On October 15, 2024 Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing cutaneous dose limiting toxicity, reported that it has completed enrollment in the phase 2 trial of lead compound, LUT014, a topically-applied novel B-Raf inhibitor, for patients with metastatic colorectal cancer (mCRC) treated with epidermal growth factor receptor (EGFR) inhibitor therapy who develop dose-limiting acneiform rash (Press release, Lutris Pharma, OCT 15, 2024, View Source [SID1234647213]). Topline results are expected in first quarter of2025.

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The phase 2, randomized, double-blind, placebo-controlled trial has enrolled a total of 117 subjects at 20 international sites, including Memorial Sloan Kettering Cancer Center, MD Anderson Cancer Center and Dana Farber Cancer Institute. The trial is evaluating the efficacy and safety of two strengths of LUT014 gel, 0.03% or 0.10%, applied once daily for 4 weeks, compared to placebo (with a randomization of 1:1:1), in patients with mCRC who develop Grade 2 or non-infected Grade 3 EGFR inhibitor-induced acneiform rash, with a 4-week follow up period. During an optional open label extension period for the placebo group, eligible subjects received the 0.03% concentration of LUT014.

The study’s primary endpoint is the proportion of subjects in each treatment group who achieve treatment success, defined as an improvement (decrease) of at least one grade in the severity of the acneiform lesions from baseline to Day 28, based on common terminology criteria for adverse events (CTCAE) V5.0 skin and subcutaneous tissue disorders grading scale or, an improvement (increase) of at least 5 points in the total score for the skin-specific (first 13 questions) of the functional assessment of cancer therapy epidermal growth factor receptor inhibitor 18 (FACT-EGFRI-18) health related quality of life (HRQoL) questionnaire, from baseline to Day 28. Key secondary endpoints include adherence to EGFR inhibitor treatment.

"Enrollment of the last patient is an important milestone for Lutris Pharma and in the progress of the international phase 2 trial of LUT014," stated Antoni Ribas, M.D., Ph.D., Chairman and Founder of Lutris Pharma. "Although EGFR inhibitors are critical treatment options, approximately 75% of patients with mCRC receiving such therapy experience acneiform rash, which can be so disruptive to quality of life that many of these patients do not receive the optimal treatment against their cancer, either due to dose reduction or even discontinuation of the anti-EGFR therapy, caused by the rash. By reversing the inhibitory effect of anti-EGFR therapy on downstream signaling in the skin cells, we believe that LUT014 has the potential to address a toxicity of otherwise effective therapeutic regimens and can have a favorable impact for patients who currently have no other treatment options.

Dr. Ribas continued, "having generated positive phase 1 results in patients with mCRC, demonstrating safety, preliminary efficacy a dose response and a therapeutic benefit in all patients, we look forward to reporting topline results from the phase 2 study early next year and are planning present them at a major medical meeting."

"Reporting data on the use of LUT014 to treat acneiform rash induced by anti-EGFR inhibitors will be timely, given the encouraging data generated with new classes of EGFR inhibitors being developed for the treatment of cancer" added Noa Shelach, Ph.D., Chief Executive Officer of Lutris Pharma. "These active anticancer agents have the same class-effect dose limiting skin toxicities that could be addressed with the topical application of LUT014, potentially broadening the clinical benefit to patients with cancer."

For more information on this clinical trial, please visit: www.clinicaltrials.gov, NCT04759664.

About EGFR Inhibitor-Induced Rash
EGFR is a receptor on the surface of cells which is expressed in many normal epithelial tissues, including skin. The EGFR signaling pathway is one of the key pathways that regulate growth, survival, proliferation, and differentiation of cells. B-Raf is a protein encoded by the BRAF gene and is a downstream effector component of EGFR signaling pathway. EGFR has been shown to be over-activated in various human cancers, including colorectal, lung, head and neck, urinary bladder, pancreatic and breast cancers, eliciting downstream phosphorylation and activation of the MAP Kinase pathway.

Drugs called EGFR inhibitors can block the EGFR signal responsible for cell growth. Among the various types of pharmacological therapies for cancer, EGFR inhibitors are increasingly being used both as primary therapy as well as in patients who have failed prior chemotherapy. Although effective as anti-cancer therapy leading to tumor shrinkage, EGFR inhibitors have many adverse reactions associated with their use. The majority of patients treated with EGFR inhibitors will experience adverse dermatological side effects typically manifested as a papulopustular skin rash, also known as acneiform lesions, which can impact quality of life and affect adherence to therapy.

About LUT014
LUT014 is a novel B-Raf inhibitor which is applied topically on the skin. When the B-Raf protein is mutated, as is the case in some human cancers such as melanoma, blocking this pathway leads to apoptosis of the cells and tumor shrinkage. However, when the same pathway is blocked in normal, non-mutated cells, the opposite happens: the MAPK pathway is activated, and cells start growing. This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT014 harnesses the paradoxical effect of B-Raf Inhibitors in order to enhance cell proliferation and balance cell destruction, typical to radiation dermatitis.

On October 15, 2024 Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported the publication of a peer-reviewed article titled "Preclinical development of T cells engineered to express a T cell antigen coupler (TAC) targeting Claudin 18.2-positive solid tumors" in Cancer Immunology Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Triumvira Immunologics, OCT 15, 2024, View Source [SID1234647212]). The article, authored by a team of scientists led by Dr. Andreas Bader, Triumvira’s Consulting Chief Scientific Officer, details the preclinical pharmacology and safety of TAC01-CLDN18.2, a novel autologous T cell therapy targeting Claudin 18.2 for the treatment of solid tumors. TAC01-CLDN18.2 is currently the subject of a clinical Phase I/II study (TACTIC-3, NCT05862324).

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"Our findings highlight the unique advantages of TAC01-CLDN18.2, which is designed to target and eliminate tumors with high specificity while minimizing the risk of adverse events that are commonly associated with T cell and other therapies," said Andreas Bader, Ph.D., Consulting Chief Scientific Officer of Triumvira Immunologics. "This research underscores our commitment to developing next-generation T cell therapies that are both effective and safe, and we are excited to continue exploring the clinical potential of TAC01-CLDN18.2 in treating patients with Claudin 18.2 positive solid tumors."

"Publishing this research is a significant milestone for Triumvira, as it reinforces the potential of our TAC technology, currently in the clinic for Claudin 18.2 positive tumors, to transform the treatment landscape for cancer patients," said Robert Williamson, President of Triumvira Immunologics. "We remain committed to bringing innovative, life-saving treatments to patients in need, and this publication is a testament to the rigorous science in the company and dedication of our team."

The study highlights the novel and proprietary T cell Antigen Coupler (TAC) technology from Triumvira Immunologics, a chimeric receptor that promotes tumor antigen-specific activation of T cells by leveraging the natural T cell receptor complex without causing tonic signaling. The preclinical results demonstrate that CLDN18.2-TAC T cells exhibit specific and durable anti-tumor activity across various in vitro and in vivo models of gastric, gastroesophageal, and pancreatic cancers. Importantly, the study reports high selectivity as these T cells did not induce notable off-target or on-target/off-tumor toxicities in these preclinical models, suggesting its potential safety and efficacy in clinical settings.

Key Findings

Specificity and Activity: TAC01-CLDN18.2 T cells demonstrated high specificity and potent cytotoxicity against Claudin 18.2 positive tumor cells in both 2D cultures and 3D tumor spheroids, including models with low antigen expression.
CLDN18.2-TAC T vs CLDN18.2 CAR-T: In a head-to-head comparison against CLDN18.2-directed 2nd-generation CAR T cells, CLDN18.2-TAC T cells exhibited greater proliferative capacity, lower levels and delayed onset of T cell exhaustion, and overall greater and longer-lasting cytotoxicity in a recursive tumor cell killing assay.
In Vivo Efficacy: In mouse models of gastric, gastroesophageal, and pancreatic cancers, TAC01-CLDN18.2 T cells effectively eradicated tumor xenografts, with durable efficacy observed in recursive killing and tumor rechallenge experiments.
Safety Profile: The preclinical data showed that TAC01-CLDN18.2 T cells did not induce notable off-target or on-target/off-tumor toxicities, as these cells were unreactive to human cells representing vital organs.
Durable Response: The research indicates that TAC01-CLDN18.2 T cells can induce a long-lasting anti-tumor response, supporting their potential as a safe and effective treatment for patients with Claudin 18.2 positive solid tumors.
Full Publication Details

Title: Preclinical development of T cells engineered to express a T cell antigen coupler (TAC) targeting Claudin 18.2-positive solid tumors
Journal: Cancer Immunology Research
Corresponding Authors: Andreas Bader, Ph.D., Christopher Helsen, Ph.D.
Full Author List: Stacey Xu, Ling Wang, Philbert Ip, Ritu Randhawa, Tania Benatar, Suzanna Prosser, Prabha Lal, Alima Khan, Thanyashanthi Nitya-Nootan, Gargi Thakor, Heather MacGregor, Danielle Hayes, Andrea Vucicevic, Princy Mathew, Sadhak Sengupta, Christopher Helsen, and Andreas Bader

On October 15, 2024 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported positive top-line results from the Phase 3 clinical trial evaluating Zepzelca (lurbinectedin) in combination with the PD-L1 inhibitor atezolizumab (Tecentriq) compared to atezolizumab alone when administered as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) following induction therapy with carboplatin, etoposide and atezolizumab (Press release, Jazz Pharmaceuticals, OCT 15, 2024, View Source [SID1234647211]). The combination of Zepzelca and atezolizumab demonstrated a statistically significant improvement in the primary endpoints of overall survival (OS) and progression-free survival (PFS), as assessed by an independent review facility (IRF), compared to treatment with atezolizumab alone.

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"Each year, approximately 30,000 new cases of small cell lung cancer (SCLC) are reported in the U.S. A majority of these patients are diagnosed with extensive stage disease, which is aggressive and often difficult to treat, with poor prognosis,i,ii,iii" said Luis Paz-Ares, M.D., Ph.D., head of medical oncology at the Hospital Universitario 12 de Octubre in Madrid, Spain, and IMforte trial principal investigator. "These trial results demonstrate the efficacy of lurbinectedin, the most widely used agent in second-line SCLC in the United States, in combination with standard-of-care atezolizumab for patients in first-line maintenance treatment, a much-needed advancement for patients with extensive disease."

"The results of the Phase 3 IMforte trial are highly encouraging and showed a statistically significant benefit for the Zepzelca and atezolizumab combination for extensive-stage small cell lung cancer patients receiving this treatment in the first-line maintenance setting. These results demonstrate the potential of this regimen to delay disease progression and extend survival for patients with this aggressive disease," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. "We are pleased with these clinically meaningful results and plan to submit an sNDA in the first half of 2025 to support this combination in the first-line maintenance setting. We thank the investigators and patients who are involved in this trial, along with our partners at Roche."

The combination was generally well-tolerated. The preliminary safety data in the ongoing trial was consistent with the known safety profiles of Zepzelca and atezolizumab with no new safety signals observed in the combination arm.

Jazz and Roche plan to submit these data for presentation at a future medical meeting.

About the IMforte Phase 3 Trial
IMforte (NCT05091567) is an ongoing Phase 3, randomized, multicenter maintenance trial evaluating the efficacy, safety and pharmacokinetics of Zepzelca plus atezolizumab, compared with standard-of-care first-line maintenance with atezolizumab alone, in adults (≥18 years) with ES-SCLC, following induction therapy with carboplatin, etoposide and atezolizumab. The primary endpoints for this study are OS and IRF-assessed PFS.

The trial consists of two phases: an induction phase and a maintenance phase. Participants were required to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 after the induction phase of four cycles of carboplatin, etoposide, and atezolizumab to be considered for eligibility screening for the maintenance phase. Eligible participants were randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase.

The trial is sponsored by Roche and co-funded by Jazz Pharmaceuticals. Additional information about the trial, including eligibility criteria and a list of clinical trial sites, can be found at: View Source (ClinicalTrials.gov Identifier: NCT05091567).

About Small Cell Lung Cancer
In the U.S., approximately 13 percent of lung cancers are small cell.ii Approximately 30,000 new cases of small cell lung cancer (SCLC) are reported in the U.S. each year.ii,iii The risk for developing SCLC is much higher among current or former tobacco smokers; however, SCLC can also be caused by exposure to secondhand smoke, asbestos, some inhaled chemicals, radiation and air pollution. People with a family history of lung cancer may also be at a higher risk, too.iv SCLC is the most aggressive form of lung cancer and it tends to spread quickly to other parts of the body including the brain, liver and bone.v,vi A large percentage of SCLC patients on treatment briefly achieve a response, although the cancer often returns and is usually more aggressive and resistant to regimens that were previously effective.ii

About Zepzelca (lurbinectedin)
Zepzelca is an alkylating drug that binds guanine residues within DNA. This triggers a cascade of events that can affect the activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in disruption of the cell cycle and eventual cell death.iv

The FDA approved Zepzelca under accelerated approval in June 2020 for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy. The approval is based on overall response rate (ORR) and duration of response demonstrated in an open-label, monotherapy clinical study. In December 2021, Jazz and PharmaMar announced the initiation of LAGOON, a confirmatory Phase 3 clinical trial of Zepzelca for the treatment of patients with relapsed small cell lung cancer. If positive, LAGOON could confirm the benefit of Zepzelca in the treatment of small cell lung cancer (SCLC) when patients progress following 1L treatment with a platinum-based regimen and support full approval in the U.S.

Zepzelca is a prescription medicine used to treat adults with SCLC that has spread to other parts of the body (metastatic) and who have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working. Zepzelca is approved based on response rate and how long the response lasted.

Important Safety Information for ZEPZELCA

Before receiving ZEPZELCA, tell your healthcare provider about all of your medical conditions, including if you:

have liver or kidney problems.
are pregnant or plan to become pregnant. ZEPZELCA can harm your unborn baby.
Females who are able to become pregnant:

Your healthcare provider should do a pregnancy test before you start treatment with ZEPZELCA.
You should use effective birth control (contraception) during treatment with and for 6 months after your last dose of ZEPZELCA.
Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with ZEPZELCA.
Males with female partners who are able to become pregnant should use effective birth control during treatment with and for 4 months after their last dose of ZEPZELCA.

are breastfeeding or plan to breastfeed. It is not known if ZEPZELCA passes into your breastmilk. Do not breastfeed during treatment with ZEPZELCA and for 2 weeks after your last dose of ZEPZELCA. Talk to your healthcare provider about the best way to feed your baby during treatment with ZEPZELCA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how ZEPZELCA works.
What should I avoid while using ZEPZELCA?
Avoid eating or drinking grapefruit, Seville oranges, or products that contain grapefruit juice and Seville oranges during treatment with ZEPZELCA.
ZEPZELCA can cause serious side effects, including:

Low blood cell counts. Low blood counts including low neutrophil counts (neutropenia) and low platelet counts (thrombocytopenia) are common with ZEPZELCA, and can also be severe. Some people with low white blood cell counts may get fever, or an infection throughout the body (sepsis), that can cause death. Your healthcare provider should do blood tests before you receive each treatment with ZEPZELCA to check your blood cell counts.
Tell your healthcare provider right away if you develop:
fever or any other signs of infection
unusual bruising or bleeding
tiredness
pale colored skin
Liver problems. Increased liver function tests are common with ZEPZELCA and can also be severe. Your healthcare provider should do blood tests to check your liver function before you start and during treatment with ZEPZELCA.
Tell your healthcare provider right away if you develop symptoms of liver problems including:
loss of appetite
nausea or vomiting
pain on the right side of your stomach area (abdomen)
Leakage of ZEPZELCA out of your vein during the infusion. If ZEPZELCA leaks into the tissues around your infusion site, it can cause damage and death of tissue cells around the infusion site. You may need to have surgery to remove any dead tissue. Tell your healthcare provider right away if you see any ZEPZELCA leaking out of your vein or around the catheter during your infusion, or if you notice any redness, swelling, itching or discomfort at the infusion site at any time.
Severe muscle problems (rhabdomyolysis). Tell your healthcare provider if you have severe muscle pain or weakness.
Your healthcare provider may temporarily stop treatment, lower your dose, or permanently stop ZEPZELCA if you develop serious side effects during treatment with ZEPZELCA.

The most common side effects of ZEPZELCA include:

tiredness
low white and red blood cell counts
increased kidney function blood test (creatinine)
increased liver function blood tests
increased blood sugar (glucose)
nausea
decreased appetite
muscle and joint (musculoskeletal) pain
low level of albumin in the blood
constipation
trouble breathing
low levels of sodium and magnesium in the blood
vomiting
cough
diarrhea
These are not all of the possible side effects of ZEPZELCA.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Jazz Pharmaceuticals at 1-800-520-5568.

Please see full Prescribing Information including Patient Information, and discuss with your doctor.

ZEPZELCA is a trademark of Pharma Mar, S.A. used by Jazz Pharmaceuticals under license.

Tecentriq (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

What is atezolizumab?
Atezolizumab is a prescription medicine used to treat:

Adults with a type of lung cancer called small cell lung cancer (SCLC). Atezolizumab may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment when your lung cancer:

is a type called "extensive-stage small cell lung cancer," which means that it has spread or grown.
It is not known if atezolizumab is safe and effective when used in children for the treatment of SCLC.

Important Safety Information

What is the most important information about atezolizumab?
Atezolizumab can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:

Lung problems

cough
shortness of breath
chest pain
Intestinal problems

diarrhea (loose stools) or more frequent bowel movements than usual
stools that are black, tarry, sticky, or have blood or mucus
severe stomach-area (abdomen) pain or tenderness
Liver problems

yellowing of your skin or the whites of your eyes
severe nausea or vomiting
pain on the right side of your stomach area (abdomen)
dark urine (tea colored)
bleeding or bruising more easily than normal
Hormone gland problems

headaches that will not go away or unusual headaches
eye sensitivity to light
eye problems
rapid heartbeat
increased sweating
extreme tiredness
weight gain or weight loss
feeling more hungry or thirsty than usual
urinating more often than usual
hair loss
feeling cold
constipation
your voice gets deeper
dizziness or fainting
changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems

decrease in your amount of urine
blood in your urine
swelling of your ankles
loss of appetite
Skin problems

rash
itching
skin blistering or peeling
painful sores or ulcers in mouth or nose, throat, or genital area
fever or flu-like symptoms
swollen lymph nodes
Problems can also happen in other organs.
These are not all of the signs and symptoms of immune system problems that can happen with atezolizumab. Call or see your healthcare provider right away for any new or worse signs or symptoms, including:

Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
Persistent or severe muscle pain or weakness, muscle cramps
Low red blood cells, bruising
Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

chills or shaking
itching or rash
flushing
shortness of breath or wheezing
dizziness
feeling like passing out
fever
back or neck pain
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with atezolizumab. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with atezolizumab. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with atezolizumab if you have severe side effects.

Before you receive atezolizumab, tell your healthcare provider about all of your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ transplant
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have received radiation treatment to your chest area
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
are pregnant or plan to become pregnant. Atezolizumab can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with atezolizumab. Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start treatment with atezolizumab.
You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of atezolizumab.
are breastfeeding or plan to breastfeed. It is not known if atezolizumab passes into your breast milk. Do not breastfeed during treatment and for at least 5 months after the last dose of atezolizumab.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of atezolizumab when used in lung cancer with other anti-cancer medicines include:

feeling tired or weak
nausea
hair loss
constipation
diarrhea
decreased appetite
Atezolizumab may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of atezolizumab. Ask your healthcare provider or pharmacist for more information about the benefits and side effects of atezolizumab.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

On October 15, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that it has administered the second dose of its CAR-T therapy to an individual patient (Press release, Anixa Biosciences, OCT 15, 2024, View Source [SID1234647210]). This follows a positive response after the initial treatment in the ongoing Phase 1 clinical trial of its chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer. The study is being conducted in collaboration with Moffitt Cancer Center.

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Previously, Anixa and Moffitt received approval for a single-patient IND application, allowing the administration of a second dose to a patient whose tumor biopsy revealed cellular infiltration and necrosis, indicating biological activity of the CAR-T therapy.

After the first infusion, the patient remained stable, did not require alternative treatment and her quality of life was good, leading to the decision to administer a second dose to further enhance these positive results. These findings offer promising indications that the CAR-T therapy may serve as a successful long-term treatment option, highlighting its potential effectiveness in the fight against ovarian cancer.

"While this is a single patient, the positive clinical activity observed, including necrosis and T cell infiltration, is an encouraging sign of the therapy’s potential effectiveness," stated Dr. Robert Wenham, Chair of the Department of Gynecologic Oncology at Moffitt and the principal investigator of the trial. "Based on these results, we recently submitted an amendment to the current trial protocol to allow patients who may benefit to receive a second dose. We are excited to continue evaluating this treatment in our ongoing trial, and we are optimistic about the potential long-term benefits it may offer to patients with ovarian cancer."

Dr. Monica Avila, the patient’s treating oncologist, stated, "My patient received her first infusion in May 2023. We are now nearly 18 months from that date, and she is doing well and is now receiving this second dose. I am thrilled with her status and look forward to observing further progress."

Dr. Amit Kumar, CEO of Anixa Biosciences, stated, "We are proud to have an outstanding team, including Dr. Wenham and Dr. Avila, and we are encouraged by the positive response seen in this patient following the initial dose of our CAR-T therapy. The continued clinical improvements reinforce our confidence in the potential of this groundbreaking treatment to provide hope for patients battling ovarian cancer. We remain committed to advancing this innovative therapy and bringing new, effective treatment options to the forefront."

The Phase 1 clinical trial at Moffitt is treating recurrent ovarian cancer patients who have failed standard-of-care therapies. To date, six patients have been treated in the dose escalation trial, three in the first cohort and three in the second cohort. Dose escalation will continue after confirming the previous dosages are safe.

On October 15, 2024 AtomVie Global Radiopharma (AtomVie), a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO), reported to have entered into an agreement with Radiopharm Ventures (RV), a Joint Venture between Radiopharm Theranostics (RAD) and MD Anderson Cancer Center (MDACC), to develop and manufacture 177Lu-BetaBart, a 177Lutetium-conjugated B7-H3 targeting radioantibody (Press release, Radiopharm Theranostics, OCT 15, 2024, View Source [SID1234647209]). This partnership leverages both companies’ expertise to advance novel radiotherapeutic solutions in areas of high unmet medical needs.

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B7-H3 is an immune checkpoint molecule that is overexpressed in several tumor types and represents a highly attractive target for antibody-based cancer immunotherapy. Deregulated B7-H3 expression is linked with tumor aggressiveness and poor outcomes. 177Lu-BetaBart is the first targeted radiopharmaceutical in development against the 4Ig subtype of B7-H3, which is the most common subtype expressed on human tumors. The monoclonal antibody, invented at MDACC, has been specifically engineered with a shorter blood circulation time and reduced affinity for on-target off-tissue toxicity, leading to a final molecule that is highly promising for human use in clinical settings. Phase I/II First-In-Human therapeutic trial with 177Lu-BetaBart in multiple tumor types in the US, is expected for mid-2025

This collaboration brings together RAD’s world-class platform of radiotherapeutic products and AtomVie’s leading in manufacturing and distributing radiopharmaceuticals globally. 177Lu-BetaBart is part of a broader pipeline of distinct, highly differentiated technologies developed by RAD and RV. These span peptides, small molecules, and monoclonal antibodies for use in cancer, sourced from top-tier universities and institutes globally. The pipeline is designed with the strong potential to be either first-to-market or best-in-class.

AtomVie’s extensive expertise in clinical development, including technology transfer, process and method development, clinical supply and global distribution, provides a reliable foundation for advancing 177Lu-BetaBart from the clinic towards commercialization. With its new state-of-the-art, scalable 72,300 sq ft facility, set to open in early 2025, AtomVie is the partner of choice to support the growing global pipeline of radiotherapeutics.

"Our collaboration with AtomVie is a significant step forward in our mission to bring innovative radiopharmaceutical therapies to patients," said Riccardo Canevari, Managing Director & CEO of RAD. "Their proven track record in manufacturing and global distribution assures us that we are in capable hands as we progress through the clinical stages and prepare for potential commercialization."

Bruno Paquin, CEO of AtomVie, commented, "We are thrilled to partner with RAD on such an important project. With our expertise in radiopharmaceutical manufacturing, we are confident that we can support RAD in advancing their innovative pipeline. This partnership reinforces our commitment to transforming patients’ lives with high-quality radiopharmaceuticals, as we continue to expand our capabilities in our new facility and empower novel radiotherapeutics to market."