On March 18, 2021 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported financial results for the fourth quarter of 2020 (Press release, Molecular Templates, MAR 18, 2021, View Source [SID1234576901]).

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"In 2020 and early 2021, we made important progress by advancing our pipeline programs, establishing a new collaboration with a premier oncology partner, and strengthening our balance sheet with a successful equity financing," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Scientific Officer. "We now have four clinical stage programs: MT-5111 targeting HER2, TAK-169 targeting CD38 in co-development with Takeda, MT-6402 with antigen seeding targeting PD-L1, and MT-3724, for which we are working to resolve the FDA partial clinical hold. We expect to generate clinical data from multiple programs and advance our earlier stage programs in 2021, including filing an IND for an ETB targeting CTLA-4, preclinical data presentations on ETBs against new targets, and continued progress in our collaborations with Bristol Myers Squibb, Vertex, and Takeda."

Company Highlights and Upcoming Milestones

Corporate

On February 11, 2021, MTEM and Bristol Myers Squibb announced a strategic research collaboration to discover and develop multiple novel therapies designed for specific oncology targets. Under the collaboration, MTEM will conduct research activities for the discovery of next generation ETBs for multiple targets, of which the first target has been selected by Bristol Myers Squibb. Bristol Myers Squibb made an up-front payment of $70 million to MTEM and MTEM is also eligible to receive near-term and development, regulatory and sales milestone payments of up to approximately $1.3 billion as well as tiered royalty payments on future sales.
On February 18, 2021, MTEM announced the pricing of an underwritten public equity offering, the gross proceeds of which were approximately $75.9 million.
MTEM has had three abstracts accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, taking place virtually from April 10-15, 2021:
MT-5111 (interim Phase 1 data as of December 2020), abstract CT130, titled "Phase 1 study of the novel immunotoxin MT-5111 in patients with HER-2+tumors."
MT-6402 (preclinical data), abstract 1628, titled "Engineered toxin bodies targeting PD-L1 to alter tumor immunophenotypes and deliver broad antigenic diversity and patient coverage."
CTLA-4 ETB (preclinical data), abstract 1627, titled "Preclinical characterization of a novel CTLA-4-targeted ETB for direct Treg depletion."
MT-5111 (HER2 ETB)

The Phase 1 study of MT-5111 in HER2-positive cancers is ongoing with multiple sites open for enrollment.
In December 2020, MTEM provided an update on the ongoing Phase 1 study. No dose limiting toxicities were observed in any cohort and no signs of cardiotoxicity have been observed to date, while monitoring the subjects’ EKGs, troponin values and pro-BNP with each treatment, and serial echocardiograms with every other cycle. No cases of capillary leak syndrome, or CLS, (any grade) were observed.
The HER2-positive breast cancer expansion cohort is planned to begin in 1H21 at a dose of 10 mcg/kg (anticipated to be a therapeutic dose level), pending adequate safety data. Dose escalation will continue to determine the recommended Phase 2 dose while the breast cancer expansion cohort collects efficacy and safety data.
MTEM expects to present interim clinical results from the dose escalation portion of the MT-5111 Phase 1 study as of December 2020, at the AACR (Free AACR Whitepaper) Annual Meeting April 10-15, 2021. MTEM expects to provide an update on additional data from both the dose escalation portion of the study and the metastatic breast cancer dose expansion cohort in 4Q21.
TAK-169 (CD38 ETB)

Takeda and MTEM are currently conducting a Phase 1 study for TAK-169 in relapsed/refractory multiple myeloma. This study, which started dosing in February 2020, had a temporary pause in the activation of new study sites and new patient enrollment (along with most of Takeda’s other early-stage studies) due to COVID-19 and was re-initiated in 4Q20.
In December 2020, preclinical TAK-169 data were presented at the 62nd ASH (Free ASH Whitepaper) Annual Meeting and Exposition.
MT-6402 (PD-L1 ETB with antigen seeding)

On January 19, 2021, MTEM announced that the U.S. Food and Drug Administration (FDA) accepted its Investigational New Drug (IND) application for MT-6402.
MTEM expects to start dosing in a first-in-human Phase 1 study in relapsed/refractory patients with PD-L1-positive solid tumors in 2Q21. The Phase 1 study is planned as a multi-center, open-label, dose escalation and dose expansion trial. Patients with confirmed PD-L1 expressing tumors or confirmed PD-L1 expression in the tumor microenvironment will be eligible to screen for enrollment in the clinical trial. Following determination of the maximum tolerated dose (MTD) or recommended Phase 2 dose, expansion cohorts are planned to study MT-6402 as a monotherapy in tumor-specific and tumor-agnostic cohorts.
MT-3724 (CD20 ETB)

Since November 4, 2020, all MT-3724 clinical studies have been on partial clinical hold as ordered by the FDA following a treatment-related fatality in one subject who experienced Grade 5 CLS in the Phase 2 MT-3724 monotherapy study. As part of the overall investigation into the partial clinical hold on MT-3724, MTEM investigated MT-3724 product quality attributes. Based on the findings, MTEM submitted a partial clinical hold response to the FDA in February 2021 in which it proposed to implement new drug product manufacturing and release specifications.
MTEM is working to address the partial clinical hold and MT-3724 product lot information requests from the FDA.
In tandem, MTEM is actively evaluating the role of MT-3724 and CD20 as a target in MTEM’s portfolio relative to other opportunities.
Research

MTEM expects to file an IND application for an ETB targeting CTLA-4 in 4Q21.
Several other ETB candidates are in preclinical development against targets including SLAMF-7 and CD45.
In 2021, MTEM expects to present preclinical data on new targets and new ETBs at medical and scientific conferences.
Financial Results

The net loss attributable to common shareholders for the fourth quarter of 2020 was $28.4 million, or $0.57 per basic and diluted share. This compares with a net loss attributable to common shareholders of $15.9 million, or $0.41 per basic and diluted share, for the same period in 2019.

Revenues for the fourth quarter of 2020 were $3.5 million, compared to $6.2 million for the same period in 2019. Revenues for the fourth quarter of 2020 were comprised of revenues from collaborative research and development agreements with Takeda and Vertex. Total research and development expenses for the fourth quarter of 2020 were $22.3 million, compared with $16.6 million for the same period in 2019. Total general and administrative expenses for the fourth quarter of 2020 were $7.1 million, compared with $6.0 million for the same period in 2019.

As of December 31, 2020, MTEM’s cash and investments totaled $93.9 million. With the addition of the $70 million upfront payment from Bristol Myers Squibb received in 1Q21 and the proceeds of the public equity offering completed in February 2021, MTEM’s current cash and investments are expected to fund operations into the second half of 2023.

On March 18, 2021 PerkinElmer, Inc., a global leader committed to innovating for a healthier world, reported its ONE Pesticide420 CRM Reagent and Consumable Kit for cannabis & hemp testing (Press release, PerkinElmer, MAR 18, 2021, View Source [SID1234576893]). Initially the kits will support pesticide and mycotoxin testing for cannabis & hemp laboratories following the California, Oregon or equivalent regulations.

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The new kits include certified calibration curves and internal standards, allowing the customer to focus on testing rather than development of complex preparation procedures for quantitative pesticide and mycotoxin testing. In addition, the kits create a simpler workflow path by providing a second batch of built-in, internal standards to help achieve regulatory compliance faster and easier and to streamline a lab’s supplier mix.

Instead of sourcing and storing a multitude of reagents and consumables from multiple vendors, as well as measuring and diluting multiple stock standards and calibrators, labs using the ONE Pesticide420 Kit can choose from 77 pesticide and five mycotoxin certified calibration levels and pre-formatted internal standards that are ready-to-use without any modification. In addition, the certified calibrations provide labs further quality assurance because each calibration level is ISO 17034 certified, reducing the risk of experimental error.

"Currently, labs have to source pesticide testing reagents from multiple companies to cover their workflow needs and go through the time to build their own formulas while simultaneously facing immense pressure to reduce the time-to-result at increasingly lower costs," said Greg Sears, VP and GM of Food & Organic Mass Spectrometry at PerkinElmer. "Our new ONE Pesticide420 Kit is designed to help labs focus on their testing requirements and not on peripheral lab protocols so that they can achieve their operational and regulatory requirements."

The new reagent kits are part of a comprehensive PerkinElmer cannabis testing portfolio spanning across safety and quality instruments and lab automation as well as software and services. To learn more please visit View Source

On March 18, 2021 Amplia Therapeutics (ATX) reported that it has signed a term sheet for a collaboration agreement with the Garvan Institute of Media Research in Sydney (Press release, Amplia Therapeutics, MAR 18, 2021, View Source;[email protected] [SID1234576887]).

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The term sheet maps out a collaborative research and clinical development program, focused on the use of Amplia’s FAK inhibitor, AMP945, to treat patients with pancreatic cancer.

The collaboration will initially look at new treatment regiments and patient selection strategies for Amplia’s clinical trials of AMP945 in pancreatic cancer patients later this year.

The collaboration will combine the Garvan Institute’s research strength in FAK biology and its extensive clinical research network with Amplia’s proprietary FAK inhibitors and drug development capability.

"The purpose of this collaboration is to optimise our planned clinical program for AMP945," said Amplia’s CEO and Managing Director, Dr John Lambert.

"Clearly, Garvan’s team has an unsurpassed understanding of FAK biology and access to an extensive clinical network. By leveraging Garvan’s deep understanding of the different biological roles that FAK can play, we aim to optimise the design of our planned clinical trials, recruit the right pancreatic cancer patients and treat them in the right way, giving AMP945 the best chance for success."

Professor Paul Timpson, Cancer Research Theme Leader at Garvan will be the lead scientist in the collaborative research program, after collaborating with Amplia for over a year.

The terms of the agreement are confidential but include future payments by Amplia to Garvan based on AMP945 achieving specified clinical, regulatory and commercial sales milestones.

The final Collaboration Agreement is expected to be signed within 90 days. While the terms of the agreement are confidential, they do include future, success-based payments by Amplia to Garvan on AMP945 achieving specified clinical, regulatory and commercial sales milestones.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics

On March 18, 2021 Aktis Oncology, a biotechnology company discovering and developing a novel class of targeted radiopharmaceuticals to treat a broad range of solid tumor cancers, reported completion of a $72 million Series A financing (Press release, Aktis Oncology, MAR 18, 2021, View Source [SID1234576886]). The company was founded and incubated by MPM Capital, which co-led the financing with EcoR1 Capital and Vida Ventures, with participation from Octagon Capital, TCG Crossover, Novartis and Bristol Myers Squibb.

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"Aktis Oncology is building on recent successes in the radiopharmaceutical field, using a novel approach to extend the efficacy of targeted radiopharmaceuticals into a wide range of solid tumors," said Todd Foley, Chairman of Aktis Oncology, and Managing Director of MPM Capital. "We’re incredibly excited by the science, the team and a world class syndicate of institutional and strategic investors that share in our vision to realize the potential of targeted radiotherapy to become a mainstream anti-cancer modality."

Aktis Oncology is developing novel alpha radiotherapies to improve upon the efficacy of conventional solid tumor therapies, while limiting toxicity. The company has developed proprietary platforms to discover best-in-class tumor targeting agents designed with optimal pharmacology for delivering alpha radiotherapy. Aktis Oncology targeting agents are highly tumor penetrant but clear from other areas of the body quickly, to maximize tumor elimination while minimizing potential side effects of treatment.

"Alpha radiotherapy is the future of radiopharmaceuticals," said Matthew Roden, PhD, President and Chief Executive Officer of Aktis Oncology. "By harnessing the power of alpha particles – with nearly 1000 times the potency of beta particles – we believe our approach has the potential to deliver game-changing results for patients."

Aktis Oncology’s theranostic approach would also enable clinicians to visualize and verify target engagement prior to exposure to therapeutic radioisotopes, allowing for better selection of patients most likely to benefit from therapy. The company plans to produce multiple development candidates with potential for efficacy against well-validated cancer targets.

Aktis Oncology was founded by Brian Goodman, PhD, Patrick Baeuerle, PhD, and Todd Foley, of MPM Capital. The company is led by:

Matthew Roden, PhD, President and Chief Executive Officer of Aktis Oncology. He is an Executive Partner of MPM Capital, and serves as Chairman of Turmeric Acquisition Corporation, and is a member of the boards of iTeos Therapeutics and NextPoint Therapeutics. Prior to joining MPM, Dr. Roden held senior leadership positions in the biopharma industry, most recently as Senior Vice President and Head of Enterprise Strategy at Bristol Myers Squibb; he held senior roles in the capital markets, including serving as head of biotechnology equity research at UBS and as a senior biotechnology equity analyst at J.P. Morgan; and has scientific training in immunology, structural biology, and cancer biology.
Paul Feldman, PhD, Chief Scientific Officer of Aktis Oncology. Prior to joining Aktis Oncology Dr. Feldman was the Head of Discovery and Translational Medicine at Intarcia Therapeutics. An accomplished drug discoverer and executive in the biopharmaceutical industry, he previously served as Senior Vice President at GlaxoSmithKline, leading the Enteroendocrine Discovery Performance Unit and GSK’S enterprise Chemistry Council, before retiring to co-found Phoundry Pharmaceuticals, a peptide hormone therapeutic company.
Brian Goodman, PhD, Head of Operations and Corporate Development of Aktis Oncology. As part of the Investment and Operations Team at MPM Capital, he is responsible for investment identification, due diligence, business development, and new company creation at a number of MPM portfolio companies. He serves as a board observer for Orna Therapeutics and Triplet Therapeutics. Prior to joining MPM Capital, Dr. Goodman co-founded and served as Head of Technology and Innovation at Evelo Biosciences, a company focused on the pharmacology of microbial drugs across multiple therapeutic areas; and was a Senior Associate at Flagship Pioneering.
Aktis Oncology is headquartered in Cambridge, Mass. with laboratory operations in Research Triangle Park, NC.

On March 18, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported its financial results for the year ended December 31, 2020, its recent business highlights, and provided a preview of anticipated selected milestones in 2021 (Press release, Sutro Biopharma, MAR 18, 2021, View Source [SID1234576885]).

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"2020 was a highly productive year for Sutro as we advanced the clinical development of our programs and navigated through the pandemic. Four product candidates that have now entered the clinic, two of which are partnered programs, were discovered and developed using our cell-free protein synthesis platform, showcasing its strength and versatility," said Bill Newell, Sutro’s Chief Executive Officer. "We were particularly encouraged to see meaningful clinical benefit for women with advanced platinum-resistant and refractory ovarian cancer who were part of the Phase 1 dose-escalation study for STRO-002, our FolRα-targeted ADC. We dosed the first patient in dose-expansion in January 2021 and are rapidly moving this program forward. Additionally, we are progressing well on our partnerships – our Bristol Myers Squibb and EMD Serono collaboration programs are enrolling patients in Phase 1 studies and we are continuing to work with Merck on the cytokine derivatives collaboration to bring its first program to the clinic. We look forward to continued progress on our clinical programs and utilizing our industry leading cell-free platform to advance additional product candidates to benefit patients with unmet medical needs."

Recent Business Highlights and Expected 2021 Milestones

STRO-002: Continued progress in Phase 1 trial of STRO-002, folate receptor-alpha (FolRα)-targeted antibody-drug conjugate (ADC) for patients with recurrent platinum resistant or refractory ovarian cancer.

Dose-escalation portion of the Phase 1 trial completed enrollment as of August 31, 2020 and interim data as of October 30, 2020 were presented by key opinion leaders (KOL) and management at the KOL Discussion of STRO-002 Data Event in December 2020.
Additional data from dose-escalation, with extended follow-up on patients remaining on study, is expected in the first half of 2021.
Dose-expansion portion of the Phase 1 trial began enrolling patients in January 2021 and initial dose-expansion data is expected to be reported in the second half of 2021.
Dose-expansion data is expected to inform regulatory interactions, potentially accelerate development of our registration strategy, and enable identification of the broadest population that may benefit from STRO-002.
STRO-001: Phase 1 dose-escalation continues for STRO-001, a CD74-targeted ADC for development in B-cell malignancies.

Dose-escalation in the Phase 1 trial enrolling patients with lymphoma and multiple myeloma is ongoing and the maximum tolerated dose has not yet been reached.
Interim data from the dose-escalation portion of the trial in patients with non-Hodgkin lymphoma and preclinical data from our collaboration with Fred Hutchinson Cancer Research Center were presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2020.
The dose-expansion portion of the Phase 1 trial is expected to begin enrolling patients in the second half of 2021.
Merck collaboration: Working collaboratively with Merck to advance two cytokine derivative programs towards the clinic.

Sutro is continuing to work with Merck to discover new therapeutics for cancer and autoimmune diseases. The collaboration is advancing two cytokine-derivative programs through the research phase.
In March 2020, Merck extended by one year the research term of the collaboration’s first program, which included a $5.0 million payment to Sutro.
In August 2020, Sutro entered into a supply agreement with Merck, giving Sutro responsibility for manufacturing pre-clinical and clinical supply for products emerging from the collaboration.
Bristol Myers Squibb (BMS) collaboration: Phase 1 trial for CC-99712, a BCMA-targeted ADC, is continuing to enroll multiple myeloma patients.

Since initiation of Phase 1 in the second half of 2019, BMS has been enrolling patients in a dose-escalation/expansion trial to assess treatment of relapsed and refractory multiple myeloma, with the last reported dose level at 3.0 mg/kg.
CC-99712 was granted Orphan Drug Designation by the FDA for multiple myeloma.
BMS is responsible for the worldwide clinical development and commercialization of CC–99712. Sutro is responsible for clinical supply manufacturing and certain development services for CC-99712 and is entitled to development and regulatory milestone or contingent payments and tiered royalties on sales ranging from mid to high single digit percentages.
Merck KGaA, EMD Serono (EMD Serono) collaboration: Phase 1 trial for M1231, a first-in-class bispecific ADC targeting MUC1–EGFR for development in solid tumors, was initiated in the first quarter of 2021.

EMD Serono is enrolling patients in the dose-escalation portion of a Phase 1 trial of M1231 for treatment of metastatic solid tumors including non-small cell lung cancer (NSCLC) and esophageal squamous cell carcinoma.
Sutro is responsible for manufacturing early clinical supply of M1231 and is eligible for milestone or contingent payments and tiered royalties.
Vaxcyte relationship: Potential vaccine application demonstrates the power of Sutro’s cell-free technology in conjugated vaccines.

Under a license from Sutro, Vaxcyte has the right to use the XpressCF and XpressCF+ platforms to discover and develop vaccine candidates for the treatment or prophylaxis of infectious diseases.
Vaxcyte is progressing their broader spectrum pneumococcal conjugate vaccine (VAX–24) through preclinical development.
Sutro is eligible to receive four percent (4%) royalties on worldwide net sales of any licensed vaccine candidates. Sutro retains the right to discover and develop vaccines for treatment or prophylaxis of any disease not caused by an infectious pathogen, including cancer.
In June 2020, Vaxcyte completed an initial public offering of its common stock. Sutro owns approximately 1.6 million shares of Vaxcyte common stock as of December 31, 2020.
Key 2020 financings

In May 2020 and December 2020, Sutro closed public offerings of its common stock, with gross proceeds of approximately $98.0 million and approximately $144.9 million, respectively.
Sutro ended 2020 with cash, cash equivalents & marketable securities of $326.5 million, with projected runway into the second half of 2023, based on current business plans and assumptions, and not including the value of its holdings of Vaxcyte common stock.
Full Year 2020 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of December 31, 2020, Sutro had cash, cash equivalents and marketable securities of $326.5 million, as compared to $133.5 million as of December 31, 2019, which represents a net cash increase of $193.0 million during 2020. The cash, cash equivalents and marketable securities balance noted above does not include the value associated with Sutro’s holdings of approximately 1.6 million shares of Vaxcyte common stock. As of December 31, 2020, the fair value of the Vaxcyte common stock held by Sutro was $41.6 million.

Unrealized Gain from Increase in Value of Vaxcyte Common Stock

The non-operating, unrealized gain of $41.5 million in 2020 consisted of $41.6 million due to the increase in the estimated fair value of Sutro’s holdings of approximately 1.6 million shares of Vaxcyte common stock, partially offset by approximately $0.1 million in adjustments related to revaluations of certain Vaxcyte equity items. Vaxcyte common stock held by Sutro will be measured at fair value based on the closing price of Vaxcyte’s common stock on the last trading day of each reporting period, with any non-operating, unrealized gains and losses recorded in Sutro’s statements of operations.

Revenue

Revenue was $42.7 million in each of the year ended December 31, 2020 and the year ended December 31, 2019, related principally to the Merck, BMS, and EMD Serono collaborations. Future collaboration revenue from Merck, BMS, and EMD Serono, and from any future collaboration partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones and other collaboration agreement payments.

Operating Expenses

Total operating expenses for the year ended December 31, 2020 were $113.8 million, as compared to $98.2 million in 2019, including non-cash stock-based compensation of $11.9 million and $10.3 million, and depreciation and amortization expense of $4.3 million and $4.8 million, in 2020 and 2019, respectively. Total operating expenses for 2020 were comprised of research and development expenses of $77.0 million and general and administrative expenses of $36.8 million, which are expected to increase in future periods as Sutro’s internal product candidates advance in clinical development and additional general and administrative expenses are incurred as a public company.