On November 9, 2023 Astrazeneca reported positive high-level results from the EMERALD-1 Phase III trial showed AstraZeneca’s IMFINZI (durvalumab) in combination with transarterial chemoembolization (TACE) and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) versus TACE alone in patients with hepatocellular carcinoma (HCC) eligible for embolization (Press release, AstraZeneca, NOV 9, 2023, View Source [SID1234637452]). The trial continues to follow the secondary endpoint of overall survival (OS).

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Liver cancer, of which HCC is the most common type, is the third-leading cause of cancer death with an estimated 900,000 people worldwide diagnosed each year.1,2Approximately 20-30% of patients are eligible for embolization, a procedure that blocks the blood supply to the tumor and can also deliver chemotherapy or radiation therapy directly to the liver.3-9 Despite being the standard of care in this setting, most patients who receive embolization experience rapid disease progression or recurrence.10-14

Dr. Riccardo Lencioni, Professor and Director of the Cancer Imaging Program in the Department of Diagnostic and Interventional Radiology of Pisa University Hospital in Pisa, Italy, and principal investigator in the trial, said: "Patients with liver cancer eligible for embolization experience high rates of progression or recurrence and do not have the opportunity for early intervention with effective systemic therapy. These results for durvalumab plus bevacizumab have the potential to reshape the treatment of this complex disease with a poor prognosis by showing for the first time that adding an immunotherapy combination to TACE significantly improves progression-free survival."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "These positive results for IMFINZI-based treatment in EMERALD-1 may bring the potential of immunotherapy to patients with earlier stages of liver cancer. We look forward to discussing these data with regulatory authorities and seeing the survival data mature over time, which will be important as we aim to bring this novel treatment option to patients."

The safety profiles for IMFINZI and TACE plus bevacizumab were consistent with the known profile of each medicine, and there were no new safety findings.

The data will be presented at a forthcoming medical meeting and shared with regulatory authorities.

AstraZeneca has an extensive clinical development program further assessing IMFINZI across multiple gastrointestinal (GI) cancer settings, including in combination with bevacizumab in adjuvant HCC (EMERALD-2) and in combination with IMJUDO (tremelimumab-actl), lenvatinib and TACE in embolization-eligible HCC (EMERALD-3).

IMPORTANT SAFETY INFORMATION

There are no contraindications for IMFINZI (durvalumab) or IMJUDO (tremelimumab-actl).

Severe and Fatal Immune-Mediated Adverse Reactions

Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if combination of IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

IMFINZI in combination with IMJUDO can cause immune-mediated pneumonitis, which may be fatal. Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.

Immune-Mediated Colitis

IMFINZI in combination with IMJUDO can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO.

Immune-Mediated Hepatitis

IMFINZI in combination with IMJUDO can cause immune-mediated hepatitis, which may be fatal. Immune‑mediated hepatitis occurred in 7.5% (29/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%) adverse reactions.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency: IMFINZI in combination with IMJUDO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.
Hypophysitis: IMFINZI in combination with IMJUDO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated. Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO.
Thyroid Disorders (Thyroiditis, Hyperthyroidism, and Hypothyroidism): IMFINZI in combination with IMJUDO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated.
Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO.
Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.
Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO.
Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Two patients 0.5% (2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up.
Immune-Mediated Nephritis with Renal Dysfunction

IMFINZI in combination with IMJUDO can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions.

Immune-Mediated Dermatology Reactions

IMFINZI in combination with IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.

Immune-Mediated Pancreatitis

IMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis. Immune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.

Other Immune-Mediated Adverse Reactions

The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI in combination with IMJUDO or were reported with the use of other immune-checkpoint inhibitors.

Cardiac/vascular: Myocarditis, pericarditis, vasculitis.
Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy.
Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.
Gastrointestinal: Gastritis, duodenitis.
Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic.
Endocrine: Hypoparathyroidism.
Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection.
Infusion-Related Reactions

IMFINZI and IMJUDO can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO based on the severity. See USPI Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. Infusion-related reactions occurred in 10 (2.6%) patients receiving IMFINZI and IMJUDO.

Complications of Allogeneic HSCT after IMFINZI

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on its mechanism of action and data from animal studies, IMFINZI and IMJUDO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. In females of reproductive potential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and advise them to use effective contraception during treatment with IMFINZI and IMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO.

Lactation

There is no information regarding the presence of either IMFINZI or IMJUDO in human milk; however, because of the potential for serious adverse reactions in breastfed infants from IMFINZI and IMJUDO, advise women not to breastfeed during treatment and for 3 months after the last dose.

Adverse Reactions

In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), the most common adverse reactions (occurring in ≥20% of patients) were rash (32%), diarrhea (27%), fatigue (26%), pruritus (23%), musculoskeletal pain (22%), and abdominal pain (20%).
In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), serious adverse reactions occurred in 41% of patients. Serious adverse reactions in >1% of patients included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%). Fatal adverse reactions occurred in 8% of patients who received IMJUDO in combination with durvalumab, including death (1%), hemorrhage intracranial (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%). Permanent discontinuation of treatment regimen due to an adverse reaction occurred in 14% of patients.
The safety and effectiveness of IMFINZI and IMJUDO have not been established in pediatric patients.

Indication:

IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).

Please see full Prescribing Information including Medication Guide for IMFINZI and IMJUDO.

Notes

Liver cancer

Liver cancer is the third-leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide.1-2 Asia holds more than 70% of the world’s new liver cancer cases.15 About 75% of all primary liver cancers in adults are HCC.1 Between 80-90% of all patients with HCC also have cirrhosis.16 Chronic liver diseases such as cirrhosis are associated with inflammation that over time can lead to the development of HCC.16 Immunotherapy is a proven treatment modality in HCC with approved options available for patients in later-line settings.17

EMERALD-1

EMERALD-1 is a randomized, double-blind, placebo-controlled, multicenter, global Phase III trial of IMFINZI plus TACE concurrently, followed by IMFINZI with or without bevacizumab until progression versus TACE alone in a total of 616 patients with unresectable HCC eligible for embolization.

The trial was conducted in 157 centers across 18 countries, including in North America, Australia, Europe, South America and Asia. The primary endpoint was PFS for IMFINZI and TACE plus bevacizumab versus TACE alone, and secondary endpoints include PFS for IMFINZI plus TACE, overall survival, patient-reported outcomes and objective response rate.

IMFINZI

IMFINZI (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses.

IMFINZI is approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer (BTC) and in combination with IMJUDO (tremelimumab-actl) in unresectable HCC in the US, EU, Japan and many other countries based on the TOPAZ-1 and HIMALAYA Phase III trials, respectively.

In addition to its indications in GI cancers, IMFINZI is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiation therapy based on the PACIFIC Phase III trial.

IMFINZI is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage small-cell lung cancer (SCLC) based on the CASPIAN Phase III trial. Additionally, IMFINZI is approved in combination with a short course of IMJUDO and chemotherapy for the treatment of metastatic NSCLC in the US, EU and Japan based on the POSEIDON Phase III trial. IMFINZI is approved in previously treated patients with advanced bladder cancer in a small number of countries.

Since the first approval in May 2017, more than 200,000 patients have been treated with IMFINZI.

As part of a broad development program, IMFINZI is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, several GI cancers, ovarian cancer, endometrial cancer and other solid tumors. In 2023, AstraZeneca announced positive results for Phase III trials including combinations with IMFINZI in ovarian (DUO-O) and endometrial (DUO-E) cancers, as well as in resectable NSCLC (AEGEAN).

In addition to the EMERALD program across multiple liver cancer settings, AstraZeneca has ongoing registrational trials investigating IMFINZI in resectable gastric and gastroesophageal junction cancers (MATTERHORN) and in locally advanced esophageal cancer (KUNLUN). In June 2023, IMFINZI added to standard-of-care neoadjuvant chemotherapy met a key secondary endpoint of pathologic complete response in the MATTERHORN Phase III trial.

On November 9, 2023 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies, reported financial results for the third quarter ended September 30, 2023 and provided a corporate update (Press release, Immunome, NOV 9, 2023, View Source [SID1234637451]).

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"The merger of Immunome and Morphimmune is a transformative transaction for both companies, resulting in a combined company with a highly focused technology platform based upon strong foundational science, coupled with a strong balance sheet, as we push forward in our mission to develop targeted cancer therapies for patients," stated Clay B. Siegall, Ph.D., Chairman and Chief Executive Officer of Immunome. "There remains a significant need for innovative and best in class treatments to address unmet medical needs for cancer patients where previous approaches have fallen short."

Highlights

Immunome and Morphimmune Complete Merger with $125 Million PIPE to Accelerate Development of Novel Targeted Cancer Therapies. In October 2023, Immunome and Morphimmune, a private biotechnology company focused on developing targeted oncology therapeutics, announced that the two companies successfully closed their previously announced merger agreement.
The newly combined company features synergistic platforms that we believe will enable the development of first-in-class and best-in-class targeted cancer therapies across multiple modalities and tumor types.
The concurrent oversubscribed private placement investment of $125 million included participation from Enavate Sciences, EcoR1 Capital, Redmile Group, Janus Henderson Investors, Avidity Partners, Woodline Partners LP, and other leading institutional investors.
IMM-ONC-01: We expect to provide guidance in Q1 2024 regarding our timeline to submit to the FDA an IND for IMM-ONC-01.
177Lu-FAP: We anticipate an IND submission with the FDA in Q1 2025.
Financial Highlights

Collaboration Revenue: Collaboration Revenue from the Collaboration Agreement with AbbVie for the three months ended September 30, 2023 was $4 million.
Research and development (R&D) expenses: R&D expenses for the three months ended September 30, 2023 were $4 million.
General and administrative (G&A) expenses: G&A expenses for the three months ended September 30, 2023 were $4 million.
Net loss: Net loss for the three months ended September 30, 2023 was $4 million, or $(0.36) per share.
Cash and cash equivalents: As of September 30, 2023, cash and cash equivalents totaled $91 million

On November 9, 2023 March Biosciences (March Bio), a clinical stage biotechnology company committed to combating challenging cancers unresponsive to existing immunotherapies, and Cancer Focus Fund, LP, a unique investment fund established in collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) to provide funding and clinical expertise to advance promising cancer therapies, reported that Cancer Focus Fund is investing $4.8 million in funding and providing clinical support for March Bio’s upcoming Phase 2 clinical trial of MB-105 for the treatment of relapsed T-cell leukemias and lymphomas (Press release, March Biosciences, NOV 9, 2023, View Source [SID1234637449]).

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MB-105 is a chimeric antigen receptor-T cell ("CAR-T") therapy targeting CD5, a protein that is widely expressed in both normal and malignant T-cells, including T-cell associated leukemias and lymphomas. This has limited its use as a target for cancer therapies, since healthy T-cells needed for normal immune system functioning would be destroyed along with the malignant T-cells. MB-105 has been specially engineered to preserve healthy T-cells while maintaining its potency against CD5 positive tumor cells. In an ongoing Phase 1 trial conducted by the Baylor College of Medicine Cell and Gene Therapy Center, MB-105 has demonstrated a favorable safety profile and encouraging early efficacy results in both relapsed T-cell lymphoma and T-cell acute lymphoblastic leukemia patients.

The prognosis is poor for patients with relapsed or refractory T-cell leukemias and lymphomas, with more than 85% dying within months of relapse. The use of later lines of salvage therapies and advances in targeted cancer therapies has not affected these dismal outcomes, with long-term survival of less than 10%. Relapsed patients who are able to achieve a second remission and proceed to a subsequent stem cell transplant have better results, but therapeutic options for achieving a second remission are severely limited, underscoring the urgent need for innovative solutions.

Sarah Hein, co-founder and CEO of March Biosciences, commented, "As a Houston-invented and headquartered biotech developing an innovative cancer therapy manufactured in collaboration with Houston’s CTMC, we are delighted that the Cancer Focus Fund is investing in our upcoming clinical trial. We believe MB-105 has the potential to become the foremost, first-in-class life-saving therapy for relapsed T-cell lymphoma patients, who have limited treatment options. We also welcome the opportunity to work with Cancer Focus Fund and MD Anderson to advance the clinical program for MB-105. The breadth and quality of the support we are receiving from our local partners and institutions underscore Houston’s increasing prominence as a worldwide leader in cancer R&D and clinical research."

The Phase 2, open label, multi-center trial will assess MB-105 in patients with CD5-positive relapsed/refractory T-cell lymphoma. Patients will receive one dose of MB-105 and will be followed for a minimum of 12 months.

"March Bio’s highly innovative approach to overcoming a key limitation of CAR-T therapy is emblematic of the breakthrough science that Cancer Focus Fund was established to support," said Ross Barrett, a founder and Managing Partner of Cancer Focus Fund. "This young company impresses with the strength of its management and science teams, including global leaders in the development of CAR-T therapies. It has already forged valuable partnerships and is advancing MB-105 with the urgency we prize in our portfolio companies. We also are pleased to be investing in a promising biotech firm with such strong roots in our Houston life sciences community."

On November 9, 2023 Bayer and US-based Recursion Pharmaceuticals, Inc., a clinical stage TechBio company decoding biology to industrialize drug discovery, reported that they have updated the focus of their research collaboration to precision oncology (Press release, Bayer, NOV 9, 2023, View Source [SID1234637450]).

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The oncology-focused collaboration will leverage Bayer’s small molecule compound library and expertise in biology and medicinal chemistry as well as Recursion’s purpose-built artificial intelligence-guided drug discovery platform. This strategic shift will enable Bayer to utilize Recursion’s capabilities to initiate and advance the identification of novel therapeutic targets for challenging oncology indications with high unmet need.

"The methodology in which Recursion uses artificial intelligence (AI) in drug discovery, could be one of the most disruptive technologies of our time," said Juergen Eckhardt, M.D., Member of the Executive Committee of Bayer’s Pharmaceuticals Division, Head of Business Development, Licensing & Open Innovation and Head of Leaps by Bayer. "As our collaboration and the usage of AI continue to evolve, we look forward to continuing to work with industry innovators to identify novel targets for oncology indications."

Bayer’s strategic approach in oncology is based on precision drug development which enables fast identification of the most promising targets and commercially viable programs. The company is continuously working to find new ways of treating cancer, so that patients do not necessarily need to undergo life-changing and invasive treatments. Artificial intelligence and the use of machine learning methods allow the processing of enormous amounts of data – including high-resolution imaging – and offers unprecedented potential for the discovery of new drug candidates for cancer and other complex diseases.

"Every cancer is different and requires an individual approach," said Dominik Ruettinger, M.D., Ph.D., Global Head of Research and Early Development for Oncology, Pharmaceuticals Division, Bayer AG. "At Bayer, we are committed to driving breakthrough innovations for patients with diseases of high unmet medical need. Nearly half of our entire pharma pipeline is dedicated to cancer therapies, and we have a strong foundation to build on to bring these innovative treatment approaches to patients."

Recursion’s drug discovery platform navigates over five trillion biological and chemical relationships within one of the world’s largest proprietary datasets. The system integrates scaled ‘wet-lab’ biology and chemistry data with computational tools, using advanced machine learning technologies to industrialize drug discovery by validating and advancing therapeutic programs efficiently and with minimal bias. Their dataset, which includes information from 50 different human cell types and a ~1.7 million small molecule library, is supported by BioHive-1, a TOP500 ranked supercomputer.

"We believe that the next generation of biopharma leaders will operate at the convergence of rigorous science, scaled datasets and accelerated computing," said Chris Gibson, Ph.D., Co-founder and CEO of Recursion. "Today, we are thrilled to announce the evolution of our collaboration with Bayer, highlighting the flexibility and broad-scale applicability of our platform, as we turn our focus together on challenging targets in oncology with the goal of bringing better medicines to patients more efficiently."

Under the terms of the agreement, the companies may initiate up to seven oncology programs and Recursion is eligible to receive potential, success-based, future payments of up to $1.5 billion plus royalties on net sales. Bayer will gain the option to exclusively license novel therapeutics derived from the research activities.

Leaps by Bayer, the impact investment arm of Bayer AG, led Recursion’s Series D financing in 2020 with an investment of USD 50 million.

On November 9, 2023 MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company evaluating novel drug candidates to address known resistance mechanisms to standard-of-care cancer therapies, reported results for the quarter ended September 30, 2023 and highlighted recent corporate events (Press release, MEI Pharma, NOV 9, 2023, View Source [SID1234637448]).

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"Our ongoing clinical studies evaluating the combination of voruciclib, our CDK9 inhibitor, with Venclexta in relapsed/refractory AML patients and ME-344, our mitochondrial inhibitor, combined with Avastin in metastatic colorectal cancer patients, continue to have strong investigator support and cohort enrollment remains on track in each program," said David M. Urso, president and chief executive officer of MEI Pharma. "We expect to report data from the dose escalation portion of the Phase 1 clinical trial evaluating voruciclib in combination with venetoclax in early calendar 2024, and data from the first cohort of patients in Phase 1b clinical trial evaluating ME-344 in the first half of 2024."

First Quarter Fiscal Year 2024 and Recent Highlights

In August 2023, MEI announced the dosing of the first patient in a Phase 1b study evaluating ME-344 in combination with bevacizumab (AVASTIN) in patients with previously treated metastatic colorectal cancer. ME-344 is a novel mitochondrial inhibitor targeting energy production through the OXPHOS pathway, which is important for supporting tumor cell survival and proliferation for many forms of cancer, including colorectal cancer. Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, and other antiangiogenics, inhibit energy production through glycolysis and, thereby, increase tumor reliance on mitochondrial energy production, providing an opportunity to evaluate a combination with ME-344 to inhibit energy production in tumor cells and induce an antitumor effect. The Company anticipates announcing safety and efficacy data from the first cohort of 20 patients in the first half of 2024.
In November 2023, MEI announced that an abstract highlighting clinical data from the monotherapy dose escalation stage of the ongoing Phase 1 study evaluating voruciclib, a selective oral cyclin-dependent kinase 9 (CDK9) inhibitor, alone and in combination with venetoclax (Venclexta), a B-cell lymphoma 2 ("BCL2") inhibitor, in patients with acute myeloid leukemia (AML) or B-cell malignancies, will be presented during a poster session at the upcoming 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held December 9 – 12, 2023.
Expected Drug Candidate Pipeline Developments

Voruciclib – Oral CDK9 inhibitor in Phase 1 Study

Report clinical data from the dose escalation portion of the ongoing Phase 1 clinical trial evaluating voruciclib plus Venclexta (venetoclax) in patients with AML early in calendar 2024.
ME-344 – Mitochondrial inhibitor in Phase 1b Study

Report clinical data from Cohort 1 of the Phase 1b clinical trial evaluating ME-344 plus Avastin (bevacizumab) in patients with relapsed colorectal cancer in the first half of calendar-year 2024.
First Quarter Fiscal Year 2024 Financial Results

As of September 30, 2023, MEI had $82.2 million in cash, cash equivalents, and short-term investments with no outstanding debt.
For the quarter ended September 30, 2023, cash used in operations was $18.5 million, compared to $14.8 million during the quarter ended September 30, 2022. The increase in cash used in operations was primarily due to changes in working capital associated with the wind down of zandelisib activities with Kyowa Kirin and professional services primarily related to advisory and legal fees associated with various stockholder-related activities, including stockholder-initiated consent solicitations.

Research and development expenses were $3.5 million for the quarter ended September 30, 2023, compared to $19.5 million for the quarter ended September 30, 2022. The decrease was primarily related to a reduction in zandelisib costs as we continued the wind down of development activities announced in December 2022, as well as reduced personnel and related costs from our fiscal year 2023 reduction in headcount.
General and administrative expenses decreased by $1.0 million to $6.5 million for the quarter ended September 30, 2023, compared to $7.5 million for the quarter ended September 30, 2022. The net decrease was primarily related to reduced personnel and related costs from our fiscal year 2023 reduction in headcount, partially offset by higher external professional services and legal expenses.

MEI recognized revenue of $65.3 million for the quarter ended September 30, 2023, compared to $8.7 million for the quarter ended September 30, 2022. The increase in revenue is due to the recognition of deferred revenue associated primarily with the termination of the Kyowa Kirin Commercialization Agreement in July 2023. As of September 30, 2023, all deferred revenue associated with that agreement has been recognized.
Net income was $56.4 million, or $8.46 per share, for the quarter ended September 30, 2023, compared to net loss of $16.6 million, or $2.49 per share for the quarter ended September 30, 2022. The Company had 6,662,857 shares of common stock outstanding as of September 30, 2023.

The Company believes its cash balance is sufficient to fund operations for at least the next 12 months, and through the reporting of clinical data readouts from the ongoing and planned voruciclib and ME-344 Phase 1 and Phase 1b clinical programs, respectively.