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!"

On May 13, 2021 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported financial results for the first quarter ended March 31, 2021, and provided an overview of recent developments (Press release, Atreca, MAY 13, 2021, View Source [SID1234579974]).

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"The first few months of 2021 have been a productive period at Atreca, and we look forward to reporting initial summary data from our Phase 1b trial of ATRC-101 in July of this year," said John Orwin, Chief Executive Officer. "We are making good progress enrolling the monotherapy cohorts, and are moving quickly to commence the combination cohorts evaluating ATRC-101 with both checkpoint inhibitors targeting the PD-1/PD-L1 axis and with chemotherapy. We also continue to advance our pre-clinical pipeline and are excited to announce our next program, targeting EphA2."

Recent Developments and Highlights

ATRC-101 Clinical Update

To date, 20 patients have been enrolled and treated in the first-in-human trial evaluating ATRC-101 in multiple solid tumor cancers. Atreca has completed enrollment in the fourth cohort (10 mg/kg) of the dose escalation portion of the trial, and all patients treated at that dose have now completed the 21 day dose-limiting toxicity (DLT) assessment period. No DLTs have been observed in the trial. Atreca and its investigators decided, out of an abundance of caution, to enroll three additional patients in the fourth dose cohort (10 mg/kg), after the first two patients enrolled experienced rapid deterioration associated with disease progression, assessed as unrelated to ATRC-101, relatively soon after completion of the DLT assesment period. Atreca anticipates commencing enrollment in the fifth and final cohort (30 mg/kg) shortly, pending review by the Dose Review Committee, and expects to announce initial summary data from the study in July 2021.

Enrollment includes additional patients treated at 3 mg/kg through backfill of the third dose escalation cohort and the initiation of a monotherapy dose expansion cohort, as previously disclosed. Atreca expects to enroll additional cohorts evaluating ATRC-101 in combination with a PD-1 inhibitor and in combination with a chemotherapeutic agent in 2Q 2021 and 2H 2021, respectively.

Pipeline Update

Atreca has designated a second program, with APN-122597, an antibody derived from the active immune response of a cancer patient, as the program lead. APN-122597 binds to a membrane proximal extracellular epitope of EphA2, a receptor tyrosine kinase (RTK) validated as a known tumor target that is overexpressed in multiple cancers, but with no approved therapies targeting it. A human normal tissue cross-reactivity study showed no reactivity of toxicological significance, and APN-122597 is active in vitro in multiple formats. Atreca expects to provide additional information on APN-122597 and other pipeline assets, including timelines for development, at an R&D Day in 4Q 2021.

"APN-122597 is another example of the power of our discovery approach," said Dr. Tito Serafini, Atreca founder and Chief Strategy Officer. "While EphA2 is validated as a known and potentially high value target, there are only a limited number of development-stage programs currently targeting EphA2, and no therapies on the market. We believe our antibody is differentiated by its apparent lack of both EphA2 activation and interference with ligand-induced activation, its unique patterns of reactivity with tumor tissue and cells, and its structural features. Furthermore, lead optimization has already yielded improved molecules with an anticipated low level of sequence-based CMC risk."

IP Update

In April 2021, the United States Patent and Trademark Office issued a Notice of Allowance for U.S. patent application serial no. 13/261,763 (exclusively licensed to Atreca), covering fundamental aspects of Atreca’s Immune Repertoire Capture technology (IRC), which forms a core part of the company’s discovery platform. This patent, once issued, further bolsters our global patent coverage for compositions of matter that are a key output of Atreca’s IRC technology.

First Quarter 2021 Financial Results

As of March 31, 2021, cash and cash equivalents and short-term investments totaled $211.7 million.

Research and development expenses for the three months ended March 31, 2021 were $18.4 million, including non-cash share-based compensation expense of $2.2 million.

General and administrative expenses for the three months ended March 31, 2021 were $7.8 million, including non-cash share-based compensation expense of $2.2 million.

Atreca reported a net loss of $25.8 million, or basic and diluted net loss per share attributable to common stockholders of $0.70, for the three months ended March 31, 2021.

On May 13, 2021 ZAP Surgical Systems, Inc. reported the imminent installation of its advanced ZAP-X Gyroscopic Radiosurgery platform at the Swiss Neuro Radiosurgery Center (SNRC), an organization within the Swiss Clinical Neuroscience Institute (SCNSI) in Zurich, Switzerland (Press release, ZAP Surgical Systems, MAY 13, 2021, View Source [SID1234579963])

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Stereotactic radiosurgery (SRS) is a well-studied and effective treatment for many brain cancers including primary and metastatic brain tumors, as well as select intracranial functional and vascular disorders. Considered an alternative to surgery for these indications, SRS is a non-invasive outpatient procedure that often provides equivalent to superior outcomes, yet no surgical incision, and little to no recovery period.

The ZAP-X system is recognized for using gyroscopic motion to direct radiosurgical beams from a multitude of unique angles which precisely concentrate radiation to the tumor target, resulting in significantly less healthy brain tissue exposure than those of multi-purpose radiation delivery systems. This unique approach supports the clinical objective of protecting healthy brain tissue and neuro-cognitive function.

ZAP-X is also the first and only dedicated radiosurgery system to no longer require Cobalt-60 radioactive sources, thus eliminating the significant costs to license, secure and regularly replace live radioactive isotopes.

"The local core-team consisting of neurosurgeon Christoph Weber, MD, radiation oncologist Cristina Picardi, MD, and myself are looking forward to putting Switzerland’s first ZAP-X into operation," said Andreas Mack, PHD, founder and chief executive officer of SNRC.

"With an interdisciplinary focus on neuro-radiosurgical treatments, the project is a cooperative effort including the Klinik Hirslanden Institute for Radiotherapy, the Center for Endoscopic and Minimally Invasive Neurosurgery, namely Robert Reisch, MD, and Nikolai Hopf, MD, and the Center for Micro Neurosurgery, namely Ralf Kockro, MD," added Mack. "Additionally, SNRC is scientifically advised by the clinical team at the University Hospital of Basel, Department of Neurosurgery, namely Luigi Mariani, MD, Raphael Guzman, MD, and Ethan Taub, MD."

"ZAP Surgical is excited to partner with SNRC to bring world-class radiosurgery to Zurich and the surrounding communities," said Hakan Baraner, ZAP Surgical’s Senior Vice President for Europe, Middle East, and Africa. "We believe SNRC’s ZAP-X program will serve as an example to many other medical centers, both locally and globally."

SNRC estimates first patient treatments with ZAP-X will commence in the summer of 2021.