On November 12, 2021 Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing transformative, targeted therapeutics to treat life-threatening cancers, reported positive new data from the Phase 1b portion of its open-label Phase 1b/2 trial evaluating batiraxcept (AVB-500) in combination with cabozantinib in patients with clear cell renal cell carcinoma (ccRCC) (Press release, Aravive, NOV 12, 2021, View Source [SID1234595379]). A subset of these data was included in a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting being held November 10-14, 2021.

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"We are encouraged by batiraxcept’s early profile in patients with clear cell renal cell carcinoma," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "The current response rate of batiraxcept in combination with cabozantinib is encouraging. Cabozantinib alone produces response rates between 17-28% in a similar population. In heavily pretreated patients, batiraxcept demonstrates clinical activity across the 15 mg/kg and 20 mg/kg doses with a tolerable safety profile. These results reinforce our confidence in the potential of batiraxcept to improve outcomes across multiple types of cancer by targeting the GAS6/AXL signaling pathway. We look forward to initiating the Phase 2 trial in the fourth quarter of 2021 and building on these promising data."

As of November 9, 2021, the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of batiraxcept 15 mg/kg and 20 mg/kg in combination with cabozantinib in patients with 2L+ ccRCC have been evaluated in 18 patients. Clinical activity across these two doses has been evaluated in 16 patients.

Safety Data:

Analysis of all safety data demonstrates that batiraxcept has been well-tolerated with no dose-limiting toxicities.
There have been no batiraxcept-related serious adverse events reported to date.
There were no batiraxcept-related Grade 4 or 5 adverse events.
3 patients experienced Grade 3 adverse events considered by the investigator as potentially being related to both batiraxcept and cabozantinib.
At the batiraxcept 15 mg/kg dose, 1 patient experienced transient hypertension and 1 patient experienced transient thrombocytopenia. Both events resolved while still receiving batiraxcept.
At the batiraxcept 20 mg/kg dose, 1 patient experienced a thromboembolic event, small bowel obstruction, abdominal pain and vomiting. The bowel obstruction, abdominal pain and vomiting resolved while the patient continued batiraxcept treatment.
All events are known adverse events associated with cabozantinib use.
PK/PD Data:

PK analyses indicate that batiraxcept trough levels were above the minimally efficacious concentration (MEC) of 13.8 mg/L prior to cycle 2 day 1 in the first 10 efficacy-evaluable patients.
Clinical Activity Data:

Best overall response of partial response was observed in 7 of 16 (44%) evaluable patients across both dose levels. 9 of 16 (56%) patients had a best overall response of stable disease. No patients had progressive disease at their first radiological exam.
7 of 16 patients have had at least 16 weeks of follow up (at least two post-baseline radiological exams). 5 of the 7 (71%) patients have confirmed partial responses and 2 of the 7 (29%) patients achieved confirmed stable disease.
88% (14/16) of patients had tumor decrease from baseline.
4 patients had 1 or more target lesions completely disappear. 3 patients were treated with batiraxcept 15 mg/kg and cabozantinib and 1 patient was treated with batiraxcept 20 mg/kg and cabozantinib.
2 patients had target lesions decrease from baseline by more than 76%. 1 patient was treated with batiraxcept 15 mg/kg and 1 patient was treated with batiraxcept 20 mg/kg.
This clinical activity was observed despite cabozantinib dose reductions with median cabozantinib dose intensity of 41 mg (68% of 60 mg prescribed dose).
"The initial Phase 1b data of batiraxcept in combination with cabozantinib are impressive and point toward the role of dual AXL and VEGF inhibition in the treatment of clear cell renal cell carcinoma," said Eric Jonasch, M.D., Professor of Medicine, The University of Texas MD Anderson Cancer Center. "These early signs of clinical activity coupled with a manageable safety profile introduce a potential new therapeutic approach for patients with advanced kidney cancer."

Poster Presentation Details

Title:
A Phase 1b/2 randomized study of AVB-S6-500 in combination with cabozantinib versus cabozantinib alone in patients with advanced clear cell renal cell carcinoma who have received front-line treatment

Presenter:
Reshma Rangwala, M.D., Ph.D., Chief Medical Officer of Aravive

Date:
November 13, 2021

Time:
7:00 a.m. – 8:30 p.m. ET

Location:
Hall E
For additional information, please visit the SITC (Free SITC Whitepaper) 36th Annual Meeting website: View Source

Conference Call Information
Aravive will host a conference call and webcast today, November 12, 2021, at 8:30 a.m. ET to discuss these clinical data. The conference call may be accessed by dialing (877) 423-9813 (domestic) and (201) 689-8573 (international) and referring to conference ID 13724115. A webcast of the conference call will be available in the Investors section of the Aravive website at View Source The archived webcast will be available on Aravive’s website after the conference call.

About the Batiraxcept (AVB-500) Phase 1b/2 ccRCC Trial
The Phase 1b portion of the clinical trial is expected to enroll approximately 25 patients in two dosing parts (15 mg/kg and 20 mg/kg) to evaluate tolerability, PK, PD, and clinical activity of batiraxcept in combination with cabozantinib. The open-label Phase 2 portion of the clinical trial is expected to enroll 55 patients across three parts. Part A is expected to enroll approximately 25 patients and investigate batiraxcept 15 mg/kg in combination with cabozantinib in 2L+ ccRCC patients. Part B is expected to enroll approximately 20 patients and evaluate batiraxcept 15 mg/kg in combination with nivolumab and cabozantinib as a potential front-line treatment for ccRCC. Part C is expected to evaluate batiraxcept 15 mg/kg monotherapy in approximately 10 patients with ccRCC who are not eligible for curative intent therapies.

About Batiraxcept (AVB-500)
Batiraxcept is a therapeutic recombinant fusion protein that has been shown to neutralize GAS6 activity by binding to GAS6 with very high affinity in preclinical models. In doing so, batiraxcept selectively inhibits the GAS6-AXL signaling pathway, which is upregulated in multiple cancer types including ovarian, renal and pancreatic cancer. In preclinical studies, GAS6-AXL inhibition has shown anti-tumor activity in combination with a variety of anticancer therapies, including radiation therapy, immuno-oncology agents, and chemotherapeutic drugs that affect DNA replication and repair. Increased expression of AXL and GAS6 in tumors has been correlated with poor prognosis and decreased survival and has been implicated in therapeutic resistance to conventional chemotherapeutics and targeted therapies. Batiraxcept is currently being evaluated in multiple clinical trials and has been granted Fast Track designation by the U.S. Food and Drug Administration and orphan drug designation by the European Commission in platinum resistant recurrent ovarian cancer.

On November 12, 2021 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated agents that target the underlying mechanisms of cancer, reported financial results for the three months ended September 30, 2021 and provided a corporate update (Press release, Aptose Biosciences, NOV 12, 2021, View Source [SID1234595378]).

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The net loss for the quarter ended September 30, 2021 was $11.3 million ($0.13 per share) compared with $13.2 million ($0.15 per share) for the quarter ended September 30, 2020. The net loss for the nine months ended September 30, 2021 was $41.0 million ($0.46 per share), compared with $40.5 million ($0.51 per share) for the nine months ended September 30, 2020. Total cash and cash equivalents and investments as of September 30, 2021 were $95.1 million. Based on current operations, Aptose expects that cash on hand and available capital provide the Company with sufficient resources to fund all planned Company operations including research and development into early 2023.

"Our recent agreement with Hanmi Pharmaceutical has provided us with a clinical-stage asset in HM43239 (or 239) that already has clinically validated anti-leukemic activity in a diverse array of AML patients, delivering multiple complete responses early in a Phase 1/2 trial thus far," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "As a complement to luxeptinib (Lux), 239 strengthens Aptose’s ability to treat a wider spectrum of AML cancer patients across genotypes; in addition, Lux has the potential to treat a range of patients with relapsed or refractory CLL and other B-cell lymphoid malignancies. Both 239 and Lux are exceptional assets that could propel us to the next level in the field of kinase inhibitors."

Key Corporate Highlights

Exclusive Worldwide License with Hanmi Pharmaceutical for Clinical Candidate HM43239 – Aptose recently entered into an exclusive license agreement with Hanmi Pharmaceutical, a Korean pharmaceutical company, to develop and commercialize HM43239, an oral, highly potent, clinical-stage myeloid kinome inhibitor (MKI), designed to target a distinct constellation of kinases operative in myeloid malignancies, including SYK, FLT3, and others. HM43239 has been well tolerated to date and demonstrated significant genotype-agnostic anti-leukemic activity in an ongoing Phase 1/2 clinical trial, including multiple complete responses (CRs) in patients with relapsed or refractory acute myeloid leukemia (AML). The CRs occurred in AML patients with both FLT3-ITD and FLT3-TKD mutations, including a prior gilteritinib failure patient, and in patients with the wild-type form of FLT3. The AML in these patients harbored additional mutations in TP53, NRAS, NPM1, IDH2, and other important driver genes. More information is available at www.clinicaltrials.gov (NCT03850574).

Luxeptinib Phase 1 a/b Clinical Study in AML and MDS – Luxeptinib, a dual lymphoid and myeloid kinome inhibitor (LKI/MKI), currently is being evaluated in a Phase 1 a/b dose escalation clinical study in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and higher risk MDS. Aptose recently completed the 750 mg dose level, and has escalated to the 900 mg dose cohort. To date, Lux has delivered encouraging anti-leukemic activity in multiple patients, including a durable MRD-negative complete response in a FLT3-ITD AML patient who had relapsed after two allogeneic stem cell transplants, multiple lines of chemotherapy, and prior FLT3 inhibitor therapy. More information is available at www.clinicaltrials.gov (NCT04477291).

Luxeptinib Phase 1 a/b Clinical Study in B-cell Malignancies – Luxeptinib also is being evaluated in a Phase 1 a/b dose escalation clinical study in patients with B-cell malignancies, including chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphomas (NHL), who have failed or are intolerant to two or more lines of established therapies, including drugs such as ibrutinib, rituximab and venetoclax or for whom no other treatment options are available. Thus far, Lux has been well-tolerated in patients treated up to 750 mg BID over multiple cycles and recently has advanced to the 900 mg dose level. Of the evaluable patients at these dose levels, two thirds experienced various reductions of lesion size compared to baseline, demonstrating measurable anti-tumor activity. More information is available at www.clinicaltrials.gov (NCT03893682).

Development of New Formulation for Luxeptinib – In parallel with the dose escalation of the current formulation of luxeptinib in patients with AML and B-cell malignancies, Aptose has made significant progress in the development of a "third generation" (G3) formulation that could deliver up to 30-fold greater exposures per mg of luxeptinib administered. The capsules have been GMP manufactured and passed stability tests; clinical studies are planned for 2022.

Accepted Abstracts for American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting – Aptose has four abstracts, one for each of its ongoing clinical trials, accepted for presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held Saturday, December 11 – Tuesday, December 14, 2021 in Atlanta, GA and virtually. Clinical data for HM43239 has been selected for an oral presentation. In addition, clinical data for luxeptinib and APTO-253 have been accepted for poster presentations.The abstracts accepted for presentation can be viewed online at the ASH (Free ASH Whitepaper) conference website. Aptose also will be holding an investor event during the ASH (Free ASH Whitepaper) timeframe. Details will be forthcoming.

RESULTS OF OPERATIONS

A summary of the results of operations for the three- and nine-month periods ended September 30, 2021 and 2020 is presented below:

The net loss for the three-month period ended September 30, 2021 decreased by $1.9 million to $11.3 million as compared with $13.2 million for the comparable period in 2020. The net loss for the nine-month period ended September 30, 2021 increased by $505 thousand to $41 million as compared with $40.5 million for the comparable period in 2020. Components of the net loss are presented below:

Research and Development
The research and development expenses for the three- and nine-month periods ended September 30, 2021 and 2020 were as follows:

Research and development expenses increased by $199 thousand to $7.7 million for the three-month period ended September 30, 2021 as compared with $7.5 million for the comparative period in 2020. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for luxeptinib increased by approximately $112 thousand, mostly as a result of higher manufacturing costs, including costs to scale up manufacturing and research costs associated with optimizing the formulation.

Program costs for APTO-253 increased by approximately $42 thousand, mostly as a result of higher clinical trial costs related to the APTO-253 Phase 1b trial.

Personnel-related expenses increased by $489 thousand, mostly related to new positions hired to support our clinical trials and manufacturing activities.

Stock-based compensation decreased by approximately $442 thousand in the three months ended September 30, 2021, compared with the three months ended September 30, 2020, mostly related to lower grant date fair value of options in the current period.
Research and development expenses increased by $5.5 million to $25.8 million for the nine-month period ended September 30, 2021 as compared with $20.3 million for the comparative period in 2020. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for luxeptinib increased by approximately $3.1 million, mostly as a result of higher manufacturing costs, including costs to scale up manufacturing and research costs associated with optimizing the formulation and higher costs related to the luxeptinib AML trial, for which we received an IND allowance in June 2020.

Program costs for APTO-253 increased by approximately $516 thousand, mostly as a result of higher manufacturing costs and higher clinical trial costs related to the APTO-253 Phase 1b trial.

Personnel-related expenses increased by $1.6 million, mostly related to new positions hired to support our clinical trials and manufacturing activities.

Stock-based compensation increased by approximately $201 thousand in the nine months ended September 30, 2021, compared with the nine months ended September 30, 2020, mostly related to higher total compensation expense in the current period on options issued in the first half of 2021.
General and Administrative
The general and administrative expenses for the three-month periods and nine-month periods ended September 30, 2021 and 2020 were as follows:

General and administrative expenses for the three-month period ended September 30, 2021 were $3.6 million as compared with $5.8 million for the comparative period in 2020, a decrease of approximately $2.1 million. The decrease was primarily as a result of the following:

General and administrative expenses, other than stock-based compensation and depreciation of equipment, increased by approximately $499 thousand in the three months ended September 30, 2021, primarily as a result of higher insurance costs, higher professional costs and higher regulatory costs offset by lower personnel related costs.

Stock-based compensation decreased by approximately $2.6 million in the three months ended September 30, 2021 as compared with the three months ended September 30, 2020, mostly as a result of a lower number of options granted in the nine month period ended September 30, 2021 as compared with the nine month period ended September 30, 2020, that those options granted in the current period had a lower grant date fair value, and that in the three months ended March 31, 2020, the Company had issued restricted share units (RSUs) that had fully vested by the end of the comparative period. No RSUs were granted in the current period.
General and administrative expenses for the nine-month period ended September 30, 2021 were $15.3 million as compared with $20.7 million for the comparative period, a decrease of approximately $5.4 million. The decrease was primarily a result of the following:

General and administrative expenses, other than share-based compensation and depreciation of equipment, increased by approximately $1.2 million in the nine months ended September 30, 2021, primarily as a result of higher insurance costs, higher professional costs, and higher investor relations advisory costs offset by lower personnel related costs, lower office administrative costs and lower travel expenses.

Stock-based compensation decreased by approximately $6.6 million in the nine months ended September 30, 2021, compared with the nine months ended September 30, 2020. Stock-based compensation decreased by approximately $8.3 million, mostly as a result of a lower number of options granted in the nine-month period ended September 30, 2021 as compared with the options granted in the nine-month period ended September 30, 2020, that those options granted in the current period had a lower grant date fair value, and that in the comparative period the Company had issued restricted share units (RSUs) that had fully vested by the end of the comparative period. This decrease was offset by increased compensation of approximately $1.7 million, mostly related to the modification of option agreements of one officer as part of a separation and release agreement. Vested options of 1,679,169 with exercise prices ranging from $1.03 to $7.44 were allowed to continue to be exercisable for an additional twelve-month period, and also 504,833 options that would have expired unvested were allowed to continue to vest for a twelve-month period. As there was no service requirement, the Company recorded $945 thousand and $663 thousand additional compensation in the nine-month period related to these modifications for the vested and unvested options, respectively.
COVID-19 did not have a significant impact on our results of operations for the nine-month period ended September 30, 2021. We have not experienced and do not foresee material delays to the enrollment of patients or timelines for the luxeptinib and HM43239 trials due to the variety of clinical sites that are actively recruiting for these trial. APTO-253, which is administered intravenously, requires the need for hospital / clinical site resources to assist and monitor patients during each infusion and based on the current conditions caused by COVID-19, future enrollment of patients on this trial is likely to be negatively impacted. As of the date of this report, we have not experienced material delays in the manufacturing of luxeptinib, HM43239, or APTO-253 directly related to COVID-19. Should our manufacturers be required to shut down their facilities due to COVID-19 for an extended period of time, our trials may be negatively impacted.

Conference Call and Webcast

Aptose will host a conference call to discuss results for the quarter ended September 30, 2021 today, Thursday, November 11, 2021 at 5:00 PM ET. Participants can access the conference call by dialing 1-844-882-7834 (North American toll-free number) and 1-574-990-9707 (international/toll number) and using conference ID # 5675957. The conference call can be accessed here and will also be available through a link on the Investor Relations section of Aptose’s website at View Source An archived version of the webcast along with a transcript will be available on the Company’s website for 30 days.

The press release, the financial statements and the management’s discussion and analysis for the quarter ended September 30, 2021 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml.

On November 12, 2021 Chemomab Therapeutics, Ltd. (Nasdaq: CMMB) (Chemomab), a clinical-stage biotech company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported financial and operating results for the third quarter ended September 30, 2021, and provided a corporate update (Press release, Anchiano Therapeutics, NOV 12, 2021, View Source [SID1234595376]).

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Recent Highlights and Upcoming Events

Presenting a poster at The Liver Meeting 2021, being held November 12-15, 2021, confirming that CCL24, the target for Chemomab’s first-in-class monoclonal antibody CM-101, induces the liver inflammation and fibrosis seen in primary cholangitis sclerosis (PSC) and other diseases. The preclinical data also show CM-101 can interfere with the core fibrotic and inflammatory mechanisms driving the pathophysiology of PSC, providing further evidence that CM-101 potentially could be an effective treatment for PSC and for other fibrotic and inflammatory diseases.
Named Donald Marvin as Chief Financial Officer, Executive Vice President and Chief Operating Officer. Mr. Marvin is a seasoned biotech executive with over 35 years of experience in corporate finance and fundraising, strategy, corporate development, mergers and acquisitions, and operations in both public and private life sciences companies.
Hosted Webinar featuring KOL Dr. Dinesh Khanna, who discussed the systemic sclerosis (SSc) treatment landscape, high unmet medical need for more holistic therapies, and how use of composite endpoints could facilitate the clinical development of disease-modifying therapies. Chemomab researchers highlighted the extensive data supporting CM-101’s anti-fibrotic and anti-inflammatory effects and unveiled the design of the upcoming Phase 2 clinical trial in SSc, expected to begin in early 2022.
Presented data on CM-101 at the Fifth Annual Antifibrotic Drug Development Summit highlighting the role of CCL24 as a key target for fibrosis and inflammation, including data describing the preclinical validation of CCL24, the development process for CM-101 from discovery to clinical trials, and optimization of the clinical trial design using patient samples.
Announced collaboration with Leeds University to further elucidate the role of CCL24 in the vascular damage associated with systemic sclerosis. Led by Professor Francesco Del Galdo, Head of the Scleroderma Program at the Leeds Musculoskeletal Biomedical Research Centre, the collaboration seeks to provide additional insights into the mechanisms underlying CCL24-associated vascular damage. It also could uncover additional application opportunities for CM-101.
Appointed Dale Pfost, PhD as Chief Executive Officer. The addition of Dr. Pfost, who brings more than 30 years of diverse experience as a life sciences senior executive, entrepreneur and venture investor, reflects a planned strategic expansion of the Chemomab senior management team. Dr. Adi Mor will continue as Chief Scientific Officer. A shareholder vote confirmed Dr. Pfost’s appointment.
"In my first weeks as CEO, I continue to be impressed with the diligence and overall excellence of the Chemomab team, and I am delighted to be part of this exceptional organization," said Dale Pfost, PhD, CEO of Chemomab. "With two established Phase 2 programs underway targeting conditions with high unmet medical need and a third Phase 2 program in systemic sclerosis, the most lethal of the rheumatic diseases, expected to begin soon, we have a great deal to look forward to in the coming year. We anticipate readouts from the ongoing Phase 2 clinical trials in PSC and liver fibrosis in 2022, and we are hopeful that the results will confirm the potential of CM-101, our ‘pipeline in a product’, to treat multiple severe fibrotic and inflammatory diseases. With targeted additions to our senior team, including life sciences veteran CFO and COO Don Marvin now onboard, we believe we are well positioned to continue advancing our pipeline while also assessing selected strategic opportunities to further grow the business."

Program Updates:

CM-101 Phase 2a SPRING trial in primary sclerosing cholangitis continues to enroll patients. The SPRING study is a multi-center, randomized, double-blind, placebo-controlled, multiple dose trial designed to evaluate CM-101’s anti-fibrotic effects in PSC patients, as well as its safety, pharmacokinetics and pharmacodynamics. In response to challenges related to the evolving COVID-19 pandemic, Chemomab has expanded the number of trial sites beyond the UK and Israel to include additional territories with significant recruitment potential. The company anticipates it will report data from this trial in the second half of 2022.

CM-101 Phase 2a SPLASH trial in liver fibrosis remains on track, with data expected in the first half of 2022. The SPLASH study is a multi-center, randomized, double-blind, placebo-controlled, multiple dose study designed to assess the mechanism of action, safety, pharmacokinetics and pharmacodynamic effects, as well as the anti-fibrotic effects of a subcutaneous formulation of CM-101 in NASH patients with fibrosis stage F2-F3.

CM-101 Phase 2 clinical trial for the treatment of systemic sclerosis is scheduled to begin early in 2022. Preparations for initiation of the Phase 2 trial in systemic sclerosis are continuing. The trial will be a multi-center, randomized, double-blind, placebo-controlled study with two treatment arms designed to assess CM-101 as a treatment for patients with diffuse systemic sclerosis. The study will enroll 220 patients who will be equally distributed between the two treatment arms. Participating patients will be treated for a period of 45 weeks. The study will include 100 participating sites in the US, EU and Israel.

Third Quarter 2021 Financial Highlights

Cash, cash equivalents (including bank deposits) as of September 30, 2021, were $64.3 million compared to $11.7 million at December 31, 2020. The existing cash position is expected to fund the Company’s current operating plan until mid-2023.
During the quarter ended September 30, 2021, Chemomab did not sell shares under the Company’s ATM program.
Research and Development expenses for the three months ended September 30, 2021, were $1.5 million, compared to $1.0 million for the three months ended September 30, 2020. The increase of about $0.5 million was primarily related to increases in expenses related to preclinical and clinical activities. R&D expenses are expected to substantially increase over the next several quarters as Chemomab continues to advance its clinical programs.
General and administrative expenses were $1.4 million for the three months ended September 30, 2021, compared to $0.2 million for the three months ended September 30, 2020. The increase of about $1.2 million is primarily derived from expenses associated with public company operations, as well as about $370,000 in non-cash expenses associated with share-based compensation.
Net loss for the three months ended September 30, 2021, was $3.0 million or ($0.01) per basic and diluted ordinary share, compared to $1.2 million, or ($0.01) per basic and diluted ordinary share, for the prior year period.
For further details on the Company’s financial results, including the results for the nine and three months ended September 30, 2021, refer to the Form 10-Q filed with the SEC.

On November 12, 2021 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported that preclinical data from its AL009 immuno-oncology program in poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36th Annual Meeting (Press release, Alector, NOV 12, 2021, View Source [SID1234595375]).

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AL009 is a first-in-class fusion protein engineered to block multiple Siglecs. Siglecs (sialic acid binding immunoglobulin-like lectins) are a family of receptors involved in immune regulation that bind to cell surface sialic acid glycans. Siglecs are predominantly expressed on myeloid cells and the overexpression of Siglecs has been linked to immune suppression and evasion by tumor cells, as well as modulating the differentiation of myeloid cells into tumor-promoting macrophages. AL009 acts as a checkpoint inhibitor, blocking the immunosuppressive effect of multiple Siglecs and thereby enhancing both the innate and adaptive immune system response to cancer. Alector is developing AL009 for the potential treatment of solid tumor cancers and plans to initiate a first-in-human clinical trial of AL009 in 2022.

"Siglecs play a critical role in regulating immune activity, and our research into the role of the Siglec family of inhibitory receptors in neurodegenerative disease led to the discovery and optimization of AL009 for immuno-oncology. AL009 is a fusion protein uniquely able to block multiple Siglec receptors and halt Siglec-sialic acid-mediated immune suppression, which may be beneficial in a number of disease states where evasion of the immune system allows disease to progress unchecked," said Daniel Maslyar, M.D., Alector’s Vice President Clinical Development. "As we compared AL009 with other immunotherapies in preclinical models, we observe higher potency in blocking immune cell suppression and promising anti-cancer activity alone and in combination with anti-PDL1 in multiple tumor types, including some that have been found resistant to other immunotherapies. We look forward to advancing AL009 into the clinic to characterize its potential to treat a variety of solid tumor types."

In a poster titled "AL009, a Fusion Protein and Multi-Siglec Inhibitor, Repolarizes Suppressive Myeloid Cells and Potentiates Anticancer Effects," Alector researchers highlighted:

AL009 led to dose-dependent increases in immune stimulatory molecules consistent with the repolarization of myeloid-derived suppressive cells to a proinflammatory state
In vitro, AL009 increased T cell function by approximately 10 to 100-fold compared to other cancer immunotherapies
In syngeneic tumor models in mice that were less responsive to anti-PD-L1, treatment with AL009 showed efficacy in reducing tumor growth both as a single agent and in combination with anti-PD-L1
In a murine model of lung metastasis, AL009 combined with anti-TRP1 therapy to reduce lung nodules
The poster is available on Alector website in the Investors section at www.alector.com. Alector management will also be conducting a call for analysts and investors to discussion data presented this week for four of the company’s pipeline programs, AL001, AL101 and AL003 being developed for the treatment of neurodegenerative diseases and AL009.

About AL009
AL009 is a first-in-class multi Siglec inhibitor that works to enhance both the innate and adaptive immune system response to tumors by blocking a critical glycan checkpoint pathway that drives immune inhibition. Alector is initially developing AL009 for the potential treatment of solid tumors, with plans to initiate first-in-human clinical studies in 2022.

On November 12, 2021 Aileron Therapeutics (NASDAQ:ALRN), a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, reported financial results and business highlights for the third quarter ended September 30, 2021 (Press release, Aileron Therapeutics, NOV 12, 2021, View Source [SID1234595374]).

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"In the third quarter, we continued our clinical progress, reporting final positive results from our chemoprotection proof-of-concept SCLC study and confirming ALRN-6924’s p21-mediated cell cycle arrest in our healthy volunteer study. We also reported healthy volunteer data on time to onset, magnitude and duration of ALRN-6924’s cell cycle arrest, which provides support for a universal dose and schedule across distinct chemotherapy regimens," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron. "In the year ahead, we anticipate key data readouts from our NSCLC trial, as we continue to advance toward our vision to deliver selective chemoprotection to patients with p53-mutant cancers regardless of type of chemotherapy or cancer."

Dr. Aivado continued, "We recently presented preclinical data demonstrating cell cycle arrest in healthy tissue outside of the bone marrow – namely, epithelial mucosa cells in the GI tract. This is another important strategic building block, as a key characteristic of ALRN-6924’s differentiated profile is the potential to selectively protect multiple tissues and organs from chemotherapy-induced toxicities with a single medicine – representing a potential paradigm shift in the care of millions of cancer patients."

Despite the rise of immunotherapies and targeted therapies, chemotherapy continues to play a central role, at some point in the treatment continuum, for nearly all cancer patients, bringing with it significant toxicities. Aileron is developing ALRN-6924 to selectively protect healthy cells in patients with p53-mutated cancers to reduce or eliminate chemotherapy-induced side effects. Nearly 1 million patients each year are diagnosed with a p53-mutated cancer in the US alone. Aileron employs a precision medicine approach, exclusively treating patients with p53-mutated cancers; ALRN-6924 is designed to selectively protect these patients’ healthy cells from chemotherapy without protecting cancer cells. This novel concept is known as selective chemoprotection. The reduction or elimination of multiple chemotherapy-induced side effects may enhance tolerability of chemotherapy, may result in fewer dose reductions or delays of chemotherapy, and the potential for improved efficacy of chemotherapy. Aileron’s vision is to bring chemoprotection to patients with p53-mutated cancers, which represent approximately 50% of cancer patients, regardless of type of cancer or chemotherapy.

Third Quarter 2021 Highlights and Recent Updates

Continued to progress randomized, double-blind, placebo-controlled Phase 1b clinical trial of ALRN-6924 for the prevention of chemotherapy-induced side effects in patients with advanced p53-mutated NSCLC. Aileron plans to enroll a total of 60 patients with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors. Patients will be randomized 1:1 to receive carboplatin/pemetrexed plus 0.3 mg/kg ALRN-6924 or placebo for at least four 21-day treatment cycles.

Currently, 12 trial sites are open for enrollment in the United States and Europe, and Aileron anticipates opening additional sites. Due to the impact of the COVID-19 Delta variant in Eastern Europe, several sites in this region began screening two months later than planned. With those sites now activated, there has been an associated increase in patient enrollment. As a result of the delay in site activation and patient enrollment, Aileron has updated its guidance for planned data readouts as follows: interim results on 20 patients with four cycles in 2Q22, and topline results on 60 patients with four cycles in 4Q22. The company also plans to conduct a blinded safety evaluation on 10 patients after one cycle in 1Q22 to determine whether the safety and tolerability profile of ALRN-6924 in NSCLC patients is consistent with the safety and tolerability profile observed in previous clinical trials.

For more information, please visit the NSCLC trial listing on clinicaltrials.gov.
Presented new preclinical data at AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) 2021 supporting potential of chemoprotection in healthy cells beyond bone marrow cells. Aileron presented new preclinical data that demonstrated ALRN-6924’s activity as a radioprotective agent in preclinical mouse models of acute radiation-induced toxicity, leveraging the same mechanism of action – p53 activation and subsequent p21 upregulation as well as p21-induced cell cycle arrest – that has clinically shown protection against chemotherapy-induced bone marrow toxicities.

As part of this poster presentation, Aileron presented preclinical data demonstrating ALRN-6924’s activation of p21-induced cell cycle arrest in murine bone marrow cells as well as in epithelial mucosa cells in the GI tract. ALRN-6924 is the first chemoprotective agent, either in clinical development or marketed, to demonstrate the potential of cell cycle arrest-mediated chemoprotection of bone marrow cells as well as cells outside of bone marrow. These findings are consistent with Aileron’s belief that ALRN-6924 may also selectively protect additional organs and tissues from chemotherapy-induced toxicities.
Presented final data from Phase 1b trial of ALRN-6924 in SCLC patients at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021. Aileron presented final results from its completed Phase 1b trial in patients with p53-mutated SCLC receiving second-line topotecan. Following the interim proof-of-concept data presented in October 2020 from this study, these final results reinforced ALRN-6924’s ‘triple-play’ reduction in neutropenia, thrombocytopenia and anemia caused by chemotherapy, as well as a reduction of platelet and red blood cell transfusions, reported in October 2020.

Presented preliminary data from ALRN-6924 Healthy Volunteer Study at International Society for Experimental Hematology (ISEH) 2021 Scientific Meeting and ESMO (Free ESMO Whitepaper) 2021. Aileron presented preliminary results from its ongoing Phase 1 pharmacology study of ALRN-6924 in healthy volunteers, which confirmed 0.3 mg/kg as the optimal dose for ALRN-6924 and confirmed the drug’s novel p53 biomarker-driven mechanism of action, as well as its pharmacodynamic effects, including time to onset, magnitude and duration.

The healthy volunteer study is evaluating ALRN-6924’s induction of p21-induced cell cycle arrest in healthy, normal bone marrow cells and other cell types in healthy volunteers receiving ALRN-6924. The aim of the study is to develop a universal dosing regimen for ALRN-6924 for use as a chemoprotection agent across a range of chemotherapies and p53-mutated tumor indications. The study is ongoing, and Aileron anticipates presenting additional findings at a later date.
Third Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and investments on September 30, 2021 were $52.2 million. The company expects, based on its current operating plan, that its existing cash, cash equivalents and investments will fund operations into the second half of 2023.

Research and Development (R&D) Expenses: R&D expenses for the quarter ended September 30, 2021 were $4.3 million, compared to $2.7 million for the quarter ended September 30, 2020. The increase of $1.6 million primarily resulted from increased spending of $0.5 million related to clinical development of ALRN-6924 for the company’s Phase 1b clinical trial in patients with advanced NSCLC and the company’s Phase 1 trial of ALRN-6924 in healthy human volunteers, $0.7 million of ALRN-6924 manufacturing costs, $0.3 million of higher employee-related costs, and $0.2 million in non-clinical research costs, all partially offset by lower facility costs.

General and Administrative (G&A) Expenses: G&A expenses for the quarter ended September 30, 2021 were $2.5 million compared to $2.3 million for the quarter ended September 30, 2020. Increased G&A expenses were primarily the result of higher employee-related costs partially offset by lower facility costs.

Net Loss: Net loss for the quarter ended September 30, 2021 was $6.7 million, compared to $5.0 million for the corresponding quarter in 2020. The basic and diluted net loss per share for the third quarter of 2021 was $0.07 compared to $0.13 for the third quarter of 2020. The change in basic and diluted net loss per share is primarily a result of increased shares outstanding as a result of sales of common stock during the first quarter of 2021 partially offset by higher operating expense.