On October 29, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, reported that its European manufacturer, BSP Pharmaceuticals S.p.A. ("BSP"), has completed the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable (Press release, CNS Pharmaceuticals, OCT 29, 2020, View Source [SID1234569448]). With the completion of manufacturing at BSP and at its U.S. manufacturer, Pharmaceutics International, Inc. ("Pii"), the Company remains poised to file an Investigational New Drug Application ("IND") and initiate its Phase 2 U.S. clinical trial for Berubicin on its anticipated timeline.

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"We are pleased to continue to execute upon our dual-track drug product manufacturing strategy, as both our U.S. manufacturer, Pii, and European manufacturer, BSP, have now completed production of Berubicin Drug Product," commented John Climaco, CEO of CNS Pharmaceuticals. "The completion of the manufacturing process at both locations represents a key milestone for us and will further support our efforts to file an IND during the fourth quarter of this year. We are encouraged by our continued execution upon our pre-trial initiatives, and believe we remain positioned to initiate a U.S. Phase 2 trial for Berubicin during the first quarter of 2021."

As previously announced, the Company implemented its dual-track drug product manufacturing strategy for Berubicin. As a part of its strategy, the Company engaged a U.S. based manufacturer, Pii, and European manufacturer BSP, for the production of Berubicin Drug Product. The Company engaged two separate manufacturers in two separate continents in order to help mitigate COVID-19-related delay risks, diversify its supply chain and provide for localized availability of Berubicin. Both Pii and BSP have now completed the manufacturing process for Berubicin.

As the Company focuses on its IND filing preparations, it has made several key advancements on the clinical front to supplement its manufacturing efforts. The Company recently engaged Worldwide Clinical Trials as the contract research organization, Image Analysis Group ("IAG") as the imaging partner, and Berry Consultants as a biostatistical advisor for its Phase 2 trial design. Furthermore, the Company also bolstered its leadership team in advance of the trial and appointed Dr. Patrick Wen, a renowned neuro-oncologist, to its Scientific Advisory Board. The FDA granted the Company Orphan Drug Designation (ODD) for Berubicin for the treatment of malignant gliomas, which include GBM. The designation provides Berubicin with certain benefits during the product’s development to treat malignant gliomas and provides CNS with the potential for market exclusivity upon the drug’s approval for that use.

On October 29, 2020 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical Company focused on oncology, reported that the Company’s lead drug candidate, the CXCR4-inhibitor Motixafortide, will be tested in combination with the anti-PD-1 cemiplimab (LIBTAYO) and standard-of-care chemotherapy (gemcitabine and nab-paclitaxel) in first-line metastatic pancreatic ductal adenocarcinoma (PDAC) (Press release, BioLineRx, OCT 29, 2020, View Source [SID1234569446]).

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This investigator-initiated Phase 2 study, led by Columbia University, will initially enroll 10-12 PDAC patients, and will be expanded to a total of 40 patients following an evaluation of the initial 10-12 patients based on pre-defined criteria. The primary endpoint of the study is the overall response rate (ORR). Secondary endpoints include safety and tolerability, progression free survival (PFS), duration of clinical benefit (DCR) and overall survival (OS). Data from the study is anticipated in mid-2022.

"Chemotherapy is the current standard of care for patients with metastatic PDAC, however the rates of response and survival remain very low. In addition, although immunotherapy has resulted in a paradigm shift in the treatment of a number of solid tumors, trials with immune checkpoint blockade in PDAC have been disappointing," stated Dr. Gulam Manji, Assistant Professor of Medicine and Director of Pancreas Medical Oncology and Translational Research at Columbia University Vagelos College of Physicians and Surgeons, and lead investigator. "Over several years of pre-clinical research, we have found that combining a CXCR4 inhibitor with immunotherapy and chemotherapy shows promising results in a mouse model of pancreatic cancer. In this regard, Motixafortide, with its high affinity and long receptor occupancy, together with the encouraging preliminary results published from the COMBAT trial, makes it an attractive candidate for a combination therapy with anti-PD-1 and chemotherapy. We look forward to initiating the first clinical trial to treat patients in first-line metastatic PDAC with this promising treatment regimen."

"We are excited to collaborate with Dr. Manji on this trial, which will further assess the utility of Motixafortide as the backbone of a potentially promising combination therapy in this challenging cancer indication," stated Philip Serlin, Chief Executive Officer of BioLineRx. "The results reported to date in our ongoing COMBAT-KEYNOTE-202 study, which is evaluating Motixafortide in combination with KEYTRUDA and chemotherapy in second-line metastatic PDAC, demonstrate an encouraging anti-tumor effect when compared to historical data. We are hopeful that we can replicate these improved responses in this first-line study and look forward to data in mid-2022. This is yet another potentially value-creating milestone that further validates Motixafortide’s potential ability to treat a range of cancers across all stages of disease."

About Motixafortide in Cancer Immunotherapy

Motixafortide is targeting CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including PDAC. CXCR4 plays a key role in tumor growth, invasion, angiogenesis, metastasis and therapeutic resistance, and CXCR4 overexpression has been shown to be correlated with poor prognosis.

Motixafortide is a short synthetic peptide used as a platform for cancer immunotherapy with unique features allowing it to function as a best-in-class antagonist of CXCR4. It shows high-affinity, long receptor occupancy and acts as an inverse agonist.

In a number of clinical and preclinical studies, Motixafortide has been shown to affect multiple modes of action in "cold" tumors, including immune cell trafficking, tumor infiltration by immune effector T cells, and reduction in immunosuppressive cells (such as MDSCs) within the tumor niche, turning "cold" tumors, such as pancreatic cancer, into "hot" (i.e., sensitizing them to immune checkpoint inhibitors and chemotherapy).

About Pancreatic Cancer

Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. Its incidence rate in the US is estimated at 3.2% of new cancer cases. In 2018, approximately 450,000 individuals globally were diagnosed with this condition, 55,000 of them in the US; and the incidence of pancreatic cancer is expected to continue to increase. Symptoms are usually non-specific and as a result, pancreatic cancer is often not diagnosed until it reaches an advanced stage. Surgical resection does not offer adequate treatment since only 20% of patients have resectable tumors at the time of diagnosis. Even among patients who undergo resection for pancreatic cancer and have tumor-free margins, the five-year survival rate is only 10%-25%. The overall five-year survival rate among pancreatic cancer patients is 10%, which constitutes the highest mortality rate among solid tumor malignancies. The overall median survival is less than one year from diagnosis, highlighting the need for the development of new therapeutic options.

Despite advances in chemotherapeutics and immunotherapy, increases in median and overall survival rates in pancreatic cancer have been modest. Pancreatic cancer remains an area of unmet medical need, with no new approved therapies since the approval of nab-paclitaxel (Abraxane) in combination with gemcitabine for first-line treatment in 2013 and Onivyde in combination with fluorouracil and leucovorin for second-line treatment in 2015. The limited clinical benefits demonstrated by these existing standard treatment options reinforce the need for additional approaches.

On October 29, 2020 AffyImmune Therapeutics reported enrollment of the first patient in its Phase I clinical study evaluating AIC100, the company’s novel affinity-tuned CAR-T cell product, in patients with advanced, refractory thyroid cancer (Press release, AffyImmune Therapeutics, OCT 29, 2020, View Source [SID1234569444]). The trial is designed to test safety, biological activity and real-time assessment of CAR T cell localization in patients.

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The study, entitled: ‘Phase I study of AIC100 in relapsed and/or refractory advanced thyroid cancer and anaplastic thyroid cancer’ is being conducted at Weill Cornell Medicine. Unlike most CAR-T cell products, AIC100 was designed to specifically target tumor cells overexpressing the target (ICAM-1) while avoiding normal cells expressing lower levels. This was accomplished by lowering the affinity of the targeting portion of the chimeric antigen receptor (CAR) of AIC100 through directed evolution to levels more comparable to physiological levels governing T cell interactions with their targets. Prior studies in animal models clearly showed that that these lower affinity CAR T cells not only spared normal cells but also persisted longer having greater anti-tumor activity in animal models.

Eric von Hofe, President of AffyImmune Therapeutics, stated: "After overcoming a few COVID-19 related delays we are excited to announce the enrollment of our first patient in the AIC100 trial, this marks another important step for us. Affinity tuning clearly provides a number of advantages over the traditional approach of designing CAR-T cells." He continued, "the resulting CAR-T cells are able to discriminate based on target expression, persist longer for better tumor cell killing and open the door to targeting antigens previously avoided for fear to on-target off-tumor toxicity. We are gratified in being able to bring this novel CAR-T product to the clinic for refractory thyroid cancers, which are notoriously aggressive with no good treatment options."

On October 29, 2020 Alkermes plc (Nasdaq: ALKS) reported that the conference call to discuss the company’s third quarter financial results is rescheduled due to technical difficulties impacting the conference call provider (Press release, Alkermes, OCT 29, 2020, View Source [SID1234569443]). The company now plans to host the conference call and webcast presentation at 10:30 a.m. ET (2:30 p.m. GMT) on Thursday, Oct. 29, 2020.

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The webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 844 602 0380 for U.S. callers and +1 862 298 0970 for international callers. The conference ID is 81030951.

A replay of the conference call will be available through Thursday Nov. 5, 2020, and may be accessed by visiting Alkermes’ website.

On October 29, 2020 Roche (SIX: RO, ROG;OTCQX: RHHBY) reported U.S. Food and Drug Administration (FDA) approval of expanded claims for the cobas EGFR Mutation Test v2 as a companion diagnostic (CDx) for a broad group of therapies in the treatment of non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, OCT 29, 2020, https://www.prnewswire.com/news-releases/roche-receives-fda-approval-for-the-cobas-egfr-mutation-test-v2-as-the-first-companion-diagnostic-test-for-expanded-egfr-tki-therapies-in-patients-with-non-small-cell-lung-cancer-301163170.html [SID1234569441]). This claim expansion allows the test to be used as a CDx for all five currently FDA-approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapies targeting EGFR mutations L858R and Exon 19 Deletions in accordance with the approved therapeutic product labeling. The group claim will also enable the test to be used as a CDx for any future approved EGFR TKI therapies targeting the same mutations, without the need to conduct individual clinical studies with the test for each new therapy.

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"Clinicians can now have greater confidence in the robustness, reliability and proven clinical utility of the cobas EGFR Mutation Test v2 when evaluating lung cancer patients who may benefit from targeted EGFR TKI therapies," said Neil Gunn, Head of Roche Sequencing Solutions. "By approving a single test for a broad group of therapies, this new and innovative approach by the FDA[3] can pave the way for future EGFR TKI therapies to utilise the cobas EGFR Mutation Test v2 to help identify patients for personalised medicine."

About the cobas EGFR Mutation Test v2
The cobas EGFR Mutation Test v2 is a real-time polymerase chain reaction (PCR) test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating tumour DNA (ctDNA) from plasma derived from ethylenediamine tetraacetic acid (EDTA) anti-coagulated peripheral whole blood.