On March 2, 2022 Prokarium, a biopharmaceutical company pioneering the oncology field of microbial immunotherapy, reported it exercised its option with Lausanne University Hospital (Centre Hospitalier Universitaire Vaudois — CHUV) for an exclusive, worldwide license for the use of Salmonella immunotherapy in the treatment of bladder cancer (Press release, Prokarium, MAR 2, 2022, View Source [SID1234609369]).

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"This intellectual property is an important milestone for our lead oncology program as it enters clinical development in 2023 and also lays the groundwork for expanding Salmonella immunotherapy into other solid tumors," said Livija Deban, PhD, Chief Scientific Officer of Prokarium. "Microbial immunotherapy is the gold standard-of-care in the treatment of bladder cancer. However, high recurrence rates and limited treatment options are currently available for patients. Prokarium is introducing a differentiated, efficacious microbial immunotherapy to a market that has seen little disruption in over 30 years."

In exchange for the exclusive license, Prokarium will make an upfront payment, as well as additional payments upon achievement of development and commercialization milestones, and, if any product is approved, will pay royalties on net sales.

"Since initiating our collaboration with Prokarium in 2019, our team at the Department of Urology at CHUV has generated a robust preclinical data package demonstrating that Prokarium’s proprietary Salmonella bacteria generates quantitatively and qualitatively superior immune responses with different kinetics compared to the standard-of-care," said Dr Denise Nardelli-Haefliger, Head of the Urology Research Unit. "Together with Prof Patrice Jichlinski, Prof Beat Roth, Dr Ilaria Lucca and Dr Sonia Domingos-Pereira, we are thrilled to see that the results of our collaboration have the potential to expand the disease-free interval and improve quality of life in patients with non-muscle invasive bladder cancer (NMIBC)."

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Bladder cancer represents 5% of all new cancer cases in the US and accounts for 550,000 new cases yearly worldwide. The clinical staging is determined by the depth of invasion into the bladder wall. More than 70% of cases are diagnosed at an early stage, also known as non-muscle invasive bladder Cancer (NMIBC). Despite early diagnosis, the only approved therapies are Bacillus Calmette-Guérin (BCG), which often faces shortages, and chemotherapy, both delivered intravesically. Because of its high incidence and the limited number of treatment options, a huge unmet medical need remains in NMIBC.

On March 2, 2022 Nuvalent, Inc. (Nasdaq: NUVL), a biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that James Porter, Ph.D., Chief Executive Officer, will participate in a virtual panel titled, "Lung Cancer Panel," during the Cowen 42nd Annual Healthcare Conference on Wednesday, March 9, 2022, at 9:10 a.m. ET (Press release, Nuvalent, MAR 2, 2022, View Source [SID1234609385]).

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A live webcast will be available in the investor section of the company’s website at www.nuvalent.com, and archived for 30 days following the presentation.

On March 2, 2022 Epsilogen Ltd, a global leader in the development of novel immunoglobulin E (IgE) antibodies to treat cancer, reported it has secured £30.75 million ($41.20 million) in an oversubscribed Series B financing round (Press release, Epsilogen, MAR 2, 2022, View Source [SID1234609402]). The round was led by new investor Novartis Venture Fund and joined by new investors 3B Future Health Fund and British Patient Capital, Schroders Capital and Caribou Property. The new syndicate joins founding Series A investor Epidarex Capital and Series A investor ALSA Ventures both of whom also committed further capital in this Series B fundraising round. In connection with the closing of the financing, Dr Marianne Uteng of Novartis Venture Fund and Dr Marianne Bjordal of 3B Future Health Fund will join Epsilogen’s Board of Directors.

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The proceeds from the financing will enable Epsilogen to establish clinical proof of concept for lead drug candidate MOv18 IgE in a phase Ib trial in platinum-resistant ovarian cancer, an aggressive cancer with poor treatment alternatives. MOv18 IgE targets the folate receptor alpha (FR alpha) antigen and is the world’s first IgE antibody to enter the clinic. Previously announced data from a phase I trial shows MOv18 IgE to be safe and well tolerated with early signs of clinical activity also seen.

The financing will also enable Epsilogen to progress the development of its proprietary IGEGTM antibody platform which combines elements from both IgE and IgG antibodies into novel and proprietary antibody molecules with enhanced functionality.

Dr Tim Wilson, Chief Executive Officer of Epsilogen, commented: "This significant, new financing round will not only fund demonstration of clinical Proof of Concept for MOv18 but also allow Epsilogen to maintain its position as the leading pioneer in the development of IgE therapeutic antibodies for the treatment of cancer. We are very pleased to have attracted new investors of the calibre of Novartis Venture Fund, 3B Future Health Fund, British Patient Capital, Schroders Capital and Caribou Property. We also appreciate the continued support and investment from our existing investors Epidarex Capital and ALSA Ventures."

On March 2, 2022 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company"), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported the first patient has been dosed in the Phase 2/3 ASPEN-06 study evaluating the combination of evorpacept, a next generation CD47 blocker, and CYRAMZA (ramucirumab), Eli Lilly and Company’s anti-VEGFR2 antibody, added to trastuzumab and paclitaxel for the treatment of patients with HER2-positive gastric cancer or gastroesophageal junction ("GEJ") cancer (Press release, ALX Oncology, MAR 2, 2022, View Source [SID1234609421]).

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ASPEN-06 (NCT05002127) is a randomized phase 2 (open-label) / phase 3 (double-blind), international, multi-center study to evaluate the efficacy of evorpacept in combination with ramucirumab, trastuzumab, and paclitaxel for the treatment of patients whose tumors have progressed following treatment with HER2-targeted therapy and chemotherapy. Approximately 450 adult patients will be enrolled in the study across both phases.

This study follows the ongoing ASPEN-01 Phase 1b trial in patients with HER2-positive gastric/GEJ cancer who have progressed following treatment with HER2-targeted therapy and chemotherapy (NCT03013218). As presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36th Annual Meeting in 2021, evorpacept used in combination with ramucirumab, trastuzumab, and paclitaxel demonstrated an initial confirmed objective response rate of 72.2% with a median duration of response of 14.8 months, a 12-month overall survival rate of 79%, and a median overall survival of 17.1 months in patients who historically have low response rates and poor outcomes in this clinical setting [SITC 2021 poster].

"Patients with HER2-positive gastric/GEJ cancer are in need of tolerable and effective treatments, particularly in the 2nd line and later settings where resistance to HER2-directed therapy may have developed," said Keun-Wook Lee, M.D., Ph.D., Professor of Seoul National University College of Medicine and Director of Clinical Trials Center, Seoul National University Bundang Hospital, Seoul, Korea. "Evorpacept’s favorable tolerability coupled with its novel approach of enhancing antibody dependent cellular phagocytosis engages the individual’s own innate anti-cancer immune response distinguishing it from other HER2-targeted approaches."

"We are greatly encouraged by the exciting data that continue to emerge from ASPEN-01 and are pleased to announce the first patient dosed in ASPEN-06," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "This milestone is an important step towards establishing evorpacept as a unique CD47 blocker that may be used in combination with other anti-cancer drugs for difficult-to-treat solid tumors, such as gastric/GEJ cancer, where more treatment options are desperately needed to improve disease outcomes."

About Gastric Cancer and Gastroesophageal Junction Cancer

Gastric cancer begins in the cells lining the inner wall of the stomach and spreads through the outer layers and eventually the body as it grows. It is estimated that there will be over 26,000 newly diagnosed cases of gastric/GEJ cancer at all stages in the U.S. in 2021, and approximately 17 percent of all gastric/GEJ cancer patients have HER2-positive disease. The five-year survival rate is only 5.5 percent for those patients diagnosed with metastatic disease. Gastric/GEJ cancer is even much more common in East Asian countries, with incidence rates 4 to 10 times higher than in the U.S.

On March 2, 2022 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported that it will take part in a fireside chat at the 42nd Annual Cowen Healthcare Conference, which will be webcast on March 9 at 10:30 a.m. P.T. / 1:30 p.m. E.T. David Meek, chief executive officer, will represent the company (Press release, Mirati, MAR 2, 2022, View Source [SID1234609481]).

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Investors and the general public are invited to listen to a live webcast of the session through the "Investors and Media" section on Mirati.com. A replay of the webcast will be made available following the event.