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Zhejiang Doer Biotechnology Co., Ltd. Announces a Clinical Trial Collaboration with Merck to Evaluate the Clinical Efficacy of DR30303 in Combination with KEYTRUDA® (Pembrolizumab) in Patients with Gastric/GEJ Cancer

On December 16, 2022 Zhejiang Daoer Biotechnology Co., Ltd. A clinical-stage biopharmaceutical company developing innovative biotherapeutics, reported that a clinical trial collaboration agreement with Merck & Co. A clinical trial of combination therapy with Merck’s PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with gastric or gastroesophageal junction cancer (Press release, Doer Biologics, DEC 16, 2022, View Source [SID1234625370]).

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According to the agreement, Daoer Bio will conduct clinical trials based on the clinical protocol agreed and finalized by both parties to evaluate the combination of DR30303 and KEYTRUDA in the treatment of Claudin18.2 positive, locally advanced unresectable or metastatic gastric cancer or gastroesophageal junction cancer (GC/ GEJ) patient safety and efficacy.

Dr. Huang Yanshan, founder and CEO of Doer Bio, said: "DR30303 is a humanized anti-Claudin18.2 single domain antibody Fc fusion protein developed by Doer Bio based on its proprietary SMART-VHHBody platform ( VHH-Fc). We believe that DR30303 exhibits strong affinity and highly selective binding to Claudin18.2, while enhancing antibody-dependent cellular cytotoxicity (ADCC) activity, and has a low risk of immunogenicity. Its small The molecular weight of DR30303 may allow DR30303 to penetrate into solid tumors faster and deeper. We believe that DR30303 may be a potential best-in-class anti-Claud in 18.2 antibody." Dr. Yong Liang, Chief Operating Officer of Doyle Bio, commented on this DAO: "DR30303 has demonstrated a favorable safety profile in ongoing monotherapy trials and an encouraging anti-tumor signal in patients with Claudin18.2-positive solid tumors. We are very excited to be exploring DR30303 with KEYTRUDA combination therapy for Claudin18.2-positive gastric cancer or gastroesophageal junction cancer (GC/GEJ) patients."

KEYTRUDA is a registered trademark owned by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Lowe, NJ, USA.

About DR30303

DR30303 is a humanized anti-Claudin18.2 single domain antibody Fc fusion protein (VHH-Fc) developed by Doyle Bio based on its proprietary SMART-VHHBody platform. Due to its tumor specificity and abnormally high expression in gastric and pancreatic cancers, Claudin18.2 is an attractive target for cancer therapy. DR30303 showed strong and highly selective binding to the Claudin18.2 target, enhanced antibody-dependent cellular cytotoxicity (ADCC) activity by engineering its Fc, and algorithm-based T cell epitope prediction showed its have a lower risk of immunogenicity. Preclinical studies have shown that DR30303 has shown strong anti-tumor activity and good pharmacokinetics when administered alone or in combination with chemotherapy drugs or PD-1 inhibitors in various mouse tumor models academic characteristics.

Personalis Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On December 16, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that the Compensation Committee of its Board of Directors granted, between the dates of December 5, 2022 and December 16, 2022, non-qualified stock options to purchase an aggregate of 35,000 shares of its common stock and restricted stock units (RSUs) covering an aggregate of 42,100 shares of its common stock to three new employees under Personalis’ 2020 Inducement Plan (Press release, Personalis, DEC 16, 2022, View Source [SID1234625368]).

The 2020 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee, or non-employee director, of Personalis, as an inducement material to such individual’s entering into employment with Personalis, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. Personalis is making this announcement as required by Nasdaq rules.

The inducement stock options have an exercise price of $2.83 per share, which is equal to the closing price of Personalis’ common stock on the date of grant, December 5, 2022, and will vest over four years, with 25% of the shares vesting on the first anniversary of the grant date and 1/48th of the remaining shares vesting monthly thereafter, subject to continued service through each applicable vesting date. The RSUs will vest over four years, with 25% of the shares vesting one year after the grant date and an additional 25% of the shares vesting annually thereafter, subject to continued service through each applicable vesting date. The options and RSUs are subject to the terms and conditions of Personalis’ 2020 Inducement Plan, and the terms and conditions of the applicable award agreement covering each grant.

Humanetics Corporation Presents at the MedInvest Oncology Investor Conference

On December 16, 2022 Humanetics Corporation, a clinical-stage pharmaceutical company focused on novel products to improve outcomes for patients with cancer, reported that it presented at the MedInvest Oncology Investor Conference in New York City on December 15, 2022 (Press release, Humanetics, DEC 16, 2022, View Source [SID1234625363]).

At the conference, Ronald Zenk, President and Chief Executive Officer at Humanetics, delivered a corporate overview and details on the company’s lead drug candidate, BIO 300. BIO 300 is a new class of drug focused on improving outcomes in cancer patients who receive first-line radiotherapy with or without concurrent chemotherapy. These patients suffer from myriad unintended side effects, which can reduce the efficacy of treatment and/or result in serious toxicities. BIO 300 acts to protect normal tissues, improving therapeutic outcomes.

BIO 300 is currently being evaluated in phase 2 clinical trials to prevent normal tissue injury resulting from cancer radiotherapy and to reduce lung damage in COVID-19 long haul patients. It is self-administered by patients in these trials as an oral liquid nanosuspension. BIO 300 also shows potential to minimize radiation damage in normal tissues without impacting the effectiveness of the radiation therapy against the tumor. BIO 300 was the recent subject of an early stage trial in non-small cell lung cancer patients undergoing chemoradiotherapy and was found to be safe, with results pointing to positive clinical outcomes.

Humanetics licensed BIO 300 from the United States Department of Defense (DOD), where it was discovered as a potent radioprotectant for warfighters on the battlefield. Its use in cancer patients is highly aligned with its military use, as it serves in both cases to protect normal tissues from radiation damage.

On Target Laboratories Announces Expanded Indication of CYTALUX® (pafolacianine) injection for Detection of Lung Cancer During Surgery

On December 16, 2022 On Target Laboratories, Inc., a privately-held biotechnology company developing intraoperative molecular imaging agents to target and illuminate cancer during surgery, reported that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for the use of CYTALUX in lung cancer (Press release, On Target Laboratories, DEC 16, 2022, View Source [SID1234625361]). CYTALUX is the first and only targeted molecular imaging agent that illuminates lung and ovarian cancer intraoperatively, enabling the detection of more cancer for removal. The new indication will provide surgeons the ability to integrate CYTALUX into their treatment plan for adult patients with known or suspected lung cancer, where it previously was only approved for adults with ovarian cancer.

The label expansion is based on safety and efficacy evidence demonstrated in the ELUCIDATE Trial, a Phase 3, multi-center, single dose, open-label trial that investigated the use of CYTALUX in patients scheduled to undergo thoracic surgery for confirmed or suspected lung cancer.

Lung cancer is the leading cause of cancer deaths, with over 130,000 deaths from the disease in the U.S.1 and nearly 1.8 million globally2 each year. While surgery is a gold-standard treatment, up to 55% of people with lung cancer who undergo surgery with curative intent have a recurrence3. During surgery for lung cancer, some lesions can be difficult for surgeons to visualize, particularly if they are small, beneath the surface of the lung, or a type of lesion called a ground glass opacity, which is becoming increasingly common as the rates of lung cancer screenings rise.

"Today’s approval of an expanded indication for CYTALUX marks an important step forward in the treatment landscape for lung cancer and for the more than 220,000 people in the U.S. who receive a lung cancer diagnosis each year," said Chris Barys, President and Chief Executive Officer of On Target Laboratories, Inc. "We are proud to continue pioneering development of targeted intraoperative molecular imaging agents that illuminate cancers intraoperatively to enhance surgeons’ ability to see cancer in real time as they operate."

"During the ELUCIDATE Trial, CYTALUX proved to be a valuable surgical tool with its ability to localize lung lesions that may have otherwise been missed," said Dr. Linda Martin, Chief of Thoracic Surgery, University of Virginia School of Medicine. "CYTALUX has potential to become standard of care in thoracic surgery because of the safety and efficacy demonstrated in the trial. It is an important tool for surgeons to consider for patients."

CYTALUX was approved in November 2021 for use in adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions. CYTALUX is the first targeted molecular imaging agent that illuminates ovarian and lung cancer intraoperatively, enabling the detection of more cancer for removal. CYTALUX, administered by standard IV in as little as one hour before surgery, binds to folate receptors that are overexpressed in certain cancers4,5 and illuminates intraoperatively under near-infrared light.

About the ELUCIDATE Trial
The ELUCIDATE (Enabling LUng Cancer IDentification Using FolATE Receptor Targeting) trial was a Phase 3, multi-center, single dose, open label trial led by Principal Investigator, Sunil Singhal, MD, the William Maul Measey Professor in Surgical Research and director of the Center for Precision Surgery at Penn Medicine and included 12 sites across the United States. The study (NCT04241315) investigated the use of CYTALUX (pafolacianine) injection in patients scheduled to undergo thoracic surgery for confirmed or suspected lung cancer.

About Intraoperative Molecular Imaging
To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. Intraoperative Molecular Imaging (IMI) is an emerging category of technology for surgical oncology in which targeted imaging agents are injected into patients to highlight cancer cells making them visible during surgery.

The CHMP has Adopted a Negative Opinion for Omburtamab for the Treatment of CNS/LM Metastasis from Neuroblastoma in Europe

On December 16, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the European Committee for Medicinal Products for Human use ("CHMP") has adopted a negative opinion recommending a refusal of the marketing authorization for omburtamab for the treatment of CNS/leptomeningeal metastasis from neuroblastoma in Europe (Press release, Y-mAbs Therapeutics, DEC 16, 2022, View Source [SID1234625360]).

"This recommendation by the CHMP is disappointing given the significant unmet medical need, which exists for patients with CNS/LM neuroblastoma who have no approved therapies available. CHMP considered that it was not possible to conclude on the effectiveness of omburtamab as the main study did not have a randomized comparator. The company does not believe it is feasible to conduct a randomized study in a life-threatening disease where no other approved therapy is available to these children," said Thomas Gad, founder, President and Interim Chief Executive Officer. "Our focus is now on assessing the implications of the negative opinion and our plans for the omburtamab program."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. MSK has institutional financial interests related to the compound and Y-mAbs.