On May 13, 2021 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, announced the closing of a $35 million Series A financing for a joint venture in China (Press release, Kinnate Biopharma, MAY 13, 2021, View Source [SID1234580009]). Established with OrbiMed Asia Partners, OrbiMed Private Investments and Foresite Capital, the joint venture will be headquartered in Shanghai and enable the potential development and commercialization of certain Kinnate targeted oncology product candidates across Greater China (mainland China, Hong Kong, Taiwan, and Macau). Kinnate Biopharma will be the majority shareholder in the joint venture. The company has also announced that veteran biopharmaceutical industry executive Wenn Sun, Ph.D., has been appointed as the joint venture’s Executive Chair.

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"Establishing operations in China creates a tremendous opportunity for Kinnate to build its global footprint and further advance our mission of expanding access to innovative targeted therapies for people battling cancer," said Nima Farzan, President and CEO of Kinnate Biopharma Inc. "OrbiMed Private Investments and Foresite Capital have been important partners in the growth of Kinnate and we are pleased to now have the support of OrbiMed Asia Partners who led this financing and brings tremendous expertise and connections in China to this new joint venture. I look forward to working with this leading team of investors and Dr. Sun to make precision medicine a reality for more people in Greater China, which is one of the world’s largest healthcare markets."

The initial focus of the joint venture is on advancing the development of KIN-2787 for the Greater China market. KIN-2787 is a Rapidly Accelerated Fibrosarcoma (RAF) inhibitor candidate being developed for the treatment of patients with lung cancer, melanoma, and other solid tumors. The joint venture will also pursue development of KIN-3248 for the Chinese market. KIN-3248 is a Fibroblast Growth Factor Receptors (FGFR) inhibitor candidate for the treatment of patients with intrahepatic cholangiocarcinoma (ICC), a cancer of the bile ducts in the liver, and urothelial carcinoma (UC), a cancer of the bladder lining. The joint venture, which will be subsequently named, has an exclusive license to one other Kinnate program and may also obtain rights to develop certain other new product candidates in Greater China from the Kinnate pipeline, as well as other third-party product candidates in China and other geographies.

"Since its founding, Kinnate has demonstrated impressive scientific discipline and exceptional execution in building a robust pipeline of targeted therapies for hard-to-treat cancers," said Steven D. Wang, Ph.D., CFA, Partner and Senior Managing Director, OrbiMed Asia Partners. "We are pleased to join them in establishing this joint venture in China and look forward to working closely with Dr. Sun and our other regional colleagues in bringing these potentially life-saving therapies to more patients."

Dr. Sun is the Founder and President of Precision Medicine Asia (PREMIA), an oncology-focused clinical genomic data company she founded in 2018. Previously, she was the Founder and Managing Partner for OxOnc Development, a venture company that, along with Pfizer Oncology, co-developed XALKORI in patients with ROS1 genetic alterations in Asia, including China. Dr. Sun also served as Head of Strategic Alliances for GSK Oncology, and helped build its alliances with various clinical research networks around the world. In 2003, in collaboration with the National Comprehensive Cancer Network (NCCN), she helped introduce the NCCN Guidelines to China. Dr. Sun was appointed Chief Business Development Officer at the Lurie Cancer Center of Northwestern University after her post-doctoral fellowship at University of Wisconsin-Madison.

"I am honored to join the Kinnate team and lead the joint venture’s efforts to help the patients in China for whom no genomically-targeted therapies exist or for which a resistance to targeted treatments has evolved," said Dr. Sun. "KIN-2787 has already demonstrated very promising results in pre-clinical studies and presents a significant opportunity to help address the tremendous demand for more effective cancer therapies across Greater China."

On May 13, 2021 Elpiscience Biopharma, a clinical stage biopharma focusing on the discovery and development of next-generation cancer immunotherapies, reported the closing of Series C round of financing of 105 million USD (Press release, Elpiscience, MAY 13, 2021, View Source;id=1385 [SID1234580008]). This round of financing was led by the Greater Bay Area Homeland Development Fund, with participation from Cormorant Asset Management, Maison Capital, Superstring Capital, Pluto Connection Limited, Unifortune Fund etc. Existing investors, including Lilly Asia Ventures, CDH Investments, Dyee Capital and Oriza Holdings continued to invest in this round of financing.

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Proceeds raised from this round will be primarily used to expand the global reach of Elpiscience’s R&D strategy, i.e. as a start, to advance Elpiscience’s innovative molecules into clinical studies in the US. Part of the proceeds will also be used for exploring novel mechanisms of cancer immunotherapy and fueling more strategic partnerships.

"We are thrilled to have the continued support and endorsement from the top tier investors. It’s been a remarkable 3.5 years," said Dr. Darren Ji, Chairman and CEO of Elpiscience, "Elpiscience is determined to become a innovation leader in developing the next generation of cancer immunotherapies. We are committed to bringing at least one world-class molecule into the clinic each year to benefit cancer patients globally."

On May 13, 2021 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY,NYSE: RDY, NSEIFSC: DRREDDY) and Shenzhen Pregene Biopharma Co., Ltd. reported an agreement whereby Dr Reddy’s will acquire an exclusive license in the Republic of India for PRG1801, Pregene’s single domain antibody-based anti-BCMA chimeric antigen receptor T (CAR-T) cell therapy injection (Press release, PreGene, MAY 13, 2021, View Source [SID1234580007]).

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Dr. Reddy’s acquires the exclusive rights to commercialize PRG1801 in India, and will be responsible for future development including clinical trials, in India. Pregene will be the exclusive supplier of the core material – lentiviral vectors for manufacturing PRG1801. Under the terms of the license agreement, Pregene will receive an upfront payment and future milestone payments of USD 5 million for first indication and up to USD 7.5 million of milestone payments for subsequent indications, and is eligible to receive a double-digit royalty, up to USD 150 million, on future sales of PRG1801 in the licensed territory.

PRG1801 is an autologous anti-BCMA CAR-T therapy in development for the treatment of relapsed/refractory multiple myeloma, and has already demonstrated strong signs of efficacy and an excellent safety profile in 34 patients in an investigator initiated trial in China. In 2020, PRG1801 was granted NMPA IND clearance, and a Phase I clinical trial of the product candidate is ongoing in China.

This license agreement provides Pregene with a strong, experienced partner in the large Indian market, and expands Dr. Reddy’s capacity in the field of immune cell therapy for cancers.

About PRG1801

PRG1801 is an autologous anti-BCMA CAR-T therapy that utilizes a humanized single-domain antibody as the antigen binding domain and lentivirus as a vector. The lentivirus vectors are produced by Pregene using a proprietary serum free suspension production system with gene-therapy-grade quality and a high transduction unit yield. This CAR-T therapy has already demonstrated strong signs of efficacy and an excellent safety profile in 34 patients in an investigator initiated trial in China.

Clinical trials of PRG1801 include:

Phase I trial to evaluate the safety and tolerance of patients with relapsed/ refractory multiple myeloma after anti-BCMA CAR-T infusion, and to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of anti-BCMA CAR-T for relapsed/refractory multiple myeloma.
Investigator initiated trial in China to evaluate the safety and efficacy of PRG1801 (NCT03661554). Among 34 patients treated, 30 (88.2%) patients achieved best objective response and 19 (55.8%) patients achieved complete response. No neurotoxicity was observed among treated patients. Grade 3 CRS occurred in only one patient (2.9%), and all the other patients had lower grade or no CRS.

On May 13, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune T-cell activating technology, reported that it will discuss its financial results for the quarter ended March 31, 2021 and provide a business update on its conference call today (Press release, PDS Biotechnology, MAY 13, 2021, View Source [SID1234579982]).

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Recent Business Highlights:

National Cancer Institute to present interim efficacy and safety data of PDS0101 Phase 2 clinical trial in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting on June 7, 2021. This trial is evaluating PDS0101 with two clinical stage immunotherapies from EMD Serono, a first in class bifunctional checkpoint inhibitor Bintrafusp Alfa (M7824) and an antibody conjugated cytokine M9241 (NHS-IL12), in patients with all types of advanced HPV-associated cancers, whose cancer has returned or spread after treatment.
COVID-19 consortium received a commitment from the Secretary for Research and Scientific Training of The Ministry of Science, Technology and Innovation of Brazil (MCTI) to fund up to approximately US$60 million to support the clinical development and commercialization of a Versamune-based COVID-19 vaccine by Farmacore in Brazil.
"We look forward to the presentation of preliminary efficacy and safety data from the National Cancer Institute (NCI)-led Phase 2 combination study of PDS0101 at the ASCO (Free ASCO Whitepaper) conference in early June. ASCO (Free ASCO Whitepaper) provides an important opportunity to present the potential of PDS0101 and the Versamune platform in oncology to the research and medical community," commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech, "The presentation of the human clinical efficacy data at ASCO (Free ASCO Whitepaper) is an important milestone both for PDS0101 and our entire Versamune-based oncology pipeline."

First Quarter 2021 Financial Results
PDS Biotech reported a net loss of approximately $3.0 million, or $0.14 per basic share and diluted share, for the three months ended March 31, 2021 compared to a net loss of approximately $4.0 million, or $0.39 per basic share and diluted share, for the three months ended March 31, 2020.

Research and development (R&D) expenses decreased 28% to approximately $1.4 million for the three months ended March 31, 2021 from approximately $2.0 million for the three months ended March 31, 2020. The decrease of approximately $0.6 million in 2021 was primarily attributable to a decrease of $0.3 million in professional services and $0.3 million in clinical studies.

General and administrative expenses decreased 21% to approximately $1.6 million for the three months ended March 31, 2021 from approximately $2.1 million for the three months ended March 31, 2020. The decrease of approximately $0.5 million is primarily attributable to a decrease in professional services of approximately $0.7 million which includes legal fees of approximately $0.2 million, offset by an increase of approximately $0.2 million in personnel costs.

Total operating expenses decreased 24% to approximately $3.0 million for the three months ended March 31, 2021 from approximately $4.0 million for the three months ended March 31, 2020.

PDS Biotech’s cash balance as of March 31, 2021 was approximately $25.0 million.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 am ET on Thursday, May 13, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotech. Participants can also access the conference call via webcast on the investor relations page of the Company’s corporate website (link).

The event will be archived in the investor relations section of PDS Biotech’s website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13716518.

On May 13, 2021 CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab (Vyrologix or PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, reported it has executed an exclusive supply and distribution agreement with Macleods Pharmaceuticals Ltd. in India (Press release, CytoDyn, MAY 13, 2021, View Source [SID1234579976]). This commercial agreement will enable Macleods to sell leronlimab in India following regulatory clearance.

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Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, "We are delighted Macleods Pharmaceuticals reached out to CytoDyn and equally excited to reach this agreement with their team so quickly. From the time they first contacted us about our drug, we were able to conclude this agreement within a few days. It is an honor to work with an organization so motivated to bring leronlimab to COVID-19 patients in India. Currently India has zero product approved for critically ill Covid-19 patients and we are delighted to be working toward being the first approved drug for this population."

Vijay Agarwal, a Business Development Director at Macleods, commented, "We are thrilled with our recently executed exclusive supply and distribution agreement with CytoDyn. We believe there is an immediate need for leronlimab in our country, to save COVID-19 infected patients who are on ventilators. We need to bring this product to market ASAP for them!"