On January 10, 2023 -NextPoint Therapeutics, a biotechnology company developing a new world of precision immuno-oncology, reported that it raised $80 million in Series B financing co-led by Leaps by Bayer, the impact investment arm of Bayer AG, and Sanofi Ventures, the strategic venture capital arm for Sanofi (Press release, NextPoint Therapeutics, JAN 10, 2023, View Source [SID1234626170]). The financing will be used to advance NextPoint’s two lead precision immuno-oncology programs into the clinic, both targeting the newly discovered HHLA2 pathway to activate anti-tumor immune responses.

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!

Additional new investors in the round include Invus, Catalio Capital Management, Sixty Degree Capital and PagodaTree Partners. Existing investors that took part in the financing include MPM Capital Management, Binney Street Capital/Dana-Farber Cancer Institute and NextPoint founder Gordon Freeman, PhD. As part of the financing, Rakhshita Dhar, Senior Director of Venture Investments Health at Leaps by Bayer, and Paulina Hill, Partner at Sanofi Ventures, will join the NextPoint Board of Directors.

NextPoint’s programs aim to deliver monotherapies for cancer patients without viable treatment options. While immune checkpoint inhibitors targeting PD-1/L1 have revolutionized cancer treatments, many patients do not benefit from these medications and require novel therapeutic strategies. Similar to PD-L1, the tumor antigen HHLA2 is a member of the B7 receptor family, is highly expressed on certain hard-to-treat cancers, and drives avoidance of detection from the immune system. Importantly, HHLA2 is independent of PD-L1 and is often most strongly expressed in PD-L1-negative cancers. NextPoint’s approach re-activates immune cells in tumors that are suppressed by HHLA2-driven immune evasion.

NextPoint originated from the combined expertise of its academic founders, Gordon Freeman, PhD, of the Dana-Farber Cancer Institute, and XingXing Zang, PhD, of Albert Einstein College of Medicine. Drs. Freeman’s and Zang’s independent discovery and characterization of the HHLA2 pathway formed the basis of the NextPoint approach. The company and its founders have shown in preclinical models and with analysis of existing clinical datasets that the HHLA2 pathway is an important tumor-suppressive mechanism in many patients1,2.

"NextPoint is building a deep understanding of the HHLA2 tumor-specific immune-escape mechanism, with the ultimate goal of establishing standalone treatments in cancers with high HHLA2 expression," said Detlev Biniszkiewicz, PhD, Chief Executive Officer of NextPoint Therapeutics. "The support of our new investors along with the continued commitment of our existing investors and founders emphasizes our momentum and progress in defining precision immuno-oncology for new patient segments."

Juergen Eckhardt, MD, Head of Leaps by Bayer, commented, "Leaps by Bayer was founded to help solve ten of the world’s biggest challenges in health and agriculture, including preventing and curing cancer. We are thrilled to support NextPoint, an exciting addition to our oncology portfolio, as it works to redefine the treatment landscape of immuno-oncology."

On January 10, 2023 Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, reported it favorable results from the CRC-PREVENT trial – a pivotal clinical trial evaluating the efficacy of its noninvasive, stool-based, at-home diagnostic screening test to detect colorectal cancer (CRC) and advanced adenomas (AA) in average-risk individuals (Press release, Geneoscopy, JAN 10, 2023, View Source [SID1234626168]). In the trial, Geneoscopy’s stool-based screening test met the clinical endpoints across all primary outcome measures, including sensitivity and specificity for CRC and AA.

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 CRC-PREVENT trial included 8,289 individuals with diverse racial, ethnic, and socioeconomic backgrounds across more than 2,900 zip codes in all lower 48 states, with colonoscopies performed in more than 3,800 endoscopy centers, which reflect the diversity of gastroenterology practices across America. Efficacy results from the study include:

94% sensitivity for detecting CRC
45% sensitivity for detecting AA
88% specificity for no findings on a colonoscopy
These sensitivity results are the highest reported for any noninvasive CRC screening test in any prospective registrational clinical study completed to date. Of note, CRC-PREVENT is the first prospective clinical study wherein a stool-based test demonstrated the ability to detect CRC amongst 45-49-year-olds in a US population.1 Additionally, CRC and AA sensitivity performance results for Geneoscopy’s test exceed those recently reported from a large clinical study for a blood-based test.2 Moreover, a recent study suggests, when given a choice, patients are more willing to comply with a stool-based screening test than a blood-based test. This was primarily attributed to the greater ability to complete a stool test at home.3

Importantly, given Geneoscopy’s decentralized clinical trial approach, the demographics of the patients who enrolled and completed the CRC-PREVENT study are more reflective of the socioeconomic and racial diversity of the country than most conventional, centralized trials. The diversity of the patient cohort confirms the test’s performance across different demographic groups and advances the important goal of increased access to healthcare innovation for historically underserved populations.

Geneoscopy’s test, performed in its St. Louis laboratory, uses a novel, proprietary method to stabilize and extract eukaryotic RNA biomarkers from stool samples that may allow for improved diagnosis and management of gastrointestinal diseases such as CRC. The FDA granted the test its Breakthrough Designation in January 2021.

"The use of our patented RNA biomarker technology is a first in CRC screening. The large-scale prospective clinical study data demonstrate that this noninvasive CRC screening test can accurately detect if people have cancer and if they have advanced adenomas that put them at higher risk of developing cancer. These results provide further evidence that our test may allow patients to get appropriate treatment, in some cases, even before cancer develops," said Dr. Erica Barnell, Chief Science Officer and Geneoscopy’s co-founder. "Our sincerest gratitude goes to all who participated in or were involved with this trial. We look forward to submitting a Premarket Approval application to the FDA to make this cutting-edge innovation available to the millions of Americans eligible to be screened for CRC."

Despite CRC being this country’s second leading cause of cancer death, millions of eligible Americans do not get screened – many due to a lack of access or avoidance of invasive options like colonoscopies.

"Colonoscopy screening rates declined during the pandemic, stressing the need for noninvasive screening options. That’s why noninvasive tests, allowing for collection to be done at home, have become a critical tool in the battle against CRC, as they make screening easier and more accessible," noted Dr. David Lieberman, Professor of Medicine, Division of Gastroenterology and Hepatology, Oregon Health Sciences University School of Medicine, and past president of the American Gastroenterology Association.4 "Geneoscopy’s test and the positive clinical trial results are promising because patients need additional convenient options that will accurately detect colon cancer, as well as advanced adenomas, before patients have cancer. If we can identify patients with advanced adenomas and remove those lesions, many cancers can be prevented. I’m hoping to have a new and highly reliable test available for patients soon – one that will allow them to conveniently screen for CRC in their own homes."

Geneoscopy’s test is not yet available for sale and is not yet approved by the U.S. Food and Drug Administration (FDA). A Premarket Approval submission to the FDA is planned for the first quarter of 2023.

About CRC-PREVENT

CRC-PREVENT was a Phase 3 prospective, single-arm study designed to evaluate the efficacy of Geneoscopy’s noninvasive, at-home diagnostic screening test to detect colorectal cancer and advanced adenomas in average-risk individuals aged 45 years and older. Using a collection kit, participants submitted self-collected stool samples via express delivery and underwent an optical colonoscopy examination. All significant lesions discovered during the colonoscopy were biopsied or removed and sent for histopathology. A comparative analysis was conducted to determine sensitivities and specificities for colorectal cancer, advanced adenomas, non-advanced adenomas, benign hyperplastic polyps, and colonoscopies with no findings.

About Colorectal Cancer & Screening

Responsible for over 50,000 deaths annually, colorectal cancer (CRC) is the second leading cause of cancer death in the United States. CRC usually begins as a growth (or polyp) that may or may not develop into cancer over time. Early detection and treatment are crucial to improve survival; however, many newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold standard for CRC screening in the U.S. Yet this method is frequently met with patient aversion due to its required bowel preparation, sedation, and potential time away from work. Currently available noninvasive screening methods demonstrate lower sensitivity to detect early-stage CRC and high-risk precancerous lesions, including advanced adenomas, which are estimated to be a precursor in 95 percent of CRC cases.

On January 10, 2023 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing biologics for the treatment of cancer and neuropathy, reported that the first adult patient has been dosed in the Phase 1b/2 Placebo Controlled, Double Blinded Study on the Efficacy and Safety of BXQ-350 in Combination with mFOLFOX7 and Bevacizumab in Newly Diagnosed Metastatic Colorectal Carcinoma (ASIST) (Press release, Bexion, JAN 10, 2023, View Source [SID1234626169]).

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 study will assess the safety and efficacy of BXQ-350 plus modified FOLFOX7 (mFOLFOX7) and bevacizumab in participants who have newly diagnosed metastatic adenocarcinoma of the colon/rectum. The study will also evaluate if the administration of BXQ-350 with mFOLFOX7 and bevacizumab may diminish chemotherapy induced peripheral neuropathy (CIPN), enabling participants to receive the total and planned doses of mFOLFOX7.

"Dosing our first patient in this trial is a major milestone for Bexion," stated Scott Shively, President and CEO. "BXQ-350 combined with its observed safety profile, potential efficacy, and possible neuropathy benefit makes BXQ-350 a worthwhile candidate to use in combination with standard of care treatment for mCRC to not only enhance the treatment of mCRC, but also to evaluate its ability to alleviate side effects related to CIPN."

Initial launch of the trial includes 6 sites with expansion up to 15 sites in the United States.

On January 10, 2023 Treadwell Therapeutics, a clinical-stage biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to CFI-402257, a best in class inhibitor of Threonine Tyrosine Kinase (TTK, also known as Mps1), for the treatment of adult patients with ER+/HER2- advanced breast cancer after disease progression on prior CDK4/6 inhibitors and endocrine therapy, both as a monotherapy and in combination with fulvestrant (Press release, Treadwell Therapeutics, JAN 10, 2023, View Source;breast-cancer-301717695.html [SID1234626167]).

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!

"There is an urgent need for new, safe and efficacious therapies to treat ER+/HER2- breast cancer, particularly when standard of care regimens fail," said Dr. Mark Bray, Treadwell CSO and Co-founder. "CFI-402257 has shown early signs of durable activity with a manageable safety profile, as a monotherapy and in combination with fulvestrant in ER+/HER2- breast cancer patients that have failed CDK4/6 inhibitors. We are thankful for the Fast Track Designation granted by the FDA and look forward to the continued development of CFI-402257 in ER+/HER2- breast cancer."

Fast Track designation seeks to streamline the development and accelerate the review of new agents with potential to treat serious or life-threatening diseases and that potentially address an unmet medical need. Drugs that are granted this designation can have more frequent interactions with the FDA, as well as potential pathways for expedited approval.

About ER+/Her2- Breast Cancer

Globally, breast cancer is the world’s most prevalent cancer and the 2nd leading cause of cancer death in women in many countries. The ER+/HER2- subtype is the most common subtype of breast cancer, accounting for 68% of all breast cancer types, with nearly 1.2 million women living with the disease in the US alone. Standard of care for ER+ patients is CDK4/6 inhibitors in combination with endocrine therapies, which have been very successful in prolonging survival for this patient population. However, resistance to this treatment occurs within a median of 2 years. As a result, the ER+ population resistant to this standard of care is growing and is an unmet medical need requiring new treatment options.

On January 10, 2023 Ajinomoto Co., Inc. ("Ajinomoto Co.") reported a license agreement with Exelixis, Inc. ("Exelixis") to incorporate AJICAP, Ajinomoto Co.’s proprietary site-specific bioconjugation and linker technologies, in the development of certain of Exelixis’ antibody-drug conjugate (ADC) programs (Press release, Ajinomoto, JAN 10, 2023, View Source [SID1234626166]).

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!

Exelixis is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Utilizing its network of biotherapeutics collaborations, the company is developing next generation ADCs for the treatment of various cancers. Ajinomoto Co. is a leading technology provider for biopharmaceuticals and the owner of CDMO Ajinomoto Bio-Pharma Services. AJICAP is Ajinomoto Co.’s proprietary site-specific bioconjugation and stable linker technologies compatible with commonly used antibody isotypes. AJICAP technology includes its "off-the-shelf" feature, allowing any therapeutic antibody at any stage of development to be conjugated to drug-payloads of choice without the need for antibody engineering or cell line development, and stable/hydrophilic linkers to generate antibody-drug conjugates with an enhanced therapeutic window.

As part of the license agreement, Exelixis will have the right to use the AJICAP technology to support its aim of advancing multiple ADCs with the potential for higher efficacy and lower toxicity than currently available options. Ajinomoto Co. is eligible to receive development, regulatory and commercial milestone payments as well as royalties on commercial sales.

Dr. Tatsuya Okuzumi, General Manager, Business Development Group, Bio-Pharma Services Department, Ajinomoto Co., expressed: "We are very excited to support Exelixis, a leader in oncology drug discovery, development, and commercialization, in the development of novel antibody-drug conjugates. The combination of Exelixis’ antibodies and payloads with Ajinomoto Co.’s AJICAP opens up a wide range of oncology applications and may be harnessed to provide a clinical benefit to patients."

About Ajinomoto Co. and Ajinomoto Bio-Pharma Services Based on the corporate message "Eat Well, Live Well.", Ajinomoto Co., Inc. has been scientifically pursuing the possibilities of amino acids to aim for future growth by creating new value through sustainable and innovative solutions for communities and society. For additional information about Ajinomoto Co. (TYO: 2802), please visit www.ajinomoto.com.

As its pharmaceutical arm, Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization (CDMO) with sites in Belgium, United States, Japan, and India, providing comprehensive development, cGMP manufacturing, and aseptic fill finish services for small and large molecule APIs and intermediates. For more information about Ajinomoto Bio-Pharma Services, please visit www.AjiBio-Pharma.com.

In addition, Ajinomoto Co. and Ajinomoto Bio-Pharma Services offer a broad range of innovative platform technologies and capabilities for pre-clinical and pilot programs to commercial quantities, including AJIPHASE oligonucleotide manufacturing technology, CORYNEX and TALAMAX protein expression systems, AJICAP site-specific conjugation and linker technologies for ADCs, continuous flow manufacturing and more. For additional information on the platform technologies, please visit View Source