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MedNess: bite-size biopharma and medtech news

14th July, 2021
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MedNess This Week
HIGHLIGHTS
Onco-I-Analyse
F-star Therapeutics and AstraZeneca announce exclusive licensing agreement
On 8th July, F-star Therapeutics and AstraZeneca entered into an exclusive licensing agreement for next-generation Stimulator of Interferon Genes (STING) inhibitors. Under the agreement, AstraZeneca will gain exclusive rights to F-star’s preclinical STING inhibitors for research, development, and commercialization.
Background: STING plays a key role in triggering the innate immune system across an array of inflammatory and autoimmune diseases. Apart from STING-mediated antitumor response of the immune system, cGAS-STING pathway has also been known to play a key role in tumor development. STING is also known to exert potential immune inhibitory effects, contribute to cancer initiation and progression via cancer-associated inflammation upon induction of type I interferon responses. Thus, the development of STING inhibitors could offer a therapeutic option for patients with immune-mediated diseases.
Details: As per the term of the agreement, F-star will retain rights to STING agonists, currently in clinical development for various cancers. The company will receive an upfront and near-term payment of up to $12 million. Additionally, it is eligible to receive development and commercialization milestone payments of more than $300 million, alongside single-digit percentage royalties.
A part of earnings will go to the company’s stockholders who previously held shares of Spring Bank Pharmaceuticals under the contingent value rights agreement (CVR 2). In November 2020, F-star gained access to STING assets after a merger with Spring Bank Pharmaceuticals.
The deal comes after other big pharmaceuticals’ deals with F-star including AbbVie, Bristol-Myers-Squibb, Denali Therapeutics and Merck.
Collated by : Shilpa Rawal, PhD
Drug Approvals
FDA Approves Expanded Indication for KEYTRUDA® (pembrolizumab) in Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)
“This approval is great news for these patients and further demonstrates Merck’s commitment to the skin cancer community. KEYTRUDA has shown meaningful efficacy in patients with locally advanced or recurrent or metastatic cutaneous squamous cell carcinoma that cannot be cured by surgery or radiation,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories. “This expanded indication reinforces the role of KEYTRUDA in this cancer type, which is the second most common form of non-melanoma skin cancer.”
Regulatory News

Update Provided from FDA Type A Meeting Regarding Oral Paclitaxel Plus Encequidar for the Treatment of Metastatic Breast Cancer
“We appreciate the FDA’s support for the development of oral paclitaxel and encequidar in this meeting and expect to maintain a collaborative dialogue on this program,” said Dr. Rudolf Kwan, Chief Medical Officer of Athenex. “We continue to believe that, if approved, oral paclitaxel and encequidar has the potential to address a major unmet need in metastatic breast cancer. We hope to agree on a program that is capital efficient and will result in value creation for our stakeholders.”
FDA approves IND for Ph 1 trial of oncolytic virotherapy 'CHECKvacc'
Imugene Managing Director and CEO Leslie Chong said, "City of Hope and Dr Yuan Yuan receiving their IND approval for CHECKvacc from the FDA is a crucial step forward for Imugene. The start of our CF33 OV study is a significant milestone for clinicians treating patients faced with the challenge of triple-negative breast cancer."
Trial Results
Updated results from Ph 3 OCEAN study shows melflufen met primary endpoint of superior PFS; OS data lead to partial clinical hold
  • Oncopeptides AB announced updated results and safety measures based on the head-to-head Ph 3 OCEAN study evaluating the efficacy and safety of melflufen (INN melphalan flufenamide) plus dexamethasone versus pomalidomide plus dexamethasone in 495 RRMM patients who have received 2 – 4 prior lines of therapy.
  • The updated OCEAN results follow a blinded reassessment by the IRC. In the final analysis melflufen met the primary endpoint of superior PFS compared to pomalidomide.
  • HR for OS, a key secondary endpoint, was 1.104 (0.846-1.441) in favor of pomalidomide for the ITT population.
  • Based on the observed large differences in OS in pre-specified subgroups, the FDA has requested a partial clinical hold of all clinical studies with melflufen, pending further investigation.
Positive Top-Line Results Announced from a Ph 1b Clinical Trial Extension of Belapectin + KEYTRUDA® in Advanced Metastatic Melanoma and Head and Neck Cancer
Dr. Pol Boudes, M.D., Chief Medical Officer at Galectin Therapeutics, added, “The advantageous tolerance and safety profile of the combination appears to be confirmed with the extension study. This may help patients to avoid frustrating side-effects that lead them to discontinue pembrolizumab (KEYTRUDA) for safety reasons even though they seem to benefit from the drug. A better tolerance would also lead to better compliance and, ultimately, a better risk/benefit profile of the combination. The apparent good safety profile is also consistent with what we see in cirrhotic patients who, like advanced cancer patients, are also very fragile. The dose used in the extension is indeed the highest dose that we are using in our NAVIGATE study in NASH cirrhosis.”
Click here for more Trial Results 
Trial/Program Status
DESTINY-Gastric04 Head-to-Head Ph 3 Trial of ENHERTU® Initiated in Patients with HER2 Positive Advanced Gastric Cancer
“In the DESTINY-Gastric04 phase 3 trial, we are evaluating whether ENHERTU will improve survival as compared to another commonly used combination therapy regimen in the second-line HER2 positive metastatic gastric cancer setting,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. “Results from our earlier research have led to approvals of ENHERTU in two regions for patients with HER2 positive metastatic gastric cancer and we are excited to continue our research in this patient population to further support our efforts to bring a new treatment option to more patients around the world.”
Preparatory work completed ahead of the anticipated initiation of patient enrollment for pivotal Ph 3 registration trial of Namodenoson in HCC
“We are eager to commence this study, as there is a dire need for a safe and effective treatment for patients with advanced liver disease, defined as CPB7, where Namodenoson has an advantage with its liver protective effect,” stated Can-Fite CEO Dr. Pnina Fishman.
MedNess Business
Onco-News
OncoSec & Merck to conduct a Pivotal Global Ph 3 Study, KEYNOTE-C87, of TAVO™ + KEYTRUDA® for Late-Stage Metastatic Melanoma
"We are thrilled to enter into this collaboration and supply agreement with Merck – one of the world's leading immuno-oncology companies – to help bring TAVO™ to patients with metastatic melanoma whose disease did not respond to initial checkpoint inhibitor therapy or who have developed progressive disease and therefore do not have additional treatment options available," said Brian Leuthner, Interim Chief Executive Officer of OncoSec.  "This Phase 3 collaboration represents a crucial milestone for OncoSec as we advance TAVO™ through the clinic and toward potential approval globally, and expands upon our initial 2017 clinical collaboration and supply agreement with Merck.  We look forward to our continued work and progress with Merck and its experienced team of immuno-oncology leaders as we continue to explore TAVO™ in combination with KEYTRUDA® with the goal of helping more patients with cancer."  
Agenus Closes $200M Upfront BMS Collaboration and Announces FDA Acceptance of IND for Partnered Anti-TIGIT Bispecific Antibody, AGEN1777
“TIGIT is becoming an increasingly important immunotherapy target, and the Fc-enhanced and bispecific design of AGEN1777 could offer improved benefit, including the potential for both single-agent and combination activity,” said Garo Armen, PhD, Chief Executive Officer of Agenus. “Together with our partner Bristol Myers Squibb, we look forward to advancing this agent into clinical studies with the goal of providing a meaningful new option for cancer patients.”
Click here for more on mergers, acquisition and business news
Collated by : Richa Tewari, PhD
Editors' Desk
Richa Tewari, PhD
Oncology News
Shilpa Rawal, PhD
Onco I-Analyse
Arundithi Ananthanarayanan
MedNess Reviews
Divyaanka Iyer
BioPharma News
Debarati Banik
HealthIT
Darpan Chakraborty
Social Media Manager
Nisha Peter, PhD
Consulting Editor
Abhi Dey
Consulting Editor
Rinki Saha
BioPharma News
Managing Editor
Shalini Roy Choudhury
Genes and Therapy
Managing Editor
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Content Editors: Richa Tewari , Esha Sehanobish , Rinki Saha ,  Shilpa Rawal, PhD ,  Debarati Banik  , Divyaanka Iyer , Arundithi Ananthanarayanan and Abhinav Dey 
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