On March 28, 2024 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported Walter Klemp, President and Chief Executive Officer of Moleculin will present at the MedInvest Biotech & Pharma Investor Conference behind held in New York City, NY on Thursday, April 4, 2024 at 4:10 PM ET (Press release, Moleculin, MAR 28, 2024, View Source [SID1234641573]).

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In addition to the presentation, management will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the event, please visit the conference website.

A live webcast of the event will be available on the Events page in the Investors section of the Company’s website (moleculin.com).

On March 28, 2024 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, known as engineered toxin bodies, to create novel therapies with potent and differentiated mechanisms of action for cancer, reported that it has entered into a definitive amended and restated securities purchase agreement with certain healthcare investors that will provide $9.5 million in gross proceeds to MTEM through the closing of the second tranche of its previously announced July 2023 private placement and purchase agreement on amended terms (Press release, Molecular Templates, MAR 28, 2024, View Source [SID1234641572]). The financing is being led by existing investor BVF Partners L.P. and includes existing investors BB Biotech AG and Santé, and other leading institutional investors.

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At the closing of the second tranche, MTEM expects to issue an aggregate of 1,209,612 shares of its common stock (and, in lieu thereof, prefunded warrants to purchase 2,460,559 shares of common stock) and accompanying warrants to purchase up to an aggregate of 7,340,342 shares of its common stock (or prefunded warrants in lieu thereof) at a combined purchase price of $2.60 per share and accompanying warrants, in accordance with the "Minimum Price" requirement as defined in the Nasdaq rules. The closing of the second tranche is subject to the satisfaction of customary closing conditions.

Stifel is acting as the sole placement agent in connection with the financing.

MTEM intends to use the net proceeds from the proceeds of the second tranche to fund its ongoing clinical studies, working capital and for general corporate purposes.

The securities sold in the second tranche, including the shares of common stock underlying the warrants, are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws and 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 applicable state securities laws. MTEM has agreed to file a resale registration statement with the Securities and Exchange Commission registering the resale of the securities issued in the second tranche.

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 March 28, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults (Press release, Merck & Co, MAR 28, 2024, View Source [SID1234641571]).

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This approval by the EC follows the positive recommendation from the Committee for Medicinal Products for Human Use received in February 2024 and was based on results from the Phase 3 KEYNOTE-671 trial. At a median follow-up of 29.8 months (range, 0.4 to 62.0 months), KEYTRUDA plus chemotherapy in the neoadjuvant setting followed by KEYTRUDA as monotherapy after surgical resection significantly improved overall survival (OS), reducing the risk of death by 28% (HR=0.72 [95% CI, 0.56-0.93]; one-sided p=0.00517) in patients with resectable stage II, IIIA or IIIB NSCLC versus placebo plus chemotherapy in the neoadjuvant setting followed by placebo after surgical resection, regardless of PD-L1 expression. For patients who received the KEYTRUDA-based regimen, median OS was not reached (95% CI, NR-NR) versus 52.4 months (95% CI, 45.7-NR) for patients who received the chemotherapy-placebo regimen. The KEYTRUDA-based regimen also improved event-free survival (EFS), reducing the risk of disease recurrence, progression or death by 41% (HR=0.59 [95% CI, 0.48-0.72]) compared to the chemotherapy-placebo regimen. For patients who received the KEYTRUDA-based regimen, median EFS was improved by nearly two and a half years compared to the chemotherapy-placebo regimen (47.2 months [95% CI, 32.9-NR] versus 18.3 months [95% CI, 14.8-22.1], respectively).

"Despite the clinical advances for patients with metastatic lung cancer, lung cancer continues to be the leading cause of cancer death in Europe, reinforcing the need to treat these patients in earlier stages of their disease, where we may have the most impact," said Dr. Solange Peters, chair of the medical oncology and thoracic malignancies department, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. "The approval of this KEYTRUDA-based regimen is an important milestone for patients diagnosed with resectable non-small cell lung cancer at high risk of recurrence, regardless of PD-L1 expression, providing a new option for these patients that has shown, through the results of the Phase 3 KEYNOTE-671 trial, the potential to help extend their lives."

This approval allows marketing of this KEYTRUDA regimen for this indication in all 27 EU member states, as well as Iceland, Liechtenstein, Norway and Northern Ireland. KEYTRUDA is now approved for six indications in NSCLC, and for 27 indications overall in the EU. In October 2023, KEYTRUDA was approved in the U.S. for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

"Today’s approval of the first anti-PD-1/L1 therapy as part of a treatment regimen in Europe for the neoadjuvant followed by adjuvant treatment of resectable NSCLC based on positive overall survival results demonstrates our continued progress to advance treatments in earlier stages of lung cancer," said Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "We are eager to build on this momentum as we plan to seek additional approvals of this regimen around the world, and to work together with the cancer community to help drive earlier diagnoses of lung cancer, an urgent need."

About the KEYNOTE-671 study design

KEYNOTE-671 is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT03425643) evaluating KEYTRUDA in combination with neoadjuvant chemotherapy, followed by surgery and continued adjuvant treatment with KEYTRUDA as a single agent, versus placebo plus neoadjuvant chemotherapy, followed by resection and adjuvant placebo, in patients with resectable stage II, IIIA or IIIB (T3-4N2) NSCLC (per the eight edition of the American Joint Committee on Cancer [AJCC] Cancer Staging Manual). The trial’s dual primary endpoints are EFS, per RECIST v1.1 by investigator assessment, and OS. Key secondary endpoints include pathologic complete response (pCR) and major pathological response (mPR). The study enrolled 797 patients who were randomly assigned (1:1) to receive either:

KEYTRUDA (200 mg intravenously [IV] every three weeks [Q3W]) plus chemotherapy (cisplatin [75 mg/m2, IV; given on Day 1 of each cycle] and either gemcitabine [1,000 mg/m2, IV; given on Days 1 and 8 of each cycle] or pemetrexed [500 mg/m2, IV; given on Day 1 of each cycle]) for up to four cycles as neoadjuvant therapy prior to surgery. Within 4-12 weeks following surgery, KEYTRUDA (200 mg) was administered every three weeks for up to 13 cycles, or;
Placebo (saline IV Q3W) plus chemotherapy (cisplatin [75 mg/m2, IV; given on Day 1 of each cycle] and either gemcitabine [1,000 mg/m2, IV; given on Days 1 and 8 of each cycle] or pemetrexed [500 mg/m2, IV; given on Day 1 of each cycle]) for up to four cycles as neoadjuvant therapy prior to surgery. Within 4‑12 weeks following surgery, placebo was administered every three weeks for up to 13 cycles.
About lung cancer

Lung cancer is the leading cause of cancer death worldwide. In 2022 alone, there were approximately 2.4 million new cases and 1.8 million deaths from lung cancer globally. Non-small cell lung cancer is the most common type of lung cancer, accounting for about 80% of all cases. In recent decades, the overall five-year survival rate for patients diagnosed with lung cancer increased from 11% to 15% on average across EU countries. Improved survival rates are due, in part, to earlier detection and screening, reduction in smoking, advances in diagnostic and surgical procedures, as well as the introduction of new therapies. Early detection and screening remain an important unmet need, as 44% of lung cancer cases are not found until they are advanced.

On March 28, 2024 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotech company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported the full-year 2023 annual results and provided a business overview (Press release, MaaT Pharma, MAR 28, 2024, View Source [SID1234641570]).

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"As we reflect on the achievements of 2023, I am proud to announce that we have successfully delivered on milestones across our entire pipeline, while being cash conscious. This past year has been pivotal, laying the foundations for the next phase of development for our lead asset MaaT013 with completion of the Phase 3 and readiness for commercialization. We look forward to reaching new milestones in 2024 and anticipate a major inflection point with the publication of the primary endpoint of our Phase 3. By relying on our team and our network of physicians, and continuing to work closely with regulators, we anticipate continuing to create value for our shareholders and make significant progress in bringing new therapeutic options for patients with cancer," states Hervé Affagard, CEO and co-founder of MaaT Pharma.

Pipeline highlights

MET-N

MaaT013

In hemato-oncology:

In April 2023, the U.S. Food and Drug Administration (FDA) lifted the clinical hold and cleared the Investigational New Drug (IND) application for MaaT013 in patients with aGvHD[4]. The Company has engaged active discussions with prominent US clinicians in the field of stem cell transplantation to explore the most efficient path forward to introduce MaaT013 to patients in the United States.
In July 2023, the Company announced that clinical data from its Phase 2 study assessing MaaT013 as a treatment for aGvHD was published in eClinicalMedicine, one of the Lancet Discovery Science suite of journals.
In October 2023, the Company announced that the DSMB[5] unanimously recommended that the open-label, single arm pivotal Phase 3 ARES clinical trial (NCT04769895), evaluating MaaT013 in aGvHD, continue without modification. The Overall Response Rate (ORR) was superior to pre-defined protocol assumptions. Therefore, the DSMB concluded that the benefit/risk ratio with "high efficacy and low toxicity" was favorable in this patient population. Primary endpoint, gastrointestinal overall response rate (GI-ORR), is now expected mid Q4 2024.
In December 2023, the Company presented positive results from the Early Access Program (EAP) in Europe involving 111 patients with aGvHD treated with MaaT013, at the 2023 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The GI-ORR was 54% at day 28, positively and significantly impacting overall survival (OS) with 47% OS at 12 months for all patients with aGvHD and 52% for a patient subgroup from the EAP with a similar profile to those in the ARES trial with GI-ORR of 61% and 58% of complete responses observed at day 28.
As a post period event, in March 2024, the Company announced that it will present for the first time extended results that include OS data after 12 months in more aGvHD patients from its EAP that were treated with MaaT013. The data will be shared during an oral presentation at the 50th Annual Meeting of the European Society for Blood and Marrow Transplantation held in Glasgow, UK, from April 14-17, 2024.
As a post period event, the Company announces the launch of a retrospective multicenter trial called CHRONOS in Europe. Its objective is to provide the Company efficacy data for 3rd-line therapies for patients not receiving MaaT013 or any Microbiome intervention. This retrospective study does not impact cash projections as funding is already secured.
In immuno-oncology:

As a post period event, in March 2024, the Company informed on the completion of patient recruitment for the Phase 2a clinical trial (NCT04988841) sponsored by AP-HP and in collaboration with INRAe[6] and Institut Gustave Roussy[7], evaluating MaaT013, the Company’s lead product candidate, in combination with immune checkpoint inhibitors (ICI), ipilimumab (Yervoy) and nivolumab (Opdivo) in ICI naïve patients with metastatic melanoma. Having reached this key recruitment milestone, the first publication will be submitted at the end of 2024 or in the first quarter of 2025.
MaaT033

In hemato-oncology:

In April 2023, data from the Phase 1b study (CIMON) with MaaT033, previously communicated during the 64th annual ASH (Free ASH Whitepaper) meeting, were also presented at the EBMT 2023 conference.
In September 2023, the Company announced that the European Medicines Agency (EMA) had granted orphan drug designation (ODD) to MaaT033, which is aimed at improving overall survival in patients undergoing allo-HSCT[8]. The EMA recognized the significant benefit that MaaT033 could therefore bring to this patient population. The status offers key benefits including market exclusivity, clinical protocol assistance, waivers or reductions in regulatory fees.
In November 2023, the Company announced that the first patient was treated in the Phase 2b trial (PHOEBUS) investigating the efficacy of MaaT033 in improving OS at 12 months in patients with blood cancer that are receiving allo-HSCT. The international, multi-center, randomized, double-blind, placebo-control study (NCT05762211), will be conducted in up to 56 clinical investigation sites and is expected to enroll 387 patients. It is, to date, the largest randomized controlled trial assessing a microbiome therapy in oncology.
In November 2023, the Company announced that its ongoing Phase 2b trial, PHOEBUS has been selected for funding of 7.4 million EUR as part of the France 2030 Health Innovation plan, in response to the ‘Innovation in Biotherapy and Bioproduction’ call for projects from the ‘Biotherapies and Bioproduction of Innovative Therapies’ acceleration strategy, operated by Bpifrance (project code: METALLO). Post period the first tranche of 1.8 million EUR was received.

In neurodegenerative diseases:

In September 2023, the Company announced that the first patient was dosed in the IASO Phase 1b pilot study (NCT05889572) in Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s disease in the U.S. and Charcot’s disease in French-speaking countries. As a post period event, in February 2024, the Company announced that the DSMB reviewed safety data in the IASO trial in the first 8 patients with ALS treated with MaaT033. The DSMB recommended that the trial continue without modifications.
MET-C

MaaT034

In immuno-oncology:

In November 2023, the Company had two presentations at the 38th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting highlighting in vitro results for its new Artificial Intelligence (AI)-generated lead product, MaaT034, designed to improve responses to immunotherapy for patients with solid tumors. MaaT034 is the first member of the
MET-C platform. Data presented at SITC (Free SITC Whitepaper) 2023 shows that MaaT034 replicates, at large industrial scale, the richness, and diversity of healthy native-based microbiome ecosystems. The first clinical batches are expected to be produced in 2024 and the first-in-human study is planned for 2025.
As a post period event, in March 2024, the Company announced that it will present new in vitro data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024, taking place on April 5-10 in San Diego, California.
Corporate update

In February 2023, the Company completed a successful capital increase of approximately €12.7 million with the support of current shareholders.
In July 2023, MaaT Pharma joined the Microbiome Therapeutics Innovation Group (MTIG). MTIG is a coalition of companies focused on developing FDA-approved microbiome therapeutics and products to improve medical care, outcomes, and cost-effectiveness.
In September 2023, the Company and Skyepharma announced completion of the cGMP manufacturing facility and the transfer of MaaT Pharma’s Production and Development teams to the new site.
During 2023 and Q1 2024, MaaT Pharma reinforced its board of directors, executive team, and key functions:
Karim Dabbagh as Chairman and Nadia Kamal as Director, both independent.
Jonathan Chriqui, as Chief Business Officer and member of the executive management team.
Guilhaume Debroas, as Head of Investor Relations.
Financial highlights

The key financial results for the 2023 full year are as follows:

Income Statement

In thousands of euros 31 December 2023 31 December 2022
Revenue 2 228 1 430
Cost of Goods Sold (573) (339)
Gross Margin 1 655 1 091
Other Income 4 667 4 122
Sales and distribution costs (449) (347)
General and administrative costs (4 965) (4 111)
Research and development costs (20 851) (14 311)
Operating income (expense) (19 943) (13 557)
Financial Income 639 45
Financial Expense (413) (201)
Net financial income (expense) 226 (156)
Income (loss) before income tax (19 717) (13 713)

Income tax expense – –
Net Income (loss) for the period (19 717) (13 713)
Prepared in accordance with international standards, IFRS.
Revenues totaled €2.2 million for the year ended December 31, 2023, the highest revenues generated thus far by the Company, which includes compensation invoiced from the Early Access Program in France and for which data was presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2023. The gross margin generated by the compassionate access program amounts to €1.7 million.

Operating expense amounted to €19.9 million compared with €13.6 million for 2022, an increase of €6.3 million. This increase reflects the growth of research and development costs which have risen from €14.3 million in 2022 to €21.2 million in 2023, representing an overall increase of €6.9 million and consistent with the advancement of clinical and operational activities as detailed in the pipeline highlights’ section above.

Other income of €4.7 million includes the R&D tax credit of €3.6 million, an increase of €0.4 million compared with prior year, which amounted to €3.2 million and in line with the growth of research and development activities and eligible expenses.

General and administrative expenses amounted to €5.0 million compared with €4.1 million in 2022 reflecting the increase in regulatory advisory costs and expenses to support the early access program.

The net loss amounts to €19.7 million for the year ended December 31, 2023, compared with €13.7 million for the year ended December 31, 2022.

Average annual employees evolved from 43 in 2022 to 53 in 2023 following the strengthening of the clinical and production and supply chain and to a lesser extent administrative teams.

Cash Position

As of December 31, 2023, total cash and cash equivalents were €24.3 million, as compared to €31.7 million as of September 30, 2023, and €35.2 million as of December 31, 2022.

The net decrease in cash position of €11.0 million between December 31, 2022, and December 31, 2023, is due to the financing of operations for a total of €18.7 million, offset by cash inflows from financing of €8.1 million. Cash inflows from financing reflects the share capital increase in February 2023 of approximately €12.7 million, offset by debt repayments over 2023 €4.2 million. Total financial debt totaled €14.1 million as of December 31, 2023, of which €0.4 million relates to state-backed loans ("PGE") and €6.1 million of lease liabilities, which includes future contractual payments due to Skyepharma for the use of the manufacturing facility completed in 2023.

Based on the development plans and corresponding cash needs, the Company believes it has sufficient cash to finance operations to the end of Q3.2024 extending the cash runway by three months compared to prior communications as a result of a voluntary slowdown in headcount growth, optimization of its manufacturing plan and prioritizing expenses to support on the roll out of the Phase 2b trial PHOEBUS in France and Germany (approved countries) and finalizing recruitment into the Phase 3 ARES trial in Europe. The Company has active discussions ongoing to finance operations beyond the end of Q3.2024 and remains confident in extending its cash runway.

Note: This press release contains financial data approved by the Board of Directors on March 27, 2024, based on the financial statements for the year ended December 31, 2023. The audit is in progress at the date of this communication.

Upcoming financial communication*

May 14, 2024: Publication of revenues for Q1 2024
May 28, 2024: Annual General Shareholders Meeting
September 19, 2024: Publication of half year financial results H1
November 5, 2024: Publication of revenues for Q3 2024
*Indicative calendar that may be subject to change.

Upcoming investor conferences participation

April 15-17, 2024 – Kempen Life Sciences Conference, Amsterdam
June 11-12, 2024 – Portzamparc Mid & Small Caps 2024 Conference
June 25-27, 2024 – Stifel European Healthcare Summit Lyon
Upcoming investor conferences participation

April 5-10, 2024 – American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024, San Diego
April 14-17, 2024 – 50th Annual meeting of the European Bone Marrow Transplant (EBMT), Glasgow
The Company’s universal registration document, which includes the annual financial report, will be available on MaaT Pharma’s website on 02/04/2024: www.maatpharma.com

On March 28, 2024 Larkspur Biosciences, a company pioneering a new wave in cancer therapy by targeting cancer-intrinsic drivers of immune evasion, reported that it will present positive preclinical efficacy data for LRK-A, Larkspur’s novel, lead investigational therapy targeting the lipid kinase PIP4K2C, in primary human tumor samples and an in vivo model of colorectal cancer (CRC) (Press release, Larkspur Biosciences, MAR 28, 2024, View Source [SID1234641568]). The data will be featured in a poster presentation at the 115th Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR 2024) in San Diego, CA.

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"Larkspur Biosciences pursues novel targets inside the cancer, like PIP4K2C, that prevent the immune system from seeing and attacking it. Our data at AACR (Free AACR Whitepaper) 2024 demonstrate the potential of targeted PIP4K2C degradation to uncloak the tumor and support the advancement of our PIP4K2C degrader program as a monotherapy to treat CRC and other solid tumors," said Catherine Sabatos-Peyton, PhD, CEO of Larkspur Biosciences. "Using LarkXCRC, our proprietary bioinformatics platform, Larkspur developed a patient biomarker strategy to select the patients most likely to respond to LRK-A. This strategy enables the design of clinical trials that are smaller, faster, and have a higher probability of success."

CRC is the second leading cause of cancer-related deaths in the U.S.; in people under the age of 50, CRC is the top cause of cancer mortality in men and second cause in women 1. Larkspur aims to shift the treatment paradigm – which hasn’t meaningfully changed in decades – by effectively activating the immune system against tumors by targeting PIP4K2C.

"PIP4K2C is part of the ‘dark kinome’ – the approximately 25% of kinases with unknown or poorly understood functions," said Nathanael Gray, PhD, professor of chemical and systems biology at Stanford University and co-founder of Larkspur. "My co-founders and I jointly discovered that PIP4K2C acts in both cancer cells and immune cells to get tumor antigens presented to the right immune cells. Lew Cantley discovered that uniquely among the family of PI5P4K isoforms, mice that were germline knockouts of PIP4K2C broke tolerance, a hallmark of key targets that drive cancer immune evasion. Larkspur’s AACR (Free AACR Whitepaper) 2024 presentation sheds further light on PIP4K2C by offering key evidence for its role as a cancer-intrinsic driver of immune evasion in both tumor and immune cells, and demonstrating the therapeutic promise of degrading the target in CRC and other solid tumors."

Presentation details:

Published Abstract Number: 5574

Title: "Degradation of PIP4K2C by novel bivalent functional degrader LRK-A induces tumor regression in CRC"

Session Category / Session Title: Tumor Biology / Tumor-Immune System Cross-Talk

Session Date and Time: Tuesday, April 9, 1:30-5:30 pm PDT

Location / Poster Board Number: Poster Section 12 / Number 30

Presenter: Eva d’Hennezel, PhD, Director of Immunology, Larkspur Biosciences