On April 19, 2022 Keymed Biosciences (2162.HK) reported that the U.S. Food and Drug Administration (FDA) granted CMG901 Fast Track Designation as monotherapy for the treatment of unresectable or metastatic gastric and gastroesophageal junction cancer which have relapsed and/or are refractory to approved therapies (Press release, Keymed Biosciences, APR 19, 2022, View Source [SID1234612519]). This is another milestone after CMG901 received Orphan-drug Designation from the FDA.

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Among all the Claudin 18.2-targeted drugs, CMG901 is the first and only one which received this FDA designation so far. This designation was granted based on the phase 1 studies that assessed the safety, tolerability, pharmacokinetic (PK), and preliminary efficacy of CMG901. The dose-escalation stage of Phase I clinical trial of CMG901 in subjects with solid tumors is about to be completed in China, and the dose-expansion stage is expected to be initiated in the second quarter of 2022.

Fast Track Designation is one of the FDA’s programs to accelerate the clinical development and review of new drugs to meet the unmet medical needs of serious diseases.

About CMG901

CMG901 is the first Claudin 18.2 ADC to obtained IND approval in China and in the U.S. CMG901 consists of three components: a monoclonal antibody targeting Claudin 18.2, a cleavable linker and a potent cytotoxic payload (MMAE). Claudin 18.2 has been identified as a highly selective molecule that is widely expressed in multiple solid tumors, including gastric cancer and pancreatic cancer, suggesting that Claudin 18.2 is an ideal target for tumor therapeutic development.

CMG901 can cause tumor cell death by several mechanism:

CMG901 binds to Claudin 18.2 positive cell via its monoclonal antibody portion. After binding, CMG901 will be internalized into lysosome by tumor cells and release the cytotoxic payload, leading to cell cycle arrest and apoptosis of the tumor cells.
CMG901 can stimulate cellular and soluble immune effectors that activate antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) to destroy the Claudin 18.2 positive cells.
Preclinical studies suggest that CMG901 can effectively kill gastric cancer cells with much stronger antitumor potency than zolbetuximab analog or the unconjugated antibody of CMG901. Meanwhile, CMG901 also shown good tolerance and favorable safety profile in preclinical studies.

On April 19, 2022 Teen Cancer America reported the science and excitement behind liquid biopsies, and their potential to change the global paradigm in early cancer detection, will go mainstream for the first time (Press release, Teen Cancer America, APR 19, 2022, View Source [SID1234612514]).

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The historic S.E.E. Summit (Safer, Easier, Earlier) is a free, virtual event created by cancer survivor/journalist Jamie Reno and Teen Cancer America, the national non-profit founded by Roger Daltrey and Pete Townshend of The Who. The online conference will feature leading biotechnology executives, researchers, oncologists, and patient advocates explaining the game-changing impact of liquid biopsy blood tests in ways that everyone can understand.

Breakthroughs in genomics have accelerated the ability of liquid biopsies to identify biomarkers in the blood that can detect cancer very early. These advancements represent a major milestone for cancer screening, diagnosis and treatment as a non-invasive alternative to tissue biopsy.

Produced by The Special Event Company, the summit will include pre-recorded segments featuring preeminent liquid biopsy experts from Caris Life Sciences, Exact Sciences/Thrive, Grail, Guardant, IV BioHoldings (IVBH), Natera, Pillar Biosciences and StageZero Life Sciences. The recorded presentations will alternate with two live panel discussions that will include leading scientists, oncologists, patients and patient advocates.

The event takes place on Thursday, April 21 beginning at 12 p.m. ET, 9 a.m. PT. Online attendance is free, and registration is available at this LINK. S.E.E. Summit run-of-show:

9:00 – Welcome

Simon Davies – Executive Director, Teen Cancer America
Jamie Reno – Healthline journalist, author, cancer survivor and advocate
9:10 – IV BioHoldings

Marty Keiser – Founder & CEO
9:25 – Natera

Dina Scaglione – Director Oncology Marketing
Adham Jurdi MD – Medical Director
9:40 – Grail

Joshua Ofman MD – President and Chief Medical Officer
9:55 – Panel #1 – Advocates

Hilary Gan – Hospital Programs and Services Director, Teen Cancer America (breast cancer survivor)
Christabel K. Cheung, PhD, MSW – Assistant Professor, University of Maryland School of Social Work; Member, University of Maryland Greenbaum Comprehensive Cancer Center; Collaborating Member, University of Hawaii Cancer Center (Non-Hodgkin’s lymphoma cancer survivor)
Judy Fulmer – Prevention Chair, PREP4 Gold (parent of a teen cancer survivor)
10:40 – Guardant

Michele Rest – Senior Director of Corporate Communications
AmirAli Talasaz – Co-founder & Co-CEO
10:55 – StageZero Life Sciences

James Howard-Tripp – Chairman & CEO
11:10 – Caris Life Sciences

Rob Clark – Sr. Vice President, Chief Communications Officer
David Spetzler PhD – President and Chief Scientific Officer
11:25 – Panel #2 – Scientists/Physicians

Jerome Madison – VP Pharma and Provider Relations, Trapelo Health
David Shulman MD – Attending Physician, Pediatric Oncology, Sarcoma Center, Dana-Farber/Boston Children’s Cancer and Blood Disorders Center
Aditya Bagrodia MD, FACS – Urologic Oncologist, Associate Professor of Urology, Disease Team Co-Leader, Genitourinary Cancer, UC San Diego Health
Umberto Malapelle – Secretary of the International Society of Liquid Biopsy; Professor in Anatomic Pathology in School of Medicine, University of Naples Federico
Abhijat Kitchlu MD – Department of Medicine, Division of Nephrology at the University of Toronto
12:10 – Exact Sciences/Thrive

Isaac Kinde, MD, PhD – VP Technology Assessment
12:25 – Pillar Biosciences

Randy Pritchard – CEO
12:40 – Concluding remarks from Jamie Reno and Simon Davies

"This is the first event to bring the science of liquid biopsy out of stealth mode," said Reno. "Our goal is to share information about this growing sector in ways that scientists appreciate but consumers, healthcare professionals, potential investors and the media can also understand."

The organizations participating in the S.E.E. Summit plan to extend the program into a series of educational media initiatives to educate and inform cancer patients, healthcare professionals, and the general public.

"Liquid biopsy is a major step forward in cancer detection among all age groups, but it is especially significant for our work at TCA," said Davies. "Late detection and misdiagnosis are not uncommon for teens and young adults with cancer, so we’re thrilled to help bring this good news to mainstream audiences for the first time."

On April 19, 2022 Alvotech Holdings S.A. ("Alvotech"), a global biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, reported that, subject to the completion of the announced business combination (the "Business Combination") between Alvotech, Alvotech Lux Holdings S.A.S. ("the Company") and Oaktree Acquisition Corp. II (NYSE: OACB.U, OACB, OACB WS) ("OACB"), a special purpose acquisition company with approximately $250 million of cash in trust sponsored by an affiliate of Oaktree Capital Management, L.P., the Company has secured a Standby Equity Purchase Agreement ("SEPA") facility from YA II PN, Ltd ("Yorkville") and signed a binding term sheet for a debt facility from Sculptor Capital Management ("Sculptor") (Press release, Alvotech, APR 19, 2022, View Source [SID1234612513]).

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The two facilities are intended to provide access of up to $250 million and are expected to be used to replace potential redemptions by OACB shareholders that may occur as part of the Business Combination. The Yorkville SEPA facility provides for up to $150 million of equity financing at the Company’s option (subject to certain limitations). Additionally, the binding term sheet with Sculptor provides for $75 million – $125 million in debt, with the exact amount to be finalized based on the level of net proceeds generated as a result of the closure of the Business Combination.

Alvotech and OACB have also agreed to reduce the minimum cash condition set forth in the merger agreement between the two companies such that, subject to certain conditions, the minimum cash condition would be satisfied through the existing private placement ("PIPE") commitments of approximately $175 million and the new loan facility from Sculptor (subject to final agreement), thereby providing enhanced deal certainty for the Business Combination.

"We believe the added facilities will strengthen Alvotech’s capitalization profile when the merger with OACB is finalized," said Robert Wessman, Founder and Chairman of Alvotech. "Specifically for the equity line, we intend to utilize the facility in amounts that are equal to or less than what we may experience in redemptions from the trust. This facility may also provide additional free float of our ordinary shares, should we experience higher than expected redemptions."

On December 7, 2021, Alvotech and Oaktree Acquisition Corp. II (NYSE: OACB.U, OACB, OACB WS), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, L.P., announced they had entered into a definitive business combination agreement. Upon completion of the transaction, the combined company’s securities are expected to be traded on NASDAQ under the symbol "ALVO."

On January 18, 2021, Alvotech announced an upsized PIPE totaling approximately $175 million, raised entirely as ordinary shares, at $10.00 per share. Investors in the PIPE include top-tier investors such as Survretta Capital, Athos (the Strüngmann Family Office), CVC Capital Partners, Temasek Holdings, YAS Holdings, Farallon Capital Management, and Sculptor Capital Management, among others.

On April 19, 2022 L-Nutra Inc., the world’s leading nutrition technology company pioneering the discovery, design, and commercialization of novel programs and therapeutics that impact both the body’s metabolism and cellular rejuvenation, reported data from a first-of-its-kind study evaluating the impact of its Fasting Mimicking Technology (FMT) on metabolic risk factors in patients with prostate cancer (PC) (Press release, L-NUTRA, APR 19, 2022, View Source [SID1234612512]). The pilot study indicates that cycles of L-Nutra’s patented program could have a role in supporting the metabolic health of patients with PC undergoing cancer therapy, especially those with metabolic impairment.

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"Leveraging our insights into the complex interrelationships between metabolic determinants and cancer biology, L-Nutra is committed to developing the next generation of nutri-solutions for patients with cancer. While most companies develop drug-based solutions to mitigate or reverse the burden of cancer, L-Nutra is pursuing a revolutionary approach centered around a Fasting Mimicking Program – an upstream intervention with systemic benefits," said Joseph Antoun, M.D., Ph.D., CEO and Chairman of L-Nutra Inc.

Obesity and metabolic dysfunction have long been linked to increased prostate cancer mortality and overall mortality rates. In addition, the treatment of prostate cancer with hormonal therapy often leads to metabolic syndrome. Data demonstrate that in men, a weight gain of more than 5% of the body weight after prostate cancer diagnosis is associated with a 65% increased risk of dying of prostate cancer and 27% higher risk of all-cause mortality and that a lifestyle modification leading to weight loss could delay or prevent disease progression, as well as improve quality of life.i,ii,iii

L-Nutra’s patented Fasting Mimicking Program is a form of periodic fasting, low in calories, sugars, and protein but high in unsaturated fats. The observational pilot study published in Prostate Cancer and Prostatic Diseases, concluded that three monthly-cycles of an investigational formulation of a five-day Fasting Mimicking Program* was safe and tolerable in a pilot cohort of patients with PC. The study, which included a representative cohort of men with PC at various stages of their illness, also assessed the effect on metabolic risk factors associated with poor prognosis and features of a metabolic syndrome.

The study represents the first report on the use of Fasting Mimicking Program cycles in patients with PC and supports a rationale for further evaluation after two major features of metabolic syndrome were reduced in the study cohort PC patients after completion of the program. The study reported crucial metabolic risk factors with an average of 3.79 kg (8.36 pounds) of weight loss, 4.57 cm (1.80 inches) of waist circumference, and a decrease in systolic and diastolic blood pressure by 9.52 mmHg and 4.48 mmHg respectively. The high overall compliance of 83% indicated that the intervention was tolerable and sustainable over the study period. Sub-analysis further suggested that this FMT had more robust effects in patients at higher risk of metabolic syndrome than those with normal risk, pointing to future research areas and potential applications.

"We tested and published last year the Fasting Mimicking Program for breast cancer in two other trials as a support to standard chemotherapy and/or hormone therapy protocols," said William Hsu, M.D., Chief Medical Officer of L-Nutra. "With this study, we continue to uncover the major role that nutrition, and therefore potential nutri-therapies, can play in cancer development, growth and treatment."

L-Nutra plans to further evaluate the impact of FMT to support the metabolic health of cancer patients undergoing cancer therapy. For more information on L-Nutra and its revolutionary approach to targeting a broad spectrum of diseases with Nutritech Therapeutics, visit: www.l-nutra.com.

* The formulation used in the research study is investigational and not currently commercially available.

On April 19, 2022 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, reported it will join the Pancreatic Cancer Action Network (PanCAN) as a Silver Sponsor of the organization’s PurpleStride Silicon Valley event to end pancreatic cancer (Press release, Renovorx, APR 19, 2022, View Source [SID1234612511]).

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In order to help improve patient outcomes, RenovoRx employees and their families have united to create Team RenovoRx with a goal to support PanCAN’s urgent mission to save lives. After two years of virtual fundraising events due to the ongoing pandemic, PurpleStride Silicon Valley 2022 will be back in person at Discovery Meadow in downtown San Jose, CA on Saturday, April 30.

"All of us at RenovoRx proudly support the PurpleStride walk, which improves pancreatic cancer awareness across the country," said Shaun Bagai, CEO of RenovoRx. "We’re continually energized by the people we meet in this important cause and are dedicated to advancing treatment options for patients impacted by pancreatic cancer."

For the first time ever, Silicon Valley’s PurpleStride walk is coordinated with nearly 60 other communities across the nation for one nationally synchronized PanCAN PurpleStride event. City-by-city, thousands of supporters will walk the nation in solidarity to raise national awareness and much-needed funds for pancreatic cancer. Funds raised through this nationwide movement fuel life-changing programs and services for pancreatic cancer patients and their families.

"By taking action locally, we have the opportunity to make a difference in the lives of pancreatic cancer patients nationwide," said Ariane Chappel, chair of PanCAN’s Silicon Valley affiliate. "We are grateful to RenovoRx’s commitment to raise vital funds and awareness to support the pancreatic cancer community through this important event."

Pancreatic cancer is the world’s deadliest cancer with a five-year survival rate of just 11 percent. In 2022, more than 62,000 Americans will be diagnosed with pancreatic cancer and nearly 50,000 will die from the disease, making it the third leading cause of cancer-related death in the U.S.