On September 9, 2021 Viewpoint Molecular Targeting, Inc., a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug application (IND) to commence a Phase I imaging study of VMT–NET for imaging of neuroendocrine tumors (NETs) (Press release, Viewpoint Molecular Targeting, SEP 9, 2021, https://viewpointmt.com/viewpoint-molecular-targetingtm-receives-fda-clearance-of-investigational-new-drug-application-for-phase-1-imaging-study-for-vmt-a-net-for-neuroendocrine-tumors/ [SID1234587507]). The Phase I imaging study is an investigator-initiated study that will be conducted at the University of Iowa Hospitals and Clinics.

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The Phase I imaging study will evaluate [203Pb]VMT–NET as an agent for imaging somatostatin receptor subtype 2 (SSTR2)-positive neuroendocrine tumors. The images obtained will inform future therapeutic trials of [212Pb]VMT–NET alpha-particle therapy for this tumor type. In parallel to this investigator initiated imaging trial, the Company plans to move forward with a Phase I/IIa therapy study of VMT–NET for the treatment of neuroendocrine tumors.

"We are incredibly pleased that our second product has received IND clearance from the FDA, allowing our collaborators at the University of Iowa to proceed with another first-in-human Phase I imaging study. We continue to be encouraged by the preclinical results demonstrated to date, that show the promise of treating this disease with targeted alpha-particle therapy. With this milestone now achieved, Viewpoint together with the team at the University of Iowa is excited to progress toward enrollment and provisional results in our imaging study over the remainder of this year," commented Frances L. Johnson, MD, Chief Executive Officer and Co-Founder of Viewpoint Molecular Targeting.

Preclinical data seen to-date provides strong evidence that the VMT–NET image-guided approach can be an effective therapy with a promising toxicity profile. Supported by over $4 million in the form of Small Business Innovation Research grants and R01 academic research grants from the NCI to advance this treatment, VMT–NET is well-positioned to apply the new transformative power of alpha-particle treatment to NET tumors and other cancers that express the SST2R biomarker.

Neuroendocrine tumors are rare forms of cancers that occur most commonly in the pancreas or other areas of the gut such as the stomach, small intestine, rectum, colon, or appendix. A neuroendocrine tumor may grow slowly or aggressively and spread to other parts of the body. Diagnosis and treatment of neuroendocrine tumors depend on the type of tumor, its location, whether it produces excess hormones, how aggressive it is and whether it has spread to other parts of the body. Some approaches may include surgery, radiation, and chemotherapy.

On September 9, 2021 Novavax presented Investor Presentation (Presentation, Novavax, SEP 9, 2021, View Source [SID1234587505]).

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On September 9, 2021 Jazz Pharmaceuticals reported that it wasn’t able to ride a breakthrough FDA nod to a pivotal trial win for conditionally approved small cell lung cancer (SCLC) drug Zepzelca (Press release, Jazz Pharmaceuticals, SEP 9, 2021, View Source [SID1234587502]). But after talking with the FDA, the company and partner PharmaMar see a new path forward.

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In previously treated SCLC, the combination of Zepzelca and doxorubicin failed to extend patients’ lives over physician’s choice of doxorubicin-based chemo or Hycamtin, according to data presented at the 2021 World Conference on Lung Cancer virtual meeting.

Jazz and PharmaMar first unveiled the phase 3 ATLANTIS failure in December. Now we know patients who mostly got the Zepzelca regimen as their second-line treatment lived a median 8.6 months, versus 7.6 months in the control arm.

If successful, the trial could have served as the confirmatory trial to convert Zepzelca’s accelerated approval earned last June into a full one. In a previous single-arm study, Zepzelca monotherapy shrunk tumors in 35% of relapsed SCLC patients as measured by investigator assessment. The response lasted a median 5.3 months.

Pascal Besman, chief operating officer at PharmaMar, noted that the ATLANTIS study used a 2-mg/m2 dose of Zepzelca, which is lower than the FDA-approved dose of 3.2-mg/m2. Although the Zepzelca-doxorubicin combo didn’t improve survival, "the overall results support the activity and tolerability of Zepzelca monotherapy in second-line therapy," Besman said in an email interview.

As ATLANTIS investigator Luis Paz-Ares, M.D., Ph.D., noted in a prepared presentation, the research team ran a so-called exposure-response analysis to gauge Zepzelca’s contribution on patient survival. The model predicted that single-agent Zepzelca, at the 3.2-mg/m2 dose, would have had a statistically significant advantage over the control arm at prolonging the lives of patients in the ATLANTIS study.

Jazz stands "firmly behind the favorable benefit/risk profile of monotherapy Zepzelca" in second-line SCLC as shown in its phase 2 trial, the company’s chief medical officer, Rob Iannone, M.D., said in a separate email interview.

For now, Zepzelca will remain on the market. Jazz and PharmaMar have agreed "in principle" with the FDA to run another phase 3 as the confirmatory trial, Besman said.

The three-arm trial will test Zepzelca monotherapy at 3.2 mg/m2, and a second experimental arm will combine the drug at 2 mg/m2 with Pfizer’s Camptosar (irinotecan).

Second-line patients in the control arm will get physician’s choice or either Camptosar or Hycamtin. The trial, expected to launch this year, will also support a regulatory filing to the European Medicines Agency, Besman added.

In addition, Jazz is collecting data from an observational phase 4 trial to understand Zepzelca’s real-world profile in second-line SCLC, Iannone noted.

Meanwhile, Jazz is also looking to move Zepzelca earlier in the treatment line. Through a partnership with Roche, a phase 3 trial dubbed ImForte will test Zepzelca with immunotherapy as a first-line maintenance therapy for patients with extensive-stage SCLC after induction chemotherapy. If successful, the new regimen could pressure AstraZeneca and its Imfinzi, which is currently dominating the front-line SCLC space.

On September 8, 2021 Diaccurate, a French biotech company that develops sole-in-class drug candidates in oncology and immunotherapy, reported the exclusive worldwide in-licensing of the dual targeted PAM inhibitor, formerly M2698, now DIACC3010, from Merck KGaA, Darmstadt, Germany, thus, transforming Diaccurate into a clinical-stage company (Press release, Merck KGaA, SEP 9, 2021, View Source [SID1234587501]).

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DIACC3010 is an oral small molecule inhibitor of the PAM pathway*, one of the most frequently dysregulated molecular circuits involved in cancer progression and resistance to therapies). By acting simultaneously on two key steps of the pathway – AKT1/3 and p70S6 – DIACC3010 is expected to result in a more favorable efficacy and safety profile when compared to other PAM inhibitors. Pre-clinical and Phase I studies have demonstrated that DIACC3010 crosses the blood-brain barrier, a physical frontier that protects the brain from numerous threats but also prevents most drugs from reaching it.

Merck KGaA, Darmstadt, Germany, has completed a multi-institutional Phase I trial led by Apostolia-Maria Tsimberidou, M.D., Ph.D., professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center. The study evaluated the safety and efficacy of DIACC3010 as monotherapy in patients with advanced, refractory solid tumors who failed standard therapies, or as combination therapy with trastuzumab and/or tamoxifen in patients with advanced breast cancer**. DIACC3010 was well tolerated as monotherapy. Combined with trastuzumab or tamoxifen, DIACC3010 demonstrated early signs of antitumor activity in patients with advanced breast cancer resistant to multiple standard therapies. Potential biomarkers of DIACC3010 pharmacological activity were seen in peripheral blood mononuclear cells and tumor tissues. Diaccurate will continue to characterize this potential sole-in-class asset in Proof-of-Concept (PoC) Phase II clinical trials in solid tumors enriched with PAM mutations and aggressive lymphomas to be initiated by H2 2022.

"We are confident that Diaccurate’s strong scientific background in developing novel mechanisms makes them the right partner to advance the development of M2698 in cancers with high unmet needs," said Andreas Stickler, Chief Financial Officer and Head of Strategy, Business Development and Portfolio Management of the Healthcare business sector of Merck, KGaA, Darmstadt, Germany.

"We are very proud that, after a highly competitive selection process, Merck KGaA, Darmstadt, Germany, has chosen Diaccurate to bring DIACC3010 into advanced clinical development", said Dominique Bridon, Ph.D., CEO of Diaccurate. "This dual PAM inhibitor could overcome limitations of existing anti-cancer treatments, and, if successful, would be a breakthrough innovation providing hope to patients with high unmet medical needs."

As part of its plan to develop DIACC3010, Diaccurate has designed an extensive PoC clinical program exploring both incurable solid tumors and refractory hemato-oncology indications. The solid tumor component of the program will first focus on cancers associated with a high-prevalence of PAM mutations: Triple Negative Breast Cancer and Gastric Cancer. The hemato-oncology program will address cancers in which the PI3K pathway plays a major role: relapsed/refractory B-cell and T-cell lymphomas. Both Phase II trials are scheduled to be initiated in H2 2022. Further details on the clinical program will be provided in due time.

"Diaccurate is laying the foundations of a successful modern biotech company with a new highly specialized portfolio approach. This is an exciting agreement that will take the Company to the next level, bringing the best of medical science innovation to patients", concluded Philippe Pouletty, M.D., Co-founder & Chairman of Diaccurate, Co-founder & CEO of Truffle Capital.

On September 9, 2021 Varian, a Siemens Healthineers company, reported that China Medical University Hospital in Central Taiwan treated its first patient with Ethos therapy, making it the first hospital in Taiwan and within the Greater China region to use Ethos therapy for advanced cancer treatment (Press release, Varian Medical Systems, SEP 9, 2021, View Source,-Expanding-Access-to-Personalized-Cancer-Care [SID1234587498]).

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The Ethos therapy system combines an image-guided radiation therapy powerhouse with adaptive capabilities in one system, creating workflow efficiencies that benefit both patient and clinician. This solution, powered by artificial intelligence (AI), is designed to deliver an entire adaptive treatment in a typical 15-minute timeslot, from patient setup through treatment delivery. Incorporating multi-modality image guidance, Ethos therapy provides the ability to personalize the patient’s treatment based on their anatomy and position at the time of treatment. The goal is to better target the tumor and potentially improve overall outcomes with a reduction in dose to healthy tissue.

"We are very excited to be able to use this sophisticated form of adaptive therapy for our patients. Ethos has addressed the challenges physicians have been encountering in adapting a course of radiotherapy to real-time changes in the patient. Now, physicians can effortlessly achieve their clinical treatment goals with the AI-driven Ethos solution," said Professor Liang, Ji-An, Director, Department of Radiation Oncology of China Medical University Hospital.

"Ethos has been recognized as a game-changer in cancer treatments. It optimizes the daily treatment plan and allows physicians to complete an adaptive treatment within a typical treatment time slot, which was impossible in the past. I believe we will set a new standard for cancer treatments and act as a model for personalized precision treatments in Taiwan," said Professor KS Clifford Chao, Superintendent, Proton Medical Center, China Medical University Hospital

"At Varian, we believe in patient-centric and personalized care," said Kevin O’Reilly, President, Radiation Oncology Solutions, Varian. "We are honored to partner with China Medical University Hospital to deliver personalized precision cancer treatments in Taiwan through our Ethos adaptive intelligence solution. Together, we are committed to expanding cancer patients’ access to advanced treatment in Taiwan."