On November 9, 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 it will host a live presentation and participate in 1-on-1 investor meetings at Stifel’s 2021 Virtual Healthcare Conference (Press release, Chemomab, NOV 9, 2021, View Source [SID1234594851]).

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On November 9, 2021 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today provided a corporate update and reported financial results for the third quarter of 2021 (Press release, Agenus, NOV 9, 2021, View Source [SID1234594867]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"With more than 100 patients treated with our Fc-enhanced CTLA-4 antibody, AGEN1181, we are very encouraged by the clinical responses achieved across tumor types. Of note, we are seeing responses in patients who have failed to respond to all other treatment, including PD-1 inhibitors," said Garo Armen, PhD, Chairman and Chief Executive Officer of Agenus. "We will be presenting detailed trial results at the SITC (Free SITC Whitepaper) conference this week. We have also successfully completed an initial public offering for MiNK Therapeutics, and have launched our adjuvant business, SaponiQx."

AGEN1181 (Fc-enhanced CTLA-4), as a monotherapy and in combination with balstilimab (anti PD-1), shows clinical benefit in 9 cold and treatment-resistant tumor types; data to be presented at SITC (Free SITC Whitepaper)

First presentation of clinical data from 100+ patients who represent a heavily pre-treated population, and were administered AGEN1181 as a monotherapy or in combination with balstilimab
Evidence of AGEN1181 monotherapy activity with multiple confirmed responses: microsatellite stable (MSS) – endometrial cancer (CR), melanoma (PR), cervical cancer (PR), and pancreatic cancer (PR), with the former three responses occurring in tumors which failed to respond to anti-PD-1 therapy
Additional responses in patients treated with AGEN1181 in combination with balstilimab, including in cold, poorly immunogenic tumors. These include:
Microsatellite stable colorectal cancer (MSS-CRC): 2 confirmed PRs, 2 unconfirmed PRs, and 7 stable disease (SD) among 17 evaluable patients for a disease control rate of 65%
Gynecological malignancies: 2 PRs, 3 SDs among 6 evaluable ovarian cancer patients; 1 PR and 1 unconfirmed PR in MSS-endometrial cancer
Other tumors: 2 unconfirmed responses in visceral angiosarcoma, and one unconfirmed response in PD-1-relapsed/refractory NSCLC
Majority of responses are durable and ongoing, with additional data to be presented at SITC (Free SITC Whitepaper) on November 12th (Abstract # 479)
Both monotherapy and combination therapy were well tolerated, with no cases of hypophysitis or pneumonitis
Based on these data, Agenus will commence Phase 2/3 trials evaluating AGEN1181, as a monotherapy and in combination with balstilimab, in colorectal and gynecological cancers
MiNK Therapeutics launched an IPO; its stock is trading on NASDAQ

MiNK Therapeutics launched a successful IPO, raising >$40M to support the rapid clinical development of its allogeneic cell therapies
MiNK has three presentations planned at SITC (Free SITC Whitepaper), which will showcase data on clinical-stage, allogeneic, iNKT cell therapy (AgenT-797), including clinical persistence and activity, preclinical anti-tumor activity and tissue distribution, as well as the tumor killing potential of engineered iNKT cells generated by leveraging a proprietary CAR platform
SaponiQx launch to accelerate development of proven and novel adjuvants, as well as optimized antigen-adjuvant constructs

Will address global need for vaccines offering long-lasting efficacy with secure production, which has been amplified by the current pandemic
QS-21 Stimulon adjuvant is proven to drive durable immunity – SHINGRIX (GSK zoster vaccine, recombinant) offers protection of >9 years
Collaborating with Phyton Biotech and Ginkgo Bioworks to develop and optimize a plant cell culture method of manufacturing QS-21 and next-generation saponin- based adjuvants for a secure and sustainable adjuvant supply
First patients dosed in multiple collaborator programs

First patient dosed with AGEN1777, our Fc-enhanced TIGIT bispecific antibody licensed to BMS, triggering a $20 million milestone payment. BMS intends to advance AGEN1777 in high-priority indications, such as non-small cell lung cancer
First patient dosed in clinical collaboration with Nelum, evaluating our first-generation CTLA-4, zalifrelimab, in combination with Nelum’s hedgehog inhibitor and chemotherapy in first-line pancreatic cancer
Planning underway to launch expanded access programs for balstilimab

BLA for balstilimab in second-line cervical cancer was withdrawn after full approval of pembrolizumab, four months ahead of the FDA goal date, based on data for pembrolizumab plus chemotherapy in first-line setting
Agenus will discontinue the confirmatory trial, resulting in a >$100M expense reduction
As balstilimab met trial endpoints with ORR of 20% in PD-L1 positive tumors and 8% in PD-L1 negative tumors, Agenus plans to launch an expanded access program in several countries, including the US, pending regulatory processes
Combination of balstilimab and zalifrelimab resulted in a near doubling of responses (33% vs. what has been reported with pembrolizumab in PD-L1+ cervical cancer patients); data was presented at this year’s ESMO (Free ESMO Whitepaper) Conference
Third Quarter 2021 Financial Results

We ended the third quarter of 2021 with a cash and short-term investment balance of $262 million as compared to $100 million at December 31, 2020.

For the third quarter ended September 30, 2021, our cash provided by operations was $131 million and we reported a net income of $177 million or $0.76 per share basic and $0.72 per share diluted. This compares to cash used in operations for the same period in 2020 of $32 million and a net loss of $52 million or $0.28 per share basic and diluted.

Our cash provided by operations for the nine-months ended September 30, 2021 was $33 million with net income of $39 million or $0.19 per share basic and $0.18 per share diluted, compared to cash used in operations of $104 million and a net loss for the same period in 2020 of $145 million or $0.87 per share, basic and diluted. Non-cash operating expenses for the nine-months ended September 30, 2021 were $46 million compared to $35 million for the same period of 2020.

We recognized revenue of $275 million and $57 million for the nine-months ended September 30, 2021 and 2020, respectively, which includes revenue related to upfront license fees received and milestones earned, non-cash royalties, and revenue recognized under our collaboration agreements.

Webcast
A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at View Source and via View Source

On November 9, 2021 EVERSANA reported that Virtual ISPOR Europe 2021 is the leading European conference for HEOR, bringing together global leaders for discussion and dissemination of the latest trends in healthcare (Press release, EVERSANA, NOV 9, 2021, View Source [SID1234594883]). This conference is made up Virtual ISPOR Europe 2021, which will take place 30 November-3 December, along with an in-person, Preconference Summit held 11 November at the Bella Center in Copenhagen, Denmark.

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The conference theme for Virtual ISPOR Europe 2021 is "Emerging Frontiers and Opportunities: Special Populations and Technologies." In recent years, rare diseases, digital therapeutics, personalized medicine, cell and gene therapies, and other new therapeutic approaches have stretched our data and methodological capabilities. Furthermore, issues associated with these special populations and technologies have important implications for a range of healthcare decisions, from regulatory pathways to coverage, reimbursement, and shared clinical decision-making. Virtual ISPOR Europe 2021 will feature HEOR scientists and stakeholders who work on these key challenges and highlight innovative solutions, advances in HEOR, as well as examples of how partnerships and dialogue with other disciplines are contributing to address these issues.

We are proud to present the following at ISPOR 2021, taking place virtually November 30 – December 3:

Join Chris Cameron, MSc, PhD on this panel discussion on December 3 at 12:30:
CAN SINGLE-ARM TRIALS OF CAR-T THERAPIES MEET THE EVIDENCE REQUIREMENTS OF GLOBAL HEALTH TECHNOLOGY ASSESSMENT AGENCIES? ARE THERE INNOVATIVE WAYS TO ADDRESS THE COMPARATIVE EVIDENCE NEEDS?

This panel will debate whether single-arm studies of CAR-T therapies can meet the evidence requirements of global HTA bodies. Dr. Satish Valluri will moderate the panel and provide an overview of the current landscape of HTA requirements on comparative evidence for CAR-T therapies, as well as pose key questions for the panelists to debate, including:

What are the challenges with conducting RCTs for CAR-T therapies?
What are alternative approaches to RCTs that can generate robust comparative evidence?
What role can RWE play in these situations?
Under what clinical and methodological conditions is it sufficient to generate comparative data using RWE to justify the value of CAR-T therapies?
Which methods are most acceptable from an HTA perspective, and what are the challenges?
Explore our library of publications to learn more about our HEOR efforts and schedule a meeting with one of our experts with your business needs and questions!

On November 9, 2021 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported financial results for the quarter ended September 30, 2021 (Press release, Janux Therapeutics, NOV 9, 2021, View Source [SID1234594899]).

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"In the third quarter, we continued to utilize our novel TRACTr and TRACIr platforms to advance our pipeline of next generation immunotherapies. We remain on-track to execute key milestones, including two IND submissions next year for our PSMA-TRACTr and EGFR-TRACTr candidates," said David Campbell, Ph.D., President and CEO of Janux. "Further, we welcomed Dr. Ron Barrett and Alana McNulty to Janux’s Board of Directors. These two key leadership additions bring important expertise to the company as we work to advance our programs towards the clinic."

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

TRACTr product candidates advancing as planned. Janux’s lead TRACTr programs of next-generation T cell engagers remain on-track.

In the first half of 2022, Janux expects to submit an Investigational New Drug (IND) application for its PSMA-TRACTr candidate, targeting prostate-specific membrane antigen (PSMA).
In the second half of 2022, Janux expects to submit an IND application for its EGFR-TRACTr candidate, targeting epidermal growth factor receptor (EGFR).
In 2023, Janux expects to submit an IND application for its TROP2-TRACTr, targeting trophoblast cell surface antigen 2 (TROP2).
On track for selection of TRACIr development candidate in 2022 as planned. Janux is applying its TRACIr technology to develop a costimulatory bispecific product candidate against programmed death-ligand 1 (PD-L1) and Cluster of Differentiation 28 (CD28) to further enhance the anti-tumor activity of T cells. This will be Janux’s first program derived from its TRACIr platform.
Strengthened Board of Directors with appointment of Ron Barrett, Ph.D., and Alana McNulty. Dr. Barrett is a scientist entrepreneur with more than 30 years of experience in the biopharmaceutical industry as a co-founder and leader of biopharmaceutical companies and has been responsible for advancing research that led to FDA approval of three drugs. Ms. McNulty has more than 30 years of experience in finance and business development for private and publicly traded biopharmaceutical companies, playing a key role over her career in a breadth of strategic transactions.
THIRD QUARTER 2021 FINANCIAL HIGHLIGHTS:

Cash and cash equivalents and short-term investments: As of September 30, 2021, Janux reported cash and cash equivalents and short-term investments of $387.5 million, compared to $7.8 million at December 31, 2020.
Research and development expenses: Research and development expenses for the quarter ended September 30, 2021 were $8.4 million, compared to $0.8 million for the comparable period in 2020. The increase in research and development expenses in 2021 was primarily attributable to the development of Janux’s platform technologies and programs. Janux also incurred additional personnel-related expenses, including stock-based compensation, as operations grew in support of program advances.
General and administrative expenses: General and administrative expenses for the quarter ended September 30, 2021 were $3.6 million, compared to $0.4 million for the same period in 2020. The increase in general and administrative expenses was primarily attributable to an increase in personnel-related expenses, including stock-based compensation, due to increased headcount in 2021. The increase in general and administrative expenses were also due to an increase in legal fees, professional fees, and other various general and administrative expenses, as Janux now operates as a public company.
Net loss: For the quarter ended September 30, 2021, Janux reported a net loss of $10.8 million, compared to a net loss of $1.3 million for the comparable period in 2020.

On November 9, 2021 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported program updates and financial results for the third quarter ended September 30, 2021 (Press release, Poseida Therapeutics, NOV 9, 2021, View Source [SID1234594915]).

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"The last quarter saw continued progress as Poseida reached multiple key strategic milestones including FDA clearance of our first fully allogeneic CAR-T IND for P-BCMA-ALLO1, the presentation of strong CAR-T data in a solid tumor indication with our P-PSMA-101 program and, shortly after the quarter, the announcement of a strategic collaboration with Takeda focused on non-viral in vivo gene therapy programs utilizing our platform technologies," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida.

"The initiation of our P-BCMA-ALLO1 clinical trial represents the beginning of a long-planned strategic transition to what we believe is the ‘holy grail’ of cell therapy for oncology, a fully allogeneic CAR-T with a fully humanized heavy chain BCMA binder and a high percentage of TSCM cells which we believe are the key to success," continued Ostertag. "While we believe the P-BCMA-101 autologous program has competitive advantages and would be approvable, one long-term strategic benefit of that program has been to inform our highly-differentiated allogeneic approach. With the P-BCMA-ALLO1 clinical program now underway and with very high confidence in our allogeneic platform, we will begin a planned wind down of P-BCMA-101."

Program Updates

BCMA Program
P-BCMA-ALLO1, the Company’s first fully allogeneic CAR-T product candidate, is in development for the treatment of relapsed/refractory multiple myeloma. In August of 2021, the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for P-BCMA-ALLO1. The IND clearance and the start-up of the Phase 1 clinical trial mark the beginning of the Company’s strategic shift toward focusing on P-BCMA-ALLO1 rather than the autologous P-BCMA-101 program.

While data in the autologous trial showed meaningful responses and a favorable safety profile, the Company’s strategic focus has long been on allogeneic CAR-T therapies, leveraging the learnings of the autologous CAR-T program to provide benefits beyond those of autologous CAR-T, including a more desirable off-the-shelf product profile for future commercialization while maintaining the tolerability advantage of our autologous product candidate. P-BCMA-ALLO1 has the potential to deliver up to hundreds of doses per manufacturing run, thereby dramatically reducing both clinical trial costs and ultimately commercial product cost compared to the autologous P-BCMA-101 program.

PSMA Program
P-PSMA-101 is a solid tumor autologous CAR-T product candidate being developed to treat patients with metastatic castrate-resistant prostate cancer (mCRPC) currently in an ongoing Phase 1 dose escalation trial.

In August of 2021, the Company presented preliminary data at the 6th Annual CAR-TCR Summit virtual meeting that demonstrated meaningful patient responses while maintaining a favorable safety and tolerability profile with modest overall rates of CRS and no neurotoxicity observed at low doses. An additional update on the P-PSMA-101 program is expected in the first half of 2022.

MUC1-C Program
P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate in preclinical development with the potential to treat a wide range of solid tumors, including breast and ovarian cancers. P-MUC1C-ALLO1 is proceeding, with an anticipated IND filing and initiation of a Phase 1 clinical trial by the end of 2021.

Liver-Directed Gene Therapy Program
P-OTC-101 is the Company’s first liver-directed gene therapy program for the in vivo treatment of urea cycle disease caused by congenital mutations in the ornithine transcarbamylase (OTC) gene, a condition characterized by high unmet medical need. The Company is currently evaluating whether to modify the P-OTC-101 program to move to the fully non-viral nanoparticle delivery system. The Company will update expected timing on program advancement once that evaluation is complete.

Other Operational Updates and Upcoming Events

Gene Therapy Research Collaboration with Takeda
In October of 2021, the Company entered into a collaboration and license agreement with Takeda Pharmaceuticals USA, Inc. to utilize Poseida’s proprietary genetic engineering platforms for the research and development of up to eight gene therapies.

The collaboration will focus on developing non-viral in vivo gene therapy programs, including Poseida’s Hemophilia A program. The Company will receive an upfront payment of $45.0 million, of which $5.0 million is for prepaid research. Per the agreement, Takeda will fund all ongoing partnered program research performed by Poseida. The collaboration may utilize all of Poseida’s novel genetic engineering platform technologies, including the piggyBac DNA Modification System for gene addition, the Cas-CLOVER Site-specific Gene Editing System for ultra-precise gene editing, biodegradable nanoparticle technologies for gene delivery and other emerging technologies. Poseida will lead research activities up to candidate selection, after which Takeda will assume responsibility for further development and commercialization.

GMP Facility
In the third quarter, the Company completed qualification and commenced GMP activity in its internal pilot manufacturing plant. The pilot plant is designed to support and speed the development of allogeneic product candidates including manufacturing clinical material for early-stage trials. The first product candidate to be produced out of the pilot plant will be P-MUC1C-ALLO1.

Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting
The Company will give two virtual poster presentations at the upcoming SITC (Free SITC Whitepaper) Annual Meeting, being held in Washington, D.C., and virtually November 10-14, 2021. The full abstracts were made available on the SITC (Free SITC Whitepaper) website earlier today, with presentations taking place on November 12, 2021.

63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition
The Company will present data from the Company’s differentiated P-BCMA-101 autologous CAR-T program including how it has informed the P-BCMA-ALLO1 allogeneic CAR-T program in a poster publication at the ASH (Free ASH Whitepaper) Annual Meeting on Monday, December 13, 2021:

Session Name: 704. Cellular Immunotherapies: Clinical: Poster III
Presentation Time: 6:00 PM – 8:00 PM Eastern time
Location: Georgia World Congress Center, Hall B5

Financial Results for the Third Quarter 2021

Research and Development Expenses
Research and development expenses were $32.5 million for the third quarter ended September 30, 2021, compared to $27.0 million for the same period in 2020. For the nine months ended September 30, 2021, research and development expenses were $97.6 million, compared to $75.6 million for the same period in 2020. The increase was primarily due to increased stock-based compensation expense, headcount, external costs related to our preclinical programs and clinical stage programs, including the ongoing enrollment and manufacturing associated with our P-BCMA-101, P-BCMA-ALLO1 and P-PSMA-101 clinical trials, and internal costs related to facilities development.

General and Administrative Expenses
General and administrative expenses were $9.1 million for the third quarter ended September 30, 2021, compared to $6.5 million for the same period in 2020. General and administrative expenses were $26.3 million for the nine months ended September 30, 2021, compared to $15.6 million for the same period in 2020. The increase was primarily due to increased stock-based compensation expense, headcount, insurance costs and professional fees.

Net Loss
Net loss was $42.4 million and $126.4 million for the three and nine months ended September 30, 2021, respectively, and $34.4 million and $93.6 million for the three and nine months ended September 30, 2020, respectively.

Cash Position
As of September 30, 2021, our cash and cash equivalents balance was $197.8 million.