPA, CA – Chief Operating Officer and Chief Financial Officer

Neil Josephson, MD – Chief Medical Officer

Bruce Hart, PhD – Senior VP, Regulatory Affairs

Mark Hollywood – Senior VP, Technical and Manufacturing Operations

Kaycia Wilde, PhD – VP, Clinical Operations

John Fann, PhD – VP, Technical Operations and Process Science

Milan Mangeshkar, PhD – VP, Biometrics

Surjit Dixit, PhD – VP, Technology

David Poon, PhD – VP, Business Development and Alliance Management

Daniel Dex, JD – VP, Legal and Corporate Secretary

Jennifer Kaufman-Shaw, JD, PhD – VP, Intellectual Property

Additional information regarding the background and experience of our leadership team is available on our website in the "Leadership" section.

In conjunction with the renewed focus on key priorities and desire for cost-efficiency in our operations, ten members (or 50%) of the former senior management team (including the Chief People Officer, Chief Commercial Officer and Chief Scientific Officer/EVP Early Development), will be leaving the Company. Additionally, in line with these reductions in the senior management team, a Company-wide reduction in workforce will be initiated with a target of reducing employee headcount by at least 25% by the end of 2022.

Mr. Galbraith said, "While we sincerely understand and appreciate the personal impact of these changes on employees in our organization, starting immediately, a smaller, more focused workforce is essential for us to improve our operating performance and accomplish our key priorities in a more cost-efficient manner. I am confident in the ability of our Board of Directors, our new leadership team and our dedicated employees to work effectively together as we move forward to carry out the work that we do every day for the benefit of patients in need, our collective success as a workforce, and in the interests of our stockholders to build a successful and valuable biotechnology company."

Updated Financial Position

The Company provided an update on its financial resources, including having cash, cash equivalents and short-term investments of approximately $250 M (unaudited) as of December 31, 2021, and reiterated its guidance on a financial runway to fund current operations through at least late 2022. The Company intends to report full Q4 and FY 2021 results and provide any further corporate updates on February 24, 2022.

"We will continue to actively consider a variety of initiatives and options to further improve our financial position during 2022 and 2023, including spending reductions and deferrals, establishing additional collaborations and partnerships, monetizing existing assets and product candidates, and various new financing alternatives in order to provide the necessary funding to continue to pursue our key priorities, and to improve our financial condition for the longer term," stated Mr. Klompas. "We will be looking at outlicensing, partnership and funding opportunities as they relate to several of our non-core early-stage R&D programs, including product candidates and intellectual property for targeting IL-12, CD47, and MET, as well as a novel ACE2 decoy program targeting SARS-CoV-2. We believe that prudent measures to grow our business in a well-managed and orderly fashion are aligned with the interests of patients in need, our employees and our stockholders, and we look forward to updating our progress on these efforts as and when appropriate."

To help improve its financial condition for the longer-term, Zymeworks anticipates that it may, from time to time and subject to market conditions and other factors, consider raising additional capital to further support its business, operations and programs.

On January 19, 2022 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company dedicated to delivering targeted therapies for rare cancers, reported the publication of a review article in the Journal of Hematology & Oncology that outlines the potential ability of momelotinib—a novel JAK1, JAK2 and ACVR1 / ALK2 inhibitor—to address the critical unmet need of anemia for myelofibrosis patients (Press release, Sierra Oncology, 19 19, 2022, View Source [SID1234605666]). Srdan Verstovsek, MD, PhD, Chief, Section for Myeloproliferative Neoplasms, Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center and co-Primary Investigator of the pivotal Phase 3 MOMENTUM study, co-authored the article.

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"We are delighted to see this publication that reinforces momelotinib as the potential JAK inhibitor of choice for myelofibrosis patients with anemia—a need that is currently not met with approved JAK inhibitors. We look forward to sharing MOMENTUM topline data the end of January 2022," said Stephen Dilly, MBBS, PhD, President and Chief Executive Officer at Sierra Oncology.

Myelofibrosis is characterized by constitutional symptoms, including fatigue, body and bone pain and excessive sweating or fever; splenomegaly (enlarged spleen); and anemia. Moderate-to-severe anemia afflicts 40-60% of myelofibrosis patients at the time of diagnosis and increases to up-to 90% of patients over time.1 Anemia is a predictor of reduced overall survival and is associated with a nearly four-fold increase in the risk of death compared to no anemia, with a median survival of just 2.1 years.2,3

While JAK inhibitors are the mainstay of treatment options for myelofibrosis patients, currently approved JAK inhibitors cause myelosuppression, worsening anemia and creating poorer outcomes for patients. This profile creates a critical gap in the myelofibrosis treatment landscape and the need for a therapy that can address all three hallmarks of disease.

The authors noted in the publication, "Momelotinib’s mechanism of action uniquely positions it amongst approved and late-stage JAK inhibitors to be able to significantly alleviate the inflammation-driven, iron-restricted anemia of MF [ myelofibrosis] and eliminate/prevent RBC [red blood cell] transfusion dependence in a significant portion of MF patients besides treating the other two cardinal features of MF (splenomegaly and constitutional symptoms)."

To read the full article, titled "Momelotinib: an emerging treatment for myelofibrosis patients with anemia," please visit the Journal of Hematology & Oncology website.

About Momelotinib

Momelotinib is a selective and orally bioavailable JAK1, JAK2 and ACVR1 / ALK2 inhibitor for the potential treatment of myelofibrosis. Myelofibrosis results from dysregulated JAK-STAT signaling and is characterized by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia.

Momelotinib is currently under investigation in the MOMENTUM clinical trial, a global, randomized, double-blind Phase 3 study for symptomatic and anemic myelofibrosis patients. The study enrolled 195 patients based on a planned 180 patients across 21 countries. Topline data are anticipated by the end of January 2022, and assuming positive results, the company intends to file an NDA with the FDA in the second quarter of 2022.

On January 19, 2022 Oasmia’s Board of Directors reported that subject to approval from the Extraordinary General Meeting on 21 February 2022, to carry out the Rights Issue of approximately SEK 151 million before deduction of issue costs (Press release, Oasmia, JAN 19, 2022, View Source [SID1234605557]).

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Those who are registered as shareholders on the record date of 4 March 2022 have the preferential right to subscribe for new shares in proportion to their existing shareholdings. Subscription of shares may also take place without subscription rights.

The Board of Directors’ resolution on the Rights Issue is subject to approval by the Extraordinary General Meeting on 21 February 2022. For further information, please see separate press release with notice of the Extraordinary General Meeting.

Terms of the Rights Issue

Those who are registered shareholders in Oasmia on the record date 4 March 2022, receive one (1) subscription right for each (1) share. The subscription rights grant the holder preferential right to subscribe for new shares, whereby five (5) subscription rights entitle the shareholder to subscribe for one (1) new share. In addition, investors are offered the possibility to subscribe for shares without subscription rights.

In the event that not all shares are subscribed for under subscription rights, the Board of Directors shall, within the maximum amount of the Rights Issue, resolve on allotment of shares without subscription rights. Allotment will then take place in the following order of priority: primarily, allotment shall be made to those who subscribed for shares under subscription rights, regardless of whether the subscriber was a shareholder on the record date or not, pro rata in relation to the number of subscription rights exercised for subscription and, to the extent that this cannot be done, by drawing lots; secondarily, allotment shall be made to others who have signed up for subscription without subscription rights. In the event that they cannot receive full allotment, allotment shall be made pro rata in proportion to the number of shares subscribed for by each and, to the extent that this cannot be done, by drawing lots; and in the third and final stage, any remaining shares shall be allotted to the parties who have guaranteed the Rights Issue, in relation to the guarantee undertakings made.

The subscription price is SEK 1.68 per new share. Assuming that the Rights Issue is fully subscribed, the share capital will be increased by a maximum of SEK 8,967,390.9 from SEK 44,836,954.6 to SEK 53,804,345.5, by new issue of a maximum of 89,673,909 new shares, resulting in the total number of shares increasing from 448,369,546 shares to 538,043,455 shares. Assuming full subscription, Oasmia will receive total proceeds of approximately SEK 151 million, before deduction of issue costs.

The subscription period runs from 8 March 2022 through 22 March 2022. The Board of Directors of Oasmia is entitled to extend the subscription period and the time for payment which, if applicable, will be announced by the Company in a press release no later than 22 March 2022. Trading in subscription rights will take place on Nasdaq Stockholm during the period from 8 March 2022 through 17 March 2022 and the trading in paid-up subscribed shares (Sw: betalda tecknade aktier) during the period from 8 March 2022 through 4 April 2022.

Shareholders who choose not to participate in the Rights Issue will, assuming that the Rights Issue is fully subscribed, have their shareholdings diluted by approximately 16.7 percent, but are able to financially compensate for this dilution by selling their subscription rights.

Subscription commitments and guarantee undertakings

The Company’s largest shareholder, Per Arwidsson through Arwidsro Investment AB and Fastighets AB Arwidsro, representing approximately 24.8 percent of the total number of shares and votes in Oasmia, has undertaken to subscribe for its pro-rata share of the shares in the Rights Issue.

Additionally, a consortium of external investors have given guarantee commitments to Oasmia of SEK 113 million, corresponding to approximately 75.2 percent of the Rights Issue. Thus, the Rights Issue is fully secured. For the guarantee undertakings, a cash compensation of 6.5 percent is paid on the guaranteed amount.

Prospectus

Complete terms and conditions for the Rights Issue and other information about the Company as well as information about subscription commitments and guarantee undertakings will be available in the prospectus that the Company is expected to publish on 3 March 2022.

Preliminary timetable

The below timetable for the Rights Issue is preliminary and may be adjusted.

2 March 2022 Last day of trading in shares including right to participate in the Rights Issue
3 March 2022 First day of trading in shares excluding right to participate in the Rights Issue
3 March 2022 Estimated date for publication of the prospectus
4 March 2022 Record date for participation in the Rights Issue, i.e. holders of shares who are registered in the share register on this date will receive subscription rights for participation in the Rights Issue
8 March – 17 March 2022 Trading in subscription rights
8 March – 22 March 2022 Subscription period
8 March – 4 April 2022 Trading in paid-up subscribed shares (Sw: betalda tecknade aktier)
24 March 2022 Estimated date for publication of preliminary results of the Rights Issue
25 March 2022 Estimated date for publication of final results of the Rights Issue
Online presentation today at 14:00 CET

The company will hold an online presentation today at 14:00 CET. The presentation will be given by CEO Francois Martelet and CFO Fredrik Järrsten in English. The presentation will be broadcast live via the link: View Source

Questions can be sent in advance to [email protected] or by phone to +46 72-376 90 10.

Advisers

In connection with the Rights Issue, Oasmia has appointed Danske Bank A/S, Danmark, Sverige Filial as financial adviser and Sole Bookrunner. Törngren Magnell & Partners Advokatfirma KB acts as legal adviser to the Company and Schjødt acts as legal adviser to Danske Bank.

On January 19, 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 positive interim clinical trial safety data demonstrating 100% completion of IMX-110 planned treatment cycles in its ongoing Phase 1b/2a clinical trial (Press release, Immix Biopharma, JAN 19, 2022, View Source [SID1234605579]). Historically, 43-67% of patients have completed planned treatment cycles with approved drugs used to treat soft tissue sarcoma (STS) according to Demetri et al., 2016, and Schöffski et al., 2016. Completion of planned treatment cycles refers to lack of drug-related interruptions (cycle delays, dose reductions, or dose interruptions due to drug toxicity).

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"With standard treatments widely used today, cancer patients face a long list of drug-related debilitating side-effects that cause treatment delays, dose reductions, or dose interruptions due to toxicity, interfering with the ability to treat them effectively," said Ilya Rachman, MD PhD, CEO of ImmixBio. "In this interim clinical trial update, we are thrilled to report that IMX-110 has been well tolerated. We believe that IMX-110 could become a potentially attractive option to improve the patient experience in oncology in the future."

The U.S. Food and Drug Administration ("FDA") has approved orphan drug designation ("ODD") for IMX-110 for the treatment of soft tissue sarcoma. The FDA has already approved rare pediatric disease ("RPD") designation to IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma.