On March 11, 2022 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, reported its leadership’s participation in two upcoming Investor Conferences this month (Press release, Renovorx, MAR 11, 2022, View Source [SID1234610011]).

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ROTH Capital Partners 34th Annual Conference
Format and Dates: In person, March 13-15, 2022
Location: The Ritz Carlton Laguna Niguel Hotel, Dana Point, CA
Presenters and Presentation Date/Time: Shaun Bagai, CEO, to present on Monday, March 14th at 1:30 p.m. PT
Webcast: View Source
Register: Visit the event website

Maxim Virtual Growth Conference
Format and Dates: Virtual, March 28-30, 2022
Presenters and Presentation Date/Time: Shaun Bagai, CEO, to present on-demand
Webcast: https://m-vest.com/events/2022-virtual-growth-conference
Register: Visit the event website

Maxim Growth Conference Panel on Pancreatic Cancer
Format and Date: Virtual, Monday March 28, 12:00 – 1:00 pm ET
Presenter: Shaun Bagai, CEO, to participate with other industry leaders on pancreatic cancer panel.
Webcast: A link to this panel will be posted to the RenovoRx Website Events page when it becomes available.

RenovoRx leadership will be available during the events for one-on-one meetings with the investment community. To schedule a meeting please reach out to your respective conference representative or by emailing KCSA Strategic Communications: [email protected].

On March 11, 2022 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported a business update and an update on its cash position at the end of December 2021 (Press release, ERYtech Pharma, MAR 11, 2022, View Source [SID1234610008]).

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"Notwithstanding the setback of our Phase 3 trial in pancreatic cancer not meeting its primary endpoint, 2021 has been a year of important achievement for Erytech," said Gil Beyen, CEO of ERYTECH. "We are very encouraged by the progress we are making towards seeking an approval for our lead product candidate GRASPA for the treatment of ALL patients who experienced hypersensitivities to pegylated asparaginase. Our BLA is ready to be submitted quickly once the FDA will have completed its review of the last information requests and gives us the green light to submit. The review of our strategic options is advancing well and different partnering discussions are in advanced stages of negotiation."

Business Highlights

Path to BLA in hypersensitive ALL, based on results of NOPHO-sponsored Phase 2 trial

The NOPHO trial evaluated the safety and pharmacological profile of eryaspase in acute lymphoblastic leukemia (ALL) patients who had previously experienced hypersensitivity reactions to pegylated asparaginase therapy. In December 2020, positive trial results were presented at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.

Eryaspase, also referred to as GRASPA, its recently approved invented name, in combination with chemotherapy and administered every two weeks, provided a sustained asparaginase enzyme activity level, and was generally well tolerated with few hypersensitivity reactions.

The Company pursues its interactions with the U.S. Food and Drug Administration (FDA) regarding a potential regulatory approval in this indication based on the NOPHO-sponsored trial. A pre-BLA meeting to discuss the submission of a Biologics License Application (BLA) took place in June 2021 after which the Company confirmed its intention to submit a BLA subject to successful completion of remaining activities.
In July 2021, the Company announced that the FDA had granted eryaspase Fast Track designation for the treatment of ALL patients who have developed hypersensitivity reactions to E. coli-derived pegylated asparaginase.
The BLA application is now almost completed, allowing a fast submission once the FDA has finalized its review of the remaining information requests and gives the green light to file.

TRYbeCA-1, pivotal Phase 3 clinical trial in second-line advanced pancreatic cancer

As reported in October 2021, the Phase 3 TRYbeCA-1 trial did not meet the primary efficacy endpoint of overall survival (OS). The median OS for patients treated with eryaspase plus chemotherapy was 7.5 months, compared to 6.7 months for chemotherapy alone, with an OS hazard ratio (HR) of 0.92 in the intent-to-treat (ITT) population (p-value 0.375).

The prespecified subgroup of patients treated with eryaspase and FOLFIRI, an irinotecan-based chemotherapy, demonstrated a nominal increase in median OS of 2.3 months, from 5.7 to 8 months (HR = 0.77; per protocol population), which the Company believes merits further investigation.
Patients treated with eryaspase demonstrated improved disease control compared to patients treated with chemotherapy only. Other secondary endpoints showed nominal improvement.
The safety profile of eryaspase was consistent with earlier clinical trials results and safety reviews.
Final data of the trial were presented as a late-breaking oral presentation at ASCO (Free ASCO Whitepaper)-GI in January 2022.
Potential continuation of development in pancreatic cancer was discussed with Key Opinion Leaders, who confirmed that further exploration of the combination of eryaspase with irinotecan- and fluoropyrimidine-based chemotherapy is of interest, and who recommended to consider further development in later lines of treatment.

rESPECT, Phase 1 investigator-sponsored trial (IST) in first-line pancreatic cancer

rESPECT is a Phase 1 trial, sponsored by the Georgetown Lombardi Comprehensive Cancer Center, evaluating the safety of eryaspase in combination with mFOLFIRINOX as a first-line treatment for locally advanced and metastatic pancreatic cancer in approximately 18 patients.

Patient enrollment started in January 2021, and the first dose cohort (75 U/kg) of three patients was enrolled by the end of February. No dose-limiting toxicity (DLT) was observed, and the trial was escalated to the next dosing cohort (100 U/kg).
After review of the safety data in the first two dose cohorts, the dose escalation committee concluded that the novel combination of mFOLFIRINOX plus eryaspase was well tolerated with no dose limiting toxicity. Consequently, the maximum tolerated dose (MTD) was determined at a dose of 100 U/kg eryaspase.
Interim data, presented as ASCO (Free ASCO Whitepaper) GI in January 2022, confirmed the acceptable safety profile and showed encouraging clinical activity. Out of the twelve patients enrolled, ten patients have been evaluated for response. They all achieved disease control; five patients with objective response and five with stable disease.

The trial will continue enrolling up to approximately 18 patients. Reporting of final data is expected in the third quarter of 2022.

TRYbeCA-2, randomized Phase 2 clinical trial in triple-negative breast cancer (TNBC)

The TRYbeCA-2 trial is evaluating eryaspase in combination with gemcitabine and carboplatin chemotherapy, compared to chemotherapy alone, in metastatic TNBC. Target enrollment is approximately 64 patients. The primary end point of the trial is objective response rate.

Following the disappointing results of eryaspase in combination with a gemcitabine-based chemotherapy in the TRYbeCA-1 trial in second-line pancreatic cancer, the Company has, in consultation with the trial’s Steering Committee, decided to stop further enrollment in the TRYbeCA-2 trial.

The results of the patients enrolled in the TRYbeCA-2 trial to date are expected to be reported around mid 2022.

Process to review strategic options and partnering alternatives well advanced

As announced on October 25th 2021, the Company has appointed a specialized advisor to evaluate its strategic and partnering options. The process is ongoing and different partnering opportunities are in advanced stage of negotiations.

Update on Q4 2021 Financial Results and Cash Position

As of December 31, 2021, ERYTECH had cash and cash equivalents totaling €33.7 million (approximately $38.1 million), compared with €44.4 million as of December 31, 2020 and €38.0 million on September 30, 2021. The €10.7 million decrease in cash position during the twelve months of 2021 was the result of a €57.1 million net cash utilization in operating activities and investing activities and €44.7 million generated in financing activities, including €34.6 million in combined net proceeds from the at-the-market (ATM) equity financing program, two Registered Direct offerings in April ($30M) and December ($7.85M), and €11.4 million from the drawdown of four tranches of convertible notes (OCABSA), while the variation of the U.S. dollar against the euro led to a €1.3 million positive currency exchange impact.
The Company believes that its current cash position, without considering future proceeds from potential strategic options, can fund its planned operating expenses and current programs well into the third quarter of 2022.
Given its ongoing discussions, the Company will need to present proforma FY2021 accounts per market regulation, to reflect the potential impact of a transaction on its operations. Consequently and given the time needed to prepare, audit and review proforma accounts with market regulators, the Company is postponing the reporting of its FY2021 financial results to a later date in April.

Key News Flow and Milestones Expected Over the Next 12 Months

Planned BLA submission of eryaspase in hypersensitive ALL (Q2 2022)
Data from the randomized Phase 2 TRYbeCA-2 trial of eryaspase in TNBC (Q3 2022)
Results from the Phase 1 rESPECT Trial of eryaspase in combination with mFOLFIRINOX in first-line pancreatic cancer (2H 2022)

Fourth Quarter and Full Year 2021 Conference Call Details

ERYTECH management will hold a conference call and webcast on Monday, March 14, 2021 at 8:30am EDT / 1:30 pm CET to discuss the recent business and financial updates. Gil Beyen, CEO, Eric Soyer, CFO/COO, and Iman El-Hariry, CMO, will deliver a brief presentation, followed by a Q&A session.

The audio call is accessible via the below registering link: View Source (Conference ID : 1086874)

Once registered, participants will receive a unique access code and the call number details to join the teleconference.

The webcast can be followed live online via the link: View Source

An archived replay of the call will be available for 7 days by dialing + 1 855 859 2056, Conference ID: 1086874#.

An archive of the webcast will be available on ERYTECH’s website, under the "Investors" section at investors.erytech.com

ERYTECH plans on attending the following upcoming investor conferences:

Investor Access Conference, April 4-5, Paris
Kempen Life Science Conference 2022, April 20-21, Amsterdam
Jefferies 2022 Global Healthcare Conference, June 8-10, New York

On March 11, 2022 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that the China National Medical Products Administration (NMPA) has granted conditional approval to BeiGene’s anti-PD-1 antibody, tislelizumab, for the treatment of adult patients with advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, including (Press release, BeiGene, MAR 11, 2022, View Source [SID1234610007]):

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Patients with advanced colorectal cancer (CRC) who had been treated with fluoropyrimidine, oxaliplatin and irinotecan; and
Other advanced solid tumors who develop disease progression after prior treatment and have no satisfactory alternative treatment options.
"Results from the clinical trial of tislelizumab in patients with MSI-H and dMMR solid tumors demonstrated that tislelizumab’s treatment effect was consistent and durable across tumor types and endpoints. We are proud of this approval in China as it underscores our ongoing commitment to pursuing the full potential of tislelizumab and expanding its access where there is unmet medical need," commented Mark Lanasa, M.D., Ph.D., Senior Vice President, Chief Medical Officer, Solid Tumors, at BeiGene.

"With seven approved indications in China, our 3,100+ science-based commercial team is working to make tislelizumab more broadly available to those who may benefit from this important immunotherapy," commented Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China, at BeiGene. "Today’s approval is a great step for patients in China with MSI-H and dMMR solid tumors."

"In the pivotal Phase 2 trial, we observed consistent responses across tumor types with tislelizumab and it was generally well tolerated," said Lin Shen, Ph.D., Vice President at the Beijing Cancer Hospital, and the principal investigator of the trial. "The NMPA’s approval of tislelizumab is welcoming news to patients with MSI-H and dMMR solid tumors, which are particularly prevalent among the many patients with cancers of the gastrointestinal tract. We are pleased to have a tissue-agnostic treatment approach with tislelizumab now available to those patients in need."

This approval was supported by clinical results from a single-arm, multi-center, open-label, pivotal Phase 2 clinical trial (NCT03736889) to evaluate efficacy and safety of tislelizumab as monotherapy in patients with previously treated locally advanced unresectable or metastatic MSI-H or dMMR solid tumors, with an enrollment of 80 patients in China. Patients received tislelizumab 200 mg intravenously every three weeks until disease progression, unacceptable toxicity, or withdrawal. The primary endpoint of this trial is objective response rate (ORR) as assessed by independent review committee (IRC) per RECIST v1.1; secondary endpoints include time to response (TTR), duration of response (DoR), disease control rate (DCR), and progression-free survival (PFS) as assessed by investigator and IRC, overall survival (OS), and safety and tolerability. Results of this study were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

About Microsatellite Instability-High or Mismatch Repair Deficient Solid Tumors

Microsatellite instability-high (MSI-H) cancer cells have a greater than normal number of genetic markers called microsatellites, which are short, repeated sequences of DNA. Cancer cells that have large numbers of microsatellites may have defects in the ability to correct mistakes (also known as mismatch repair deficiency, or dMMR) that occur when DNA is copied in the cell. MSI-H and dMMR tumors are found most often in colorectal cancer, other types of gastrointestinal cancer and endometrial cancer, although they may also be found in cancers of the breast, prostate, bladder and thyroid.i

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

The China National Medical Products Administration (NMPA) has approved tislelizumab in seven indications, including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy, for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and for second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy. The NMPA has also granted conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies, for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, for the treatment of patients with hepatocellular carcinoma (HCC) who have received at least one systemic therapy, and for the treatment of patients with advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials or other confirmatory trials approved by the health authority.

In addition, two supplemental Biologics License Applications for tislelizumab are under review by the Center for Drug Evaluation (CDE) of the NMPA, including for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression following or are intolerant to first-line standard chemotherapy, and for first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC).

In the U.S., a Biologics License Application for tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic ESCC after prior systemic therapy is currently under review by the U.S. Food and Drug Administration with a PDUFA target action date of July 12, 2022.

BeiGene has initiated or completed 17 potentially registration-enabling clinical trials in China and globally, including 13 Phase 3 trials and four pivotal Phase 2 trials.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

Tislelizumab is not approved for use outside of China.

About the Tislelizumab Clinical Program

Clinical trials of tislelizumab include:

Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with NSCLC (NCT03358875);
Phase 3 trial comparing tislelizumab to salvage chemotherapy in patients with relapsed or refractory classical Hodgkin Lymphoma (cHL; NCT04486391);
Phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced squamous NSCLC (NCT03594747);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC (NCT03663205);
Phase 3 trial of tislelizumab in combination with platinum-based doublet chemotherapy as neoadjuvant treatment for patients with NSCLC (NCT04379635);
Phase 3 trial of tislelizumab combined with platinum and etoposide versus placebo combined with platinum and etoposide in patients with extensive-stage small cell lung cancer (NCT04005716);
Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC; NCT03412773);
Phase 2 trial in patients with previously treated unresectable HCC (NCT03419897);
Phase 2 trial in patients with locally advanced or metastatic urothelial bladder cancer (NCT04004221);
Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC; NCT03430843);
Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442);
Phase 3 trial of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590);
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657);
Phase 2 trial of tislelizumab in patients with relapsed or refractory cHL (NCT03209973);
Phase 2 trial in patients with MSI-H/dMMR solid tumors (NCT03736889); and
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986).
BeiGene Oncology

BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the United States, China, the EU and U.K., Canada, Australia and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under FDA review, BeiGene and Novartis announced an option, collaboration and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.

On March 11, 2022 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company dedicated to delivering targeted therapies for rare cancers, reported the company will participate in the 32nd Annual Oppenheimer Healthcare Conference being held virtually from March 15-17, 2022 (Press release, Sierra Oncology, MAR 11, 2022, View Source [SID1234610006]). President and Chief Executive Officer Stephen Dilly, MBBS, PhD, will provide an overview of the company on Tuesday, March 15, 2022, beginning at 3:20 pm ET.

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A replay of the presentation will be available following the conference on the Investors section of Sierra’s corporate website in the Events & Webcast tab. The replay will be available for approximately 30 days following the presentation.

On March 11, 2022 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported that the Company’s CEO, Dr. Pnina Fishman, will deliver a poster presentation titled "Inhibition of Hepatocellular Carcinoma Growth and Liver Fibrosis by Nanomolar Cannabinoids Concentrations" at the CannX Medical Cannabis Conference in Tel Aviv which takes place March 14 – 15, 2022 (Press release, Can-Fite BioPharma, MAR 11, 2022, View Source [SID1234610005]). The abstract will additionally be published in the peer-reviewed scientific journal Medical Cannabis and Cannabinoids. Can-Fite will conduct 1×1 meetings with companies in the cannabis field regarding potential licensing and partnership opportunities.

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Cannabinoids bind to CB1 and CB2 receptors regulating the function of multiple organs and tissues of the body. Interestingly, cannabinoids also bind to Can-Fite’s platform technology’s primary target, the Gi protein associated A3 adenosine receptor (A3AR) which is up-regulated in inflammatory and tumor cells.

Can-Fite’s extensive body of research shows that A3AR agonists can knock down inflammation and cancer via the specific induction of apoptosis in these cells.

The study findings to be presented at CannX and published in Medical Cannabis and Cannabinoids highlight the ability of CBD-rich T3/C15 in nanomolar concentrations to inhibit the growth of hepatocellular carcinoma and liver stellate cells via A3AR activation and de-regulation of the Wnt/β-catenin pathway.

"These findings open a novel therapeutic opportunity in liver cancer and fibrosis with minute CBD concentrations and low content of psychotropic THC fraction," stated Dr. Fishman. "We have filed patent applications on our discovery of cannabinoid-based therapies where the A3AR target is overexpressed including in liver cancer."