On June 16, 2022, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco") reported that the first bispecific antibody-receptor recombinant protein targeting human CD47 x HER2 (IMM2902), authorized by the United States Patent Office (APPLICATION No.: US 16/535,075) (Press release, ImmuneOnco Biopharma, JUN 16, 2022, View Source [SID1234655660]). As the most important pharmaceutical markets in the world, the United States took the lead in approving the patent authorization of IMM2902, which will greatly improve the market competitiveness of the product. The patent authorization and approval of the IMM2902 project in China, Japan, the European Union and other countries/regions is also in progress.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

IMM2902 is a CD47 x HER2 bispecific antibody in the world’s most cutting-edge research field for solid tumors. The project was previously approved by the China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) to conduct clinical trials on June 29 and August 21, 2021, respectively. The new drug candidate targeting CD47 has entered the clinical research stage. On February 15, 2022, IMM2902 completed the first subject enrollment and dosing, and the clinical trial is progressing smoothly. The IMM2902 project was authorized by the US Patent Office is another major milestone for the company!

Dr. Tian, Wenzhi, the founder, chairman and CEO of ImmuneOnco, said: "I am very pleased to see that our IMM2902 project invention patent has been authorized by the US Patent Office. The IMM2902 is designed based on our mAb-Trap technology platform. It is a bi-specific molecule targeting CD47 and HER2. The molecule is developed through the high affinity activity of HER2 to enable the drug to preferentially bind to tumor cells, so that at the same time it has the characteristics of not binding to human erythrocytes and avoiding the "antigen sink effect", thus greatly enhancing the specific synergistic effect of the dual targets against tumors. IMM2902 will have great value of clinical and commercial potentials."

On June 16, 2022 Invectys, Inc. (Invectys), The University of Texas MD Anderson Cancer Center and the Cell Therapy Manufacturing Center (CTMC), a joint venture between MD Anderson and National Resilience, Inc., reported a strategic collaboration to jointly develop a reliable, compliant and scalable process for human leukocyte antigen (HLA)-G targeted chimeric antigen receptor (CAR) T cell therapy for solid tumors (Press release, Invectys, JUN 16, 2022, View Source [SID1234616043]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The collaboration will build upon the HLA-G platform pioneered by Invectys to advance novel CAR T cell therapies through preclinical development with CTMC into early-phase clinical studies at MD Anderson. The collaboration brings Invectys’ technology together with the cell therapy development and manufacturing expertise of CTMC and the clinical trials expertise of MD Anderson.

Uniting the complementary capabilities of Resilience and MD Anderson, CTMC was launched to accelerate the development and manufacturing of innovative cell therapies for patients with cancer.

"This agreement is truly about joining the strengths of each collaborator for the benefit of cancer patients," said Praveen Tyle, Ph.D., President and Chief Executive Officer of Invectys. "Invectys is a cancer immunotherapy company developing novel approaches to target HLA-G. With our combined expertise and shared goals, we can act quickly to advance impactful new cell therapies."

The HLA-G molecule is a powerful modulator of the human immune system that is normally found during pregnancy, when it acts to protect the fetus from rejection by the mother’s immune system. However, HLA-G is aberrantly expressed in cancer, making it an attractive tumor-specific antigen because the HLA-G tumor cells suppress a patient’s own innate immune responses. Invectys’ technology is designed to target and remove tumor cells that express HLA-G, thus reducing these immunosuppressive effects and thereby reactivating the patient’s own immune system.

"Immunotherapies have revolutionized the treatment landscape for cancer, but currently approved treatments are able to overcome immune suppression only in limited groups of patients," said Aung Naing, M.D., professor of Investigational Cancer Therapeutics at MD Anderson. "This novel HLA-G technology can revitalize immune cells by identifying and killing solid tumor cancer cells, thereby offering the potential to improve treatment outcomes for a wider group of cancer patients."

Together with researchers at Invectys, the CTMC team will work to develop a clinical-grade HLA-G targeted CAR T cell therapy for solid tumors that can be produced at scale. The collaboration will facilitate therapeutic development toward a Phase I clinical trial to be co-led by Naing and Samer Srour, M.D., assistant professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson.

"CTMC was established to accelerate patient impact by addressing the hurdles associated with the development and manufacturing of cell therapies," said Jason Bock, Ph.D., Chief Executive Officer of CTMC. "We are excited to work with the Invectys team and their unique technology to enable the anti-HLA-G CAR T cell therapy to reach its full potential, hopefully bringing an effective new treatment option to patients in need."

On June 16, 2022 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the launch of a human papillomavirus (HPV) self-sampling solution in countries accepting the CE mark (Press release, Hoffmann-La Roche, JUN 16, 2022, View Source [SID1234616241]). This new solution enables a patient to privately collect her sample for HPV screening while at a healthcare facility, following instructions provided by a healthcare worker. The clinically-validated vaginal sample is analysed with the Roche cobas HPV test on a Roche molecular instrument.
Screening for human papillomavirus (HPV) can help identify women who are at risk of developing cervical cancer, so that the disease can be found and treated early before it has a chance to develop. There are many drivers that contribute to women not participating in cervical cancer screening programs, including limited access to testing, past experiences, embarrassment, and cultural influences. Roche’s self-sampling solution helps reduce these barriers by offering women an alternative to more invasive clinician collection procedures, while also providing accurate and reliable results enabling clinicians to make patient care decisions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The elimination of cervical cancer is within reach. Reducing barriers to HPV screening by enabling women to self-collect their own specimen for HPV testing is a critical tool in the fight against cervical cancer," said Thomas Schinecker, CEO Roche Diagnostics.

In low- and middle-income countries, women are often diagnosed with cervical cancer at a more advanced stage, where the opportunity for cure is low. By broadening access through removing barriers and enabling screening in additional healthcare environments, Roche highlights its commitment to achieving the World Health Organisation’s global strategy to eliminate cervical cancer and reduce the overall mortality rate.3

About the cobas HPV test

The cobas HPV test is indicated for use for routine cervical cancer screening as per professional medical guidelines, including HPV primary screening, co-testing (or adjunctive screen) with cytology, and for triage of women with abnormal cytology, to assess the risk for cervical precancer and cancer. Test performance for this new sampling method demonstrates that selfcollected vaginal specimens tested using a molecular technology are fully adequate, and provide
results that are comparable to clinician-collected cervical samples.

Cervical cancer screening using the cobas HPV test is clinically validated in large, FDA registrational trials for use on cobas Systems, and the assay individually identifies the presence of the DNA of HPV genotypes 16 and 18 – the two genotypes responsible for about 70 percent of all cervical cancers4 – and reporting the 12 other high-risk HPV types as a combined result, all in
one test and from one patient sample. More information about the cobas HPV tests is available at diagnostics.roche.com/cervicalcancer or cervicalcancer-screening.com.

The fully automated cobas 6800/8800 Systems offer the fastest time to results, providing up to 96 results in about three hours and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an eight hour shift. Learn more now: View Source

On June 16, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with cancer, reported the closing of its acquisition of Cancer Prevention Pharmaceuticals, Inc. (CPP), a private clinical stage company developing therapeutics to reduce the risk and recurrence of cancer and rare diseases, for a combination of stock and future milestone payments (Press release, Panbela Therapeutics, JUN 16, 2022, View Source [SID1234616044]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The combined entity will focus on maximizing its extensive pipeline addressing an estimated aggregate $5 billion market opportunity for the areas of initial focus: familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, colorectal cancer prevention and ovarian cancer.

"Closing this transaction achieves our goal of creating a diversified pipeline with an ability to hit multiple targets, four clinical stage assets, two of which are late-stage registration assets, thereby increasing the potential of the combined company," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "Together, our capabilities will have an even greater chance to help more patients. The addition of CPP is an excellent fit that we feel produces substantial shareholder value."

The closing of the merger follows the satisfaction of all customary closing conditions, including the unanimous approval by the boards of directors of each company and the stockholders of CPP.

About our Pipeline

The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of catalysts with programs ranging from pre-clinical to registration studies.

SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months which is final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .

Flynpovi

Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increase polyamine export and catabolism. In a Phase 3 clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal tract anatomy in the recent Phase 3 trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), Flynpovi showed statistically significant benefit compared to both single agents (p≤0.02) in delaying surgical events in the lower GI for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP.

CPP-1X

CPP-1X (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes. Preclinical studies as well as Phase 1 or Phase 2 investigator-initiated trials suggest that CPP-1X treatment is well tolerated and has potential activity.

On June 16, 2022 PerkinElmer Inc., a global leader committed to innovating for a healthier world, reported that it is collaborating with Novartis, a leading global medicines company, to expand newborn screening for sickle cell disease (SCD) in sub-Saharan Africa (Press release, PerkinElmer, JUN 16, 2022, View Source [SID1234616045]). PerkinElmer together with the Novartis Africa Sickle Cell Disease program aims to expand advocacy efforts to educate patients, caregivers and communities about the importance of newborn screening and early intervention with hydroxyurea (HU) and other SCD treatments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Newborn screening for SCD and comprehensive disease management in high-income countries like the United States has reduced mortality in children under five years old by 94%[1]. Yet, in sub-Saharan Africa which bears the highest burden of the disease, no national newborn screening program exists. This collaboration aims to galvanize governments to provide universal newborn screening as part of national health programs in support of early diagnosis and comprehensive interventions such as prophylactic penicillin, a pneumococcal vaccination and therapies like HU. With effective screening and management of SCD, governments could save many precious lives.

The Novartis Africa Sickle Cell Disease program was launched in Ghana in 2019 as an end-to-end effort that encompasses SCD screening, diagnosis, treatment, education, research and advocacy. Today this unique program has been expanded to Uganda, Tanzania, Kenya and Zambia, with plans to reach a total of 10 countries.

Among its varied contributions to the program, PerkinElmer will work toward strengthening existing SCD programs by providing training, consultations, support and related services to health care professionals and lab technicians across participating countries in sub-Saharan Africa. The Company will also help establish new lab facilities to build capacity for SCD screening in participating countries.

"As a global leader in newborn screening solutions we are pleased to be working with Novartis to assist people across sub-Saharan Africa affected by this condition," said Petra Furu, general manager, reproductive health at PerkinElmer. "By building awareness around the importance of newborn screening, our hope is that more babies receive an early diagnosis that leads to earlier treatment – ensuring they have the best possible chance of a healthy start to life."

"This collaboration with PerkinElmer reaffirms our commitment to reimagining care for sickle cell disease patients, by accelerating access to national newborn screening and hydroxyurea through public-private partnerships with local governments and other organizations," said Racey Muchilwa, Country President and the Head of Novartis sub-Saharan Africa. "We will also be educating patients, caregivers and communities on the importance of newborn screening, early intervention and treatments while elevating the capacity for healthcare professionals to address the high unmet need of SCD."

In an initiative announced in March 2021, PerkinElmer works alongside the American Society of Hematology (ASH) (Free ASH Whitepaper) and its Consortium on Newborn Screening in Africa (CONSA) to provide resources for SCD screening programs in countries throughout sub-Saharan Africa, including Ghana, Kenya, Nigeria, Uganda, Zambia, Liberia and Tanzania. Novartis announced its partnership with ASH (Free ASH Whitepaper) in early June, which will advance ASH (Free ASH Whitepaper)’s CONSA objectives to demonstrate the benefits of newborn screening and early interventions for children with SCD and create a sustainable infrastructure for SCD newborn screening.