On November 19, 2020 Alphamab Oncology and 3D Medicines reported that it filed a China NDA for their partnered anti-PD-L1 therapy as a treatment for MSI-H/dMMR cancer (Press release, Alphamab, NOV 19, 2020, View Source [SID1234571462]). In a Phase II registration trial, patients with MSI-H/dMMR colorectal cancer experienced an objective response rate of 32%. The patients had previously failed a fluoropyrimidine, oxaliplatin and irinotecan regimen. The results were roughly equivalent to those produced by BMS’s Opdivo and Merck’s Keytruda. In the US, Tracon Pharma partners the candidate with the two China pharmas

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On November 19, 2020 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported partner Juventas has completed the equivalent of $65 million financing and has initiated and enrolled the first patient in a Phase II registration study for CNCT19 (CD19 CAR-T) in China in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) (Press release, CASI Pharmaceuticals, NOV 19, 2020, View Source [SID1234571426]).

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Dr. Wei-Wu He, CASI’s Chairman, and CEO, commented, "Initiating the Phase II B-NHL registration study and enrolling the first patient is an exciting milestone for the development of CNCT19. Our partner Juventas is also making good progress in the Phase I clinical trial for the treatment of relapsed or refractory acute lymphoblastic leukemia (B-ALL) and is expecting to start the Phase II study by the end of 2020. Its financing provides Juventas with resources to continue moving CNCT19 through registration and we remain excited about its potential as a first-line treatment for B-NHL. In addition, as a large (16%) shareholder of Juventas, we are pleased to see Juventas’ progress in their pipeline and expect its financing to help accelerate its pipeline development. Juventas is an example of CASI’s entrepreneurial partnership model that is built on two components, co-development and equity investment. We believe investments in our partners deepen our collaboration and provides additional potential return to our shareholders. With this approach, we will continue to build CASI’s pipeline, one asset at a time."

About CNCT19

CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CD19- targeted CAR constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). CD19 antigen is the most frequently used target in the CAR-T cell therapy clinical trials for hematological malignancies such as leukemia and lymphoma. Juventas is responsible for the development of CNCT19. CASI and Juventas with co-commercialize together under the direction of the program’s joint steering committee.

About Juventas

Juventas Cell Therapy Ltd. is a China-based domestic company located in Tianjin City, China focused on cell therapy. The company’s lead product, CNCT19, devolved from the CD19 CAR-T, was originally created at the Institute of Hematology, Chinese Academy of Medical Sciences, one of the top hematology centers in China. CD19 CAR-T is used to treat patients with acute lymphoblastic leukemia and relapsed non-Hodgkin lymphoma.

On November 19, 2020 Varian (NYSE: VAR) and the Cincinnati Children’s/UC Health Proton Therapy Center reported the start of the first clinical trial of FLASH therapy as part of the recently opened FAST-01 study (FeAsibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases) (Press release, Varian Medical Systems, NOV 19, 2020, View Source [SID1234571413]). The clinical trial involves the investigational use of Varian’s ProBeam particle accelerator modified to enable radiation therapy delivery at ultra-high dose rates (dose delivered in less than 1 second) and is being conducted at the Cincinnati Children’s/UC Health Proton Therapy Center with John C. Breneman M.D., Medical Director of the center, serving as principal investigator.

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The first clinical trial patient was treated this week. The FAST-01 study is expected to enroll up to 10 patients with bone metastases to evaluate clinical workflow feasibility, treatment-related side effects, and efficacy of treatment as assessed by measuring pain relief of trial participants. The clinical trial, informed by years of preclinical work, was designed by experts at Varian and multiple centers in the FlashForwardTM Consortium, including Cincinnati’s Children’s/UC Health Proton Therapy Center and the New York Proton Center.

Varian FLASH Cincinnati

Varian FLASH Cincinnati
"Treating the first patient in this FLASH clinical trial is a milestone that many thought was still years ahead of us," said Kolleen Kennedy, Chief Growth Officer and President of Proton Therapy Solutions at Varian. "There was overwhelming support from Dr. Breneman and his team for this clinical trial, which was designed in collaboration with the FlashForward Consortium and with significant contributions from the New York Proton Center. These efforts help Varian safely advance potential therapy options towards our vision of a world without fear of cancer."

Breneman noted that, because this is the first in human trial of FLASH radiotherapy, it will build a foundation for extending this therapy to other types of cancer treatments.

"Trials using FLASH radiotherapy for lung cancer and other malignancies are currently being developed," said Breneman, a UC Health radiation oncologist and a professor emeritus at the University of Cincinnati College of Medicine. "Using FLASH treatment for these cancers could deliver higher cancer-killing doses without causing inordinate side effects, which would be a real advance."

"FLASH therapy has the potential to be practice changing and dramatically improve the experience of cancer care for a new generation of patients. The launch of the first FLASH clinical trial, a project that has come to fruition after years of intensive study, is an important milestone in the progress of radiation therapy," said FlashForward Consortium member Dr. Charles B. Simone, II, FACRO, Chief Medical Officer at New York Proton Center. "We are optimistic that the results of the FAST clinical development program will transform the way the industry approaches treatment. The New York Proton Center is proud to be a partner in this future-focused study."

John Perentesis, MD, Director of the Division of Oncology & Cancer Programs at Cincinnati Children’s, said FLASH is potentially a transformational advance for cancer treatment for many patients."If the side effects of radiation on the normal tissues surrounding a tumor can be significantly reduced, the dose of radiation to treat a cancer can be greatly increased," Perentesis said. "This would raise hope to cure malignancies that respond to radiation but aren’t completely cured at current doses, including pediatric brain tumors like DIPG/pontine glioma and medulloblastoma, sarcomas, and neuroblastoma."

On November 19, 2020 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported the enrollment and dosing of the first patient in a Phase 1 clinical trial evaluating the ability of BP1002 to treat refractory/relapsed lymphoma and chronic lymphocytic leukemia (CLL) patients (Press release, Bio-Path Holdings, NOV 19, 2020, View Source [SID1234571429]).

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BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. High expression of Bcl-2 has been correlated with adverse prognosis for patients diagnosed with relapsed CLL or with relapsed, aggressive non-Hodgkin’s lymphoma. Preclinical studies have shown BP1002 to be a potent inhibitor against the Bcl-2 target, and the Company believes that its benign safety profile should enable BP1002 combination therapy with approved agents.

A total of six evaluable patients will be treated with BP1002 monotherapy in a standard 3+3 design, with a starting dose of 20 mg/m2. The treatment cycle consists of two doses per week over four weeks, resulting in eight doses administered over twenty-eight days. The primary objectives of the study include safety and tolerability of escalating doses of BP1002, recommended Phase 2 dose of BP1002, pharmacokinetics of BP1002 and BP1002 activity on Bcl-2 expression. Secondary endpoints include several efficacy measurements of tumor response.

"This study will mark a critical step in understanding the potential benefits that BP1002 may bring to patients suffering with advanced lymphoid malignancies," said Jorge Cortes, M.D., Director of the Georgia Cancer Center and Chairman of the Bio-Path Scientific Advisory Board. "Importantly, BP1002 activity is based on blocking the Bcl-2 messenger RNA and not the BH3 domain, as is the case with venetoclax. As a result, we believe BP1002 may provide a much-needed alternative for patients with malignancies that relapsed or are refractory to venetoclax."

"We are delighted to initiate this first-in-human clinical study of our second drug product candidate derived from the DNAbilize platform. Given the encouraging pre-clinical data and safety profile seen to date, we are very excited to begin this study, which is expected to demonstrate safety and to show initial efficacy signals in these indications with significant unmet medical need," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings.

Ian W. Flynn, M.D. will serve as the national coordinating Principal Investigator for the Phase 1 trial. Dr. Flynn is the director of lymphoma research at the Sarah Cannon Research Institute. Other sites for the clinical trial include the Georgia Cancer Center at Augusta University and The University of Texas M.D. Anderson Cancer Center.

On November 19, 2020 Ampersand Capital Partners, a leading private equity firm dedicated to growth-oriented investments in the healthcare sector, reported the oversubscribed, $670 million closing of the Ampersand Continuation Fund together with related investment vehicles ("AMP-CF") (Press release, Ampersand Medical Group, NOV 19, 2020, View Source [SID1234571445]). AMP-CF was formed to acquire the equity interests of three portfolio companies previously held by multiple mature Ampersand funds. StepStone Group and affiliated investors ("StepStone"), a leading player in the private equity secondary market, is the lead investor in the transaction.

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AMP-CF provided all Ampersand limited partners the option of reinvesting their proceeds or receiving full or partial liquidity, and also admitted new limited partners who wished to invest in the growth prospects of the three portfolio companies. In addition to StepStone, AMP-CF received commitments from a broad group of secondary and primary investors, including many prior Ampersand limited partners that elected to reinvest.

Notably, the closing of the fund was completed less than 45 days after StepStone’s commitment and exceeded the $600 million target necessary to acquire the AMP-CF assets, providing additional capital to support Confluent’s continued growth.

Ampersand Partner Trevor Wahlbrink commented, "We are very pleased that AMP-CF was so well received in the marketplace. The strong response from current and new limited partners confirms our belief that creating AMP-CF was a win-win opportunity for all of Ampersand’s key constituents. All of the AMP-CF portfolio companies are high-quality assets that we know exceptionally well, and the Ampersand team remains excited about their long-term growth prospects."

Ampersand Founder and Confluent Chairman Rick Charpie noted, "With an initial five-year term, and access to capital for additional acquisitions and secondary purchases, AMP-CF positions Confluent’s management and investors to continue taking a long-term view of the Company’s future growth opportunities. As the majority investor in Confluent, we look forward to working with the Company’s exceptional management team to build on Confluent’s position as a leading designer and manufacturer of complex, finished medical devices to the world’s largest OEM’s."

Goodwin Procter LLP served as legal counsel to Ampersand. Debevoise & Plimpton LLP served as legal counsel to StepStone.