On May 12, 2022 Coherus Biosciences of Redwood City, CA, reported that returned the US rights to market an Innovent Avastin biosimilar to Innovent (Press release, Coherus Biosciences, MAY 12, 2022, View Source [SID1234614512]). Coherus announced the move in its Q1 earnings call with analysts, blaming the COVID-19 epidemic for slowing its development of the biosimilar. Coherus has signed several big deals to market China-developed drugs in North America, a major part of its business plan. However, during the first three months of 2022, it also dissolved a partnership with Junshi Biosciences for an Eylea (aflibercept) biosimilar.

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On May 12, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with cancer, reported its financial results for the quarter ended March 31, 2022 (Press release, Panbela Therapeutics, MAY 12, 2022, View Source [SID1234614511]). Management is hosting an earnings call today at 4:30 p.m. ET.

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The first quarter was marked by meaningful progress.

Q1 and Recent Highlights:

• Agreed to acquire Cancer Prevention Pharmaceuticals, Inc. (CPP). The combined entity would target an estimated $5 billion aggregated market opportunity upon closing.

• Hosted a virtual R&D Day on the company’s investigational drug, SBP-101, as a polyamine metabolism modulator in ovarian cancer.

• Poster presentation highlighting the results for SBP-101 as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April 2022. The work reflects the company’s ongoing collaboration with Johns Hopkins University School of Medicine.

• Initiated our ASPIRE trial-a global, randomized, double-blind, placebo controlled clinical trial of SBP-101 in combination with Gemcitabine and Nab-Paclitaxel versus Gemcitabine, Nab-paclitaxel and placebo in patients with untreated metastatic pancreatic ductal adenocarcinoma.

• Announced a new development program in ovarian cancer expected to start in the first half 2022 as the result of positive preclinical data supporting the activity of SBP-101 in ovarian cancer cell lines.

• Poster presentation of abstract for SBP-101 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January 2022.

• Median overall survival of 12.53 months for the phase 1 first line metastatic pancreatic trial was reached shortly after the January poster presentation.

"Q1 and year to date have represented a transformational time of value creation for Panbela. During the quarter, we signed a definitive agreement to acquire CPP, presented ovarian cancer data at AACR (Free AACR Whitepaper) and initiated our global randomized trial in pancreatic cancer," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "Through the pending acquisition and organic execution, Panbela is better positioned to be able to treat more patients, and drive shareholder value

Milestones:

We announced:

• The ASCO (Free ASCO Whitepaper) GI poster presentation in January, and

• The research day to review the ovarian cancer data and ovarian cancer treatment standards. Additionally in the first half, we anticipate:

• First patient enrolled in our ASPIRE trial as well as expansion outside the US.

• Satisfaction of conditions and closing of the CPP acquisition.

• Final data from our Phase I untreated metastatic pancreatic cancer study.

• Initiation of the ovarian cancer clinical program for SBP-101 mid-year.

In addition, during the second half of 2022, we expect to announce the opening of a neoadjuvant pancreatic cancer investigator initiated trial. Subject to closing the CPP transaction, we anticipate announcing additional milestones for 2022 that will reflect the increased flow of planned development activity and data.

First Quarter ended March 31, 2022 Financial Results

General and administrative expenses were $1.8 million in the first quarter of 2022, compared to $1.1 million in the first quarter of 2021. The change is due primarily to expenses, including legal and financial advisory fees, associated with the acquisition of CPP. Research and development expenses were $2.2 million in the first quarter of 2022, compared to $1.1 million in the first quarter of 2021. The change is due primarily to an increase in spending on our clinical studies as we launched the global ASPIRE clinical trial. Net loss in the first quarter of 2022 was $3.7 million, or $0.27 per diluted share, compared to a net loss of $2.3 million, or $0.23 per diluted share, in the first quarter of 2021.

Total cash was $7.4 million as of March 31, 2022. Total current assets were $7.9 million and current liabilities were $4.5 million as of the same date. Also at March 31, 2022, total noncurrent assets, consisting of cash deposits held by our contract research organization, were $3.2 million. The company had no debt as of March 31, 2022. Conference Call Information To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

About: SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma, ovarian cancer and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 12.53 months, which is now final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source

On May 12, 2022 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its DeltEx platform, reported financial results and operational highlights for the quarter ended March 31, 2022 (Press release, In8bio, MAY 12, 2022, View Source [SID1234614483]). In addition, the Company provided an overview of recent corporate developments.

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"Our team continues to execute and advance our programs on multiple fronts despite these challenging times in biotech," said William Ho, CEO and co-founder of IN8bio. "Our Phase I clinical trials for both DeltEx gamma-delta product candidates, INB-200 in GBM and INB-100 in leukemia patients, continue to progress with encouraging early data. We added key clinical and regulatory expertise to our senior management team and we will be introducing our iPSC derived gamma-delta T cell platform at ASGCT (Free ASGCT Whitepaper) next week. The IN8bio team will continue to be disciplined with our capital and we will use our resources to continue to accelerate the growth and momentum in our Company."

Business Highlights & Updates

In January 2022, IN8bio provided a clinical update from the Phase 1 clinical trial of its genetically modified gamma-delta T cell therapy candidate, INB-200, in newly diagnosed GBM. In the single ascending dose cohort 1 (n=3), all three
patients showed no dose limiting toxicities (DLTs), no cytokine release syndrome (CRS) or neurotoxicity and demonstrated a manageable safety profile. Cohort 2, which will receive three repeat doses of INB-200, includes one patient who has already received all three doses without any DLTs or significant cell therapy related adverse events. All of the patients treated have exceeded their expected progression-free survival (PFS) interval based on age and MGMT status and exceeded median expected PFS of up to seven months with encouraging trends in overall survival.

IN8bio presented a clinical update from the ongoing Phase 1 clinical trial of INB-100, an allogeneic gamma-delta T cell therapeutic candidate in leukemia patients undergoing hematopoietic stem cell transplantation. All three patients treated remain in morphologic CR with durable remissions ranging from nine to 23 months through March 2022. We observed robust immune reconstitution in the patients including T cells, B cells and gamma-delta T cells. INB-100’s safety profile continues to be manageable with no DLTs, no grade 3 or greater graft vs. host disease (GvHD), no CRS and no neurotoxicity. The data were presented at the EBMT 48th Annual Meeting. These are encouraging results given up to 51% are expected to relapse within a year with standard of care treatment.

In April 2022, IN8bio announced the continued expansion of its clinical and regulatory teams with the appointments of Urvashi Patel, Ph.D., Vice President, Regulatory Affairs, and Stacey Bilinski, Vice President, Clinical Operations. They bring deep clinical and regulatory experience to the IN8bio team, from early to late-stage development across the biotechnology and pharmaceutical industry with more than 45 years of combined experience. Dr. Patel has provided regulatory guidance to biopharmaceutical companies, including WindMIL Therapeutics, Precision for Medicine, Janssen, Elan Pharmaceuticals and Genentech. Ms. Bilinski has initiated numerous first in-human and early-phase clinical development programs at biopharmaceutical companies, including Taiho Oncology, Onconova, Insmed, Amicus Therapeutics and Covance.

Upcoming Milestones and Events

In May 2022, IN8bio unveiled a new preclinical program focused on developing iPSC derived gamma-delta T cells to be presented at the ASGCT (Free ASGCT Whitepaper) Annual Meeting, which will be held from May 16-19, 2022. Scalable iPSC-based cellular manufacturing is designed to create for a uniform and renewable therapeutic product available "off-the-shelf" for patients. IN8bio will be holding an investor event via webcast at the conference to introduce the program to the investment community on May 17, 2022, at 6:00 p.m. EDT. A link to the webcast will be available on the Events & Presentations page of the Company’s website.

IN8bio plans to submit an investigational new drug (IND) application for a Phase 1b/2 clinical trial of INB-400 in GBM during the second half of 2022.

Expected Upcoming Presentations

ASGCT 25th Annual Meeting, Washington, D.C., May 2022: introducing a new program on "The Development of Off-the-Shelf" Manufacturing Strategies for iPSC-Based Gamma-Delta T Cells" along with an oral presentation by Dr. Lamb, "Off the Shelf Cell Therapies – Beyond T Cells (Education Session) and The Next Generation of γδ T Cell-based Therapies" by Dr. Lamb.

Advanced Therapies Congress Live, London, May 2022: presenting "New Directions in the Treatment of Solid Tumors with gdT Cells" by Dr. Lamb.

Cambridge Healthcare Immuno-Oncology Therapeutic Development,
London, May 2022: presenting "Genetically Modified gamma delta T cells in
combination with chemotherapy: now in the clinic" by Dr. Lamb

Cell Engager summit, Boston, May 2022: presenting "Gamma-Delta T-cells: Novel approaches to genetic engineering and cell-type specific therapeutic applications" by Dr. Rochlin.

H.C. Wainwright Global Investment Conference, May 2022: Mr. Ho will participate in a fireside chat on May 25, 2022, at 2 p.m. EDT.

American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper), June 2022: presenting "Phase 1 study of drug-resistant immunotherapy (DRI) with gene-modified autologous γδ T cells in patients with newly diagnosed glioblastoma multiforme (GBM) receiving maintenance temozolomide (TMZ)" by Louis B. Nabors, M.D.

Jefferies Healthcare Conference, June 2022: Mr. Ho will present at 1:30 p.m. EDT on Wednesday, June 8, 2022.

First Quarter 2022 Financial Highlights

Cash position: As of March 31, 2022, the Company had cash of $32.1 million, compared to $37.0 million as of December 31, 2021. The decrease in cash was primarily due to cash used by the Company in research and development and continued operations to advance its programs.

Research and Development (R&D) expenses: R&D expenses were $2.4 million for the three months ended March 31, 2022, compared to $1.2 million for the comparable prior year period. The increase in R&D expenses were primarily due to (i) increased third-party clinical trial and IND-related activities, (ii) contract manufacturing costs for the ongoing INB-200 clinical trial and (iii) increased personnel-related costs, including salaries, benefits and stock-based compensation due to increased headcount.

General and administrative expenses: General and administrative expenses were $3.8 million for the three months ended March 31, 2022, compared to $1.1 million for the comparable prior year period. The increase was primarily
due to increased legal expenses, insurance costs and expenses associated with operating as a public company.

Net loss: The Company reported a net loss attributable to common stockholders of $6.1 million, or $0.33 per basic and diluted common share, for the three months ended March 31, 2022, compared to a net loss attributable to common stockholders of $3.1 million, or $0.82 per basic and diluted common share, for the comparable prior year period.

On May 12, 2022 Xilio Therapeutics, Inc. (Nasdaq: XLO), a biotechnology company developing tumor-selective immuno-oncology therapies for people living with cancer, reported pipeline and business highlights and reported financial results for the first quarter ended March 31, 2022 (Press release, Xilio Therapeutics, MAY 12, 2022, View Source [SID1234614482]).

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"Leveraging our geographically precise solutions (GPS) platform, we are developing a pipeline of tumor-selective immunotherapies that have the potential to achieve meaningful anti-tumor activity while minimizing serious, systemic effects," said René Russo, Pharm.D., president and chief executive officer of Xilio. "We continue to progress enrollment in our Phase 1 clinical programs, XTX101 and XTX202, with planned preliminary data readouts later this year, and we remain on track with our plans to submit an IND application for XTX301 in the second half of 2022. With our strong financial position and an outstanding team in place, we believe we are well-positioned to advance our pipeline of tumor-selective immuno-oncology programs with the goal of transforming the lives of people living with cancer."

Pipeline and Business Progress

Cytokine Programs

Enrollment is ongoing in the Phase 1 clinical trial evaluating XTX202 for the treatment of patients with solid tumors, with preliminary data anticipated to be reported in the second half of 2022. XTX202 is a tumor-selective interleukin-2 (IL-2) designed to localize activity in the tumor microenvironment, with the goal of overcoming the known tolerability challenges of existing IL-2 therapies while achieving enhanced anti-tumor activity as monotherapy and in combination with standard of care agents.
Preclinical data from the XTX301 program was presented at the New York Academy of Sciences Frontiers in Cancer Immunotherapy 2022 conference on May 10, 2022. XTX301 demonstrated tumor-selective activation in patient-derived tumor explants, and a murine surrogate of XTX301 (mXTX301) induced significant tumor growth inhibition in a mouse model and improved tolerability compared to a non-tumor-selective version of mXTX301. View the poster online here.
Xilio continues to anticipate submitting an investigational new drug application (IND) for XTX301, a tumor-selective interleukin-12 (IL-12), in the second half of 2022 for evaluation in patients with solid tumors.

Upcoming Presentations

A trials-in-progress poster outlining details of the ongoing Phase 1/2 clinical trial for XTX202 will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting:

Presentation title: A first-in-human, multicenter, phase 1/2, open-label study of XTX202, a masked and tumor-selective recombinant human interleukin-2 (IL-2) protein, in patients with advanced solid tumors
Session date and time: Sunday, June 5, 2022, 8:00-11:00 AM CDT
Abstract number: TPS2697
Checkpoint Inhibitor Program

Enrollment is ongoing in the Phase 1 clinical trial evaluating XTX101, a tumor-selective anti-CTLA-4 monoclonal antibody, as a monotherapy and in combination with pembrolizumab, an anti-PD-1, for the treatment of patients with advanced solid tumors.
Preliminary data for the Phase 1 clinical trial for XTX101 is anticipated to be reported from the monotherapy cohort in the middle of 2022 and from the combination cohort in the second half of 2022.
First Quarter 2022 Financial Results

Cash Position: Cash and cash equivalents were $177.0 million as of March 31, 2022, as compared to $198.1 million as of December 31, 2021. The decrease was primarily driven by cash used in operations for the three months ended March 31, 2022.
Research & Development (R&D) Expenses: R&D expenses were $14.9 million for the first quarter of 2022, compared to $11.6 million for the first quarter of 2021. The increase was primarily driven by increased costs associated with XTX301 and other preclinical programs, as well as higher personnel-related costs due to increased headcount.
General & Administrative (G&A) Expenses: G&A expenses were $6.3 million for the first quarter of 2022, compared to $4.9 million for the first quarter of 2021. The increase was primarily driven by higher personnel-related costs due to increased headcount and other costs related to operating as a publicly traded company.
Net Loss: Net loss was $21.4 million for the first quarter of 2022, compared to $16.7 million for the first quarter of 2021.
Financial Guidance

As a result of prioritization within the company’s preclinical portfolio, Xilio now anticipates that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the first half of 2024.

On May 12, 2022 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported financial results for the first quarter ended March 31, 2022 (Press release, Crinetics Pharmaceuticals, MAY 12, 2022, View Source [SID1234614481]).

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"We continue to build the foundation needed to establish Crinetics as the world’s leading endocrine company, as recent progress has strengthened our clinical dataset, balance sheet and leadership team," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "This is highlighted by CRN04777’s recent Phase 1 top-line results, which further demonstrated the molecule’s dose-dependent effects on biomarkers that are critically important to the pathophysiology and medical management of hyperinsulinism. Later this quarter, we expect to report data from a healthy volunteer study designed to evaluate CRN04894’s potential to counteract the effects of excess ACTH with a novel mechanism of action. The pharmacologic proof-of-concept these Phase 1 studies aim to achieve highlights the unique efficiency of our endocrine drug development paradigm. Looking forward, we will continue to combine the advantages of this paradigm with the efforts of our deeply talented drug discovery team to thoughtfully expand our pipeline as we work to advance our current clinical-stage candidates towards registration."

First Quarter 2022 and Recent Highlights

Reported positive top-line results from multiple-ascending dose (MAD) cohorts of the CRN04777 Phase 1 study. In March 2022, Crinetics announced positive data from the MAD cohorts of a Phase 1 study of CRN04777, a somatostatin receptor type 5 (SST5) agonist being developed as a treatment for congenital and syndromic hyperinsulinisms. The results built upon previously reported pharmacologic proof-of-concept data from the trial’s single-ascending dose (SAD) cohorts, as they showed strong dose-dependent suppression of fasting insulin as well as dose-dependent suppression of sulfonylurea-induced insulin secretion. Pharmacokinetic data indicated CRN04777 was orally bioavailable and supported a once daily dosing schedule. CRN04777 was shown to be well tolerated in the Phase 1 trial, with no dose discontinuations due to adverse events. Crinetics plans to initiate a Phase 2 study of CRN04777 in congenital hyperinsulinism patients in the second half of 2022, following discussions with global regulators.

Entered into strategic licensing agreement with Sanwa Kagaku Kenkyusho Co., Ltd. ("Sanwa") for the development and commercialization of paltusotine in Japan. Crinetics received $13 million upfront in connection with the license agreement and is also eligible to receive payments related to development, regulatory, and commercial milestones. In addition, Crinetics will be eligible to receive tiered royalties on net product sales in Japan should paltusotine receive marketing approval in Japan. In exchange, Sanwa was granted an exclusive right to develop and commercialize paltusotine in Japan and will assume all costs associated with clinical trials and regulatory applications in the territory. Crinetics retains all rights to develop and commercialize paltusotine outside of Japan.

Strengthened balance sheet with successful $125 million common stock offering. In April 2022, Crinetics completed an underwritten follow-on offering of 5,625,563 shares of its common stock at a price to the public of $22.22 per share, raising gross proceeds of approximately $125.0 million.

Strengthened company leadership with appointments to management team and Board of Directors. In the first quarter of 2022, Crinetics built upon its strong leadership and scientific expertise by appointing James Hassard to the role of chief commercial officer, Chris Robillard to the role of chief business officer, and Dr. Rogério Vivaldi Coelho and Caren Deardorf to the Board of Directors.
First Quarter 2022 Financial Results

Research and development expenses were $28.3 million for the three months ended March 31, 2022, compared to $17.6 million for the same period in 2021. The increase was primarily attributable to increased spending on manufacturing and development activities of $7.0 million associated with our clinical and nonclinical activities for paltusotine and our other clinical and preclinical programs, and an increase in personnel costs of $3.0 million, of which stock-based compensation was $1.4 million.

General and administrative expenses were $8.7 million for the three months ended March 31, 2022, compared to $5.3 million for the same period in 2021. The increase was primarily attributable to an increase in personnel costs of $2.1 million, of which stock compensation was $1.0 million.

Net loss for the three months ended March 31, 2022, was $34.6 million, compared to a net loss of $22.9 million for the same period in 2021.

Revenues were $3.1 million for the three months ended March 31, 2022, consisting of license revenue recognized from the Sanwa license agreement.

Unrestricted cash, cash equivalents and investments totaled $319.7 million as of March 31, 2022, compared to $333.7 million as of December 31, 2021. The $319.7 million in unrestricted cash, cash equivalents and investments does not include the $125.0 million in gross proceeds from the company’s April 2022 common stock offering. Based on its current plans, the company expects that current cash, cash equivalents and short-term investments will fund its current operating plan into the second half of 2024.

The company had 53,505,809 common shares outstanding as of May 9, 2022.